Study mapping structures with relevant mandates, tasks, and functions to HERA within Member States and globally : final report.
Date: 2025-01-24
Institutions: Health Emergency Preparedness and Response Authority
Subjects: EU Member State, Health Emergency Preparedness and Response Authority, crisis management, emergency aid, epidemic, infectious disease, international cooperation, medicinal product, organisation of health care, protective equipment, third country

HERA – Health Emergency Preparedness and Response Authority 

Study mapping structures with relevant 
mandates, tasks, and functions to HERA 
within Member States and globally 

Final Report 

November 15, 2024 

Prepared by Ernest & Young (E&Y) 

Study mapping structures with relevant mandates, tasks, and functions to HERA within Member States and globally 

Final Report 

Manuscript completed in November 2024 
1st  edition 

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Authors 

Names 
Christina Castella 

Marco Laoreti 

Myriam Oukkal 

Marie Savani 

Olivier Borraz 

Laetitia Atlani-Duault 

Entity 

EY France 

EY France 

EY France 

EY France 

SciencesPo 

CEPED Paris Cité 

PDF 
Print 
Html 

ISBN 978-92-9413-010-5 
ISBN 978-92-9413-009-9 

doi:10.2929/3636805 
doi:10.2929/3235548 

LN-01-24-002-EN-N 
LN-01-24-002-EN-C 
LN-01-24-002-EN-Q 

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Study mapping structures with relevant mandates, tasks, and functions to HERA within Member States and globally 

Final Report 

Table of Contents 

1.

Introduction ...................................................................................................................................... 4 

1.1 

1.2 

3.1 

2.

3.

Objectives and scope of the Study ....................................................................................................... 4 

Stages of the study ............................................................................................................................... 4 

Main conclusions ............................................................................................................................... 6 

Overview ........................................................................................................................................ 10 

EU Member States’ approaches to public health emergency preparedness 
and response in the area of MCMs .................................................................................................... 10 

3.1.1 

3.1.2 

3.1.3 

Mapping of entities in EU Member States .................................................................................... 10 

Synthesis ........................................................................................................................................ 12 

Cross-country overview ................................................................................................................. 12 

3.2 

Third Countries’ approaches to public health crisis preparedness and response in MCMs .............. 20 

3.2.1 

3.2.2 

3.2.3 

3.2.4 

3.2.5 

3.2.6 

3.2.7 

3.2.8 

Synthesis ........................................................................................................................................ 22 

Africa ............................................................................................................................................. 24 

Asia ................................................................................................................................................ 33 

Europe ........................................................................................................................................... 43 

North America ............................................................................................................................... 49 

South America ............................................................................................................................... 55 

Oceania.......................................................................................................................................... 60 

Supra-regional organisation .......................................................................................................... 64 

3.3 

Overview of international organisations’ approaches to public health crisis preparedness 
and response in MCMs ...................................................................................................................... 65 

3.3.1 

3.3.2 

3.3.3 

3.3.4 

3.3.5 

3.3.6 

3.3.7 

Monitoring, Intelligence gathering and analysis ........................................................................... 65 

Advanced Research and Development capacities ......................................................................... 66 

Production / Manufacturing capacities ......................................................................................... 67 

Procurement of MCMs .................................................................................................................. 67 

Stockpiling and distribution capacities .......................................................................................... 68 

International cooperation ............................................................................................................. 68 

Health security coordination ......................................................................................................... 68 

4.

5.

5.1 

5.2 

Glossary .......................................................................................................................................... 70 

Appendices ..................................................................................................................................... 71 

Kick-off meeting minutes ................................................................................................................... 71 

Inception Report – Entities identified at this stage ............................................................................ 74 

5.2.1 

5.2.2 

5.2.3 

Preliminary list of identified entities in EU Member States .......................................................... 74 

Preliminary identification of HERA-like organisations at multinational or regional levels ............ 76 

Preliminary identification of HERA-like entities in Third Countries ............................................... 78 

5.3 

Third-countries selection criteria – Table ........................................................................................... 80 

6.

Annex: Descriptive Fiches ................................................................................................................ 83 

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Study mapping structures with relevant mandates, tasks, and functions to HERA within Member States and globally 

Final Report 

1.

Introduction

1.1  Objectives and scope of the Study 

The main aim of the Study is to provide a comprehensive overview and understanding of functions / missions / tasks of 
entities with a scope of activity similar to that of HERA.  In line with HERA's mission and tasks, this study focuses on the role 
of identified entities in preparedness and response to health crises in the area of medical countermeasures. 

Included in the scope of this study are: 

•
•
•

National entities having a similar mission and performing the same tasks as HERA in EU27 Member States, 
National HERA-like entities that could potentially be partners of HERA,
Regional or multinational entities in each continent, separate from national HERA-like structures, having a similar
mission and performing the same tasks as HERA.

The objectives of the study are: 

• The identification of national entities in EU Member States and in non-EU states having similar mission and performing

similar tasks as HERA or entitled to do so.

• The description of the identified entities, including an overview of their key competencies, their organisational structure,

and their position within the wider healthcare and emergency response structure.

• The comparison of the identified entities with HERA’s mission and tasks. 

Focus on Medical Countermeasures 
Consistent  with  the  understanding  of  HERA's  mandate,  the  study  focuses  on  activities  related  to  the  development, 
manufacturing, procurement, and equitable distribution of medical countermeasures. According to the serious cross-border 
2
health threat Regulation
, medical devices and other 
goods or services that are necessary for the purpose of preparedness for and response to serious cross-border threats to 
health.  Examples  are  vaccines,  antibiotics,  medical  equipment,  chemical  antidotes,  therapeutics,  diagnostic  tests,  and 
personal protective equipment (PPE), such as gloves and masks3. 

1
, medical countermeasures include medicinal products for human use

Three geographical scopes of the study 
The study covers three geographical scopes: 

• EU Member States,
• Third Countries,
• Organisations in a regional or international context.

1.2 

Stages of the study 

The study was carried out in three consecutive phases: 

• an inception phase that aims to define the scope of the study and identify key issues, 
• an  interim  phase  of  documentary  research  and  entity  identification,  during  which  relevant  entities  were  selected  for

further analysis, 

• a final phase of entity mapping and analysis.
Each phase of study culminated in the production of a report (Inception report, Interim report, Draft final report, and Final 
report). These reports were subject to review and comment by HERA, and any necessary amendments were made by the 
study team. The communication between the study team and HERA was ensured through regular bi-weekly meetings, on top 
of milestone meetings held following the submission of the three aforementioned reports.   

1 REGULATION (EU) 2022/2371 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 November 2022 on serious cross-border 
threats to health and repealing Decision No 1082/2013/EU
2 As defined in Directive 2001/83/EC of the European Parliament and of the Council  
3
 COM(2021) 576 final : Introducing HERA, the European Health Emergency preparedness and Response  
Authority, the next step towards completing the European Health Union 

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Study mapping structures with relevant mandates, tasks, and functions to HERA within Member States and globally 

Final Report 

Inception Phase 
The Inception Phase commenced following the kick-off meeting between HERA and EY on January 10, 2024. This phase aimed 
to  enhance  the  understanding  of  the  study's  objectives  and  scope,  refine  the  methodological  approach,  and  develop  a 
comprehensive data collection plan. Key activities in this phase included: 

•

•

•

Kick-off Meeting: Held on January 10, 2024, between HERA and EY. Minutes of this meeting are documented in
Annex I. 

Initial documentary review: reviewed documents listed in the technical proposal to identify HERA’s core mission
and tasks and preliminary identify entities in Member States and Third Countries. This review expanded to include
pandemic plans for most Member States and additional documents provided by HERA and during scoping
interviews. 

Scoping interviews: conducted with six representatives from HERA and WHO to gain a deeper understanding of
the study's context and needs. These interviews helped identify potential challenges, confirm preliminary findings,
and fill evidence gaps regarding HERA's mission and tasks.

• Methodological approach and consultation strategy: reviewed and finalized the methodological approach and

data collection strategy based on inputs from HERA and EY experts, as well as initial desk and field research. 

•

Pre-identification of third countries relevant to the study: A pre-identification analysis was conducted during the
Inception Phase. Due to the broad scope of third countries, the study team identified three streams: G20
countries, countries recognized for their significant roles within regional/multinational organisations (such as
Norway and Rwanda), and other countries identified through the study for their important contributions to
bilateral cooperations relevant to HERA’s tasks or for their pivotal roles in the Covid-19 crisis 4
.

Interim Phase 
During the Interim Phase, the study team focused on the detailed identification and description of HERA-like entities, primarily 
through desk research and consultations. Specific activities included: 

►

►

In-depth desk research: further identified and detailed HERA-like entities, supported by desk research conducted by local
EY health experts, where necessary.
Ad-hoc  questionnaires:  distributed  questionnaires  to  HERA-like  entities  in  EU  Member  States  Third  Countries  and  to
regional and international organisations. These questionnaires confirmed and complemented the collected information. 
At least one response was received from each EU Member State, except for Hungary, where desk research conducted by 
EY national experts was mainly relied upon. Responses from Third Countries and regional and international organisations 
were limited; hence information came mainly from desk research.

Final Phase 
In the Final Phase, the study team continued identifying entities and detailing their descriptions. In addition, the study team 
verified information through follow-up calls with entities, as well as the involvement of national EY health experts. 

4
 For further details, the preliminary analysis conducted in the inception report has been included in the appendix. 

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Study mapping structures with relevant mandates, tasks, and functions to HERA within Member States and globally 

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2.

Main conclusions

The  study  includes 258  entities  which  perform  activities  related  to  the  development,  manufacturing,  procurement,  and 
equitable distribution of MCMs, spread across the 72 countries included in the study: 

•
•

108 in EU Member States, 

150 in the 45 third countries included in the mapping.

In addition, 11 supranational organisations and six international organisations have been identified in the mapping as entities 
aiming to reinforce the global health emergency preparedness & response architecture. 

Main observations from the mapping on the coverage of HERA's tasks in the countries and organisations included in the 
study 
This  study  mapping  entities  with  relevant  mandates,  tasks,  and  functions  to  HERA  within  Member  States  and  globally 
emphasises the vital necessity of international collaboration and synchronised preparedness in order to effectively address 
health crises. 
The EU countries and third countries have established a large range of entities and mechanisms which cover all or part of 
HERA's tasks for the management of medical countermeasures. Overall, the number of entities which map to HERA’s mission 
and tasks ranges from 1 to 9 (3.6 on average), 2-9 in EU Member States (4 on average), and 1-6 in third countries (3.3 on 
average). 

Although significant verification work was carried out as part of this study, it is sometimes complex to distinguish between 
aspects related to general health security and those specifically related to MCMs within the identified institutions. 

Within the European Union, each Member State has its own established systems for preparedness and response to health 
crises. Disparities exist between Western and Eastern countries as Western countries are characterised by the presence of 
more sophisticated systems and a larger number of specialised entities in comparison to their Eastern counterparts. 
Notable  trends  in  EU  Member  States  include  the  centralisation  of  strategic  stockpiles  at  the  national  level,  decentralised 
management by local authorities, and the implementation of multi-level management systems. Transnational collaboration, 
exemplified  by  the  RescEU  initiative,  serves  to  enhance  collective  preparedness,  and  facilitate  a  rapid  response  during 
emergencies. 
In  third  countries,  approaches  vary  significantly.  G20  countries,  including  the  United  States,  Japan,  and  Australia,  have 
substantial capabilities in the research and development of medical countermeasures and the production of such products, 
supported  by  advanced  infrastructure.  In  contrast,  EU  candidate  countries  and  some  nations  in  Africa  and  Latin  America 
demonstrate comparatively less developed capacities, despite notable efforts to enhance preparedness for health crises. It 
should  be  noted  that  there  is  a  gradual  strengthening  of  capacities  in  Africa,  with  significant  efforts  being  made  at  both 
national and regional levels. Of the 10 African countries included in this study, all have entities that cover all or part of the 
HERA tasks. Egypt is the only country for which some HERA tasks have not been identified. 

One of the main findings of the study is the central role of Ministries of Health in most countries. Firstly, in the Member 
States, the Ministry of Health plays a central role in preparedness and response to health crises, covering most of HERA's tasks 
in  almost  all  countries.  Exceptions  are  Hungary  (National  Centre  for  Public  Health  and  Pharmacy)  and  the  Netherlands 
(National Institute for Public Health and the Environment (RIVM)), where national public health institutes cover most of HERA’s 
functions. 
This observation is also evident in third countries, where the central role of Ministries of Health is crucial, especially for tasks 
such  as  monitoring,  intelligence  gathering,  health  security  coordination,  and  enhancing  production  and  manufacturing 
capacities. 

The study also highlights that many countries have implemented initiatives to strengthen their preparedness and response 
capacities in response to the COVID-19 crisis, especially in third countries. This is notably the case in Africa, with initiatives 
and projects to promote local manufacturing and advanced R&D of medical countermeasures. 
Additionally, 5 third countries have established new entities to strengthen their capacities for certain tasks: Australia with 
the new CDC (2024), Singapore with the Communicable Disease Agency (2023), Japan with the Cabinet Agency for Infectious 
Disease Crisis Management (2023), New Zealand with the Public Health Agency - Te Pou Hauora Tūmatanui (2022) and the 
United Kingdom with ARIA (2022). 

The study also underscores that supranational and international organisations play a major role in promoting the sharing 
of information and best practices and coordinating on a range of topics and projects related to MCMs and health security 
coordination.  These  organisations  aim  to  support  their  member  states  in  strengthening  their  preparedness  and  response 
capacities. 
Eleven supranational organisations have been identified: 

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Study mapping structures with relevant mandates, tasks, and functions to HERA within Member States and globally 

Final Report 

•

•
•
•
•

Three in Africa: the Africa CDC, the African Pharmaceutical Technology Foundation, and the Indian Ocean
Commission,

Three in the Americas: the PAHO, the Caribbean Public Health Agency, the ORAS,

Two in Asia: the ASEAN and the Gulf-CDC,

One in Europe: The Nordic Pharmaceutical Forum, 

Two other organisations for cooperation between different continents: the 'Medical Countermeasures
Consortium' and the HeDPAC.

Four supranational organisations identified, including Africa CDC, PAHO, ASEAN, and Gulf-CDC, share broad competencies with 
HERA, focusing on activities related to its seven tasks. Others, like the African Pharmaceutical Technology Foundation and 
Nordic Pharmaceutical Forum, concentrate on specific aspects of health crisis preparedness and response, such as enhancing 
regional pharmaceutical capabilities and facilitating collaborative efforts among countries. These organisations also contribute 
to global health architecture through projects and information sharing initiatives. 

Monitoring, Intelligence gathering and analysis 
All the countries studied have entities that perform activities related to monitoring, intelligence gathering, and analysis. A 
total of 147 such entities have been identified, with between 1 and 4 per country. 

Among the studied countries, two different types of organisations have been identified: 

•

•

the centralisation in a single entity, which is either:

the Ministry of Health,
the Centres for Disease Control and Prevention (e.g. Taiwan and Nigeria),
another dedicated entity (e.g. the Office of the Principal Scientific Adviser in India, the UKSHA in the UK).

-
-
-

the organization with a central entity that compiles and manages all the information, with the support of one or
several technical/scientific entities (e.g. the National Council for Science and Technology CONACYT in Paraguay, the
Japanese National Institute of Infectious Disease).

Furthermore, in certain EU countries, central coordination is complemented by regional or local entities, which are responsible 
for ensuring that monitoring and response are carried out at the local level (France for instance). 

Regarding  international  organisations,  the  WHO  manages  global  health  threats  by  producing  technical  documents  with 
guidelines  for  diagnosis,  treatment,  prevention,  and  controls.  It  conducts  ongoing  surveillance  of  global  health  issues, 
including  disease  outbreaks  and  emergencies,  by  collecting  and  analysing  data  from  various  sources.  Additionally,  WHO's 
regional offices, such as PAHO, support member states by monitoring and analysing health threats and their regional impacts. 

Advanced Research and Development capacities 
The study highlights that many countries have implemented policies and projects to strengthen their MCMs R&D capacities, 
including in developing countries. The promotion and coordination of advanced R&D is mostly led by governmental agencies, 
ministries, or national public health institute.  
The entities involved in the development of MCMs typically engage in distinct roles: 

•

•

•

•

Research and Development: Some entities focus on directly creating new MCMs, such as vaccines and medicines.
Institutions  like  the  Pasteur  Institutes  in  France  and  Senegal,  the  Australian  Institute  for  Infectious  Disease,  and 
BioCubaFarma in Cuba develop treatments for emerging health threats.
Infectious Disease Research: These entities advance MCM development by studying disease dynamics. For example,
Portugal’s IPATIMUP and Brazil’s FIOCRUZ focus on infectious disease research that informs MCM innovation.
Funding:  Funding  agencies  provide  financial  support  for  MCM  research,  promoting  healthcare  innovation  and
5
 is a funding agency which aims to advance medical R&D. The agency supports
development. In Japan, the AMED
various aspects of medical R&D, including management, concentration of funding, and monitoring, as well as the
6
enhancement  of  clinical  research  infrastructures.  In  the  USA,  ARPA-H
  supports  transformative  biomedical  and
health breakthroughs. As a research funding agency, ARPA-H operates as a lean organisation: it makes investments
in  breakthrough  technologies  and  broadly  applicable  platforms,  capabilities,  resources,  and  solutions  with  the
potential to transform important areas of medicine and health. 

Guidelines  and  Recommendations:  Regulatory  bodies,  like  Germany’s  PEI  and  Belgium’s  KCE,  issue  guidelines,
oversee clinical trials, and evaluate treatments to ensure the safety and effectiveness of MCMs. 

5
 Japan Agency for Medical Research and Development 
6
 The Advanced Research Projects Agency for Health 

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Study mapping structures with relevant mandates, tasks, and functions to HERA within Member States and globally 

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Three international organisations specialize in the R&D of MCMs: CEPI and FIND focus on global R&D and manufacturing of 
vaccines and diagnostics, respectively, while DNDi targets drug R&D specifically for low- and middle-income countries. 
WHO plays a broader global role in coordinating worldwide information sharing and supporting initiatives involving 
international cooperation for the R&D of medical countermeasures. 

Production / Manufacturing capacities 
The task of production/manufacturing capacities of MCMs is one where different trend are observed between Member States 
and third countries. In fact, in Member States, a notable trend is the establishment of dedicated agencies and inter-ministerial 
collaborations with the objective of overseeing and enhancing production capacities (e.g. in Austria and Germany). 

In parallel, in third countries, it  is observed that this task is generally under the Ministries of Health, sometimes with the 
cooperation of other entities. For instance, the Chinese National Health Commission is responsible for the management of 
manufacturing capacities and ensuring the availability of critical technologies and production sites for MCMs, while, in Ivory 
Coast,  the  Ministry  of  Health,  Public  Hygiene,  and  Universal  Health  Coverage  is  dedicated  to  promoting  local  drug 
manufacturing with the goal of increasing the local drug production rate from 6% to 30% by 2030. 
It is worth noting that this trend does not apply to all third countries. Some countries have dedicated agencies similar to those 
in the Member States, such as BARDA in the USA, PHARMAC in New Zealand, and the MedCM program of Health Security 
Systems Australia. 

Regarding international organisations, CEPI seeks to support projects that advance manufacturing innovations for scalable 
and  equitable  vaccine  access.  It  focuses  on  strengthening  capabilities  in  high-risk  areas  and  support  technology  transfers 
technology to manufacturers during outbreaks for rapid production and distribution. 
WHO provides guidelines and supports initiatives which aim to ensure the production and access to medical countermeasures 
in its member states. 

•
•

Procurement of MCMs 
In most countries, the procurement of MCMs is centralized within a single entity, which is either: 
the Ministry of Health (in most countries, including the EU Member States),
another  government  agency  (e.g.  by  the  National  Institute  for  Public  Health  and  the  Environment  in  the
Netherlands, the Norwegian Medicines Agency),
an  agency  dedicated  to  procurement  (e.g.  Medical  procurement  of  Ukraine,  the  Egyptian  Authority  for  Unified
Procurement, the National centralized drug procurement centre in Vietnam).

•

In Member States, there is a growing trend towards decentralised procurement at regional or local levels, particularly to meet 
specific local needs and to ensure a rapid response during emergencies. 

Two of the identified international organisations aims to ensure the swift procurement of MCMs: FIND and UNICEF Supply 
Division. The Global Fund, as the largest multilateral provider of grants in global health, operates as a financing mechanism 
rather than an implementing agency. 

Stockpiling and distribution capacities 
Regarding the stockpiling of MCMs, a notable trend is the centralisation of strategic stockpiling at the national level, typically 
overseen by health ministries or analogous agencies. This approach ensures the implementation of standardised protocols 
and coordination during emergencies. 
In many cases, the entities responsible for procurement also handle the stockpiling and distribution of MCMs (e.g. the New 
Public Health Pharmacy of Ivory Coast, the Ministry of Health in Indonesia, the Australia Department of Health and Aged 
Care). 

However, it should be noted that not all countries have established a stockpiling strategy to date (e.g., Bosnia and Herzegovina, 
Kosovo, and North Macedonia). In addition, in certain countries, the information available to the team did not enable for the 
precise identification of the entity responsible for this task and how this activity operates in the country. 

In terms of distribution capacities, in case of a health emergency, the UNICEF Supply Division is capable of delivering supplies 
from a network of global supply hubs. Regarding stockpiling, it is responsible for establishing emergency stockpiles of vaccines 
and ensuring rapid supply. 
The  WHO  provides  guidelines  and  protocols  to  its  Member  States  regarding  the  stockpiling  and  distribution  of  medical 
countermeasures to enhance their capacities of preparedness and response to health emergencies. 

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International Cooperation 
Entities in EU Member States actively engage with international organisations such as the WHO and the Global Fund in order 
to align national health policies  with global standards and participate in global initiatives such as the Pandemic Fund and 
COVAX. 
Likewise in third countries, all the 150 entities studied contribute to strengthening the global health emergency preparedness 
and response architecture at various levels. Ministries of Health frequently participate in cooperation projects; nonetheless, 
international cooperation activities extend beyond ministries to include other heavily involved entities. 

This mapping revealed three main dynamics of collaboration between countries: 

•

cooperations related to geographical proximity:

the Nigerian Federal Ministry of Health led the design of a multi-lateral framework for cross-border
collaboration between Nigeria, Benin, Chad, Cameroon, and Niger to strengthen cross-border
surveillance and sharing of information,
collaboration between Spain and Morocco, for the mitigation of cross-border health risks,
the trilateral cooperation between China, Japan, and South Korea on a range of issues, including health.

-

-
-

•

cooperations related to historical and linguistic circumstances:

-
-
-

-

Portugal and Spain have signed health cooperation agreements with Latin American countries,
France collaborates with several African countries, 
Australia, Canada, the United Kingdom, and the United States cooperate in the framework of the
Medical Countermeasures Consortium,
FIOCRUZ in Brazil has a unit in Mozambique which aims to coordinate, monitor, and evaluate health
cooperation programs with African countries.

•

cooperations within a South-South dynamic: the HeDPAC for instance is an international not-for-profit
organisation which aims to bolster South-South health cooperation and enhance institutional capacity both within
and between the two regions and beyond. 

Furthermore,  international  organisations  play  crucial  roles  in  pandemic  preparedness  and  response  at  international  scale. 
Three specialize in the R&D of MCMs: CEPI and FIND focus on global R&D and manufacturing of vaccines and diagnostics, 
respectively, while DNDi targets drug R&D specifically for low- and middle-income countries. 
UNICEF  Supply  Division  enhances  emergency  preparedness  through  supply  management,  and  the  Global  Fund  provides 
financial support for health programs and pandemic preparedness. 
WHO  coordinates  global  efforts,  providing  technical  guidance,  enhancing  health  system  capacities,  and  facilitating 
international collaboration for R&D and emergency response. 

Overall,  the  multitude  and  variety  of  entities  identified  in  the  study  underscores  the  vital  importance  of  international 
collaboration and coordinated preparedness to effectively manage health crises. 

Health security coordination 
Across  all  studied  countries,  the  steering  and  governance  of  health  security  coordination  fall  under  the  purview  of  the 
Ministry of Health. 
In some cases, ministries are advised and supported in this coordination by other entities that provide guidelines and support 
for the Ministry's decision-making. This involves collaboration with different government departments, health agencies and 
non-health sectors, such as interior ministries, civil protection units and the armed forces. Regulatory agencies can also be 
involved  (e.g.  ANVISA  in  Brazil).At  international  scale,  WHO's  role  in  health  security  coordination  is  to  enhance  global 
preparedness, ensure rapid and effective response to health crises, and support member states in protecting the health of 
their  populations.  Its  role  is  organized  into  several  activities  including  technical  guidance,  capacity  building,  information 
Dissemination and communication, etc. 

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Final Report 

3.

Overview

EU Member States’ approaches to public health emergency 

3.1 
preparedness and response in the area of MCMs 

The aim of this section is to provide HERA with an extensive analysis on the functioning of preparedness and crisis 
response in each Member State in respect of medical countermeasures. The analysis clearly indicates the coverage of 
HERA’s mission and tasks across the different national entities identified in the Member States. In addition, the section 
presents an overall analysis cross-country around HERA’s key mission and tasks with more detailed analysis provided in the 
country fiches in the Annex. 

The analysis was informed mainly by (i) responses to questionnaires that the team administered directly to the entities, (ii) 
desk research activities mainly on entities’ websites, as well as (iii) consultation of EY’s local healthcare experts.  

3.1.1  Mapping of entities in EU Member States 

In EU Member States, a total of 115 entities had been originally identified. Upon analysis of their mission and tasks, 108 
entities were retained. After a thorough analysis, 108 entities were ultimately retained. The exclusion of the other entities 
can be explained as follows: either they were disbanded after the end of the pandemic and were therefore removed from 
the scope of the study, or the in-depth analysis of their missions revealed that they did not operate within the scope of 
HERA's tasks. 

The table below presents the mapping of the entities in EU Member States: 

Member State 

Entities 

Austria 

Belgium 

Bulgaria 

Croatia 

Cyprus 

Czechia 

Denmark 

Estonia 

Finland 

France 

Ministry of Social Affairs, Health, Care and Consumer Protection (BMSGPK) 
Ministry of Labour and Economics (BMAW) 
Ministry of Defence (BMLV) 
Federal states' health authorities and provinces 
Austria Agency for Health and Food Safety (AGES) 
National multidepartment Crisis Centre at Federal level - NCCN - (Homeland minister) 
Federal Public Service Health (FPS Health) 
Sciensano 
Federal Agency for Medicines and Healthcare Products (FAMHP) 
Belgian Healthcare Knowledge Centre (KCE) 
Communities and regions 
Ministry of Health 
Ministry of Economy 
National Centre for Infectious and Parasitic Diseases 
Regional Health Inspectorates 
Ministry of Health – Crisis Headquarters 
Civil Protection Directorate – National Crisis Headquarters 
Croatian Institute of Public Health 
Agency for medicinal products and medical devices of Croatia (HALMED) 
Ministry of Health 
State Healthcare Services Organisation 
Ministry of Health 
Regional Public Health Authorities 
Ministry of the Interior and Health 
AMGROS 
Danish Health Authority 
Statens Serum Institut 
Danish Medicine Agency 
Danish Critical Supply Agency (SFOS) 
Danish Regions 
Ministry of Social Affairs – Health Board 
State Agency for Medicines (SAM) 
Estonian Stockpiling Agency 
Estonian Health Insurance Fund 
Ministry of Social Affairs and Health (MSAH) 
National Emergency Supply Agency (NESA) 
Finnish Institute for Health and Welfare (THL) 
Ministry of Solidarity and Health - Direction Générale de la Santé (DGS) 
General Secretariat for Defence and National Security (SGDSN) 
ANRS - Emerging Infectious Diseases 
Ministry of Interior 
Santé Publique France 

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Germany 

Greece 

Hungary 

Ireland 

Italy 

Latvia 

Lithuania 

Luxembourg 

Malta 

Netherlands 

Poland 

Portugal 

Romania 

Slovakia 

Slovenia 

Spain 

Sweden 

Agence pour l'innovation en santé 
High Authority on Health (HAS) 
Institute Pasteur 
Haut conseil de la santé publique 
Federal Ministry of Health (BMG) 
Federal Ministry for the Environment, Nature Conservation, Nuclear Safety and Consumer Protection (BMUV) 
Federal Office for Civil Protection and Disaster Assistance (BBK) 
Federal Ministry of Education and Research (BMBF) 
Federal states 
PEI - Paul Ehrlich Institute (ZEPAI - Centre for Pandemic Vaccines and Therapeutics) 
Robert Koch Institute 
Ministry of Health (General Secretariat for Public Health; the General Secretariat for Health and Quality of Life) 
Directories for Public Health in Regions 
National Public Health Organisation (NPHO/ΕΟΔΥ) 
National Organisation for Medicines (NOM/ΕΟΦ) 
Ministry of Interior 
National Centre for Public Health and Pharmacy (NNGYK) 
Department of Health 
Health Service Executive (HSE) 
Health Research Board (HRB) 
Government Task Force on Emergency Planning (GTF) and Office of Emergency Planning (OEP) 
Department of Enterprise, Trade and Employment 
Ministry of Health 
National Department of the Civil Protection (CPD) 
Istituto Superiore di Sanità (IIS) 
Italian Medicines Agency (AIFA) 
Regions/Autonomous provinces 
Ministry of Enterprises and Made in Italy 
Ministry of Health 
Centre for Disease Prevention and Control (SPKC) 
Ministry of Interior 
Ministry of Health 
Health Emergency Situations Centre (HESC) 
National Crisis Management Centre (NCMC) 
Ministry of Health - Unit on Emergency Preparedness and Response 
High Commission for National Protection (HCNP) 
Laboratoire National de Santé (LNS) 
Ministry of Health 
Infectious Disease Prevention and Control Unit (IDCU) 
National Institute for Public Health and the Environment RIVM (Ministry of Health) 
Health Council of the Netherlands 
Ministry of Health 
Chief Sanitary Inspectorate 
Chief Pharmaceutical Inspectorate 
National Institute of Public Health 
Government Agency for Strategic Reserves (RARS) 
National Institute of Health (INSA-Instituto Nacional de Saude) 
Direção-Geral da Saúde (DGS) 
National Authority of Medicines and Health Products 
National Institute for Public Health (INSP) 
Ministry of Health 
Department of Emergency Situations (DSU) 
Ministry of Health 
Public Health Authority of the Slovak Republic 
Regional Public Health Authorities in the Slovak Republic 
Ministry of Health 
National Institute of Public Health (NIJZ) 
Ministry of Health - Coordination Centre for Health Alerts and Emergencies (CCAES) 
The Spanish Agency of Medicines and Medical Devices (AEMPS) 
Carlos III Health Institute 
Instituto Nacional de Gestión Sanitaria (INGESA) 
Public Health Agency of Sweden 
The National Board of Health and Welfare 
Swedish Civil Contingencies Agency (MBS) 
Karolinska Institute 

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3.1.2  Synthesis 

In all EU Member States, there are entities that perform activities aligned with the mission and tasks of HERA. Typically, 
these tasks are managed by several entities that cooperate or engage in complementary activities. Within EU Member States, 
2-9 entities perform tasks similar to those carried out by HERA.
This  collaborative  approach  ensures  comprehensive  coverage  of  preparedness  and  response  to  public  health  crises,
particularly concerning medical countermeasures. However, the specific organisation and complexity of these systems vary
across Member States.

Countries  have  generally  established  systems  to  respond  to  public  health  crises  involving  MCMs.  Nevertheless,  there  are 
notable variations across the EU, particularly between Western and Eastern European countries. In fact, Western European 
countries tend to have more advanced and sophisticated systems, with a larger number of specialised entities in charge of 
tasks like those of HERA, compared to their Eastern European counterparts. 
Furthermore,  the  complexity  of  these  systems  and  the  number  of  entities  involved  vary  significantly  between  larger  and 
smaller  Member  States.  In  larger  Member  States,  the  management  of  various  aspects  of  health  crisis  response  is  often 
entrusted to numerous entities, reflecting the capacity and resources available. In contrast, smaller Member States tend to 
adopt a more streamlined approach, utilising fewer entities to achieve similar goals. This streamlined approach can enhance 
efficiency  and  clarity  in  smaller  countries,  while  larger  countries  benefit  from  the  specialisation  and  distribution  of  tasks 
among multiple entities. 

Given  these  variations,  the  role  of  international  cooperation  and  regional  partnerships  is  critical  to  the  successful 
implementation of health crisis management within the European Union and its partnerships. 

Overall, while there are overarching trends in how EU Member States manage preparedness and response to health crises, 
each  country  tailors  its  approach  to  suit  its  governance  structures  and  capacities.  International  cooperation,  regional 
coordination and centralised strategies are common themes, contributing to the development of a resilient and responsive 
health security framework across the EU. 

3.1.3  Cross-country overview 

HERA occupies a distinctive position within the EU public health framework, insofar as no single entity in the Member States 
can be identified that precisely reflects the mission and tasks of the organisation. However, an analysis of the way in which 
each Member State organises its preparedness and response to health crises, particularly with regard to MCMs, reveals that 
various  systems  have  been  established  in  which  different  entities  carry  out  tasks  similar  to  those  of  HERA  within  their 
respective jurisdictions. 

In almost all EU Member States, the Ministry of Health plays a central role in preparedness and response to health crises, 
covering most of the tasks of HERA. Exceptions are Hungary (National Centre for Public Health and Pharmacy (NNGYK)) and 
the Netherlands (National Institute for Public Health and the Environment (RIVM)), where national public health institutes 
cover most of HERA’s functions. In all EU Member States, the Ministry of Health relies on strong inter-ministerial collaboration 
involving  multiple  ministries  (e.g.,  interior,  economy,  labour,  education  and  research)  and/or  public  health  or  medicine 
agencies to complement their tasks in relation to preparedness and response to public health crises with regards to MCMs. 
For example, in France, the Ministry of Health is supported by several key agencies, including Santé Publique France, which is 
responsible  for  public  health  surveillance  and  response,  and  the  National  Agency  for  the  Safety  of  Medicines  and  Health 
Products (ANSM), which is responsible for the safety of vaccines, medicines and health products. 

Within EU Member States, the Ministry of Health plays a central role in implementing crisis preparedness and response plans 
in  collaboration  with  local  authorities.  In  Sweden,  for  instance,  the  county  administrative  boards  act  as  the  Ministry’s 
representatives,  ensuring  the  operational  implementation  of  health  measures  at  the  local  level.  Similarly,  other  Member 
States have established comparable structures to manage these tasks at the regional level. 

A distinguished role in the delivery of preparedness and crisis response plans with regards to MCMs is granted to regional 
public health entities in federal states (i.e., Germany, Austria, Belgium) or in regions and provinces in specific countries (i.e., 
Italy, Denmark, Sweden, Spain). In such countries, the Ministry of Health generally plays a coordinating role, whereas federal 
states or regional authorities manage operational activities on the ground independently within their jurisdictions. 

Moreover, international cooperation efforts align closely with global health security standards, and European partnership 
frameworks are critical components of each Member State's strategy. It is evident that while there are overarching trends in 
health crisis management across the EU, each Member State tailors its approach to suit its specific governance structures and 
capabilities. For instance, France engages in extensive collaboration with its overseas territories to address distinctive health 
challenges. This approach ensures comprehensive crisis response and health security in regions such as the Caribbean and 

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the Indian Ocean. Furthermore, Germany maintains robust collaborative relationships with neighbouring countries such as 
Austria and Switzerland, with the objective of effectively addressing cross-border health concerns, particularly in the context 
of infectious diseases. Italy, situated in a pivotal position in the Mediterranean, maintains close ties with the European Centre 
for  Disease  Prevention  and  Control  (ECDC)  and  other  international  bodies,  with  the  objective  of  effectively  managing  the 
health risks associated with migration. Similarly, Spain engages in collaborative efforts with Portugal and France to enhance 
preparedness  and  response  capabilities,  particularly  in  addressing  the  spread  of  vector-borne  diseases  such  as  Zika  and 
dengue fever. 

3.1.3.1  Monitoring, Intelligence gathering and analysis 

The cross-country analysis indicates that entities with a specific focus on monitoring, intelligence gathering, and analysis of 
MCMs are relatively uncommon within EU Member States. In most cases, entities that perform this role are part of a broader 
framework of action, where entities carrying out different monitoring activities collectively contribute to the monitoring and 
management of MCMs. 

Entities responsible for monitoring, intelligence gathering, and analysis are typically engaged in activities pertaining to the 
surveillance of health risks and the continuous evolution of threats to public health within their jurisdictions, in addition 
to the management of the corresponding MCMs. It is of paramount importance to implement effective surveillance measures 
in order to detect, monitor, and respond to health threats in a timely and appropriate manner. By analysing health data and 
trends, entities provide valuable insights into disease patterns, which can inform policy-making and targeted interventions in 
preparation  for  or  during  health  emergencies.  This  includes  the  need  for  specific  MCMs  to  be  acquired,  developed,  or 
distributed. 

In most EU Member States, a central entity or ministry has been established with responsibility for the overall coordination 
of  monitoring,  analysis  and  intelligence  gathering  efforts.  In  certain  countries,  central  coordination  is  complemented  by 
regional or local entities, which are responsible for ensuring that monitoring and response are carried out at the local level. 
For example, in France, Santé Publique France is responsible for national surveillance and health data analysis, while Regional 
Health Agencies (ARS) monitor local health threats and coordinate response efforts. 

Furthermore,  collaboration  between  multiple  government  agencies  and  organisations  for  monitoring,  analysis,  and 
intelligence  gathering  is  also  a  prevalent  trend.  For  instance,  in  Belgium,  coordination  is  achieved  through  the  National 
Multidepartment  Crisis  Centre,  the  Federal  Public  Service  Health,  and  Sciensano.  This  approach  ensures  the  pooling  of 
expertise and resources for effective monitoring and analysis. Similarly, Germany relies on the Robert Koch Institute (RKI) for 
nationwide health monitoring and analysis, while state-level health authorities are responsible for regional surveillance and 
response.  In  Italy,  the  Instituto  Superiore  di  Sanità  (ISS)  plays  a  pivotal  role  in  public  health  surveillance  and  intelligence 
gathering, collaborating closely with regional health authorities to monitor and respond to health threats. Other countries 
rely on public health institutes to play a pivotal role in the collection, analysis, and dissemination of health-related data, as 
well as in the provision of advice on the relative MCMs. In Spain, the Carlos III Health Institute collaborates with the Ministry 
of Health to collect and analyse health data, thereby supporting decision-making processes regarding MCMs. The Netherlands' 
National Institute for Public Health and the Environment (RIVM) also exemplifies this approach, providing comprehensive data 
analysis and information. The RIVM also coordinates the UNITED4Surveillance project, an EU4Health Joint Action which aims 
to contribute to surveillance capacity-building within Europe. 

Finally, the cooperation among 5 member states - Austria, Belgium, the Netherlands, Ireland, and Luxembourg - through 
the BeNeLuxA initiative is noteworthy. The BeNeLuxA initiative aims to ensure sustainable access to and appropriate use of 
medicines  in  the  participating  countries.  To  achieve  this  goal,  the  cooperation  focuses  on  horizon  scanning,  information 
sharing,  health  technology  assessment,  and  pricing  (to  negotiate  medicine  prices  with  the  industry  and  demand  greater 
transparency). 

3.1.3.2  Advanced Research and Development capacities 

Entities engaged in advanced research and development in medical countermeasures tend to pursue distinct activities within 
the field of research. A distinction can be made between entities that engage directly in research and development activities, 
those that conduct research on infectious diseases with the aim of informing the development of MCMs, entities that provide 
funding for research, and those that produce guidelines and recommendations with regards to MCMs development. 

• Entities that directly carry out research and development to develop new medical countermeasures focus on creating
new medicines, vaccines, and diagnostic tools to combat emerging health threats. For instance, the Karolinska Institute
(KI) in Sweden works closely with pharmaceutical and biotech companies to translate research into effective therapies
and MCMs. The Paul Ehrlich Institute (PEI) in Germany, researches, tests and approves biomedical medicinal products. It
approves clinical trial procedures and records and evaluates possible side effects. In France, the Institute Pasteur, conducts

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research to develop treatments and vaccines, including the first PCR tests and a COVID-19 vaccine candidate. Similarly, 

the Statens Serum Institute (SSI) in Denmark plays a critical role in developing vaccines and other essential MCMs

7

. 

• Entities focusing on research in infectious diseases contribute significantly to the understanding and development of
MCMs. These organisations study disease characteristics, transmission dynamics, and potential interventions, providing
critical insights that inform MCM development. In Portugal, the Institute of Molecular Pathology and Immunology at the
University of Porto (IPATIMUP) collaborates with DGS to advance research on infectious diseases. The Finnish Institute for 
Health  and  Welfare  (THL)  supports  similar  efforts  in  Finland,  leveraging  its  Biobank  Laboratory  to  facilitate  research
projects that enhance public health responses. These institutions provide the foundational knowledge required to develop 
effective MCMs

8
.

• Funding entities contribute to advancing MCMs development by providing the necessary financial support for research
initiatives. In Ireland, the Department of Enterprise, Trade and Employment (DETE) offers RD&I  funding to companies
developing new healthcare products and services, supporting innovation in the health sector. Germany's Federal Ministry 
of  Health  (BMG)  funds  significant  research  programs  focused  on  MCMs  and  promotes  healthcare  innovation  through
initiatives like the Digital Healthcare Act 9. In addition, Germany's Federal Ministry of Education and Research (BMBF) is
supporting  several  national  and  international  (non-profit)  initiatives,  funding  programs,  and  networks  with  the aim  to
develop  vaccines,  therapeutics, and  diagnostics  for  pathogens  with  epidemic  and  pandemic  potential  and  to  enhance
equitable  access  to  these  MCMs.  The  BMWK  (Federal  Ministry  for  Economic  Affairs  and  Climate  Action)  is  also  an
important actor. For instance, it funded the Artificial Intelligence TooLs for Outbreak Detection and ResponSe (AIOLOS)
. Similarly, in the Netherlands, the National Institute for Public Health, and the Environment (RIVM)
modelling project
allocates funds to research on infectious diseases such as tuberculosis and HIV, which are critical for developing effective
medical countermeasures (MCMs). France's National Agency for Research (ANR) provides grants for projects aimed at
combating infectious diseases, including the development of vaccines and diagnostic tools for diseases such as COVID-19
and influenza. In Germany, the BMG's funding has facilitated the advancement of digital health technologies, including
telemedicine  and  electronic  health  records,  which  are  of  paramount  importance  during  health  crises  for  the  efficient
management of patients and the tracking of diseases. Research on infectious diseases such as tuberculosis and HIV, which 
are critical for the development of effective MCMs, has also been supported. France's National Agency for Research (ANR) 
provides financial support for research projects aimed at combating infectious diseases, including the development of
vaccines and diagnostic tools for diseases such as SARS-CoV-2 and influenza. 

10

►

Entities  that  produce  guidelines  and  recommendations  are  essential  for  translating  research  findings  into  practical
applications  and  policy  decisions.  These  organisations  provide  comprehensive  regulatory  guidelines,  oversee  clinical
trials, and conduct assessments of medicinal products. The Paul Ehrlich Institute (PEI) and the Federal Institute for Drugs 
and Medical Devices (BfArM) in Germany, exemplify this role by providing regulatory oversight and scientific assessments 
for vaccine development and therapeutic interventions. In 2021 a new organizational unit was set up within the PEI, the
ZEPAI  that  has  the  mission  to  support  especially  the  development  and  manufacture  of  pandemic  vaccines  and
therapeutics,  however,  is  not  involved  in  regulatory  duties  of  the  PEI.  In  Belgium,  the  Belgian  Healthcare  Knowledge
Centre (KCE) evaluates potential treatments and preventive measures, offering evidence-based recommendations that
guide  public  health  strategies.  In  France,  this  activity  is  under  the  HSCP  and  the  HAS.  These  entities  bridge  the  gap
between  research  and  implementation,  ensuring  that  MCMs  are  safe,  effective,  and  aligned  with  public  health
priorities

11
.

In  the  European  Union,  there  is  a  notable  emphasis  on  the  collaboration  between  government  agencies  and  specialised 
research institutions. This collaboration facilitates scientific advancement and ensures that research efforts are aligned with 
public health priorities. For example, the Finnish Institute for Health and Welfare (THL) collaborates closely with the Ministry 
of Social Affairs and Health (STM) to advance the development of new influenza vaccines. The THL engages in comprehensive 
research on infectious diseases and vaccine development, with financial and policy support from the STM. This collaboration 
ensures that research objectives are aligned with national health priorities. 

7
 Other relevant entities are: Medical Research Agency (MRA), Poland, Vilnius University Life Sciences Centre (VU LSC), Lithuania 
8
 Other relevant entities are: Luxembourg Institute of Health (LIH), ANRS - Emerging Infectious Diseases (ANRS MIE), France, NCIPD, 
Bulgaria 
9
 Other relevant entities are: Dutch Research Council (NWO), Enterprise Ireland, Ministry of Health, Czechia 
10 
https://aiolos-project.org/ 
 Other relevant entities are: National Organisation for Medicines (NOM/ΕΟΦ), Greece, Swedish Medical Products Agency (MPA), Sweden, 

11

Malta Medicines Authority (MMA), Malta 

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Collaboration  with  international  partners  and  participation  in  EU-funded  projects  are  common  trends
collaborations enhance research capacities and facilitates knowledge exchange and innovation.  
For  instance,  the  United  Kingdom  maintains  a  substantial  collaborative  engagement  with  other  European  Union  Member 
States through the Horizon Europe programme, with a particular focus on areas such as antimicrobial resistance and pandemic 
preparedness.  Similarly,  Poland  participates  in  the  European  Joint  Programme  on  Rare  Diseases,  in  collaboration  with 
international partners, with the objective of advancing research on treatments and diagnostic tools for rare conditions. 
Furthermore, Hungary is engaged in the Joint Action on Antimicrobial Resistance and Healthcare-Associated Infections (EU-
JAMRAI),  contributing  to  the  reduction  of  the  threat  of  antibiotic  resistance  across  Europe.  These  examples  illustrate  the 
continued significance of international collaboration in enhancing preparedness and response capabilities in the event of a 
health crisis. 

.  These

12

3.1.3.3  Production / Manufacturing capacities 

The  support  for  production  and  manufacturing  capacities  of  medical  countermeasures  across  EU  Member  States 
demonstrates a multifaceted approach, characterized by strategic partnerships, dedicated agencies, regulatory frameworks, 
and collaborative efforts that adapt to both preparedness and emergency contexts.  

A  notable  trend  is  the  establishment  of  dedicated  agencies  and  inter-ministerial  collaborations  with  the  objective  of 
overseeing  and  enhancing  production  capacities.  Austria  and  Germany  have  established  specialized  bodies,  such  as  the 
Federal  Office  for  Safety  in  Health  Care  (BASG)  and  the  Paul-Ehrlich-Institut  (PEI),  respectively,  to  manage  risks,  ensure 
regulatory compliance, and maintain a steady supply of medicinal products and vaccines. 
In Germany, the ZEPAI implements the centralized distribution of pandemic vaccines and has established structures for this. 
At PEI, ZEPAI was also established because the Government was concluding contracts with companies for the reservation of 
vaccine manufacturing capacities. In order to avoid any conflicts of interests, ZEPAI, a new and independent entity, was set-
up at the PEI to manage these contracts. It is evident that the National Emergency Supply Agency (NESA) of Finland and the 
Health Innovation Agency (HIA) of France play a pivotal role in the expansion of local manufacturing capabilities during periods 
of crisis. Similarly, the Danish Ministry of Health collaborates with the Danish Medicines Agency and AMGROS to ensure the 
availability  of  production  capacities.  The  Netherlands  supports  the  expansion  of  production  capacities  through  the 
collaboration of the Ministry of Health, the Ministry of Economic Affairs, and initiatives such as PharmaNL.  In Poland, the 
National Medicines Institute collaborates closely with the Ministry of Health to facilitate the production of essential medicines 
whereas the National Institute of Public Health collaborates in the field of vaccines manufacturing. This collaboration ensures 
that the requisite regulatory compliance and quality standards are met. 

Another notable trend is the emphasis on strategic partnerships and industrial policies aimed at fostering local production. 
Belgium, Bulgaria, Portugal, Slovakia, and Hungary actively engage their respective Ministries of Health and Economy to boost 
local industrial capacities and reduce dependency on imports. 
For instance, Belgium's FPS Health and FPS Economy encourage European production of essential medicines to address market 
challenges.  Bulgaria  supports  its  pharmaceutical  and  biotechnology  industries  through  industrial  policy  and  development. 
Portugal facilitates local production capabilities by negotiating contracts with pharmaceutical companies. Slovakia enhances 
production capabilities through regulatory facilitation, financial incentives, and infrastructural support. 
In addition, France’s ambitious France 2030 plan aims to enhance the country's capacity to produce medical countermeasures, 
with  a  particular  focus  on  infectious  diseases  and  vaccine  development.  Germany  also  signed  pandemic  preparedness 
contracts with five pharmaceutical companies based the country to ensure a rapid and sufficient supply of vaccines in the 
event  of  a  pandemic.  Furthermore,  ZEPAI  will  prepare  for  the  pandemic  response  together  with  the  industry  during  the 
pandemic-free  period.  Countries  in  Eastern  Europe  also  contribute  significantly  to  the  EU’s  capacity  for  medical 
countermeasure production. Additionally, in Romania, the National Institute for Medical-Military Research and Development 
"Cantacuzino"  is  responsible  for  the  development  and  manufacturing  of  vaccines  and  biological  products,  thereby 
contributing to the country's health security. Similarly, in Slovenia, the National Institute of Public Health (NIJZ) collaborates 
with local pharmaceutical companies to enhance the production and distribution of essential medicines. 
Sweden  has  also  demonstrated  strong  capabilities  in  the  production  of  medical  countermeasures.  The  Swedish  Medical 
Products Agency (MPA) ensures that medical products meet high standards. The country’s strategic focus on biotechnology 
and  pharmaceutical  innovation  supports  robust  production  capacities.  Collaborative  efforts  with  neighbouring  Nordic 
countries further bolster these capabilities, ensuring a coordinated regional response to health crises. Additionally, Sweden 
has invested in advanced manufacturing technologies to produce complex biological therapies and vaccines, enhancing its 
readiness to respond to emerging health threats.  

12

 Luxembourg, Finland, Austria, Croatia, Cyprus, Czechia, Estonia, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Slovakia, and 

Slovenia 

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Regional  cooperation  and  coordination  are  key  elements  in  some  countries'  strategies.  Italy  leverages  regional  support 
through financial incentives to boost the production capacities of local manufacturers, ensuring a stable supply chain during 
health emergencies. The Netherlands’ initiatives like  PharmaNL involve  collaboration between the Ministry of  Health, the 
Ministry of Economic Affairs, and research institutions to stimulate MCM production. Spain’s national plan, implemented by 
the  Spanish  Agency  of  Medicines  and  Medical  Devices  (AEMPS),  identifies  critical  production  sites,  and  promotes  local 
production  capacities.  Finally,  Sweden's  regional  health  authorities  collaborate  with  national  bodies  to  enhance  the 
production and stockpiling of essential medical supplies, ensuring regional preparedness and rapid response capabilities. 

Finally,  quality  control  and  regulatory  oversight  are  fundamental  aspects  of  the  production  and  manufacturing  processes 
across the EU. Poland and Spain exemplify robust regulatory frameworks that ensure the effective monitoring, authorisation, 
and compliance of medicinal products and medical devices. The Polish Chief Pharmaceutical Inspectorate (CPI) monitors and 
controls the distribution of medicinal products, the manufacturing and import of medicinal products as well as manufacturing, 
import  and  distribution  of  active  substances.  CPI  is  further  responsible  for  issuing  permits  for  the  import  and  export  of 
narcotics and psychotropic substances. Spain’s AEMPS has been implementing a national plan to guarantee the security of 
supply since 2019. This regulatory effort is crucial for maintaining high standards and addressing production bottlenecks, as 
evidenced by the coordinated efforts in Denmark involving the Danish Medicines Agency and AMGROS. In addition, Croatia’s 
Agency for Medicinal Products and Medical Devices (HALMED) and the Czechia’s State Institute for Drug Control (SUKL) also 
play a pivotal role in regulatory oversight.  The mission of the Lithuania State Medicines Control Agency (VVKT) is to guarantee 
the quality and safety of medical products, and to provide support to local manufacturers in scaling up production during 
health crises. The French National Authority for Health (HAS) and the National Agency for the Safety of Medicines and Health 
Products (ANSM) also play a pivotal role in the approval and regulation of new medications. 

3.1.3.4  Procurement of MCMs 

The procurement of MCMs across EU Member States reveals a complex and nuanced landscape characterized by diverse 
strategies tailored to national and regional needs. 

One prominent tendency is the centralisation of procurement processes, often overseen by national ministries of health or 
designated government agencies. This centralisation allows for streamlined procurement, ensuring consistent and efficient 
acquisition  of  MCMs.  Austria,  Bulgaria,  Croatia,  Cyprus,  Czechia,  Finland,  France,  Germany,  Greece,  Hungary,  Italy,  Latvia, 
Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden all demonstrate 
centralized procurement models, where the Ministry of Health or equivalent bodies play a pivotal role in managing and 
coordinating the acquisition of essential medical supplies. By way of illustration, the Netherlands’ centralised procurement 
is overseen by the National Institute for Public Health and the Environment (RIVM), thereby guaranteeing uniform quality and 
supply of vaccines and medical equipment. 

In addition, there is a growing trend towards decentralised procurement at regional or local levels, particularly to meet 
specific  local  needs  and  to  ensure  a  rapid  response  during  emergencies.  This  decentralised  approach  provides  a 
complementary  dimension  to  central  efforts,  allowing  for  flexibility  and  tailored  responses.  Belgium,  Germany,  Italy,  the 
Netherlands,  Portugal,  and  Spain  have  decentralised  elements  within  their  procurement  frameworks,  where  regional 
authorities  or  healthcare  institutions  manage  day-to-day  procurement  to  address  localised  demands  effectively.  More 
specifically, in Germany, the Länder governments have the autonomy to procure medical supplies such as masks, gowns, and 
gloves during emergencies, ensuring that hospitals and healthcare facilities can quickly respond to local needs. 

Joint procurement initiatives, both at the national and EU levels, represent another significant trend, reflecting a collective 
approach to enhance bargaining power and ensure equitable access to MCMs during crises.  Member States have participated 
in EU-led joint procurement agreements, leveraging collaborative frameworks to secure better pricing and reliable supplies, 
especially  during  pandemics  or  other  health  emergencies.  For  instance,  during  the  COVID-19  pandemic,  the  European 
Commission's Joint Procurement Agreement enabled EU countries to collectively purchase personal protective equipment 
(PPE), ventilators, and COVID-19 vaccines, ensuring more equitable distribution and access. 

The role of specialised agencies and entities in managing specific aspects of procurement is also becoming increasingly 
important. Denmark employs several agencies, including AMGROS for securing essential products and SFOS for managing 
public procurement processes. In Estonia, the Estonian Health Insurance Fund (EHIF) is responsible for vaccine procurement, 
while the Health Board Crisis Department handles other MCMs. In Finland, entities such as the THL and NESA are utilised, 
while in France, NESA and Santé Publique France are incorporated to support the country's procurement strategies. 

Additionally, legal and regulatory frameworks provide the flexibility needed for expedited procurement during emergencies. 
Cyprus,  Italy,  Luxembourg,  Malta,  and  Slovakia  have  adapted  their  public  tender  laws  to  allow  for  rapid  acquisition  of 
necessary supplies, highlighting the importance of adaptable legal mechanisms in managing health crises effectively. 

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3.1.3.5  Stockpiling and distribution capacities 

The  stockpiling  and  distribution  of  medical  countermeasures  among  EU  Member  States  exhibit  several  discernible  trends 
characterized by strategic coordination, decentralisation, multi-level management, regular updates, and collaborative efforts, 
reflecting a comprehensive approach to preparedness and crisis management. 

A notable trend is the centralisation of strategic stockpiling at the national level, typically overseen by health ministries or 
analogous  agencies.  This  approach  ensures  the  implementation  of  standardised  protocols  and  coordination  during 
emergencies. This approach is exemplified in countries such as Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, 
Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Latvia,  Lithuania,  Luxembourg,  Malta,  the  Netherlands, 
Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden. In these nations, the central authorities are responsible for 
formulating  the  overarching  strategy,  and  where  stockpiles  are  established,  they  are  also  responsible  for  inventory 
management and distribution plans, ensuring a unified response during public health crises. 

Another critical pattern is the decentralisation of federal states or regions, which allows for tailored responses that address 
specific local needs. Austria, Belgium, Bulgaria, Croatia, Czechia, Germany, Italy, Spain, and Sweden exemplify this approach, 
where  regional  or  local  authorities  are  responsible  for  the  management  of  their  respective  stockpiles  and  distribution 
networks. This approach serves to complement national reserves and enhance responsiveness at the grassroots level. 

Moreover,  the  implementation  of  multi-level  management  appears  as  a  key  feature,  whereby  various  organisations  and 
entities collaborate to ensure efficient stockpiling and distribution. This also encompasses the involvement of Ministries of 
Health,  Defence,  Civil  Protection  Directorates,  Regional  Health  Authorities,  and  Specialised  Agencies  such  as  AMGROS  in 
Denmark, NESA in Finland, THL in Finland, SpF in France, BBK, ZEPAI and THW in Germany, RARS in Poland, and MSB in Sweden. 
These  entities  collaborate  to  leverage  their  collective  expertise  and  resources  in  order  to  maintain  and  distribute  critical 
supplies in an effective manner. 

It is of the utmost importance that regular updates and inspections of stockpiled items are carried out across Member States, 
in order to ensure the readiness and usability of MCMs. Belgium, Denmark, France, and Spain appear to place a particular 
emphasis on the importance of continuous evaluation of stock levels, expiration dates, and replenishment needs in order to 
maintain operational effectiveness during crises. 
Collaborative efforts both within countries and across EU Member States, such as the RescEU initiative, enhance collective 
preparedness. Countries participating in RescEU contribute to a shared pool of resources that can be deployed rapidly during 
emergencies. This collective approach not only strengthens individual national capacities but also fosters solidarity and mutual 
support among EU nations. 

Logistics  and  infrastructure  play  a  significant  role  in  stockpiling  and  distribution  efforts.  Countries  invest  in  establishing 
centralized  storage  facilities,  developing  transportation  networks,  and  implementing  inventory  management  systems  to 
streamline operations and facilitate timely distribution of MCMs. 

3.1.3.6 

International cooperation 

Entities  in  EU  Member  States  are  typically  well  connected  internationally  and  actively  contribute  to  international  public 
health actions in collaboration with other nations or international bodies. 

International  cooperation  necessitates  the  extensive  sharing  of  information  and  knowledge  between  countries  and 
international  partners.  This  encompasses  the  sharing  of  best  practices,  lessons  learned  from  past  emergencies,  and  the 
exchange of data and expertise with the objective of enhancing collective response capabilities and addressing public health 
challenges. 
The  objective  is  to  collaborate  on  pandemic  preparedness,  including  joint  actions  to  address  emerging  health  threats, 
negotiate  international  agreements,  and  participate  in  global  initiatives  such  as  the  Pandemic  Fund.  The  objective  of  this 
collaboration is to enhance global readiness and response capacity. 

In all EU Member States, the Ministry of Health or an equivalent national health authority is the most prevalent entity 
representing the country in matters pertaining to international cooperation with regard to MCMs. This is evidenced by the 
involvement of such ministries in coordinating and engaging with international health bodies, participating in global health 
initiatives, and ensuring the implementation of international health regulations and best practices. 
Overall,  such  entities  actively  engage  with  international  organisations  such  as  the  WHO,  European  Centre  for  Disease 
Prevention  and  Control  (ECDC),  EMA,  and  other  EU  institutions  in  general  (e.g.,  DGs  HERA,  SANTE).  This  engagement 
includes  participation  in  joint  initiatives,  collaborations  on  research  and  surveillance,  and  adherence  to  international 
standards  and  regulations.  Countries  are  represented  by  their  entities  in  various  international  forums,  committees,  and 
working  groups  related  to  public  health  and  emergency  response.  This  representation  allows  for  active  participation  in 

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decision-making processes, sharing national perspectives, and contributing to the development of international strategies 
and policies. 
Another  key  initiative  is  the  European  Medical  Corps,  part  of  the  EU  Civil  Protection  Mechanism,  which  provides  medical 
teams  and  resources  for  international  emergency  response.  This  initiative  guarantees  that  EU  Member  States  can  rapidly 
mobilise assistance for countries experiencing health crises, both within and outside the EU. 

Furthermore,  the  EU  is  a  partner  in  the  Global  Health  Security  Initiative  (GHSI),  a  collaborative  effort  of  countries  and 
organisations  working  together  to  enhance  global  health  security.  The  EU  works  with  partners  such  as  the  United  States, 
Canada,  and  Japan  through  the  GHSI  to  share  information  and  coordinate  efforts  to  address  biological,  chemical,  and 
radiological threats. 

It is also worth noting the alignment with global health initiatives and contributions to global health security. Member States 
actively contribute to global health platforms such as the Pandemic Fund, COVAX, and SHARP JA, which foster international 
collaboration on pandemic preparedness and response. In particular, Austria, Belgium, Cyprus, Denmark, Estonia, Finland, 
France,  Germany,  Ireland,  Italy,  Lithuania,  the  Netherlands,  Portugal,  Romania,  Slovakia,  Slovenia,  and  Spain  have  made 
significant contributions to these initiatives, demonstrating their dedication to enhancing global health security. 

Member States also engage in bilateral and multilateral agreements to enhance cross-border cooperation and information 
sharing. Countries such as Austria, Belgium, Bulgaria, Croatia, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, 
Ireland,  Italy,  Latvia,  Luxembourg,  the  Netherlands,  Poland,  Portugal,  Slovakia,  Spain,  and  Sweden  have  established  a 
multitude of partnerships and agreements with neighbouring countries and international health bodies. These partnerships 
are  instrumental  in  coordinating  responses  to  health  threats  and  facilitating  the  sharing  of  knowledge,  expertise,  and 
resources. 

Some  EU  Member  States  also  engage  in  international  cooperation  due  to  their  distinctive  geographical  and  linguistic 
circumstances. France has established close health cooperation with its overseas territories, including the Caribbean, Indian 
Ocean, and Pacific regions, in order to address unique public health challenges and ensure coordinated responses to health 
emergencies. France also works with African countries through WHO regional offices, utilising its historical links and linguistic 
commonalities to enhance health systems and epidemic preparedness. 
Switzerland, notwithstanding its non-membership in the EU, actively participates in EU health initiatives and maintains strong 
bilateral agreements with neighbouring countries such as France, Germany and Italy. Switzerland's participation in the Horizon 
Europe research programme and its contributions to the European Medical Corps demonstrate its dedication to global health 
security.  
Finally, Portugal and Spain have signed health cooperation agreements with Latin American countries due to their linguistic 
and  historical  links.  These  agreements  facilitate  the  sharing  of  knowledge  and  resources,  particularly  in  the  fight  against 
infectious diseases such as Zika and dengue fever. Furthermore, the collaboration between Spain and Morocco prioritises the 
mitigation of cross-border health risks and the enhancement of public health infrastructure in North Africa. 

3.1.3.7  Health security coordination 

Health safety coordination in the EU Member States shows distinct organisational patterns, reflecting both centralised and 
decentralised approaches. 

One  significant  trend  observed  is  the  centralisation  of  health  safety  coordination  within  national  health  ministries  or 
equivalent  bodies.  Countries  such  as  Austria,  Bulgaria,  Cyprus,  Estonia,  France,  Greece,  Hungary,  Ireland,  Italy,  Lithuania, 
Poland,  Portugal,  Romania,  Slovakia,  Slovenia  and  Sweden  adopt  a  centralised  approach  in  which  a  lead  national  body  is 
responsible for public health crisis management, including the deployment and use of MCMs. These national authorities often 
oversee crisis management plans, ensure coordination between different governmental and non-governmental entities, and 
ensure that health measures are implemented in a uniform manner across all regions. For instance, in France, the Ministry of 
Health, through Santé Publique France, coordinates responses to health crises at national level, ensuring unified and effective 
deployment of resources and MCMs. In Ireland, the Health Service Executive (HSE) plays a similar role, managing public health 
responses and coordinating with the various stakeholders. 

Another dominant pattern is the integration of multi-departmental and cross-sectoral coordination mechanisms. This involves 
collaboration between different government departments, health agencies and non-health sectors, such as interior ministries, 
civil protection units and the armed forces. Belgium, Denmark, Finland, Germany, Latvia, Luxembourg, Malta, the Netherlands, 
and  Spain,  embody  this  approach.  They  use  multi-departmental  crisis  centres,  inter-agency  platforms,  and  strategic 
coordination  committees,  to  manage  health  security  and  MCMs.  These  structures  ensure  a  comprehensive  and  coherent 
response, addressing the different aspects of crises, from logistics and communication to public health measures and resource 
allocation.  For  example,  the  German  Federal  Ministry  of  Health  works  closely  with  the  Robert  Koch  Institute  and  the 
Bundeswehr (armed forces) to coordinate global responses to health crises. In Finland, the Ministry of Social Affairs and Health 
works with various agencies through its crisis room to manage health emergencies. 

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The role played by regional and local authorities is significant in coordinating health security. Countries with decentralised 
health systems rely on regional public health authorities to adapt responses to local contexts and needs. These regional bodies 
are responsible for implementing national strategies at local level, ensuring that MCMs are distributed and used effectively 
within  their  jurisdiction.  In  Italy,  regional  health  authorities  play  a  key  role  in  managing  health  crises,  adapting  national 
guidelines to local conditions, and ensuring the effective distribution of medical supplies and resources. Spain also uses a 
decentralised approach, with regional health ministries managing public health responses within their territory, with support 
from  the  national  health  ministry.  In  the  UK,  local  authorities  played  a  crucial  role  in  managing  the  distribution  and 
procurement of PPE during the COVID-19 pandemic, ensuring that hospitals and care homes had the necessary supplies. 

Some  Member  States  have  set  up  crisis  management  centres  or  crisis  rooms  to  facilitate  real-time  coordination  and 
decision-making during health emergencies. The Austrian Federal Alarm Centre (FAC), the crisis room of the Finnish Ministry 
of Social Affairs and Health (MSAH) and the Polish crisis management centre are examples of this trend. These centres act as 
information hubs, constantly monitoring, coordinating, and disseminating essential information during crises. They ensure 
that  national  responses  are  timely  and  based  on  the  most  up-to-date  data,  improving  the  overall  effectiveness  of  the 
deployment of crisis management and public health measures. In the Netherlands, the National Institute for Public Health 
and  the  Environment  (RIVM)  operates  a  crisis  coordination  centre  that  integrates  data  from  regional  health  services  to 
effectively manage national responses. 

Expert and advisory bodies also play a crucial role in coordinating health safety in several countries. Institutions such as Santé 
Publique France, the Haute Autorité de Santé (HAS) and the HCSP in France, the Robert Koch Institute (RKI) in Germany and 
the  Health  Council  in  the  Netherlands  provide  scientific  advice,  risk  assessments  and  policy  recommendations.  Their 
involvement ensures that health security strategies are evidence-based and reflect the latest scientific knowledge, thereby 
contributing to the effective management of MCM during public health crises. 
The  Estonian  Health  Board  and  the  Latvian  Centre  for  Disease  Prevention  and  Control  also  play  a  significant  role  in  their 
respective countries, providing expertise and coordinating health security measures. 

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Third  Countries’  approaches  to  public  health  crisis 

3.2 
preparedness and response in MCMs 

The study encompasses 45 third countries, comprising a total of 150 entities engaged in activities and operations relevant to 
HERA. 
Given the breadth of the third-country scope, the study team followed different criteria for the selection and study of those 
countries: 

•
•

•

•

•

the G20 countries: all the G20 have been included
the EU candidate countries have been included (Albania, Bosnia and Herzegovina, Georgia, Moldova, Montenegro, 
North Macedonia, Serbia, Türkiye, Ukraine). As a potential candidate, Kosovo has also been included,

13
,

countries with a strong involvement in health crisis preparedness and response on their continent and/or heavily
engaged in supranational organisations on their continent. For instance, this is the case for Rwanda, which has
been significantly involved in the implementation of the African Pharmaceutical Technology Foundation, and
Norway, as Norway and South Africa have co-chaired the Facilitation Council of the Access to Covid-19 Tools
Accelerator. Ecuador, Paraguay, and Peru also participate in the ‘Immunization Capacity Scaling Project’ of PROSUR
to foster regional capacities for vaccine research, development, production, and distribution.

countries with a bilateral cooperation in health emergency preparedness and response with other countries
included (Singapore has a strong bilateral cooperation with Australia, Colombia has a bilateral agreement with
Denmark),

countries that stand out due to specific situations relevant to HERA's tasks, including: 

o

o

Cuba with the context of the embargo: The U.S. embargo has significantly impacted Cuba's
pharmaceutical production by restricting access to essential medicines and equipment. Despite these
challenges, Cuba has developed a robust biotech sector, focusing on import substitution and domestic
production, and creating innovative solutions (for instance a anti-meningitis B vaccine),
Countries which are significant technology hub (e.g. Singapore) or countries that have recently
implemented strong policies to boost R&D and local production of MCMs such as Kenya, Ethiopia,
Senegal

14
. 

The selection criteria are reiterated at the beginning of each section by continent. 

These various selection criteria have ultimately led to the inclusion of the following countries in the study: 

Continent 

Africa 

Asia 

Europe (non-EU) 

North America 

South America 

Oceania 

Total 

Nb. of 
countries 

Nb. of entities 
identified 

List of countries included 

10 

10 

13 

4 

6 

2 

45 

32 

37 

39 

16 

15 

11 

Egypt, Ethiopia, Rwanda, South Africa, Kenya, Zambia, 
Morocco, Ivory Coast, Nigeria, Senegal 

China, India, Indonesia, Japan, Saudi Arabia, South Korea, 
Taiwan, Malaysia, Vietnam, Singapore 

Türkiye, Russia, Norway, UK, Albania, Bosnia and 
Herzegovina, North Macedonia, Montenegro, Kosovo, Serbia, 
Moldova, Ukraine, Georgia 

Canada, USA, Mexico, Cuba 

Argentina, Ecuador, Brazil, Peru, Paraguay, Colombia 

Australia, New Zealand 

150 

- 

Figure 1 - Table of third countries covered by the study. 

The 150 identified entities are distributed as follows: 

13

14

 The G20 countries which are also Member States are addressed in the Member States section. 
 A summary table is included in the appendix, detailing the selection criteria for each country. 

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Figure 2 - Graph showing the distribution of identified HERA-like entities by continent. 

The following sections present a cross-country overview by geographic regions, aimed at highlighting the characteristics and 
operations of the various identified entities. More detailed information on each country is provided in the descriptive sheets 
in the Annex. 

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3.2.1  Synthesis

In third countries, the study identified entities that carry out all or part of the HERA tasks in 45 countries. Overall, the number 
of entities which map to HERA’s mission and tasks ranges from 1 to 6 in third countries (3.3 on average). There are disparities 
between regions and countries. Some countries already have established and structured entities with strong preparedness 
and response capacities; this is notably the case for the USA, Australia, Japan, and South Korea. 
It should be noted that in Africa, there is a gradual strengthening of capacities in this region, with significant efforts being 
made at both national and regional levels. Of the 10 African countries included in this study, all have entities that cover all or 
part of the HERA tasks. Egypt is the only for which some HERA tasks have not been identified

15
. 

The  study  highlighted  that  many  countries  have  implemented  initiatives  to  strengthen  their  preparedness  and  response 
capacities in response to the COVID-19 crisis. This is notably the case in Africa, with initiatives and projects to promote local 
manufacturing and advanced R&D of medical countermeasures. 
Additionally, 5 countries have established new entities to strengthen their capacities for certain tasks: 

•

•

•

•

•

Australia  with  the  new  CDC  launched  in  2024,  aims  to  enhance  the  national  health  emergency  planning  and
preparedness  by  strengthening  partnerships  with  stakeholders  and  providing  transparent  and  consistent  public
health advice,

Singapore  with  the  Communicable  Disease  Agency  established  in  2023,  aims  to  oversee  disease  preparedness,
prevention, surveillance, risk assessments and outbreak response, 

Japan with the Cabinet Agency for Infectious Disease Crisis Management established in 2023 within the Cabinet
Secretariat  as  a  permanent  entity  for  infectious  disease  crisis  management.  It  has  the  authority  to  plan  and
formulate important policies with the Cabinet and to coordinate all administrative departments so that the agency
functions as a leader during both daily operations and in emergency situations,

New Zealand with the Public Health Agency - Te Pou Hauora Tūmatanui, established in 2022 lead all public health
and population health strategy, policy, regulatory, intelligence, surveillance, knowledge, and monitoring functions
in New Zealand to support the Ministry of Health. Its core mission is to support the Ministry of Health in the health
security coordination,

The United Kingdom with the creation of ARIA in 2022. The Agency encourages, facilitates, and provides advice
regarding R&D and provides financial support by way of grants, loans, investments in companies or other entities.
It also aims to make available rights or other property. ARIA gives weight to the potential for significant benefits to
be achieved or facilitated through scientific research, or the development and exploitation of scientific knowledge,
that carries a high risk of failure.

The study revealed that all 150 entities studied contribute to strengthening the global health emergency preparedness and 
response architecture at various levels. Ministries of Health frequently participate in cooperation projects; nonetheless, the 
study underscores that cooperation extends beyond ministries to include other heavily involved entities. The study particularly 
highlights certain well-established cooperations: 

•

•

•

The  trilateral  cooperation  between  China,  Japan,  and  South  Korea  on  a  range  of  issues,  including  health.
Recognizing the critical role of cooperation in the health field, particularly in response to emerging and re-emerging 
infectious diseases, the governments adopted the Joint Statement on Future Pandemic Prevention, Preparedness,
and Response during the 9th Trilateral Summit Meeting in June 2024. The statement aims to enhance collaboration
in managing health emergencies, including infectious diseases, among the Ministries of Health and other national
agencies for disease control in the three countries.
The bilateral cooperation established between Singapore and Australia has led to several notable achievements.
Firstly, the two Ministries of Health have agreed to a dose-sharing arrangement of COVID-19 vaccines, which will
support  each  other  in  optimising  their  respective  schedules  for  vaccinating  their  populations  against  COVID-19.
Secondly, the two new agencies created in response to the Covid-19 crisis – the new Communicable Disease Agency 
of Singapore and the interim Australian Centre for Disease Control – have been engaged in exchanges of experiences 
and ideas. 
The  Quadrilateral  Medical  Countermeasures  Consortium,  a  four-nation  partnership  involving  the  Defence  and
Health Departments of Australia, Canada, the United Kingdom, and the United States. Its objective is to develop
medical countermeasures to assist with all-hazard preparedness and response for the participant countries. The
Consortium focuses on sharing information and cooperation regarding the advanced development of MCMs. Its goal
is to enable participating countries to stay abreast of diagnostic and therapeutic developments, to act swiftly in
deploying appropriate treatments, and to achieve significant cost savings by accessing the results of joint research
and development with other countries.

15

 The information available to the study team did not allow for a precise identification of which entities are responsible for these tasks. 

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•

At regional level, the Rwandan Ministry of Health has played a significant role in establishing the African
Pharmaceutical Technology Foundation (APTF) and elevating it to the status of an international agency. This was
achieved through collaboration with the African Development Bank and the signing of the Host Country
Agreement for the Foundation in Kigali in December 2023. 

Furthermore,  developing  countries  are  actively  involved  in  South-South  cooperation  dynamics,  developing  strategic 
partnerships  with  other  developing  countries  to  share  knowledge,  technologies,  and  resources  in  order  to  strengthen 
capacities and promote sustainable common development. 
The Health Development Partnership for Africa and the Caribbean (HeDPAC) is an international not-for-profit organisation 
which aims to bolster South-South cooperation and enhance institutional capacity both within and between the two regions 
and beyond. Local manufacturing is one of the priorities of this initiative; it promotes advances in technology transfer to 
enhance self-reliance, improved access to quality and affordable medical products with increased regulatory capacity in the 
regions. 

The study also underscored that supranational organisations play a major role in promoting the sharing of information and 
best practices and coordinating on a range of topics and projects. These organisations aim to support their member states 
in strengthening their preparedness and response capacities. 
Eleven supranational organisations have been identified. Nine of these involve cooperation based on geographic proximity, 
such as continental organisations like Africa CDC or regional groups like Gulf-CDC and the Indian Ocean Commission. 
The other two organisations are supraregional cooperations:  

•
•
•

The Medical Countermeasures Consortium, a four-nation partnership involving the Defense 

and Health Departments of Australia, Canada, the United Kingdom, and the United States. 

The Health Development Partnership for Africa and the Caribbean (HeDPAC), which brings together countries from
the African Union and CARICOM in a South-South cooperation initiative. It aims to bolster South-South
cooperation, enhance institutional capacity both within and between the two regions and beyond, maximize
health development impact, and promote technology transfer.

In terms of activities and tasks, 4 out of the 11 identified supranational organisations have a scope of competence as broad 
as HERA and engage in activities related to HERA's seven tasks: Africa CDC, PAHO, ASEAN, and the Gulf-CDC. The remaining 
seven  organisations  focus  on  specific  aspects  of  preparedness  and  response  to  health  crises.  For  instance,  the  African 
Pharmaceutical  Technology  Foundation  aims  to  enhance  the  capabilities  of  African  businesses,  research  institutions,  and 
governments to foster a robust and competitive pharmaceutical industry in the region. Similarly, the Nordic Pharmaceutical 
Forum promotes knowledge sharing and facilitates collaborative efforts among countries, such as joint procurement and joint 
price negotiations. 
It should also be noted that these organisations are not limited to the local level: they seek to reinforce the global health 
architecture through projects (e.g., ASEAN-Australia cooperation) or information sharing. 

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3.2.2  Africa 

Figure 3 - Map of African countries and regional organisations covered by the study, and summary table. 

Africa accounts for 2% of global research on new infections and hosts 375 pharmaceutical manufacturers, with 15% of these 
being locally owned. Access to basic diagnostics remains limited, with 19% of the African population able to access them, and 
few African manufacturers produce new testing technologies 16. 
In parallel, Africa faces the largest burden of endemic diseases globally, with infectious diseases posing a particularly severe 
threat. Outbreak-prone diseases are also increasingly devastating, contributing to the majority of the estimated 10 million 
deaths per year from infectious diseases, which occur in Africa. 
The  African  continent  is  facing  several  other  challenges  that  could  potentially  lead  to  health  emergencies.  One  of  these 
challenges  is  the  continent's  significant  vulnerability  to  climate  change,  which  is  exacerbating  extreme  weather  events, 
desertification,  and  water  scarcity,  seriously  affecting  agricultural  production  and  food  security.  In  addition,  the  effects  of 
conflict and economic shocks are further exacerbating the issue of recurrent famines and food insecurity. The lack of access 
to safe drinking water and sanitation continues to present a significant public health challenge, with the risk of the spread of 
water-borne  diseases.  Furthermore,  the  prevalence  of  conflict  and  political  instability  in  many  regions  has  led  to  the 
emergence of complex humanitarian and health crises. 

Numerous initiatives and projects are gradually being implemented at national and regional levels to enhance the continent's 
capacities and improve its resilience in the face of health emergencies. 

At the continental scale, three entities play a significant role in preparedness and response to health crises, in connection 
with medical countermeasures: 

• The  Africa  CDC,  the  Africa  Centres  for  Disease  Control  and  Prevention,  which  aims  to  strengthen  the  capacity  and
capability of Africa’s public health institutions as well as partnerships to detect and respond quickly and effectively to
disease threats and outbreaks, based on data-driven interventions and programs,

• The  African  Pharmaceutical  Technology  Foundation,  dedicated  to  enhancing  the  capabilities  of  African  businesses,
research institutions, and governments to ensure a robust and competitive pharmaceutical industry in the region,

16

 The APTF web site 

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• The  Indian  Ocean  Commission  (IOC),  whose  objective  in  public  health  is  to  improve  health  of  member  states’
populations through better and more intense cooperation, collaboration, integration, capacity building and coordination
at regional level.

In terms of medical countermeasures in preparedness and response at national levels, the roles of the 10 studied countries 
are diverse: 

• Known as one of the pioneering countries in the establishment of a national surveillance system for monitoring infectious
disease, Egypt stands out as the largest producer and consumer of pharmaceuticals in the Middle East and North Africa
region  and  plays  a  significant  role  in  global  pharmaceutical  supply  chains.  Notably,  Egypt  hosts  the  Northern  Africa
Regional Coordination Centre (RCC) of the Africa CDC, contributing to regional health coordination efforts.

• Rwanda  emerges  as  a  focal  point  for  African  initiatives  aimed  at  strengthening  regulatory  harmonisation,  enhancing
access to affordable medicines, and bolstering domestic manufacturing capacity for drugs and vaccines. Key milestones
include the inauguration of Africa's first mRNA vaccines plant in Kigali and the establishment of the African Pharmaceutical
Technology Foundation to bolster the continent's pharmaceutical industry. Additionally, Rwanda hosts the headquarters
and secretariat of the African Medicines Agency (AMA), which will facilitate regulatory harmonisation efforts across Africa.

• South Africa co-led the Johannesburg process with Norway, a cooperation initiative aimed at fostering collaboration for
equitable access to medical countermeasures against pandemic threats. The country is a major pharmaceutical producer
for  the  continent  as  Morocco  and  South  Africa  together  provide  more  than  70%  of  pharmaceutical  product  demand
through local production 17. The country continues to demonstrate an interest in establishing itself as a pharmaceutical
and biotech production hub, with partnerships between local and international pharmaceutical manufacturers underway.

• Ethiopia  has  received  substantial  support  from  the  World  Bank  to  bolster  its  public  health  emergency  preparedness.
Efforts are underway to develop industrial parks and establish a pharmaceutical hub, reflecting Ethiopia's commitment
to transforming its pharmaceutical industry into an internationally competitive and compliant sector.

• Ivory Coast has received support from the WHO for the preparation and response to the COVID-19 health crisis, including 
assistance with the logistics of MCMs. In 2021, the country also conducted a response to the outbreak of Ebola cases; the 
country swiftly initiated the vaccination of frontline healthcare workers and contacts of confirmed cases. In parallel, Ivory
Coast  is  seeking  to  enhance  its  local  production  of  pharmaceutical  products  with  the  objective  of  covering  20%  of
national needs by 2025 and 30% by 2030, up from the current 6%.

• In the context of its 'Bottom-Up Economic Transformation Agenda', the Kenyan government is committed to promoting
local  pharmaceutical  production  and  aims  to  become  a  leading  regional  hub  in  the  production  of  medicines  and
healthcare supplies. One of the objectives is to achieve a production of at least 50% of health products and technologies
listed in the Kenya Essential Medicines List locally by 2026.  Moreover, Kenya is  the host country of the Eastern Africa
Regional Coordination Centre of Africa CDC.

• Morocco is actively pursuing the development of self-reliance and local production of pharmaceuticals, vaccines, and
PPE, including masks, gloves, gowns, overshoes, and head coverings. In 2022, the Government launched a new program
for the pharmaceutical sector for the period 2022-2027, which sets objectives for job creation and revenue figure within
the sector. 

• To date, Senegal imports over 90% of its medicines and 99% of its vaccines. Several projects are being implemented to
increase  this  capacity.  One  such  project  is  MADIBA,  'Manufacturing  in  Africa  for  Disease  Immunisation  and  Building
Autonomy,' spearheaded by the Institute Pasteur of Dakar. Moreover, in 2024, the Senegalese government presented the 
Plan for an Emerging Senegal', which includes the objective of locally manufacture 50% of the country’s pharmaceutical
products by 2035. Moreover, the IPD of Dakar plays a crucial role in the global monitoring and surveillance network and
was designated as reference laboratory for the region during the Covid-19 crisis.

• Nigeria was one of the countries heavily affected by Ebola in 2014, and the country's effective response was recognized
both  locally  and  internationally.  The  COVID-19  pandemic  has  spurred  and  expedited  actions  towards  enhancing  local
manufacturing  of  medicines  and  vaccines  in  the  country.  Nigeria  has  studied  the  feasibility  of  domestically  producing
COVID-19 vaccines and was selected as one of six African countries to receive the technology required for manufacturing 
mRNA vaccines. In addition, the Federal Ministry of Health led the design of a multi-lateral framework for cross-border
collaboration between Nigeria, Benin, Chad, Cameroon, and Niger to strengthen cross-border surveillance and sharing of
information.

• Zambia is the host country of Africa CDC’s Regional Coordination Centre in Southern Africa. The government is trying to
reduce  costs  on  the  importation  by  promoting  the  setting  up  of  local  manufacturing  of  essential  medicines.  Zambia's
ambition  is  to  become  a  producer  and  eventually  an  exporter  of  pharmaceutical  products  in  the  region  and  beyond.
Furthermore, Zambia is implementing various initiatives to enhance its capacities. For instance, The Zambia Multisectoral
Pandemic  Preparedness  and  Response  Project,  supported  by  the  Pandemic  Fund,  aims  to  strengthen  the  national

17

 In 2022 

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surveillance, laboratory systems, and workforce capacity for preparedness and response to public health events, especially 
those requiring a One Health approach. 

In  addition,  the  Team  Europe  Initiative  on  Manufacturing  and  Access  to  Vaccines,  Medicines  and  Health  Technologies 
(MAV+) works with African partners to strengthen their local pharmaceutical systems and manufacturing capacity. It focuses 
on  three  key  areas:  supply-side  investment  in  local  pharmaceutical  companies,  demand-side  market  integration,  and 
enhancing the regulatory environment to ensure the quality of health products. 
Announced in 2021 with an initial €1 billion investment, the initiative supports projects like vaccine manufacturing in Senegal 
and local production in South Africa (MADIBA project) and collaborates with entities such as the African Medicines Agency. In 
December 2023, it led to a €40 million financial agreement to strengthen the ecosystem for manufacturing health products 
in Rwanda, as the first mRNA facility opens in Kigali. 

At the beginning of each paragraph, the study team refers to these 10 countries and specifies for which countries the task has 
been properly identified, along with the number of entities identified. 
The following paragraphs aim to highlight the synergies and differences among the various entities identified in Africa. 

3.2.2.1  Monitoring, Intelligence gathering and analysis 

In  Africa,  all  the  10  countries  studied  have  entities  identified  as  being  responsible  for  the  analysis  of  health  threats,  the 
intelligence gathering and evaluation of the potential consequences and impact on public health

18
. 

Among the studied countries, it is observed that this task is generally under the Ministries of Health. 
5 countries have centralized this activity exclusively within the Ministry of Health: Egypt, Kenya, Morocco, Rwanda, and 
South Africa. 
In the other five countries, this task is carried out by the Ministry in coordination with other entities: 

•
•
•
•
•

The Public Health Institute in Ethiopia,
The National Institute of Public Health in Ivory Coast,
The Nigeria Centre for Disease Control and Prevention (NCDC),
The Zambia National Public Health Institute (ZNPHI),
The Centre for Health Emergency Operations and the Institute Pasteur of Dakar in Senegal. 

More specifically in Zambia, the ZNPHI is mandated to lead in safeguarding Zambia’s health security through surveillance and 
disease intelligence systems. The Institute analyses health threats, conducts hazard mapping and risk assessments for districts 
and evaluates the potential consequences and impacts of health threats. The entity also provides an integrated platform for 
information collection, collation, and dissemination regarding health threats. Moreover, the Institute collaborates with Africa 
CDC and the World Bank to strengthen continental and regional infectious disease detection and response systems through a 
project called "The Africa CDC Financing Project". 
In Senegal, the COUS is a permanent institution responsible for coordinating, early detection, and managing the response to 
health crises. Its missions include the continuous monitoring of events that could lead to national-scale health crises, and the 
investigations when an event that could lead to a health crisis is identified. The COUS also conducts intelligence gathering and 
maintains an updated list of health threats that could impact health in Senegal. 

At the regional organisation level, both the Africa CDC and the Indian Commission ensure this task. These organisations 
analyse  health  threats,  evaluate  their  potential  consequences,  and  impact  on  public  health,  and  provide  guidelines  to 
countries on the implementation of medical countermeasures. 
The role of the APTF is slightly different: this foundation focuses more on strengthening Africa's technological capacities to 
boost  its  R&D  and  pharmaceutical  production  capabilities.  Consequently,  this  organisation  is  more  focused  on  the 
identification, intelligence gathering, and analysis of R&D and pharmaceutical production technologies. 

3.2.2.2  Advanced Research and Development capacities 

At  the  regional  level,  both  the  Africa  CDC  and  the  APTF  promote  R&D  efforts  aimed  at  developing  effective,  safe,  and 
affordable  MCMs.  Similar  to  the  aforementioned  case,  the  APTF  is  particularly  focused  on  enhancing  Africa's  overall 
capacities  in  the  pharmaceutical  domain.  For  instance,  in  the  realm  of  R&D,  the  foundation  invests  in  critical  regional 
pharmaceutical  infrastructure  and  fosters  collaborative  linkages.  Its  objectives  also  include  building  stronger  centres  of 
excellence and networks for basic and translational research. 

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At national level, 15 entities have been identified as ensuring this task. 
In Rwanda, two entities have been identified for their activities regarding R&D of MCMs. Firstly, the National Council for 
Science and Technology (NCST) conducts studies and analyses current trends and future needs in science, technology, and 
innovation (STI), with the aim of enhancing regional and international collaboration in these areas. The NCST also regulates 
research activities in Rwanda to prevent potential duplications and provides policy recommendations on science, technology, 
research,  and  innovation.  In  parallel,  the  Rwanda  Biomedical  Centre  (RBC)  also  plays  a  significant  role  in  this  field  by 
conducting research and implementing innovative health interventions to safeguard the nation against diseases and other 
health threats. 

South Africa is a major technological hub in Africa. A mRNA vaccine technology transfer hub has been established in Cape 
Town to enhance capacity in low- and middle-income countries for manufacturing mRNA vaccines. This centre of excellence 
and training, supported by WHO, facilitates the sharing of technology and technical expertise with local producers. Research 
and technology transfer play a crucial role for South Africa by facilitating innovation and industrial development through the 
practical application of technological advancements. 
The National Department of Health supports the R&D of vaccines and medicines for communicable and non-communicable 
diseases to ensure access to affordable essential medicines and vaccines. The National Institute for Communicable Diseases 
(NICD)  provides  specialist  advice  during  outbreak  situations  and  offers  technical  support  for  all  aspects  of  communicable 
disease  outbreaks  nationwide.  Its  activities  also  focus  on  laboratory  services,  as  the  institute  aims  to  optimize  available 
laboratory services during outbreak events. 

National institutes of public health or medical research play a predominant role in this task: 

•
•

•

•

•

In Zambia, the Zambia National Public Health Institute promotes advanced R&I regarding laboratory capacities.
In Kenya, the Kenya Medical Research Institute (KEMRI) promotes and coordinates advanced R&D on MCMs.
Notably, the Institute has developed the Infectious and Parasitic Diseases Research Programme, which aims to
develop tools and technologies for the reduction of disease burden due to infectious and parasitic agents.
In Senegal, the Institute Pasteur of Dakar promotes and encourages R&I for the development of effective and
affordable MCMs. It also plays a crucial role in the diagnostic activities.
In Ivory Coast, the National Institute of Public Health promotes R&I, supervises, and develops operational
research and applied research in public health, particularly in the pharmaceutical field.
In Ethiopia, the Ethiopian Public Health Institute promotes R&I in vaccines and diagnostics. Its missions include
acting as a focal point within Ethiopia for human vaccine R&D with external partners and organisations, as well as
promoting, initiating, and implementing collaborative R&D platforms for vaccines.

In Morocco, the Moroccan Foundation for Advanced Science, Innovation and Research (MAScIR) is a central actor for the 
promotion of advanced R&I for the development of MCMs. It seeks to promote and develop technological research hubs in 
the  fields  of  materials  and  nanomaterials,  biotechnology,  microelectronics,  and  life  sciences.  Its  work  is  oriented  towards 
applied R&I to meet market needs. The MAScIR Foundation also aims to capitalize on the results of its R&I patents through 
technology transfer and the creation of startups, to contribute to the emergence of a knowledge-based economy in Morocco. 
For instance, the MAScIR Foundation has developed a diagnostic RT-PCR test in the context of the SARS-CoV-2 crisis, which is 
characterized by its specificity, high degree of sensitivity and reliability, and controlled cost. Once these tests were developed, 
they became the subject of a collaborative project on the African continent led by Africa CDC. 
In addition, in Morocco, the Ministry of Industry and Trade also encourages and coordinates the research and development 
of MCMs in times of health crisis, in collaboration with the Ministry of Health and Social Protection. 
In Nigeria, the Federal Ministry of Health and the NCDC cooperate to coordinate and promote R&I for MCMs. One example 
is  the  establishment  of  the  Nigeria  COVID-19  Research  Consortium  which  brought  together  academics  and  scientists,  to 
promote high-quality scientific research on identified national priorities in line with the WHO research roadmap for COVID-
19. 
Moreover, the National Institute for Pharmaceutical Research and Development, under the Federal Ministry of Health, is 
responsible  of  the  promotion  and  coordination  of  R&D  of  MCMs:  drugs,  vaccines,  phytomedicines,  commodities,  and 
diagnostics, in this objective of improving sustainable access to safe, affordable, and high-quality healthcare. The Institute 
also seeks for the development of contextual partnerships that can accelerate access to healthcare. 

The study did not reveal any entity responsible for this task in Egypt. 

3.2.2.3  Production / Manufacturing capacities 

Capacity-building  activities  for  the  manufacturing  and  production  of  MCMs  are  relatively  underrepresented  among  the 
identified national entities in Africa. 

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8 of the 10 African countries studied
MCMs, with a total of 12 entities. The study did not reveal any entity responsible for this task in Egypt. 

 have entities dedicated to enhancing the production / manufacturing capacities of 

19

Among the studied countries, it is observed that this task is generally under the Ministries of Health, sometimes with the 
cooperation of other entities:  

•

•

•

•
•

•

•

•

In Ivory Coast, the Ministry of Health, Public Hygiene, and Universal Health Coverage is dedicated to promoting
local drug manufacturing with the goal of increasing the local drug production rate from 6% to 30% by 2030. In
pursuit of this objective, it commenced the process of establishing a new local production and distribution facility
for essential medicines in the country in early 2023,

The  Rwandan  Ministry  of  Health  has  published  a  vision  to  transform  the  country  into  a  regional  hub  for
pharmaceutical production and vaccine manufacturing. It is in this context that Rwanda has played a significant
role in establishing the African Pharmaceutical Technology Foundation (APTF) and elevating it to the status of an
international agency. This was achieved through collaboration with the African Development Bank and the signing
of the Host Country Agreement for the Foundation in Kigali in December 2023, 

The Zambian Ministry of Health launched the “Zambian Government's Pharmaceutical Manufacturing Initiative
(ZPMI)”  in  2022.  Zambia's  ambition  with  this  program  is  to  become  a  producer  and  eventually  an  exporter  of
pharmaceutical products in the region and beyond. To achieve this, the ZPMI aims to enhance access to technology 
in  the  country  and  strengthen  partnership  mentorship  programs  to  help  local  pharmaceutical  manufacturers
prepare  themselves  for  partnerships  with 
institutions,  and
development partners,

international  pharmaceutical  firms,  financial 

In South Africa, the Ministry of Health is also involved in the promotion of local manufacturing,

Kenya  seeks  to  increase  pharmaceutical  local  manufacturing.  Indeed,  through  the  Bottom-Up  Economic
Transformation  Agenda  (BETA),  the  country  has  set  the  objective  of  producing  a  minimum  of  50%  of  health
products and technologies listed in the Kenya Essential Medicines List locally by 2026. In this context, the Ministry
of Industrialization, Trade and Enterprise Development cooperates with the Ministry of Health to realize Kenya’s
goal of becoming a regional hub for the manufacture and distribution of pharmaceutical products,

In Morocco, in 2022, the Ministry of Health launched a new program contract for the pharmaceutical sector for the
period 2022-2027, in partnership with the Ministry of Industry and Trade and other stakeholders. This policy sets
objectives for job creation and revenue figure within the sector. More specifically, in terms of preparedness and
response  to  health  crises,  the  ministries  have  signed  partnerships  and  cooperation  agreements  with  a  range  of
stakeholders in the field of healthcare products and pharmaceuticals in both the public and private sectors. These
collaborations seek to enhance Morocco’s capacity in preparedness and response to public health emergencies and
strive to provide the requisite technologies for drug development and clinical trials within Morocco,

In Ethiopia, the Ministry of Health is implementing a government strategy aimed at establishing a pharmaceutical
hub  through  the  development  of  industrial  parks.  This  strategy  aims  to  strengthen  and  transform  the  Ethiopian
pharmaceutical industry across the entire value chain, making it internationally competitive and compliant.

In Senegal, the Ministry of Health and Social Action promotes local manufacturing projects in the framework of
the Plan for Emerging Senegal. In addition, the National Procurement Pharmacy changed its status in April 2023 to
become  a  Public  Establishment  of  an  Industrial  and  Commercial  Nature  (EPIC).  This  new  status  represents  a
significant move by the Senegalese government towards pharmaceutical sovereignty. With this change, the NPP
now plays a larger role in enhancing manufacturing capacities, as it can invest in the share capital of pharmaceutical 
companies and focus on producing certain essential molecules locally. This aligns with the government's objective
of meeting 60% of the country's local pharmaceutical needs. 
Finally, the Institute Pasteur de Dakar (IPD) is also a key player for the reinforcement of the local manufacturing
capacities. It is leading the MADIBA project, which stands for Manufacturing in Africa for Disease Immunisation and 
Building Autonomy. This project aims to enhance local production capacity through the construction of a messenger 
RNA  vaccine  manufacturing  unit.  Team  Europe,  together  with  other  international  partners,  has  committed  to  a
significant  package  of support  for  the  medium- to  long-term  sustainability  of  this  project:  €6.75 million  in  grant
support to enable technical feasibility studies and project preparation for the new facility at the Institute Pasteur in
Dakar.

In Nigeria, this task is not under the Ministry of Health but under the National Institute for Pharmaceutical Research and 
Development which seeks for the development of contextual partnerships that can accelerate access to healthcare. 

Outside of the example set by the Rwandan government, the study identifies a greater emphasis on this task at the regional 
level: 

19

   Refer to the introductory section for the African continent. 

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• The Africa CDC is taking steps to support and enhance local vaccine production, aiming to have 60% of the continent's
vaccine needs manufactured locally by 2040. Furthermore, in February 2024, the African Union expanded the Africa CDC’s
mandate to include the manufacturing of medicines and diagnostics alongside vaccines.

• The APTF aims to boost the pharmaceutical manufacturing capacities across Africa through comprehensive support
and strategic investments. This includes providing scale-up support and capacity development initiatives, co-financing
investments in private companies and public sector institutions, and collaborating with countries to develop conducive
industrial policies. By investing in critical pharmaceutical infrastructure and promoting impactful technology engagement 
at the regional level, the foundation seeks to drive sustainable manufacturing practices. Additionally, the APTF assists local
African companies in acquiring technology and upgrading their capabilities to enhance competitiveness globally.

• The SEGA One-Health network aims to strengthen diagnostic capacities, particularly focusing on improving capabilities 
for  priority  diseases.  This  involves  enhancing  technical  platforms  at  the  Member  States'  level.  Since  2020,  several
acquisitions of laboratory equipment and reagents have begun for Comoros, Madagascar, Mauritius, and the Seychelles.
These  acquisitions  will  continue,  encompassing  PCR  platforms,  sequencing  devices,  training  programs,  and  various
reagents.

3.2.2.4  Procurement of MCMs 

At the regional level, Africa CDC leads a pooled procurement initiative in collaboration with continental and global partners 
to acquire MCMs. Additionally, the Indian Ocean Commission has also been involved in procuring MCMs during the COVID-
19  crisis  by  purchasing  medical  equipment,  protective  gear,  and  medicines  for  Comoros,  Madagascar,  Mauritius,  and 
Seychelles. 

At national level, 13 entities have been identified. Some countries have chosen to centralize the procurement within a single 
entity: 
•

The Egyptian Authority for Unified Procurement, Medical Supply and The Management of Medical Technology in
Egypt,
the National Department of Health in South Africa,
the New Public Health Pharmacy of Ivory Coast, 
the Medical Supplies Agency in Kenya,
the National Procurement Pharmacy in Senegal, 
the Nigeria Centre for Disease Control and Prevention,
the Zambia Medicines and Medical Supplies Agency,
the Ministry of Health and Social Protection in Morocco.

•
•
•
•
•
•
•

Meanwhile, in Ethiopia and Rwanda, this task is coordinated among multiple entities: 

•

•

Ethiopian Pharmaceuticals Supply Agency (EPSA) cooperates with the Ministry of Health (which is responsible for
overseeing the national procurement activity),
Rwanda Medical Supply Ltd is responsible for regularly procuring drugs, medical supplies, and consumables for
the country. During health emergencies, the Rwanda Biomedical Centre enters into agreements with
manufacturers or distributors to procure medical countermeasures. Additionally, the Ministry of Health may
engage in regional or international partnerships for the procurement of MCMs.

3.2.2.5  Stockpiling and distribution capacities 

At the regional level, one of Africa CDC's strategic objectives is to create and oversee national and regional stockpiles for 
public health emergency response. The Indian Ocean Commission is responsible for distributing procured MCMs, though 
there is currently no publicly available evidence of stockpiling. 

All  10  African  countries  included  in  the  study
countermeasures to enhance their preparedness and response to health crises, totalling 15 entities. 
More precisely: 

  have  implemented  a  strategy  for  stockpiling  and  distributing  medical 

20

• In Rwanda, the Ministry of Health and the Rwanda Biomedical Centre collaborate to establish a stockpile of medical
countermeasures for national use in case of emergencies. This involves setting up necessary infrastructures, acquiring
medical products and consumables, and entering into agreements with manufacturers or distributors to procure MCMs

20

   Refer to the introductory section for the African continent. 

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Final Report 

during public health emergencies. Additionally, the Rwanda Biomedical Centre is responsible for identifying and recruiting 
resources/staffing  for  logistics,  tracking,  and  distribution  of  MCMs.  In  parallel,  Rwanda  Medical  Supply  Ltd  manages 
warehouse operations, distribution, quantification, and stock monitoring, 

• In South Africa, the National Department of Health has implemented a system to ensure the availability of stockpiles
when needed. This includes storing personal protective equipment and vaccines in strategic locations at both national
and provincial levels, including within the private sector,

• In  Egypt,  the  Egyptian  Drug  Authority  is  responsible  for  stockpiling,  while  the  Egyptian  Authority  for  Unified

Procurement, Medical Supply, and The Management of Medical Technology oversee distribution,

• In Ethiopia, the Ethiopian Public Health Institute and the Ethiopian Pharmaceuticals Supply Agency (EPSA) maintain a
national stockpile of medical countermeasures, serving as the primary points of contact in case of emergencies. EPSA is
responsible for monitoring inventory and distribution,

• In Zambia, the Zambia Medicines and Medical Supplies Agency is mandated to procure, store, and distribute medicines
and  medical  supplies  to  all  public  health  institutions  in  Zambia  on  behalf  of  the  Zambian  Government.  The  scope  of
ZAMMSA includes essential medicines, medical and surgical supplies, anti-malarial, anti-retroviral, blood commodities,
and laboratory products, 

• In  Ivory  Coast,  the  New  Public  Health  Pharmacy  oversees  stockpiling  essentials  medicines  and  medical  supplies  and
ensures stock control through regular inventories. The entity is responsible for the distribution to all healthcare facilities
in the country,

• In Kenya, the Medical Supplies Agency (KEMSA) is responsible for the management of the national strategic stock reserve.
For distribution, KEMSA delivers medical supplies to each health facility in Kenya. It has established a distribution network
with the capacity to reach all Public Hospitals, Health Centres and Dispensaries countrywide,

• The  Nigeria  CDC  is  responsible  for  the  management  of  the  national  stockpile.  The  national  stockpile  is  a  reserve  of

essential supplies including drugs, reagents, equipment, vaccines, antidotes, PPE,

• In Morocco, the management of the national stockpile is under the Ministry of Health and Social Protection,
• In Senegal, the COUS oversees the stockpiling of PPE (masks, gloves…) and pharmaceuticals and collaborates with the

National Procurement Pharmacy to monitor and coordinate stock availability for the response.

3.2.2.6 

International cooperation 

All of the studied African regional agencies contribute to strengthening the global health emergency preparedness and 
response architecture through collaboration with global partners. 
Notably, Africa CDC serves as an example with cooperation agreements with the European Commission and collaboration with 
CEPI, UNICEF, among others. 

At the national level, the 10 African countries engage in international cooperation to varying degrees. For instance: 

•

•

•

•

The National Department of Health in South Africa is highly visible on the international stage, collaborating with
Norway under the i-MCM-net initiative of the WHO to enhance collaboration for timely and equitable access to
medical countermeasures against pandemic threats, through the Johannesburg Process. 
The Kenyan Ministry of Health aims to contribute to reinforcing the global health emergency preparedness and
response  architecture  through  several  bilateral  collaborations.  Indeed,  it  cooperates  with  Egypt  (the  Egyptian
Authority for Unified Procurement, Medical Supply, and the Management of Medical Technology, and the Egyptian
Drug Authority) to strengthen pooled procurement, facilitate bilateral trade in health products and technology, and 
build capacity for local manufacturing in the healthcare sector. It also cooperates with Italy on strengthening local
production  of  pharmaceuticals  and  medical  supplies  to  improve  healthcare  self-sufficiency  and  global  health
security, and South Korea in the area of vaccine production (exchange of technology, expertise, and finance).

The Moroccan Ministry of Health and Social Protection is involved in international cooperation to strengthen
capacities for health crisis preparedness and response, particularly at the African continent level. It was notably
the initiator of the 1st African Conference on Health Risk Reduction, which falls within the framework of the global
health system dynamics and the increasing need for reform, particularly in response to the impact of the Covid-19
pandemic. This initiative aimed to encourage the adoption of a scientific and medical approach firmly focused on
Africa's future, emphasizing the necessity of concerted collaboration to address health crises. The conference took
place in November 2022 in Marrakech, with the participation of national and international researchers and
scientists.

To strengthen cross-border collaboration for health security between its neighbours from West and Central Africa,
the Nigerian Federal Ministry of Health led the design of a multi-lateral framework for cross-border
collaboration between Nigeria, Benin, Chad, Cameroon, and Niger. This framework establishes a foundation for
bilateral agreement on sharing infectious disease surveillance information. It also sets the stage for broader
collaboration in incident reporting, joint investigations, and cross-border response efforts.

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•

•

•

•

The  Rwandan  Ministry  of  Health  has  played  a  significant  role  in  establishing  the  African  Pharmaceutical
Technology Foundation (APTF) and elevating it to the status of an international agency. This was achieved through
collaboration with the African Development Bank and the signing of the Host Country Agreement for the Foundation
in Kigali in December 2023. 
In Senegal, the Institute Pasteur of Dakar and CEPI have established a partnership to improve vaccine access in
Africa,  aligning  with  the  African  Union's  60%  vaccine  self-reliance  goal  by  2040.  This  partnership  focuses  on
enhancing IPD's manufacturing capacity to supply vaccines within 100 days of identifying new pathogens, crucial for 
pandemic prevention. The Institute Pasteur of Dakar has also signed an agreement with the Global Health Innovative 
Technology Fund to advance research on infectious diseases in low- and middle-income countries.
The Ethiopian Public Health Institute has established a partnership with an institute in Cuba for technology transfer
for vaccine production.
The Zambia National Public Health Institute (ZNPHI) with Africa CDC and the World Bank to strengthen continental
and regional infectious disease detection and response systems through a project called "The Africa CDC Financing
Project". The project includes the construction, equipping, and staffing of an office complex that serves as a Regional
Centre of Excellence and provides additional capacity to support the Southern Africa region.

Beyond the aforementioned cooperations, Africa is involved in intercontinental and/or global regional cooperations, there are 
established  cooperations  between  certain  countries,  including  Africa-EU  cooperations.  For  example,  the  collaboration 
between Spain and Morocco aims to mitigate cross-border health risks and enhance public health infrastructure in North 
Africa. 
More recently, in February 2024, during the visit to Addis Ababa, Ethiopia, Team Europe emphasized strengthening Africa-EU 
cooperation  in  health,  particularly  in  health  production  and  R&D.  Discussions  and  initiatives  were  centred  on  enhancing 
capabilities  in  vaccine  production,  medical  research,  and  public  health  infrastructure  in  Africa.  This  visit  underscored  the 
commitment to collaborative efforts  aimed at bolstering health resilience and addressing healthcare challenges through 
joint projects and partnerships between Africa and the European Union. 

Africa  is  also  actively  involved  in  South-South  cooperation  dynamics,  developing  strategic  partnerships  with  other 
developing  countries  to  share  knowledge,  technologies,  and  resources  in  order  to  strengthen  capacities  and  promote 
sustainable common development. 
For instance, the Health Development Partnership for Africa and the Caribbean (HeDPAC) is an international not-for-profit 
organisation which aims to bolster South-South cooperation and enhance institutional capacity both within and between the 
two regions and beyond. Local manufacturing is one of the priorities of this initiative; it promotes advances in technology 
transfer to enhance self-reliance, improved access to quality and affordable medical products with increased regulatory 
capacity  in  the  regions.  It  leverages  on  the  Pharmaceutical  Equity  for  Global  Health  Initiative,  particularly  in  the  local 
manufacturing of medical products 21. 

3.2.2.7  Health security coordination 

In all the countries studied, it is the Ministry/Department of Health that oversees health security coordination in case of 
health emergencies. 
Depending on the country, other entities may also provide support by offering advice on specific topics within their scope, for 
example: 
•

The National Institute of Communicable Diseases in South Africa, which provides laboratory-derived information to
assist the NDoH in decision-making. 
The Ethiopian Public Health Institute, which has been given the mandate to serve as a referral medical laboratory
service and to establish and support National Laboratory Quality Assurance programs and systems.
In Zambia, the National Public Health Institute is a key cornerstone in health security coordination, as its mission
is  to  coordinate  public  health  security  by  ensuring  robust  surveillance  systems,  effective  preparedness,  and
emergency response mechanisms to support evidence-based decision-making. For instance, since its establishment 
in 2020: the Institute coordinated the response to scabies outbreak and developed EVD and Cholera contingency
plans. The ZNPHI also provides training of staff, just as the training in eastern province in terms of preparedness for
the threat of cholera due to the outbreak in neighbouring Malawi.
In Senegal, the COUS is central to health security coordination. In case of a health emergency, the entity ensures
the liaison between emergency response actors and the Minister of Health and Social Action. It is also in charge of
the establishment of guidelines to respond to different health threats and, the definition the emergency measures
to be implemented according to health emergency situations.

•

•

•

21

 The role and tasks of the HeDPAC is further detailed in the Supra-regional organisations section (2.2.8). 

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Final Report 

•

In  Nigeria,  the  CDC  oversees  disaster  and  emergency  mitigation  and  manages  their  impact.  It  leads  outbreak
response activities, including the deployment of Rapid Response Teams. During the 2016/2017 Meningitis outbreak,
the  Directorate  oversaw  the  establishment  of  an  Emergency  Operations  Centre,  which  coordinates  outbreak
response activities nationwide. Moreover, its Directorate of Public Health Laboratory Services manages the national
and regional reference laboratories.

Africa  CDC  plays  a  crucial  part in  health  security  coordination by  overseeing  the  African  preparedness  and  response  to 
health crisis, bringing together Member States and relevant stakeholders. 
During  the  Covid-19,  Africa  CDC  played  a  central  role  in  coordinating  the  continent’s  response  by  supporting  informed 
decision-making and the development of common efforts. 
Regarding the Indian Ocean Commission, its SEGA One-health Network seeks to promote regional cooperation in efforts to 
prevent and response to health crisis. 

Africa's  contribution  to  global  research  on  new  infections  is  2%,  with  limited  access  to  basic  diagnostics  and  few  local 
manufacturers producing new testing technologies. However, there is a gradual strengthening of capacities in this region, 
with significant efforts being made at both national and regional levels. 

Of  the  10  African  countries  included  in  this  study,  all  have  entities  that  cover  all  or  part  of  the  HERA  tasks.  Egypt  and 
Ethiopia are the two countries for which some HERA tasks have not been identified. 

It should be noted that in terms of international cooperation, African countries are committed to the reinforcement of 
the preparedness and response capacities at both regional and international levels. 
For  instance,  the  Rwandan  Ministry  of  Health  has  played  a  significant  role  in  establishing  the  African  Pharmaceutical 
Technology Foundation (APTF) and elevating it to the status of an international agency, while the Nigerian Federal Ministry 
of  Health  led  the  design  of  a  multi-lateral  framework  for  cross-border  collaboration  between  Nigeria,  Benin,  Chad, 
Cameroon, and Niger for sharing infectious disease surveillance information. 

Regional entities such as Africa CDC and the APTF are actively engaged in strengthening R&D and manufacturing capacities 
to better prepare African countries to respond to health crises. 
The Indian Ocean Commission also plays a significant role in the region (south-western Indian ocean islands) regarding 
MCMs, and developed a disease surveillance network within the region: the SEGA “One Health” regional surveillance and 
monitoring network. 

Furthermore,  Africa  participates  in  both  intercontinental  and  global  regional  cooperations,  including  significant 
collaborations  with  the  EU.  For  instance,  Team  Europe's  visit  to  Addis  Ababa  in  2024  emphasized  enhancing  Africa-EU 
cooperation in health, particularly in vaccine production, medical research, and public health infrastructure. Africa is also 
deeply  involved  in  South-South  cooperation,  exemplified  by  the  Health  Development  Partnership  for  Africa  and  the 
Caribbean (HeDPAC), which aims to strengthen local manufacturing and technology transfer to promote self-reliance and 
improve access to quality medical products. 

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Final Report 

3.2.3  Asia 

Figure 4 – Map of Asian countries and regional organisation covered by the study, and summary table. 

Historically,  Asia,  particularly  China  and  Southeast  Asia,  has  experienced  the  emergence  of  severe  human  viral  diseases, 
including  several  influenza  pandemics.  In  recent  years,  the  region  has  seen  an  increase  in  viral  outbreaks,  such  as 
haemorrhagic fever, H5N1 avian influenza, Nipah virus, and notably SARS and COVID-19

22
. 

Asia is a major player in biomedical and vaccine R&D, with the East and Southern Asia region alone representing 40% of global 
R&D  expenditures.  China,  in particular,  has  made  significant  strides  in manufacturing  inactivated  COVID-19  vaccines,  with 
several  Chinese  pharmaceutical  companies  developing  their  own  inactivated  vaccines  that  have  successfully  completed 
clinical trials. 
In addition, Singapore is also considered a significant pharmaceutical technology and innovation hub as well as an important 
manufacturing country for pharmaceutical companies. 

In terms of pharmaceutical and medical equipment production, Asia holds significant international influence, largely due to 
the substantial manufacturing capacities of China, India, and Indonesia. 
The  COVID-19  pandemic  highlighted  the  critical  role  of  Asia,  particularly  China,  in  the  global  supply  chain  of  medical 
countermeasures, as the Chinese lockdown led to disruptions in supply processes. Despite its manufacturing capabilities, Asia 
faces challenges due to interdependencies between countries. For instance, disruptions in China's API manufacturing affected 
India's production of generic drugs. Indeed, China is a very important supplier of API to global pharmaceutical manufacturers 
and represents 70% of API imports by India, which itself is a very important pharmaceutical product producer. India is a major 
player in the vaccine market, manufacturing 44% of all vaccine doses globally. 

Despite considerable progress in recent decades, significant inequities persist in Asia. Some countries, like Afghanistan and 
Bangladesh, still experience high rates of poverty and limited access to healthcare. Disparities are also evident in health crisis 
preparedness  and  response.  The  COVID-19  pandemic,  for  example,  highlighted  the  inequitable  access  to  vaccines,  with 
developing and least developed economies struggling to obtain vaccines compared to high-income economies that secured 
bilateral deals for procurement. 

At  the  regional  cooperation  level,  two  entities  are  particularly  significant  in  preparedness  and  response  to  health  crises, 
working in conjunction with efforts related to medical countermeasures. 

• The Association of Southeast Asian Nations (ASEAN), with the ASEAN Health Sector which aims to support the ASEAN

countries to respond to all hazards and emerging threats and strengthening health systems.

22

 Emergence of New Viruses in Asia: Are Climate Changes to Blame? Journal of Infectious Disease Medicine, November 2004 

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Final Report 

• The  Gulf-Centre  for  Disease  Prevention  and  Control,  semi-autonomous  technical  body  of  the  Gulf  Health  Council,
dedicated to promoting coordination, building knowledge and generate evidence to enable prevention of communicable
and non-communicable diseases, mitigating public health emergencies, and promoting healthy communities across the
Gulf.

As detailed in the introduction, the study team selected 10 Asian countries to study, based on the following criteria

23
: 

•

The G20 countries located in Asia (6): China, India, Indonesia, Japan, Saudi Arabia, South Korea.

•
• Malaysia was selected due to its significant burden of infectious diseases and experience with outbreaks (such as
Nipah, SARS, MERS, and H1N1), along with its success in managing the COVID-19 pandemic, evidenced by lower
death and infection rates compared to neighbouring countries and many developed economies. Additionally,
Malaysia is currently collaborating with CEPI to enhance its vaccine research and development capabilities.
Singapore is a significant technology and innovation hub with strong bilateral cooperation with Australia. The
country also has extensive involvement in regional initiatives such as the COVID-19 ASEAN Response Fund. 
Vietnam is a hotspot for influenza virus evolution, with a significant track record in pandemic management. It was
the first country to be declared SARS-free by the WHO and was proactive in vaccine research and development
during the Covid-19 crisis.
Taiwan was significantly impacted by the 2003 SARS outbreak. It has developed a joint research agreement with
Japan and established detailed procurement and stockpiling strategies. 

•

•

The study conducted across these 10 countries scope identified 37 entities. At the beginning of each paragraph, the study 
team  refers  to  these  10  countries  and  specifies  for  which  countries  the  task  has  been  properly  identified,  along  with  the 
number of entities identified. 

3.2.3.1  Monitoring, Intelligence gathering and analysis 

In  Asia,  the  10  countries
intelligence gathering and evaluation of the potential consequences and impact on public health. 

  studied  have  entities  identified  as  being  responsible  for  the  analysis  of  health  threats,  the 

24

Among the studied countries, it is observed that this task is generally assigned to a single entity, which is either a Ministry 
25
. 
(the Ministry of Health in Indonesia) or the Centres for Disease Control and Prevention (the Chinese CDC and Taiwan CDC)
In  India,  this  task  is  undertaken  by  the  Office  of  the  Principal  Scientific  Adviser,  under  the  Cabinet  Secretariat,  which  is 
dedicated to analysing trends in science and technology. For the preparedness and response to health crises, the Principal 
Scientific Adviser reviews and recommends technologies and technology products to ensure India’s readiness and response. 

In the other 5 countries studied, this task is carried out in coordination between several entities. In South Korea and Japan, 
this task is undertaken through collaboration between a Ministry and one or several technical/scientific entities that support 
the Ministry by conducting surveillance, information gathering, and health threats analysis: 

-

-

-

-

In South Korea, the Korea Disease Control and Prevention Agency analyses health threats and produces guidelines
(including guidelines on MCMs), while the Ministry of Food and Drug Safety oversees the collection of relevant
information on MCMs in the context of preparedness and emergencies,

In Japan, the National Institute of Infectious Disease collect date, conducts health threats analysis and intelligence
gathering.  In  the  meantime,  the  Ministry  of  Health,  Labour,  and  Welfare  undertakes  intelligence  gathering  and
analysis  to  gather  pertinent  information  on  outbreak  situations  and  countermeasures,  both  domestically  and
internationally.  Additionally,  during  emergencies  and  post-crisis  phases,  the  MoHLW  evaluates  past
countermeasures and revises guidelines as necessary. 

The  Malaysian  Ministry  of  Health  collaborates  with  the  National  Public  Health  Laboratory  which  analyses,
monitors,  and  reports  laboratory  results  to  support  the  surveillance  activity,  and  the  Institute  for  Public  Health 
which conducts epidemiological and public health research to provide evidence-based guidelines,

In Vietnam, the Ministry of Health collaborates with the National Institute of Hygiene and Epidemiology which
focuses on research in the fields of epidemiology, microbiology, and immunology, and the Pasteur Institute, which
conducts epidemiological surveillance of infectious diseases, 

23

 Refer to the introduction for more details on the methodology and the appendix 4.3 for further details. 

24

 Refer to the introduction for Asia. 

25

 The Chinese CDC and the Taiwan CDC are placed under the supervision of their ministries of health, but their activities in this report are 

distinguished for the sake of detailing and clarity of entities. 

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Study mapping structures with relevant mandates, tasks, and functions to HERA within Member States and globally 

Final Report 

-

In Saudi Arabia, the Ministry of Health cooperates with the Public Health Authority.

Singapore has the singularity among Asian countries of recently announcing (in March 2023) the establishment of a new 
entity, the Communicable Disease Agency, which is involved in monitoring and health risk analysis tasks26. This new entity 
aims to oversee disease preparedness, prevention, surveillance, risk assessments, and outbreak response, in cooperation and 
support of the Ministry of Health. 
Therefore,  the  activity  of  monitoring  and  health  threats  analysis  in  Singapore  is  based  on  the  collaboration  between  the 
Ministry of Health, the new Communicable Disease Agency, and the National Centre for Infectious Disease. 
In addition, the A*STAR (Agency for Science, Technology and Research) supports efforts for surveillance and conducts health 
threats analysis and research. 

At the regional level, both the ASEAN and the Gulf CDC undertake this task to ensure the preparedness and response to 
health  crises  of  their  Member  States.  These  organisations  play  an  important  role  in  intelligence  gathering  and  sharing 
information among its Member States: preparedness and response strategies, best practices, lessons learned, operational 
challenges, gaps… 

3.2.3.2  Advanced Research and Development capacities 

9 of the 10 Asian countries 27 studied have entities dedicated to the promotion and the coordination of advanced R&D to 
develop effective, safe, and affordable MCMs and related technologies, with a total of 18 entities. The study did not reveal 
any entity responsible for this task in Indonesia. 

4  countries  have  specific  entities  dedicated  to  developing  the  country’s  science  and  technology  capabilities,  boosting 
research, and strengthening their international competitiveness. These entities play a significant role in the development of 
MCMs by the country and are also involved in cooperation with other national entities on the subject: 

• In Japan, the AMED (Japan Agency for Medical Research and Development)

 serves as a central coordinating body for
integrated research, overseeing activities from basic research to practical application. It holds a pivotal role in MCMs R&D
within Japan. As a funding agency, aims to advance medical research and development and contribute to Japan's economy
by promoting medicine, drugs, and medical devices as strategic industries. The agency supports various aspects of medical 
R&D, including management, concentration of funding, monitoring, and administration, as well as the enhancement of
clinical research infrastructures.

28

In parallel, the Ministry of Health, Labour and Welfare is responsible for advancing the R&D of medical countermeasures,
including vaccines and drugs, at every stage of a pandemic and the National Institute of Infectious Disease (under the
Ministry) promotes and coordinates basic and applied research projects on infectious diseases. 

• In South Korea, two entities play a major role in advanced R&D for MCMs. Firstly, the Korea Health Industry Development 
Institute (KHIDI) is responsible for overseeing national initiatives aimed at fostering the domestic health industry and
enhancing  its  international  competitiveness.  KHIDI  specializes  in  planning,  evaluating,  and  managing  domestic  R&D
projects  related  to  healthcare.  It  primarily  invests  in  promising  next-generation  technologies,  such  as  innovative  new
drugs, medical devices, and regenerative medicine. Additionally, KHIDI focuses on supporting the development of medical 
technologies  based  on  the  4th  Industrial  Revolution,  including  big  data  and  AI.  Moreover,  KHIDI  is  expanding  its  R&D
activities  into  areas  addressing  social  issues  such  as  contagious  diseases,  dementia,  and  mental  health  by  reinforcing
public investments.

Secondly, the Korea Disease Control and Prevention agency (KCDA) is a central agency specializing in evidence-based 
public  health  management  and  healthcare  R&D,  under  the  Ministry  of  Welfare  and  Health.  It  also  promotes  R&D  on
medical countermeasures. Notably, South Korea is establishing a vaccine library of prototypes to combat target pathogens
within 100 days and adapt to related pathogens within 200 days. In line with this, the KCDA is progressively increasing its 
investment in R&D, following a 2021 pledge by then President Moon Jae-in to invest $1.9 billion to position South Korea
among the world’s top five vaccine producers by 2025.

• In  Singapore,  A*STAR  -  the  Agency  for  Science,  Technology,  and  Research,  is  responsible  for  developing  Singapore's

science, technology, and engineering capabilities to drive economic growth.

In response to the COVID-19 pandemic, A*STAR founded the A*STAR Infectious Disease Lab (ID Labs) to bring together
scientists globally to promote R&D collaboration and partnerships with industry, clinical, and public sector collaborators.

26

 Japan has also implemented a new entity following the COVID crisis, The new Cabinet Agency for Infectious Disease Crisis Management. 

However, this entity primarily plays a role in health security coordination, as will be discussed further. 
27

 Refer to the introduction for Asia. 

28

 HERA and AMED signed a working arrangement to strengthen their cooperation on MCMs to step up prevention, preparedness, and 

response to serious cross border health threats. Source: EU News185/2023, Oct. 2023 

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Study mapping structures with relevant mandates, tasks, and functions to HERA within Member States and globally 

Final Report 

ID Labs focuses on translational research in respiratory and vector-borne diseases, antimicrobial resistance, and epidemic 
preparedness, aiming to develop new technologies for detecting, intervening, and preventing emerging pathogens. 

Moreover, the Epidemic Preparedness Horizontal Technology Coordinating Office, within ID Labs, coordinates A*STAR’s 
research and capabilities in surveillance, detection, intervention, and prevention of infectious diseases. EP HTCO facilitates 
an  integrated  response  to  manage  outbreaks,  fosters  multi-disciplinary  research,  and  promotes  collaboration  and 
communication among researchers. 

The Singapore Ministry of Health is also involved in the promotion and coordination of advanced research and innovation 
to  develop  MCMs.  Indeed,  it  set  up  a  national  program  called  PREPARE,  as  “Program  for  Research  in  Epidemic 
Preparedness  and  Response”,  which  aims  to  support  and  strengthen  Singapore’s  key  essential  research  capabilities, 
translational platforms, and expertise to develop tools, methods and products that can be tapped on to detect, respond 
to, and contain future infectious disease threats. 

• In India, the Office of the Principal Scientific Adviser plays a crucial role in R&D by shaping international discussions and 
advising on private sector engagement. The Empowered Technology Group, one of its initiatives, focuses on coordinating
national R&D policies and offering timely advice.

Additionally,  the  Indian  Council  of  Medical  Research  and  the  Ministry  of  Health  and  Welfare  promote  biomedical
research and advanced R&D through programs like the Ayushman Bharat Digital Mission and the PM-Ayushman Bharat
Health Infrastructure Mission, focusing on enhancing healthcare infrastructure and research capacity.

In other countries, apart from Malaysia, the promotion and coordination of advanced R&D to develop MCMs is primarily 
led by Ministries, in collaboration with other entities in some cases: 

• As  a  new  emerging  high-tech  innovator,  China  has  gradually  increased  public  input  into  infectious  disease-related
innovation and research, emerging as a major player due to its production capabilities and scientific advancements. Amid 
the COVID-19 pandemic, China made rapid advancements in COVID-19 vaccine R&D, launching the world's first clinical
trial  in  March  2020  and  obtaining  regulatory  approval  for  vaccines  by  December  2020.  To  achieve  this,  Chinese
pharmaceutical companies and research institutions collaborated extensively, leading to the development and approval
of  several  vaccines,  including  Sinopharm  and  Sinovac.  These  vaccines  have  been  distributed  globally,  contributing
significantly  to  the  worldwide  vaccination  efforts  against  COVID-19.  Regarding  the  entities  involved,  the  Ministry  of
Science and Technology (MOST) plays a crucial role in the R&D sector. Its main responsibilities include formulating and
implementing strategies and policies for innovation-driven development, coordinating the national innovation system,
leading efforts in developing the national technology transfer system, and promoting collaboration among enterprises,
universities, and research institutes. 

During the Covid-19 crisis, MOST led the R&D response by initiating emergency research projects to accelerate vaccine
development  and  rollout.  The  Ministry  sponsored  multiple  vaccine  candidates,  including  those  developed  by  private
companies and startups.

Additionally, the China CDC is involved in promoting scientific and technological innovation and development.

• The Taiwan Ministry of Economic Affairs (MOEA) is responsible for formulating policy and laws for industry and trade,
foreign direct investment, energy, minerals, measurement standards, intellectual property, state-owned enterprises. In 
2016, the MOEA launched the Biomedical Industry Innovation Program to push forward the development of Taiwan's
biomedical industry. The program aims to promote advanced R&D and the growth of the industry in Taiwan, develop
innovation clusters, connect to global markets, and promote key specialty industries.

• In Vietnam, the Ministry of Health seeks to reinforce the country’s autonomy in research and production of MCMs. In
2022,  it  launched  a  program  aimed  at  ensuring  vaccine  supply  for  vaccination  through  2030.  This  program  sets  the
objective  of  mastering  the  technology  needed  to  produce  15  types  of  vaccines and  manufacturing  at  least  5  of these
vaccines domestically by 2030. It also aims to promote research and production of vaccines, especially for emerging,
dangerous, and highly infectious diseases, new vaccines not available in Vietnam, combination vaccines, and vaccines
against diseases not yet included in the Expanded Program on Immunization.

In Vietnam, the National Institute of Hygiene and Epidemiology and the Pasteur Institute also ensures the promotion of
research. 

• The Saudi Arabian Ministry of Health supports and encourages scientific research, ensures the coordination with the
relevant authorities to encourage medical research and clinical trials. It supports the cooperation with other countries for
clinical studies (e.g., with China during covid-19).

Finally, in Malaysia, the Institute for Medical Research promotes and encourages advanced R&D to develop effective and safe 
MCMs. In fact, with a primary focus on MCMs, it plays a role in advancing the nation's capacity to combat infectious diseases, 
emerging health threats, and other medical challenges.  

Regarding regional cooperation, the ASEAN Health Sector promotes R&I initiatives to enhance the preparedness and response 
to health emergencies. 

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Final Report 

In the Gulf countries, one of the goals of Gulf CDC is to "promote the principle of cooperation in conducting research studies 
related  to  public  health  of  priority  and  coordination  among  its  members".  More  specifically  on  MCMs,  Gulf  CDC  ensures 
research prioritisation and advocacy for regional public health research. The organisation also shares information across the 
Member States on R&D. 

3.2.3.3  Production / Manufacturing capacities 

9  of  the  10  Asian  countries  studied
MCMs. 
The study did not reveal any entity responsible for this task in Malaysia. 

29

  have  entities  dedicated  to  enhancing  the  production  /  manufacturing  capacities  of 

China  holds  a  substantial  role  in  global  pharmaceutical  production  and  a  pivotal  influence  on  the  supply  chain  and 
accessibility  of  medications  internationally.  The  COVID-19  pandemic  highlighted  the  critical  role  of  China,  in  the  global 
supply chain of medical countermeasures, as the Chinese lockdown led to disruptions in supply processes. 
The country is a major supplier of APIs to global manufacturers of generic pharmaceuticals, notably to India, which is itself a 
significant producer of pharmaceuticals. India imports nearly 70% of its APIs from China. 
China's pivotal position in the global supply chain extends beyond medicines; it plays a crucial role in manufacturing other 
MCMs as well. For instance, during the COVID-19 pandemic, global demand for medical masks surged, prompting China to 
significantly ramp up production capacities to meet the increased need. Chinese exports of disinfectants and masks soared by 
over 1000% compared to the previous year, helping alleviate shortages caused by lockdowns in countries affected by the virus. 
In China, the National Health Commission is responsible for the management of manufacturing capacities and ensuring the 
availability of critical technologies and production sites for MCMs. 

In order to boost their manufacturing capacities of Medical Countermeasures during the preparedness phase, certain Asian 
countries/entities have implemented initiatives: 

• In India, the Office of the PSA launched in 2023 the “National Diagnostics Catapult”

 to boost India’s preparedness for
current  &  future  pandemics,  scale  up  diagnostics  for  infectious  diseases  for  Covid  and  beyond.  The  objective  of  this
program  is  to  foster  the  development  and  scaling  up  of  manufacturing  capacities  in  diagnostics,  enabling  the  Indian
diagnostic ecosystem to achieve self-sufficiency in the manufacturing of molecular diagnostics kits for infectious diseases
while also gaining export capabilities.

30

• The Indonesian Ministry of Health is conducting an initiative to carry out health transformation activities that include 6
types  of  transformation,  such  as  the  transformation  of  Primary  Services,  Referral  Services,  Health  Resilience  Systems,
Health Financing Systems, Health Human Resources, and Health Technology.
The pillar "Health Resilience System Transformation" aims to maintain a robust health system amidst global health
threats. To achieve this, it seeks to increase the resilience of the pharmaceutical and medical device sector by promoting
domestic production of 14 routine vaccines, the top 10 drugs, and the top 10 medical devices.

• As mentioned previously, the Vietnamese Ministry of Health seeks to reinforce the country’s autonomy in production
of MCMs. In 2022, it launched a program aimed at ensuring vaccine supply for vaccination through 2030. This program
sets the objective of mastering the technology needed to produce 15 types of vaccines and manufacturing at least 5 of
these vaccines domestically by 2030.

In addition, in October 2023, Vietnam approved a national strategy to develop its pharmaceutical industry, aiming to
ensure access to essential medicines, enhance research capacity, and produce original brand-name drugs. The goal is to
become a regional hub for drug manufacturing, with objectives including producing 80% of domestically consumed drugs 
and capturing 70% of the market value by 2030. 

Beyond these initiatives, this tasks often falls to Ministries, in both preparedness and response phases: 

the Ministry of Health in Saudi Arabia, 
the Ministry of Health, Labour, and Welfare in Japan,
the Indonesian Ministry of Health,
the Vietnamese Ministry of Health,
the Singaporean Ministry of Health.

-
-
-
-
-

More precisely in Japan, the Ministry of Health, Labour, and Welfare promotes the production of medical supplies before 
outbreaks and seeks to enhance production during pandemics, addressing supply chain bottlenecks and ensuring continuous 
operations. It has the authority to request producers and sellers of vaccines to suspend their classic production and shift to 
the production of pandemic vaccines to optimize capacity utilisation. 

29

 Refer to the introduction for Asia. 

30

 Initiative supported by the Rockefeller Foundation, Bill & Melinda Gates Foundation India, FIND, and Bangalore Life Science Cluster. 

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Final Report 

The Korean Health Industry Development, previously mentioned for its activities in the field of MCMs R&D, seeks to boost 
the domestic health industry in both preparedness and emergency phases. In case of a health emergency, for instance during 
the Covid-19 pandemic, the KHIDI operated a support centre to alleviate problems faced by companies developing Covid-19 
treatments and vaccines. 
The  A*STAR  in  Singapore,  previously  mentioned  for  its  R&D  activities,  is  also  involved  in  enhancing  and  strengthening 
production and manufacturing capabilities, notably through the Advanced Remanufacturing and Technology Centre (ARTC). 
The ARTC is a platform built upon public-private partnerships aiming to accelerate the transfer of innovation from applied 
research to industrial applications and solutions and building capabilities through collaboration with industry members. 

Lastly, in Taiwan, Taiwan CDC holds the authority over policies governing vaccine manufacturing and collaborates with the 
Ministry of Economics Affaires to bolster capacities in case of emergency. 
In fact, in times of health crises, the Ministry of Economic Affairs can engage in negotiations with domestic manufacturers to 
ramp up production capacities of medical countermeasures. For instance, during the COVID-19 pandemic, the government 
collaborated with domestic manufacturers to increase the production capacities of COVID-19 rapid tests and masks. 

In terms of regional cooperation, ASEAN aims to bolster the manufacturing capabilities of medical countermeasures across 
Southeast Asian nations. Through its ongoing initiative, the 'ASEAN Drug Security and Self-Reliance' project (ADSSR), it seeks 
to enhance collaboration among member states to strengthen drug security and self-reliance for MCMs in the region. 
For its part, Gulf CDC has a role in advocating for local manufacturing and production capacities. For this task, the role of 
Gulf CDC is limited to advocacy, and the organisation does not handle the coordination or implementation of projects. 

3.2.3.4  Procurement of MCMs 

All 10 countries studied in Asia

31

 have entities that operate in the procurement of medical countermeasures.  

Some Asian countries have chosen to centralize this activity: 

• Within a dedicated entity for the purchase of medical countermeasures. This is the case in Saudi Arabia with the
National Unified Company for Medical Supplies (NUPCO) and in Vietnam with the National centralized drug
procurement centre.
Or within an entity also performing other functions: 

•

-
-
-
-
-
-

the National Healthcare Security Administration in China,
the Ministry of Health in Indonesia, 
the Japanese Ministry of Health, Labour, and Welfare,
Taiwan CDC,
the Ministry of Health in Malaysia,
the Ministry of Health in Singapore.

More specifically regarding Vietnam: although the procurement of MCMs is centralized under the National Centralized Drug 
Procurement  Centre,  the  Ministry  of  Health  defines  guidelines  and  policies  for  procurement.  It  is  worth  noting  that  the 
Ministry recently announced its strategy "Solutions to Overcoming Shortage of Medicines and Medical Supplies" in response 
to  significant  shortages  encountered  since  2020  due  to  the  COVID-19  crisis.  According  to  the  Ministry  of  Health,  these 
shortages could be attributed in part to complex and lengthy bidding processes. A new legislation published in 2022 by the 
Ministry aimed to address these shortages by simplifying and expediting the bidding process. 

In India, the Central Medical Services Society is the central procurement agency under the Ministry of Health and Family 
Welfare. It ensures the procurement of medicines, vaccines, contraceptives, and medical equipment's for the MoHFW. CMSS 
is also in charge of the quality control and distribution of the mentioned goods. 
The CMSS works in coordination with the Office of the PSA, which is in charge of coordinating and overseeing national policies 
related to the procurement of technologies. 

In  South  Korea,  the  KCDA  and  the  Ministry  of  Health  and  Welfare  cooperates  for  the  procurement  of  medical 
countermeasures, during the preparedness and response phases. 
Additionally,  the  Central  Pharmaceutical  Affairs  Council,  under  the  Ministry  of  Food  and  Drug  Safety,  manages  the 
procurement of essential drugs. 

31

 Refer to the introduction for Asia. 

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Final Report 

Regarding regional cooperation, ASEAN aims to facilitate the procurement of MCMs among the Southeast Asian countries, 
with the objective of ensuring that medicines are available and continuously supplied in both normal times and emergencies. 
Gulf CDC does not directly intervene in the procurement of MCMs. However, the Gulf CDC is part of the Gulf Health Council, 
which operates one of the oldest regional joint procurement programs. Gulf CDC plays a role in providing scientific advice 
for the joint procurement. 

3.2.3.5  Stockpiling and distribution capacities 

9 out of the 10 countries studied have entities have entities in charge of managing the stockpiling of these countermeasures 
and ensuring their timely and efficient distribution during public health emergencies.  
In China, the information available to the team did not enable for the precise identification of the entity responsible for this 
task and how this activity operates in the country. 
In some countries, strategies for stockpiling and distribution of MCMs have been implemented, and detailed information is 
provided on this subject: 

• In Taiwan, the CDC maintains national reserves of antiviral drugs sufficient to supply at least 10% of the population, and
manages stockpiles of vaccines and PPE, such as surgical masks, N95 respirators, and coveralls. Furthermore, Taiwan CDC
has established detailed allocation strategies and is responsible for distributing MCMs in the event of a health emergency,

• In South Korea, the KCDA has identified 11 priority infectious diseases, serving as the foundation for strategic planning
and  resource  allocation.  On  this  basis,  the  KCDA  has  established  a  Strategic  National  Stockpile  comprising  medical
countermeasures pertinent to these eleven diseases. Additionally, similar reserves are maintained to address chemical
and radiation emergencies,

• In Singapore, the Ministry of Health ensures the management of the national stockpile of MCMs. It also monitors the
stock levels of commonly used medicines and medical supplies and, if necessary, cooperates with retailers to procure
additional  stocks  to  meet  the  demand.  Regarding  the  distribution,  in  extreme  situations  where  there  may  be  global
shortages, the Ministry can take measures such as imposing sales limits to prevent hoarding and ensure the medicines
and medical supplies are timely and efficiently distributed. 

Most of the entities responsible for procurement also handle the stockpiling and distribution of MCMs: 

•
•
•
•
•
•

NUPCO in Saudi Arabia, in coordination with the Ministry of Health,
The Ministry of Health, Labour and Welfare in Japan,
The Central Medical Services Society in India, 
The Ministry of Health in Indonesia, 
The Ministry of Health in Malaysia,
The Vietnamese Ministry of Health through the General Department of Preventive Medicine.

National  Disaster  Management  Agencies  also  play  a  role  in  certain  countries  to  establish  stocks  of  MCMs  and  their 
distribution. This is the case in Indonesia (agency also known as BNPB) and in India, where the National Disaster Management 
Agency ensures the stockpiling of MCMs in case of a CBRN

 emergency. 

32

At regional level, the ASEAN ensures this task for South-East Asian countries. For instance, During the COVID-19 crisis, the 
ASEAN  ensured  the  provision  of  medical  supplies  and  equipment  at  bilateral  and  regional  levels,  cooperating  with  China, 
Canada, and South Korea. 
In the Gulf region, Gulf CDC supports the Gulf Health Council to coordinate and monitor national stockpiling efforts in the 
Member States. 

3.2.3.6 

International cooperation 

16 entities in Asia that contribute to reinforcing the global health emergency preparedness and response architecture have 
been identified, spread across the 10 countries studied. 

It is crucial to mention the health diplomacy actions undertaken by Asia within major international diplomatic forums: the 
Japanese presidency of the G7 in 2023, and the Indian presidency of the G20 in the same year. 

• Japan G7 Presidency
During the G7 Hiroshima Summit, Japan promoted the development and strengthening of the global health architecture for 
public health emergencies as well as health innovation as priorities on the agenda. Japan emphasized the importance of 

32

 CBNR: Chemical Biological Radiological and Nuclear 

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strengthening the global health architecture based on the lessons from the COVID-19 pandemic and reinforced the focus on 
health innovation and MCMs. 
In this context, the G7 leaders committed to bridging the gap in equitable access to MCMs by announcing the G7 Hiroshima 
Vision for Equitable Access to MCMs, which emphasizes the importance of ensuring that MCMs are accessible, safe, effective, 
and affordable, especially for low-income and middle-income countries. To support these efforts, the G7 leaders announced 
the  MCM  Delivery  Partnership  for  equitable  access,  an  initiative  informed  by  the  lessons  from  the  delivery  of  COVID-19 
vaccines. This commitment underscores the importance of ensuring that developed MCMs reach the people who need them. 

• India G20 presidency
India played a significant role in the international architecture of health emergency preparedness and response during its 
G20  presidency.  In  fact,  the  Indian  government  designated  the  strengthening  of  cooperation  in  the  field  of  medical 
countermeasures as one of the objectives of its G20 presidency. 
In  this  context,  India  proposed  the  creation  of  a  medical  countermeasure  coordination  platform:  the  G20-Chief  Science 
Advisers' Roundtable (G20-CSAR), led by the Office of the Principal Scientific Adviser to the Government of India with the 
support of the Ministry of Health. The G20-CSAR provided a platform to discuss and devise common frameworks to address 
some  of  the  pressing  policy  challenges  through  inclusive  global  science  advice,  including  pandemic  preparedness  and 
response. 

In parallel to international forums, there are also cooperations between different countries. 
It is worth noting the trilateral cooperation between China, Japan, and South Korea on a range of issues, including health. In 
terms of preparedness and response to health crises, this collaboration was strengthened in June 2024 during the 9th Trilateral 
Summit  Meeting  among  China,  Japan,  and  South  Korea.  Recognizing  the  critical  role  of  cooperation  in  the  health  field, 
particularly in response to emerging and re-emerging infectious diseases, the governments adopted the Joint Statement on 
Future Pandemic Prevention, Preparedness, and Response at this summit. The statement aims to enhance collaboration in 
managing health emergencies, including infectious diseases, among the Ministries of Health and other national agencies for 
disease  control  in  the  three  countries.  It  is  in  this  context  that  the  annual  Japan-China-Korea  Forum  on  Communicable 
Disease Control and Prevention takes place, bringing together infectious disease experts from the Japanese National Institute 
of Infectious Disease, Korea Disease Control and Prevention Agency, and China CDC. 
Other collaborations in Asia also exist beyond these three countries, for example: 

-

-

the Japanese National Institute of Infectious Disease also collaborates with the Taiwan CDC under a joint research
agreement  signed  in  2011  and  with  the  Indian  Council  of  Medical  Research  on  projects  about  Antimicrobial
Resistance Research,
there is bilateral cooperation between the Ministries of Health of Saudi Arabia and South Korea, particularly in the
training of healthcare professionals.

Also, beyond cooperation among Asian countries, there are also international bilateral collaborations. Specifically, we note 
the bilateral cooperation established between Singapore and Australia. This cooperation has notably led to: 

-

-

•

an  agreement  between  the  two  Ministries  of  Health  for  a  dose-sharing  arrangement  of  COVID-19  vaccines,  to
support each other in optimizing their respective schedules for vaccinating their populations against COVID-19.
exchanges of experiences and ideas between the two new agencies created in response to the Covid-19 crisis: the
new Communicable Disease Agency of Singapore and the interim Australian Centre for Disease Control.
Additionally, the following entities are undertaking initiatives and projects collaboratively with other entities across the world: 
the A*STAR in Singapore, actively involved in ASEAN's R&D dynamics and in bilateral technology transfers targeting
low- and middle-income countries,
the China CDC cooperates with Africa CDC since 2015, with exchanges and expert visits annually,
the Indian Council of Medical Research,
the Indonesian Ministry of Health,
the Vietnamese Ministry of Health and the Pasteur Institute in Vietnam. 

•
•
•
•

Finally, there are cooperation with the EU and the Member States. 
For instance, the EU and India have long-standing cooperation on health since 2004. The partnership focuses on addressing 
common public health challenges, such as AMR, communicable and non-communicable diseases. During the EU-India Leaders' 
meeting in May 2021, the partners underscored the importance of collaborating in better preparing and responding to global 
health emergencies, and in building resilient medical supply chains, vaccines, and APIs. 

At the regional level, ASEAN and the Gulf CDC seek to strengthen the global health emergency preparedness and response 
architecture by participating in several initiatives with international partners and establishing cooperation agreements with 
international partners. 
ASEAN initiatives include technical assistance and exchanges, provision of medical supplies and equipment at bilateral and 
regional  levels  during  the  Covid-19  crisis,  working  relationship  with  the  WHO  WRPO  and  WHO  SEARO,  discussions  with 
multilateral key actors (ex: Gavi). For instance, ASEAN launched in 2023 the ASEAN One Health Joint Plan of Action (2023-
2030) with the objective of: 

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-

-

-

Guiding  the  ASEAN  One  Health  Network  in  facilitating  and  streamlining  the  implementation  and  resource
mobilisation for identified OH priorities,
Serving as reference for the ASEAN Member States in developing and implementing their respective national One
Health plans of actions or equivalent,
Strengthening the health of humans, animals, plants, and environment, as well as food safety, and AMR, through
cross-sectoral collaboration between the relevant sectors, (including bilateral and multilateral cooperation).

ASEAN and the EU have a 45 years-partnership, with includes health matters. 
The plan of action to implement the 2023-2027 ASEAN-EU partnership includes the following actions: 

• the enhancement of the cooperation in addressing the challenges of communicable diseases and emerging infectious and 

zoonotic diseases, including pandemics,

• the  improvement  of  the  effectiveness  of  regional  surveillance  and  response  towards  emerging  infectious  diseases,

including tropical diseases, 

• the strengthening of both regions ‘preparedness for and capacity to respond effectively to public health emergencies. 
Gulf CDC seeks to establish collaboration agreements to reinforce the global health preparedness and response architecture. 
In  February  2024,  it  signed  a  cooperation  agreement  with  the  UKHSA,  with  ‘the  aim  of  exchanging  experiences  and  best 
practices in the field of public health. The organisation is willing to develop other collaborations and is interested in exploring 
possibilities for EU-Gulf CDC collaboration in these fields. 

3.2.3.7  Health security coordination 

Across  all  studied  countries,  the  steering  and  governance  of health  security  coordination  fall  under  the  purview  of  the 
Ministry of Health. 
In some cases, ministries are advised and supported in this coordination by other entities that provide guidelines and support 
for the Ministry's decision-making: 

•

•
•

•

•

In Saudi Arabia, the Public Health Authority supports the Ministry of Health as it monitors, measures, evaluates,
controls, and prevents any risk factors related to the public health in the Kingdom of Saudi Arabia, 

In China, the CDC ensures the local-level coordination, providing guidance to local CDCs,

The Indian Disaster Management Authority advice the Ministry of Health and Family Welfare for disaster
management to ensure timely and effective response to disasters,

In South Korea, the Ministry of Health and Welfare cooperates with the KDCA and the Ministry of Food and Drug
Safety to share information and coordinate actions,

In Malaysia, the National Disaster Management Agency supports the Ministry of Health by facilitating the
communication and supporting the coordination with the stakeholders while the National Public Health
Laboratory coordinates the laboratory and diagnostic activities,

It is important to note that two Asian countries have created agencies following the COVID-19 crisis to strengthen their 
preparedness and response capacities for health crises: Japan and Singapore. 
In Singapore, the establishment of the new Communicable Disease Agency (previously mentioned) was announced in March 
2023.  This  Agency  will  aim  to  oversee  disease  preparedness,  prevention,  surveillance,  risk  assessments  and  outbreak 
response. As of June 2024, it is in the interim stage (iCDA), serving as a pre-operations structure to facilitate the transition and 
develop the corporate strategy and plans. 
Although its tasks are not yet fully defined, the CDA will notably strengthen health security coordination capacities. 
In Japan, the new Cabinet Agency for Infectious Disease Crisis Management was established in September 2023 within the 
Cabinet Secretariat as a permanent entity for infectious disease crisis management. It has the authority to plan and formulate 
important policies with the Cabinet and to coordinate all administrative departments so that the agency functions as a leader 
during both daily operations and in emergency situations. 
It  also  has  centralized  control  over  government-wide  policy  planning  and  comprehensive  coordination  of  administrative 
departments related to preparations during normal operations, initial response to infectious disease crises, and the affairs of 
the Government countermeasures Headquarters during crises. 

In Asia, all the countries studied have entities that undertake some or all HERA's tasks. 
This region of the world holds significant international weight in terms of R&D and manufacturing of MCMs. 
Several countries such as China, India, Japan, and South Korea are implementing initiatives to further strengthen their 
capacities and enhance their competitiveness. 

Furthermore,  all  the  Asian  countries  studied  have  established  mechanisms  for  health  security  coordination,  with  the 
steering and governance falling under the purview of the Ministries of Health. 

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To strengthen their capabilities in this area, two countries have chosen to create new entities: Japan and Singapore. 

Regarding cooperation, there are agreements between Asian countries, including a trilateral agreement between Japan, 
China, and South Korea, as well as agreements with other countries (for example, the cooperation between Singapore and 
Australia). 
In addition, Japan and India played a significant role in the international architecture of health emergency preparedness 
and  response  during  their  G7  and  G20  presidency,  respectively.  Indeed,  the  Indian  government  designated  the 
strengthening of cooperation in the field of medical countermeasures as one of the objectives of its G20 presidency. For 
its part, Japan focused on Health Innovation, thereby reinforcing the emphasis on MCMs. In this context, the G7 leaders 
committed to bridging the gap in equitable access to MCMs by announcing the G7 Hiroshima Vision for Equitable Access 
to MCMs. 

At the regional level, ASEAN and Gulf CDC are significantly involved in HERA tasks to strengthen the capacities of their 
Member States and reinforce the international cooperation. 

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3.2.4  Europe 

Figure 5 - Map of European non-EU countries and regional organisation covered by the study, and summary table. 

Disparities  in  wealth  and  access  to  healthcare  persist  within  the  European  continent,  including  among  non-EU  European 
countries.  While  countries  like  Norway  as  Western  Europe’s  top  petroleum  producer  are  among  the  richest  countries  of 
Europe 33, Ukraine, Moldova and Albania face substantial economic challenges 34. For example, during the health crisis, Eastern 
Europe was the most severely affected region in terms of the number of deaths per million, both within the EU and outside 
of it. 

As  detailed  in  the  introduction,  the  study  team  selected  13  European  non-EU  countries  to  study,  based  on  the  following 
criteria: 

•

•
•

The current EU candidate countries and potential candidates have been included, due to their proximity to the EU
and HERA’s activities: Albania, Bosnia and Herzegovina, Georgia, Moldova, Montenegro, North Macedonia, Serbia,
Türkiye, Ukraine, and Kosovo

35
,

The G20 countries: Russia, the UK, Türkiye,

Norway has also been included for its strong involvement in health crisis preparedness and response. In fact, 
Norway and South Africa have co-chaired the Facilitation Council of the Access to Covid-19 Tools Accelerator.
Norway is also a Member of the Nordic Pharmaceutical Forum.

The study conducted across these 13 countries scope identified 38 entities. At the beginning of each paragraph, the study 
team  refers  to  these  13  countries  and  specifies  for  which  countries  the  task  has  been  properly  identified,  along  with  the 
number of entities identified. 

At  both  the  national  and regional  levels,  entities  have  been  identified  as  responsible  for  carrying  out  tasks  related  to  the 
availability and accessibility of relevant medical countermeasures in case of a health emergency. 

33

 EU and non-EU countries included. 

34

 Richest countries in the World – 2024, Global Finance 

35

 Kosovo is a potential candidate.

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Regarding  national  level,  13  non-EU  European  countries  have  been  studied,  totalling  38  entities:  Albania,  Bosnia  and 
Herzegovina, Georgia, Kosovo, Moldova, Montenegro, North Macedonia, Norway, Russia, Serbia,  Türkiye, UK, Ukraine. 

At  the  regional  level,  the  Nordic  Pharmaceutical  Forum  brings  together  five  Nordic  countries  (Finland,  Iceland,  Norway, 
Sweden, Denmark) with the aim of ensuring timely access to 'the right pharmaceuticals at the right price for patients' in the 
five member states. 

3.2.4.1  Monitoring, Intelligence gathering and analysis 

24 entities in Europe [in non-Eu countries], spread across the 13 countries studied, have been identified as operating health 
threat analysis, health intelligence gathering and evaluation of the potential consequences and impact on public health. 

In most countries, this task is carried out by the Ministry of Health. In some cases, this activity is conducted with the support 
of another entity: 

•
•

•
•
•
•
•
•

•
•

The Ministry of Health in Albania, with the support of the Institute of Health, 
The Federal Ministry of Health in Bosnia and Herzegovina, in cooperation with the Agency for Medical Products
and Medical Devices,

The Ministry of Health in Kosovo, in cooperation with the National Institute of Public Health,
The Ministry of Health of the Republic of Moldova,
The Ministry of Health in Montenegro, with the support of the Institute for Public Health,
The Ministry of Health in Serbia, with the support of the Institute of Public Health, 
The Turkish Ministry of Health,
The Ministry of Internally Displaced Persons from the Occupied Territories, Health, Labour and Social Affairs of
Georgia, in coordination with the National Centre for Disease Control and Public Health,
The Ministry of Health in North Macedonia, with the support of the Institute for Public Health,
The Centre for Public Health, part of the Ministry of Health, in Ukraine.

In Norway, the Norwegian Medicines Agency (NOMA) is the national regulatory authority for new and existing medicines 
and the supply chain. This agency assumes overall responsibility for the security of supply and emergency preparedness of 
medical products (since January 2024). In preparedness and response to health emergencies, NOMA oversees intelligence 
gathering and analysis regarding medicines. 
The  Norwegian  Institute  of  Public  Health  ensures  the  surveillance  and  infectious  disease  research.  The  Institute  also 
participates  in  the  UNITED4Surveillance  project,  an  EU4Health  Joint  Action  with  over  40  partners  from  across  Europe. 
Coordinated  by  the  Dutch  National  Institute  for  Public  Health  and  the  Environment  (RIVM),  this  project  aims  to  integrate 
existing and new data sources for more comprehensive EU/EEA infectious disease surveillance, prevention, and control. 

In  Russia,  the  Ministry  of  Health  of  the  Russian  Federation  ensures  the  intelligence  gathering  and  the  evaluation  of  the 
potential consequences and impact on public health, in coordination with the Ministry of Civil Defence, Emergencies and 
Elimination of the Consequences of Natural Disasters and the Smorodintsev Research Institute of Influenza. 
Rospotrebnadzor,  the  Russian  Federal  Service  for  Surveillance  on  Consumer  Rights  Protection  and  Human  Wellbeing, 
supports this activity as it is responsible for carrying out the federal state sanitary and epidemiological surveillance. 

In the UK, the UK Health Security Agency (UKHSA), executive agency sponsored by the DHSC, oversees the management of 
emerging infectious diseases, implementing various pandemic preparedness measures, which include but are not limited to 
surveillance and the provision of medical countermeasures. 
In terms of monitoring, intelligence gathering and analysis, the UKHSA role is crucial in the UK: it collects information and 
provides evidence-based analysis and advice on the safety and effectiveness of vaccines, data on disease incidence, vaccine 
coverage, and vaccine safety. 
In 2021, the UKSHA signed a MoU with ECDC aimed to strengthen the collaboration between the two agencies on matters of 
communicable diseases prevention and control. 

At regional level, while each member state conducts its own horizon scanning activities, the Nordic Pharmaceutical Forum 
ensures  knowledge  sharing  and  collaboration  in  this  area  in  the  objective  of  providing  for  a  better  understanding  of  the 
products that are forthcoming. 
Additionally, the Forum aims to facilitate knowledge-sharing among Member States, concerning strategic initiatives aimed at 
enhancing supply security in each country. Subsequently, member states and organisations within the Nordic Pharmaceutical 
Forum engage in knowledge-sharing regarding strategic and practical initiatives aimed at enhancing supply security in each 
respective country. 

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3.2.4.2  Advanced Research and Development capacities 

Regarding advanced R&D capacities, 8 out of the 13 countries studied have entities responsible for this activity, totalling 12 
entities. 
The  study  did  not  reveal  any  entity  responsible  for  this  task  in  the  other  5  countries:  Bosnia  and  Herzegovina,  Moldova, 
Montenegro, North Macedonia, and Serbia. 

In most countries, the promotion and coordination of advanced R&D is led by governmental agencies, ministries, or national 
public health institute: 

•
•
•
•
•

The Institute of Public Health, along with the Ministry of Health in Albania,
The National Institute of Public Health in Kosovo,
The National Centre for Disease Control and Public Health of Georgia,
The Turkish Ministry of Health,
The Ukrainian Academy of Sciences, and its network.

More  precisely  in  Ukraine,  before  the  war,  clinical  research  had  a  significant  economic  impact  in  Ukraine.  The  country 
contributed 2% of the global patient pool in clinical trials, with 30,000 active participants in 500 studies annually. In the five 
years before the war, the number of new clinical studies increased 2.5 times, research sites grew by 20%, and the number of 
active researchers in the field rose by 44%. This activity has been significantly impacted by the war. 

In Norway, the Research Council and Innovation Norway, the Government's instrument for innovation and development of 
Norwegian enterprises and industry, cooperate in promoting and coordinating advanced R&D capacities. 
Innovation Norway in particular supports companies in developing their R&I competitive advantage and enhancing innovation 
through grants and loans. 

In the UK, the UKSHA has played a crucial role for several years as it coordinates R&D efforts to develop MCMs. However, in 
response to the Covid-19 crisis and as part of its objective to enhance advanced R&D capabilities, the UK government founded 
a new research funding agency in 2023: The Advanced Research and Invention Agency, also called “ARIA”, which performs 
complementary tasks. 
Indeed, ARIA is dedicated to the promotion and facilitation of R&D initiatives carrying a high risk of failure. The Agency 
encourages, facilitates, and provides advice regarding R&D and provides financial support by way of grants, loans, investments 
in companies or other entities, or in any other form. It also aims to make available rights or other property. ARIA focuses on 
the  potential  for  significant  benefits  to  be  achieved  or  facilitated  through  scientific  research,  or  the  development  and 
exploitation of scientific knowledge, that carries a high risk of failure. 

In Russia, the Ministry of Health promotes advanced R&D for the development of effective and safe MCMs.  
The Smorodintsev Research Institute of Influenza, under the Ministry of Health, also plays a crucial role as it is mandated to 
focus on finding solutions to fundamental and applied problems in the fields of virology, epidemiology, and infectious disease. 
It  promotes  and  coordinates  R&D  on  medical  countermeasures,  including  the  development  of  viral  infection  diagnostic 
reagents, development of approaches to the creation of new generation influenza vaccines, R&D for new antiviral drugs. 
The Institute also works on the development of biological repository systems to reinforce the preparedness and response 
capacities. 

3.2.4.3  Production / Manufacturing capacities 

The study identified 8 entities responsible for tasks related to capacity-building for the manufacturing and production of 
MCMs, covering 7 out of 13 countries. 

Capacity-building activities for the manufacturing and production of MCMs are relatively underrepresented in the Western 
Balkans, as the study did not reveal any entity responsible for this task in 5 out of the 6 countries. 
Only Albania is an exception; this activity falls under the responsibility of the Ministry of Health and Social Protection. 

As with the monitoring and intelligence gathering activity, it is primarily the ministries that ensure the task of strengthening 
production/manufacturing capacities in non-EU European countries: 

•

•
•

The Ministry of Internally Displaced Persons from the Occupied Territories, Health, Labour and Social Affairs in
Georgia,
The Ministry of Health of the Russian Federation,
The Ministry of Health in Türkiye. 

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In  Ukraine,  the  State  Service  of  Ukraine  on  Medicines  and  Drugs  Control  is  the  regulatory  authority  overseeing  the 
pharmaceutical sector. As regard to HERA’s tasks, it aims to monitor supply chains, prevent shortages, and combat counterfeit 
drugs, thereby safeguarding public health during emergencies. 
The war between Ukraine and Russia has severely disrupted pharmaceutical production in Ukraine. Many production facilities 
have been damaged or destroyed, leading to a shortage of medications and limited access to healthcare for the population. 

In the UK, UKHSA seeks to maintain critical national infrastructure and specialist capabilities required to respond to emerging 
and high consequence infectious diseases, such as high containment laboratories and specialist diagnostic equipment. During 
COVID-19  pandemic,  UKHSA  has  worked  with  Moderna  and  other  stakeholders  to  ensure  early  vaccine  development, 
supporting the G7 mission to get from variant to vaccine in 100 days and greater UK manufacturing capacity. 

In Norway, the Research Council and Innovation Norway play an important role in enhancing Norway's production capacities. 
In 2022/2023, they were tasked with evaluating potential strategies, arrangements, and actions to implement the objectives 
outlined  in  the  Government’s  policy  platform,  referred  to  as  ‘the  Hurdal  Platform’.  This  initiative  aims  to  facilitate  the 
production of critically important drugs in Norway, including vaccines, biopharmaceuticals, and pharmaceutical raw materials. 
The assignment also involved assessing measures that could contribute to the profitable production of pharmaceuticals in 
Norway, potentially including the establishment of a central facility. 

At regional level, the Nordic Pharmaceutical Forum aims to strengthen cooperation between Nordic countries to produce 
safe and effective medicines. The Forum seeks to look at opportunities for collaboration within the Nordic countries for the 
development and production of unlicensed pharmaceutical preparations, especially in case of medical shortages. 
The Nordic Pharmaceutical Forum has discussed the potential for sharing or selling locally produced pharmaceuticals among 
Member States in crisis situations. However, this would require new legislation and involvement from the authorities. 
The Nordic Pharmaceutical Forum has also attempted to create an overview of product types, illustrating schematically which 
production facilities are available in the Nordic countries. However, the overview has not been completed yet. 

3.2.4.4  Procurement of MCMs 

Regarding the procurement of MCMs, 11 out of the 13 countries studied have entities responsible for this activity, totalling 
14 entities. 
The  available  documentation  has  not  allowed  for  the  identification  of  an  entity  carrying  out  this  activity  in  the  following 
countries: Bosnia and Herzegovina, and Kosovo. 

Similar  to  the  observation  made  in  other  regions  of  the  world,  several  non-EU  European  countries  have  centralized  this 
activity within a single entity. This can be done either: 

•
•
•

within the Ministry of Health: Albania, Georgia, Moldova, North Macedonia, Serbia, UK,

within another government agency: the Norwegian Medicines Agency, 

or within an agency dedicated to procurement: Medical procurement of Ukraine, national agency that ensures
centralized procurement of medicines and medical devices for Ukraine.

In Montenegro, the procurement of medical countermeasures is made in coordination between the Ministry of Health and 
the Institute of Public Health. 
In Russia, this task is under the Ministry of Health, in collaboration with the Ministry of Industry and Trade. 

In Türkiye, the Ministry of Health also oversees the procurement of medical devices and supplies, participating in long-term 
and centralized procurement schemes. 
In  addition,  the  Turkish  Federation  of  Medical  Device  Manufacturers  and  Suppliers  (TUMDEF),  a  non-governmental 
organisation operating within the medical device industry in Türkiye, plays a pivotal role in facilitating communication and 
collaboration  between  the  government  and  the  private  sector.  Through  close  liaison  with  both  sectors,  TUMDEF  ensures 
effective procurement processes, thereby contributing to the nation's healthcare preparedness and response capabilities. 

At regional level, the Nordic Pharmaceutical Forum supports efforts of its member organisations to collaborate on joint Nordic 
procurement of medicines to ensure that patients in the Nordic countries have access to primarily older medications. 
However, there is no specific process for joint procurement during a public health crisis. 

3.2.4.5  Stockpiling and distribution capacities 

In  10  out  of  the  13  non-EU  European  countries  included  in  the  study,  strategies  for  stockpiling  and  distributing  medical 
countermeasures are in place, totalling 14 entities. 
The three countries that have not implemented a strategy to date are Bosnia and Herzegovina, Kosovo, and North Macedonia. 

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In the UK, the DHSC collaborates with the UKHSA to maintain a centralised stockpile of relevant clinical and non-clinical 
products stored on a ‘Just-In-Case’ basis and a contract for the provision of a pandemic specific influenza vaccine at the time 
of a pandemic. These products include PPE, hygiene consumables, and therapeutics, such as antivirals and antibiotics. They 
also have several storage and distribution contracts to ensure that the right product can be delivered to the right place in the 
right quantity when needed.  
Additionally, in response to Covid-19, the DHSC created in 2020 a stockpile of PPE equivalent to "the 120-day demand". 

In Ukraine, the State Emergency Service of Ukraine (SESU), operating under the Ministry of Internal Affairs, is responsible for 
managing  emergencies  and  disaster  response  nationwide  which  include  the  management  of  reserve  of  medical 
countermeasures. In addition, Medical Procurement of Ukraine guarantees the distribution of the MCMs procured in case of 
an emergency. 

In the other countries, this activity is under the Ministry of Health or another governmental body: 

Centralized within the Ministry of Health in Albania, Georgia, Montenegro, Russia, Serbia, Türkiye,

•
• Managed in coordination between the Ministry of Health and the General Inspectorate for Emergency Situations
(IGSU) in Moldova, in coordination between the Ministry of Industry and Trade and the Ministry of Health in
Russia,
Centralized in another governmental agency in Norway, the Norwegian Medicines Agency.

•

At regional level, to address supply chain difficulties, the Nordic Pharmaceutical Forum shares knowledge on how to handle, 
operationally, day-to-day supply problems. The focus has mostly been on back orders and short-term initiatives. 
Additionally, in its strategy for 2023-2025, the Forum mentions that “it may be relevant for the Nordic Pharmaceutical Forum 
to discuss whether there is a possible need to establish a common Nordic stock of pharmaceuticals in order to improve 
security  of  supply  across  the  Nordics”.  The  Nordic  Pharmaceutical  Forum  informed  the  study  team  that,  at  the  time  of 
conducting this study, the project has not progressed and is still under consideration. However, if this idea were to materialize, 
there would likely be a requirement for legal adoption. 

3.2.4.6 

International cooperation 

Entities  that  contribute  to  reinforcing  the  global  health  emergency  preparedness  and  response  architecture  have  been 
identified in all European non-EU countries studied. 

Various entities are engaged in bilateral collaboration initiatives, notably the Russia-China cooperation. The Russian-Chinese 
Symposium on Infectious Diseases has been held annually for 6 years. This collaboration involves discussions and exchanges 
between researchers from the Smorodintsev Research Institute of Influenza and the China CDC. 

, aiming to bring the 
It is worth noting that the European Commission adopted a new Growth Plan for the Western Balkans
Western Balkan partners closer to the EU by offering some benefits of EU membership to the region in advance of accession, 
thus boosting economic growth and accelerating socio-economic convergence. These efforts include collaborations with these 
countries through strategic partnerships to enhance the security of the supply of critical medicines. 

36

The UKSHA is also involved in several initiatives aiming to reinforce the global preparedness and response architecture. For 
instance, UKHSA has worked directly with WHO to support development of the WHO Berlin Hub and is invited to join future 
leadership of the new International Pathogen Surveillance Network. 

In  addition,  since  2020,  Government  of  Norway  (Ministry  of  Health)  played  a  leading  role  in  the  international  effort  to 
promote equitable access to Covid-19 vaccines, medicines, tests, and protective equipment. Indeed, Norway and South Africa 
have co-chaired the Facilitation Council of the Access to Covid-19 Tools Accelerator (ACT-A), an initiative launched in 2020 in 
response to the Covid-19 crisis. 

At  regional  level,  the  Nordic  Pharmaceutical  Forum  seeks  to  participate  in  reinforcing  the  global  health  emergency 
preparedness and response architecture, including through cooperation with the EU. 

3.2.4.7  Health security coordination 

Across  all  studied  countries,  the  steering  and  governance  of health  security  coordination  fall  under  the  purview  of  the 
Ministry of Health. 

36

 Albania, Bosnia and Herzegovina, North Macedonia, Montenegro, Kosovo and Serbia 

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The study identified 25 entities involved in this task. 

In some cases, ministries are advised and supported in this coordination by other entities that provide guidelines and support 
for the Ministry's decision-making. For instance, in Bosnia and Herzegovina, the Federal Ministry of Health cooperates with 
the  Federal  Civil  Protection  while  in  Norway,  the  Norwegian  Directorate  of  Health  oversees  the  coordination,  and  the 
Norwegian Medicines Agency aims to ensure the security of supply. 

In non-EU European countries, significant disparities exist in terms of MCMs. 

The United Kingdom and Norway emerge as important stakeholders, with rich and structured ecosystems of entities. 
These countries are notably engaged in significant initiatives to enhance their R&D and manufacturing capabilities. 
Particularly, and as was the case with Japan and South Korea mentioned earlier, the UK has established a new entity in 
response to the Covid-19 crisis: ARIA, The Advanced Research and Invention Agency. ARIA seeks to fund and support "high-
risk" R&D projects. 

For  its  part,  Russia  holds  an  important  position,  particularly  in  advanced  R&D  to  develop  effective  and  safe  medical 
countermeasures. 
Additionally, the country has established bilateral cooperations to strengthen preparedness and response to health crises 
(e.g. with China CDC). 

Meanwhile, candidate countries (or potential candidates) for the EU are relatively less advanced in R&D and production 
of MCMs and encounter more difficulties. 
It is worth noting that the European Commission has adopted a Growth Plan for the Western Balkans, aimed at advancing 
the region's integration with the EU by providing pre-accession benefits, including strategic partnerships to strengthen the 
security of critical medicine supplies. 

Finally, at the regional level, the Nordic Pharmaceutical Forum undertakes similar tasks to HERA for the Nordic countries. 

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3.2.5  North America 

Figure 6 - Map of North American countries and regional organisation covered by the study, and summary table. 

In North America, infectious diseases and outbreaks are diligently monitored and addressed in each country. Canada, the 
United States, Mexico, and Cuba implement seasonal flu vaccination campaigns to protect their populations but also face 
other challenges. Sporadic outbreaks of diseases such as tuberculosis and dengue can occur in certain regions. Specifically in 
the Caribbean region, which is one of the poorest regions of the world, dengue fever and other infectious diseases are major 
health threats in this region.  
Additionally,  due  to  its  geographical  location,  North  America  is  also  exposed  to  natural  hazards  (tornadoes,  floods, 
earthquakes, heatwaves) which can be important health threats. 

As detailed in the introduction, the study team selected 4 North American countries to study, based on the following criteria: 

•
•

The G20 countries: the USA, Canada, Mexico,

Cuba, for its specific context due to the embargo, which led to a strong commitment to local vaccine development
and self-sufficiency.

Regarding medical countermeasures, the countries of North America have varied situations and capabilities. 
The  significant  pharmaceutical  R&D  and  production  capabilities  of  the  United  States  have  been  highlighted  during  the 
COVID-19 pandemic. Cutting-edge R&D facilities and rapid manufacturing capabilities enabled the United States to swiftly 
develop and produce vaccines and treatments to address the global health crisis. This agility and expertise not only supported 
the  national  response  but  also  had  positive  implications  for  the  region's  ability  to  contribute  to  global  health  security  by 
strengthening MCM production capacities and fostering international cooperation in preparedness and response to health 
emergencies. 
Canada also possesses robust capabilities in medical countermeasures, and ensuring access to critical vaccines, therapeutics, 
and other life-saving medicines remains a priority for the Government of Canada. To bolster this capacity, Canada has invested 
over $1.2 billion in rebuilding its vaccine, therapeutics, and biomanufacturing capabilities. The country has played a significant 
role  in  international  cooperation  to  address  the  Covid-19  emergency,  having  donated  the  equivalent  of  over  201  million 
vaccine doses. This contribution has been crucial in meeting the demand for vaccines in various countries,  including 46.6 
million doses that were surplus from Canada's domestic supply and donated to COVAX
On its part, in response to the embargo imposed by the USA, Cuba has implemented initiatives to foster the local production 
of  biomedical  products  and  significant  investments  have  been  made  by  the  Cuban  state  into  R&D  to  ensure  access  to 

37
. 

37

 Canada’s COVID-19 vaccine supply and donation strategy, Government of Canada 

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medicines  in  the  event  of  an  outbreak.  In  addition,  Cuba  has  fully  committed  to  local  vaccine  development  and  self-
sufficiency, even opting out of the COVAX mechanism by Gavi. 
Finally,  Mexico  is  an  important  pharmaceutical  industry,  with  a  solid  production  network  and  strong  supply  capabilities. 
However, in terms of health crisis preparedness, the Council of the Americas assesses that the Mexican healthcare system 
was inadequately equipped and unprepared to handle the scale of the Covid-19 pandemic. 

At  both  the  national  and  regional  levels,  entities  have  been  identified  as  responsible  for  carrying  out  tasks  related  to  the 
availability and accessibility of relevant medical countermeasures in case of a health emergency. At the regional cooperation 
level, two entities are particularly significant: 

• The Pan American Health Organisation (PAHO), the Regional Office for the Americas of the WHO,
• The Caribbean Public Health Agency (CARPHA), dedicated to strengthening and reorienting the health system approach

so that the Caribbean countries are equipped to address public health challenges.

Note: PAHO operates throughout the Americas. For the sake of clarity in this report, its activities are presented in the North 
America section, and references to relevant sections are provided in the South America section. 

3.2.5.1  Monitoring, Intelligence gathering and analysis 

In  North  America,  the  4  countries  under  study  each  have  entities  responsible  for  analysing  health  threats,  gathering 
intelligence, and evaluating potential consequences and impacts on public health, totalling seven entities. 

In the USA, the US CDC monitors and analyses health threats. It ensures the disease surveillance.  
BARDA is the Biomedical Advanced Research and Development Authority in the USA, which operates under the supervision 
of ASPR. This agency holds a crucial role in managing MCMs in preparedness and response to health crises within the country. 
BARDA's significance lies in its ability to oversee and analyse MCMs, primarily by ensuring effective portfolio management. 
During preparedness phases, BARDA evaluates its capability to handle public health emergencies and identifies opportunities 
for innovation through additional product development. When health crises emerge, BARDA promptly evaluates its portfolio 
to pinpoint suitable MCMs for response. Despite maintaining a diverse pipeline of products, some threats may be unforeseen, 
and not all MCMs can be readily deployed. Consequently, BARDA has established the BARDA Incident Management Team, 
which can be activated to bolster response efforts during various public health emergencies. 
Furthermore, BARDA aims to gather intelligence and understand the operational challenges that users may encounter when 
administering an MCM. To achieve this, BARDA collaborates with all stakeholders (patients, healthcare providers, professional 
societies,  etc.)  to  gain  insights  and  devise  solutions  for  operational  challenges.  For  example,  BARDA  has  partnered  with 
organisations such as the American Burn Association and American College of Surgeons to develop thermal burn MCMs. 
In cooperation with BARDA, the Public Health Emergency Medical Countermeasure Enterprise, under the leadership of ASPR, 
monitors and analyses data to identify national health security needs, assess gaps in MCM preparedness and response, and 
address challenges associated with meeting these needs. 

In  Canada,  two entities  collaborate  on  this  task:  Health  Canada,  the  federal  department  responsible  for  safeguarding  the 
health of Canadians, and The Public Health Agency of Canada. 

In  Mexico,  this  responsibility  falls  under  the  purview  of  the  Secretariat  of  Health,  Mexico's  executive  agency  tasked  with 
disease prevention and the advancement of population health. 
In Cuba, the Ministry of Public Health ensures the analysis of health threats and evaluate the potential consequences and 
impact on public health. It is also responsible for intelligence gathering regarding MCMs and produces a 'basic drug list' each 
year, classifying the drugs as essential, non-essential, or special. 

At  regional  level,  PAHO  collects  data  and  provides  guidelines  (including  on  MCMs)  to  ensure  that  Member  States  receive 
evidence-based  guidance,  tools,  and  equipment  to  adequately  manage  cases  and  protect  healthcare  workers  from  the 
infection. 

3.2.5.2  Advanced Research and Development capacities 

All the 4 North American countries studied have entities dedicated to the promotion and the coordination of advanced R&D 
to develop effective, safe, and affordable MCMs and related technologies, with a total of 7 entities: 

•

•

In  Canada,  the  National  Research  Council  (NRC)  focuses  on  supporting  the  Canadian  ecosystem  in  developing,
translating,  and  implementing  medical  device  innovations.  Regarding  health  emergency  response,  during  the
COVID-19 crisis, the NRC launched the "Pandemic Response Challenge Program," aimed at accelerating research
and development to address specific gaps and challenges identified by Canada's health experts. 
In Mexico, the National Institute of Public Health actively supports and promotes advanced R&D efforts.

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•

In the USA, BARDA plays a crucial role regarding R&D capacities. Firstly, it develops partnerships with the private
sector to advance the development of MCMs. BARDA directs investments toward technologies with the potential
to accelerate the availability of MCMs while enhancing their safety and accessibility. Secondly, BARDA is tasked with 
identifying opportunities for product development aimed at filling preparedness gaps, collaborating closely with
partner agencies within the Public Health Emergency Medical Countermeasure Enterprise (PHEMCE, which is under 
the leadership of ASPR).
Additionally,  the  National  Institutes  of  Health  (the  US’s  medical  research  agency)  supports  various  research
initiatives, including those related to medical countermeasures. 
Moreover, the Advanced Research Projects Agency for Health (ARPA-H) supports transformative biomedical and
health breakthroughs. As a research funding agency, ARPA-H operates as a lean organisation: it makes investments
in  breakthrough  technologies  and  broadly  applicable  platforms,  capabilities,  resources,  and  solutions  with  the
potential to transform important areas of medicine and health. 

38

In  a  proactive  approach,  ARPA-H  is  modelled  after  DARPA
  in  several  respects.  ARPA-H  does  not  have  its  own
laboratories or research facilities. Its organisational structure is organized around Program Managers who design,
launch, and run an ever-changing portfolio of programs. To foster a continual flow of new ideas, Program Managers 
have a term limit of up to six years, and the programs they develop will not align with their tenure. 
For  instance,  ARPA-H  launched  a  project  to  combat  AMR:  “The  Defeating  Antibiotic  Resistance  through
Transformative  Solutions  (DARTS)”.  This  project  focuses  on  developing  a  set  of  diagnostic  and  experimental
platforms  that  can  reveal  insights  into  how  antibiotic  resistance  starts,  search  for  new  antibiotics,  and  rapidly
identify the right antibiotic to prescribe for a particular infection in real time.

•

In Cuba, the Ministry of Public Health sets the sector’s R&D priorities in accordance with the country’s economic
and  social  policy  guidelines  and  promotes  these  research  activities.  In  parallel,  BioCubaFarma,  a  state-run
biotechnology  organisation, promotes and  coordinates  the  research  and  development  of  MCMs  to  enhance  the
preparedness and response capacities.

At regional level, PAHO encourages and promotes coordinated R&D and aims to facilitate research on critical knowledge gaps. 

3.2.5.3  Production / Manufacturing capacities 

3 of the 4 North American countries studied have entities dedicated to enhancing the production / manufacturing capacities 
of MCMs, with a total of 4 entities. The study did not reveal any entity responsible for this task in Mexico. 

To boost manufacturing capacities in the US, BARDA fosters partnerships to ensure the long-term sustainability  of critical 
manufacturing  capabilities.  Through  initiatives  like  the  National  Biopharmaceutical  Manufacturing  Partnership  (BioMaP), 
BARDA promotes not only capacity but also manufacturing capabilities, ensuring facilities are adequately staffed, trained, 
and actively producing high-quality products. 

In Canada, recognizing the importance of addressing drug shortages and aiming to improve access to health products, Health 
Canada established a Drug Shortages Task Force. This task force is tasked with identifying challenges and exploring solutions 
to enhance the availability and accessibility of drugs and other health products for all Canadians. 

In Cuba, the Ministry of Public Health sets the priorities for the local production of medicines and other medical supplies. It 
cooperates  with  BioCubaFarma  on  this  point.  Both  entities  are  responsible  for  preparing  an  annual  plan  for  domestically 
manufactured and imported drugs, utilizing analyses at the provincial level that consider demand and follow epidemiological 
data in the event of health crises. 
Furthermore,  during  health  crises,  the  Ministry  has  the  capability  to  facilitate  the  redirection  of  companies  towards  local 
manufacturing of MCMs. For instance, amidst the Covid-19 pandemic, certain companies were mobilized to produce masks. 

At regional level, PAHO's Special Program, Innovation, and Regional Production Platform aims to improve communication 
and knowledge sharing to identify opportunities for regional cooperation. The goal is to enhance production capacities for 
medicines, vaccines, and other vital health technologies, promoting equitable access to these products. The platform will 
support  research,  incentivize  development,  and  expand  manufacturing  capacities  in  the  Americas,  facilitating  information 
exchange and fostering cooperation between partners and countries to ensure access to safe, effective, and quality health 
products. 

38

 Defence Advanced Research Projects Agency 

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3.2.5.4  Procurement of MCMs 

Two countries made the choice of centralizing the procurement of MCMs: 

•

•

Public Services and Procurement Canada, the central purchasing agent of the Federal Government, is responsible
for procuring vaccines, therapeutics, personal protective equipment (PPE), and medical supplies during health
emergencies,
In Mexico, this task falls under the purview of the Secretariat of Health. 

In the USA, ASPR oversees the management of the Strategic National Stockpile, which encompasses the full life cycle of 
stockpile assets, including procurement of the required MCMs. 
For its part, BARDA develops partnerships with private stakeholders and aims to leverage acquisition vehicles that facilitate 
swift responses, through the development and implementation of new acquisition methods. 

In  Cuba,  the  Ministry  of  Public  Health  is  tasked  with  defining  the  policies  and  guidelines  for  procurement  of  MCMs  and 
overseeing the procurement. MEDICUBA ensures the central procurement of MCMs. 

At regional level in case of emergency, both PAHO and CARPHA aims to facilitate centralized procurement of medical devices 
and supplies specifically for addressing the challenges posed by the disease outbreak. 

3.2.5.5  Stockpiling and distribution capacities 

The  USA,  Canada  and  Mexico  have  implemented  a  strategy  for  stockpiling  medical  countermeasures  to  enhance  their 
preparedness and response to health crises. More precisely: 

•

•

•

In Mexico, the Secretariat of Health manages the storage, distribution, and administration of the Federal Reserve
of medicines and supplies,

The Public Health Agency of Canada manages the National Emergency Strategic Stockpile (including distribution),
which includes PPE, medical supplies, pharmaceuticals, as well as emergency triage units. PHAC is responsible for
overseeing the whole process of management of the NESS, which includes the definition of the MCM
Requirements (capability analysis, identification of gaps by comparing MCMs needs and the NESS holdings,
prioritisation of MCM requirements in consultation with Subject Matter Experts), identification of product
candidates through MCM market assessment, acquisition planning, stockpiling, and deployment.

In the USA, ASPR oversees the management of the Strategic National Stockpile and the PHEMCE is dedicated to 
optimizing the U.S. government’s portfolio of medical countermeasures by addressing logistics, deployment,
distribution, dispensing, and utilisation of these measures. 
BARDA is in charge of the National Pre-Pandemic Vaccine stockpile (including distribution) and collaborates with
FDA-licensed influenza vaccine manufacturers to bolster pandemic readiness, maintain, and enhance stockpile
management. BARDA also partners with industry stakeholders to guarantee the availability of drug substance
manufacturing, fill/finish, distribution, and administration capacities to respond effectively to public health
emergencies. 

In Cuba, for distribution of MCMs, the Ministry of Public Health collaborates with EMCOMED and the BioCubaFarma. More 
broadly, the Ministry sets the strategy and guidelines for the distribution of all MCMs in the event of a health crisis. 
However, Cuba's system for responding to public health emergencies does not include a stockpile of Medical Countermeasures 
for national use during such events. 

At regional level, the CARPHA provides guidelines for the equitable distribution of the MCMs, though there is currently no 
publicly available evidence of stockpiling. 
PAHO provides guidelines on both stockpiling and distribution to its member states. 

3.2.5.6 

International cooperation 

The 4 North American countries studied contribute to reinforcing the global health emergency preparedness and response 
architecture: 
• In Mexico, this task is the responsibility of the Secretariat of Health.
• In Canada, Health Canada and the Public Health Agency cooperates with foreign partners in this objective, while the
National Research Council engages in international cooperation through collaborations and funding partnerships with
other countries, including Germany, Japan, India, and others. 

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• In the USA, ASPR and its subordinate authority BARDA engage in collaborations with international partners in diverse
projects (e.g., Western African countries, HERA…). For instance, BARDA assisted in devising an access protocol for Ebola
vaccines in West Africa through partnerships with local entities.

In addition, the Centres for Disease Control and Prevention, national public health agency of the USA, maintains regional
offices worldwide to support its Global Health Strategy, advancing programs and fostering collaboration within regions
to build capacity across borders,

• The Cuban Ministry of Public Health established bilateral cooperation agreements with other countries. It has notably

established bilateral cooperation agreements regarding the research and development of MCMs with Portugal

It  is  also  worth  noting  that  the  USA  and  Canada  are  part  of  the  Medical  Countermeasures  Consortium,  a  four-nation 
partnership  involving  the  Defence  and  Health  Departments  of  Australia,  Canada,  the  United  Kingdom,  and  the  United 
States. The Consortium seeks to develop medical countermeasures to assist with all-hazard preparedness and response for 
the participant countries.  
In the context of this consortium, the MCMC is part of the Subject Matter Experts consulted by The Public Health Agency of 
Canada as it manages the National Emergency Strategic Stockpile, for the identification of gaps by comparing MCMs needs 
with the National Emergency Strategic Stockpile holdings and prioritisation of MCM requirements in consultation with Subject 
Matter Experts. 

At regional level, PAHO establishes international partnerships to reinforce the global emergency preparedness and response 
architecture.  

Furthermore,  just  like  the  African  continent,  the  Caribbean  region  develops  strategic  partnerships  with  other  developing 
countries to strengthen capacities and promote sustainable common development. 
The Health Development Partnership for Africa and the Caribbean (HeDPAC) aims to bolster South-South cooperation and 
enhance  institutional  capacity  both  within  and  between  the  two  regions  and  beyond.  Local  manufacturing  is  one  of  the 
priorities of this initiative; it promotes advances in technology transfer to enhance self-reliance, improved access to quality 
and affordable medical products with increased regulatory capacity in the regions. It leverages on the Pharmaceutical Equity 
for Global Health Initiative, particularly in the local manufacturing of medical products 39. 

3.2.5.7  Health security coordination 

While in Mexico, health security coordination is centralized at the Secretariat of Health, in Canada and the USA, this task is 
distributed among several actors. 

In the USA, ASPR takes the lead in federal efforts to bolster preparedness against health threats, focusing on MCMs strategies 
through  the  PHEMCE.  This  entails  providing  recommendations  to  the  Secretary  of  HHS  on  various  aspects  such  as  R&D, 
procurement, stockpiling, distribution, and utilisation of MCMs. Additionally, the PHEMCE identifies national health security 
needs  and  develops  strategies  for  logistics,  deployment,  distribution,  and  dispensing  of  countermeasures,  particularly  in 
relation to the Strategic National Stockpile. 
The  US  CDC,  through  the  Division  of  State  and  Local  Readiness  assists  state,  local,  and  territorial  health  departments  in 
preparing  for,  responding  to,  and  recovering  from  emergencies  and  disasters.  DSLR  monitors  and  evaluates  public  health 
capabilities, plans, and operational readiness, providing funding and technical expertise to support nationwide preparedness 
and response efforts. 
BARDA supports the coordination efforts in providing the information on MCMs and, during health crises, swiftly assesses its 
portfolio to identify MCMs suitable for response. 

In  Canada,  Public  Safety  Canada  plays  a  key  role  in  coordinating  the  overall  government  response  when  the  federal 
government  is  involved  in  emergency  response  efforts.  It  cooperates  with  Health  Canada  and  the  PHAC  to  ensure  a 
coordinated and effective response to health emergencies across the country. 

At regional level, PAHO provides leadership, coordination, and logistical support for the emergency response phase of the 
epidemics in the Region. 

39

 The role and tasks of the HeDPAC is further detailed in the Supra-regional organisations section (2.2.8). 

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In North America, Canada and the USA are particularly structured and organized in terms of preparedness and response 
to health crises through medical countermeasures. 

The USA specifically has a highly relevant entity within the scope of HERA's activities: BARDA. 
BARDA  serves  as  a  key  entity  for  MCMs  in  the  USA,  with  significant  and  structured  activities  aimed  at  enhancing  all 
necessary capacities for the anticipation and management of MCMs. Indeed, this entity is dedicated to the development 
of MCMs and ensures important work in intelligence gathering and understanding of operational challenges that users 
may face when administering an MCM. BARDA is especially a central player in strengthening advanced R&D capacities and 
local manufacturing, by developing a set of partnerships. 

Canada also has an organized ecosystem around MCMs, and the country continues its efforts to enhance its capacities 
as  ensuring  access  to  essential  medical  supplies  remains  a  priority  for  its  government.  The  tasks  related  to  MCMs  are 
distributed among different agencies. The Public Health Agency of Canada plays a particularly important role in managing 
the National Emergency Strategic Stockpile, which includes PPE, medical supplies, pharmaceuticals, and more. The agency 
is  responsible  for  overseeing  the  entire  process  of  managing  the  NESS,  from  defining  the  MCM  requirements  and 
identifying product candidates, to conducting MCM market assessments by scanning drug databases, acquisition planning, 
stockpiling, and deployment. 

In Mexico, as in Cuba, most tasks are centralized within the Ministry of Public Health/Secretariat of Health. It should be 
noted, however, that due to the embargo, the Cuban government has implemented initiatives to foster the local production 
of biomedical products, and significant  investments have been made by the Cuban state into R&D to ensure access to 
medicines in the event of an outbreak. Today, the Cuban biotechnology industry is driven by the state entity BioCubaFarma, 
which is a major player in the R&D and production of MCMs. 

The four North  American countries included in  this study seek to contribute to the reinforcement of the global health 
emergency preparedness and response architecture. 
That is the case, for instance, of the USA and Canada which are part of the Medical Countermeasures Consortium, a four-
nation partnership involving the Defence and Health Departments of Australia, Canada, the United Kingdom, and the 
United  States.  The  Consortium  seeks  to develop  medical  countermeasures  to  assist  with  all-hazard  preparedness  and 
response for the participant countries. 

Finally, in terms of regional organisation, PAHO plays an important role in the region as the Regional Office for the Americas 
of the WHO. 

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3.2.6  South America 

Figure 7 - Map of South American countries and regional organisation covered by the study, and summary table. 

South America grapples with intricate socio-demographic dynamics, marked by varying levels of poverty and development 
across its nations. Despite strides towards progress, persistent disparities underscore the complex challenges faced by its 
populations. 
In terms of public health, Latin American countries are subject to infectious and neglected tropical diseases outbreaks. Since 
the start of 2024, South America is facing the accelerated spread of the dengue fever. PAHO officials have described the 
situation as potentially the worse outbreak in the Americas to date 40. 
In addition, countries in Latin America are historically prone to natural disasters such as hurricanes, floods, landslides, and 
droughts. 

In terms of preparedness and response to health crises, South America has been severely impacted by the COVID pandemic, 
notably due to significant shortages. Indeed, South America faces diverse challenges in its pharmaceutical supply chain, with 
some countries having developed pharmaceutical industries while others heavily rely on imports. Disruptions such as delivery 
delays  or  natural  disasters  can  lead  to  medicine  shortages.  To  address  this,  many  countries  are  implementing  policies  to 
promote local medicine production and diversify their supply sources. For instance, in the context of the significant dengue 
outbreak across Latin America previously mentioned, Argentina is facing a shortage of insect repellents. 

As  detailed  in  the  introduction,  the  study  team  selected  6  South  American  countries  to  include,  based  on  the  following 
criteria: 

•
•

The G20 countries: Argentina and Brazil,

Colombia, for its involvement in regional initiative in health in South America (PRET under PAHO, and ORAS
project to strengthen decision-making in controlling the Covid-19 pandemic through genomic surveillance 41) and
its bilateral agreement with Denmark 42,

40

 Argentina battles dengue surge and repellent shortage, BBC, April 2024 

41

 For further information, refer to the International Cooperation section (2.2.6.6.). 

42

   Denmark and Colombia strengthen bilateral cooperation in health, Colombian government news, March 2017 (press release published 

in Spanish, link: https://www.minsalud.gov.co/Paginas/Dinamarca-y-Colombia-fortalecen-cooperaci%C3%B3n-bilateral-en-salud.aspx) 

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•

Peru, Paraguay, and Ecuador for their involvement in ORAS and PROSUR projects to reinforce health emergencies
preparedness and response 43.

The study conducted across these 6 countries scope identified 15 entities. At the beginning of each paragraph, the study team 
refers to these 6 countries and specifies for which countries the task has been properly identified, along with the number of 
entities identified. 

Two regional organisations have been identified as performing tasks similar to HERA’s: the PAHO and the ORAS. 
The PAHO is the Regional Office for the Americas of the WHO. As mentioned in the North America chapter, its activities have 
been presented in the North America section; in this section, only the main information has been replicated, with references 
to corresponding sections when necessary. 
, the Andean Regional Health Agency, is a subregional integration body within the Andean Integration System which 
ORAS
aims to coordinate and support the efforts made by member countries, individually or collectively, to improve the health of 
their populations. 

44

3.2.6.1  Monitoring, Intelligence gathering and analysis 

In South America, the 6 countries studied have entities identified as being responsible for the analysis of health threats, the 
intelligence gathering and evaluation of the potential consequences and impact on public health. 

In all countries, this task is overseen by the Ministry of Health. However, there are distinctions: 

-
-

Countries where this activity is solely under the purview of the Ministry: Argentina, Ecuador,
Countries where this activity is carried out by both the Ministry of Health and another entity: the National Food
and Drug Surveillance Institute in Colombia, the National Council for Science and Technology CONACYT in Paraguay,
the National Institute of Health in Peru, FIOCRUZ in Brazil.

Indeed, in Colombia, the Ministry of Health and Social Protection ensures the health threats monitoring and evaluation of the 
potential consequences. The National Food and Drug Surveillance Institute, called INVIMA, supports the Ministry of Health 
and Social Protection in gathering and analysing intelligence regarding medicines and medical supplies. In preparedness, 
the entity assists the Ministry in identifying medications and medical supplies at risk of shortages in cooperation with INVIMA. 
In Brazil, FIOCRUZ analyses health threats and evaluates their potential consequences in support to the Ministry of Health. 
The Foundation has units dedicated to health surveillance and epidemiology and conducts studies on the prevention and 
control of diseases through computational and simulation methods. 

As mentioned previously, at regional level, PAHO collects data and provides guidelines (including on MCMs) to ensure that 
Member States receive evidence-based guidance, tools, and equipment to adequately manage cases and protect healthcare 
workers from the infection. 
In the Andean Region, ORAS supports its member states in analysing health threats and evaluating potential consequences 
and impacts on public health. ORAS has established a platform called the "Regional Genomic Surveillance Observatory" which 
utilizes genomic surveillance for monitoring and serves in the analysis and dissemination of findings to support the member 
states in decision-making. 
Furthermore,  ORAS  has  facilitated  the  implementation  of  the  Andean  Medicines  Observatory,  a  platform  containing 
information on medication access, quality, effectiveness, and safety, rational medication use, and research and development. 

3.2.6.2  Advanced Research and Development capacities 

4 of the 6 countries in South America have entities identified as actively involved in promoting and coordinating advanced 
R&D to produce effective and safe medical countermeasures: 

• In Argentina, this task is undertaken by the National Institute of Industrial Technology (INTI), federal agency in charge of
the developing of Industrial technology. INTI is committed to bolstering the growth of Argentine small and medium-sized
enterprises  and  promoting  the  expansion  of  the  national  industry.  This  involves  fostering  innovation  and  facilitating
technology transfer,

• In Peru, the National Institute of Health promotes R&I of technological interventions that effectively and timely address

the public health needs and demands, 

43

44

 For further information, refer to the International Cooperation section (2.2.6.6.). 
 In Spanish: Organismo Andino de Salud 

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45

• In Paraguay, the CONACYT

 plays a significant role in promoting and coordinating R&D efforts aimed at developing safe
and effective MCMs by encouraging and fostering related initiatives. At the peak of the Covid-19 pandemic, CONACYT
issued a call for competitive funding of R&D projects to support scientific research within the context of the coronavirus
pandemic. The funded projects encompass a wide range of areas, including epidemiological studies, research on social
behaviour,  the  development  of  medical  devices,  and  preclinical  trials  of  treatments  designed  to  prevent  and  treat
infectious diseases. 

In Brazil, the Ministry of Health ensures the promotion of advanced R&D capacities. In response to the Covid-19 crisis, it had 
allocated  nearly  USD  9.3  million  in  R&D  initiatives,  with  a  particular  focus  on  treatments,  vaccines,  diagnostics,  disease 
pathogenesis, healthcare, prevention, and control. 
Beyond  the  activity  of  the  Ministry  of  Health,  FIOCRUZ  plays  a  very  important  role  in  Brazil  for  the  promotion  and 
coordination of R&D for the development of MCMs. It conducts and coordinates research projects to produce knowledge for 
the control of diseases (AIDS, malaria, Chagas, tuberculosis, leprosy, rubella) and innovation projects to develop products and 
processes  with  potential  applications  such  as  vaccines,  diagnostic  methods…  Its  technological  management  coordination 
centre ensures the guidance, protection, negotiation, and transfer of the Institution's intellectual assets. 

Regarding the regional level, both PAHO and ORAS encourages and promotes coordinated R&D and aims to facilitate research 
on critical knowledge gaps. 

3.2.6.3  Production / Manufacturing capacities 

4 of the 10 South American countries studied have entities dedicated to enhancing the production / manufacturing capacities 
of MCMs, with a total of 7 entities. 
The study did not reveal any entity or initiative for this task in Ecuador and Peru. 

In Argentina, the National Institute of Industrial Technology is committed to bolstering the growth of Argentine SMEs and 
promoting the expansion of the national industry, which involves spearheading initiatives such as the Strategic Projects in 
Public Production of Medicines aimed at enhancing pharmaceutical production. 

In  Colombia,  the  Ministry  of  Health  and  Social  Protection  encourages  and  promotes  the  local  manufacturing  of  MCMs, 
particularly vaccines, as part of its policy to achieve health sovereignty. To this end, two local vaccine production initiative 
projects are currently underway, led by the Ministry in coordination with other entities. 
INVIMA, the National Food and Drug Surveillance Institute, supports the efforts to strengthen local manufacturing capacities. 
It collaborates with universities in initiatives to unite experts to deliberate on "the standardisation, validation, verification, 
and implementation of testing methods" necessary for establishing Colombia's public medicine production facility. 

In Paraguay, in emergency situations, the Ministry of Public Health and Social Welfare can collaborate with the Ministry of 
Industry and Commerce to stimulate local production. For example, during the COVID-19 pandemic, a National Agreement 
was established with the textile and metallurgical industries to facilitate the production of PPE. 

In Brazil, the Ministry of Health launched the National Development Strategy for the Health Economic-Industrial Complex in 
October 2023, aimed at expanding Brazil's capacity to produce essential items for its Unified Health System. This strategy 
entails the implementation of structural programs, including new sanitary regulations to foster the development of vaccines 
for emerging pandemics. 
FIOCRUZ supports the Ministry’s efforts to boost local manufacturing capacities. Since, they cooperate on the construction of 
the Industrial Complex of Biotechnology in Health, a new complex of FIOCRUZ. It aims to increase the production capacity of 
vaccines and biopharmaceuticals thus reinforcing the country's self-sufficiency in the field of immunobiological and reducing 
external technological dependence. 

At regional level, PAHO's Special Program, Innovation, and Regional Production Platform aims to improve communication 
and knowledge sharing to identify opportunities for regional cooperation
In the same way, ORAS aims to facilitate collaboration channels between member countries for the exchange of technology 
and the supply of biological products. 

46
. 

45

 CONACYT: National Council for Science and Technology

46

 Refer to the North America section - Production / Manufacturing capacities. 

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3.2.6.4  Procurement of MCMs 

Across all the South American countries included in the study, the procurement of MCMs is overseen by the Ministries of 
Health. 

4 countries that have chosen to leave this task solely to the Ministry of Health: Argentina, Brazil, Ecuador, and Paraguay. 
It is noteworthy that Ecuador has implemented an accelerated procurement process during health crisis response phases. 
Indeed, in emergency situations, the Ecuadorian Ministry of Public Health is empowered to directly contract necessary works, 
goods, or services essential for overcoming the crisis and ensures their distribution accordingly. 

In Peru, the procurement of MCMs is also the responsibility of the Ministry of Health on a national scale (including vaccines, 
PPE,  and  medical  devices  related  to  Covid-19).  However,  it  may  collaborate  with  the  Public  Procurement  Centre  "Perú 
Compras". 

In Colombia, “Colombia Compra Eficiente” is the national public procurement Agency, mandated to develop and promote 
public  policies  and  tools  for  state  procurement  processes,  aiming  to  generate  greater  efficiency,  transparency,  and 
optimisation  of  state  resources.  For  the  preparedness  and  response  to  health  emergencies,  the  agency  ensures  the 
procurement of MCMs. 

At  regional  level  in  case  of  emergency,  PAHO  seeks  to  facilitate  centralized  procurement  of  medical  devices  and  supplies 
specifically for addressing the challenges posed by the disease outbreak. 
ORAS supports its member countries for the negotiation and procurements of medicines and supplies at the Andean regional 
level. 

3.2.6.5  Stockpiling and distribution capacities 

5  of  the  6  South  American  countries  included  in  the  study  have  a  strategy  for  stockpiling  medical  countermeasures  to 
enhance their preparedness and response to health crises. 
Colombia  is  the  exception:  its  Ministry  of  Health  and  Social  Protection  develops  the  distribution  policy  and  oversees  the 
distribution of MCMs. However, there is no national stockpiling strategy in place. 

In other countries, the stockpiling and distribution is under the responsibility of the Ministry of Health.  
In Peru, the Ministry issued a decree in March 2024 regarding the establishment of a stockpile of essential medications. This 
decree sets forth the requirement that pharmacies, drugstores, and private health establishments maintain a minimum stock 
of  30%  of  essential  generic  medications,  with  a  financial  penalty  for  non-compliance.  The  ministry  is  responsible  for 
establishing the list of products involved. 
In Brazil, the Ministry of Health oversees the storage and distribution of MCMs such as vaccines, PPE, and ventilators, and 
manages  national  stockpiles.  The  ANVISA,  the  Brazilian  Health  Regulatory  Agency,  supports  this  activity  by  developing 
guidelines and protocols. 

At regional level, PAHO provides guidelines on both stockpiling and distribution to its member states. 

3.2.6.6 

International cooperation 

The six South American countries included in the study contribute to reinforcing the global health emergency preparedness 
and response architecture. 
In most countries, this cooperation is led by the Ministries of Health through bilateral cooperation agreements with other 
countries or initiatives with regional or international organisations, for instance: 

• The Argentine Ministry of Health participates in the preparedness and response globally, through collaborations with
international partners such as Chile, PAHO, etc.The Ministries of Health of Brazil, Ecuador, Peru, and Paraguay participate
.  This  initiative  aims  to  foster  regional
in  the  'Immunization  Capacity  Scaling  Project  in  the  countries'  of  PROSUR
capacities  for  vaccine  research,  development,  production,  and  distribution,  thereby  enhancing  preparedness  and
response capabilities across PROSUR member countries,

47

• The Colombian Ministry of Health has established a bilateral agreement with Denmark focused on access to medicines,
• As member countries of ORAS, the Ministries of Health of Colombia, Peru, Ecuador, and Bolivia cooperated on a project 

aimed at strengthening decision-making in controlling the COVID-19 pandemic through genomic surveillance.

In Brazil, FIOCRUZ is deeply committed to reinforcing the global health emergency preparedness and response architecture, 
particularly in advanced R&D capacities. Its unit in Africa (Mozambique) aims to coordinate, monitor, and evaluate health 

47

 Which also includes the Ministry of Health of Chile, a country not included in this study. 

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cooperation programs with African countries. This unit ensures technology transfer to boost local production and supports 
the strengthening of health systems in the countries of the Community of Portuguese-Speaking Countries. Within this South-
South  cooperation  dynamic,  FIOCRUZ  also  has  partnerships  with  entities  in  Latin  America  (Argentina,  Ecuador,  etc.)  to 
strengthen production chains, reduce external dependence, and promote mutual. 
Additionally, FIOCRUZ establishes bilateral partnerships, such as with the China CDC for joint research and laboratory diagnosis 
development and is the only Brazilian institution that belongs to the Pasteur World Network. 

At regional level, PAHO establishes international partnerships to reinforce the global emergency preparedness and response 
architecture. 
For instance, the Preparedness and Resilience against Emerging Threats (PRET) initiative, organized by PAHO, which brings 
together Bolivia, Colombia, Guatemala, Mexico, and Saint Lucia. This initiative aims to provide comprehensive guidance to 
countries to strengthen health emergency preparedness, response coordination, sustainable financing, and core capacities 
for responding to future public health events. 

ORAS is also committed to enhancing the global health emergency preparedness and response framework, with a particular 
focus on the Americas region. 
The "Strengthening Tuberculosis Laboratory Diagnostics in the Americas Region" program is being carried out in collaboration 
with Argentina, Mexico, Nicaragua, and other countries. 

3.2.6.7  Health security coordination 

In 4 countries, health security coordination is centralized at the Ministry of Health: Argentina, Ecuador, Paraguay, and Peru. 

In Brazil, this task is distributed among several actors: 

•

•

The Ministry of Health assumes a critical role in coordinating health security, notably through its Public Health
Emergency Operations Centre for Dengue and other Arboviruses, which aims to ensure a synchronized and
efficient response to epidemiological challenges associated with these diseases nationwide. Its goal is to enhance
planning and coordination efforts with state and municipal authorities against arboviruses, 

The ANVISA supports the Ministry of Health, through protocols and guidelines. 

In Colombia, the Ministry of Health and Social Protection is at the forefront of health security coordination. It is supported 
by  INVIMA,  the  National  Institute  for  Food  and  Drug  Surveillance,  which  offers  technical  assistance  to  the  Ministry  in 
developing policies, standards, and guidelines for the National Laboratory Network. 

At regional level, ORAS supports its member states in health security coordination by providing guidelines to national and 
local governments to prepare for and respond to health crises. 
PAHO provides leadership, coordination, and logistical support for the emergency response phase of the epidemics in the 
Region. 

Among the Latin American countries included in this study, it is noteworthy that the preparedness and response to health 
crises related to MCMs are largely the responsibility of the Ministries of Health. 

Brazil, with FIOCRUZ, stands out for its strong dynamics in promoting and encouraging the reinforcement of advanced R&I 
for the development of MCMs at the national level, as well as in Latin America and internationally. Other countries also 
implement policies and initiatives across various tasks to strengthen their capacities, such as Peru, which issued a decree 
in March 2024 for the stockpiling of essential medicines, or Colombia with two local vaccine production initiative projects 
are currently underway, led by the Ministry in coordination with other entities. 

In terms of cooperation, there is regional collaboration among these countries to enhance their capacities. Organisations 
such as PAHO (and consequently WHO) and ORAS play a significant role in this region by facilitating exchanges and leading 
projects. 

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3.2.7  Oceania 

Figure 8 – Map of the countries in Oceania covered by the study, and summary table. 

Australia and New Zealand are highly developed high-income countries, with high performing health system. 
Like other high-income countries, they face the challenges posed by an ageing population, health inequities, as well as the 
growing burden of non-communicable and chronic diseases. 
In addition, the Oceania region is very prone to natural disasters (cyclones, landslides…), and these phenomena are expected 
to intensify with climate change

48
. 

New  Zealand  is highly  dependent  on  the  importation  of  medical  supplies,  with  most  of  its  pharmaceuticals  sourced  from 
international markets, including major countries such as the United States, Germany, and Australia. This reliance on global 
supply chains can make New Zealand vulnerable to disruptions in the availability of essential medicines and the country faced 
shortages due to the covid-19 pandemic, the Russia-Ukraine war, the Red Sea conflicts… Similarly, Australia, while having a 
more robust domestic pharmaceutical manufacturing sector, also relies significantly on imports for certain medications and 
active pharmaceutical ingredients, primarily from countries like the United States, Germany, and China. 

In  terms  of  cooperation  for  health  crisis  preparedness  and  response,  New  Zealand  and  Australia  have  a  well-established 
partnership.  This  collaboration  was  particularly  evident  during  the  COVID-19  pandemic,  where  the  two  countries  worked 
together to optimize their vaccination schedules and share resources. 
In addition, recognizing the impact of the Covid-19 crisis, they have both established new entities post-pandemic, the Australia 
CDC, and the New Zealand Public Health Agency, to further enhance their health security coordination as well as health threats 
monitoring and analysis capacities. 

Furthermore,  Australia  and  New  Zealand  are  committed  to  reinforcing  health  emergency  preparedness  and  response 
capacities in the Pacific and Southeast Asia through targeted capacity-building initiatives. They actively support the Pacific 
Public Health Surveillance Network, collaborate with ASEAN on health security initiatives, and provide specialized training 
programs for healthcare workers in the region. Through these efforts, they aim to strengthen local expertise and ensure that 
countries in these regions are better prepared for future health crises. 

In the context of this study, 11 entities have been identified in Oceania, covering all of HERA's tasks in these two countries. 

3.2.7.1  Monitoring, Intelligence gathering and analysis 

In Oceania, 4 entities have been identified as being responsible for the analysis of health threats, the intelligence gathering 
and evaluation of the potential consequences and impact on public health. 
In Australia: 

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 Current and Emerging Disaster Risks Perceptions in Oceania: Key Stakeholders Recommendations for Disaster Management and Resilience Building, Int J 

Environ Res Public Health, Feb. 2019 

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•

•

The Australia Department of Health and Aged Care conducts intelligence gathering and resource mapping of the
medical countermeasures, to address identified gaps at national, state and territory levels,
The Defence Science and Technology (DST) Group, an Australian government agency under the Australian
Department of Defence, conducts intelligence gathering and analysis related to applied science and technology to
respond to health risks affecting both the military and the public.

In New Zealand, this activity is mainly ensured by the Institute of Environmental Science and Research (ESR). The Institute 
provides intelligence on notifiable diseases and other serious health threats, such as influenza and antimicrobial resistance. 
It  undertakes  surveillance  of  notifiable  diseases  in  New  Zealand  and  manages  the  national  notifiable  disease  database 
(EpiSurv) on behalf of the Ministry of Health - Manatū Hauora. 
The Public Health Agency, new agency established in 2022, supports the ESR in this activity. 

3.2.7.2  Advanced Research and Development capacities 

6  entities  in  Oceania  intervene  to  promote  and  coordinate  advanced  R&D  to  develop  effective  and  safe  medical 
countermeasures. 
5 of them are Australian: 
• The Health Security Systems Australia division, division of the Defence Materials Technology Centre, primarily focuses on
advanced R&D and manufacturing capacities through its MedCM program. This program aims to foster industry-research
collaborations in the development of MCMs, advancing technologies and directing skilled resources toward activities that 
bolster Australian defence, health, and national security objectives.

• The  DST  Group  seeks  to  grow  Australia’s  MCM  capability.  In  this  objective,  it  conducts  research  on  MCMs  aimed  at

effectively prevent, respond to, and defend against CBRN attacks (e.g., specific PPE).

• The Australian Institute for Infectious Disease (AIID), new initiative of the Victorian government to enhance Australia

49

R&D capabilities

, will aim to facilitate the development of MCMs, such as therapeutics, diagnostics, vaccines.
• The Australia Department of Health and Aged Care promotes and encourages advanced R&D regarding MCMs, 
• The  interim  CDC  seeks  to  build  Australia's  One  Health  and  health  security  capabilities.  The  agency  is  still  being

implemented, with one of its objectives being to promote R&D capacities regarding MCMs

50
.

In New Zealand, the Ministry of Business, Innovation and Employment works to develop and deliver on policy, services, and 
regulation to promote and support business growth. 
In the context of its activities, the MBIE promotes and encourages advanced research and innovation. Notably, during the 
Covid-19 crisis, it created the "Covid-19 Innovation Acceleration Fund" aiming: 

•

•

to accelerate the operational deployment of innovative solutions to support responses to COVID-19 and alleviate
the direct impacts of the virus threat,
to provide rapid short-term support to NZ based entities to develop and more quickly deploy a range of new
products, processes, or services. 

3.2.7.3  Production / Manufacturing capacities 

Regarding the task of enhancing the production / manufacturing capacities of MCMs, both Australia and New Zealand have 
entities responsible for this activity. 

In New Zealand, the PHARMAC – Te Pātaka Whaioranga is mandated “to secure the best health outcomes that are reasonably 
achievable from pharmaceutical treatment and from within the amount of funding provided”. 
In this context, during the Covid-19 crisis, the Agency aimed at enhancing the production capacities of pharmaceuticals. It 
supported suppliers with guidelines and protocols. 

To foster production and manufacturing in Australia, the MedCM program of Health Security Systems Australia (previously 
mentioned regarding R&D capacities) seeks to boost manufacturing capacities through industry-research collaborations and 
direct skilled resources toward activities. 
In addition, the Australian Department of Health and Aged Care oversees production and manufacturing capacities related 
to  health  crisis  preparedness  and  response.  This  includes  collaborating  with  relevant  departments  and  stakeholders  to 

49

 To date, the AAID is still a project, it will aim to be a centre of expertise dedicated to research against future diseases and pandemics. 

50

 New agency launched in January 2024, within the Department of Health and Aged Care 

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establish  liability  protection  concerning  the  manufacture,  testing,  development,  distribution,  administration,  and  use  of 
medical countermeasures during response efforts. 
The interim CDC is still being implemented, however one of its objectives will be ‘to support the Australian efforts to enhance 
national capabilities’. 

3.2.7.4  Procurement of MCMs 

Three  entities  in  Oceania  have  been  identified  as  actively  involved  in  the  procurement  of  medical  countermeasures  in 
preparedness and response to health crisis. 

In  Australia,  this  activity  is  centralised  by  the Australia  Department  of  Health  and  Aged  Care.  Indeed,  the  Department  is 
responsible of the management of the National Medical Stockpile, which includes procurement. 

In  New  Zealand,  two  entities  share  responsibilities  regarding  the  procurement  of  MCMs.  In  preparedness  and  response 
phases, Health New Zealand, the national public health agency, is mandated for the procurement of MCMs related to the 
national reserve of medical supplies. In situations of health emergencies, PHARMAC can support Health New Zealand in this 
activity. 

3.2.7.5  Stockpiling and distribution capacities 

Both Australia and New Zealand have implemented a strategy for stockpiling and distributing medical countermeasures to 
enhance their preparedness and response capabilities. 

In Australia, the National Medical Stockpile is managed by the Department of Health and Aged Care. It serves as a strategic 
reserve of drugs, vaccines, antidotes, and PPE for use in national health emergencies. 

In New Zealand, the Ministry of Health and Health New Zealand cooperate in the management of the National reserve of 
medical supplies, encompassing PPE, antivirals, medicines, vaccines, clinical equipment, and vaccination supplies. The role of 
the Ministry is to establish the national reserve policy direction, including its composition, while Health New Zealand ensures 
the supply functions (storage and distribution). 
In case of emergency, PHARMAC can provide support in the distribution of MCMs (as was the case during the COVID crisis). 

3.2.7.6 

International cooperation 

Firstly, it is noteworthy that there is strong cooperation between New Zealand and Australia in terms of health emergency 
preparedness and response. To illustrate this, it can be noted that experts from New Zealand are part of the initiatives of 
the  Department  of  Health  and  Aged  Care,  which  oversees  surveillance  and  intelligence  gathering  (the  Communicable 
Diseases Network Australia) and health security coordination (the AHPC). Additionally, the two countries have had exchanges 
in the creation of their respective new agencies (the interim Australia CDC and the New Zealand Public Health Agency). 
In addition, these two countries are key players in the regional health emergency preparedness and response architecture, 
as they collaborate with each other and with other countries in the Pacific to strengthen capacities. For instance, during the 
COVID-19 crisis, Australia and New Zealand supported the Autonomous Bougainville Government’s response. They provided 
technical  assistance  and  helped  distribute  information  to  local  communities  on  how  to  prevent  the  spread  of  COVID-19. 
Another example is their collaboration with the Pacific Public Health Surveillance Network. Australia and New Zealand actively 
support the PPHSN, which aims to improve the ability of Pacific Island countries to detect and respond to public health threats. 
They provide training, technical assistance, and resources to enhance epidemiological surveillance and laboratory capabilities. 

It is also interesting to note the other agreements: 

-

-

the bilateral cooperation established between Singapore and Australia. This cooperation has notably led
to (1) an agreement between the two Ministries of Health for a dose-sharing arrangement of COVID-19
vaccines, to support each other in optimizing their respective schedules for vaccinating their populations
against COVID-19, and (2) exchanges of experiences and ideas between the two new agencies created in
response  to  the  Covid-19  crisis:  the  new  Communicable  Disease  Agency  of  Singapore  and  the  interim
Australian Centre for Disease Control.
, the joint initiative between the New Zealand Ministry of Business, Innovation and Employment
FRIENZ
and the European Commission to enhance the engagement of the New Zealand research, science and
innovation community with the European Union’s Framework Programme for Research and Innovation. It
includes health innovation.

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 FRIENZ: Facilitating Research and Innovation co-operation between Europe and New Zealand 

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Internationally, both Australian Department Health and Aged Care and the Ministry of Health of New Zealand are involved 
in cooperation with ASEAN to reinforce the global health emergency preparedness and response architecture. 
In addition, in Australia, the Department of Health and Aged Care develops policies to supports local development initiatives 
for such countermeasures in foreign countries. The DST Group, for its part, has multilateral relationships with foreign countries 
(New Zealand, UK…) and is involved in the Medical Countermeasures Consortium

52
. 

3.2.7.7  Health security coordination 

Similar to what has been observed for previous continents, the steering and governance of health security coordination in 
Australia and New Zealand fall under the purview of the Ministry of Health/Department of Health and Aged Care (and its 
CDC in Australia). 

Notably,  to  strengthen  their  health  security  coordination  after  COVID-19,  both  countries  established  new  entities:  the 
Australia CDC and the New Zealand Public Health Agency. 

Both Australia and New Zealand seek to enhance their preparedness and response capacities. 
New Zealand is gradually structuring itself and aims to strengthen its capabilities. 
Australia appears to be a highly committed and structured country in terms of MCMs. It is notably engaged in significant 
initiatives  to  enhance  its  production  and  R&D  capabilities  (such  as  the  MedCM  program  of  Health  Security  Systems 
Australia). 

Both countries have established mechanisms for health security coordination, with the steering and governance falling 
under the purview of the Ministries of Health. 
Furthermore, both have decided to establish new entities to reinforce their capacities following the Covid-19 pandemic: 
the Australia CDC and the New Zealand Public Health. 

There  is  strong  cooperation  between  New  Zealand  and  Australia  in  terms  of  health  emergency  preparedness  and 
response. To illustrate this, it can be noted that experts from New Zealand are part of the initiatives of the Department of 
Health  and  Aged  Care,  which  oversees  surveillance  and  intelligence  gathering  (the  Communicable  Diseases  Network 
Australia) and health security coordination (the AHPC). Additionally, the two countries have had exchanges in the creation 
of their respective new agencies. 
In addition, these two countries are key players in reinforcing the regional and global health emergency preparedness 
and response architecture, as they collaborate with other countries in the Pacific to strengthen capacities. They particularly 
support Pacific countries in enhancing their response capabilities (e.g., during the COVID-19 crisis) and are also heavily 
involved with ASEAN in strengthening the capacities of Southeast Asian countries. 

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 Refer to 2.2.7. 

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3.2.8  Supra-regional organisation 

3.2.8.1  The Medical Countermeasures Consortium, a 4-nation partnership 

Established in 2012, the Medical Countermeasures Consortium (MCMC) is a four-nation partnership involving the Defence 
and Health Departments of Australia, Canada, the United Kingdom, and the United States. 

Also called “Quadrilateral Medical Countermeasures Consortium”, the MCMC is a working group under the CBR Memorandum 
of Understanding, signed in 2006 between the Defence Departments of the US, the UK, Australia, and Canada.  
The MCMC includes Defence and Health Departments of each of those nations. 

The strategic drivers of the Medical Countermeasures Consortium have been defined by the traditional issues associated with 
medical countermeasure development and include burden sharing, nontraditional development methods and overcoming 
the strategy gap. 
The  Consortium  seeks  to  develop  medical  countermeasures  to  assist  with  all-hazard  preparedness  and  response  for  the 
participant countries.  
Initially, the emphasis of the Consortium is on chemical, biological and radiological (CBR) threats affecting civilian and military 
populations. It has been expanded to include emerging infectious diseases and pandemics. 

The Consortium focuses on sharing information and cooperation regarding the advanced development of MCMs (drugs, 
vaccines, and diagnostics) that are already at Technology Readiness Levels 5-8. 
Its  goal  is  to  enable  participating  countries  to  stay  abreast  of  diagnostic  and  therapeutic  developments,  to  act  swiftly  in 
deploying  appropriate  treatments,  and  to  achieve  significant  cost  savings  by  accessing  the  results  of  joint  research  and 
development with other countries. 

This Consortium leads to enhanced cooperation between entities of member countries to share information and identify 
innovations for MCMs. 
For instance, ASPR has integrated the defence and health departments of the four member nations of the MCMC into the 
Portfolio Tracking and Coordination Initiative (PTCI), enabling portfolio data interoperability and providing appropriate 
access to data and information. 
Additionally, the MCMC is part of the Subject Matter Experts consulted by The Public Health Agency of Canada as it 
manages the National Emergency Strategic Stockpile, for the identification of gaps by comparing MCMs needs with the 
National Emergency Strategic Stockpile holdings and prioritisation of MCM requirements in consultation with Subject 
Matter Experts. 

3.2.8.2  HeDPAC, to strengthen South-South cooperation between Africa and the Caribbean 

Launched in 2023, the Health Development Partnership for Africa and the Caribbean (HeDPAC) is an initiative to strengthen 
South-South health cooperation between Africa and the Caribbean. 

The primary objective of HeDPAC, the Health Development Partnership for Africa and the Caribbean, is to bolster South-South 
cooperation and enhance institutional capacity both within and between the two regions and beyond, to maximize health 
development impact and achieve Universal Health Coverage. HeDPAC will align its catalytic role with existing national and 
regional development plans to ensure efficiency, synergy, and coherence. 

The HeDPAC focuses on three main priorities: 

•

•

•

Human health workforce, to address the challenges faced by the workforce of the Africa and Caribbean region
including education, employment, retention, and performance, 

Resilient Health Systems, to build health systems capable of withstanding the climate crisis and other emerging
threats with a particular emphasis on robust primary health care, 

Local manufacturing of medical products.

Regarding  local  manufacturing  of  medical  products,  HeDPAC  promotes  advances  in  technology  transfer  to  enhance  self-
reliance, improved access to quality and affordable medical products with increased regulatory capacity in the Africa and 
the  Caribbean  regions.  It  leverages  on  the  Pharmaceutical  Equity  for  Global  Health  Initiative,  particularly  in  the  local 
manufacturing of medical products. 

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3.3  Overview  of  international  organisations’  approaches  to 
public health crisis preparedness and response in MCMs 

Six  international  organisations  have  been  identified  in  the  mapping  as  entities  aiming  to  reinforce  the  global  health 
emergency preparedness & response architecture.  

Figure 9 - Summary diagram of identified international organisations and their mandates. 

3.3.1  Monitoring, Intelligence gathering and analysis 

Except  for  the  UNICEF  Supply  Division,  all  identified  organisations  analyse  health  threats,  conduct  health  intelligence 
gathering, and assess potential consequences on public health. 

Firstly, WHO carries out this task on an international scale and produces technical documents on health threats, including 
guidelines for diagnosis, treatment, prevention, and controls (including MCMs). 
WHO  conducts  continuous  surveillance  and  monitoring  of  global  health  threats,  including  infectious  disease  outbreaks, 
natural disasters, and other health emergencies. This involves collecting and analysing data from member states and other 
sources to detect potential health threats early. 
WHO also plays a major role at the regional level with its regional offices (such as PAHO, presented earlier). Regarding this 
task, WHO ensures surveillance and analysis of health threats and potential consequences at the regional level to support its 
member states.  

Furthermore, CEPI, DNDi, and FIND all lead initiatives in this field: 

• FIND  works  with  partners  to  tailor  testing  strategies  and  delivery  models  that  can  help  meet  national  and  regional
health delivery goals, including supporting the development and implementation of national essential diagnostics lists,

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• Since its creation in 2003, DNDi has supported the creation and maintenance of five regional clinical research platforms 
which aim to help to identify and evaluate patients’ needs and R&D gaps, strengthen and sustain clinical research capacity,
facilitate access to new treatments, advocate for an enabling policy and regulatory environment for needs-driven R&D,

• CEPI supports and coordinates the CEPI’s Centralized Laboratory Network, a large network of vaccine testing laboratories
which aims to evaluate CEPI priority-pathogen vaccines against common protocols to ensure alignment and information
sharing when identifying the most promising candidates. In the event of an outbreak of infectious disease, having an
established global clinical laboratory network in place will facilitate faster data readouts by harmonizing analyses and
reducing sample shipping times due to its worldwide footprint. In addition, CEPI’s Laboratory Research and Innovations
Team works with WHO to develop international standards, and with PATH to identify gaps in the creation or validation of
diagnostics for its priority pathogens. 

3.3.2  Advanced Research and Development capacities 

4 out of the 6 identified international organisations also play a role in promoting and coordinating advanced R&D to develop 
safe, effective, and affordable medical countermeasures. 

While CEPI and FIND aim to promote and accelerate the R&D of medical countermeasures within their respective scopes 
(diagnostic tools for FIND, vaccines and other biological countermeasures for CEPI), DNDi focuses on the development of drugs 
and treatments to prepare for future viral pandemics in low- and middle-income countries. 
WHO  plays  a  broader  global  role  in  coordinating  worldwide  information  sharing  and  supporting  initiatives  involving 
international cooperation for the R&D of medical countermeasures. 

• CEPI plays a pivotal role in the global R&D ecosystem in terms of vaccines and biological countermeasures. 
Launched  in  2017,  in  reaction  to  the  2014-2015  Ebola  outbreak  in  west  Africa,  CEPI  aims  to  finance  and  coordinate  the 
development of vaccines and other biological countermeasures against epidemic and pandemic. 
Concerning the response to health threats, CEPI sets the objective of a '100-day mission' regarding vaccine development and 
manufacturing capacities: aiming to develop a safe and effective vaccine within 100 days from the moment a pathogen is 
sequenced and/or the need for a vaccine is recognized, to its initial availability for use. 

In  practice,  CEPI  supports  enabling  science  activities  to  accelerate  development  of  vaccines  and  other  biological 
countermeasures and supports the development of vaccines candidates against its priority pathogens. 
CEPI  also  promotes  and  invests  in  the  development  of  platforms  technologies  to  develop  vaccines  against  Disease  X,  to 
facilitate rapid responses to emerging threats. 
Additionally, CEPI is actively seeking a coalition to develop the guidelines and principles to enable partners to progressively 
build  a  ‘Global  Vaccine  Library’,  a  global  repository  of  vaccine  resources,  capabilities  and  data  that  would  maximise 
epidemic and pandemic preparedness and accelerate vaccine development when new viral threats arise. It advocates for 
enhanced coordination among R&D funders in support of a Global Vaccine Library, and for the Pandemic Accord to establish 
a normative framework for the establishment of such a library. 

• FIND is a major player in the global architecture for the R&D of diagnostic tools aimed at strengthening capacity for

outbreak detection and rapid response.

FIND's  pandemic  threats  strategy  is  focused  on  expediting  the  development  of  diagnostic  tools  that  can  support  acute 
outbreak management and strengthen in-country capacity for outbreak detection and rapid response. FIND's work includes 
new rapid diagnostic tests for outbreak diseases (Marburg, yellow fever), development of a point-of-care molecular testing 
platform  (for  Lassa  fever),  test  evaluations  for  priority  outbreak  diseases,  strengthening  of  outbreak  preparedness  and 
response, and optimisation of diagnostic networks. 

• DNDi promotes and fosters collaboration for the development of drugs and treatments to prepare for and respond to

future pandemics in low- and middle-income countries.

DNDi  works  to  promote  and  to  foster  collaborations  among  key  actors  in  endemic  countries,  including  health  ministries, 
national disease control programmes, regulatory authorities, WHO, academia, and civil society groups. 
In terms of pandemic preparedness and response, DNDi leverages its experience in public-interest R&D and its alliances with 
research partners, notably in Africa and Latin America, to contribute to prepare for and response to future pandemics in 
low- and middle-income countries. 
Its missions are: 

•

•

to coordinate clinical trials by leveraging its expertise and network of partners to design and conduct urgently
needed clinical research, 

to facilitate and accelerate research through cooperation and coordination of partners, to guarantee that clinical
research meets the specific needs of resource-constrained settings,

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•
•

to identify drug candidates for the treatment of future viruses of pandemic potential,

to advocate for accountability from governments, industry, and the research community to make sure that
pandemic R&D is driven by the public interest and that new health tools reach everyone who needs them. 

• WHO fulfils the role of global coordinator for strengthening advanced R&D capacities for MCMs, facilitating information

sharing and cooperation initiatives. 

WHO  convenes  meetings  to  promote  cooperation  and  capacity-building  for  R&D  in  health  emergency  preparedness  and 
response.  For  example,  in  2022,  WHO  organized  a  meeting  on  respiratory  pathogen  pandemic  preparedness  in  Belfast  to 
discuss global guidance, drawing on lessons from the COVID-19 pandemic. 
Additionally, WHO supports initiatives like the ACT-Accelerator to enhance R&D capacities for the development of Medical 
Countermeasures  (MCMs),  fostering  global  collaboration  among  various  stakeholders  to  expedite  the  development, 
production, and equitable access to COVID-19 tests, treatments, and vaccines… 

3.3.3  Production / Manufacturing capacities 

Two  of  the  identified  international  organisations  are  involved  in  strengthening  the  production  capacities  of  MCMs.  CEPI 
focuses on vaccines manufacturing, while WHO operates on a broader scope. 

CEPI seeks to support projects that advance manufacturing innovations for scalable and equitable vaccine access. It focuses 
on  strengthening  capabilities  in  high-risk  areas  and  support  technology  transfers  technology  to  manufacturers  during 
outbreaks for rapid production and distribution. 
In its 2022-2026 strategy, CEPI emphasizes promoting equitable access principles and coordinating a scalable manufacturing 
network through cooperation with the public and private sectors. 

WHO  provides  guidelines  and  supports  initiatives  which  aim  to  ensure  the  production  and  access  to  medical 
countermeasures in its member states. 
For instance, in 2021, WHO and partners established the mRNA Technology Transfer Hub in South Africa, to build sustainable 
manufacturing capacity in low- and middle-income countries for COVID-19 and other global health threats including malaria 
and tuberculosis. 

3.3.4  Procurement of MCMs 

Two of the identified international organisations aims to ensure the swift procurement of MCMs: FIND and UNICEF Supply 
Division. 
• FIND works in partnership with the industry, global health procurement agencies, and private sector buyers to provide

tools that fill gaps where no global procurement mechanism currently exists.
FIND also provides market information and works with manufacturers to make diagnostic prices more affordable.
• UNICEF's Procurement Services Centre can assist governments in the procurement of strategic medical goods, including
vaccines, safe injection materials, essential medicines, medical and diagnostic supplies, pharmaceuticals, equipment and
supplies to ensure safe drinking water.

The Global Fund is also involved, as the largest multilateral provider of grants in global health. To contrast with UNICEF and 
FIND, the Global Fund operates as a financing mechanism rather than an implementing agency. 
It allocates funding for eligible countries to support HIV, TB, and malaria programs. The foundation uses an allocation model 
to distribute funds to eligible countries. Whether a country or region is eligible is determined by its income classification and 
disease burden.  
Over the 2021-2023 funding cycle, it invested US$4.9 billion, or US$1.5 billion a year, in formal and community health systems 
through core grants and its COVID-19 response – about one-third of its total investments. 

The  financial  support  of  the  Global  Fund  contributes  significantly  to  pandemic  preparedness,  supporting  countries  to 
prepare for, prevent, detect, and respond to new outbreaks. For instance, laboratories equipped with advanced diagnostics 
and skilled technicians can diagnose diseases like HIV and TB and quickly adapt to new threats. The diagnostic machines used 
for TB testing were repurposed to test for COVID-19, allowing countries like India and Bangladesh to test for both diseases 
simultaneously. 

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3.3.5  Stockpiling and distribution capacities 

Two of the identified international organisations seek to increase the stockpile capacity of medical countermeasures, manage 
the stockpiling of these countermeasures, and ensure their timely and efficient distribution during public health emergencies: 
the UNICEF Supply Division and WHO. 

In terms of distribution capacities, in case of a health emergency, the UNICEF Supply Division is capable of delivering supplies 
from a network of global supply hubs. 
Regarding  stockpiling,  the  UNICEF  Supply  Division  is  responsible  for  establishing  emergency  stockpiles  of  vaccines 
(meningococcal, yellow fever, oral cholera, and Ebola), and ensuring rapid supply of vaccines to disease outbreaks. 

The WHO provides guidelines and  protocols to its Member States regarding the stockpiling and distribution of medical 
countermeasures to enhance their capacities of preparedness and response to health emergencies.  
For  instance,  in  2023,  WHO  published  the  “National  stockpiles  for  radiological  and  nuclear  emergencies:  policy  advice”,  a 
document  describing  protocols  and  practices  for  ensuring  the  essential  elements  of  a  national  stockpile  of  medical 
countermeasures for radiation emergencies, particularly of the pharmaceuticals required to treat radiation injuries. It also 
addresses governance and management of such stockpiles. 

3.3.6 

International cooperation 

By their nature, the identified organisations are involved in reinforcing the global health emergency preparedness & response 
architecture: 
•

•

•

DNDi works in consortiums of research institutes, universities, not-for-profit organisations, and pharmaceutical
companies to develop new drugs and improve access to treatment. It also has partners in different regions of the
world (USA, UK, India, France, Mali, South Africa), including NGOs, Networks, Universities, Ministries of Health,
industries,
CEPI aims to support greater agility and resilience in regional R&D, supply chain and global health architecture,
establishing partnerships with vaccine developers, manufacturers, governments, philanthropies, civil society, and
global health organisations,
UNICEF Supply Division develops country programmes of cooperation on several objectives including helping
countries to strengthen their national capacity in planning for supply needs, selection of supplies and equipment,
effective delivery, and distribution, 
•
FIND’s work includes direct cooperation with countries to support their diagnostic capacity-building,
• WHO supports initiatives aiming at reinforcing the global architecture. It also led the interim coordination
mechanism (i-MCC-Net) which seeks to enhance collaboration for timely and equitable access to medical
countermeasures against pandemic threats, through a network-of-networks approach.
In addition, during health crises, WHO coordinates international response efforts, mobilizing resources and
expertise from member states, other UN agencies, NGOs, and the private sector. It aims to ensure a cohesive and
effective response to health emergencies.

3.3.7  Health security coordination 

WHO's role in health security coordination is to enhance global preparedness, ensure rapid and effective response to health 
crises, and support member states in protecting the health of their populations. Its role is organized into several activities: 

• Technical Guidance and Standards: WHO provides technical guidance, sets international health standards, and develops
protocols for disease prevention, detection, and response. This includes guidelines for managing outbreaks, vaccination
strategies, and emergency health interventions.

• Capacity  Building:  WHO  supports  countries  in  building  and  strengthening  their  health  systems  and  preparedness
capacities.  This  includes  training  health  workers,  enhancing  laboratory  capacities,  and  improving  disease  surveillance
systems. 

• Emergency Response Operations: WHO directly engages in emergency response operations, deploying teams of experts
to  affected  areas  to  provide  on-the-ground  support.  This  includes  establishing  field  hospitals,  distributing  medical
supplies, and providing technical assistance to local health authorities.

• Information  Dissemination  and  communication:  WHO  serves  as  a  central  hub  for  disseminating  accurate  and  timely
information about health threats and emergencies. This includes issuing situation reports, public health advisories, and
risk communication to inform and guide public health actions globally.

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• Policy Advocacy: WHO advocates for strong health security policies and frameworks at the national, regional, and global
levels. This includes promoting the IHR, which provide a legal framework for international cooperation and response to
public health emergencies.

In terms of international organisations, CEPI and FIND are involved in strengthening R&D and manufacturing capacities 
on  a  global  scale,  with  different  scopes  of  MCMs.  Indeed,  CEPI  aims  to  finance  and  coordinate  the  development  of 
vaccines and other biological countermeasures against epidemics and pandemics, while FIND fulfils this role in diagnostics 
tools. 

DNDi also works on the R&D of MCMs but with a specific focus of low- and middle-income countries. It aims to initiate 
and  coordinate  drug  R&D  projects  in  collaboration  with  the  international  research  community,  the  public  sector,  the 
pharmaceutical  industry,  and  other  relevant  partners  prepare  for  future  viral  pandemics  in  low-  and  middle-income 
countries. 

UNICEF Supply Division supports emergency preparedness by collaborating with country offices to strategically position 
supplies locally and enhance readiness and response capacities. It also ensures functions of procurement, stockpiling and 
distribution of MCMs. 

The Global Fund is the largest multilateral provider of grants in global health. It operates as a financing mechanism, 
allocating funding for eligible countries to support HIV, TB, and malaria programs. 
The  financial  support  of  the  Global  Fund  contributes  to  pandemic  preparedness,  supporting  countries  to  prepare  for, 
prevent, detect, and respond to new outbreaks. For instance, laboratories equipped with advanced diagnostics and skilled 
technicians can diagnose diseases like HIV and TB and quickly adapt to new threats. 

WHO fulfils the role of global coordinator for strengthening advanced R&D capacities for MCMs, facilitating information 
sharing and cooperation initiatives. 
It undertakes a range of tasks to enhance global preparedness, ensure rapid and effective response to health crises, and 
support member states in protecting the health of their populations: 

-
-
-

-
-
-
-
-

Global surveillance and monitoring, health threats analysis, 
Production of technical guidance and standards, 
Capacity  building  to  support  countries  in  strengthening  their  health  systems  and  preparedness
capacities (training health workers, enhancing laboratory capacities…) 
Coordination of the international response with the relevant stakeholders, 
Promotion and coordination of R&D of medical countermeasures, 
Emergency response operations with the deployment of teams of experts to affected areas, 
Communication and information dissemination,
Policy Advocacy.

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4.

Glossary

Acronym 

Definition 

Africa CDC 

the Africa Centres for Disease Control and Prevention 

AMR 

API 

APTF 

Antimicrobial Resistance 

Active Pharmaceutical Ingredient 

African Pharmaceutical Technology Foundation 

ASEAN 

Association of Southeast Asian Nations 

CARICOM 

COVAX 

ECDC 

EMA 

Gulf-CDC 

HeDPAC 

IPD 

MCMs 

MoU 

PAHO 

PPE 

R&D 

RescEU 

The  Caribbean  Community  and  Common  Market,  group  of  20  developing  countries  in  the 
Caribbean 

COVID-19 Vaccines Global Access 

European Centre for Disease Prevention and Control 

European Medicines Agency 

Gulf-Centre for Disease Prevention and Control 

Health Development Partnership for Africa and the Caribbean  

Institute Pasteur of Dakar 

Medical Countermeasures 

Memorandum of Understanding 

Pan American Health Organisation 

Personal Protective Equipment 

Research and Development 

rescEU was established as a reserve of European capacities, fully funded by the EU. It includes a 
fleet of firefighting planes and helicopters, a medical evacuation plane, and a stockpile of medical 
items and field hospitals that can respond to health emergencies. 

WHO 

World Health Organisation 

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5.

Appendices

5.1  Kick-off meeting minutes

Meeting:  

Present: 

Kick-off meeting 
HERA 

Pepios George 

Montazeri Nadia 

Kurcz Bartlomiej 

Date: 10 January 2024 

Study Team 

Christina Castella (EY France) 

Marco Laoreti (EY France) 

Myriam Oukkal (EY France) 

Olivier Borraz (SciencesPo) 

Laetitia Atlani-Duault (CEPED Paris Cité) 

Introduction 

The  kick-off  meeting  (KoM)  began  with  a  roundtable  presentation  of  the  Project  Team  from  HERA  and  the 
members of the EY study team. This meeting was meant to discuss the objectives and scope of the study, as well 
as the methodology proposed including the consultation strategy, agree on the timeline for the study and key 
milestones. 

Presentation of the Study Team 

The Study Team for the assignment was presented to COM. It was highlighted that Christina Castella, Director at 
EY, would act as the Project Director for the Study, with Myriam Oukkal acting as Project Manager. They will be 
the key contact points throughout the Study. The Core Team would be composed of both Better Regulation, 
organisational  and  health  experts,  with  high-level  experts  in  public  health  emergencies  preparedness  and 
response (Olivier Borraz and Laetitia Atlani-Duault), as well as country experts from the EY Network of Health 
Experts mobilized throughout the Study.  

Objectives of the study 

The main aim of the Study is to provide the Commission with an overview of Member States and third countries’ 
entities which perform key functions in areas falling under the competences of HERA, with a focus on entities 
responsible  for  ensuring  preparedness  and  response  against  cross  border  threats  on  health.  This  general 
objective  translated  into  three  specific  objectives:  (i)  identify  existing  entities  in  Member  States  and  third 
countries acting in the field of competences of HERA or entitled to do so, (ii) describe the entities including an 
overview of their key competencies, their organisational structure, and their position within the wider healthcare 
and emergency response organisation, (iii) compare the identified entities with HERA’s core functions in its two 
operating modes, namely, preparedness and crisis. 

► During the KoM, HERA clarified its evidence needs in relation to the objectives of the study: HERA is
looking for a comprehensive understanding of the existing structures within Member States (MS) that
deal with Medical Counter Measures (MCMs). This shall extend beyond Ministries of Health and include
any entity or structure involved in the development and distribution of MCMs.

Scope of the study 

In terms of the identification of HERA-like entities, the study will focus on entities in the following categories in 
both  Member  States  and  Third  Countries:  (i)  Governmental  bodies,  authorities,  agencies  and  budget  offices 
active  in  the  field  of  health  crisis,  (ii)  Bodies/organisations/structures  carrying  out  advanced  research  in  the 
development of MCM, (iii) Bodies/organisation/structures carrying out local support to the production of MCM, 
(iv) Surveillance organisations.

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In terms of geographical scope, the study will cover all EU27 Member States, as well as Third Countries including 
the USA and the UK. Additional countries may be selected if relevant to the study (selection criteria have been 
developed).  

► The study team noted that HERA already has already relevant knowledge and material on entities in
Member States, as well as a preliminary list and contacts, as a result of its coordination efforts with MS.
The study team will therefore be in a position to build upon the material that HERA can share with them
with regards for the identification and description entities in EU Member States. The same applies to
the US and UK, for which HERA can also provide evidence.

► HERA requested the study team to place their efforts on investigating the global aspect of the study
more extensively. This means that the scope of the study shall be extended to cover multinational and
regional  structures,  such  as  Africa  CDC,  which  presents  a  model  for  regional  cooperation.  Similar
structures covering multiple countries shall be identified, primarily in the following geographies: Latin
America, Asia, Africa.

► On top of multinational and regional structures, third countries may be identified for study. The list shall
include the UK and USA, for which HERA already can share documentation; however, additional third
countries may be selected and analyzed based on their relevance and on the specific selection criteria,
including their strength in MCMs. In this case, the team shall focus efforts on countries in Asia, Africa
and Latin America.

Approach of the study 

The Study Team presented the approach for the assignment, focusing on specific Tasks where clarification was 
needed, as outlined in detail below.  

Task 0: Inception 

► Scoping interviews with HERA: 3-4 individuals from HERA unit responsible for this study will be carried
out  in  the  next  weeks  (preferably  already  next  week).  HERA  informed  the  study  team  that  their
colleagues have deep knowledge in the subject area and can provide the team with insights on (i) HERA’s
core tasks and functions, (ii) similar structures in Member States, (iii) relevant multinational, regional
structures outside of the EU, as well as third countries’ structures similar to HERA.

o The team proposed to hold interviews with HERA in Brussels over the course of one day. HERA

has committed to provide contacts for these interviews.

► Additional  interviews  may  be  organized  with  representatives  from  HERA  Advisory  Forum  (Member

States) in case needed.

o Contacts of Member States representatives can be provided by HERA colleagues during scoping 

interviews.

► A  scoping  interview  will  be  carried  out  with  the  WHO,  as  it  is  expected  that  the  organisation  has

knowledge of relevant multinational, regional entities, as well as entities in specific countries.

► Initial desk research: an initial review of the documentary evidence that is available to the study team
will be carried out. This will include the analysis of legislative, non-legislative EU documents, as well as
from Member States and Third countries, documents on HERA (e.g., workplans) and from international
organisations (e.g., WHO).

o HERA has committed to provide the relevant and available in-house documentation to inform
a clear identification of its core tasks and functions, as well as on Member States and Third
Countries’ (USA, UK) structures, to the extent possible. It will be paramount for the team to
have access to such documentation for a successful continuation of the study.

Task 2: Description of mapped structures 

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► It  was  discussed  that  the  need  of  written  questionnaires  may  be  questionable,  due  to  previous
experience of stakeholder fatigue in Member States and a probable difficulty to engage actors in third
countries to fill in a questionnaire.

o It was agreed that, based on the results of the desk research, the team may decide to favor
direct  interviews  rather  than  launching  a  written  questionnaire.  This  approach  ensures
personalized  interaction  and  richer  data  collection,  as  well  as  avoiding  stakeholder  fatigue.
Specific  entities  and  individuals  would  be  targeted  according  to  information  gained  during
scoping interviews and in the desk research phase.

Timeline and communications 

► It was decided that, at this stage, a bi-weekly meeting will be set up between the Study Team and HERA

to track progress and ensure smooth organisation.

o The study team proposes to hold it on Wednesdays at 14h30. HERA shall confirm availability

for bi-weekly meetings on Wednesdays at 14h30 or to propose a different day/time.

► It was agreed that the deadline for the completion of the Inception Report will be 9 February 2024 and

the Interim Meeting shall be held on 19 February 2024 in Brussels.

► It was agreed that deadlines for the other deliverables are to be rediscussed in the Inception Meeting.

Decision 

Minutes of the kick-off meeting 

Responsible 

Study Team  

Date 

12 January 2024 

Provision of documentation relevant to the study objectives 

HERA 

15-19 January 2024

Organisation of first exploratory interviews with HERA and 
identification of additional stakeholders to be contacted 

Study Team/HERA 

22-26 January 2024

Organisation of weekly progress meeting  

Study Team/HERA 

Bi-weekly - Wednesdays at 
14h30 

Submission of Inception Report  

Meeting on the Inception Report 

Action points 

Study Team  

9 February 2024 

Study Team /COM 

19 February 2024 

► It was discussed that HERA shall provide the study team with:

o Any  in-house  documentation  that  may  be  relevant  to  the  objectives  of  our  study  and
specifically  to  identify  (i)  HERA’s  core  tasks  and  functions,  (ii)  similar  structures  in  Member
States,  (iii)  relevant  multinational,  regional  structures  outside  of  the  EU,  as  well  as  third
countries’ structures similar to HERA.

o Following on the provision of documentation, schedule a day for holding scoping interviews in

Brussels with HERA colleagues.

o A list of contacts (if any) for scoping interviews in Member States as well as with the WHO.
o An accreditation letter for interviews with other stakeholders.

► The team shall start undertaking an extensive desk research and carry out scoping interviews beginning

from the week commencing on 15 January 2024.

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5.2  Inception Report – Entities identified at this stage 

5.2.1  Preliminary list of identified entities in EU Member States 

Table 1 Preliminary list of identified entities in EU Member States 

Country 

Entities 

Austria 

Belgium 

Bulgaria 

Croatia 

Cyprus 

Czech 
Republic 

Denmark 

Estonia 

Finland 

France 

► Ministry of Social Affairs, Health, Care and Consumer Protection (BMSGPK) - National COVID-19 crisis unit
►
►
►

Austrian Agency for Health and Food Safety (AGES)
Federal Office for Safety in Health Care (BASG)
Federal states’ health authorities and provinces

National Multidepartment Crisis Center - NCCN - (Homeland Minister) 
Health Crisis Center at Health Department (FPS Health)
Sciensano
Federal Agency for Medicines and Healthcare Products (FAMHP)
Joint Community Commission (Brussels) 
Agency for Care and Health (Flanders) 
Agence wallonne pour une vie de qualité - AVIQ (Wallonie) 

►
►
►
►
►
►
►
► Ministry of Health
►
►
►
►
► Ministry of Health – Crisis Headquarters
►
►
►
► Ministry of Health
►
►

Regional Health Inspectorates
National Pandemic Committee 
Bulgarian Drug Agency 
National Operations Headquarters (NOH)

State Healthcare Services Organisation
Health Insurance Organisation

Civil Protection Directorate - National Crisis Headquarters
Croatian Institute of Public Health 
Agency for medicinal products and medical devices of Croatia (HALMED)

Regional Public Health Authorities 
National Institute of Public Health - Centre for Epidemiology and Microbiology 
SÚKL - State Institute for Drug Control

► Ministry of Health
►
►
►
► Ministry of Health
AMGROS
►
Danish Health Authority 
►
Statens Serum Institut 
►
Danish Medicine Agency
►
► Ministry of Social Affairs – Health Board
►
►

State Agency for Medicines 
Estonian Stockpiling Agency

► Ministry of Social Affairs and Health – Preparedness Unit 
►
►

National Emergency Supply Agency
Finnish Institute for Health and Welfare (THL)

General Secretariat for Defence and National Security (SGDSN)
ANRS - Emerging Infectious Diseases

► Ministry of Solidarity and Health - Health Surveillance and Safety Sub-Directorate (VSS)
►
►
► Ministries of Interior and Defense
►
►
►
►
►

Santé Publique France - Unité Établissement pharmaceutique 
Agence Nationale de sécurité du médicament et des produits de sante
French High Council in Public Health 
Haute autorité de santé (HAS)
Institute Pasteur 

Germany 

►
►
►

Federal Ministry of Health (BMG)
Federal Ministry of Education and Research (BMBF) 
Federal  Ministry  for  the  Environment,  Nature  Conservation,  Nuclear  Safety  and  Consumer  Protection
(BMUV)

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Country 

Entities 

Federal Office for Civil Protection and Disaster Assistance (BBK)
Länder 
PEI - Paul Ehrlich Insitut (ZEPAI - Center for Pandemic Vaccines and Therapeutics)
Robert Koch Institute 

►
►
►
►
► Ministry of Health (General Secretariat for Public Health; the General Secretariat for Health and Quality of

Life) 
Directories for Public Health in Regions 
National Public Health Organisation (NPHO/ΕΟΔΥ)
National Organisation for Medicines (NOM/ΕΟΦ)

National Public Health and Medical Officer Service (NPHMOS)

►
►
►

►

Department of Health 
Health Service Executive (HSE)
Health Protection Surveillance Centre (HPSC)
Health Research Board (HRB)
Government Task Force on Emergency Planning (GTF) and Office of Emergency Planning (OEP) 
National Emergency Coordination Group (NECG)
National Public Health Emergency Team (NPHET)
Department of Enterprise, Trade and Employment

►
►
►
►
►
►
►
►
► Ministry of Health
►
►
►
►
► Ministry of Enterprises and Made in Italy 

National Department of the Civil Protection (CPD)
Instituto Superiore di Sanità (IIS) 
Italian Medicines Agency (AIFA)
Regions/Autonomous provinces

Centre for Disease Prevention and Control (SPKC)

►
► Ministry of Health
► Ministry of Interior 

Greece 

Hungary 

Ireland 

Italy 

Latvia 

Lithuania 

Health Emergency Situations Centre (HESC)
National Crisis Management Centre (NCMC)

►
►

Luxembourg 

Malta 

High Commission for National Protection (HCNP)
Laboratoire National de Santé (LNS)
Luxembourg Institute of Health

► Ministry of Health – Unit on Emergency Preparedness and Response
►
►
►
► Ministry of Health
► Malta Medicines Authority  (MMA)
►

Infectious Disease Prevention and Control Unit (IDCU)

Netherlands 

► Ministry of Health - National Institute for Public Health and the Environment RIVM
►

Health Council of the Netherlands

Poland 

Portugal 

Romania 

Slovakia 

Slovenia 

Chief Sanitary Inspectorate
Chief Pharmaceutical Inspectorate

►
►
► Ministry of Health
►

National Institute of Public Health 

National Institute of Health (INSA)
DG Health
National Authority of Medicines and Health Products

►
►
►

National Institute for Public Health (INSP)

►
► Ministry of Internal Affairs - Emergency Situation Department
►

General Inspectorate for Emergency Situations 

Public Health Authority of the Slovak Republic 
Regional Public Health Authorities in the Slovak Republic

National Institute of Public Health (Slovenia)

►
►

►

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Study mapping structures with relevant mandates, tasks, and functions to HERA within Member States and globally 

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Country 

Entities 

Spain 

Sweden 

►
►
►
►

►
►

►
►
►
►
►

Coordination Centre for Health Alerts and Emergencies (CCAES)
The Spanish Agency of Medicines and Medical Devices (AEMPS)
National Institute for Health Management (INGESA)
Carlos  III  Health  Institute  of  the  Ministry  of  Economy  and  Competitiveness  (belongs  organically  to  the
Ministry of Science, Innovation and Universities) 
Public Health State Agency (under development)
Autonomous communities

Public Health Agency of Sweden
The National Board of Health and Welfare 
Swedish Civil Contingencies Agency
Swedish Medical Products Agency
Regional councils

5.2.2  Preliminary  identification  of  HERA-like  organisations  at  multinational  or  regional 

levels 

The inception phase, through the initial documentary review and scoping interviews, enabled us to establish selection criteria 
to identify relevant organisations at multinational or regional levels to include in our study to meet HERA's expectations. 

Selection criteria 

For our study, we considered only organisations carrying out one or more activities related to HERA's key responsibilities. 
Therefore, organisations dedicated to disease surveillance, not linked to medical countermeasures, were not included. 

List of identified regional or multinational organisations. 

Based on the elements and selection criteria mentioned above, the following list of relevant organisations for the study 
could be established. For each one, there is a note providing justification for its selection. 

Name 

Geographical area 

Justification for inclusion in the benchmark 

Regional organisations 

PAHO: The Pan 
American Health 
Organisation 

Americas 

Africa CDC 

Africa 

SEGA One Health 
network 

Indian Ocean 

- Specialized international health agency for the Americas, 
in  technical  cooperation  with 
- Engages 

its  member  countries  to  fight
communicable and noncommunicable diseases and their causes,  to strengthen
health systems, and to respond to emergencies and disasters. 

- Health  emergency  preparedness:  Enhances  all  countries'  capabilities  for  health
emergency and disaster risk management, encompassing contingency planning,
stockpiling of supplies, and coordination mechanisms. 

- Response:  Assists  countries  in  leading  and  coordinating  international  health
responses to contain disasters, including outbreaks, and provide effective relief to 
affected populations

53
. 

- Continental autonomous health agency of the African Union, with 5 Regional
Coordination Centres for the Northern Africa, Central Africa, Eastern Africa, 
Western Africa, and Southern Africa, 

- Support Member States in health emergency responses, particularly those 

which have been declared a public health emergency of international concern, 

- Promote partnership and collaboration among Member States to address

emerging and endemic diseases and public health emergencies, 

- Harmonize disease control and prevention policies and the surveillance systems 

in Member States, 

- Support Member States in public health capacity-building through medium- and 

long-term field epidemiological and laboratory training programmes

54
.

- Member states: Union of the Comoros, Réunion/France, Madagascar, Mauritius, 

and Seychelles 

- To improve health of member states’ populations through better and more 

intense cooperation, collaboration, integration, capacity building and 

53

 PAHO Official website, Health Emergency and Disaster Preparedness and Major Emergencies Response 

54

 Africa CDC official website, About us 

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Final Report 

PROSUR: the Forum for 
the Progress and 
Development of South 
America 

coordination in public health at regional level, by following a comprehensive 
approach that integrates health in all policies

55
. 

- Mechanism  for  dialogue  and  cooperation  between  all  the  countries  of  South
America,  to  advance  towards  a  more  effective  integration  that  allows  for  the
growth, progress, and development of South American countries. 

- Aims to contribute to building sustainable vaccine production capacities to ensure 

South America 

equitable and timely access for PROSUR countries. 

- Aims to Facilitate the exchange of information, data analysis, and experiences in
epidemiology, with special attention to individuals and families in conditions of
human  mobility,  to  support  decision-making  and  the  implementation  of  public
health policies in the region

56
. 

- Member states: Finland, Iceland, Norway, Sweden, and Denmark.
- To ensure timely access to the right pharmaceuticals to the right price for patients 

in the Nordic countries. 

Nordic Pharmaceuticals 
Forum 

Nordic countries 

- Ambition  in  2025  to  be:  «Recognized  Nordic  collaboration,  developing  and

delivering sustainable solutions to supply medicines to the public sector»

57
.

ASEAN: The Association 
of Southeast Asian 
Nations 

South-East Asia 

CARPHA: Caribbean 
Public Health Agency 

The Caribbean 

public health emergencies and threats, 

- HERA visited the Nordic Pharmaceuticals Forum to learn about how the Nordic
countries organise tendering procedures and about their close collaboration to
secure supplies of medicines

58
. 

- Member  states:  Thailand,  Vietnam,  Singapore,  Philippines,  Malaysia,  Lao  PDR,

Myanmar, Indonesia, Cambogia, Brunei 

- ASEAN  Strategic  Framework  on  Public  health  Emergency:  to  enhance  ASEAN’s
59
.
preparedness, detection, response, and resilience to public health emergencies

- Aims  to  provide  strategic  direction,  in  analysing,  defining,  and  responding  to

public health priorities of the Caribbean Community, 

- Aims  to  support  the  Caribbean  Community  in  preparing  for  and  responding  to

- Ongoing project: Health Systems Strengthening for CARICOM Member States to
Respond  to  the  COVID-19  Pandemic  and  Other  Emerging  and  Re-emerging
Threats 

60
.

- Member  states  of  the  Gulf  Cooperation  Council:  The  Kingdom  of  Bahrain,  the
State of Kuwait, the Sultanate of Oman, the State of Qatar, the Kingdom of Saudi 
Arabia, and the United Arab Emirates. 

- Launched in 2021, with the aim of enhancing coordination, building knowledge,
and  producing  evidence  to  enable  prevention  of  communicable  and  non-
communicable  diseases,  mitigate  public  health  emergencies,  and  promote
healthy communities throughout the GCC countries

61
. 

- 4-nation partnership involving their Defence and Health Departments
- seeks to develop medical countermeasures to assist with all-hazard preparedness

and response for the participant countries. 

- Emphasis on chemical, biological and radiological (CBR) threats affecting civilian
62
. 
and military populations and on emerging infectious diseases and pandemics

Gulf-Centre for Disease 
Prevention and Control 

the Gulf region 

Multinational organisations 

The 'Medical 
Countermeasures 
Consortium' 

Australia, Canada, 
the United 
Kingdom, USA 

International organisations 

WHO (including its 
regional offices) 

International 

HERA collaborates with the WHO on several projects:  

55

 SEGA One Health, official website: https://segaonehealth.org/objectifs-du-reseau/  

56

 PROSUR Official website, Salud : Salud | PROSUR (foroprosur.org) 

57

 Nordic Pharmaceutical Forum official website: https://nordicpharmaceuticalforum.com/index.php/about-nordic-pharmaceutical-forum-

nlf  
58

 Amgros news, January 2024: HERA visit the Nordic pharmaceuticals forum 

59

 Asean Strategic Framework for Public Health Emergencies, November 2020 

60

61

62

 CARPHA Official website 
 Gulf CDC Official website 
 Australian Government, Department of Defence, Partnerships -The Medical Countermeasures Consortium 

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- clinical trials with WHO R&D Blueprint, including GARDP

- Data collection and exchange with the WHO AFRO Dakar Hub
the expansion of the stockpiling of MCMs in the Dakar Hub

66
.

63

 and SECURE
65

64
, 

, and support to

CEPI: Coalition for 
Epidemic Preparedness 
Innovations 

- Global  partnership  between  public,  private,  philanthropic,  and  civil  society

organisations, 

- Aims  to  accelerate  the  development  of  vaccines  and  other  biologic

International 

-

countermeasures against epidemic and pandemic threats
In  2022,  HERA  and  the  CEPI  have  agreed  to  strengthen  cooperation  and
information  exchange  on  end-to-end  vaccine  research  and  development,
manufacturing capacity and capacity building both within the EU and globally

68
.

67
.

FIND 

International 

UNICEF Supply Division 

International 

- Global non-profit organisation driving innovation in the development and delivery 
of  diagnostics  to  combat  major  diseases  affecting  the  world’s  poorest
populations, 

- Pandemic threats strategy focused on expediting the development of diagnostic
tools that can support acute outbreak management, and strengthening in-country 
capacity for outbreak detection and rapid response, 

- Ongoing actions: New rapid diagnostic tests for outbreak diseases, development
of  a  point-of-care  molecular  testing  platform,  test  evaluations  for  priority
outbreak diseases, strengthening of outbreak preparedness and response in West
Africa

69
. 

- Procurement services: seek to offer UNICEF's knowledge, purchasing capacity and
logistics expertise to partners, so they can use their own financial resources and
donor funds to procure life-saving essential supplies for children. 

- UNICEF serves as a procurement agency responsible for establishing emergency
,  and  for  ensuring  rapid  supply  of  vaccines  to  disease

stockpiles  of  vaccines
outbreaks upon request from the International Coordinating Group (ICG)

71
. 

70

5.2.3  Preliminary identification of HERA-like entities in Third Countries 

HERA  aims  to  achieve  a  comprehensive  mapping  of  the  coverage  of  its  mission  and  tasks  by  entities in  third  countries. 
Therefore, with regards to the scope of third countries, the Study Team will aim to: 
Provide a panorama of countries as wide-ranging as possible, 
For  each  country  included,  a  matrix  will  be  developed  to  clearly  map  the  coverage  of  missions and  tasks  across
entities within these countries. 

-
-

The inception phase has already identified entities with activities similar to HERA’s in third countries. The next phase of the 
mission will involve conducting more in-depth and comprehensive research. The table below presents these initial findings: 

Country / 
Geographical areas 

Africa 

South Africa 

Figure 10 – Preliminary list of Third countries 

Preliminary identification of HERA-like entities 

The National Institute for Communicable Diseases (NICD)

72
: 

63

 Global Antibiotic Research and Development Partnership 

64

 Initiative to provide access to essential antibiotics, as well as prepare and respond to pandemics. 

65

 The market intelligence platform and the COVID-19 technology platform 

66

 HERA Work plan 2024 

67

 CEPI Official website, Mission and approach  

68

 European Commission, News announcement – October 2022: HERA and CEPI agree on stronger cooperation in the development of 

medical countermeasures. 
69

 FIND Official website, Pandemic threats programme 

70

 meningococcal, yellow fever, oral cholera and Ebola 

71

 UNICEF Supply Division official website, « For governments and partners » 

72

 NICD official website 

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Ethiopia 

Asia 

Singapore 

Taiwan 

Europe 

UK 

Norway 

Oceania 

Australia 

- performs  molecular  diagnosis,  typing,  and  isolation  of  influenza  viruses  to  assess  genetic  drift  and  viral

resistance and provide influenza strains for vaccine formulation. 

- Has a role in optimising the available laboratory services during outbreak events. 

- The Government of Ethiopia strives to establish a pharmaceutical hub through developing industrial parks
to  realize  the  vision  of  strengthening  and  transforming  the  Ethiopian  pharmaceutical  industry  along  the
entire value chain to an internationally competitive and compliant industry 73.

- Ethiopia  Pharmaceuticals  Supplies  Agency  (public  procurement  agency  responsible  for  purchasing
pharmaceuticals,  medical  supplies,  and  equipment),  has  developed  a  suite  of  applications  for  ensuring
proximity of EPSA distribution hubs to health facilities across Ethiopia and to establish efficient systems for
inventory, fleet, and information management74. 

- Ministry of Health:

o

o

Programme for Research in Epidemic Preparedness and Response (PREPARE): set up by the
Ministry of Health, to support and strengthen Singapore's key essential research capabilities,
translational  platforms,  and  expertise  to  develop  tools,  methods  and  products  that  can  be

tapped on to detect, respond to, and contain future infectious disease threats
Restructuration  of  the  MOH  to  be  better  prepared  for  the  next  crisis.  A  Communicable
Diseases Agency will consolidate functions from various agencies. 

75
.

- The Taiwan Center for Disease Control encompasses a wide range of activities related to preparedness and
response,  including  the  procurement  and  management  of  drugs  for  disease  control,  manufacturing  and
supply,  research,  development,  and  technology  transfer  of  vaccines  and  biological  products,  as  well  as
laboratory testing for various diseases

76
. 

- UK Health Security Agency (UKHSA): responsible for handling public health emergencies and coordinating
the national response to pandemics, infectious diseases, and other health emergencies in the UK, works
closely with other public health entities to develop guidance, provide training, and undertake research to
improve public health preparedness and response, 

- UK National Institute for Health and Care Excellence (NICE): independent organisation that provides advice
to the NHS on healthcare provision, public health emergency management, and use of medical technologies. 
During health emergencies, NICE provides guidance on the use of MCMs. 

- Project CoMeCT (Coordination Mechanism for Cohorts and Trials) led by The Norwegian Institute of Public 
Health:  aims  to  coordinate  activities  across  Europe’s  multinational  clinical  trials  and  cohort  studies  on
infectious diseases with epidemic potential. CoMeCT will work closely with preparedness initiatives at the
national and EU level

77
,

- Australia  is  currently  establishing  a  Centre  for  Disease  Control  (CDC)  to  improve  its  preparedness  and

response for public emergencies, 

- The Australian Institute for Infectious Disease (AIID) project: to develop a collaboration involving world-
leading medical research and public health organisations in Victoria. Allowing for access to state-of-the-art 
infrastructure and technologies to further enhance the capacity to protect Australia and the region against 
infectious diseases and future pandemics

78
.

- The Medical Countermeasures (MCM) Program, led by Health Security Systems Australia (HSSA), is focused
on  the  development  of  vaccines,  therapeutics,  and  diagnostics  for  the  protection  of  military  and  civilian
personnel  against  chemical,  biological  and  radiological  (CBR)  threats,  emerging  infectious  diseases  and
pandemics

79
.

New-Zealand 

- Medical supplies stockpiling strategy has been in place since 2006. The Ministry's role is to establish the
national  reserve  supplies  policy  direction,  while  the  supply  chain  functions,  such  as  procurement  and
storage, are the responsibilities of Te Whatu Ora – Health New Zealand.

73

 WHO, July 2020: WHO provides technical support for Kilinto Pharmaceutical Industry Park (KPIP) in Ethiopia on preparing a roadmap that 

meets international standards. 
74

 International Trade Administration, US Department of Commerce: Ethiopia - Healthcare 

75

 The Programme for Research in Epidemic Preparedness and Response (PREPARE), Official website: 

https://www.moh.gov.sg/prepare/about-us  
76

 Taiwan Centres for Disease Control official website 

77

 University of Oslo, WGH News: New ambitious EU-project - led by the Norwegian Institute of Public Health 

78

 Australian Institute for Infectious Disease official website: https://aiid.edu.au/about-us/#  

79

 DMTC (Defence Materials Technology Centre) official website – Medical Countermeasures 

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Country 

AFRICA 

Egypt 

Ethiopia 

Ivory Coast 

Kenya 

Morocco 

Nigeria 

Rwanda 

Senegal 

5.3  Third-countries selection criteria – Table 

Selection criteria 

Historically one of the pioneering countries in the establishment of a national surveillance system, 1st country 
to achieve WHO validation on the path to elimination of hepatitis C, largest producer of pharmaceutical in the 
MENA region, host country of Northern Africa RCC 
mentioned in scoping interviews - ongoing project to establish a pharmaceutical hub by developing industrial 
parks, to strengthen and transform the Ethiopian pharmaceutical industry, partnership with Cuba 
Ebola outbreak response in 2021, government strategy to enhance local production of pharmaceutical 
products 
In the context of the 'Bottom-Up Economic Transformation Agenda' , the Kenyan government is committed to 
promoting local pharmaceutical production and aims to become a leading regional hub in the production of 
medicines and healthcare supplies, cooperation with Egypt, South Korea and Italy, host country of Eastern 
Africa RCC 
initiator of the 1st African Conference on Health Risk Reduction, the Government recently launched a new 
program for the pharmaceutical sector for the period 2022-2027 
Nigeria was selected as one of six African countries to receive the technology required for manufacturing 
mRNA vaccines, cross-border collaboration with neighbours 
mentioned in scoping interviews - Strong involvement in health crisis preparedness and response on their 
continent and/or heavily engaged in supranational organisations (African Pharmaceutical Technology 
Foundation) 

Partnership CEPI - Institute Pasteur of Dakar to improve vaccine access in Africa, government programme to 
enhance local manufacturing of MCMs 

South Africa  G20, South Africa is the co-leader of the Johannesburg process with Norway 

Zambia 

ASIA 

China 

India 

Indonesia 

Japan 

Malaysia 

Host country of Southern Africa RCC, the “Zambian Government's Pharmaceutical Manufacturing Initiative 
(ZPMI)” in 2022 supported by the Team Europe Initiative, cooperation with its neighbours 

G20 

G20 

G20 

G20 
Significant burden of infectious diseases and experience with outbreaks (Nipah, SARS, MERS, and H1N1), 
considered successful in managing the COVID-19 pandemic with the number of deaths and infections lower 
than neighbouring countries and many developed economies, 
collaboration with CEPI to improve its vaccine R&D capabilities 

Saudi Arabia  G20 

Singapore 

Significant technology and innovation hub, significant role in bilateral cooperation with other countries included 
in the study with Australia), contributed to regional initiatives like the COVID-19 ASEAN Response Fund 

South Korea  G20 

Taiwan 

Vietnam 

EUROPE 

Albania 
Bosnia and 
Herzegovina 
Georgia 

Significantly impacted by the 2003 SARS outbreak, joint research agreement with Japan NIID, detailed 
procurement and stockpiling strategies 

Hotspot for influenza virus evolution, strong track record in managing pandemics, the first country to be 
declared SARS-free by the WHO, proactive in vaccine R&D during Covid-19 crisis 

EU candidate / Potential enlargement of the European Union 

EU candidate / Potential enlargement of the European Union 

EU candidate / Potential enlargement of the European Union 

Kosovo 

Potential EU candidate / Potential enlargement of the European Union 

Moldova 

EU candidate / Potential enlargement of the European Union 

Montenegro 
North 
Macedonia 

EU candidate / Potential enlargement of the European Union 

EU candidate / Potential enlargement of the European Union 

Norway 

Russia 

Serbia 

Türkiye 

UK 

Strong involvement in health crisis preparedness and response on their continent and/or heavily engaged in 
supranational organisations (Norway and South Africa have co-chaired the Facilitation Council of the Access 
to Covid-19 Tools Accelerator, Member of the Nordic Pharmaceutical Forum) 

G20 

EU candidate / Potential enlargement of the European Union 

G20 

G20 

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Ukraine 

EU candidate / Potential enlargement of the European Union 

NORTH AMERICA 

Canada 

G20 

Cuba 

Mexico 

USA 

OCEANIA 

Specific context (Embargo, committed to local vaccine development and self-sufficiency), partnership with 
Ethiopia 

G20 

G20 

Australia 

G20 

New Zealand 

Significant role in bilateral cooperation with other countries included in the study (with Australia) and 
significant role in the region 

SOUTH AMERICA 

Argentina 

G20 

Brazil 

Colombia 

Ecuador 

Paraguay 

Peru 

G20 
Bilateral agreement with Denmark + involved in regional initiative in South America (PRET initiative organized 
by PAHO, ORAS project to strengthen decision-making in controlling the Covid-19 pandemic through genomic 
surveillance) 
involved in regional initiative in South America (project 'Immunization Capacity Scaling Project' with several 
MoH under PROSUR, ORAS project to strengthen decision-making in controlling the Covid-19 pandemic 
through genomic surveillance) 
involved in regional initiative in South America (project 'Immunization Capacity Scaling Project' with several 
MoH under PROSUR) 
involved in regional initiative in South America (project 'Immunization Capacity Scaling Project' with several 
MoH under PROSUR, ORAS project to strengthen decision-making in controlling the Covid-19 pandemic 
through genomic surveillance) 

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| 82 

Study mapping structures with relevant 
mandates, tasks, and functions to 
European Commission within Member 
States and globally  

Final Report 
Annex: Descriptive Fiches 

Descriptive sheets 

I.  European Union ...................................................................................................................... 85 

1)  Member States .................................................................................................................... 85 

2) 

Supranational organisation - BeNeLuxA ........................................................................... 225 

II.  Third countries ...................................................................................................................... 227 

1) 

2) 

3) 

Africa .................................................................................................................................. 227 

Asia .................................................................................................................................... 264 

Europe ............................................................................................................................... 301 

4)  North America .................................................................................................................... 338 

5) 

South America ................................................................................................................... 353 

6)  Oceania .............................................................................................................................. 372 

III.  Supranational organisations ................................................................................................ 383 

1) 

2) 

3) 

4) 

5) 

Africa .................................................................................................................................. 383 

Americas ............................................................................................................................ 393 

Asia .................................................................................................................................... 402 

Europe ............................................................................................................................... 409 

Supraregional organisations .............................................................................................. 413 

IV. 

International organisations .................................................................................................. 417 

1)  DNDi: Drugs for Neglected Diseases initiative .................................................................. 417 

2) 

FIND, Diagnosis for all ....................................................................................................... 420 

3)  CEPI: the Coalition for Epidemic Preparedness Innovations ............................................ 422 

4)  UNICEF Supply Division .................................................................................................... 425 

5) 

6) 

The Global Fund ................................................................................................................ 427 

The World Health Organisation ......................................................................................... 429 

84 

 
 
 
 
I.  European Union 

1) Member States 

Monitoring, Intelligence Gathering and Analysis 

Entity 

Ministry of Social Affairs, Health, Care and Consumer 
Protection (BMSGPK)  

Federal states' health authorities and provinces 

Federal Public Service (FPS) Health  

Federal Agency for Medicines and Healthcare Products 
(FAMHP)  
National Center for Infectious and Parasitic Diseases 
(NCIPD) 

Ministry of Health – Crisis Headquarters 

Civil Protection Directorate - National Crisis Headquarters 

Croatian Institute of Public Health 

Ministry of Health 

State Healthcare Services Organisation (SHSO) 

Ministry of Health 

Regional Public Health Authorities 

Ministry of the Interior and Health 

AMGROS 

Danish Health Authority 

Statens Serum Institut (SSI) 

Danish Regions 

Ministry of Social Affairs – Health Board (MoSA) 

State Agency for Medicines (SAM) 

Finnish Institute for Health and Welfare (THL) 

France Public Health / “Santé Publique France” (SpF) 

High Council for Public Health (HCSP) 

High Authority on Health (HAS) 

Institute Pasteur 

Federal Ministry of Health (BMG) 

Country 

Austria 

Austria 

Belgium 

Belgium 

Bulgaria 

Croatia 

Croatia 

Croatia 

Cyprus 

Cyprus 

Czech Republic 

Czech Republic 

Denmark 

Denmark 

Denmark 

Denmark 

Denmark 

Estonia 

Estonia 

Finland 

France 

France 

France 

France 

Germany 

85 

 
 
 
Federal Ministry for the Environment, Nature 
Conservation, Nuclear Safety and Consumer Protection 
(BMUV) - and the Federal Office for Radiation Protection 
(BfS) 
Federal states (public health authorities, civil 
protection/disaster control authorities) 

Robert Koch Institute 

Ministry of Health  

Directories for Public Health in Regions 

National Public Health Organisation (NPHO/ΕΟΔΥ) 

National Centre for Public Health and Pharmacy (NNGYK) 

Health Service Executive (HSE) 

Health Research Board (HRB) 

Government Task Force on Emergency Planning (GTF) 
and Office of Emergency Planning (OEP) 

Ministry of Health (MoH) 

National Institute of Health (IIS) 

Regions/Autonomous provinces 

Centre for Disease Prevention and Control (SPKC) 

National Crisis Management Centre (NCMC) 

Ministry of Health  

Ministry of Health - Unit on Emergency Preparedness and 
Response 

High Commission for National Protection (HCNP) 

National Health Laboratory (LNS) 

Ministry of Health 

Infectious Disease Prevention and Control Unit (IDCU) 

National Institute for Public Health and the Environment - 
RIVM (Ministry of Health) 

Health Council of the Netherlands 

Chief Sanitary Inspectorate (CSI) 

Ministry of Health 

National Institute of Public Health 

National Institute of Health (INSA) 

Directorate-General of Health (DGS)  

National Institute for Public Health (INSP) 

Department of Emergency Situations (DSU) – Ministry of 
Internal Affairs 

Public Health Authority of the Slovak Republic (PHA SR) 

Germany 

Germany 

Germany 

Greece 

Greece 

Greece 

Hungary 

Ireland 

Ireland 

Ireland 

Italy 

Italy 

Italy 

Latvia 

Lithuania 

Lithuania 

Luxembourg 

Luxembourg 

Luxembourg 

Malta 

Malta 

Netherlands 

Netherlands 

Poland 

Poland 

Poland 

Portugal 

Portugal 

Romania 

Romania 

Slovakia 

86 

 
Ministry of Health 

Regional Public Health Authorities in the Slovak Republic 
(RPHA SR) 

Ministry of Health 

National Institute of Public Health (NIJZ) 

Ministry of Health  

Carlos III Health Institute (ISCIII) 

Public Health Agency of Sweden (PHAS) 

The National Board of Health and Welfare (NBHW) 

Advanced Research and Development Capacities  

Entity 

Ministry of Social Affairs, Health, Care and Consumer 
Protection (BMSGPK)  

Sciensano 

Federal Agency for Medicines and Healthcare Products 
(FAMHP)  

Belgian Healthcare Knowledge Centre (KCE) 

National Center for Infectious and Parasitic Diseases 
(NCIPD) 

Ministry of Health – Crisis Headquarters 

Croatian Institute of Public Health 

Ministry of Health 

Ministry of Health 

Statens Serum Institut (SSI) 

Danish Regions 

Ministry of Social Affairs – Health Board (MoSA) 

Finnish Institute for Health and Welfare (THL) 

ANRS - Emerging Infectious Diseases (ANRS MIE) 

Institute Pasteur 

Federal Ministry of Health (BMG) 

Federal Ministry of Education and Research (BMBF) 

PEI - Paul Ehrlich Institut  

Ministry of Health  

Slovakia 

Slovakia 

Slovenia 

Slovenia 

Spain 

Spain 

Sweden 

Sweden 

Country 

Austria 

Belgium 

Belgium 

Belgium 

Bulgaria 

Croatia 

Croatia 

Cyprus 

Czech Republic 

Denmark 

Denmark 

Estonia 

Finland 

France 

France 

Germany 

Germany 

Germany 

Greece 

87 

 
 
 
 
National Organisation for Medicines (NOM/ΕΟΦ) 

Ministry of Interior 

National Centre for Public Health and Pharmacy (NNGYK) 

Department of Enterprise, Trade and Employment (DETE) 

Ministry of Health (MoH) 

Italian Medicines Agency (AIFA) 

Regions/Autonomous provinces 

Ministry of Health 

Ministry of Health  

Ministry of Health - Unit on Emergency Preparedness and 
Response 

National Health Laboratory (LNS) 

Infectious Disease Prevention and Control Unit (IDCU) 

National Institute for Public Health and the Environment - 
RIVM (Ministry of Health) 

Ministry of Health 

National Institute of Public Health 

National Institute of Health (INSA) 

Directorate-General of Health (DGS)  

National Institute for Public Health (INSP) 

Public Health Authority of the Slovak Republic (PHA SR) 

Ministry of Health 

Regional Public Health Authorities in the Slovak Republic 
(RPHA SR) 

Ministry of Health 

National Institute of Public Health (NIJZ) 

Ministry of Health  

Carlos III Health Institute (ISCIII) 

Swedish Civil Contingencies Agency (MSB) 

Karolinska Institute 

Greece 

Hungary 

Hungary 

Ireland 

Italy 

Italy 

Italy 

Latvia 

Lithuania 

Luxembourg 

Luxembourg 

Malta 

Netherlands 

Poland 

Poland 

Portugal 

Portugal 

Romania 

Slovakia 

Slovakia 

Slovakia 

Slovenia 

Slovenia 

Spain 

Spain 

Sweden 

Sweden 

88 

 
 
 
 
 
Production / Manufacturing Capacities 

Entity 

Ministry of Social Affairs, Health, Care and Consumer 
Protection (BMSGPK)  

Ministry of Labour and Economics (BMAW) 

Austrian Agency for Health and Food Safety (AGES) 

Federal Public Service (FPS) Health  

Federal Agency for Medicines and Healthcare Products 
(FAMHP)  

Communities and regions 

Ministry of Economy 

Agency for medicinal products and medical devices of 
Croatia (HAMLED) 

Ministry of Health 

Ministry of Health 

Ministry of the Interior and Health 

AMGROS 

Danish Medicine Agency (DKMA) 

Danish Critical Supply Agency (SFOS) 

Estonian Stockpiling Agency (ESA) 

National Emergency Supply Agency (NESA) 

Health Innovation Agency (HIA) 

Federal Ministry of Health (BMG) 

PEI - Paul Ehrlich Insitut (ZEPAI - Center for Pandemic 
Vaccines and Therapeutics) 
Federal states (public health authorities, civil 
protection/disaster control authorities) 

Ministry of Health  

Health Research Board (HRB) 

Department of Enterprise, Trade and Employment (DETE) 

Regions/Autonomous provinces 

Ministry of Enterprises and Made in Italy 

Ministry of Health 

Ministry of Health  

Ministry of Health - Unit on Emergency Preparedness and 
Response 

Ministry of Health 

Infectious Disease Prevention and Control Unit (IDCU) 

National Institute for Public Health and the Environment - 
RIVM (Ministry of Health) 

Chief Pharmaceutical Inspectorate (CPI) 

Directorate-General of Health (DGS)  

National Authority of Medicines and Health Products 

National Institute for Public Health (INSP) 

Country 

Austria 

Austria 

Austria 

Belgium 

Belgium 

Belgium 

Bulgaria 

Croatia 

Cyprus 

Czech Republic 

Denmark 

Denmark 

Denmark 

Denmark 

Estonia 

Finland 

France 

Germany 

Germany 

Germany 

Greece 

Ireland 

Ireland 

Italy 

Italy 

Latvia 

Lithuania 

Luxembourg 

Malta 

Malta 

Netherlands 

Poland 

Portugal 

Portugal 

Romania 

89 

 
 
Ministry of Health 

Ministry of Health 

Ministry of Health  

The Spanish Agency of Medicines and Medical Devices 
(AEMPS) 

The National Board of Health and Welfare (NBHW) 

Procurement of MCMs  

Ministry of Defence (BMLV) 

Entity 

Federal states' health authorities and provinces 

Federal Public Service (FPS) Health  

Federal Agency for Medicines and Healthcare Products 
(FAMHP)  

Belgian Healthcare Knowledge Centre (KCE) 

Communities and regions 

Ministry of Health   

Regional Health Inspectorates 

Ministry of Health – Crisis Headquarters 

Civil Protection Directorate - National Crisis Headquarters 

Croatian Institute of Public Health 

Ministry of Health 

State Healthcare Services Organisation (SHSO) 

Ministry of Health 

Regional Public Health Authorities 

Ministry of the Interior and Health 

AMGROS 

Danish Health Authority 

Statens Serum Institut (SSI) 

Danish Critical Supply Agency (SFOS) 

Danish Regions 

Ministry of Social Affairs – Health Board (MoSA) 

State Agency for Medicines (SAM) 

Estonian Health Insurrance Fund (EHIF) 

Estonian Stockpiling Agency (ESA) 

Ministry of Social Affairs and Health (MSAH) 

National Emergency Supply Agency (NESA) 

Finnish Institute for Health and Welfare (THL) 

Ministry of Solidarity and Health  

Ministry of Interior 

France Public Health / “Santé Publique France” (SpF) 

Slovakia 

Slovenia 

Spain 

Spain 

Sweden 

Country 

Austria 

Austria 

Belgium 

Belgium 

Belgium 

Belgium 

Bulgaria 

Bulgaria 

Croatia 

Croatia 

Croatia 

Cyprus 

Cyprus 

Czech Republic 

Czech Republic 

Denmark 

Denmark 

Denmark 

Denmark 

Denmark 

Denmark 

Estonia 

Estonia 

Estonia 

Estonia 

Finland 

Finland 

Finland 

France 

France 

France 

90 

 
 
 
 
High Council for Public Health (HCSP) 

Federal Ministry of Health (BMG) 

Federal Ministry for the Environment, Nature 
Conservation, Nuclear Safety and Consumer Protection 
(BMUV) - and the Federal Office for Radiation Protection 
(BfS) 
Federal Office for Civil Protection and Disaster Assistance 
(BBK) 
Federal states (public health authorities, civil 
protection/disaster control authorities) 

Ministry of Health  

National Organisation for Medicines (NOM/ΕΟΦ) 

Ministry of Interior 

National Centre for Public Health and Pharmacy (NNGYK) 

Health Service Executive (HSE) 

Ministry of Health (MoH) 

Italian Medicines Agency (AIFA) 

Regions/Autonomous provinces 

Ministry of Health 

Ministry of Interior 

Health Emergency Situations Centre (HESC) 

Ministry of Health  

Ministry of Health - Unit on Emergency Preparedness and 
Response 

High Commission for National Protection (HCNP) 

National Health Laboratory (LNS) 

Ministry of Health 

National Institute for Public Health and the Environment - 
RIVM (Ministry of Health) 

Health Council of the Netherlands 

Ministry of Health 

Government Agency for Strategic Reserves (RARS) 

Directorate-General of Health (DGS)  

Department of Emergency Situations (DSU) – Ministry of 
Internal Affairs 

National Institute for Public Health (INSP) 

Ministry of Health 

Ministry of Health 

National Institute of Public Health (NIJZ) 

Ministry of Health  

The National Board of Health and Welfare (NBHW) 

France 

Germany 

Germany 

Germany 

Germany 

Greece 

Greece 

Hungary 

Hungary 

Ireland 

Italy 

Italy 

Italy 

Latvia 

Latvia 

Lithuania 

Lithuania 

Luxembourg 

Luxembourg 

Luxembourg 

Malta 

Netherlands 

Netherlands 

Poland 

Poland 

Portugal 

Romania 

Romania 

Slovakia 

Slovenia 

Slovenia 

Spain 

Sweden 

91 

 
 
 
 
 
Stockpiling and Distribution Capacities 

Entity 

Ministry of Social Affairs, Health, Care and Consumer 
Protection (BMSGPK)  

Ministry of Defence (BMLV) 

Federal states' health authorities and provinces 

Federal Public Service (FPS) Health  

Sciensano 

Federal Agency for Medicines and Healthcare Products 
(FAMHP)  

Belgian Healthcare Knowledge Centre (KCE) 

Communities and regions 

Ministry of Health   

Regional Health Inspectorates 

Ministry of Health – Crisis Headquarters 

Civil Protection Directorate - National Crisis Headquarters 

Croatian Institute of Public Health 

Ministry of Health 

State Healthcare Services Organisation (SHSO) 

Ministry of Health 

Regional Public Health Authorities 

Ministry of the Interior and Health 

AMGROS 

Statens Serum Institut (SSI) 

Danish Medicine Agency (DKMA) 

Danish Critical Supply Agency (SFOS) 

Danish Regions 

Ministry of Social Affairs – Health Board (MoSA) 

State Agency for Medicines (SAM) 

Estonian Health Insurrance Fund (EHIF) 

Estonian Stockpiling Agency (ESA) 

National Emergency Supply Agency (NESA) 

Finnish Institute for Health and Welfare (THL) 

Ministry of Solidarity and Health  

Country 

Austria 

Austria 

Austria 

Belgium 

Belgium 

Belgium 

Belgium 

Belgium 

Bulgaria 

Bulgaria 

Croatia 

Croatia 

Croatia 

Cyprus 

Cyprus 

Czech Republic 

Czech Republic 

Denmark 

Denmark 

Denmark 

Denmark 

Denmark 

Denmark 

Estonia 

Estonia 

Estonia 

Estonia 

Finland 

Finland 

France 

92 

 
 
Ministry of Interior 

France Public Health / “Santé Publique France” (SpF) 

High Council for Public Health (HCSP) 

Federal Ministry of Health (BMG) 

Federal Ministry for the Environment, Nature 
Conservation, Nuclear Safety and Consumer Protection 
(BMUV) - and the Federal Office for Radiation Protection 
(BfS) 
Federal Office for Civil Protection and Disaster Assistance 
(BBK) 
Federal states (public health authorities, civil 
protection/disaster control authorities) 

Ministry of Health  

Ministry of Interior 

National Centre for Public Health and Pharmacy (NNGYK) 

Department of Health (DoH) 

Ministry of Health (MoH) 

Regions/Autonomous provinces 

Centre for Disease Prevention and Control (SPKC) 

Ministry of Health 

Ministry of Interior 

Health Emergency Situations Centre (HESC) 

Ministry of Health  

Ministry of Health - Unit on Emergency Preparedness and 
Response 

High Commission for National Protection (HCNP) 

National Health Laboratory (LNS) 

Ministry of Health 

National Institute for Public Health and the Environment - 
RIVM (Ministry of Health) 

Health Council of the Netherlands 

Ministry of Health 

Government Agency for Strategic Reserves (RARS) 

Directorate-General of Health (DGS)  

Department of Emergency Situations (DSU) – Ministry of 
Internal Affairs 

National Institute for Public Health (INSP) 

Ministry of Health 

Regional Public Health Authorities in the Slovak Republic 
(RPHA SR) 

France 

France 

France 

Germany 

Germany 

Germany 

Germany 

Greece 

Hungary 

Hungary 

Ireland 

Italy 

Italy 

Latvia 

Latvia 

Latvia 

Lithuania 

Lithuania 

Luxembourg 

Luxembourg 

Luxembourg 

Malta 

Netherlands 

Netherlands 

Poland 

Poland 

Portugal 

Romania 

Romania 

Slovakia 

Slovakia 

93 

 
Ministry of Health 

Ministry of Health  

Carlos III Health Institute (ISCIII) 

National Institute of Health Management (INGESA) 

Public Health Agency of Sweden (PHAS) 

The National Board of Health and Welfare (NBHW) 

Swedish Civil Contingencies Agency (MSB) 

International Cooperation  

Entity 

Ministry of Social Affairs, Health, Care and Consumer 
Protection (BMSGPK)  

Austrian Agency for Health and Food Safety (AGES) 

National multidepartement Crisis Center at Federal level - 
NCCN - (Homeland minister) 

Federal Public Service (FPS) Health  

Federal Agency for Medicines and Healthcare Products 
(FAMHP)  

Belgian Healthcare Knowledge Centre (KCE) 

Ministry of Health   

Ministry of Health – Crisis Headquarters 

Ministry of Health 

Ministry of Health 

Ministry of the Interior and Health 

AMGROS 

Danish Health Authority 

Statens Serum Institut (SSI) 

Danish Medicine Agency (DKMA) 

Ministry of Social Affairs – Health Board (MoSA) 

State Agency for Medicines (SAM) 

Ministry of Social Affairs and Health (MSAH) 

Finnish Institute for Health and Welfare (THL) 

Ministry of Solidarity and Health  

ANRS - Emerging Infectious Diseases (ANRS MIE) 

France Public Health / “Santé Publique France” (SpF) 

Institute Pasteur 

Slovenia 

Spain 

Spain 

Spain 

Sweden 

Sweden 

Sweden 

Country 

Austria 

Austria 

Belgium 

Belgium 

Belgium 

Belgium 

Bulgaria 

Croatia 

Cyprus 

Czech Republic 

Denmark 

Denmark 

Denmark 

Denmark 

Denmark 

Estonia 

Estonia 

Finland 

Finland 

France 

France 

France 

France 

94 

 
 
 
 
Federal Ministry of Health (BMG) 

Federal Ministry of Education and Research (BMBF) 

Federal Ministry for the Environment, Nature 
Conservation, Nuclear Safety and Consumer Protection 
(BMUV) - and the Federal Office for Radiation Protection 
(BfS) 
Federal Office for Civil Protection and Disaster Assistance 
(BBK) 

Ministry of Health  

National Centre for Public Health and Pharmacy (NNGYK) 

Department of Health (DoH) 

Government Task Force on Emergency Planning (GTF) 
and Office of Emergency Planning (OEP) 

Ministry of Health (MoH) 

Italian Medicines Agency (AIFA) 

Regions/Autonomous provinces 

Centre for Disease Prevention and Control (SPKC) 

Ministry of Health 

Ministry of Health  

Ministry of Health - Unit on Emergency Preparedness and 
Response 

High Commission for National Protection (HCNP) 

National Health Laboratory (LNS) 

Ministry of Health 

Infectious Disease Prevention and Control Unit (IDCU) 

National Institute for Public Health and the Environment - 
RIVM (Ministry of Health) 

Chief Sanitary Inspectorate (CSI) 

Ministry of Health 

Directorate-General of Health (DGS)  

Department of Emergency Situations (DSU) – Ministry of 
Internal Affairs 

National Institute for Public Health (INSP) 

Ministry of Health 

Ministry of Health 

Ministry of Health  

The Spanish Agency of Medicines and Medical Devices 
(AEMPS) 

Carlos III Health Institute (ISCIII) 

Public Health Agency of Sweden (PHAS) 

The National Board of Health and Welfare (NBHW) 

Swedish Civil Contingencies Agency (MSB) 

Germany 

Germany 

Germany 

Germany 

Greece 

Hungary 

Ireland 

Ireland 

Italy 

Italy 

Italy 

Latvia 

Latvia 

Lithuania 

Luxembourg 

Luxembourg 

Luxembourg 

Malta 

Malta 

Netherlands 

Poland 

Poland 

Portugal 

Romania 

Romania 

Slovakia 

Slovenia 

Spain 

Spain 

Spain 

Sweden 

Sweden 

Sweden 

95 

 
Health Security Coordination 

Entity 

Ministry of Interior  

National multidepartement Crisis Center at Federal level - 
NCCN - (Homeland minister) 

Federal Public Service (FPS) Health  

Sciensano 

Belgian Healthcare Knowledge Centre (KCE) 

Communities and regions 

Ministry of Health   

Regional Health Inspectorates 

Ministry of Health – Crisis Headquarters 

Civil Protection Directorate - National Crisis Headquarters 

Ministry of Health 

State Healthcare Services Organisation (SHSO) 

Ministry of Health 

Regional Public Health Authorities 

Ministry of the Interior and Health 

Danish Health Authority 

Danish Critical Supply Agency (SFOS) 

Danish Regions 

Ministry of Social Affairs – Health Board (MoSA) 

State Agency for Medicines (SAM) 

Ministry of Social Affairs and Health (MSAH) 

Finnish Institute for Health and Welfare (THL) 

Ministry of Solidarity and Health  

General Secretariat for Defence and National Security 
(SGDSN) 

Health Innovation Agency (HIA) 

Country 

Austria 

Belgium 

Belgium 

Belgium 

Belgium 

Belgium 

Bulgaria 

Bulgaria 

Croatia 

Croatia 

Cyprus 

Cyprus 

Czech Republic 

Czech Republic 

Denmark 

Denmark 

Denmark 

Denmark 

Estonia 

Estonia 

Finland 

Finland 

France 

France 

France 

96 

 
 
 
 
Institute Pasteur 

Federal Ministry of Health (BMG) 

Federal Office for Civil Protection and Disaster Assistance 
(BBK) 

Federal states (public health authorities, civil 
protection/disaster control authorities) 

Ministry of Health  

National Organisation for Medicines (NOM/ΕΟΦ) 

National Centre for Public Health and Pharmacy (NNGYK) 

Department of Health (DoH) 

Health Service Executive (HSE) 

Government Task Force on Emergency Planning (GTF) 
and Office of Emergency Planning (OEP) 

Ministry of Health (MoH) 

National Department of the Civil Protection (CPD) 

National Institute of Health (IIS) 

Regions/Autonomous provinces 

Centre for Disease Prevention and Control (SPKC) 

Ministry of Health 

Ministry of Interior 

National Crisis Management Centre (NCMC) 

Ministry of Health - Unit on Emergency Preparedness and 
Response 

High Commission for National Protection (HCNP) 

National Health Laboratory (LNS) 

Ministry of Health 

Infectious Disease Prevention and Control Unit (IDCU) 

National Institute for Public Health and the Environment - 
RIVM (Ministry of Health) 

Health Council of the Netherlands 

Chief Sanitary Inspectorate (CSI) 

Ministry of Health 

Directorate-General of Health (DGS)  

France 

Germany 

Germany 

Germany 

Greece 

Greece 

Hungary 

Ireland 

Ireland 

Ireland 

Italy 

Italy 

Italy 

Italy 

Latvia 

Latvia 

Latvia 

Lithuania 

Luxembourg 

Luxembourg 

Luxembourg 

Malta 

Malta 

Netherlands 

Netherlands 

Poland 

Poland 

Portugal 

97 

 
National Authority of Medicines and Health Products 

Department of Emergency Situations (DSU) – Ministry of 
Internal Affairs 

National Institute for Public Health (INSP) 

Ministry of Health 

Ministry of Health 

Ministry of Health  

Carlos III Health Institute (ISCIII) 

The National Board of Health and Welfare (NBHW) 

Portugal 

Romania 

Romania 

Slovakia 

Slovenia 

Spain 

Spain 

Sweden 

98 

 
 
 
 
a. Austria 

Overview of approach to preparedness and response to public health emergency in MCMs 

Monitoring, Intelligence Gathering, and Analysis 
During the COVID-19 pandemic, the Ministry of Social Affairs, Health, Care and Consumer Protection 
(BMSGPK)  played  a  central  role  in  monitoring  the  virus's  spread,  coordinating  closely  with  federal 
states'  crisis  units  and  the  Agency  for  Health  and  Food  Safety  (AGES).  These  activities  involved 
gathering and analysing essential data to inform public health decisions. Post-pandemic, this role has 
seamlessly integrated into BMSGPK's regular operations, emphasizing the importance of continuous 
health surveillance and intelligence gathering. The federal states complement this monitoring, ensuring 
localized oversight and reporting, which supports a unified national response strategy. 

Advanced Research and Development Capacities 
Although the Ministry of Education, Science, and Research (BMBWF) primarily manages funding and 
overseeing research and innovation, BMSGPK also contributes by supporting specific applied research 
projects  that  address  public  health  concerns.  This  collaborative  effort  ensures  that  scientific 
advancements  are  leveraged  to  enhance  preparedness  and  response  capabilities  effectively.  The 
Austrian Ministry of Defence (BMLV) contributes with national and European defence research funding. 

Production and Manufacturing Capacities 
The  Federal  Office  for  Safety  in  Health  Care  (BASG),  subordinate  to  BMSGPK,  addresses  risks 
associated with medicinal products and medical devices, coordinating actions during supply shortages 
and engaging with industry stakeholders to maintain medicine availability. Meanwhile, the Ministry of 
Labour and Economics (BMAW) oversees broader production and manufacturing processes, ensuring 
quality and regulatory compliance in the production of pharmaceuticals and medical devices. 

Procurement of Medical Countermeasures (MCMs) 
The Ministry of Defence (BMLV) took a leading role during the pandemic by managing the procurement 
of  essential  supplies  such  as  personal  protective  equipment  (PPE)  and  medical  devices.  This  role 
includes ongoing responsibility for the national emergency stockpile. BMSGPK, in exceptional cases, 
engages  in  joint  procurement  to  ensure  the  availability  of  necessary  medical  supplies  during 
emergencies. 

Stockpiling and Distribution 
The  Ministry  of  Defence  (BMLV)  is  tasked  with  the  strategic  stockpiling  and  distribution  of  critical 
medical supplies, a role that has proven vital during public health crises. In parallel, federal states have 
the autonomy to manage stockpiling and distribution within their jurisdictions, which allows for tailored 
responses to regional needs. This decentralized approach helps ensure that stockpiles are managed 
effectively across the country. 

International Cooperation  
BMSGPK  is  actively  involved  in  international  cooperation,  working  with  global  and  regional 
organisations to enhance health security frameworks. This includes participation in international health 
regulation negotiations and contributing to global preparedness platforms such as the Pandemic Fund.  

Health Security Coordination 
The Federal Ministry of the Interior manages health security coordination through the National Crisis 
and  Disaster  Management  (SKKM).  The  SKKM  ensures  coordination  among  federal  and  provincial 
entities  during  public  health  crises,  guided  by  the  SKKM-Strategie  2020  policy.  A  coordination 
committee,  including  federal  ministries,  provinces,  rescue  organisations,  and  media,  handles  major 

99 

 
 
 
 
 
 
 
 
threats and planning. The Federal Alarm Centre (FAC), part of the Ministry of Interior's Operations and 
Coordination Centre since 2006, serves as a 24/7 information hub and national contact point. 

Comprehensive mapping of identified entities 

Ministry of Social Affairs, Health, Care and Consumer Protection (BMSGPK) 
The primary focal point for health emergencies, including the pandemic management of COVID-19, is 
the Ministry of Social Affairs, Health, Care and Consumer Protection (BMSGPK). The BMSGPK bears 
an array of responsibilities which include monitoring diseases, guiding outbreak management, drafting 
health  legislation,  issuing  guidelines  and  recommendations  for  health  safety  and  to  some  extent 
managing matters such as procurement, stockpiling, and joint procurement of MCMs on a case-by-case 
evaluation and not as a general rule.  

Mode of operation 
The BMSGPK operates within a framework of preparedness and response to public health crises, with 
a  focus  on  integrating  lessons  learned  from  the  COVID-19  pandemic.  Ongoing  efforts  include  the 
revision  of  key  legislative  instruments  like  the  national  Epidemic  Act,  the  Epidemiological  Reporting 
System, and the national Pandemic Preparedness Plan. These revisions are crucial for ensuring that 
the legal and regulatory frameworks are up-to-date and responsive to evolving public health challenges. 

In times of crisis, BMSGPK foresees the establishment of a Crisis Unit within the Ministry. This unit 
would  play  a  central  role  in  issuing  legal  frameworks  and  passing  regulations  necessary  for  a 
coordinated and collaborative national public health emergency response. This Crisis Unit acts as a 
focal point for decision-making and ensures that the necessary measures are implemented swiftly and 
effectively. It serves as the hub for coordinating activities across various departments within the Ministry 
and with external stakeholders. 

Recognizing  the  need  for  comprehensive  coordination  during  crises,  BMSGPK  plans  to  establish 
overarching, multisectoral coordination and steering committees. This approach aligns with the National 
Crisis  Safety  Act  that  entered  into  force  in  2024.  These  committees  are  designed  to  facilitate  rapid 
information exchange and collaboration between key stakeholders from different sectors such as health, 
labour,  economics,  education,  and  more.  By  bringing  together  expertise  from  various  fields,  these 
committees ensure a holistic and coordinated response to public health emergencies. 

BMSGPK's  responsibilities  in  preparedness  are  multifaceted.  Firstly,  the  Ministry  is  responsible  for 
revising key legislative instruments such as the Epidemic Act. This involves updating laws to reflect 

100 

 
 
 
 
 
 
 
 
 
 
lessons learned from past crises, ensuring they are robust and adaptable to new challenges. Secondly, 
the Ministry oversees the revision of the Epidemiological Reporting System, essential for real-time data 
collection and analysis during outbreaks. This ensures that public health authorities have timely and 
accurate  information  for  decision-making.  Thirdly,  BMSGPK  is  actively  involved  in  updating  and 
enhancing  the  national  Pandemic  Preparedness  Plan.  This  plan  outlines  strategies,  protocols,  and 
response  mechanisms  to  be  activated  during  a  pandemic,  ensuring  a  structured  and  coordinated 
approach to crisis management. Lastly, in times of crisis, the Ministry establishes and manages the 
Crisis Unit. This unit is responsible for issuing emergency regulations, coordinating response efforts, 
and ensuring a cohesive national public health emergency response. 

During the response phase of a public health crisis, BMSGPK's responsibilities come to the forefront. 
The  Crisis  Unit,  under  BMSGPK,  issues  necessary  legal  frameworks  and  regulations  to  guide  the 
response.  This  includes  measures  such  as  quarantine  protocols,  travel  restrictions,  and  resource 
allocation. The Ministry also coordinates with various stakeholders, including federal states' crisis units, 
agencies like AGES, and other relevant ministries. This ensures a unified and synchronized response 
across all levels of government. Through multisectoral coordination committees, BMSGPK facilitates 
rapid  information  exchange.  This  includes  sharing  data  on  cases,  resource  availability,  and  best 
practices for response. Resource management during crises, including procurement of MCMs like PPE 
and  medical  devices,  falls  under  the  Ministry's  oversight.  This  ensures  that  essential  supplies  are 
available  where  needed.  Additionally,  BMSGPK  is  responsible  for  public  communication  strategies 
during public health crises. This involves providing clear and timely information to the public, addressing 
concerns, and promoting preventive measures. 

Monitoring, Intelligence Gathering and Analysis 
During the COVID-19 pandemic, monitoring activities were pivotal for understanding the spread of the 
virus and informing response efforts. This crucial task was undertaken by the National COVID-19 Crisis 
Unit, within the BMSGPK, in close coordination with federal states' crisis units and AGES (Agency for 
Health and Food Safety). These entities provided essential data on public testing, contact tracing, and 
other  key  metrics,  including  the  identification  of  countermeasures  for  public  health  threats.  Post-
pandemic, these monitoring activities have been reintegrated into the regular structure of BMSGPK, 
emphasizing the importance of ongoing surveillance to detect and respond to potential public health 
threats promptly. This includes overseeing, guiding, and coordinating the detection and response to 
public health threats on a national level, with surveillance data collection and analysis conducted by 
national agencies, reference laboratories, and local/regional health authorities. Intelligence gathering 
and analysis during the COVID-19 crisis were instrumental in understanding the evolving situation and 
making informed decisions. The National Crisis Unit and AGES played significant roles in this, providing 
valuable insights into the pandemic's progression. In the post-pandemic phase, intelligence gathering 
and analysis have been integrated back into the regular structures of BMSGPK.  

Advanced Research and Development capacities 
While the BMSGPK does not directly handle financing for research and innovation activities, it plays a 
role  in  supporting  applied  research  projects  related  to  public  health  concerns.  Research  and 
development  are  primarily  under  the  purview  of  the  Ministry  of  Education,  Science,  and  Research 
(BMBWF).  However,  BMSGPK  may  fund  specific  applied  research  projects  that  address  emerging 
scientific questions in the realm of public health. This collaboration ensures that scientific advancements 
are applied to enhance preparedness and response capabilities. 

Procurement of MCMs 
In exceptional cases, BMSGPK may centrally procure medicines via Joint Procurement, emphasizing 
the importance of coordinated efforts in ensuring sufficient supplies during emergencies. 

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Production / Manufacturing capacities 
As  a  subordinate  authority  of  the  Federal  Ministry  of  Social  Affairs,  Health,  Care  and  Consumer 
Protection (BMSGPK), the Federal Office for Safety in Health Care (BASG) acts on the identified risks 
related to the medicinal products and medical devices as identified by the Agency for Health and Food 
Safety  (AGES),  as  well  as  on  supply  shortages  reports  from  consumers,  health  professionals,  and 
companies. 

A  dedicated  taskforce  for  medicines  shortages  is  located  at  BASG  and  collaborates  with  various 
stakeholders,  including  industry  representatives,  pharmacies,  and  wholesalers,  to  develop  and 
coordinate national action plans ensuring the safety and continuity of access to medicines in Austria. 
When shortages are identified whether from a disruption in supply chains or a sudden surge in demand, 
BASG has the competence to take necessary actions. These might range from issuing alerts about the 
shortages, taking steps to find alternative sources of supply or, if required, even coordinating with other 
medical authorities in the European Economic Area (EEA) to address the shortage at an international 
level.  Through  its  commitment  to  transparency,  BASG  also  keeps  the  public  informed  about  supply 
issues and export restrictions. 

Stockpiling and distribution capacities 
The  BMSGPK  provides  technical  expertise  on  the  quantities  needed  for  the  stockpile,  however  the 
responsibility for both procurement and stockpiling rests with the Ministry of Defence (BMLV). Recently, 
Austria issued an ordinance to establish the stockpiling of critical medicines for a duration of 4 months. 
BMSGPK  contributes  to  this  by  providing  technical  information  based  on  lessons  learned  from  the 
pandemic,  such  as  quantities,  average  deployment  frequency,  and  shared  knowledge  from 
consultations within various MCM working groups. 

International Cooperation 
BMSGPK actively engages in international cooperation to strengthen global health preparedness and 
response. Partnerships with organisations such as Beneluxa and IHSI are essential for sharing best 
practices  and  resources.  The  Ministry  also  supports  the  extension  of  the  WTO  TRIPS  waiver, 
emphasizing  equitable  access  to  essential  medicines  and  technologies.  At  the  European  and 
international levels, BMSGPK collaborates within various frameworks to enhance global health security. 
Efforts  include  participating  in  the  development  of  new  international  pandemic  agreements  and 
negotiations  on  International  Health  Regulations  (IHR)  with  other  countries  and  the  World  Health 
Organisation (WHO). Closer to home, collaboration with the European Centre for Disease Prevention 
and Control (ECDC), Health Security Committee (HSC), and other European institutions is vital for a 
unified approach to health security. Furthermore, Austria is supporting the Pandemic Fund that aims on 
strengthening  critical  pandemic  prevention,  preparedness,  and  response  capabilities  in  low-  and 
middle-income countries. 

The BMSGPK entertains close cooperation with HERA through mechanisms such as the HERA Board 
and the Health Crisis Board, in agreement with the Pandemic Preparedness Plan. These collaborations 
facilitate  swift  and  coordinated  actions  during  health  crises,  leveraging  expertise  and  resources  to 
mitigate risks. BMSGPK's involvement in these coordination efforts ensures a cohesive approach to 
addressing health security challenges at both national and international levels.  

Ministry of Labour and Economics (BMAW) 
The Ministry of Labour and Economics (BMAW) is a government department in Austria responsible for 
overseeing policies and initiatives related to labor, employment, and economic development. 

Production / Manufacturing capacities 
The management of production and manufacturing capacities, including pharmaceuticals and medical 
devices,  falls  under  its  responsibility.  This  includes  overseeing  the  production  processes,  ensuring 

102 

 
 
 
 
 
 
 
quality  standards,  and  addressing  any  issues  related  to  manufacturing.  Furthermore,  BMAW  has 
supported the establishment of ASCII (Supply Chain Intelligence Institute Austria) to address supply 
chain issues. 

Ministry of Defence (BMLV) 
The Ministry of Defence (BMLV) in Austria serves as the central government agency responsible for 
safeguarding the nation's security and defence interests. As the primary authority overseeing Austria's 
military forces and national defence policies, the ministry plays a role in ensuring the protection of the 
country's sovereignty, territorial integrity, and national interests. Since the COVID-19 pandemic, its role 
has evolved to include the security of supply of MCMs. 

Procurement of MCMs 
During the COVID-19 pandemic, the procurement of MCMs, such as personal protective equipment 
(PPE) and medical devices, was managed by the Ministry of Defence (BMLV) for the federal COVID-
19 stockpile. This involved acquiring essential supplies to support the pandemic response efforts. Post-
pandemic,  the  Ministry  of  Defence  (BMLV)  continues  to  manage  the  procurement  process  for  the 
national emergency stockpile of PPE and medical devices for respiratory diseases. In exceptional cases, 
BMSGPK  may  centrally  procure  medicines  via  Joint  Procurement,  emphasizing  the  importance  of 
coordinated efforts in ensuring sufficient supplies during emergencies. 

Stockpiling and distribution capacities 
Efficient stockpiling and distribution of critical medical supplies are essential for effective crisis response. 
During the COVID-19 pandemic, the operational management of the federal COVID-19 stockpile was 
handled  by  the  Ministry  of  Defence  (BMLV),  whereas  BMSGPK  provided  technical  expertise  on  the 
quantities  needed  for  the  stockpile.  This  process  remains  consistent  for  the  national  emergency 
stockpile  of  PPE  and  medical  devices,  which  remains  the  responsibility  of  the  Ministry  of  Defence 
(BMLV). 

Advanced Research and Development Capacities 
Research and development are primarily under the purview of the Ministry of Education, Science, and 
Research (BMBWF). However, BMLV may fund and/or support specific applied research projects that 
address  emerging  and  disruptive  scientific  topics  regarding  defence  related  health  and  resilience, 
especially the development of defence-related medical countermeasures, particularly those addressing 
chemical, biological, radiological, and nuclear (CBRN) threats. This collaboration ensures that scientific 
advancements are applied to enhance preparedness and response capabilities. 

Federal states' health authorities and provinces 
The legislative competences related to health care is shared by the Federation and the Federal States, 
also known as Länder in Austria. The principle-setting authority rests with the federal government, while 
enforcing these principles and implementing the pertinent laws are the responsibility of the regional and 
provincial  authorities.  Among  their  tasks,  they  ensure  adequate  hospital  services  and  pre-clinical 
emergency care alongside local authorities. Moreover, the provinces play a key role in the social sector, 
as they are accountable for enacting crucial social legislation and providing social services.  

Mode of operation 
Enforcement related to the monitoring and control of communicable diseases primarily falls under the 
jurisdiction  of  the  federal  states.  They  work  closely  with  BMSGPK  and  other  national  authorities  to 
enforce  regulations  and  guidelines.  In  addition,  experts  from  various  institutions,  including  AGES, 
reference centres, and universities, play a crucial role in advising the federal states on technical matters. 
Their expertise is utilized during preparedness and response efforts, providing valuable insights into 
best practices and strategies. The federal states, through their regional authorities, are actively involved 

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in decision-making processes related to public health emergencies. This includes assessing regional 
needs, allocating resources such as MCMs. 

Monitoring, Intelligence Gathering and Analysis 
The federal states in Austria play a crucial role in monitoring and assessing health threats within their 
jurisdictions. Local and regional health authorities are tasked with managing health threats at the local 
level.  This  includes  actively  monitoring  public  health  indicators,  identifying  potential  outbreaks,  and 
assessing  the  severity  of  the  situation.  Additionally,  these  authorities  are  responsible  for  promptly 
reporting  any  identified  health  threats  to  the  national  authorities,  particularly  the  Federal  Ministry  of 
Social Affairs, Health, Care and Consumer Protection (BMSGPK) in the case of communicable diseases. 
This reporting is essential for centralized data collection and analysis at the national level, enabling a 
coordinated response. 

Procurement of MCMs 
The federal states have a role in assessing their regional needs of MCMs and procuring necessary 
supplies accordingly. The exchange of information between BMSGPK and federal states’ authorities on 
emergency  stockpiling  for  MCMs  continues  regularly  since  the  pandemic.  However,  the  actual 
procurement  activities  are  carried  out  independently  by  the  federal  states  based  on  their  specific 
regional requirements. This decentralized approach allows for tailored responses to the unique needs 
of each federal state. 

Stockpiling and Distribution Capacities 
The federal states are responsible for the assessment, stockpiling, and distribution of MCMs within their 
jurisdictions.  While  there  is  ongoing  information  exchange  between  BMSGPK  and  federal  state 
authorities, the operational activities related to stockpiling and distribution are managed independently 
by the federal states. This includes assessing the quantity of MCMs needed, maintaining stockpiles, 
and  ensuring  distribution  to  healthcare  facilities  as  needed.  The  regular  exchange  of  information 
provides a basis for potential alignment of MCM stockpiling efforts if coordination is required across 
regions. 

Ministry of Interior 
In  Austria,  the  coordination  of  national  crisis  management  and  disaster  management  as  well  as 
international disaster relief affairs falls within the responsibility of the Federal Ministry of the Interior. In 
particular,  when  crisis  and  disaster  happen,  including  public  health  crises,  the  National  Crisis  and 
Disaster Management (SKKM), as part of the Ministry of Interior, coordinates the activities of various 
national actors. 

Health security coordination 
SKKM's operational strategies are designed to complement and coordinate federal and local entities’ 
responsibilities with regards to public health crises. The SKKM ensures rapid and efficient coordination 
among various federal and provincial entities during complex crises. This involves directing the flow of 
information, resources, and efforts to where they are most needed, guided by the overarching SKKM-
Strategie  2020  policy.  In  specific,  a  new  coordination  committee  has  been  set  up,  which  includes 
Federal ministries, Federal provinces, rescue organisations and the media. In case of major threats, 
the committee is responsible for the coordination and consultation regarding the necessary measures 
at the Federal and Provincial levels. The committee is active as coordinating body not only in case of 
disasters but also in basic planning. Also, consultation with the Federal provinces, eight expert groups 
have been set up for the basic planning, for example, for legal, technical, and operational matters. 

The Federal Alarm Center (FAC), since January 2006 part of the Operations and Coordination Center 
(EKC) at the Ministry of Interior, has been serving as 24/7-staffed information hub and national contact 

104 

 
 
 
 
 
 
 
point.  It  is  the  point  of  contact  for  the  Federal  provinces,  the  neighbouring  countries,  the  European 
Union and International Organisations. 

Austria Agency for Health and Food Safety (AGES) 
Among other organisations that operate in specific areas related to health emergencies, the Austrian 
Agency  for  Health  and  Food  Safety  (AGES)  has  the  primary  responsibilities  for  the  assessment, 
investigation,  and  surveillance  of  communicable  diseases,  crucial  during  any  health  crisis.  AGES 
ensures medicinal products and medical devices' safety and efficacy and carries out monitoring the 
supply  situation  of  medicinal  products  which  ensures  stable  supply  chains  in  case  of  a  health 
emergency.  

Production / Manufacturing capacities 
AGES plays a crucial role in providing information and maintaining transparency regarding distribution 
restrictions  and  supply  bottlenecks  for  medicinal  products  in  Austria.  It  operates  the  "Shortages 
Catalogue," where notifications of shortages are published. This catalogue serves as a common register 
for all reported procedures related to medicine shortages. 

In the event of a supply bottleneck, AGES has the authority to: 

•  Determine the circumstances and extent of distribution restrictions. 
•  Communicate with stakeholders, including marketing authorization holders and other national 

regulatory authorities. 

•  Advocate  for  priority  processing  of  applications  for  authorizations  or  variations  of  medicinal 

products. 

•  Process and approve applications for the import and shipment of medicinal products to Austria. 

AGES also collaborates with other national regulatory authorities and the European Medicines Agency 
(EMA)  to  address  supply  bottlenecks  and  ensure  the  availability  of  essential  medicines.  Based  on 
AGES'  knowledge  of  a  supply  bottleneck,  the  Federal  Ministry  of  Social  Affairs,  Health,  Care  and 
Consumer Protection (BMSGPK) can determine a crisis situation, enabling further legal measures to 
mitigate the bottleneck. 

International Cooperation 
AGES is a key national stakeholder in relevant international public health organisations such as the 
European  Centre  for  Disease  Prevention  and  Control  (ECDC)  and  the  World  Health  Organisation 
(WHO). AGES hosts ECDC national focal points for various areas including preparedness and response, 
threat detection, surveillance, and microbiology. AGES is also a member of the ECDC scientific advisory 
board.  Additionally,  AGES  participates  in  EU4Health  projects,  contributing  to  international  health 
initiatives and collaborations

105 

 
 
 
 
 
 
 
 
 
b. Belgium 

Overview of approach to preparedness and response to public health emergency in MCMs 

Monitoring, Intelligence Gathering, and Analysis 
The Federal Public Service (FPS) Health actively participates in monitoring and intelligence gathering, 
focusing  on  chemical,  biological,  radiological,  and  nuclear  (CBRN)  threats  and  other  cross-border 
health  risks.  In  collaboration  with  the  National  Multidepartment  Crisis  Centre  (NCCN),  FPS  Health 
ensures a comprehensive surveillance coverage. Additionally, the Federal Agency for Medicines and 
Healthcare  Products (FAMHP)  also  monitors  the  stock and availability  of  medical countermeasures, 
using advanced tools to anticipate shortages and manage supplies effectively. 

Advanced Research and Development Capacities 
While  direct  involvement  in  advanced R&D  is  not  a  primary  function  of  entities  like  Sciensano,  they 
support  organisations  such  as  the  VirusBank,  which  focuses  on  developing  strategies  to  manage 
epidemics  and  pandemics.  The  Belgian  Healthcare  Knowledge  Centre  (KCE)  also  plays  a  role  by 
funding clinical trials to evaluate potential treatments and preventive measures. 

Production / Manufacturing Capacities 
The  FPS  Health  encourages  European  production of  essential medicines  to reduce dependency  on 
imports, in cooperation with the FPS Economy and the Federal Agency for Medicines and Healthcare 
Products. This is aimed at boosting local industrial capacities and addressing market challenges. 

Procurement of MCMs 
FPS  Health  undertakes  the  procurement  process  through  detailed  market  research  and  tender 
processes, occasionally using expedited methods during emergencies. Regions and communities are 
also  involved  in  procurement  to  ensure  adequate  and  timely  availability  of  MCMs  within  their 
jurisdictions. 

Stockpiling and Distribution Capacities 
FPS Health manages national strategic stockpiles and is also responsible for the RescEU stockpile, a 
collective European effort to ensure the availability of essential medical resources. Regular inspections 
and updates of stockpiled items are critical tasks to maintain the readiness of these supplies. Regions 
and communities, like the Joint Community Commission in Brussels and the Department of Care (DoC) 
in Flanders, manage local stockpiles and focus on optimizing distribution protocols. 

International Cooperation 
FPS Health actively engages in international health preparedness, participating in initiatives such as 
RescEU and Joint Procurements. They also align with global best practices through cooperation with 
international  bodies  like  WHO,  NATO,  and  the  EU.  The  FAMHP  fosters  international  relations  to 
manage and mitigate shortages, maintaining an active presence in various international pharmaceutical 
forums. 

Health Security Coordination 
The  NCCN  plays  a  pivotal  role  in  coordinating  national  emergency  plans  and  facilitating  crisis 
management  cells  across  various  levels  of  government.  It  supports  platforms  like  the  Surveillance 
Platform  of  the  Risk  Management  Group  and  the  Strategic  Pharmaceutical  Stockpile  Coordination 
Platform,  ensuring  integrated  and  cohesive  responses  to  health  emergencies.  FPS  Health,  together 
with  regional  bodies,  organizes  responses  tailored  to  specific  crises,  reflecting  the  distributed  but 
coordinated nature of Belgium's health security infrastructure. 

106 

 
 
 
 
 
 
 
 
 
 
Comprehensive mapping of identified entities 

National multidepartement Crisis Center at Federal level - NCCN - (Homeland minister) 
The National Multidepartment Crisis Center (NCCN), operating under the Homeland Ministry, serves 
as a central hub for crisis coordination and societal resilience, adept at handling crises of any nature 
and scale. As a multidisciplinary and interdepartmental organisation, the NCCN commands a strategic 
key position to respond to societal challenges and offer strategic support in collaboration with all security 
actors. This synergy ensures that the NCCN provides efficient, appropriate, and adequate infrastructure, 
personnel, and procedures for crisis management. The NCCN is at the forefront during a health crisis, 
directing the interplay of crisis management activities among government departments, and between 
state and federal entities, to guarantee an efficient national and regional emergency response.  

International Cooperation 
The NCCN takes charge of orchestrating emergency planning and crisis management at the national 
scale, ensuring readiness and coherent action in the face of health crises. This involves coordinating 
efforts among different national departments and integrating with international partners, such as the EU, 
NATO, and the UN. Through these cooperative efforts, the NCCN helps to align national health security 
measures with global best practices and policies. 

In its role as an active overseer, the NCCN serves as a national and international contact point for alerts 
that may indicate a threat to the country's security, including health threats. With the capability to collect 
and  analyse  such  alerts  round-the-clock,  the  NCCN  is  positioned  to  act  swiftly  in  disseminating 
information  to  the  authorities  tasked  with  public  safety,  thus  enabling  a  pre-emptive  approach  to 
managing potential health security threats. 

Health security coordination 
As the entity responsible for the multidisciplinary coordination of such instances, the NCCN's duties 
extend  to  activating  national  emergency  plans  and  facilitating  the  various  crisis  management  cells, 
including  the  Federal  Coordination  Committee,  Policy  Cell,  Assessment  Cell,  Measuring  Cell,  and 
Information Cell. These cells collaborate to ensure that emergency responses are well-rounded and 
robust, tackling crises from every necessary angle. 

In health emergencies, the NCCN adopts a support role by engaging in critical platforms such as the 
Surveillance  Platform  of  the  Risk  Management  Group  and  the  Strategic  Pharmaceutical  Stockpile 
Coordination Platform, both operated by the Federal Public Service Health. Through its involvement in 
these platforms, the NCCN helps to ensure that health emergencies are managed in conjunction with 
wider  national  crisis  planning,  providing  a  comprehensive  and  cohesive  response.  Furthermore,  the 

107 

 
 
 
 
 
 
 
 
NCCN  is  dedicated  to  enhancing  societal  resilience  against  health  crises.  Part  of  this  commitment 
involves developing a global strategy that strengthens society's capacity to respond to and recover from 
health  threats.  This  strategy  encompasses  creating  robust  methodologies  for  both  national  and 
functional risk analyses and initiating preventive information campaigns to educate the public on health 
risks  in  Belgium.  Such  preventive  measures  are  a  fundamental  part  of  the  NCCN's  approach  to 
bolstering societal resilience against health-related emergencies. 

Federal Public Service (FPS) Health  
The Federal Public Service (FPS) Health is in charge of preparing and coordinating crises within the 
health department. As a part of its disaster preparedness efforts, FPS Health oversees the strategic 
storage of various MCMs. The FPS is responsible to establish and coordinate a national strategy for 
the  preparedness  of  a  potential  future  health  crisis  in  collaboration  with  the  Federated  Entities. 
Depending on the emergency it will not have the leading role, but a supporting one, however, for other 
potential future emergencies the FPS has the lead (such as future pandemics).   

Monitoring, Intelligence Gathering, and Analysis 
FPS Health actively participates in risk analyses to identify potential health threats, collaborating with 
departments  such  as  the  National  Crisis  Communication  Center  (NCCN)  to  ensure  a  wide-reaching 
surveillance scope. Apart from this, the FPS specifically monitors chemical, biological, radiological, and 
nuclear (CBRN) threats and manages the corresponding MCMs. They also implement “health vigilance” 
mechanisms  to  monitor  cross-border  threats  and  maintain  a  high  level  of  preparedness  against 
emerging health risks, including their corresponding countermeasures. 

Production / Manufacturing Capacities 
FPS  Health  does  not  generally  intervene  in  market  dynamics  but  explores  initiatives  to  encourage 
European production and reduce dependency on importing essential medicines. This is considered in 
collaboration with the FPS Economy and the Federal Agency for Medicines and Healthcare Products, 
considering local support, market challenges, and boosting industrial capacities. Furthermore, the FPS 
Health evaluates the needs for MCMs in other health risk scenarios, including pandemics and medical 
shortages. 

Procurement of MCMs 
FPS Health contributes to the procurement of MCMs by conducting market research first. This initial 
step  is  crucial  as  it  provides  a  comprehensive  understanding  of  available  options,  feasibility,  and 
supplier  landscapes,  which  inform  the  detailed  tender  process.  FPS  Health  initiates  the  tender 
procedure,  which  is  designed  to  be  thorough  and  transparent,  ensures  that  the  procurement  is 
competitive and that the  MCMs meet the specific needs of the healthcare system while adhering to 
budget  constraints.  In  emergency  situations,  FPS  Health  is  equipped  with  expedited  procedures  to 
swiftly procure MCMs, bypassing some of the more time-consuming steps of the standard process.  

Stockpiling and Distribution Capacities  
For stockpiling and distributing MCMs, in conjunction with advice from scientific bodies, the FPS Health 
prioritizes  potential  MCMs  for  strategic  stockpiles.  The  FPS  partners  with  private  entities  that  are 
selected based on their capacity for effective storage and rapid deployment. These logistical partners 
are  equipped  to  handle  major  emergencies  swiftly,  while  smaller  crises  can  often  be  managed  by 
existing  stocks  at  the  anti-poison  centre  or  hospitals.  Storage  and  distribution  are  organized  by  the 
Federal  Strategic  Stock  housed  within  the  FPS  Public  Health.  FPS  Health  currently  responds  to 
requests  for  activating  strategic  stockpiles  but  is  in  the  process  of  establishing  a  more  defined  and 
structured  operating  procedure.  This  procedure  will  dictate  how  the  strategic  stock  is  activated  and 
deployed through logistical partners to meet the needs swiftly. In cases where demand exceeds the 
foreseen  strategic  stock,  the  FPS  will  seek  alternative  MCMs  and  acquisition  methods  to  ensure 
sufficient supply and maintain health security. 

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When it comes to stockpiling, the FPS is tasked with the crucial responsibility of managing not only its 
national  reserves  but  also  the  RescEU  stockpile.  The  RescEU  stockpile  represents  a  collective 
European effort, established as a direct response to significant health emergencies, such as the COVID-
19 pandemic, to provide a centralized repository of medical equipment and supplies. This pan-European 
stockpile is designed to guarantee the availability of essential medical resources across the European 
Union  when  they  are  most  needed,  thereby  alleviating  the  pressure  on  individual  member  states, 
including Belgium, during times of crisis. 

FPS Health's stewardship of the RescEU stockpile involves more than just warehousing MCMs. The 
service meticulously tracks the quantity, quality, expiry dates, and the conditions under which these 
MCMs  are  stored.  Regular  inspections  are  a  vital  part  of  FPS  Health's  duties  to  ensure  that  the 
stockpiled  items  are  in  optimal  condition  and  ready  for  deployment.  This  involves  the  systematic 
replacement of expired or compromised supplies to maintain the stockpile's integrity and reliability. 

In the event of a health emergency, FPS Health becomes the central coordinator for the distribution of 
resources  from  the  RescEU  stockpile.  Their  responsibilities  extend  to  identifying  the  most  critically 
affected areas and ensuring that the MCMs reach those locations promptly and efficiently. To achieve 
this, FPS Health coordinates closely with regional health bodies and other healthcare providers. The 
goal is to ensure that the distribution of these vital supplies is not only timely but also aligns with the 
immediate needs presented by the crisis, thereby maximizing the effectiveness of the response and 
minimizing  the  impact  on  public  health.  The  implementation  of  these  strategies  is  fundamental  to 
maintaining health security both within Belgium and across the broader European community. 

International Cooperation 
The  FPS  Health  actively  engages  in  international  health  preparedness  initiatives,  collaborating  with 
neighbouring and European countries on crisis preparedness and strategic stockpiling through projects 
such as RescEU and Joint Procurements. The FPS adheres to WHO guidelines and supports national 
diplomatic  efforts  in  the  negotiation  of  WHO  Pandemic  Agreements.  Additionally,  the  FPS  Health 
donates MCMs internationally, with recent contributions directed to Ukraine, Türkiye, and Gaza, among 
others. 

Health Security Coordination  
The FPS Health is responsible to establish and coordinate a national strategy for the preparedness of 
a potential future health crisis in collaboration with the Federated Entities. Depending on the emergency, 
FPS Health will have either a leading or a supporting. The exact responsibilities and role will depend 
on  the  health  crisis.  In  case  of  a  future  pandemic,  the  FPS  Health  will  have  a  leading  role  in  the 
coordination  and  response  for  the  pandemic.  Whitin  FPS  Health,  based  on  the  advice  of  the  Risk 
Assessment Group, the Risk Management Group (RMG) decides what measures are needed to protect 
public health. The RMG consists of representatives of health authorities and is chaired by the National 
Focal Point for the International Health Regulations. 

If a crisis becomes serious, the RMG meets regularly to manage all health-related aspects of the crisis. 
If that crisis requires coordination between different sectors and administrations, a crisis cell is set up 
at the FPS Interior crisis centre. 

Sciensano 
Sciensano,  the  Belgian  Institute  for  Health,  has  a  broad  and  critical  mandate  centered  on providing 
scientific  expertise  to  support  public  health  initiatives  and  manage  health  crises.  Its  main  mission 
involves  assisting  and  advising  the  competent  authorities  with  the  goal  of  minimizing  the  impact  of 
health crises on citizens. This encompasses a wide range of activities, from epidemiological research 

109 

 
 
 
 
 
 
 
 
and  health  surveillance  studies  to  risk  assessments,  which  are  fundamental  in  informing  the 
government's health and safety actions, as well as MCM strategies. 

Advanced Research and Development Capacities  
While  Sciensano  does  not  directly  contribute  to  the  development  of  advanced  research  and 
development  capacities  for  countermeasures,  it  does  provide  essential  advice  to  entities  like  the 
VirusBank that are tasked with these responsibilities. The VirusBank, funded by the Belgian Federal 
Government, is built to expedite the development of strategies to prevent and treat future epidemics 
and pandemics. Sciensano's collaboration with the VirusBank underscores the integration of Belgium's 
virology and research expertise into the broader framework of pandemic preparedness. 

Stockpiling and Distribution Capacities  
Although Sciensano is not directly involved with stockpiling and distribution capacities, its surveillance 
work and advisory input are critical in identifying when and where MCMs stockpiled by other entities 
should be distributed. 

Health Security Coordination  
Sciensano  serves  primarily  as  an advisory body  to  the  authorities,  eschewing any operational  crisis 
management role. It works in direct and close cooperation with the Risk Management Group (RMG). 
The RMG is charged with the development and implementation of measures, while Sciensano provides 
the scientific underpinning required to inform these processes effectively. This collaboration ensures 
that public health interventions are based on sound scientific principles and up-to-date intelligence on 
emerging health threats. 

Federal Agency for Medicines and Healthcare Products (FAMHP) 
The Federal Agency for Medicines and Healthcare Products (FAMHP) is the central regulatory authority 
that regulates and oversees the authorization, supply chain distribution, and quality control of medicines 
and healthcare products. This includes the necessary activities involved in the procurement process, 
such  as  evaluating,  authorizing,  and  monitoring  the  safety  and  efficacy  of  medicines  and  medical 
devices.  

Monitoring, Intelligence Gathering, and Analysis 
The Agency was involved in the identification of MCMs and their proper use during both the COVID-19 
crisis, as well as during the Monkeypox crisis. This suggests that the Agency may be involved in such 
activities during future public health emergencies. In addition, the Agency monitors the available current 
and  future  stock  of  medicines.  This  enables  FAMHP  to  have  an  overview  of  the  availability,  detect 
problems and take action if necessary. For this purpose, the Agency developed a Stock Monitoring Tool 
to monitor information for a crisis-specific list of critical medicinal products during a crisis. 

Advanced Research and Development Capacities 
FAMHP does not have specific responsibilities with regards to advanced research and development 
capacities with regards to MCMs. However, the Agency set up a national innovation office to facilitate 
and support innovation in pharmaceutical research and development (R&D). 

Production / Manufacturing Capacities 
Addressing market challenges with regards to MCMs is among FAMHP’s priorities. FAMHP actively 
engages in various initiatives to address market challenges and ensure access to essential healthcare 
products and promotes this point in international conferences (e.g., on the EU Health Union) as well as 
though  international  partnerships  for  supply.  In  cooperation  with  Enabel,  FAMHP  is  considering  the 
development  of  bilateral  relations  with  some  key  countries  with  a  view  to  fostering  regulatory 
convergence, developing its intelligence of the upstream supply chain and, potentially, to understand, 
anticipate and mitigate shortages caused at that level. 

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Procurement of MCMs 
Procurement does not fall under the Agency’s responsibilities. However, during the COVID-19 crisis, 
FAMHP  set  up  the  taskforce  on  shortages  and  supported  the  Ministry  of  Health  to  deal  with  the 
procurement of MCMs. This suggests that the Agency may be covering this role again during future 
public health emergencies. 

Stockpiling and Distribution Capacities 
The  role  of  FAMHP  in  relation  to  stockpiling  of  FCMs  is  limited  to  the  assurance  of  the  quality 
assessment of MCMs, which forms part of the assessment and stockpiling of MCMs. The Agency was 
involved in supporting the Ministry of Health to deal with the transportation, storage, distribution and 
proper use of MCMs during the COVID-19 crisis. This suggests that the Agency may be called upon to 
assume this role again in the future in case of public health emergency. 

International Cooperation 
FAMHP  is  actively  engaged  in  national  and  international  collaborations.  The  Agency  concluded  a 
framework agreement with Enabel (Belgian development cooperation agency) to increase regulatory 
capacity in its field of action in Enabel’s partner countries. FAHMP also fosters international relations to 
deal with shortages of MCMs. FAMHP cooperates with EU actors and is represented in the MSSG, 
MDSSG and the Medicines Shortages Working Party.  

Belgian Healthcare Knowledge Centre (KCE) 
The Belgian Healthcare Knowledge Centre's (KCE) core mission involves conducting research in Health 
Services Research, Health Technology Assessment, and developing Clinical Practice Guidelines. Their 
work aims to inform policy and to optimize healthcare practices. The KCE operates in a consultative 
capacity, making its findings public and providing policy recommendations developed with input from 
various stakeholders in the Belgian healthcare landscape. Through its activities, the KCE informs and 
guides  health  security  strategies  and  healthcare  improvements,  fostering  a  prepared  and  effective 
response to public health challenges. 

Advanced Research and Development Capacities 
KCE supports advanced research by funding comparative effectiveness and repurposing clinical trials 
of  countermeasures  through  KCE  Trials.  These  trials  focus  on  evaluating  potential  therapeutic  or 
preventive interventions for conditions like COVID-19. The KCE Trials platform facilitates multi-center 
clinical trials and plays a pivotal role in evidence generation for medical interventions. 

Procurement of MCMs 
While the KCE does not perform actual procurement, it is involved in the process through the Task 
Force Therapeutics for Viral Diseases, which assesses treatments and advises the government on what 
molecules should be purchased and stockpiled. 

Stockpiling and Distribution Capacities 
The  KCE  contributes  to  the  decision-making  process  regarding  the  stockpiling  of  MCMs.  It  has 
developed  a  framework  to  streamline  decisions  on  stockpiling  MCMs,  providing  guidance  on  which 
drugs to stockpile to the Ministry of Health and the FPS Public Health. 

International Cooperation 
KCE  experts  are  involved  in  international  collaborations  that  foster  the  swift  setup  and  conduct  of 
platform  trials  and  the  selection  of  candidate  molecules.  This  participation  ensures  that  KCE  keeps 
abreast of international developments in healthcare interventions, contributing to the collective body of 
knowledge that informs decision-making and recommendations at home. 

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Health Security Coordination 
The KCE offers support primarily through study work and serves as a host and participant in committees 
that provide important strategic advice. During the COVID-19 pandemic, KCE hosted the Task Force 
Therapeutics for Viral Diseases, which played a crucial role in evaluating and advising on treatment 
options for managing the outbreak. 

Communities and regions 
Belgium's regionalized health crisis management system allows for tailored approaches contributing to 
a cohesive national strategy. Belgian regions and communities play a role in preparedness and crisis 
response with regards to MCMs in their own territories through dedicated entities: the Joint Community 
Commission in Brussels, the Department of Care (DoC) in Flanders and the Agence wallone pour une 
vie de qualité (AVIQ) in Wallonia. 

Production and Manufacturing Capacities 
The DoC in Flanders is tasked with exploring industrial partnerships for future MCM development, which 
underscores the importance for the region of ready manufacturing capabilities in response to health 
emergencies. This activity suggests that the other regions and communities may be involved in carrying 
out a similar tasks through their dedicated entities; however, this information could not be confirmed. 

Procurement of MCMs 
All regions and communities actively engage in the procurement of medical countermeasures. The Joint 
Community Commission, as part of the collaboration with FAMHP and other regional health entities, is 
involved in coordinating to secure an adequate and timely supply of MCMs in Brussels, ensuring that 
the  necessary  countermeasures  are  available  as  needed.  In  Flanders,  the  DoC  purchases  and 
stockpiles  countermeasures  for  use  in  healthcare  facilities.  It  is  currently  working  on  Vaccinnet  2.0, 
aimed  at  streamlining  the  registration  and  ordering  of  MCMs.  Meanwhile,  Wallonia  handles  the 
procurement of PPE and medical equipment. 

Stockpiling and Distribution Capacities 
Effective stockpiling and distribution are critical in crisis management, a task that all regions address 
robustly. The Joint Community Commission in Brussels manages MCM stockpiles, focusing on supply 
chain  efficacy  during  health  crises.  Flanders  maintains  strategic  reserves  of  PPE  and  is  refining  its 
distribution  protocols,  whereas  Wallonia  has  established  systematic  procedures  for  managing  and 
deploying stockpiles, although details on specific distribution strategies remain limited. 

Health Security Coordination 
Communities  and  regions  contribute  to  the  national  health  security  coordination  by  coordinating 
activities  during  health  crises  in  their  jurisdictions.  The  Joint  Community  Commission  focuses  on 
coordinating within the urban context of Brussels, ensuring effective local responses. Flanders’ Crisis 
Preparedness  Cell  develops  standardized  protocols  for  rapid  MCM  deployment,  while  Wallonia's 
development of a Health Emergency Plan aims to streamline and enhance the efficiency of its crisis 
responses

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c. Bulgaria 

Overview of approach to preparedness and response to public health emergency in MCMs 

Monitoring, Intelligence Gathering, and Analysis 
In  Bulgaria,  monitoring,  intelligence  gathering,  and  analysis  are  undertaken  by  both  the  Ministry  of 
Health and the National Centre for Infectious and Parasitic Diseases (NCIPD). The Ministry of Health 
relies on the National Centre for Public Health and Analysis (NCPHA) to monitor and analyse public 
health  data  and  trends  with  regards  to  MCMs.  Concurrently,  the  NCIPD  conducts  surveillance  on 
various infections and contributes to identify MCMs.  

Advanced Research and Development Capacities 
The  NCIPD  engages  in  research  across  immunology,  virology,  bacteriology,  and  parasitology.  Its 
research underpins the development of medical countermeasures in Bulgaria. 

Production / Manufacturing Capacities 
Bulgaria's production and manufacturing capacities for medical countermeasures are supported by a 
collaborative  effort  between  the  Ministry  of  Health  and  the  Ministry  of  Economy.  The  Ministry  of 
Economy  supports  the  pharmaceutical  and  biotechnology  industries  through  industrial  policy  and 
development, creating a conducive environment for manufacturing MCMs. 

Procurement of MCMs 
The procurement of medical countermeasures in Bulgaria is primarily managed by the Ministry of Health, 
with supplementary roles played by the Regional Health Inspectorates. The Ministry of Health oversees 
the central procurement of essential medical supplies, medications, vaccines, and equipment required 
to  manage  health  crises  effectively.  At  the  regional  level,  the  Regional  Health  Inspectorates  tailor 
procurement efforts to the specific needs of their areas, ensuring that local health crises are addressed 
with appropriate resources. 

Stockpiling and Distribution Capacities 
The Ministry of Health is responsible for maintaining a state emergency stockpile to respond to public 
health crises in Bulgaria. This includes overseeing the stockpiling and distribution of MCMs to ensure 
they  are readily  available and can be  efficiently  disseminated  throughout  the country when  needed. 
Regional Health Inspectorates manage local stockpiles and distribution networks, ensuring that MCMs 
are accessible at the regional level.  

International Cooperation 
In  the  event  of  a  health crisis,  Bulgaria  engages  in  international cooperation  through  the  Ministry  of 
Health. The Ministry coordinates with international health bodies and other countries to ensure a unified 
and informed response to global health threats.  

Health Security Coordination 
Health security coordination in Bulgaria is centrally managed by the Ministry of Health, which acts as 
the  primary  body  overseeing  the  public  health  response.  The  Ministry  coordinates  between  various 
healthcare facilities, government agencies, and the private sector to ensure an integrated and effective 
response to health emergencies. Regional Health Inspectorates complement this effort by preparing 
region-specific pandemic preparedness plans and coordinating local stakeholders to ensure readiness 
and an integrated response at the regional level. 

113 

 
 
 
 
 
 
 
 
 
 
Comprehensive mapping of identified entities 

Ministry of Health 
The Ministry of Health of Bulgaria plays a vital role in the management of health crises within the country. 
Its  main  mission  includes  the  implementation  of  anti-epidemic  measures  and  maintaining  the  public 
health system's readiness to respond to health emergencies. Ensuring that the healthcare system is 
equipped with appropriate strategies and resources to address such crises is central to its mandate. 

Monitoring, Intelligence Gathering, and Analysis 
Within  the  Ministry  of  Health,  the  National  Centre  for  Public  Health  and  Analysis  (NCPHA)  plays  a 
crucial role in public health protection, health promotion, and disease prevention. It provides information 
support for healthcare management, which involves monitoring and analysing public health data and 
trends also with regards to medical countermeasures.  

Procurement of MCMs 
The Ministry of Health is directly responsible for the central procurement of MCMs. This includes the 
acquisition  of  medical  supplies,  medications,  vaccines,  and  any  other  necessary  equipment  or 
interventions required to manage a health crisis effectively (personal protective equipment (PPE), lab 
testing kits, and ventilators). 

Stockpiling and Distribution Capacities 
The  Ministry  keeps  a  state  emergency  stockpile  in  case  of  public  health  crises.  It  oversees  the 
stockpiling  and  distribution  of  MCMs,  ensuring  that  they  are  readily  available  and  effectively 
disseminated throughout the country when needed.  

International cooperation 
In  case  of  health  crisis,  The  Ministry  engages  in  international  collaboration,  coordinating  with 
international health bodies and other countries to ensure a unified and informed response to the global 
crisis. 

Health Security Coordination 
The  Ministry's  has a  central  role  in ensuring  that  medical  interventions  are available  and  distributed 
effectively across Bulgaria. The Ministry acts as the central body in managing the public health response, 
coordinating between various healthcare facilities, other government agencies, and the private sector. 

114 

 
 
 
 
 
 
 
 
 
This includes the allocation and management of resources like hospital beds and medical supplies. The 
Ministry  also  serves  as  the  central  communication  hub,  providing  regular  updates  to  the  public  and 
other stakeholders about the situation, guidelines, and measures being implemented.  

Ministry of Economy 
Production / Manufacturing Capacities 
In cooperation with the Ministry of Health, the Ministry of Economy is involved in industrial policy and 
development, which includes supporting the pharmaceutical and biotechnology industries. They work 
on creating a conducive environment for manufacturing, including MCMs, by offering incentives and 
regulatory  support  to  boost  production  capacities  and  innovation  within  the  sector.  The  Ministry  of 
Economy also focuses on solving supply chain bottlenecks by promoting infrastructure development 
and logistics optimization. 

National Centre for Infectious and Parasitic Diseases (NCIPD) 
The primary goal of the National Centre for Infectious and Parasitic Diseases (NCIPD) is to establish 
the scientific foundations for combating infectious diseases and to create effective methods for disease 
control and prevention, including identifying related countermeasures. The centre seeks to steer the 
scientific  direction  in  these  endeavours  to  improve  public  health  outcomes  in  the  face  of  infectious 
threats. 

Monitoring, Intelligence Gathering, and Analysis 
The NCIPD operates as a central body for monitoring and gathering intelligence on infectious diseases. 
Its  National  Reference  Laboratories  (NRLs)  carry  out  surveillance  of  various  bacterial,  viral,  and 
parasitic  infections,  offering  timely  and  accurate  information  for  informed  responses  to  infectious 
disease  outbreaks,  contributing  significantly  to  the  data  and  understanding  necessary  for  identifying 
effective medical countermeasures. 

Advanced Research and Development Capacities 
The NCIPD is home to laboratories that are equipped for cutting-edge research across immunology, 
virology, bacteriology, and parasitology. The centre carries out advanced research on the epidemiology, 
ethiopathogenesis,  immune  reactivity,  and  diagnostics  of  infectious  and  parasitic  diseases.  This 
research underpins the development of MCMs by providing scientific foundations and methodologies. 

Regional Health Inspectorates 
The Regional Health Inspectorates are responsible for delivering a localized response to health crises 
within their respective regions. They focus on implementing tailored anti-epidemic measures based on 
the specific needs and circumstances of their region. The overarching goal is to harness local resources 
and capabilities to guarantee an effective regional response during a health crisis. 

Procurement of MCMs 
Regional  Health  Inspectorates  play  a  role  in  the  procurement  of  medical  countermeasures  at  the 
regional/local level. They are responsible for acquiring necessary medical supplies and interventions 
needed during a health crisis, tailored to the requirements of their specific region. 

Stockpiling and Distribution Capacities 
Regional Health Inspectorates manage stockpiles and the distribution of MCMs within their territories.  

Health Security Coordination 
The Regional Health Inspectorates are tasked with preparing region-specific pandemic preparedness 
plans,  which  involves  coordinating  various  local  stakeholders,  including  healthcare  providers, 
emergency services, and local governments, to ensure readiness and an integrated response to public 
health threats.

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d. Croatia 

Overview of approach to preparedness and response to public health emergency in MCMs 

Monitoring, Intelligence Gathering, and Analysis 
In Croatia, the task of monitoring, intelligence gathering, and analysis is a collaborative effort involving 
multiple entities. The Ministry of Health’s Crisis Headquarters (HQ) utilizes surveillance systems and 
maintain communication with local and international health bodies to comprehensively understand the 
scope and potential impact of health emergencies. The Croatian Institute of Public Health complements 
this  by  employing  sophisticated  methods  in  epidemiology  to  track  health  events,  identify  trends  and 
countermeasures, and project future health implications. The Civil Protection Directorate adds to this 
by monitoring situations across multiple sectors. 

Advanced Research and Development Capacities 
The Ministry of Health participates in EU-wide initiatives, contributing to strategic research agendas for 
pandemic  preparedness,  and  pooling  research  capacities  to  fund  innovative  health  solutions.  This 
collaboration  supports  the  development  of  diagnostics,  vaccines,  and  therapeutics.  The  Croatian 
Institute of Public Health engages in advanced research to understand disease patterns and develop 
health promotion strategies, thus informing policy decisions and creating innovative health interventions.  

Production / Manufacturing Capacities 
HALMED, the Agency for Medicinal Products and Medical Devices of Croatia, plays a crucial role in 
overseeing  the  production  and  manufacturing  capacities  of  medicinal  products.  It  ensures  the 
continuous availability of these products by monitoring market trends, analysing supply and demand 
data, and predicting potential shortages. 

Procurement of MCMs 
The  procurement  of  MCMs  in  Croatia  is  primarily  managed  by  the  Ministry  of  Health  through  its 
designated department. This central point of procurement coordinates with various entities to ensure 
the timely acquisition of necessary medicines and countermeasures. The Civil Protection Directorate 
supports this process by expediting and streamlining procurement procedures across sectors, ensuring 
that  MCMs  are  readily  available  when  needed.  The  Croatian  Institute  of  Public  Health  provides 
consultative  support,  advising  on  the  types  of  MCMs  required  based  on  epidemiological  data  and 
current health threats.  

Stockpiling and Distribution Capacities 
The Ministry of Health is responsible for maintaining strategic reserves and coordinating with the HERA 
to manage these reserves. The Civil Protection Directorate plays a pivotal role in managing the logistics 
of stockpiling and distribution, securing storage facilities, managing inventories, and creating distribution 
networks  to  ensure  resources  reach  critical  areas  promptly.  The  Croatian  Institute  of  Public  Health 
provides  expert  advice  on  the  composition  and  quantity  of  items  to  be  stockpiled  based  on 
epidemiological insights.  

International Cooperation 
The Ministry of Health’s Crisis Headquarters engages in partnerships with international health bodies 
and other countries to enhance capabilities, share best practices, and secure access to MCMs globally.  

Health Security Coordination 
Health security coordination in Croatia is managed at the highest levels by the Ministry of Health’s Crisis 
Headquarters  and  the  Civil  Protection  Directorate.  The  Crisis  HQ  orchestrates  the  health  system's 
response,  ensuring  all  aspects,  from  surveillance  to  MCM  deployment,  work  in  unison  to  safeguard 

116 

 
 
 
 
 
 
 
 
 
public  health.  The  Civil  Protection  Directorate  ensures  multi-sectoral  coordination,  aligning  efforts 
across various sectors to avoid duplication and achieve strategic response goals.  

Comprehensive mapping of identified entities 

Ministry of Health – Crisis Headquarters 
The Ministry of Health of Croatia, through its Crisis Headquarters (HQ), plays a role in managing public 
health emergencies. This specialized unit is led by the Deputy Minister or State Secretary within the 
Ministry of Health. They orchestrate the necessary actions and strategies to handle health crises as 
they  unfold.  During  these  critical  times,  the  Crisis  HQ  becomes  the  nerve  centre  for  coordination, 
drawing on the collaborative efforts of all key structures within the health sector—ensuring efforts are 
streamlined towards the resolution of the imminent threat posed by the emergency. 

Monitoring, Intelligence Gathering, and Analysis 
The  Crisis  HQ  maintains  a  vigilant  eye  on  the  evolution  of  public  health  threats.  This  involves  a 
continuous  process  of  collecting  data,  assessing  situations,  and  interpreting  the  findings  to  make 
informed decisions. Real-time intelligence gathering is also a significant function of the Crisis HQ. They 
gather  intelligence  through  various  means,  including  surveillance  systems  and  communication  with 
local and international health entities. By doing this, they can grasp the full scope of the emergency and 
its potential impact. 

The Crisis HQ is responsible for interpreting the data gathered during the monitoring and intelligence 
phase. The analysis aids in understanding the complexity of the crisis, predicting potential outcomes, 
and  developing  strategies  to  counteract  the  emergency  effectively,  including  the  identification  of 
countermeasures. 

Advanced Research and Development Capacities 
The  Ministry  participates  support  advanced  research  and  development  with  regards  to  MCMs  by 
participating in EU-wide initiatives. This includes contributing to the strategic EU research agenda for 
pandemic  preparedness,  which  is  designed  to  pool  research  capacities  and  fund  innovative  health 
solutions. This collaboration aims to support the development of diagnostics, vaccines, and therapeutics. 
The Ministry also cooperates with the Ministry of Science and Education and scientific institutions, as 

117 

 
 
 
 
 
 
 
 
well  as  with  Croatian  institute  of  Public  Health  to  advance  research  and  development  capacities  of 
Croatia in the field of MCM. 

Procurement of MCMs 
The Ministry acts as the central point of procurement for medicines and medical countermeasures. The 
Ministry is in charge of the State Stock Supply, which on the request of the Ministry, procures MCMs.  

Stockpiling and Distribution Capacities 
The Ministry is involved in maintaining strategic reserves of MCMs and in coordinating with HERA to 
manage these reserves. For swift deployment of MCMs during crises, the Ministry closely cooperates 
with the Croatian Institute of Public Health and county institutes of public health, as well as with Ministry 
of  Interior,  Civil  Protection  Headquarters  and  the  Croatian  Pharmacists’  Chamber  which  then 
coordinates pharmacies on the national scale enabling the distribution of medicines. 

International Cooperation 
Through partnerships and collaboration with various international health bodies and countries, the Crisis 
HQ would aim to enhance the country's capabilities in responding to health emergencies, share best 
practices, and secure access to MCMs from global sources. 

Health Security Coordination 
The health security coordination responsibilities of the Crisis HQ extend to the highest levels of health 
emergency  management.  They  take  on  the  leadership  role  in  orchestrating  the  health  system's 
response, ensuring that every aspect, from surveillance to the deployment of MCMs, works in unison 
to safeguard the health security of Croatia's population.  

Civil Protection Directorate – National Crisis Headquarters 
The Civil Protection Directorate, helmed by the Deputy Prime Minister of Croatia, is in charge of crisis 
response within sectors beyond the health system during public health emergencies. As the National 
Crisis HQ, it activates when the complexity of an emergency transcends the sphere of health, requiring 
a  more  extensive,  multi-sectoral  approach.  This  body  assumes  a  commanding  role,  pooling  the 
collective strengths and resources of various sectors to mount a robust and comprehensive response. 
Given its expansive mandate, the Civil Protection Directorate is involved in the orchestration of logistics. 
Its oversight includes operations involved in transportation, ensuring that MCMs and other essential 
resources reach where they are most needed promptly.  

Monitoring, Intelligence Gathering, and Analysis 
The Civil Protection Directorate plays a supplementary role in monitoring the situation across multiple 
sectors. It gathers intelligence from these sectors, including transportation, public order, and essential 
services, to gain a comprehensive understanding of the emergency's impact on society. It then analyses 
this information to inform decision-making, including with regards to MCMs, and planning for a multi-
sectoral emergency response. 

Procurement of MCMs 
The Directorate coordinates with the Ministry of Health and other sectors to ensure that procurement 
processes for MCMs are expedited and streamlined. 

Stockpiling and Distribution Capacities 
The Civil Protection Directorate is central in managing the logistics of stockpiling essential resources 
and organizing their distribution. This includes securing storage facilities, managing inventories, and 
creating a distribution network to ensure that MCMs and other resources are delivered to the areas of 
most critical need.  

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Health Security Coordination 
The Civil Protection Directorate plays a role in unifying the various sectors during crises. By coordinating 
multi-sectoral efforts, it ensures that all stakeholders are aligned in their objectives, avoid duplication of 
efforts,  and  collectively  contribute  to  the  strategic  goals  of  the  response  efforts.  Beyond  immediate 
emergency  scenarios,  the  Civil  Protection  Directorate  engages  with  entities  in  the  health  but  also 
defence  and  internal  affairs  sectors  to  develop  contingency  plans  and  strategies  that  bolster  the 
country's preparedness for future crises.  

Croatian Institute of Public Health 
The Croatian Institute of Public Health has multifaceted responsibilities, particularly during health crises, 
which span various critical aspects of public health. 

Monitoring, Intelligence Gathering, and Analysis 
The  Institute  is  involved  in  epidemiology,  and  in  tracking  and  understanding  the  distribution  and 
determinants of health events in populations. It is involved in rigorous monitoring of health data and 
employs  sophisticated  methods  to  gather  intelligence  on  emerging  health  threats.  The  Institute  is 
capable of conducting robust analysis, identifying trends, and projecting future implications of health-
related events, which is essential for crafting effective responses to health crises, including with regards 
to MCMs. 

Advanced Research and Development Capacities 
The Institute undertakes advanced research towards understanding disease patterns, health promotion 
strategies,  and  disease  prevention  methods.  Its  research  activities  are  geared  towards  generating 
knowledge  that  can  inform  policy  decisions  and  the  development  of  innovative  health  interventions, 
including MCMs. 

Procurement of MCMs  
The Croatian Institute of Public Health plays a consultative role on the types of MCMs required based 
on epidemiological data and current health threats.  

Stockpiling and Distribution Capacities 
The  Institute  plays  a  consultative  role  in  determining  the  composition  and  quantity  of  items  to  be 
stockpiled in national reserves based on epidemiological insights and public health expertise. 

Agency for medicinal products and medical devices of Croatia (HALMED) 
Production/Manufacturing Capacities 
HALMED  is  responsible  for  overseeing  the  supply  chain  of  medicinal  products  and  ensuring  their 
continuous availability. This entails monitoring market trends, analysing data related to the supply and 
demand  of  medications,  and  predicting  potential  shortages.  HALMED,  together  with  the  Ministry  of 
Health, cooperate with the Ministry of Economy and the State Stock Supply and through them reaches 
out to manufacturers and their representatives to boost autonomy in production and stocks.

119 

 
 
 
 
 
 
 
 
 
e. Cyprus 

Overview of approach to preparedness and response to public health emergency in MCMs 

Monitoring, Intelligence Gathering, and Analysis 
The  Ministry  of  Health  of  Cyprus,  through  its  Epidemiological  Surveillance  and  Control  of  Infectious 
Diseases Unit, leads efforts in monitoring and analysing health threats and identifying countermeasures. 
Although  the  State  Healthcare  Services  Organisation  (SHSO)  does  not  directly  engage  in  national 
surveillance, it contributes valuable data from public healthcare facilities, aiding in the identification of 
potential  outbreaks  and  informing  the  Ministry's  response  with  regards  to  the  treatments  and 
countermeasures. 

Advanced Research and Development Capacities 
Both the Ministry of Health and the Ministry of Defence in Cyprus support and implement research that 
contributes to the development of medical countermeasures, and cooperate in European initiatives to 
support R&D in this field. 

Production / Manufacturing Capacities 
The  Ministry  of  Health  manages  and  promotes  the  national  supply  and  demand  for  medical 
countermeasures  through  a  centralized  management  team  established  in  2020.  This  team's  role 
includes  ensuring  that  national  production  capabilities  align  with  health  security  needs,  thereby 
maintaining a steady supply of essential medical products.  

Procurement of MCMs 
The Ministry of Health oversees the procurement of MCMs, leveraging the flexibility of Cyprus' public 
tender laws to rapidly acquire necessary medical supplies during emergencies. This legal framework 
allows the Ministry to efficiently manage resources and respond to health threats. The SHSO supports 
this process by communicating the needs and consumption rates of its medical facilities, ensuring that 
procurement efforts are aligned with actual demand within the healthcare system. 

Stockpiling and Distribution Capacities 
The  Ministry  of  Health  maintains  a  central  warehousing  system  for  stockpiling  MCMs  and  personal 
protective  equipment,  ensuring  preparedness  for  health  crises.  In  emergencies,  the  Ministry 
collaborates  closely  with  the  SHSO  to  ensure  the  swift  distribution  of  these  supplies  to  healthcare 
facilities. The SHSO plays a critical role in managing the availability and distribution of MCMs within its 
jurisdiction,  ensuring  that  public  hospitals  and  primary  care  centres  are  well-equipped  to  handle 
emergencies. 

International Cooperation 
The  Ministry  of  Health  actively  engages  in  international  cooperation  to  enhance  its  health  security 
capabilities. It collaborates with organisations such as the WHO, HERA, and ECDC, and participates in 
the  EU  surveillance  system  and  joint  activities  on  MCMs.  These  international  partnerships  provide 
valuable insights and resources, enabling the Ministry to effectively manage health emergencies. This 
cooperation is crucial for maintaining robust preparedness and response strategies, informed by global 
best practices and threat assessments. 

Health Security Coordination 
The Ministry of Health coordinates national health security efforts through a dedicated decision-making 
group,  established  under  the  national  crisis  plan.  This  group  directs  the  response  to  public  health 
emergencies, including the deployment and use of MCMs. In conjunction with the SHSO, the Ministry 
implements measures within public healthcare facilities, ensuring that patient care, hospital triage, and 

120 

 
 
 
 
 
 
 
 
 
MCM administration are effectively managed during crises. The SHSO contributes to this coordination 
by developing contingency plans and organizing staff deployment, ensuring a cohesive and effective 
response to health emergencies. 

Comprehensive mapping of identified entities 

Ministry of Health 
The  Ministry  of  Health  of  Cyprus,  anchored  by  its  Medical  and  Public  Health  Services  (MPHS) 
Department, is a critical entity to the handling and governance of MCMs during health crises. Under 
typical  circumstances,  the  MPHS's  main  role  encompasses  the  prevention  and  control  of  infectious 
diseases, but this role expands significantly during periods of health emergencies. 

Mode of operation 
Public  awareness  campaigns  and  educational  initiatives  for  healthcare  professionals  are  key  to  the 
Ministry's  approach  to  public  health  communication,  ensuring  the  population  and  medical  staff  are 
aware of potential health threats and the importance of preparedness. During health emergencies, the 
Ministry activates its national crisis plans, which detail the operations of various Ministry departments. 
The  legal  framework  guiding  these  actions affords  flexibility  for  emergency procurement  procedures 
and outlines the roles and decision-making processes during an emergency response. 

Monitoring, Intelligence Gathering, and Analysis 
In managing the monitoring, intelligence gathering, and analysis within the healthcare framework, the 
Ministry operates through its Epidemiological Surveillance and Control of Infectious Diseases Unit. This 
unit actively performs disease surveillance, monitors the spread of illness, forecasts potential disease 
trends, and devises strategies to manage disease transmission. Such strategies include advising the 
use of MCMs. In response to identified threats, the Ministry is involved in identifying and implementing 
appropriate  countermeasures.  The  Ministry  also  actively  assesses  data  on  disease  outbreaks  and 
engages  with  the  Early  Warning  and  Response  System  (EWRS)  for  early  warning  and  response 
coordination, drawing insights from international threat assessments by organisations like ECDC and 
WHO. 

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Advanced Research and Development Capacities 
The Ministry of Health plays a role in supporting and implementing research and initiatives related to 
medical countermeasures. This includes collaborating with academic institutions and research centres 
to  advance  health-related  research,  particularly  in  the  areas  of  public  health  and  emergency 
preparedness. The Ministry of Health's involvement in research and development is often in partnership 
with European initiatives, such as HERA. Additionally, the Ministry of Defence also contributes to the 
development  of  defence-related  medical  countermeasures,  particularly  those  addressing  chemical, 
biological, radiological, and nuclear (CBRN) threats.  

Production / Manufacturing Capacities 
The Ministry of Health actively controls and promotes national supply and demand through a central 
management team established in 2020. 

Procurement of MCMs 
As part of its mandate, the Ministry procures MCMs to tackle health threats during both preparedness 
and crisis response times. In case of emergency, Cyprus’ public tender law allows enough flexibility to 
the  Ministry  for  procuring  and  managing  resources  necessary  for  emergency  response,  including 
medical supplies, equipment and other goods/services. 

Stockpiling and Distribution Capacities 
Stockpiling  and  distribution  capacities  of  the  Ministry  rely  on  their  central  warehousing  system  and 
mechanisms  for  managing  inventory.  The  Ministry  maintains  stockpiles  of  MCMs  and  personal 
protective  equipment  to  ensure  readiness  for  crisis  situations.  In  emergencies,  there  is  close 
cooperation with the State Health Services Organisation to ensure prompt delivery of MCMs and other 
needed supplies. The Ministry prepares policies that outline instructions and procedures for managing 
strategic stock, including rapid transport to healthcare facilities in urgent situations. 

International Cooperation 
Internationally, the Ministry of Health engages with organisations such as WHO, HERA and ECDC and 
signs  agreements  with  various  countries  to  reinforce  its  preparedness  and  response  capabilities. 
Participation in the EU surveillance system, the implementation of the International Health Regulations, 
and EU joint activities on MCMs are part of the coordinated approach to managing health emergencies. 
The  Ministry  also  relies  on  published  threat  assessments  and  communications  with  other  countries, 
which provide valuable insights into the likelihood and potential impact of different health threats, aiding 
the Ministry in prioritizing preparedness efforts and allocating resources effectively. 

Health security coordination 
The Ministry of Health sets up a decision-making group in accordance with the national crisis plan to 
coordinate  the  response  to  public  health  emergencies,  including  in  relation  to  MCMs.  The  group  is 
conceived to give instructions to relevant entities on how to operate during an emergency. 

State Healthcare Services Organisation (SHSO) 
The  State  Healthcare  Services  Organisation  (SHSO)  carries  out  a  pivotal  role  within  the  healthcare 
system of Cyprus, primarily overseeing the functioning of public hospitals and primary care centres. It 
is mainly focused on the operational management of public health facilities, ensuring they are equipped 
and ready to provide care. Its role in preparedness and response to health emergencies closely aligns 
with executing the policies and strategies derived from the Ministry of Health’s overarching framework. 
It does not directly engage in areas such as surveillance or international cooperation but serves as a 
critical operational arm that would enact the strategies and directives in the event of a national health 
emergency. 

122 

 
 
 
 
 
 
 
 
Monitoring, Intelligence Gathering, and Analysis 
While  the  SHSO  is  not  directly  responsible  for  monitoring  infectious  disease  spread  or  intelligence 
gathering at a national surveillance level, it facilitates the collection of data regarding patient admissions, 
hospital occupancy rates, and healthcare supply usage within public healthcare facilities. This data can 
be crucial for the analysis of emerging healthcare trends and could assist in flagging potential outbreaks 
or health crises, as well as the countermeasures to respond to such situations of emergency. 

Procurement of MCMS 
The  SHSO  expresses  the  needs  and  consumption  rates  of  its  medical  facilities  to  inform  the 
procurement processes of the Ministry with regards to MCMs. 

Stockpiling and Distribution Capacities 
During  an  emergency,  the  SHSO  manages  and  ensures  the  availability  of  MCMs,  as  well  as  their 
distribution within the health facilities under its jurisdiction.  

Health Security Coordination 
In  case  of  a  health  crisis,  the  SHSO,  alongside  the  Ministry  of  Health  and  the  MPHS,  implements 
measures within public healthcare facilities to manage patient care, hospital triage, and administration 
of  MCMs.  The  SHSO  contributes  to  developing  contingency  plans  for  the  facilities  it  manages, 
organizing staff deployment and care strategies to respond effectively to the crisis

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f.  Czechia 

Overview of approach to preparedness and response to public health emergency in MCMs 

Monitoring, Intelligence Gathering, and Analysis 
In Czechia, the Ministry of Health takes the lead in monitoring the health status of the population and 
disease  outbreaks  to  swiftly  identify  emerging  threats  as  well  as  countermeasures.  This  involves 
collecting  data  from  hospitals,  clinics,  laboratories,  and  international  health  organisations.  Regional 
Public Health Authorities supplement these efforts by monitoring health status within their jurisdictions, 
detecting deviations from normal health patterns, and responding to local health emergencies. 

Advanced Research and Development Capacities 
The  Ministry  of  Health  fosters  innovation  and  research  in  the  healthcare  sector  by  supporting  and 
funding  research  initiatives  aimed  at  developing  new  medical  technologies,  countermeasures, 
treatments, and preventive measures.  

Production / Manufacturing Capacities 
The Ministry of Health, in collaboration with the State Institute for Drug Control (SUKL), oversees and 
regulates the production and manufacturing of MCMs. This ensures that these countermeasures meet 
quality standards and are produced in sufficient quantities to meet demand during crises.  

Procurement of MCMs 
The Ministry of Health is responsible for procuring MCMs through public procurement processes. This 
includes  negotiating  contracts  with  suppliers,  managing  inventory,  and  distributing  resources  to 
healthcare  facilities  nationwide.  The  Ministry's  procurement  efforts  ensure  timely  access  to  critical 
resources during health emergencies. Regional Public Health Authorities cooperate with the Ministry in 
procuring MCMs for their respective jurisdictions, ensuring that regional needs are met. 

Stockpiling and Distribution Capacities 
The  Ministry  of  Health  maintains  strategic  stockpiles  of  essential  medical  supplies  and  MCMs, 
strategically located for rapid deployment in emergencies. The Ministry develops distribution plans to 
efficiently  deliver  these  resources,  collaborating  with  regional  authorities  and  healthcare  facilities. 
Regional Public Health Authorities manage regional stockpiles in cooperation with the Ministry, ensuring 
that resources are readily available to address local health crises. 

International Cooperation 
The Ministry of Health plays a key role in fostering international collaboration, participating in global 
health initiatives, sharing information and best practices, and engaging in joint research and response 
efforts. This collaboration enhances Czechia's preparedness and response capabilities. Together with 
SUKL, the Ministry addresses shortages of medicinal products at the EU level, ensuring that Czechia 
benefits from international resources and support. 

Health Security Coordination 
The Ministry of Health assumes a central coordinating role in health security, especially when regional 
capacities are overwhelmed during crises. It deploys resources, personnel, and expertise to manage 
health  emergencies  effectively.  Regional  Public  Health  Authorities  coordinate  health  security  efforts 
within their regions, implementing regional emergency and crisis/contingency plans. 

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Comprehensive mapping of identified entities 

Ministry of Health 
The Ministry of Health of Czechia holds a multifaceted role in managing various aspects of public health, 
particularly during crises.  

Monitoring, Intelligence Gathering, and Analysis 
One of its primary responsibilities lies in monitoring the health status of the population. This involves 
tracking  and  analysing  health  data,  trends,  and  disease  outbreaks  to  swiftly  identify  any  emerging 
threats  or  potential  crises  as  well  as  medical  countermeasures  to  tackle  them.  Through  continuous 
monitoring, the Ministry can proactively respond to health challenges, directing resources where they 
are  most  needed.  The  Ministry  has  competences  in  collecting  data  from  various  sources,  such  as 
hospitals,  clinics,  laboratories,  and  international  health  organisations.  The  Ministry  analyses  this 
information to gain insights into the current health landscape, predict future trends and assess potential 
risks.  This  intelligence  forms  the  basis  for  strategic  decision-making  in  health  crisis  management, 
including the purchasing, stocking and distribution of MCMs. 

Advanced Research and Development Capacities 
The Ministry plays a role in fostering innovation and research within the healthcare sector. This includes 
supporting  and  funding  research  initiatives  aimed  at  developing  new  medical  technologies, 
countermeasures, treatments, and preventive measures. By investing in research and development, 
the Ministry aims to enhance the country's preparedness for health emergencies. 

Production/Manufacturing Capacities 
Regarding  production  and  manufacturing  of  MCMs,  the  Ministry  oversees  and  regulates  these 
processes. This ensures that MCMs meet quality standards, are readily available when needed, and 
are produced in sufficient quantities to meet demand during a crisis. The Ministry works in collaboration 
with manufacturers to ensure a reliable supply chain. The Ministry cooperates in supporting production 
and manufacturing capacities with the State Institute for Drug Control (SUKL). By monitoring production 
facilities, SUKL helps to maintain the integrity of the pharmaceutical supply chain. 

125 

 
 
 
 
 
 
 
 
Procurement of MCMs 
Procurement of MCMs is a responsibility of the Ministry. It engages in public procurement processes to 
acquire essential medical supplies, equipment, and medications. This includes negotiating contracts 
with suppliers, managing inventory, and distributing resources to healthcare facilities across the country. 
The  Ministry's  procurement  efforts  are  aimed  at  securing  timely  access  to  critical  resources  during 
health emergencies. 

Stockpiling and Distribution Capacities 
The Ministry maintains strategic stockpiles of essential medical supplies and MCMs. These stockpiles 
are strategically located to ensure rapid deployment in response to emergencies. The Ministry develops 
distribution  plans  to  efficiently  deliver  these  resources  to  affected  areas,  collaborating  with  regional 
authorities and healthcare facilities to coordinate distribution efforts. 

International Cooperation 
The  Ministry  plays  a  key  role  in  fostering  collaboration  with  international  partners.  This  includes 
participating in global health initiatives, sharing information and best practices, and engaging in joint 
research and response efforts. By collaborating with other countries and international organisations, 
Czechia's  Ministry  of  Health  strengthens  its  preparedness  and  response  capabilities.  Together  with 
SUKL, the Ministry contributes to address shortages of medicinal products at the EU level. 

Health Security Coordination 
When regional capacities are overwhelmed during crisis, the Ministry assumes a central coordinating 
role. It can take over the coordination of health services upon request from regional authorities. This 
involves deploying resources, personnel, and expertise to manage the crisis effectively. The Ministry's 
central authority in health crisis management ensures a unified and coordinated response to protect 
public health. 

Regional Public Health Authorities 
Regional Public Health Authorities manage health emergencies primarily at the regional level. They use 
regional emergency and crisis/contingency plans, and providers of health services in these regions are 
required  to  have  a  mass  casualty  plan.  Regional  authorities  are  also  responsible  for  local 
implementation of the tracing program during a pandemic.  

Monitoring, Intelligence Gathering, and Analysis 
Regional authorities are tasked with continuously monitoring the health status of the population within 
their regions. This involves collecting and analysing health data, disease trends, and emerging health 
threats, as well as the need for countermeasures. Through this ongoing monitoring, regional authorities 
can detect any deviations from normal health patterns, enabling them to respond promptly to potential 
health emergencies.  

Procurement of MCMs 
Regional authorities cooperate with the Ministry of Health in procurement of MCMs for their jurisdictions. 

Stockpiling and Distribution Capacities 
Regional authorities cooperate with the Ministry of Health in managing regional stockpiles. 

Health Security Coordination 
Regional authorities coordinate health security efforts within their regions with the Ministry of Health, 
including  implementing  regional  emergency  and  crisis/contingency  plans.  During  the  COVID-19 
pandemic,  the  challenges  arising  from  limited  guidance  from  the  central  authority  underscored  the 
importance  of  effective  health  security  coordination  at  the  regional  level.  Regional  authorities  must 

126 

 
 
 
 
 
 
 
 
 
ensure that resources, including medical countermeasures, personnel, and information are efficiently 
managed to protect public health within their jurisdictions.

127 

 
 
 
g. Denmark 

Overview of approach to preparedness and response to public health emergency in MCMs 

Monitoring, Intelligence Gathering, and Analysis 
In Denmark, the Ministry of Health holds the overall responsibility for monitoring the health landscape 
to  identify  potential  risks  and  vulnerabilities,  in  cooperation  with  regions’  health  authorities.  This  is 
achieved  through  continuous  coordination  with  key  agencies  such  as  the  Danish  Health  Authority, 
Statens Serum Institute (SSI), and the Danish Medicine Agency. These entities collect data on disease 
trends,  healthcare  capacity,  emerging  health  challenges,  and  identify  countermeasures.  AMGROS 
engages in monitoring to stay updated on medicine needs and shortages. The Danish Health Authority 
provides  preparedness  planning  and  threat  modelling,  while  SSI  focuses  on  infectious  disease 
surveillance.  

Advanced Research and Development Capacities 
Danish  regions  support  R&D  by  fostering  innovation  through  investments  in  research  projects  and 
collaborations with universities and research institutions on MCMs. SSI plays a critical role in vaccine 
development. 

Production / Manufacturing Capacities 
The Ministry of Health collaborates with the Danish Medicines Agency and the Danish Critical Supply 
Agency  (SFOS)  to  secure  production  capacities.  AMGROS  manages  registrations  for  medicines 
produced by hospital pharmacies and owns marketing authorizations for products tailored to Danish 
hospitals’ specific needs. SFOS conducts analyses to identify strategic dependencies in supply chains 
and ensures the availability of critical medical supplies during emergencies. 

Procurement of MCMs 
The procurement of MCMs is a collaborative effort involving the Ministry of Health, the regions, Danish 
Health  Authority,  SSI,  AMGROS,  and  SFOS.  Regions  and  municipalities  handle  day-to-day 
procurement,  while  the  Ministry  coordinates  national  procurement  processes  when  necessary. 
AMGROS secures essential products at the best price through negotiation and tendering procedures, 
ensuring hospitals have access to diverse medicines. SFOS manages public procurement processes 
for essential medical supplies and equipment, ensuring timely acquisition during health emergencies. 

Stockpiling and Distribution Capacities 
Stockpiling and distribution capacities are managed through coordinated efforts between the Ministry 
of  Health,  AMGROS,  SSI,  SFOS,  and  Danish  regions.  AMGROS  established  a  dynamic  National 
Strategic Warehouse in 2023, ensuring the availability of treatment-critical and supply-critical medicines. 
SFOS  maintains  strategic  stockpiles,  including  a  rescEU  emergency  stockpile,  to  facilitate  rapid 
distribution  during  crises.  The  Ministry  provides  strategic  direction  for  stockpiling  priorities,  ensuring 
adequate reserves are maintained for emergency response, ensured by regions in their territories. SSI 
ensures efficient distribution of vaccines and rare antisera to healthcare providers. 

International Cooperation 
The Ministry of Health engages with organisations such as the EU, WHO, NATO, and the Nordic Council 
of  Ministers  to  share  best  practices  and  coordinate  responses  to  global  health  threats.  The  Danish 
Health  Authority  represents  Denmark  in  international  forums,  coordinating  with  the  ECDC  and 
implementing International Health Regulations (IHR). SSI collaborates with WHO and ECDC on vaccine 
research and participates in European training programs. AMGROS is part of the Critical Medicines 
Alliance  and  collaborates  with  the  Nordic  Pharmaceutical  Forum,  enhancing  global  health  security 
through shared knowledge and practices. 

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Health Security Coordination 
Health security coordination in Denmark involves the Ministry of Health, Danish Health Authority, SFOS, 
and  regional  authorities.  During  crises,  the  Ministry  assumes  a  supervisory  role,  aligning  strategies 
across  sectors.  The  Danish  Health  Authority  coordinates  national  and  international  public  health 
emergency responses, issuing guidelines for disease management and contact tracing. SFOS provides 
guidance  on  supply  chain  management,  ensuring  critical  supplies  are  available  and  efficiently 
distributed.  Danish  regions  implement  emergency  plans,  manage  healthcare  resources,  and  work 
closely with national health authorities to ensure a unified response to health emergencies.  

Comprehensive mapping of identified entities 

Ministry of the Interior and Health 
The Ministry of Health in Denmark holds the overall political responsibility concerning health matters in 
the  country.  It  is  tasked  with  health  preparedness  and  prevention,  developing  policies,  and  guiding 
principles to ensure the Danish health system's readiness for potential crises.  

Monitoring, Intelligence Gathering, and Analysis 
The Ministry's role involves continuous assessment of the health landscape to identify potential risks 
and vulnerabilities. Coordinating with key agencies such as the Danish Health Authority, Statens Serum 
Institut (SSI), and the Danish Medicine Agency, the Ministry gathers data on disease trends, healthcare 
capacity,  emerging  health  challenges  as  well  as  the  countermeasures  needed  to  tackle  them.  This 
intelligence is analysed to inform policies and strategies for effective crisis management and response, 
including the identification and management of MCMs. 

Production/Manufacturing Capacities 
In coordination with the Danish Medicines Agency and the Danish Critical Supply Agency, the Ministry 
supports and secures production and manufacturing capacities with regards to MCMs in Denmark. 

Procurement of MCMs 
Actors with responsibility for day-to-day operations in the health sector (e.g. regions and municipalities) 
are responsible for MCM procurement in their own area. In cases where there is need of a national 
procurement  process  and  funding,  the  procurement  of  MCMs  is  coordinated  by  the  Ministry,  in 
consultation  with  key  agencies  such  as  the  Danish  Health  Authority,  SSI,  and  the  Danish  Medicine 
Agency. These agencies provide recommendations on MCMs, including whether to procure, quantities 
needed, and specific n health aspects of the products. The Ministry's role ensures a unified approach 

129 

 
 
 
 
 
 
 
 
and effective utilization of resources during health emergencies. Typically, regions and municipalities 
are  responsible  for  MCM  procurement  in  their  areas.  However,  in  cases  requiring  a  national 
procurement process, the Ministry of Health and the Interior coordinate this process. 

Stockpiling and Distribution Capacities 
The Ministry's coordination efforts in stockpiling and distribution of MCMs extend to entities such as 
AMGROS and the Danish Critical Supply Agency. These organisations manage stockpiles of essential 
medical supplies and MCMs, ensuring their availability in times of crisis. The Ministry provides strategic 
direction and guidance on stockpiling priorities, working collaboratively to maintain adequate reserves 
for emergency response. 

International Cooperation 
The  Ministry  engages  with  organisations  such  as  the  EU,  WHO,  NATO,  and  The  Nordic  Council  of 
Ministers.  Participating  in  international  forums  allows  Denmark  to  share  best  practices,  exchange 
information,  and  coordinate  responses 
to  medical 
countermeasures. 

threats  with  regards 

to  global  health 

Health Security Coordination 
During crises, the Ministry assumes an overarching supervisory role, aligning strategies and actions 
across various sectors and agencies. Directing and coordinating the activities of the regions, Danish 
Health Authority, SSI, and the Danish Medicine Agency, the Ministry fosters synergy between these 
entities for efficient crisis management. This coordination ensures a unified and effective response to 
health emergencies, safeguarding public health. 

AMGROS 
AMGROS, an organisation owned by the Danish Regions, plays a vital role in ensuring the availability 
of  medicines  for  patients  at  public  hospitals  in  Denmark.  Focused  on  securing  stable  supplies  of 
medicines, AMGROS operates under the main areas of Negotiation, Tendering Procedures, and Supply. 

Monitoring, Intelligence Gathering, and Analysis 
AMGROS engages in monitoring and intelligence gathering to stay updated with medicine needs and 
shortages.  This  proactive  approach  enables  the  organisation  to  monitor  trends  in  medicine  usage, 
potential  shortages,  and  emerging  needs  within  the  healthcare  system.  AMGROS  contributes  to 
identifying critical medicines for the national list, as well as to the discussion on the prioritization of the 
number of critical medicines on stock. 

Production/Manufacturing Capacities 
AMGROS contributes to securing production and manufacturing capacities in Denmark by managing 
registrations  for  medicines  produced  by  the  hospital  pharmacies.  AMGROS  owns  the  marketing 
authorizations for a product line exclusively for Danish hospitals. Such products are relevant as they 
cover  special  requirements  at  Danish  hospitals.  They  are  usually  small  and  typically  commercially 
unappealing for other medicines companies. They are manufactured at hospital pharmacies in two out 
of five regions in Denmark, and they are an element in the security of supply for hospitals. Furthermore, 
AMGROS has a close collaboration with hospital pharmacies, which are important as they can produce 
magistral pharmaceuticals also in time of crisis. 

Procurement of MCMs 
AMGROS's  primary  purpose  within  the  area  of  procurement  of  MCMs  is  to  secure  these  essential 
products at the best price. It plays a crucial role in coordinating the supply of medicines, whether they 
are  procured  externally  or  produced  at  hospital  pharmacies.  AMGROS  ensures  that  hospitals  have 
access  to  a  diverse  range  of  medicines  through  efficient  supply  chain  management.  Through 
Negotiation  and  Tendering  Procedures,  AMGROS  procures  for  strategic  stockpiles  and  handles 

130 

 
 
 
 
 
 
 
 
backorders  in  general,  on  the  basis  of  the  monitoring  of  potential  emergencies  and  stockout  crises 
nationally  and  internationally.  AMGROS  primarily  handles  the  procurement  of  treatment-critical  and 
especially supply-critical medicine for the National Strategic Warehouse.  

Stockpiling and Distribution Capacities 
AMGROS ensures the timely and efficient distribution of medicines to public hospitals in Denmark. In 
close  cooperation  with  hospital  pharmacies,  AMGROS  established  in  2023  a  dynamic  National 
Strategic Warehouse to stock countermeasures including treatment-critical and supply-critical medicine 
covering the entire country. These countermeasures are distributed to hospital pharmacies upon their 
request and demand locally. In times of crisis urgent orders from hospital pharmacies are dispatched 
within a few hours. 

International Cooperation 
AMGROS is part of the Critical Medicines Alliance, collaborates with the Nordic Pharmaceutical Forum 
and shares experience with delegations from around the world on their procurement set-up and the 
work on security of supply. 

Danish Health Authority 
The Danish Health Authority serves as the top-tier body overseeing emergency preparedness within 
the Danish health sector, playing a critical role in the nation's readiness for health crises. It is an integral 
part of the national cross-sectoral contingency plan, which outlines steps and measures to mitigate and 
restore  normal  operations  during  various  emergencies,  including  health  crises,  infrastructure 
disruptions, and weather-related events. 

Monitoring, Intelligence Gathering, and Analysis 
The Danish Health Authority is the overall responsible authority with regards to preparedness planning 
within the health care sector. As such the authority advises both the health sector, government and 
other  agencies  on  health  preparedness  planning  and  has  a  coordinating  role  with  regards  to  threat 
modeling, prioritization and awareness related to all health crises. Regarding MCMs, the Danish Health 
Authority typically gathers and evaluates information from risk assessments and surveillance provided 
by specialized agencies and, on the basis of this information, develops a basis for political level decision 
making on procurement as well as guidelines for the use of MCMs. 

Procurement of MCMs 
The  Danish  Health  Authority  advises  the  Ministry  on  health  aspects  of  MCMs,  providing 
recommendations  and  guidance  on  procurement  decisions.  In  cases  where  a  national  procurement 
process and funding are needed, the authority provides recommendations for or against procurement, 
quantities needed, and guidelines for their use.  

International Cooperation 
The Danish Health Authority is actively involved in international cooperation on health security matters. 
It  represents  Denmark  in  the  Health  Security  Committee,  coordinates  the  implementation  of 
International Health Regulations (IHR) in Denmark, and serves as the Coordinating Competent Body 
for Danish collaboration with the European Centre for Disease Prevention and Control (ECDC). The 
authority  advises  the  Danish  government  on  pandemic  agreements,  amendments  to  the  IHR,  and 
collaborates  extensively  with  counterparts  in  other  Nordic  countries.  This  international  collaboration 
strengthens Denmark's health security efforts and fosters a global response against health threats. 

Health Security Coordination 
The  Danish  Health  Authority  has  a  national  responsibility  for  coordinating  national  and  international 
public health emergencies both within the health sector as well as across sectors, whereas the operative 
and executive role lies with the 5 health care regions and the 98 municipalities. It issues guidelines for 

131 

 
 
 
 
 
 
 
 
disease management, contact tracing, and provides information to the public and advice to government 
agencies. The authority coordinates with regions, municipalities, and government agencies to ensure a 
unified response. As such The Danish Health Authority is also representing the health care sector in 
the national system for crisis management in Denmark.  

Statens Serum Institut (SSI) 
Statens Serum Institut (SSI) is a pivotal institution in Denmark responsible for a wide range of tasks 
related to infectious disease surveillance, vaccine development, procurement and distribution, as well 
as international collaboration for health security. 

Monitoring, Intelligence Gathering and Analysis 
SSI plays a role in monitoring, intelligence gathering and analysis on medical countermeasures, with 
regards to vaccines, their use, uptake and effectiveness to combat infectious diseases. 

Advanced Research and Development Capacities 
With  a  dedicated  Vaccine  Development  Department,  SSI  engages  in  R&D  for  new  vaccines.  The 
institute  focuses  on  developing  vaccines  against  diseases  such  as  tuberculosis  and  chlamydia, 
evaluating  their  effects  before  marketing.  SSI's  research  in  vaccine  development  contributes  to 
expanding  the  arsenal  of  preventive  measures  against  infectious  diseases,  enhancing  public  health 
outcomes. 

Procurement of MCMs 
SSI is responsible for the procurement of vaccines included in the national vaccination programs. This 
responsibility ensures that Denmark has access to essential vaccines for its population. By overseeing 
the  procurement  process,  SSI  contributes  to  the  availability  and  accessibility  of  vaccines  critical  for 
disease prevention. 

Stockpiling and Distribution Capacities 
SSI's role includes the distribution of vaccines and rare antisera. The institute's responsibility for vaccine 
procurement extends to ensuring the efficient distribution of vaccines to healthcare providers across 
Denmark. This ensures that vaccines reach those who need them, contributing to the country's public 
health efforts. 

International Cooperation 
SSI  is  involved  internationally,  particularly  in  research  activities  related  to  vaccine  development, 
effectiveness, and safety studies. The institute collaborates with organisations such as the World Health 
Organisation  (WHO)  and  the  European  Centre  for  Disease  Prevention  and  Control  (ECDC).  SSI's 
participation in the European EPIET and EUPHEM training programs demonstrates its commitment to 
capacity-building and knowledge sharing in infectious disease epidemiology. Additionally, SSI serves 
as  Denmark's  National  Focal  Points  for  the  Early  Warning  and  Response  System  (EWRS)  and  the 
International Health Regulations (IHR), highlighting its crucial role in global health security. 

Danish Medicine Agency (DKMA) 
As part of the health preparedness under the Danish Health Agency, the Danish Medicines Agency 
(DKMA) is responsible for ensuring the control and security of the supply of medicines. This includes 
maintaining a steady and uninterrupted stream of medicines during a crisis, anticipating and meeting 
changed requirements for consumption, supply, and distribution of drugs and medical devices in case 
of a public health emergency. 

Production/Manufacturing Capacities 
DKMA's  responsibilities  in  monitoring  and  intelligence  gathering  are  crucial  for  anticipating  and 
responding  to  potential  shortages  of  medical  products.  Within  the  legal  framework  of  "Drug 

132 

 
 
 
 
 
 
 
 
 
Preparedness" (Lægemiddelberedskabet), DKMA has various options for actions such as redistribution 
or  build-up  of  stocks.  By  monitoring  supply  chains,  consumption  trends,  and  potential  risks,  DKMA 
ensures the availability of essential medicines during emergencies. 

Stockpiling and Distribution Capacities 
Within  the  framework  of  "Drug  Preparedness"  (Lægemiddelberedskabet),  DKMA  has  the  option  to 
stockpile  essential  medicines and medical  devices  to  ensure  rapid  deployment  during  emergencies. 
DKMA's role in monitoring supply chains and anticipating changes in demand contributes to efficient 
stockpiling and distribution strategies. 

International Cooperation 
DKMA's  participation  in  the  Medicine  Shortages  Steering  Group  (MSSG)  and  Medicine  Shortages 
Single  Point  of  Contact  Working  Party  (MS  SPOC  WP)  indicates  its  involvement  in  international 
cooperation  related  to  medical  products.  This  collaboration  allows  DKMA  to  share  best  practices, 
exchange  information  on  regulatory  standards,  and  coordinate  responses  to  international  health 
emergencies. Additionally, as part of the health preparedness under the Danish Health Agency, DKMA 
likely collaborates with international organisations such as the World Health Organisation (WHO) and 
the European Medicines Agency (EMA) to ensure alignment with global health standards. 

Danish Critical Supply Agency (SFOS) 
The Danish Critical Supply Agency (Styrelsen for Forsyningssikkerhed, SFOS) plays several roles in 
ensuring the robustness of Denmark's supply chains for medical countermeasures.  

Production / Manufacturing Capacities 
SFOS  conducts  analyses  to  identify  strategic  dependencies  and  vulnerabilities  in  Denmark’s  supply 
chains. This includes assessing the risks associated with relying on imports for critical supplies and 
performing scenario analyses to predict potential shortages. This ensures that critical medical supplies 
meet the necessary standards and are available in sufficient quantities during emergencies. 

Procurement of MCMs 
SFOS is actively involved in the procurement of MCMs, managing public procurement processes to 
secure essential medical supplies, equipment, and medications. It negotiates contracts with suppliers 
and coordinates with other state agencies to ensure the timely acquisition of these resources during 
health emergencies. 

Stockpiling and Distribution Capacities  
SFOS maintains strategic stockpiles of essential medical supplies and MCMs. It manages a rescEU 
emergency stockpile, which includes vast quantities of personal protective equipment and other critical 
medical supplies. These stockpiles are strategically located to facilitate rapid distribution during crises. 

Health Security Coordination 
SFOS  plays  a  central  role  in  health  security  coordination  by  working  with  various  governmental 
agencies to implement strategies and contingency plans for supply chain management during crises. It 
provides guidance and support to ensure that critical supplies are available and distributed efficiently 
across the healthcare system during emergencies. 

Danish Regions 
The Danish healthcare system, managed by regional authorities, plays a pivotal role in health security 
and MCMs. The regions are involved in monitoring health data, supporting research and development, 
managing the procurement and stockpiling of medical supplies, and ensuring their distribution during 
crises.  They  also  engage  in  international  cooperation  and  coordinate  health  security  measures  with 
national authorities. 

133 

 
 
 
 
 
 
 
 
 
Monitoring, Intelligence Gathering, and Analysis  
Danish regions collect and analyse health information from hospitals and other healthcare facilities to 
identify trends, potential health threats and countermeasures in cooperation with national level entities. 
This data collection is crucial for understanding the spread of diseases and the effectiveness of MCMs. 
Additionally,  regions  collaborate  with  national  health  authorities  to  share  insights  and  ensure  a 
coordinated response to health emergencies. 

Advanced Research and Development Capacities 
Danish regions support advanced research and development in healthcare through initiatives that foster 
innovation. This includes investing in research projects and collaborating with universities and research 
institutions to develop new medical technologies and treatments.  

Procurement of MCMs 
Danish regions manage the acquisition of medical supplies, equipment, and medications needed for 
healthcare facilities in their territories. This includes negotiating contracts with suppliers and ensuring 
that the necessary resources are available to meet the demands during health emergencies. Regions 
work  closely  with  the  national  government  to  streamline  procurement  processes  and  ensure  timely 
delivery of critical medical supplies. 

Stockpiling and Distribution Capacities  
Regions in Denmark maintain strategic stockpiles of essential medical supplies and MCMs locally. They 
are responsible for ensuring that these stockpiles are adequately managed and readily available for 
distribution  during  health  crises.  The  regions  develop  distribution  plans  to  deliver  these  resources 
efficiently  to  healthcare  facilities,  ensuring  that  the  healthcare  system  can  respond  promptly  to 
emergencies. 

Health Security Coordination 
Danish regions play a crucial role in health security coordination, particularly in the implementation of 
emergency plans and the management of healthcare resources. They work closely with national health 
authorities to ensure a unified and effective response to health emergencies. This includes coordinating 
the  distribution  of  MCMs,  managing  healthcare  personnel,  and  implementing  contingency  plans  to 
maintain health security during crises. 

134 

 
 
 
 
 
 
 
 
h. Estonia 

Overview of approach to preparedness and response to public health emergency in MCMs 

Monitoring, Intelligence Gathering, and Analysis 
In  Estonia,  the  Ministry  of  Social  Affairs  (MoSA)  oversees  monitoring  and  intelligence  gathering  on 
MCMs  through  the  Health  Board.  Additionally,  the  State  Agency  for  Medicines  (SAM)  coordinates 
pharmacovigilance efforts, gathering and analyzing public health data to ensure the safety and efficacy 
of medicines.  

Advanced Research and Development Capacities 
The  MoSA  supports  research,  development,  and  innovation  in  MCMs  through  collaboration  with 
national  and  international  institutions.  Key  research  activities  are  conducted  by  major  Estonian 
universities on various components of emergency response, including laboratory diagnostics, vaccines, 
and medical technology. 

Production / Manufacturing Capacities 
Estonia’s  production  and  manufacturing  capacities  for  MCMs  involve  collaboration  between  various 
agencies. The Estonian Stockpiling Agency (ESA) oversees the production capacities and seeks supply 
solutions during shortages, working closely with SAM for medicines. SAM ensures the availability and 
quality of medicines, particularly during health emergencies.  

Procurement of MCMs 
Procurement of MCMs in Estonia is managed by multiple entities. The Department of Communicable 
Diseases of MoSA assesses the need for vaccines and other MCMs based on epidemiological data. 
The Estonian Health Insurance Fund (EHIF) handles the procurement of vaccines in the immunization 
program, while the Health Board Crises Department manages other MCM procurements. ESA is also 
entrusted  with  procuring  MCMs  for  the  national  stockpile.  During  cross-border  crises,  Estonia 
participates in joint procurement initiatives with European counterparts.  

Stockpiling and Distribution Capacities 
Estonia's stockpiling and distribution of MCMs are managed by several organisations. The Health Board 
maintains  a  stockpile  of  vaccines  and  hospital  drugs.  SAM  initiates  the  deployment  of  the  national 
stockpile of medicines through pharmacies and can mitigate handling requirements during crises. ESA 
oversees strategic reserves of essential supplies, managing the acquisition, storage, and distribution of 
critical  items.  EHIF  is  responsible  for  the  storage  and  distribution  of  vaccines  in  the  immunization 
program. 

International Cooperation 
The Health Board handles the early warning and response system of the ECDC and liaises with the 
international  health  regulations.  The  Department  of 
WHO  and  European  Commission  on 
Communicable Diseases Epidemiology contributes data to ECDC, WHO, and other networks, sharing 
information on infectious diseases and vaccination coverage. SAM collaborates internationally through 
pharmacovigilance  communication  channels  and  participates  in  EU  health  initiatives,  ensuring 
alignment with global health standards and best practices. 

Health Security Coordination 
Health security coordination in Estonia involves all key entities being involved in crisis management. 
The Health Board has the responsibility for activating the emergency response plan coordinates the 
implementation of emergency measures across the various entities.  

135 

 
 
 
 
 
 
 
 
 
 
Comprehensive mapping of identified entities 

Ministry of Social Affairs – Health Board (MoSA) 
The Ministry of Social Affairs (MoSA) plays a pivotal role in Estonia's public health landscape. With a 
focus on surveillance, prevention, and control of communicable diseases (through its "Department of 
Communicable Disease"), it contributes significant resources to minimizing the spread and impact of 
diseases within the Estonian population. Besides, it performs risk analyses in epidemiology, providing 
data-driven  insights  into  potential  health  threats,  and  enacting  policies  to  control  them.  In  terms  of 
MCMs  preparedness,  it  keeps  a  stockpile  of  vaccines  and  hospital  drugs  on  hand,  aiding  in  rapid 
response to public health emergencies or outbreaks. 

Monitoring, Intelligence Gathering and Analysis 
The Health Board Department of Communicable Diseases Epidemiology is responsible for infectious 
diseases  monitoring  and  surveillance,  epidemic  intelligence  and  analysis,  risk  assessments  and 
prognosis and managing regional outbreaks together with the Health Board regional departments. The 
department advises on infectious diseases control and prevention measures, including the identification 
of MCMs, and gives recommendations and guidelines to the public and health-care institutions. The 
department  has  expertise  also  in  immunization  and  vaccine  preventable  diseases  and  gives 
recommendations  and  guidelines  on  immunization.  In  case  of  outbreaks  the  necessity  of  rapid 
immunization of close contacts or specific groups is being assessed and organised together with the 
Estonian Health Insurance Fund. 

Advanced Research and Development Capacities 
The  MoSA  has  a  department  for  supporting  research,  development  and  innovations  on  MCMs  and 
promotes  cooperation  with  other  national  and  international  institutions  on  this  matter.  Research  on 
various  components  of  emergency  response  (e.g.,  laboratory  diagnostics,  vaccines,  medical 
technology)  is carried out by the main universities, e.g. Tallinn University, TalTech, University of Tartu 
and academy of Security Sciences. 

Procurement of MCMS 
The Department of Communicable Diseases of MoSA gives input about the need and assesses the 
need of procurement of vaccines and other MCMs with the regards to the epidemiological situation. The 
procurements  are  done  either  by  the  Estonian  Health  Insurance  Fund  (mainly  vaccines  in  the 
immunization program) or the Health Board Crises Department. In case of cross-border crisis situation, 
the government of Estonia together with other European counterparts participates in joint procurement 
initiatives.  

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Stockpiling and distribution capacities:  
Health  care  stocks  in  Estonia  are  divided  into  several  separate  types  of  stockpiles  and  their 
management is organised by several organisations in Estonia. The Health Board, on behalf of MoSA, 
keeps a stockpile of vaccines and hospital drugs. For the health care sector, the state's operational 
stocks  include  medicines,  medical  equipment  and  supplies  to  ensure  unavoidable  assistance  to 
hospitals  and  ambulance  services.  30  days  of  physical  stock  availability  is  the  goal  set  for  stock 
availability. The HB deals daily with supplementing and updating the nomenclature and quantities of 
the  state's  healthcare  stockpile  of  medical  countermeasures.  Decisions  on  distribution  of  medical 
countermeasures during a shortage are taken by the government on the proposal of the authorities the 
agencies responsible for solving the emergency situation.  

International Cooperation:  
The Health Board has to handle the early warning and response system of the European Centre for 
Disease  Prevention  and  Control  in  Estonia.  The  Health  Board  is  the  liaison  body  authorised  by  the 
World Health Organisation and European Commission concerning biological agents in connection with 
the  application  of  international  health  regulations.  The  Department  of  Communicable  Diseases 
Epidemiology  participates  in  international  surveillance  and  preparedness  and  response  and  threat 
detection networks, namely provides data to ECDC, WHO and other networks on infectious diseases 
cases and outbreaks and vaccination coverage. Besides, it shares data through EpiPulse, EWRS and 
EIS. 

Health security coordination:  
The  Department  of  Communicable  Diseases  Epidemiology  carries  out  risk  assessments  about 
infectious diseases threats, creates timely situational overviews and prognoses and advises on control 
measures. 
The health board activates the emergency response plan concerning public health crisis and gives the 
right to implement emergency measures. 

State Agency for Medicines (SAM) 
The State Agency for Medicines (SAM) is focused on pharmacovigilance and regulation of medicines. 
SAM ensures the safety, quality, and efficacy of medicines available in Estonia. Its role extends to the 
verification  and  validation  of  new  drugs,  periodic  review  and  assessment  of  licensed  products,  and 
active  monitoring  for  potential  adverse  reactions.  It  also  regulates  medication  prices,  negotiate 
procurement contracts for MCMs, and monitor market supply during health emergencies. The mission 
also  includes  the  validation,  assessment,  safety  monitoring and  inspection  of the  following research 
areas, potentially of HERA’s concern: 

Monitoring, Intelligence Gathering and Analysis: 
The  State  Agency  for  Medicines  (SAM)  is  in  charge  of  coordinating  pharmacovigilance  efforts  at  a 
national level. It therefore gathers and analysis public health data and share it to the government and 
the Estonian population.  

Procurement of MCMs:  
Given its mandate, the agency contributes to a resilient pharmaceutical supply chain, particularly during 
medical  emergencies  when  demand  may  surge  unexpectedly.  By  ensuring  the  availability  and 
negotiating procurement contracts of necessary medicines, it supports the country's strategy to manage 
MCMs efficiently.  

Stockpiling and distribution capacities:  
SAM is responsible for initiating the deployment of the national stockpile of medicines supplied through 
pharmacies. The agency can also mitigate the requirements for handling medicinal products in crisis 
situations and may restrict the quantity of medicines dispensed from a pharmacy. In case of emergency, 
it may also ban exports. 

137 

 
 
 
 
 
 
 
 
 
International Cooperation:   
SAM is active in international safety surveillance, by collaborating with other Member States through 
pharmacovigilance communication channels (Rapid Alerts, Emerging Safety Issues in the context of 
signal  management).  Besides,  SAM  has  active  representatives  in  Executive  Steering  Group  on 
Shortages and Safety of Medicinal Products (MSSG) and Medicine Shortage Single Point of Contact 
(SPOC) Working Party. It also participates in EU4Health CHESSMEN project’s work package focusing 
on prevention and mitigation of shortages. 

Health security coordination: 
SAM is coordinating health security through the National Pharmacovigilance Committee. The group of 
experts  meets  periodically  in  normal  conditions  and  more  intensively  in  crisis  situations,  with  the 
purpose  of  evaluating  the  causality  of  the  reported  adverse  events.  It  aims  to  detect  and  analyze 
potential safety signals and to propose regulatory procedure or national guidelines. The Committee has 
an advisory prerogative towards the government and major actors of the Greek healthcare system.  

Estonian Stockpiling Agency (ESA) 
The  Estonian  Stockpiling  Agency  (ESA)  is  a  government  organisation  tasked  with  managing  and 
maintaining  strategic  reserves  of  essential  supplies  and  resources  for  use  during  emergencies  and 
crises.  

Production/Manufacturing capacities 
The Estonian Stockpiling Agency, formerly known as the Estonian Oil Stockpiling Agency and originally 
overseen primarily by the Ministry of Climate, has on overview of the production capacities in Estonia. 
If shortages occur, ESA is responsible to seek supply solutions in collaboration with other stakeholders 
like SAM for medicines. 

Procurement of MCMs 
ESA is entrusted with procuring MCMs. Its responsibilities include acquiring vital supplies like Personal 
Protective Equipment (PPE) and managing the contracts of a pharmacy drugs stockpiling (in Estonia a 
delegated stock model is in use). As such, the agency essentially ensures the country's readiness to 
handle health crises effectively.  

Stockpiling and Distribution Capacities 
As  the  central  authority  responsible  for  stockpiling  in  Estonia,  the  agency  oversees,  on  top  of  the 
acquisition, the storage, and distribution of critical items such as food, fuel, and equipment, as well as 
medical supplies and medical countermeasures. 

Estonian Health Insurance Fund (EHIF) 
The main task of the Health Insurance Fund (EHIF) is to organize national health insurance to provide 
insured people with access to necessary healthcare services, medicines, medical equipment and cash 
benefits.  

Procurement of MCMs, Stockpiling and Distribution Capacities 
The EHIF is responsible for procurement, storage, distribution of vaccines in the immunisation program, 
and of financing the vaccination service and vaccinators. In case of an emergency situation the EHIF 
will be responsible for organising rapid vaccinations, mass-vaccinations if necessary, in coordination 
with the Health Board, Ministry of Social Affairs and the State Agency of Medicines.

138 

 
 
 
 
 
 
 
 
 
 
i.  Finland 

Overview of approach to preparedness and response to public health emergency in MCMs 

Monitoring, Intelligence Gathering, and Analysis 
In Finland, the Ministry of Social Affairs and Health (MSAH) oversees strategic planning and direction, 
ensuring municipalities are prepared for public health emergencies. The Finnish Institute for Health and 
Welfare (THL) plays a crucial role in monitoring and intelligence gathering. THL directs and supports 
national surveillance systems for infectious diseases and the national vaccination program. It conducts 
surveillance, evaluates infectious disease threats, identifies countermeasures, and supports outbreak 
investigations.  

Advanced Research and Development Capacities 
Finland’s advanced research and development capacities are bolstered by THL, particularly through its 
Biobank  Laboratory.  THL  supports  R&D  by  providing  professional  support  for  data  selection  and 
interpretation, facilitating research projects that enhance public health responses.  

Production / Manufacturing Capacities 
The National Emergency Supply Agency (NESA) oversees production and manufacturing capacities in 
Finland,  ensuring  local  manufacturing  capabilities  can  be  repurposed  or  scaled  up  during  health 
emergencies. NESA collaborates with the private sector and THL to secure necessary medical supplies.  

Procurement of MCMs 
Procurement of MCMs in Finland involves collaboration between several entities. MSAH coordinates 
the procurement efforts and finances official bodies for this task, including THL, NESA, and  welfare 
counties. NESA acquires medical supplies for preparedness and emergency situations, while THL has 
successfully procured various MCMs through rescEU funding. Additionally, Finland's participation in the 
Joint  Procurement  Agreement  (JPA)  with  other  countries  enhances  collective  procurement  efforts, 
ensuring a robust supply of necessary medical supplies. 

Stockpiling and Distribution Capacities 
Both  NESA  and  THL  play  roles  in  stockpiling  and  distribution  capacities.  NESA  oversees  the 
maintenance  of  national  emergency  stockpiles,  ensuring  critical  materials  are  available  during 
emergencies. It works with companies to ensure steady rotation of goods and coordinates distribution 
to university hospital districts. THL ensures the availability of vaccines for the national immunization 
program and manages the distribution of vaccines through everyday commercial operations and pre-
distribution to regional levels as needed.  

International Cooperation 
MSAH, through its International Affairs Unit, actively participates in international cooperation to shape 
social  welfare  and  healthcare  policies  within  the  EU  and  globally.  The  Ministry  engages  with 
organisations like the UN, WHO, ILO, and the Nordic Council of Ministers, promoting universal policies 
and  social  sustainability.  THL  also  plays  a  significant  role  in  international  cooperation,  coordinating 
projects such as the Joint Action on Strengthened International Health Regulations and Preparedness 
in the EU (SHARP JA). THL collaborates with ECDC, WHO, and other international bodies, enhancing 
Finland's global health security efforts and facilitating knowledge sharing and capacity building. 

Health Security Coordination 
MSAH  is  the  primary  actor  coordinating  health  security  measures  in  Finland.  During  emergencies, 
MSAH establishes a situation room to support sectoral efforts and maintain situational awareness. THL 
provides advisory support for decision-making on public health crises, including recommendations on 

139 

 
 
 
 
 
 
 
 
 
public health measures and vaccine deployment. NESA coordinates with other government agencies 
to manage supply chains and ensure the availability of critical supplies.  

Comprehensive mapping of identified entities 

Ministry of Social Affairs and Health (MSAH) 
The Ministry of Social Affairs and Health (MSAH) in Finland plays an integral role in the country's health 
landscape. The Ministry and its Preparedness Unit plan preparedness at strategic level and prepare 
legislative initiatives. It is tasked with general planning, steering, and providing direction and supervision 
to municipalities for the more practical aspects of the work. MSAH represents a centralized approach, 
where coordination of efforts and resources during special situations and public health emergencies 
concerning social and health care are ensured. It is also responsible for making key decisions regarding 
the use of medical devices and procurement of emergency healthcare supplies.  

Procurement of MCMs: 
MSAH itself does not procure MCMs, but may give orders to and finance official bodies for procurement, 
including the Finnish Institute for Health and Welfare, National Emergency Supply Agency and welfare 
counties. It works in close collaboration with the National Emergency Supply Agency (NESA), deciding 
on  the  use  of  stored  medical  devices  and  materials  and  on  the  procurement  of  emergency  health 
supplies.  After  Finland’s  decision  to  join  the  Joint  Procurement  Agreement  (JPA),  the  Ministry  also 
actively engages in collective procurement efforts with other countries. 

International Cooperation  
MSAH through its International Affairs Unit actively participates in shaping social welfare and healthcare 
policies within the EU and on a global scale, adhering to its obligations as part of the government. It 
champions human rights, gender equality, and the UN's Agenda 2030, advocating for universal policies 
in social welfare and healthcare. 

MSAH's international efforts concentrate on influencing legislation, standards, and policy programs both 
in  the  EU  and  beyond,  ensuring  they  are  implemented,  enforced,  and  reported  on  nationally.  The 
Ministry  bases  its  international  collaborations  on  Finland's  stances  within  the  EU,  the  Government 
Programme,  and  the  ministry's  own  policies.  It  aligns  with  international  commitments  and 

140 

 
 
 
 
 
 
 
recommendations from bodies such as the UN, WHO, the Council of Europe, and the ILO, all in support 
of social sustainability. The Ministry engages in wide-ranging cooperative work through key platforms 
like the EU, UN, WHO, ILO, OECD, Nordic Council of Ministers, Council of Europe, alongside regional 
forums  like  the  Northern  Dimension  Partnership  in  Public  Health  and  Social  Wellbeing  (NDPHS), 
intergovernmental organisations, and councils focusing on the Barents and Baltic regions and the Arctic. 
A  significant  component  of  its  work  involves  coordinating  projects  in  nearby  regions,  particularly  in 
managing communicable diseases. 

Health Security Coordination 
The Ministry of Social Affairs and Health is the main public actor coordinating security measures in case 
of public health measures. The Duty officer of the Ministry is the primary point of contact for welfare 
counties and state officials. During the emergency, a situation room (manning of the situation room is 
formed  depending  on  the  crisis)  is  established  to  support  the  sector  and  maintain  a  situational 
awareness within the government and political decision makers.  

National Emergency Supply Agency (NESA) 
The National Emergency Supply Agency (NESA) in Finland, also known as the National Emergency 
Supply Organisation, operating under the Ministry of Economic Affairs and Employment, serves as a 
critical component of Finland coordination of national emergency supplies and preparedness. NESA's 
key  missions  revolve  around  securing  the  vital  functions  of  society  during  severe  disruptions  and 
emergencies  responsible  for  fire  safety,  rescue  operations,  and  civil  protection  within  Estonia.  It 
manages  emergency  situations  and  aim  to  mitigate  their  impact  on  people,  property,  and  the 
environment. 

Production/Manufacturing capacities:  
NESA oversees the identification of local manufacturing capabilities that could be repurposed or scaled 
up  to  produce  MCMs  during  a  health  emergency,  collaborating  with  the  private  sector  and  other 
government agencies like the Finnish Institute for Health and Welfare (THL). 

Procurement of MCMs:  
NESA is in charge of acquiring medical supplies both for preparedness and emergency situations. It 
works in close collaboration with MSAH, deciding on the use of stored medical devices and materials 
and on the procurement of emergency health supplies.  

related 

Stockpiling and distribution capacities:  
NESA  contributes  significantly  to  Finland's  security  of  supply.  NESA  oversees  the  practical 
arrangements 
to 
to  maintaining national  emergency  stockpiles 
companies) and security  (availability  of  health  care  services)  and  compulsory  (pharmaceuticals) 
stockpiles.  Despite  not  owning  actual  stockpiles,  it  exerts  a  key  influence  by  agreeing  with  relevant 
companies on the amounts to be stockpiled. The Finnish model allows for public-private partnership 
where the products included in stockpiles form part of the regular operations of the companies, ensuring 
a steady and practical rotation of goods. During the pandemic, the distribution of the emergency stocks 
to  the  five  university  hospital  districts  was  carried  out  by  NESA  and  the  districts  coordinated  the 
decentralisation and use of supplies in their own catchment areas based on needs.  

(critical  material 

Finnish Institute for Health and Welfare (THL) 
The Finnish Institute for Health and Welfare (THL) is an expert and research institute that offers insights 
for decision-making and activities in the health and welfare field in Finland. Its pharmaceutical wholesale 
service  ensures  a  steady  supply  of  vaccines  for  the  national  vaccination  programme  in  addition  to 
antibodies  and  research  materials  needed  to  combat  dangerous  or  rare  infectious  diseases.  Its 
dedicated  Department  of  Health  Security  bolsters  Finland's  health  preparedness  and  response 
capabilities, focusing on preventing, combating, and monitoring infection and environmental threats at 
the national level. 

Monitoring, Intelligence Gathering and Analysis: 
THL  is  in  charge  of  preventing,  combating  and  monitoring  infection  and  environmental  threats  on  a 
national  level.  It  directs,  supports  and  develops  national  monitoring  and  surveillance  systems  for 

141 

 
 
 
 
 
 
 
infectious  diseases  and  the  national  vaccination  programme,  conducts  surveillance  of  infectious 
diseases, evaluates infectious disease threats, identifies countermeasures (in this case vaccines) as 
well  as  the  population-level  impacts  of  vaccines.  It  supports  and,  if  necessary,  conducts  outbreak 
investigations and draws up national guidelines for infectious disease control. In addition, THL maintains 
preparedness to diagnose and control serious bacterial and viral diseases that are emerging or rare, 
and  works  as  the  Regional  Reference  Laboratory  for  Polio  (World  Health  Organisation,  WHO),  a 
National Influenza Centre (WHO) and a Measles and Rubella laboratory. 

Advanced Research and Development Capacities:  
THL participates in R&D thank to its Biobank Laboratory. Biobank is a biorepository of both population 
and  disease-specific  research  collections,  which  contain  high-quality  samples  and  data.  The  data 
includes large amount of lifestyle, demographic and physical data added to sample donors and data 
determined from the samples. The entity hosts a large amount of genomic and other omics data and 
can provide professional support for data selection and interpretation.  All samples of the THL Biobank 
belong to a certain research cohort with a specific target group of donors and including a specific set of 
samples, sample- and donor-derived data and collection protocols. The applied biobank material for 
research projects doesn’t have to be limited to a specific collection, and suitable samples and data can 
be requested from the full repository of the THL Biobank. 

Procurement of MCMs:  
THL has procured multiple different MCMs through RescEU funding. Swift procurement is enabled by 
product  specific  procurement  strategy,  including  procurement  types  such  as  public  tenders,  direct 
procurements, and joint procurements.  

Stockpiling and distribution capacities: 
Nationally, THL ensures the availability of vaccines for the national immunization program by reserving 
a  certain  number  of  stockpiled  vaccines.  In  national  preparedness,  the  transportation,  storage  and 
distribution mainly rely on everyday commercial operations. In some cases, pre-distribution to regional 
level might be needed. In international context, especially in rescEU, swift deployment is enabled by 
preplanning  operations  and  sufficient  physical  stockpiles  of  deployment  material  (cold  chain 
transportation boxes, data loggers, and other packing material). THL has created “Donation Agreement” 
-template, to allow sufficient transparency of different responsibilities/liabilities between the receiving 
nation and Finland in the case of medicinal product deployments.  

International Cooperation:  
THL has a long and extensive experience in implementing development cooperation globally. Recently, 
THL coordinated the Joint Action on Strengthened International Health Regulations and Preparedness 
in the EU (SHARP JA), and is currently running an EU Twinning project aiming to strengthen sustainable 
and adequate capacities of the health care system in Serbia to diagnose, monitor, alert and respond to 
communicable diseases, in order to make the health sector more aligned with those of the EU Member 
States as well as to effectively participate in the EU communicable diseases surveillance networks. The 
Institute also arranges international training on the prevention and control of infectious diseases and 
vaccinations and is a part of an international network of authorities that monitors and controls infectious 
diseases (ECDC, WHO).  

Health Security Coordination:  
THL  has  an  advisory  role  for  decision-making  on  the  management  of  public  health  crises,  such  as 
decisions on public health and social measures and deployment and use of vaccines

142 

 
 
 
 
 
 
 
 
j.  France 

Overview of approach to preparedness and response to public health emergency in MCMs 

Monitoring, Intelligence Gathering, and Analysis 
In France, the Ministry of Solidarity and Health (MoSH) plays a central role in health monitoring and 
intelligence gathering. It coordinates with various agencies to implement health monitoring and vigilance 
systems.  Santé  Publique  France  (SpF),  the  national  public  health  agency,  operates  surveillance 
systems  such  as  the  French  National  Public  Health  Surveillance  System  (SSP),  monitoring  health 
indicators  including  infectious  diseases,  environmental  health  hazards,  and  health  behaviours.  The 
Institute  Pasteur  contributes  by  conducting  epidemiological  surveillance  and  developing  predictive 
models during pandemics. The Haut Conseil de la Santé Publique (HCSP) also actively monitors and 
analyses public health data, providing scientific guidance for public health strategies. 

Advanced Research and Development Capacities 
France's advanced research and development capacities are supported by ANRS - Emerging Infectious 
Diseases (ANRS MIE) and the Institute Pasteur. ANRS MIE facilitates and funds research on infectious 
diseases, boosting health innovation and early development of medical countermeasures. The Institute 
Pasteur conducts research to develop treatments and vaccines, having developed the first PCR tests 
and a COVID-19 vaccine candidate. 

Production / Manufacturing Capacities 
The Health Innovation Agency (HIA) plays a crucial role in enhancing production and manufacturing 
capacities  for  MCMs.  As  part  of  the  Health  Innovation  Plan  2030,  HIA  finances  factories  producing 
MCMs in France, ensuring the country can scale up production during health emergencies. The National 
Emergency Supply Agency (NESA) oversees local manufacturing capabilities, collaborating with private 
sector entities to secure necessary medical supplies.  

Procurement of MCMs 
The MoSH, through its Direction Générale de la Santé (DGS), is responsible for procuring MCMs. NESA 
works  closely  with  MoSH  to  acquire  medical  supplies  for  preparedness  and  emergency  situations. 
Santé  Publique  France  (SpF)  supports  relevant  authorities  by  providing  scientific  expertise  for  the 
selection,  purchase,  and  distribution  of  MCMs.  The  Ministry  of  the  Interior  (MoI)  also  adheres  to 
guidelines from MoSH and SGDSN to procure MCMs for civil protection units.  

Stockpiling and Distribution Capacities 
MoSH, in collaboration with SpF and NESA, manages the stockpiling and distribution of MCMs. SpF's 
Pharmaceutical Establishment stores large volumes of medicines and medical devices, ensuring rapid 
delivery throughout the country. NESA oversees the practical arrangements for maintaining national 
emergency stockpiles and coordinates distribution during crises. The Ministry of the Interior contributes 
to logistics, ensuring the availability of general items like PPEs.  

International Cooperation 
The MoSH and DGS are actively involved in international cooperation, participating in initiatives within 
the EU and globally. They engage with organisations such as the WHO, European Commission, and 
the Nordic Council of Ministers. ANRS MIE has developed a vast international network, collaborating 
with partners in low- and middle-income countries and participating in European projects. The Institute 
Pasteur is exposed globally through the Pasteur Network. 

143 

 
 
 
 
 
 
 
 
 
Health Security Coordination 
Health security coordination in France involves multiple entities. MoSH, through its Central Crisis Staff 
(CCS) and Regional Crisis Coordination Units (CORRUSS), drafts emergency plans and coordinates 
the national medical response. The General Secretariat for Defence and National Security (SGDSN) 
oversees  the  national  strategy  for  health  security,  coordinating  government  response  efforts.  The 
Institute Pasteur and HCSP provide expert advice and scientific guidance, ensuring informed decision-
making during crises.  

Comprehensive mapping of identified entities 

Ministry of Solidarity and Health 
The  Ministry  of  Solidarity  and  Health  is  the  engine  of  France’s  health  emergency  preparedness.  In 
addition to developing policy for the prevention, surveillance, and management of risks associated with 
emerging  and  re-emerging  diseases  and  pathogens,  it  is  also  tasked  with  coordinating  the 
implementation of health monitoring and vigilance systems. This entity plays a major role in crafting 
legislative and regulatory texts, as well as contributing to the development of strategic health security 
orientations at national and international levels. 

Procurement of MCMs:  
Within  the  Ministry  of  Solidarity  and  Health  (MoSH),  the  Direction  Générale  de  la  Santé  (DGS)  is 
responsible for the procurement of all types of MCMs.  

Stockpiling and distribution capacities:  
MoSH is in charge with Santé Publique France  (SpF) to manage the use of national stockpiles and 
ensure its rapid and fair distribution, mainly using hospital local hubs or the private classical distribution 
network. Following expert advice, DGS mandates SpF to supply and stockpile relevant MCMs. DGS 
also mandates hospitals to maintain specific stockpiles for crisis response. Besides, DGS coordinates 
the French part of the European rescEU medical stockpiles. 

International Collaboration:  
The Ministry of Solidarity and Health and the DGS are involved in several European and international 
initiatives. Within EU, DGS is directly involved in boards and working groups for DG SANTE, DG HERA 
and  HSC,  and  indirectly  through  agencies  for  EMA  or  ECDC.  DGS  represents  France  (the  French 
representative is the Chief medical officer (CMO) i.e., the head of DGS) in WHO global and regional 
entities and supports diplomatic actions like the Pandemic Treaty.  

144 

 
 
 
 
 
 
 
 
the Central  Crisis  Staff 

Health Security Coordination:  
Within 
(CCS) or Regional  Crisis  Coordination  Units 
the  ministry, 
(CORRUSS) are  elevated  to  a  higher  level  of  readiness.  These  entities,  together  with  DGS,  draft 
emergency  plans  and  coordinate  the  national  medical  response.  MoSH  ensures  that  well-prepared 
plans are swiftly put into action by managing the use of the national stockpiles and its deployment and 
strengthening the resilience of healthcare systems. It collaborates with the government and regional 
actors and is the point of contact regarding countermeasures application in time of health crisis.  

General Secretariat for Defence and National Security (SGDSN) 
The General Secretariat for Defence and National Security (SGDSN) is an interministerial body that 
oversees  the  development  and  implementation  of  security  threats  monitoring  mechanisms,  the 
preparation  of  governmental  emergency  response  plans,  as  well as  the  coordination  of  public  crisis 
management.  Its  wide-ranging  expertise  spans  from  military  programs,  nuclear  deterrence,  internal 
security as part of national security, economic and energy security, counterterrorism, to crisis response 
plans. It offers advice to the government in matters of security and defense and carries out a variety of 
operational tasks ranging from security clearance to cybersecurity. 

Health Security Coordination:  
One of its primary competencies is to oversee the national strategy for health security, ensuring that 
France is adequately prepared to prevent, detect, and respond to various health threats. During the 
COVID-19  pandemic,  the  SGDSN  coordinated  the  government's  response  efforts,  including 
implementing measures to contain the spread of the virus, securing medical equipment and supplies, 
and managing crisis communication. 

ANRS - Emerging Infectious Diseases (ANRS MIE) 
ANRS MIE (Emerging Infectious Diseases), an autonomous agency of Inserm, supports research to 
provide scientific responses to infectious diseases in times of crisis and over the long term. Successor 
to the French National Agency for Research on AIDS and Viral Hepatitis (ANRS) – founded to respond 
to the urgency and extent of the HIV/AIDS epidemic – and to the Inserm REACTing consortium, ANRS 
MIE was created on 1 January 2021. Its purpose is to facilitate, coordinate, evaluate and fund research 
into  HIV/AIDS,  viral  hepatitis,  sexually  transmitted  infections,  tuberculosis,  and  emerging  and  re-
emerging  infectious  diseases,  such  as  COVID-19,  viral  haemorrhagic  fevers  and  arboviruses,  in  all 
areas  of  research:  basic,  translational,  clinical,  public  health,  and  human  and  social  sciences.  It 
operates under the simultaneous auspices of the France’s Ministry of Higher Education and Research 
and Ministry of Health and Prevention. 

Mode of operation:  
ANRS MIE has developed a framework for systematically responding to emerging infectious disease 
epidemics (in France and internationally), based on a gradation of response according to the specific 
features of the emergence: type of pathogen, location, risk of extension, existence or non-existence of 
medical countermeasures. In the event of an emerging or re-emerging epidemic in France or worldwide, 
ANRS MIE can activate a facilitation and watch procedure for a rapid response to health crises. While 
the agency plays a central support role in preparing responses to future infectious threats, it also plays 
a particular role in the French and international scientific landscape in the response to epidemic crises 
that fall within its remit. The Agency uses a multimodal system with three levels of response according 
to the severity of progressive response levels. 

Advanced Research and Development capacities: 
The  ANRS  MIE  is  in  charge  of  the  French  PEPR  (Programme  et  Equipements  Prioritaires  de 
Recherche) on emerging infectious diseases. One of its objectives is to boost health innovation or early 
development  of  innovations.  ANRS  MIE  actively  defines  technology  transfer  instruments  adapted  to 
emergency  situations  and  establishes  a  coordinated  organisation  system  between  innovative 
companies 
institutions, 
innovation/technology transfer organisations, government), and industry (pharmaceutical companies, 
biotech companies, diagnostic companies, and start-ups).  

stakeholders 

laboratories, 

healthcare 

(research 

public 

and 

International Cooperation:  
ANRS  MIE  has  developed  a  vast  international  network  of  multimodal  partnerships.  Historically,  this 
network  has  been  built  up  since  the  1990s,  when  the  agency  was  committed  to  consolidating  and 

145 

 
 
 
 
 
 
 
 
forging  numerous  collaborations  with  its  international  partners  in  low-  and  middle-income  countries 
(LMICs), where French and national research teams worked together on research projects. ANRS MIE 
allocates annual budgets – excluding recurring projects – to support research development and help 
train and build teams over the long term. ANRS MIE is also a member of numerous networks, such as 
GloPID-R, where ANRS MIE facilitates scientific reflexion with international funders on data sharing, 
clinical trial coordination and supporting research in LMICs. 

The ANRS MIE is member of the CSA “Coordination Mechanism for Cohorts and Trials (COMECT)”. 
This project gathers main European cohorts and clinical trial networks: EU Response, Ecraid, the Trial 
Coordination Board (TCB), Vaccelerate, the Cohorts Coordination Board and ECRIN. The purpose of 
COMECT is to enhance Europe’s clinical research preparedness and response capacity to infectious 
disease (ID) outbreaks with epidemic potential through sustained strategic and scientific coordination 
of  adaptive  platform  trials  and  cohort  studies.  The  ANRS  MIE  oversees  the  design  of  the  Outbreak 
Response Board (ORB) which will design criteria to help MS and EC to decide when to fund emergency 
clinical research.  

The  ANRS  MIE  is  coordinating  the  European  Coordinated  and  Support  Action  (CSA)  “Building  a 
European strategic Research and Innovation Area in Direct Synergy with EU and International Initiatives 
for Pandemic Preparedness (BE READY)”. BE READY gathers 26 institutions from 16 European and 
associated countries. BE READY aims on laying the preparatory groundwork for the foundation of the 
future European Partnership for Pandemic Preparedness.  

At international level, the ANRS MIE is participating in the Joint Undertaking EDCTP3 and ensures the 
Secretariat  of  the  French  mirror  group  of  the  Joint  Undertaking  .  In  this  position  the  ANRS  MIE 
contributes  to  reinforce  the  collaborations  within  teams  in  the  EU  and  partner  countries  in  clinical 
research and provides support for low and middle-income countries. 

Ministry of Interior 
The Ministry of Interior (MoI) is involved and usually leader for general crisis management at national 
level  (security,  local  authorities’  involvement,  logistics,  etc.).  Regarding  public  health  crisis,  it  works 
alongside the Ministry of Solidarity and Health to manage the responsibility of stockpiling necessary 
resources. This includes the storage of medical supplies, drugs, vaccines, and other materials useful 
to combat infectious diseases and other health emergencies.  

Procurement of MCMs :  
The Ministry of the Interior (MoI) adheres to the guidelines provided by the Ministry of Health (MoH) or 
the Secretariat General for Defence and National Security (SGDSN), to acquire all types of Medical 
Countermeasures used by civil protection units. 

Stockpiling and distribution capacities: 
MoI  is  not  involved  in  the  distribution of  medicines  because  the  pharmaceutical  regulation  does  not 
allow it but the Ministry contributes for the logistics of more general items (e.g. PPEs).  

France Public Health / “Santé Publique France” (SpF) 
France Public Health (SpF) is the national public health agency of France, tasked with safeguarding 
and  promoting  the  health  of  the  population.  As  a  government  agency  under  the  Ministry  of  Health, 
France  Public  Health  plays  a  role  in  shaping  public  health  policies,  conducting  research,  and 
coordinating responses to health threats. Its mission encompasses a wide range of activities, including 
disease surveillance, health promotion, prevention initiatives, and emergency preparedness. 

Monitoring, Intelligence Gathering and Analysis: 
France Public Health employs a variety of specific mechanisms for monitoring, intelligence gathering, 
and analysis to bolster its readiness for public health crises. This includes the operation of surveillance 
systems such as the French National Public Health Surveillance System (Système de Surveillance en 
Santé  Publique  -  SSP),  which  continuously  monitors  a  wide  range  of  health  indicators  including 
infectious  diseases,  environmental  health  hazards,  and  health  behaviours.  During  the  COVID-19 
pandemic, SpF utilized SSP to track the spread of the virus, monitor hospital admissions, and analyze 
demographic and geographic patterns of transmission. 

146 

 
 
  
 
 
 
 
 
 
 
Procurement of MCMs 
SpF plays a crucial role in advising and supporting relevant authorities in their MCM procurement For 
instance, SpF provides scientific expertise to inform decision-making regarding the selection, purchase, 
and distribution of vaccines, antiviral drugs, and other MCMs during public health emergencies such as 
pandemics. SpF is also involved in carrying out purchasing procedures in the event of a crisis, especially 
within very short deadlines. Additionally, SpF contributes to the development of national guidelines and 
strategies for the equitable distribution of MCMs, ensuring that they reach priority populations in a timely 
and efficient manner.  

Stockpiling and distribution capacities 
SpF  is  also  involved  in  the  stockpiling  and  distribution  of  MCMs.  In  specific,  SpF’s  Pharmaceutical 
Establishment  stores  large  volumes  of  medicines,  medical  devices  and  other  health  products  in 
numerous platforms, including overseas. Logistics flows are organized to ensure delivery in less than 
12 hours throughout the country to deliver to pharmacies and hospitals. Its expertise concerns maritime, 
road and air transport in all temperatures. 

International cooperation 
At the request of the central government, SpF participates in international health crises by donating 
equipment, medicines or other health products to other countries. 

Health Innovation Agency (HIA) 
The Health  Innovation  Agency (HIA)  was  established  to coordinate  interministerial  efforts  related  to 
health innovation and promote the emergence, development, and dissemination of such innovations. 
Its responsibilities include driving and monitoring the Health Innovation Plan 2030, anticipating future 
healthcare innovations, accelerating existing processes, and supporting strategic innovative projects. 
Additionally,  the  agency  provides  tailored  support  for  innovative  projects,  regardless  of  their 
development stage. 

Production/Manufacturing capacities:  
HIA participates in financing factories producing MCMs on the French territory as part of the Health 
Innovation Plan 2030. 

Health security coordination:   
ANSM operates under the authority of the Prime Minister's office and leads strategies for responding to 
health crises in France. As part of its mandate, ANSM coordinates with entities like the MoH to develop 
and implement comprehensive response plans to mitigate the impact of public health emergencies. 

High Authority on Health (HAS) 
The High Authority on Health (HAS) in France is the national health authority responsible for evaluating 
the quality, efficacy, and safety of healthcare practices, technologies, and services. Its mission includes 
providing independent recommendations and guidelines to healthcare professionals, policymakers, and 
the public to improve the quality and efficiency of healthcare delivery. 

Monitoring, Intelligence Gathering and Analysis: 
HAS conducts risk assessments and epidemiological surveillance to monitor health threats and identify 
emerging  risks,  as  well  as  countermeasures.  For  example,  during  the  COVID-19  pandemic,  HAS 
actively  tracked  the  spread  of  the  virus,  assessed  its  impact  on  public  health,  and  provided  regular 
updates to inform decision-making. 

Institute Pasteur 
Institute Pasteur is a private, non-profit foundation. Its mission is to help prevent and treat diseases, 
mainly  those  of  infectious  origin,  through  research,  teaching,  and  public  health  initiatives.  Insitute 
Pasteur contributes to the research and development of MCM, conducts epidemiological surveillance 
of infectious diseases, provides capacity-building training, and collaborates with global entities for joint 
research  and  information  sharing.  It  also  provides  expertise  and  advice  during  public  health 
emergencies. 

147 

 
 
 
 
 
 
 
 
 
 
Monitoring, Intelligence Gathering and Analysis: 
The  Institute’s  monitoring,  intelligence  gathering,  and  analysis  efforts  mainly  focus  on  disease 
prevention, identification of treatments and surveillance. Among the Global Health Department, teams 
play  a  role  in  gathering  data  and  to  elaborate  vaccination  during  pandemics  (e.g.,  during  the  Covid 
crisis),  as  well  as  in  overseeing  predictive  models  during  pandemics.  Such  models  support  the 
government in informing the general population.  

Advanced Research and Development Capacities:  
The Institute conducts research to develop countermeasures in order to enhance France’s response 
capacity toward diseases, especially in case of pandemics. This included in the past the development 
of the first PCR tests used in France and of a vaccine candidate for COVID-19. A Technology Transfer 
Department  allows  the  institute  to  scale  up  findings  and  producing  commercial  products  thanks  to 
industrial partners. 

International Cooperation:  
The main tool for Pasteur Institute to collaborate internationally is the Pasteur Network. The Institute 
finances research projects to institute all over the world. The Insitute is represented at the WHO level 
and collaborates with HERA. It also participates in the MediLab Secure project with European partners.  

Health security coordination: 
During  public  health  crisis,  the  Institute  is  in  close  contact  with  the  European  Commission,  Santé 
Publique  France  and  with  the  Prime  Minister's  departments.  It  has  a  leading  advising  role  to  the 
government and is an integral part of the response network in case of health emergency in France. The 
Institute was also represented at the Covid-19 French Scientific Council, which gave scientific inputs to 
the government to shape France’s responsive measures regarding the epidemic.  

High Council for Public Health (HCSP) 
The  High  Council  for  Public  Health  (HCSP)  is  a  French  public  health  advisory  body  established  to 
provide  scientific  expertise  and  recommendations  on  health  policies  and  strategies.  It  advises  the 
government  on  public  health  issues,  evaluates  health  risks,  and  contributes  to  the  development  of 
national health plans. The HCSP is composed of various commissions and expert groups that focus on 
different  areas  of  public  health,  ensuring  a  comprehensive  approach  to  health  security  and  disease 
prevention in France. 

Monitoring, Intelligence Gathering and Analysis 
The  HCSP  actively  monitors  and  analyzes  public  health  data,  focusing  on  infectious  diseases  and 
environmental health risks. They evaluate these risks and provide scientific guidance to inform public 
health  strategies.  This  includes  issuing  advisories  and  reports  based  on  the  latest  health  data  and 
trends. 

the  HCSP  does  not  directly  procure  medical  countermeasures, 

Procurement of MCMs  
While 
issues  detailed 
recommendations and guidelines for their procurement. This includes guidance on essential supplies 
such as personal protective equipment (PPE) and other critical medical resources, particularly during 
public health emergencies like the COVID-19 pandemic. 

it 

Stockpiling and Distribution Capacities  
The HCSP advises on the necessary quantities and types of medical supplies to be stockpiled to ensure 
public  health  safety.  They  provide  strategic  recommendations  on  maintaining  adequate  supplies  of 
masks,  respiratory  protection,  and  other  essential  medical  equipment  to  manage  health  crises 
effectively.

148 

 
 
 
 
 
 
 
 
 
 
k. Germany 

Overview of approach to preparedness and response to public health emergency in MCMs 

Monitoring, Intelligence Gathering and Analysis 
The Federal Ministry of Health (BMG) leads the monitoring and intelligence gathering efforts, working 
closely with the Robert Koch Institute (RKI) to detect, evaluate, and identify countermeasures for health 
threats. The BMG provides recommendations and evaluates medical countermeasures in collaboration 
with RKI. Strategic health threats, particularly from bioterrorism, are assessed at the federal level by 
both security sectors and public health authorities. The Federal Office for Radiation Protection (BfS) 
supports hospital preparedness in radiological emergencies by providing critical information on the use 
of specific drugs for managing internal contamination. The federal states' public health authorities are 
informed about threats and involved in decision-making. 

Advanced Research and Development Capacities 
The BMG funds significant research programs focused on MCMs and promotes healthcare innovation 
through initiatives like the Digital Healthcare Act, which finances digital health innovations. The Paul 
Ehrlich  Institute  (PEI)  conducts  scientific  research  and  provides  regulatory  oversight  for  the 
development, testing, and approval of vaccines, therapeutics, and diagnostics. In addition, Germany's 
Federal Ministry of Education and Research (BMBF) is supporting several national and international 
(non-profit) initiatives, funding programs, and networks with the aim to develop vaccines, therapeutics, 
and diagnostics for pathogens with epidemic and pandemic potential and to enhance equitable access 
to these MCMs. 

Production / Manufacturing Capacities 
The  BMG  plays  a  role  in  regulating  and  ensuring  the  availability  of  medical  products  by  promoting 
policies and frameworks that support their development. The federal states contribute by maintaining 
standards and exploring strategies to address production bottlenecks. ZEPAI, an independent unit at 
PEI, manages Pandemic Preparedness Contracts to ensure the availability of vaccine manufacturing 
capabilities and raw materials.  

Procurement of MCMs 
Procurement  activities  are  integrated  into  the  broader  healthcare  strategy  led  by  the  BMG,  which 
ensures the availability of necessary MCMs, especially during crises like the COVID-19 pandemic. The 
BBK also procures drugs and medical equipment for defence purposes. Federal states manage local 
procurement,  establishing  temporary  structures  during  health  crises,  and  participating  in  joint 
procurement  efforts  with  the  European  Commission.  The  BMUV/BfS  procures  protective  agents  for 
radiological emergencies, ensuring availability during crises. 

Stockpiling and Distribution Capacities 
The  BMG  oversees  the  strategic  stockpiling  and  distribution  of  critical  medical  supplies,  as 
demonstrated during the COVID-19 pandemic. The BBK maintains stockpiles for defence purposes. 
Federal  states  manage  their  own  stockpiles,  with  some  establishing  pandemic  warehouses.  The 
BMUV/BfS coordinates a decentralized stockpiling approach for radiological emergencies. Logistics for 
the  provision  of  pandemic  equipment  are  supported  by  the  Technisches  Hilfswerk  (THW)  under  a 
contract with the BMG. ZEPAI is as an entity that implements the centralized distribution of pandemic 
vaccines  and  has  established structures  for  this  purpose.  Distribution  efforts are  tailored  to  regional 
needs, with states responsible for the logistics, distribution, and transport of MCMs during biological 
threats. 

149 

 
 
 
 
 
 
 
International Cooperation 
The BMG actively participates in global health emergency efforts through partnerships with international 
bodies like WHO, OECD, HERA and the G7. It contributes to EU health policy and joint efforts on MCMs. 
BBK engages in international cooperation via the EU Civil Protection Mechanism, HERA, and RescEU, 
facilitating shared resources and coordinated responses. BMUV/BfS is involved in WHO's Radiation 
Emergency Medical Preparedness and Assistance Network and cooperates with DG HERA and DG 
ECHO for CBRN-MCMs stockpiling.  

Health Security Coordination 
The BMG develops and implements emergency preparedness and response plans, coordinating with 
federal  states,  local  authorities,  healthcare  providers,  and  other  stakeholders  to  ensure  effective 
response  efforts.  The  BBK  coordinates  health  security  measures  and  prepares  civil  protection 
strategies, working closely with federal and state authorities. Federal states have their own structures 
for  managing  MCMs  and  coordinating  health  emergency  responses,  with  support  from  the  federal 
government to ensure unified efforts. The RKI provides specialized expertise and clinical management 
advice, ensuring coordinated and informed responses during crises. 

Comprehensive mapping of identified entities 

Federal Ministry of Health (BMG) 
The Bundesministerium für Gesundheit (BMG) is Germany's Federal Ministry of Health, responsible for 
national health policy and public health management. It oversees the health system's legal framework, 
ensures healthcare delivery, and develops policies to promote public health and prevent diseases. The 
BMG collaborates with federal states, healthcare providers, and international partners to address health 
threats and improve health security. 

Monitoring, Intelligence Gathering and Analysis 
The  BMG  at  the  national  level  provides  information  for  the  states  on  detection,  evaluation,  and 
countermeasures identification of health threats. The BMG provides recommendations, and evaluation 
of  MCMs  in  cooperation  with  RKI.  Strategic  health  threats  from  bioterrorism  are  assessed  by  the 
security sector and public health at the Federal level. 

150 

 
 
 
 
 
 
 
 
 
Advanced research and development capacities 
The BMG funds research programs on MCMs. It promotes innovation in healthcare through the Digital 
Healthcare  Act,  which  funds  digital  health  innovations  and  supports  research  to  improve  healthcare 
provision. This includes the investment of €200 million per year in the innovation fund until 2024. 

Production / Manufacturing Capacities 
The Ministry plays a role in regulating and ensuring the availability of medical products and innovations 
through policies and frameworks that encourage their development and integration into the healthcare 
system. 

Procurement of MCMs  
Procurement  activities  are  part  of  their  broader  healthcare  strategy,  ensuring  necessary  medical 
countermeasures and resources are available, especially highlighted during crises, such as the COVID-
19  pandemic,  when  it  sourced  and  distributed  masks,  tests,  and  vaccines  to  federal  states.  For 
bioterrorism threats, the BMG is involved in prioritizing agents, determining preparedness levels, and is 
tasked with the provision of MCMs, which includes managing logistics and distribution. This involves 
working alongside agencies like the RKI and clinical expert groups to identify necessary MCMs, while 
PEI/BfArM assesses product safety.  

Stockpiling and distribution capacities 
The  Ministry  oversees  the  strategic  stockpiling  and  distribution  of  critical  medical  supplies  and 
pharmaceuticals. This was particularly evident during the pandemic when the distribution of vaccines 
and protective equipment was coordinated on a large scale. The BMG is also in charge of stockpiling 
and distribution for bioterrorist and civil protection scenarios. In coordination with the BMG, the THW 
(Technisches Hilfswerk) operates logistics centres for the provision of pandemic equipment procured 
by  the  BMG  and,  if  necessary,  ensures  the  logistical  processes  for  its  delivery.  This  is  based  on  a 
contract between the BMG and the BMI/THW. More detailed information on this extensive project can 
be provided on request. 

International Cooperation 
The BMG actively engages in strengthening global health emergency architecture through collaboration 
with international partners and bodies such as the WHO, the OECD and is represented in the G7. It 
also plays a significant role in reinforcing health policy within the EU and contributes to joint efforts on 
medical  countermeasures,  which  includes  supporting  surveillance  systems,  aiding  low  and  middle-
income countries, and promoting knowledge and data exchange. 

Health security coordination 
The BMG develops and implements emergency preparedness and response plans to address a wide 
range  of  health  emergencies,  including  pandemics,  natural  disasters,  and  bioterrorism  events.  It 
coordinates with federal states (Länder), local authorities, healthcare providers, and other stakeholders 
to ensure that response efforts are well-coordinated and effectively executed. 

Federal Ministry of Education and Research (BMBF) 
Germany's  Federal  Ministry  for  Education  and  Research  (BMBF)  promotes  education,  science  and 
research. One of the main areas of research is health research. 

Advanced research and development capacities 
The BMBF is funding several national and international (non-profit) initiatives, funding programs, and 
networks with the aim to develop vaccines, therapeutics, and diagnostics for pathogens with epidemic 
and pandemic potential and to enhance equitable access to these MCMs. 

International Cooperation 
The BMBF funds not only national but also international initiatives, funding programs, and networks on 
the research and development of MCMs and equal access to these. 

151 

 
 
 
 
 
 
 
 
 
 
Federal Office for Civil Protection and Disaster Assistance (BBK) 
The  role  of  BBK  -  Federal  Office  for  Civil  Protection  and  Disaster  Assistance  is  crucial  in  handling 
emergencies as they are responsible for procuring sanitary materials essential during such times. It 
plays a significant role in civil protection, disaster management, and emergency preparedness, which 
includes preparation and response for health crises. If there is a health crisis, for instance, BBK ensures 
there  are  enough  sanitary  materials  to  prevent  the  spread  of  the  disease  and  to  maintain  hygiene 
standards. 

Procurement of MCMs 
The BBK procures drugs and medical equipment for defence purposes. These are procured according 
to  the  usual  procurement  procedures.  Where  possible,  framework  contracts  are  concluded  to  allow 
rapid procurement when required. 

Stockpiling and distribution capacities  
The BBK only stocks drugs and medical equipment for defence purposes. In case of mass casualty 
incidents (also involving CBRN) in the event of (partially) destroyed infrastructure, the BBK stockpiles 
drugs and medical equipment for special war-related injury patterns. This includes the stockpiling of 
drugs and medical devices for traumatic-thermal injury patterns and the stockpiling for CBRN incidents. 
The BBK stocks most of its medical supplies dislocated at hospital pharmacies. This ensures a turnover 
and short transportation route. The stockpiling is regularly evaluated and updated by a group of experts.  

International cooperation 
BBK is actively involved in international cooperation through frameworks like the EU Civil Protection 
Mechanism,  HERA  and  RescEU.  This  cooperation  allows  for  shared  resources,  expertise,  and 
coordinated responses to cross-border emergencies. 

Health Security Coordination 
BBK coordinates health security measures, including planning and preparing civil protection strategies. 
They work closely with federal and state authorities to ensure a unified and effective response to health 
emergencies. 

Federal states (public health authorities, civil protection/disaster control authorities) 
The German federal system is mainly based on the principles of devolution and subsidiarity. Because 
of  that,  the  German  federal  states  or  Länder  have  a  wide  range  of  own  legislative  (and  executive) 
competences. While the legislative power for civil protection (in peacetime) is assigned to the Länder, 
the responsibilities in the field of public health and health emergency preparedness and response are 
shared  between  federal  level  and  the  Länder.  Each  Land  has  its  own  public  health  authorities  and 
disaster control authorities working closely together in regard of possible public health emergencies. 
The regional public health authorities are primarily responsible for the specific sectoral prevention of, 
preparation for and response to public health emergencies, including medical countermeasures. This 
comprises among others setting up emergency plans for pandemics as well as procuring and stockpiling 
medical equipment and medicines. In this respect, each Land will manage its own MCMs, including 
storage, distribution, and administration. The civil protection or disaster control authorities have at the 
most  a  coordinating  role  in  public  health  emergencies  and  cooperate  in  this  respect  with  the  public 
health sector. However, the responsibility for the implementation of specific countermeasures or their 
preparation remains the responsibility of the respective public health authorities. 

Monitoring, Intelligence Gathering and Analysis 
Public health authorities of the states do not carry out monitoring, intelligence gathering and analysis 
by themselves. Rather, they are informed about bioterrorism threat and risk assessment by the federal 
level and involved in the decision-making process concerning MCMs. Public health authorities of the 
states can raise interests in training needs, which will be addressed by the RKI. 

Production / Manufacturing Capacities 
Federal states in Germany contribute to the strategic autonomy in medical countermeasures production 
by complementing federal strategies and enforcing federal laws. They, for instance, maintain contact 
with pharmaceutical industry to uphold production site standards, explore strategies like temporary local 
production to address bottlenecks, assess infrastructure status and needs for governmental support, or 

152 

 
 
 
 
 
 
 
 
coordination with the EU, and strengthen local biotech infrastructure and ensures MCM storage. These 
efforts collectively bolster resilience against supply challenges. 

Procurement of MCMs 
The federal states in Germany are responsible for managing procurement of MCMs at the local level. 
During health crises, they may establish temporary procurement and distribution structures, as seen 
during the COVID-19 pandemic. They also partake in negotiations for joint procurement of pandemic 
influenza  vaccines  in  collaboration  with  the  European  Commission  and  vaccine  manufacturers. 
However, outside of crises, permanent structures for MCM procurement are typically not maintained, 
except for specific emergency supplies like potassium iodide tablets. Central procurement has been 
necessary  during  past  emergencies  and  was  handled  by  the  federal  government.  This  ensured 
coordination and resource optimization. Each state adheres to its own legal basis and procedures for 
procurement  and  manages  its  resources  based  on  specific  needs  and  in  alignment  with  federal 
directives.  Decisions  regarding  procurement  of  MCMs  in  case  of  biological  threat  fall  within  their 
jurisdiction.  

Stockpiling and distribution capacities 
Federal states are involved in stockpiling and logistics with regards to MCMs in their jurisdictions. Some 
states have established pandemic warehouses to secure a supply of personal protective equipment. 
They  are  also  responsible  for  the  distribution  of  specific  emergency  supplies  like  potassium  iodide 
tablets, with prepared distribution through public pharmacies in case of an emergency. Furthermore, 
the  Länder  manage  their  own  medical  countermeasures,  including  storage,  distribution,  and 
administration,  according  to  their  specific  emergencies  and  directives,  with  central  support  from  the 
federal government in crisis situations to promote unified coordination and resource optimization. They 
also work with local public health authorities to develop specific distribution concepts for MCMs, tailoring 
their approaches to the needs and circumstances within their regions. They are also responsible for the 
logistics, distribution, and transport of MCMs in case of biological threat.  

Health security coordination 
Federal states cooperate with the federal government to coordinate health emergencies’ responses. 
They have their own structures for release and distribution of MCMs stockpiled in their states. Federal 
states  cooperate  also  with  the  RKI,  which  provides  them  with  specialized  expertise  on  clinical 
management from an individual medical perspective (STAKOB, COVRIIN) during crisis. 

Federal  Ministry  for  the  Environment,  Nature  Conservation,  Nuclear  Safety  and  Consumer 
Protection (BMUV) - and the Federal Office for Radiation Protection (BfS) 
The Federal Office for Radiation Protection (BfS) in the portfolio of the BMUV play a vital role in the 
event of a radiological emergency. Preparation of the radiological situation report as a basis for official 
action  and  for  the  implementation  of  protective  measures  via  the  disaster  control  authorities  of  the 
federal  states.  The  office  advices,  assists  and  contributes  to  the  planning  of  the  health  and  civil 
protection bodies.  

Monitoring, Intelligence Gathering and Analysis 
The  BMUV/BfS  supports  the  health  advisory  bodies  with  the  mapping  of  hospital  capabilities  and 
capacities  for  medical  management  of  patients  in  a  radio-nuclear  emergency.  For  hospital 
preparedness planning, BMUV/BfS provides information on the use of specific drugs for "decorporation" 
(e.g. Prussian Blue or DTPA) for patients with internally contaminated. 

Procurement of MCMs 
As part of the preparation for radiological emergencies, the BMUV/BfS procure protective agents and 
make  them  available  to  the  federal  states  for  disaster  control  purposes.  It  acts  already  at  a 
preparedness stage in order to avoid bottlenecks and price increases during emergencies. 

Stockpiling and distribution capacities 
BMUV/BfS  coordinates  a  decentralised  stockpiling  approach,  where  potassium-iodide  as  well  as 
decorporation  drugs  are  stored  in  distribution  facilities  at  community  level  in  order  to  enable  a  swift 
dispensing of tablets to populations at risk.  

153 

 
 
 
 
 
 
 
 
 
International Cooperation 
BfS  is  member  of  WHO's  "REMPAN  -  Radiation  Emergency  Medical  Preparedness  and  Assistance 
Network", which includes information exchange, mutual support for specific diagnostic procedures (e.g. 
incorporation measurement or biological dosimetry) and specialised treatment capacities. Furthermore, 
BMUV/BfS  is  active  on  the  IHR  (International  Health  Regulations)  by  contributing  to  the  yearly 
evaluations  for  capabilities  and  capacities  in  RN  preparedness  and  response.  BMUV/BfS  has  also 
cooperation with DG HERA and SG ECHO with regards to stockpiling of CBRN-MCMs.   

PEI - Paul Ehrlich Institut (ZEPAI - Center for Pandemic Vaccines and Therapeutics) 
The  PEI  -  Paul  Ehrlich  Institut  and  in  specific  the  ZEPAI  -  Center  for  Pandemic  Vaccines  and 
Therapeutics  deals  with  vaccines  and  therapeutics  for  pandemics.  It  is  tasked  with  providing 
infrastructure that can quickly produce necessary medical countermeasures during a pandemic. As of 
1  May  2022,  ZEPAI  also  actively  manages  the  supply  of  these  essential  medical  resources,  further 
accelerating the response during health emergencies. 

Advanced research and development capacities  
The PEI conducts scientific research and provides regulatory oversight for the development, testing, 
and approval of vaccines, therapeutics, and diagnostics. It evaluates the safety, efficacy, and quality of 
MCMs  through  preclinical  and  clinical  studies,  assesses  manufacturing  processes,  and  grants 
marketing  authorizations  for  products  intended  for  use  in  public  health  emergencies.  Regulatory 
oversight is solely the duty of PEI, not ZEPAI. 

Production / Manufacturing Capacities 
The responsibilities of ZEPAI at the PEI is supporting the manufacturing and production capacities of 
MCMs  include  managing  Pandemic  Preparedness  Contracts  to  ensure  vaccine  manufacturing 
capabilities and raw material availability within Germany. ZEPAI oversees tenders for establishing end-
to-end manufacturing capacities, requiring contracted companies to deliver vaccines rapidly during a 
pandemic and to secure raw materials for vaccine production.  

Robert Koch Institute 
The  Robert  Koch  Institute  (RKI),  serving  as  Germany's  national  public  health  body,  specializes  in 
infectious  disease  epidemiology.  Under  the  German  Protection  against  Infection  Act,  it  records  and 
analyses  data  on  numerous  infectious  diseases  in  Germany,  ensuring  informed  and  data-driven 
decisions and responses during health emergencies. 

Monitoring, Intelligence Gathering and Analysis: 
RKI conducts surveillance, epidemic intelligence, risk assessment, outbreak investigations, modelling 
as well as training activities on biological threats, at the national level and supports the federal states in 
these matters. Public health recommendations on some medical countermeasures are issued by RKI, 
however,  vaccination  recommendations  are  formulated  by  the  independent  NITAG  (STIKO)  and 
treatment  recommendations  come  from  scientific  physicians  associations  (Leitlinien).  The  RKI  has 
existing structures (STAKOB, FG COVRIIN) for clinical evaluation of the necessity of MCMs and clinical 
advise to their usage, which are available 24/7 for evaluation from an individual medical perspective. 
The clinical use of MCM will be advised by advisory groups linked to RKI, while training on distribution 
of MCM is done by the federal states.

154 

 
 
 
 
 
 
 
 
l.  Greece 

Overview of approach to preparedness and response to public health emergency in MCMs 

Monitoring, Intelligence Gathering, and Analysis 
In Greece, the responsibility for monitoring, intelligence gathering, and analysis is distributed among 
several entities. The Ministry of Health (MoH) plays a role by conducting disease surveillance, managing 
health  information  systems,  carrying  out  epidemiological  investigations  to  assess  health  risks  and 
inform decision-making and in the identification of countermeasures. Public health directories provide 
up-to-date  information  on  healthcare  resources  and.  The  National  Public  Health  Organisation 
(NPHO/ΕΟΔΥ)  complements  these  efforts  by  conducting  the  National  Health  Survey  which  aids  in 
identifying health priorities and countermeasures, as well as by monitoring market supplies of MCMs 
during health emergencies.  

Advanced Research and Development Capacities 
The Ministry of Health oversees health-related research projects often in collaboration with universities 
and  research  institutions.  The  National  Organisation  for  Medicines  (NOM/ΕΟΦ)  further  supports 
medical  and  pharmaceutical  research  by  facilitating  collaborations  between  Greek  pharmaceutical 
companies and international organisations and participating in EU-funded projects.  

Production / Manufacturing Capacities 
The  Ministry  of  Health  supports  the  scaling  up  of  production  capabilities  for  local  pharmaceutical 
companies, especially during health crises.  

Procurement of MCMs 
The  Ministry  of  Health  is  primarily  responsible  for  the  procurement  of  medical  supplies  and 
countermeasures  in  Greece,  employing  centralized  procurement  strategies  managed  by  the  Health 
Procurement  Committee  (EPY).  The  National  Organisation  for  Medicines  (NOM/ΕΟΦ)  negotiates 
procurement contracts. 

Stockpiling and Distribution Capacities 
The Ministry of Health ensures the maintenance and rapid deployment of strategic reserves of essential 
medicines and equipment in case of public health emergencies.  

International Cooperation 
The  Ministry  of  Health  actively  participates  in  international  programs  and  initiatives  to  tackle  public 
health  challenges.  It  also  collaborates with  neighbouring  countries  through  regional  health  networks 
such as the South-Eastern Europe Health Network (SEEHN) to address common health issues and 
enhance cross-border cooperation.  

Health Security Coordination 
The Ministry of Health oversees the implementation of public health policies and coordinates national 
strategies  during  health  emergencies.  The  National  Organisation  for  Medicines  (NOM/ΕΟΦ)  also 
contributes  to  health  security  through  its  National  Pharmacovigilance  Committee,  which  evaluates 
adverse events and proposes regulatory procedures or guidelines.  

155 

 
 
 
 
 
 
 
 
 
 
Comprehensive mapping of identified entities 

Ministry of Health  
The Ministry of Health (MoH) in Greece serves as the primary governmental authority responsible for 
overseeing the nation's healthcare system and ensuring the well-being of its citizens. The Greek MoH 
plays a multifaceted role in various aspects of public health, including policy formulation, regulation, and 
healthcare service delivery. 

Monitoring, Intelligence Gathering and Analysis: 
The  Ministry  of  Health  (MoH)  is  involved  in  intelligence  gathering,  monitoring,  and  analysis  to  track 
public  health  trends,  assess  health  risks,  and  inform  decision-making.  This  includes  disease 
surveillance,  managing  health  information  systems,  conducting  epidemiological  investigations, 
assessing health risks and identifying medical countermeasures. 

Advanced Research and Development Capacities:  
Greece  participates  in  European  research  initiatives  but  also  supports  local  research  efforts.  The 
Ministry of Health oversees the development and implementation of health-related research projects, 
often  in  collaboration  with  universities  and  research  institutions  in  Greece.  This  includes  innovative 
projects aimed at improving diagnostic and therapeutic tools. 

Production / Manufacturing Capacities 
Greece's  Ministry  of  Health  supports  local  pharmaceutical  companies  in  scaling  up  production 
capabilities, especially during health crises. 

Procurement of MCMs:  
The Ministry of Health is responsible for the procurement of medical supplies and countermeasures 
within  Greece.  This  includes  negotiating  and  securing  necessary  medical  products  and  equipment 
through both national and EU-level procurement processes. The Ministry has implemented centralized 
procurement strategies to streamline the acquisition of medical devices, pharmaceuticals, and other 
essential supplies. This centralized approach, managed by the Health Procurement Committee (EPY), 
aims  to  reduce  costs,  improve  the  efficiency  of  procurement  processes,  and  ensure  uniformity  in 
medical requests across different healthcare facilities. The committee also manages the redistribution 
of redundant materials and oversees the proper management of medical stock, including the expiration 
of products. 

156 

 
 
 
 
 
 
 
 
 
Stockpiling and Distribution Capacities 
The Ministry of Health, through its various departments and agencies, ensures that strategic reserves 
of essential medicines and equipment are maintained and can be rapidly deployed in case of public 
health emergencies 

International Cooperation:  
MoH in Greece participates in various international programs and initiatives to address public health 
challenges. For instance, Greece actively contributes to the WHO's global health programs, including 
initiatives  focused  on  disease  surveillance,  health  promotion,  and  capacity  building.  The  MoH  also 
represents Greece in regional and international health forums, such as the World Health Assembly and 
the  EU  Health  Council,  advocating  for  policies  and  strategies  to  advance  public  health  goals. 
Additionally, Greece collaborates with neighbouring countries through regional health networks, such 
as the South-Eastern Europe Health Network (SEEHN), to address common health issues and enhance 
cross-border cooperation. 

Health Security Coordination:  
MoH  is  tasked  with  guiding  the  country's  response  to  health  emergencies  by  overseeing  the 
implementation of public health policies, managing relevant resources, and coordinating strategies at a 
national level. For instance, during the COVID-19 pandemic, its secretariats led efforts to enforce public 
health measures such as lockdowns, testing, and contact tracing. Besides, it coordinates with regional 
health  authorities  and  healthcare  facilities  to  monitor  disease  trends,  assess  risks,  and  implement 
targeted interventions to mitigate the spread of infectious diseases. 

Directories for Public Health in Regions 
Public health directories in Greece serve a vital purpose, offering accessible information on healthcare 
resources  and  services  at  a  local  scale.  Their  mission  is  to  provide  the  public  and  healthcare 
professionals  with  easy  access  to  relevant  data,  facilitating  informed  decision-making  and  efficient 
collaboration.  These  directories  engage  with  various  stakeholders,  including  healthcare  institutions, 
government  agencies,  and  community  organisations,  to  compile  comprehensive  listings  of  contact 
information, services, and relevant data. 

Monitoring, Intelligence Gathering and Analysis: 
Public health directories in Greece play a role in both preparing for and responding to public health 
crises. For example, during the COVID-19 pandemic, these directories provided up-to-date information 
on  testing  sites,  vaccination  centres,  and  healthcare  facilities,  helping  individuals  locate  necessary 
services and resources. Additionally, they disseminated important public health guidance and directives 
issued  by  the  Ministry  of  Health,  ensuring  widespread  awareness  and  adherence  to  preventive 
measures.  

National Public Health Organisation (NPHO/ΕΟΔΥ) 
The National Public Health Organisation (NPHO/ΕΟΔΥ) operates at a national level, with a focus on 
public health. NPHO is often the lead on epidemiological surveillance, providing health advisories, and 
research  on  public  health  matters.  Their  efforts  also  include  designing  targeted  health  promotion 
programs and disease control strategies, as well as devising guidelines and directives for healthcare 
facilities to ensure uniformity in managing health crises. 

Monitoring, Intelligence Gathering and Analysis: 
The National Public Health Organisation (NPHO/ΕΟΔΥ) in Greece conducts the National Health Survey 
(NHS).  This  comprehensive  survey  aims  to  assess  the  health  status,  behaviours,  and  needs  of  the 
population across different regions of Greece. It collects data on various health indicators, including 
chronic diseases, lifestyle factors, healthcare utilization, and access to healthcare services. The findings 
from  the  NHS  provide  valuable  insights  into  the  health  priorities  and  challenges  facing  the  Greek 
population and serve as a basis for the identification of countermeasures during both preparedness and 
public health crisis.  

National Organisation for Medicines (NOM/ΕΟΦ) 
The National Organisation for Medicines (NOM/ΕΟΦ) is focused on pharmacovigilance and regulation 
of medicines. NOM ensures the safety, quality, and efficacy of medicines available in Greece. Its role 

157 

 
 
 
 
 
 
 
 
extends  to  the  verification and validation  of  new drugs,  periodic  review  and  assessment  of  licensed 
products,  and  active  monitoring  for  potential  adverse  reactions.  It  also  regulates  medication  prices, 
negotiate procurement contracts for MCMs, and monitor market supply during health emergencies. The 
mission  also  includes  the  validation,  assessment,  safety  monitoring  and  inspection  of  the  following 
research areas, potentially of HERA’s concern: 

Advanced Research and Development Capacities:  
The National Organisation for Medicines promotes medical and pharmaceutical research by supporting 
initiatives that foster innovation in the health sector. This includes facilitating collaborations between 
Greek pharmaceutical companies and international organisations, as well as participating in EU-funded 
projects aimed at enhancing pandemic preparedness and response capabilities 

Procurement of MCMs:  
The National Organisation for Medicines has a key role regarding procurement of MCMs (and notably 
medicines) as it negotiates procurement contracts for Greece and monitors market supply during health 
emergencies.  

Health security coordination: 
NOM is coordinating health security through the National Pharmacovigilance Committee. The group of 
experts  meets  periodically  in  normal  conditions  and  more  intensively  in  crisis  situations,  with  the 
purpose  of  evaluating  the  causality  of  the  reported  adverse  events.  It  aims  to  detect  and  analyse 
potential safety signals and to propose regulatory procedure or national guidelines. The Committee has 
an advisory prerogative towards the government and major actors of the Greek healthcare system.

158 

 
 
 
 
 
 
m. Hungary 

Overview of approach to preparedness and response to public health emergency in MCMs 

Monitoring, Intelligence Gathering and Analysis  
The National Centre for Public Health and Pharmacy (NNGYK) in Hungary is responsible for epidemic 
surveillance,  and  has  relevant  laboratory  capacity.  NNGYK  is  pivotal  in  monitoring,  intelligence 
gathering,  and  analysis  related  to  public  health  and  epidemiology.  The  ongoing  research  and 
surveillance  activities  help  in  proactively  identifying  and  assessing  public  health  risks  and  medical 
countermeasures.  

Advanced Research and Development Capacities  
The Ministry of Interior, State Secretariat for Health has no direct role in the supervision or coordination 
of health-related scientific research activities. Regarding the research area, NNGYK primarily supports 
and  participates  at  research  and  development  of  new  vaccines.  The  successor  of  the  Ministry  for 
Innovation and Technology provides funding and support for R&D activities in the pharmaceutical and 
biotechnology sectors, fostering collaborations with academic institutions and industry to facilitate the 
commercialization of research outcomes.  

Production / Manufacturing Capacities  
The successor of the Ministry for Innovation and Technology supports the enhancement of Hungary's 
industrial  base,  including  pharmaceutical  and  biotechnology  industries.  It  supports  high-tech 
manufacturing  and  production  through  policies  and  funding  aimed  at  boosting  innovation  and 
manufacturing capacities.  

Procurement of MCMs  
The procurement of MCMs in Hungary is managed by both the Ministry of Interior, State Secretariat for 
Health  and  the  NNGYK  for  vaccines,  where  the  Ministry  coordinates  the  preparation  of  the 
governmental  decision-making  for  vaccine-procurements  coming  from  the  EU  joint  procurement 
scheme,  while  NNGYK  coordinates  primarily  vaccine  procurements  for  vaccines  included  in  the 
National Immunization Program. The National Directorate General for Hospitals (OKFŐ) is responsible 
for the procurement of all other health-related products. OKFŐ is responsible for maintaining stockpiles 
and ensuring efficient distribution of critical pharmaceuticals and medical devices. It also coordinates 
the  storage  and  distribution  of,  essential  MCMs  to  healthcare  facilities  across  the  country,  ensuring 
timely access during emergencies. The Ministry of Interior ensures a steady supply of essential medical 
supplies  and  medications  through  the  OKFŐ,  overseeing  overall  procurement  processes  for  the 
national health system. 

Stockpiling and Distribution Capacities  
The Ministry of Interior, State Secretariat for Health defines the strategic guidelines for setting up and 
maintaining  of  the  National  Health  Reserve  Stockpile  for  pharmaceuticals  and  medical  devices  to 
ensure the nationwide availability of MCMs during health emergencies. The National Health Reserve 
Stockpile is placed in the National Directorate General for Hospitals being responsible for maintaining 
stockpiles and ensuring the efficient distribution of critical pharmaceuticals and medical devices.  

International Cooperation  
The Ministry of Interior, State Secretariat for Health is actively cooperating with EU and WHO relevant 
bodies, as well as global partners including industry actors in all areas covered by HERA (preparedness, 
early  response,  health  security,  etc.)  and  involved  in  the  work  of  professional  bodies,  committees, 
working  groups  in  the  related  areas.  NNGYK  collaborates  with  ECDC,  WHO,  global  partners  and 
participates  in  international  networks  to  share  expertise,  best  practices,  and  resources,  enhancing 

159 

 
 
 
 
 
 
 
 
collective  readiness  for  health  emergencies.  Also,  it  actively  engages  in  EU  networks,  facilitating 
information exchange and joint efforts in disease surveillance and outbreak investigation.  

Health Security Coordination 
The Ministry of Interior, State Secretariat for Health is primarily responsible on the governmental level 
for the high-level coordination of the national health security issues, and also participates in the work of 
the  EU  Health  Security  Committee  (HSC)  and  its  subgroups  along  with  NNGYK.  The  NNGYK  has 
special roles defined in the corresponding legislation e.g., in case of a health emergency is declared.  

Comprehensive mapping of identified entities 

Ministry of Interior 

National  Centre  for  Public Health 
and Pharmacy (NNGYK) 

Monitoring, 
Analysis 

Intelligence  Gathering  and 

Advanced  Research  and  Development 
capacities 

Production / Manufacturing capacities 

Procurement of MCMs 

Stockpiling and distribution capacities 

International Cooperation 

Health security coordination 

Preparedness 

Response 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

Ministry of Interior 
The Ministry of Interior, State Secretariat for Health coordinates and implements government policies 
to ensure the health and well-being of Hungarian citizens, managing public health initiatives, the health 
care  system,  and  the  National  Health  Insurance  Fund  to  ensure  the  efficient  delivery  of  healthcare 
services. 

Procurement of MCMs 
The Ministry manages overall procurement processes for the national health system, ensuring a steady 
supply of essential medical supplies and medications through the OKFŐ. 

Stockpiling and distribution capacities 
The Ministry oversees strategic stockpiling and logistical coordination, ensuring nationwide distribution 
and availability of MCMs during health emergencies. 

National Centre for Public Health and Pharmacy (NNGYK) 
Acting as the country's overarching public health and epidemiological agency, the National Centre for 
Public  Health  and  Pharmacy  (NNGYK)  formed  by  the  merger  of  the  National  Public  Health  Centre 
(NNK) and the National Institute of Pharmacy and Nutrition (OGYÉI). It oversees the management of 

160 

 
 
 
 
 
 
 
 
 
 
 
 
 
public  health  concerns  from  everyday  health-related  affairs  to  managing  crises  and  public  health 
emergencies.  

Monitoring, Intelligence Gathering and Analysis:  
Through  its  various  constituent  entities,  the  Centre  maintains  a  comprehensive  surveillance 
infrastructure  to  monitor  disease  trends,  detect  potential  health  threats,  and  gather  intelligence  on 
emerging risks, as well as on their related countermeasures both domestically and internationally. The 
Epidemiology department plays a pivotal role in this regard, leveraging its expertise to monitor disease 
patterns  and  closely  cooperating  with  ECDC  and  other  relevant  EU  bodies.  Additionally,  the  entity 
conducts  ongoing  research  and  surveillance  activities  to  identify  and  assess  public  health  risks 
proactively.  

Advanced Research and Development Capacities:  
The National Centre for Public Health and Pharmacy primarily supports and participates at research 
and development of new vaccines. 

Procurement of MCMs:  
The National Centre for Public Health and Pharmacy coordinates primarily vaccine procurements for 
vaccines included in the National Immunization Program. 

International cooperation:  
Collaborating with global partners and participating in international networks, NNGYK shares expertise, 
best  practices,  and  resources  to  enhance  collective  readiness  for  health  emergencies.  The  Centre 
actively  engages  in  EU  networks,  facilitating  information  exchange  and  joint  efforts  in  disease 
surveillance and outbreak investigation. 

161 

 
 
 
 
 
 
 
 
 
n. Ireland 

Overview of approach to preparedness and response to public health emergency in MCMs 

Monitoring, Intelligence Gathering, and Analysis 
In  Ireland,  the  Health  Service  Executive  (HSE)  is  the  key  entity  responsible  for  monitoring  and 
intelligence gathering related to public health. The HSE systematically collects and analyzes data from 
healthcare  facilities,  public  health  surveillance  systems,  and  research  studies  to  identify  emerging 
health  threats  and  trends.  Additionally,  the  HSE  conducts  intelligence  gathering  to  assess  potential 
health  risks  and  vulnerabilities,  thereby  enabling  the  formulation  of  effective  countermeasures.  The 
Health Research Board (HRB) complements these efforts by conducting rapid evidence reviews for the 
Department of Health to inform health policy making.  

Advanced Research and Development Capacities 
Ireland's advanced research and development capacities in the health sector are significantly supported 
by the Health Research Board (HRB) and the Department of Enterprise, Trade and Employment (DETE). 
The HRB is central to funding and coordinating health and social care research. This funding supports 
the advancement of health knowledge and preparedness for public health emergencies by sponsoring 
relevant research studies. The DETE, through agencies like IDA Ireland and Enterprise Ireland, offers 
RD&I funding to companies developing new healthcare products and services.  

Production / Manufacturing Capacities 
The DETE also plays a role in ensuring Ireland's production and manufacturing capacities for medical 
countermeasures. By engaging with industry partners, including producers of MCMs, the DETE ensures 
the  availability  of  essential  emergency  supplies  during  health  crises.  The  DETE  maintains 
communication with these entities to align government health policies with industrial operations. 

Procurement of MCMs 
The Health Service Executive (HSE) is the primary entity responsible for the procurement of MCMs in 
Ireland. The HSE ensures the availability and continuity of supply for essential items such as vaccines, 
medicines, medical equipment, and diagnostics.  

Stockpiling and Distribution Capacities 
Stockpiling  and  distribution  of  medical  countermeasures  are  managed  by  the  Department  of  Health 
(DoH)  through  the  Office of  the  Chief Medical  Officer  (CMO).  The  DoH  is  developing  a  coordinated 
approach  to  stockpiling  MCMs  for  serious  cross-border  health  threats.  This  involves  assessing  and 
updating Ireland’s national stockpiling policies to ensure readiness for public health emergencies. The 
stockpiling strategy aims to maintain sufficient reserves of critical medical supplies, which can be rapidly 
deployed in response to health crises, ensuring that healthcare providers have access to necessary 
resources. 

International Cooperation 
The Department of Health's Health Security Unit coordinates Ireland's positions and collaborates with 
EU  partners,  the  UN,  and  other  international  bodies  to  enhance  global  health  security.  Ireland's 
involvement in the WHO's Intergovernmental Negotiating Body and the 'Group of Friends of the Treaty' 
underscores  its  commitment  to  strengthening  global  frameworks  for  pandemic  preparedness  and 
response. 

Health Security Coordination 
The  coordination  of  health  security  in  Ireland  is  primarily  managed  by  the  Health  Service  Executive 
(HSE) and the Department of Health (DoH). The National Public Health Emergency Team (NPHET), 
though currently disbanded, played a crucial role in coordinating responses to significant public health 

162 

 
 
 
 
 
 
 
 
emergencies and would be reactivated if needed. Additionally, the Office of Emergency Planning (OEP) 
supports the strategic coordination of emergency management and resilience efforts, ensuring that key 
government departments have the necessary information and guidance to respond effectively to health 
emergencies. The OEP also provides the infrastructure for national emergency coordination.  

Comprehensive mapping of identified entities 

Department of Health (DoH) 
The Department of Health (DoH) is the primary government body responsible for public health policy, 
strategic planning, and overall guidance in Ireland. The Office of the Chief Medical Officer within the 
department holds the core responsibility for the formulation and implementation of strategies related to 
emergency preparedness and response. This office works closely with internal divisions, governmental 
organisations, international bodies like HERA, and the general medical community to develop health 
crisis policies. 

In Ireland crisis management is governed by a Strategic Emergency Management (SEM) Framework 
which  outlines  how  different  Governmental  Departments  should  collaborate  with  each  other  and 
coordinate  within  their  own  Departments  to  (a)  prepare  for,  (b)  respond  to,  and  (c)  recover  from 
emergencies and disasters.  
DOH  is  the  lead  government  department  for  5  incident  types,  including:  (1)  incidents  of  pandemic 
potential,  (2)  biological  incidents,  (3)  volcanic  eruptions  impacting  on  Ireland  that  may  affect 
food/water/air  contamination,  (4)  food  contamination  impacting  on  public  health  as  well  as  (5)  food 
safety incidents in food processing plants. 

Stockpiling and distribution capacities  
As part of preparedness activities, the office of the Chief Medical Officer (CMO), part of the DoH, is 
currently  seeking  to  develop  a  coordinated  approach  to  stockpiling  of  medical  countermeasures  for 
serious cross-border threats to health. The objective of this work is to assess and update Ireland’s policy 
position  on  national  stockpiling  of  medical  countermeasures  for  use  in  case  of  a  public  health 
emergency. 

International Cooperation 
Ireland has been participating in the International Health Regulations (IHR) amendment process along 
with EU partners. The Department of Health, Health Security Unit is leading coordination on Ireland’s 
position in respect of proposals for amendments to the IHR.  They are working with the relevant policy 
units in the Department, other Government Departments, Ireland's Permanent Representation to the 
UN in Geneva and EU partners on this matter. The Department of Health is also involved in the WHO-
led process to negotiate a binding legal instrument on pandemic preparedness and response. The aim 
of such a Pandemic Agreement is to protect public health and to help save lives in the event of future 
pandemics. An Intergovernmental Negotiating Body (INB) was established and met for the first time on 

163 

 
 
 
 
 
 
 
 
24 February 2022. Ireland has been participating in the INB process along with EU partners and is also, 
along with a majority of EU Member States, part of the ‘Group of Friends of the Treaty’. 

Health Security Coordination 
DoH  acts  as  a  coordinator  for  health  security  through  its  National  Public  Health  Emergency  Team 
(NPHET – in process of being rebranded). NPHET is the mechanism for coordinating the health sector 
response to significant public health emergencies. It facilitates the sharing of information between the 
Department of Health and its agencies. It is a long-standing structure which has been utilised over many 
years  to  provide  a  forum  to  steer  strategic  approaches  to  public  health  emergencies  in  Ireland  and 
mobilise the necessary health service responses. NPHET has been disbanded after lowering concerns 
regarding Covid-19 but would be reactivated in case of new public health crisis. 

Health Service Executive (HSE) 
The  Health  Service  Executive  (HSE)  is  Ireland's  primary  public  service  organisation  responsible  for 
providing health and social care services to the population. During health crises, the HSE assumes the 
responsibility to lead and coordinate responses, utilizing both national and regional resources. Among 
its  duties  are  monitoring  and  assessing  population  health  status,  controlling  infectious  diseases, 
managing vaccination programs, and implementing preventive measures. 

Monitoring, Intelligence Gathering and Analysis 
The  Health  Service  Executive  (HSE)  in  Ireland  is  tasked  with  monitoring  and  assessing  population 
health status to proactively identify health threats and trends. This involves collecting and analysing 
data  from  various  sources,  including  healthcare  facilities,  public  health  surveillance  systems,  and 
research  studies.  By  closely  monitoring  indicators  such  as  disease  incidence,  mortality  rates,  and 
healthcare  utilization  patterns,  the  HSE  can  detect  emerging  health  issues  and  prioritize  resource 
allocation  accordingly.  Additionally,  the  HSE  conducts  intelligence  gathering  activities  to  gather 
information on potential health risks, vulnerabilities and their respective countermeasure response.  

Procurement of MCMs 
The HSE in Ireland plays a significant role in the procurement of MCMs. The HSE is responsible for the 
procurement  of  goods  and  services  to  support  health  and  social  care  delivery  across  Ireland.  This 
includes  ensuring  the  availability  and  continuity  of  supply  for  essential  items  such  as  vaccines, 
medicines, medical equipment, and diagnostics. The HSE coordinates with other public sector bodies 
and  follows  a  stringent  process  for  sourcing  suppliers  and  managing  contracts.  They  utilize  various 
tools and systems to support procurement activities, including the Procurement Support Request (PSR) 
form for competitive sourcing and the Procurement Agreements & Contracts eRepository (PACE) for 
managing contracts and agreements.  

Health Security Coordination 
In  times  of  health  crises,  the  Health  Service  Executive  (HSE)  plays  a  central  role  in  coordinating 
responses to safeguard public health and ensure effective management of the situation. This involves 
mobilizing national and regional resources, including healthcare facilities, personnel, and supplies, to 
respond to the crisis promptly and efficiently. The HSE leads efforts to control infectious diseases by 
implementing containment measures, conducting contact tracing, and providing guidance on infection 
prevention  and  control.  Additionally,  the  HSE  manages  vaccination  programs  to  immunize  the 
population against infectious diseases, mitigating the spread of outbreaks. 

Health Research Board (HRB) 
The  Health  Research  Board  (HRB)  in  Ireland  is  a  government  agency  dedicated  to  promoting  and 
supporting  health  research  and  innovation.  Established  to advance  the  understanding  of  health  and 
improve healthcare outcomes, the HRB plays a central role in funding, coordinating, and conducting 
research across various areas of health and healthcare delivery. 

Monitoring, Intelligence Gathering and Analysis 
The Health Research Board conducts rapid evidence reviews for the Department of Health to inform 
health policy making. They also manage four national health information and data collection systems, 
including  HRB  National  Drug  Library, a  specialist  information  resource  for  health  practitioners, 
researchers and policy makers in the drug and alcohol field. HRB shaped Ireland's public health and 
policy response to COVID-19 by enabling secure and controlled data access for health research.  

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Advanced Research and Development capacities 
The Health Research Board (HRB) supports and provides funding for health and social care research 
in Ireland. It oversees a €45 million investment in health research activity each year. HRB plays a role 
in advancing health knowledge to improve national healthcare standards and providing decision-makers 
with evidence-based research to inform policy and practice. It is instrumental in enhancing public health 
preparedness and emergency response by funding relevant research studies.  

Government Task Force on Emergency Planning (GTF) and Office of Emergency Planning (OEP) 
The  Government  Task  Force  on  Emergency  Planning  (GTF)  oversees  the  emergency  planning 
activities  of  all  government  departments  and  public  authorities,  ensuring  a  comprehensive  and 
synchronized response mechanism. The Office of Emergency Planning (OEP) mission is to coordinate, 
facilitate, and educate on issues relating to strategic emergency management and societal resilience in 
Ireland. 

Monitoring, Intelligence Gathering and Analysis 
The  Health  Threats  Coordination  Group  (HTCG)  is  a  sub-group  of  the  Government  Task  Force  on 
Emergency  Planning  and  was  established  in  accordance  with  the  provisions  of  the  Government's 
Strategic  Emergency  Management  Framework.  Chaired  by  the  Department  of  Health,  the  HTCG's 
provides  a  forum  for  communications  and  sharing  of  health-related  emerging  risks  and  other  health 
related issues by the Department of Health, Health Service Executive and other health sector agencies 
with  their  counterparts  in  other  Government  Departments  and  Agencies.  The  HTCG  also  facilitates 
collaboration and communication between the HSE, other health sector agencies and their counterparts 
in other agencies on cross-cutting health emergency planning issues. 

OEP strives to develop a repository of knowledge in relation to emergency preparedness, management, 
recovery and resilience. This effort include, though may not be limited to, independent research, the 
sharing of this information, and the support in embedding this information in Government Departments 
in order to support their emergency response efforts. This repository will be used for the purpose of 
developing policy which is under pinned by research and data for strategic emergency management. 
OEP also develops strategies, guidance and background material to enhance societal resilience. 

International Cooperation 
OEP acts as the focal point for the Critical Entities Resilience Group at EU level and the resilience goal 
of the ITPP agreement between Ireland and NATO. 

Health Security Coordination 
The OEP plays a role in generating and distributing vital information and guidance pertinent to strategic 
emergency management. It is responsible for ensuring that the principal Government Departments are 
furnished with this critical information in a timely manner, which then informs their strategic decisions 
concerning  emergency  preparedness.  Additionally,  the  OEP  is  tasked  with  harmonizing  national 
resilience policies, drawing upon the finest practices emerging from commitments to the EU and the 
Partnership  for  Peace  (PfP)  program.  When  necessary  or  upon  request,  the  OEP  also  engages  in 
bilateral coordination to foster cooperative efforts toward meeting emergency-related goals. Achieving 
these  objectives  is  facilitated  by  employing  key  mechanisms  such  as  the  Strategic  Emergency 
Management National Structures and Framework, the National Risk Assessment, and evaluating Risk 
Management Capabilities.  

Besides, OEP provides the physical or virtual structures, when required, to support the gathering of 
relevant  individuals,  collaborating  in  preparation  for,  response  to,  or  recovery  from  an  emergency 
requiring national level coordination. This will be achieved through the maintenance and provision of 
the  National  Emergency  Coordination  Centre  (NECC).  At  the  NECC,  meetings  of  the  National 
Emergency Coordination Group (NECG) are held. The latter is the structure that coordinates the cross-
government response to a national level emergency, including health related emergencies. The NECG 
consists of the members of the Government Task Force on Emergency Planning (GTF). The Office of 
Emergency  Planning  (OEP)  convenes  the  NECG  on  behalf  of  the  relevant  Lead  Government 
Department (LGD). Arrangements are in place to facilitate a meeting of the Group within a one hour 
time-frame. The NECG is chaired by a senior official or Minister from the lead government department 
as set out in Annex ‘A’ of the Strategic Emergency Management: National Structures and Framework. 

Department of Enterprise, Trade and Employment (DETE) 

165 

 
 
 
 
 
 
 
 
The Department of Enterprise, Trade and Employment (DETE) in Ireland is a government department 
responsible  for  fostering  economic  growth,  promoting  job  creation,  and  supporting  businesses.  Its 
primary mission is to create a competitive and innovative business environment.   

Advanced Research and Development Capacities 
Through various grants DETE ensures the development of life sciences companies at every stage of 
development. In specific, IDA Ireland and Enterprise Ireland offer RD&I funding to assist companies in 
developing  new  products  or  services  that  involve  significant  technical  challenges  or  represent  a 
substantial advancement in their RD&I capabilities.  

The COVID-19 Non-Exclusive Royalty-Free (NERF) Licence is an example of action undertaken under 
the  Department  of  Enterprise,  Trade  and  Employment  in  terms  of  facilitating  enterprise  innovation 
during the COVID-19 Pandemic. This was set up in April 2020 by Knowledge Transfer Ireland (KTI), an 
office  within  Enterprise  Ireland  under  the  aegis  of  DETE.  KTI  worked  with  the  Technology  Transfer 
Offices in the Irish higher education sector nationwide to produce a simple two-page agreement aimed 
at speeding up the dissemination of critical COVID-19 related intellectual property from Irish universities, 
technological  universities  and  institutes  of  technology  to  companies.  The  COVID-19  NERF  licence 
provided cutting edge IP free of charge to organisations engaged in critical research and development 
activities  for  the  sole  purposes  of  diagnosing,  preventing,  containing,  treating  and/or  minimising  the 
impact of the virus. It remained in place until the World Health Organisation declared the COVID-19 
pandemic to have ended.  

Production / Manufacturing Capacities 
The  Department  of  Enterprise,  Trade  and  Employment  plays  a  role  in  engagement  with  industry 
partners, including producers of MCMs, to ensure adequate emergency supplies during a health crisis. 
It has the responsibility to maintain communication lines with these entities and to align government 
health policies with industrial operations, ensuring effective emergency preparedness. Generally liaising 
with  employers  and  industry  to  ensure  clear  communications  around  issues  would  be  partly  the 
responsibility of DETE in a crisis. During the Covid-19 pandemic, DETE administered crisis-relevant EU 
export controls.

166 

 
 
 
 
 
 
o. Italy 

Overview of approach to preparedness and response to public health emergency in MCMs 

Monitoring, Intelligence Gathering and Analysis 
In Italy, the Ministry of Health (MoH) carries out monitoring and intelligence gathering, utilizing robust 
risk  assessment  and  surveillance  systems  to  detect  and  respond  to  health  threats  early,  including 
identifying medical countermeasures. The Instituto Superiore di Sanità (ISS) significantly contributes by 
collecting  and  analysing  health  data,  conducting  epidemiological  studies,  and  monitoring  disease 
patterns to inform public health decisions. Regions and autonomous provinces implement and adapt 
national surveillance protocols, ensuring that local health data is accurately collected and transmitted 
to national systems.  

Advanced Research and Development Capacities 
The Ministry of Health is primarily involved in promoting advanced research and development capacities 
in the field of MCMs. Regions and autonomous provinces also play a role by collaborating with local 
universities and research institutions to conduct research on new medical technologies and treatments. 
The  Italian  Medicines  Agency  (AIFA)  is  promoting  scientific  research  on  strategic  drug  sectors,  and 
financing studies not aimed at commercial purposes. This initiative is supported by contributions from 
pharmaceutical companies.  

Production / Manufacturing Capacities 
The Ministry of Enterprises and Made in Italy ensures the continuous production of necessary medical 
supplies, devices, and personal protective equipment (PPE) on a national scale. This initiative is crucial 
for maintaining supply chain stability during health crises. Regions and autonomous provinces support 
this by providing financial incentives and subsidies to local manufacturers to boost production capacities, 
ensuring a steady supply of essential MCMs during emergencies. 

Procurement of MCMs 
The Italian MoH develops national guidelines for the procurement of MCMs, ensuring consistency and 
standardization  across  regions.  The  Ministry  leads  centralized  procurement  efforts  during  crises. 
Regions  and autonomous provinces  also  have  the autonomy  to  procure  additional  MCMs  based  on 
local  needs,  complementing  national  efforts.  AIFA  collaborates  with  various  stakeholders,  including 
regions and research institutes, to ensure the availability and proper supply of medicines.  

Stockpiling and Distribution Capacities 
The MoH oversees the national stockpiling of MCMs, maintaining strategic reserves and coordinating 
with  regional  authorities  for  efficient  distribution  during  emergencies.  Regions  and  autonomous 
provinces manage their own stockpiles of essential medical supplies, complementing national reserves 
and ensuring timely delivery to local healthcare providers.  

International Cooperation 
The Italian MoH actively engages in international cooperation with entities like the ECDC, WHO, and 
EU health security projects. It supports low- and middle-income countries in strengthening their health 
surveillance systems and manages cross-border health threats through joint actions and data-sharing 
mechanisms. AIFA, in collaboration with the Ministry of Health, participates in international projects to 
manage  medicine  shortages  and  establish  agreements  with  third  countries  on  MCMs.  Regions  and 
autonomous  provinces,  especially  those  bordering  other  countries,  also  participate  in  cross-border 
health emergency drills and joint response strategies. 

167 

 
 
 
 
 
 
 
 
 
Health Security Coordination 
The  MoH  coordinates  national  public  health  crisis  responses,  collaborating  with  regional  health 
authorities, emergency services, and other stakeholders. The CPD plays a critical role in health security 
coordination  during  emergencies,  developing  and  implementing  response  plans.  Regions  and 
autonomous  provinces  develop  specific  health  security  plans  that  align  with  national  strategies, 
ensuring effective implementation of health security measures.  

Comprehensive mapping of identified entities 

Ministry of Health (MoH) 
The Ministry of Health (MoH) in Italy is the government department responsible for safeguarding public 
health and ensuring the delivery of high-quality healthcare services to citizens. The ministry oversees 
the national healthcare system, coordinates public health initiatives, and monitors healthcare delivery 
to ensure accessibility, effectiveness, and equity across the country. 

Monitoring, Intelligence Gathering and Analysis 
The Ministry engages in robust risk assessment and surveillance to monitor health threats and identify 
potential  outbreaks  early  on.  This  involves  monitoring  disease  patterns,  conducting  epidemiological 
studies, identifying countermeasures and assessing the effectiveness of public health interventions. 

Advanced Research and Development Capacities 
The  Ministry 
financing  research  and  development  of  medical 
countermeasures.  It  provides  financial  support  for  research  projects  through  grants  and  funding 
programs to universities, research institutes, and private sector companies engaged in developing new 
medical technologies, pharmaceuticals, vaccines, and other countermeasures. 

funding  and 

involved 

in 

is 

Procurement of MCMs 
The Italian MoH is responsible for developing national guidelines and frameworks for the procurement. 
These guidelines ensure consistency and standardization across all regions. The Ministry sets priorities 
for national health security and outlines the types of MCMs that should be procured based on threat 
assessments and public health needs. In some cases, the Ministry of Health engages in centralized 
procurement  to  leverage  bulk  purchasing  power.  This  centralised  approach  was  used  during  the 
COVID-19  pandemic,  when  the  Ministry  of  Health  led  efforts  to  procure  COVID-19  vaccines  from 
various  manufacturers,  negotiating  contracts  and  securing  doses  to  meet  the  country's  vaccination 
needs.  Generally,  the  Ministry  oversees  the  acquisition  of  vaccines,  antiviral  medications,  personal 
protective  equipment  (PPE),  and  other  essential  medical  supplies  necessary  to  ensure  an  effective 
response to health crises.  

Stockpiling and distribution of MCMs 
As for procurement, the Ministry develops national guidelines and frameworks for stockpiling of MCMs 
and  prioritises  MCMs  that  should  be  stockpiled.  The  Ministry  oversees  the  management  of  national 

168 

 
 
 
 
 
 
 
 
 
stockpiles of MCMs, maintains strategic reserves of vaccines, antiviral medications, and other critical 
medical countermeasures to respond promptly to outbreaks and health emergencies. Among others, it 
maintains stockpiles of influenza vaccines to mitigate the impact of seasonal flu outbreaks and protect 
vulnerable populations.  It also includes the storage of essential medical supplies, such as ventilators, 
respirators, and intensive care unit (ICU) equipment. It coordinates with regional authorities to distribute 
these supplies efficiently during emergencies, ensuring that regions receive the necessary resources 
based on the severity of local outbreaks. 

International Cooperation 
The Ministry cooperates with the ECDC and the WHO on initiatives like epidemic intelligence and global 
health  security.  It  participates  in  EU  health  security  projects  such  as  EU4Health  to  supports  the 
development of strategic MCM stockpiles and enhanced laboratory capacities. The Ministry also aids 
low- and middle-income countries by strengthening their health surveillance systems in partnership with 
the African CDC and other global entities. It is involved in managing cross-border health threats through 
joint  actions,  establishing  efficient  data-sharing  mechanisms.  Additionally,  the  Ministry  engages  in 
bilateral  and  multilateral  agreements  for  coordinated  health  emergency  responses  and  actively 
participates in EU health policy development to ensure robust health security frameworks. 

Health security coordination 
Italy’s MoH is in charge of coordinating public health crisis response. In the event of a health emergency, 
the Ministry coordinates national response efforts, including the deployment of MCMs. This involves 
collaboration with regional health authorities, emergency services, and other relevant stakeholders to 
ensure a unified and effective response. The Ministry also oversees the logistical aspects of distributing 
MCMs to regions, such as vaccines, medications, and personal protective equipment (PPE). 

National Department of the Civil Protection (CPD) 
The  Civil  Protection  Department  (CPD)  in  Italy  is  a  key  organisation  responsible  for  managing  and 
coordinating responses to emergencies and disasters throughout the country. Under the oversight of 
the  Presidency  of  the  Council  of  Ministers,  the  CPD  focuses  on  disaster  prevention,  preparedness, 
response, and recovery efforts. 

Health Security coordination 
CPD plays a critical role in health security coordination, particularly during public health emergencies 
and crises. One of its primary missions is to develop and implement emergency response plans and 
protocols to address health-related hazards and threats effectively. During the COVID-19 pandemic, 
the  CPD  worked  in  collaboration  with  the  Italian  Ministry  of  Health  to  coordinate  the  deployment  of 
medical resources, such as personal protective equipment, ventilators, and other essential supplies, to 
areas  experiencing  surges  in  COVID-19  cases.  The  CPD  also  facilitated  the  establishment  of  field 
hospitals and temporary medical facilities to expand healthcare capacity and ensure adequate care for 
patients. 

National Institute of Health (IIS) 
The National Institute of Health (IIS), stands as a cornerstone of public health research, policy, and 
guidance  within  Italy.  Established  with  the  aim  of  safeguarding  and  promoting  the  health  of  the 
population, the ISS plays a pivotal role in advancing scientific knowledge, providing expert advice to 
policymakers, and coordinating national health initiatives. 

Monitoring, Intelligence Gathering and Analysis: 
The  Institute  collects  and  analyses  data  on  various  health  indicators,  including  disease  incidence, 
prevalence, and trends, to assess the health status of the population and detect potential health threats 
early. The ISS conducts surveillance of infectious diseases, chronic conditions, environmental health 
hazards, and other health-related factors. This information contributes to the identification of medical 
countermeasures and is key for decision making within the Ministry of Health in case of health crisis, 
also with regards to decisions concerning MCMs. 

Health security coordination:  
ISS engages in health security coordination through various initiatives and activities. During the COVID-
19  pandemic,  the  ISS  worked  closely  with  the  Italian  Ministry  of  Health  and  regional  authorities  to 
establish a national surveillance system for monitoring COVID-19 cases, conducting contact tracing, 
and assessing the impact of containment measures. The institute also led efforts to provide training and 

169 

 
 
 
 
 
 
 
 
technical assistance to healthcare professionals and public health workers across the country, ensuring 
a standardized approach to pandemic response. 

Italian Medicines Agency (AIFA) 
The Italian Medicines Agency (AIFA) is the national public body that regulates medicines for human 
use in Italy.  

Advanced Research and Development Capacities  
AIFA promotes public scientific research on strategic drug sectors, even in areas of little interest for 
profit  research.  The  AIFA  independent  research  program  is  aimed  at  all  Italian  researchers  from 
institutions who intend to conduct studies not for commercial purposes and is financed by a share of 
the fund made up of the contribution equal to 5% of the promotional expenses incurred annually by 
pharmaceutical companies.  

Procurement of MCMs 
AIFA cooperates with the regions and autonomous provinces, the Italian National Institute of Health 
(ISS),  scientific  institutes  for  research,  hospitalisation  and  healthcare,  patient  associations  and 
physicians to ensure the availability and proper supply and distribution of medicines. In addition, AIFA 
is actively involved in international projects relating to the management of shortages (e.g. leading role 
in the CHESSMAN joint action; participation in the HMA-EMA TFAAM). 

International Cooperation 
Collaborative  relationships  with  both  EU  and  non-EU  countries  are  regulated  by  specific  bilateral 
agreements. AIFA, in collaboration with the Ministry of Health, participates in the initiatives promoted 
by  the  Ministry  of  Foreign  Affairs  aimed  at  stipulating  agreements  with  third  countries  on  medical 
countermeasures. 

Regions/Autonomous provinces 
Regions and autonomous provinces act as frontline forces during health crisis. These local entities fulfil 
their  roles  by  implementing  pandemic  plans  effectively.  This  includes  procuring  the  necessary 
medicines, supplies, and medical devices, and coordinating with the Ministry of Health to maintain or 
identify storage facilities to secure critical healthcare supplies such as PPE, vaccines, and medicine. 

Monitoring, Intelligence Gathering and Analysis 
Regions  and  autonomous  provinces  implement  and  adapt  national  health  surveillance  protocols  to 
monitor public health trends, manage outbreaks, and ensure adherence to national health standards. 
This includes monitoring the performance of diagnostic and therapeutic pathways for specific diseases, 
as  well  as  the  supply  of  MCMs  locally.  Each  region  and  autonomous  province  is  responsible  for 
collecting health data from their respective healthcare facilities and transmitting this data to the national 
health information systems. 

Advanced Research and Development Capacities 
Regions  and  autonomous  provinces  collaborate  with  local  universities,  research  institutions,  and 
healthcare facilities to conduct research on new medical technologies and treatments. For instance, 
they may fund or participate in clinical trials and public health research projects aimed at improving 
health outcomes and developing new MCMs. Some regions have established innovation hubs or health 
technology clusters that focus on the development and commercialization of new healthcare solutions, 
including MCMs.  

Production / Manufacturing capacities 
Regions  and  autonomous  provinces  can  provide  financial  incentives,  grants,  and  subsidies  to  local 
manufacturers of medical supplies and pharmaceuticals to boost production capacities. This support 
helps ensure a steady supply of necessary MCMs during health emergencies. 

170 

 
 
 
 
 
 
 
 
 
 
Procurement of MCMs 
Regions and autonomous provinces are involved in the procurement of medical supplies, working in 
coordination with national authorities to acquire MCMs efficiently. Regions and autonomous provinces 
have  the  autonomy  to  procure  additional  MCMs,  on  top  of  those  that  are  covered  by  national 
procurement efforts, based on their specific needs and circumstances. 

Stockpiling and Distribution Capacities 
Regions and autonomous provinces maintain strategic reserves of essential medical supplies, including 
vaccines, antiviral drugs, and protective equipment. Each region is responsible for maintaining its own 
stockpiles of essential medical supplies. These regional stockpiles complement the national reserves. 
Regions and autonomous provinces develop plans in place for the rapid distribution of stockpiled MCMs 
during public health crises. Finally, they manage the distribution of MCMs to local healthcare providers, 
ensuring timely delivery to hospitals, clinics, and pharmacies based on assessed needs and priority 
areas. 

International Cooperations 
Regions  and  autonomous  provinces,  particularly  those  bordering  other  countries,  engage  in 
international  health  cooperation.  This  involves  sharing  information  and  resources  with  neighbouring 
regions in other countries and participating in cross-border health emergency drills and joint response 
strategies. 

Health Security Coordination 
Each region and autonomous province develop specific health security plans that align with national 
strategies.  These  plans  address 
the  roles  and  responsibilities  of 
local  risks  and  outline 
regional/provincial health authorities in managing public health emergencies. They work closely with 
the Ministry of Health and other national entities to ensure that health security measures are effectively 
implemented. 

Ministry of Enterprises and Made in Italy 
The Ministry of Enterprises and Made in Italy in Italy is a governmental department tasked with fostering 
economic  development,  supporting  entrepreneurship,  and  promoting  the  country's  renowned 
craftsmanship and products. 

Production / Manufacturing capacities 
Recognizing the vital role of supply chains in managing health crises, the Ministry of Enterprises and 
Made in Italy ensures the continuous production of necessary supplies, medical devices, and PPE on 
a national scale. This proactive strategy has been shaped by the lessons Italy learned from the COVID-
19 crisis.

171 

 
 
 
 
 
 
 
 
p. Latvia 

Overview of approach to preparedness and response to public health emergency in MCMs 

Monitoring, Intelligence Gathering, and Analysis 
In Latvia, the Centre for Disease Prevention and Control (SPKC) is the primary entity responsible for 
monitoring,  intelligence  gathering,  and  analysis.  The  SPKC  conducts  epidemiological  surveillance, 
monitors infectious diseases and identifies countermeasures.  

Advanced Research and Development Capacities 
Advanced research and development capacities in Latvia are supported by the Ministry of Health and 
institutions such as Riga Stradins University. The Ministry of Health promotes research and innovation 
to develop medical countermeasures.  

Production / Manufacturing Capacities 
The  Ministry  of  Health  negotiates  with  local  medicines  manufacturers  to  ensure  access  to  essential 
medicines during emergencies. This coordination helps maintain a stable supply chain and enhances 
the country's capacity to respond effectively to health emergencies. 

Procurement of MCMs 
The procurement of MCMs in Latvia is managed by the Ministry of Health and the Ministry of Interior 
under  the  framework  of  the  Law  on  the  State  Material  Reserves.  The  Ministry  of  Health  evaluates 
potential health threats, conducts risk assessments, and collaborates with subordinate institutions to 
plan and manage the creation of state material reserves. The Ministry of Interior supports these efforts, 
ensuring  the  storage,  maintenance,  and  readiness  of  these  reserves  in  alignment  with  disaster 
management plans. 

Stockpiling and Distribution Capacities 
The  Ministry  of  Health,  in  collaboration  with  the  Ministry  of  Interior,  oversees  the  stockpiling  and 
distribution of MCMs as per the Law on the State Material Reserves. The Ministry of Health submits 
annual reports on reserve activities and proposes necessary changes based on evaluations. It oversees 
the issuance of MCMs to authorities involved in disaster management and ensures regular evaluations 
of reserve security. The SPKC plays a role in the vaccine distribution process, coordinating requests 
from healthcare providers and managing distribution plans during emergencies. 

International Cooperation 
International cooperation is facilitated by the Ministry of Health’s Department for European Affairs and 
International  Cooperation  and  the  SPKC.  The  Ministry  of  Health  collaborates  with  international 
organisations like the WHO, EU, and neighbouring countries to exchange best practices and coordinate 
joint initiatives. The SPKC serves as a competent body and focal point for various international topics, 
cooperating with the ECDC and WHO, and in joint EU activities on MCM planning and procurement.  

Health Security Coordination 
Health  security  coordination  in  Latvia  involves  multiple  entities,  primarily  the  Ministry  of  Health,  the 
SPKC, and the Ministry of Interior. The Ministry of Health coordinates disaster management related to 
epidemics  under  the  Civil  Protection  and  Disaster  Management  Law.  The  State  Operative  Medical 
Commission,  convened  by  the  State  Secretary  of  the  Ministry  of  Health,  coordinates  health  sector 
response during disasters. The SPKC plans and coordinates measures for the prevention and control 
of infectious diseases and manages state immunization policy. The Ministry of Interior oversees civil 
protection and disaster management. 

172 

 
 
 
 
 
 
 
 
 
 
Comprehensive mapping of identified entities 

Ministry of Health  
The Ministry of Health of Latvia is the government department responsible for overseeing and regulating 
healthcare  policies,  services,  and  initiatives  within  the  country.  Its  primary  mission  is  to  protect  and 
promote public health, ensure access to quality healthcare services, and coordinate responses to health 
emergencies  and  crises.  The  Ministry  formulates  health  policies,  regulates  healthcare  providers, 
manages public health programs, and collaborates with national and international partners to address 
health  challenges  effectively.  Additionally,  it  oversees  the  allocation  of  healthcare  resources  and 
funding, conducts research, and provides guidance on health-related matters to ensure the well-being 
of the population. 

Advanced Research and Development capacities: 
The Ministry of Health supports advanced research, innovation, and development for effective, safe, 
and  affordable  medical  countermeasures.  Institutions  subordinate  to  the  Ministry  of  Health,  such  as 
Riga Stradins University, participate in research.  

Production / Manufacturing capacities :  
The Ministry of Health negotiates with local medicines manufacturers to ensure access to medicines in 
emergencies and to produce medicines on the critical list. 

Procurement of MCMs:  
The Ministry of Health of Latvia is tasked with the procurement of medical countermeasures as part of 
its responsibilities outlined in the Law on the State Material Reserves. In accordance with this law, the 
Ministry  evaluates  potential  threats  and  conducts  risk  assessments  to  determine  the  need  for  State 
material reserves in the health sector. Collaborating with subordinate institutions, the Ministry plans and 
manages the creation of these reserves, ensuring their adequacy and readiness for emergencies. This 
includes purchasing MCMs according to approved nomenclature within allocated financial resources, 
as well as replenishing reserves as needed. 

173 

 
 
 
 
 
 
 
 
Stockpiling and distribution capacities:  
The  Ministry  of  Health  of  Latvia  fulfils  a  crucial  role  in  the  stockpiling  and  distribution  of  medical 
countermeasures in accordance with the Law on the State Material Reserves. The Ministry submits 
annual reports on reserve activities to the Ministry of the Interior and proposes necessary changes to 
the nomenclature of state material reserves based on evaluation outcomes. The Ministry oversees the 
issuance of MCMs to relevant authorities involved in disaster management, military, and other threats, 
while also managing inventory and conducting regular evaluations of reserve security.  

International cooperation:  
Through  its  Department  for  European  Affairs  and  International  Cooperation,  the  MoH  engages  in 
collaborative  efforts  with  international  organisations  such  as  the  WHO,  the  EU,  and  neighbouring 
countries to exchange best practices, share expertise, and coordinate joint initiatives. For instance, the 
MoH actively participates in EU networks and initiatives, contributing to the development of regional 
and global strategies for disease prevention and control. 

Health Security cooperation:  
The  Latvian  Ministry  of  Health  is  entrusted  with  monitoring,  intelligence  gathering,  and  analysis  to 
ensure  effective  preparation  and  response  to  public  health  crises.  Through  its  Crisis  Management 
Division, the MoH oversees the coordination of disaster management related to epidemics of human 
infectious diseases, as stipulated by the Civil Protection and Disaster Management Law. It collaborates 
with the State Emergency Medical Service and other institutions to conduct risk assessments, develop 
preventive strategies, and formulate plans for crisis management in the health sector. 

Upon receiving information about a medical emergency from the State Emergency Medical Service, the 
State Secretary of the Ministry of Health promptly convenes the State Operative Medical Commission 
to address the situation. This Commission coordinates the response efforts of health sector institutions 
during disasters, including medical and public health emergencies. It evaluates the emergency's causes, 
progression, and  measures  taken,  providing  recommendations  to the  Minister  for  Health  on utilizing 
national material reserves and seeking assistance from foreign entities. Empowered by the Ministry, 
the Commission's Chairman, the Secretary of State, holds the authority to declare medical or public 
emergencies within the country. 

Centre for Disease Prevention and Control (SPKC) 
The Centre for Disease Prevention and Control (SPKC) operates under the Minister of Health. It plays 
a crucial role in implementing public health policy, focusing on epidemiological safety and health care 
quality.  Key  responsibilities  include  ensuring  epidemiological  surveillance  and  monitoring  infectious 
diseases, implementing measures to prevent the spread of infectious diseases, and coordinating and 
monitoring  policy  implementation  in  the  field  of  epidemiological  safety.  The  SPKC  also  engages  in 
international cooperation regarding epidemiological safety. 

Monitoring, Intelligence Gathering and Analysis: 
In  accordance  with  the  legislation,  SPKC  provides  epidemiological  surveillance  and  monitoring  of 
infectious  diseases,  epidemic  intelligence,  prevention,  and  control  measures  in  Latvia,  including  the 
identification  and  implementation  of  countermeasures  for  various  public  health  concerns.  SPKC 
performs  epidemiological  investigations  of  cases  of  infectious  diseases  or  outbreak,  organise  the 
laboratory examination of environmental objects and exposed persons, organise prevention and control 
measures  in  the  foci  of  infectious  diseases.  SPKC  also  performs  epidemiological  investigations  of 
diseases caused by threats of unknown origin, including detection and medical observation of exposed 
persons, and, where necessary, isolation.  

Stockpiling and distribution capacities:  
Even though SPKC is not directly in charge of stockpiling and is not the distributor of any MCMs, it 
coordinates vaccine distribution process, collects requests from health care providers, evaluates, and 
forwards  them  to  appropriate  pharmaceutical  wholesalers  for  distribution.  It  therefore  has  a  strong 
power regarding distribution plans in case of emergency.  

174 

 
 
 
 
 
 
 
International Cooperation:  
SPKC cooperates with ECDC as the competent body and focal points on various topics. SPKC also 
collaborates  with  WHO  on  infectious  disease  surveillance  and  immunization  and  with  the  Latvian 
authorities responsible for joint EU activities on MCMs planning and procurement. 

Health Security Coordination:  
SPKC plans and coordinates measures for the prevention and control of infectious diseases. It manages 
the implementation of the state immunization policy, evaluates its effectiveness, plans vaccination of 
the population and provides information on the required quantity of vaccines to the Ministry of Health. 

Ministry of Interior 
The Ministry of Interior of Latvia is a key government body responsible for maintaining public order, 
ensuring national security, and coordinating emergency response efforts. In the context of public health 
crises, the Ministry plays a role in supporting and complementing the efforts of SPKC and Ministry of 
Health. It oversees civil protection and disaster management, including the coordination of responses 
to health emergencies such as pandemics or natural disasters with health implications. 

Procurement of MCMs:  
The Ministry of Interior is tasked with MoH of the procurement of medical countermeasures as part of 
its responsibilities outlined in the Law on the State Material Reserves. 

Stockpiling and distribution capacities:  
The  Ministry  of  Interior  is  responsible  for  the  management  of  State  material  reserves,  including  the 
stockpiling of MCMs. It ensures the storage, maintenance, and readiness of these reserves, separate 
from  other  material  resources,  to  be  involved  in  implementing  measures  specified  in  disaster 
management  plans.  The  Ministry  oversees  the  replenishment  of  MCM  stocks  as  needed,  based  on 
evaluations of reserve security and risk assessments. Collaboration with the Ministry of Health ensures 
that distribution and utilization of MCMs are coordinated effectively, aligning with public health priorities 
and response strategies. 

Health Security Coordination:  
The Ministry of Interior of Latvia assumes a HERA-like role in coordinating disaster management and 
civil protection efforts, including those related to public health crises. Under the Civil Protection and 
Disaster Management Law, the Ministry oversees the management of various disasters, such as fires, 
earthquakes, and transport accidents, extending its responsibilities to include epidemics and pandemics. 
Together with its subordinate institution, the State Fire and Rescue Service, the Ministry develops and 
updates the State Civil Defence Plan, which encompasses preventive, preparedness, response, and 
mitigation measures for diverse threats, including health emergencies.

175 

 
 
 
 
 
 
 
 
 
q. Lithuania 

Overview of approach to preparedness and response to public health emergency in MCMs 

Monitoring, Intelligence Gathering, and Analysis 
In Lithuania, monitoring and intelligence gathering are key responsibilities of the Ministry of Health and 
the National Crisis Management Centre (NCMC). The Ministry of Health oversees the surveillance of 
communicable diseases and other health threats, collecting and analysing health data to identify the 
need  for  specific  medical  countermeasures.  The  NCMC  continuously  monitors  potential  threats  to 
national security, including health-related risks. 

Advanced Research and Development Capacities 
Advanced research and development capacities in Lithuania are supported by the Ministry of Health 
and  carried  out  by  institutions  like  the  Vilnius  University  Life  Sciences  Center  (VU  LSC).  While  the 
Ministry facilitates and supports research initiatives aimed at developing new medical countermeasures, 
research institutions, such as the VU LSC, contribute to the development of diagnostics, vaccines, and 
other therapeutic measures essential for addressing public health emergencies. 

Production / Manufacturing Capacities 
The Ministry of Health plays a crucial role in supporting the healthcare infrastructure, which includes 
aspects  related  to  the  production  and  manufacturing  of  health  products.  The  Ministry  ensures  the 
availability of medicines and medical supplies across the country by monitoring data from healthcare 
providers and other stakeholders to identify potential shortages and supply chain issues. In the event 
of  identified  shortages,  the  Ministry  coordinates  with  manufacturers,  distributors,  and  healthcare 
facilities to address these issues, ensuring a stable supply of essential medical products. 

Procurement of MCMs 
The procurement of MCMs in Lithuania is managed by the Ministry of Health and the Health Emergency 
Situations  Centre  (HESC).  The  Ministry  regulates  procurement  processes,  while  the  HESC  is 
responsible for the operational management of MCM procurement.  

Stockpiling and Distribution Capacities 
Stockpiling and distribution of MCMs are overseen by the Ministry of Health and managed by the HESC. 
The  Ministry  coordinates  the  activities  related  to  stockpiling,  whereas  HESC  handles  the  practical 
aspects  of  maintaining  and  distributing  stockpiles,  including  strategic  planning,  management,  and 
deployment of vital medical supplies during crises. Medical institutions are required by law to maintain 
adequate stockpiles. 

International Cooperation 
Lithuania's  Ministry  of  Health  actively  participates  in  international  health  initiatives  and  programs, 
engaging with organisations such as the ECDC and the WHO. The Ministry collaborates on EU-wide 
health policies and participates in the Joint Procurement Agreement. 

Health Security Coordination 
Health security coordination in Lithuania involves multiple entities, primarily the Ministry of Health, the 
HESC, and the NCMC. The Ministry of Health, through its regulatory and oversight functions, ensures 
the  implementation  of  health  legislation  and  the  coordination  of  health  policies.  The  HESC  plays  a 
pivotal role in managing health emergencies by coordinating the activities of the National Health System 
institutions and administering the State Medical Reserve. During crises, the NCMC disseminates critical 
information to national authorities and consolidates input from various sectors to ensure a coordinated 
and effective response. 

176 

 
 
 
 
 
 
 
 
 
Comprehensive mapping of identified entities 

Ministry of Health  
The Ministry of Health of Lithuania is the principal government institution responsible for the country's 
public  health  policies,  regulation,  and  oversight.  It  ensures  the  implementation  of  health  legislation, 
formulates health policy, and oversees the National Health Insurance Fund (NHIF). 

Monitoring, Intelligence Gathering and Analysis 
The Ministry is involved in monitoring health data and gathering intelligence on various health indicators. 
This  is  part  of  its  broader  public  health  responsibilities,  which  include  surveillance  of  communicable 
diseases and other health threats. Based on the data collected through monitoring and surveillance, 
the Ministry identifies the need for specific medical countermeasures. 

Advanced Research and Development 
While the Ministry itself does not directly conduct research, it supports and facilitates research initiatives 
aimed at developing new countermeasures. This support includes funding, collaboration with research 
institutions,  and  participation  in  international  research  efforts.  In  specific,  support  to  the  Vilnius 
University Life Sciences Center (VU LSC) contributes to advancing research and development of MCMs 
in  Lithuania.  This  institution  is  heavily  involved  in  biotechnology  and  life  sciences  research,  which 
includes  the  development  of  diagnostics,  vaccines,  and  other  therapeutic  measures  essential  for 
addressing public health emergencies. 

Production / Manufacturing Capacities 
The  Ministry  supports  the  healthcare  infrastructure,  which  includes  aspects  of  production  and 
manufacturing  related  to  health  products.  This  includes  approving  capital  investments  in  healthcare 
facilities and working with the National Health Insurance Fund (NHIF). The Ministry closely monitors the 
availability of medicines and medical supplies across the country. It uses data collected from healthcare 
providers and other stakeholders to identify potential shortages and supply chain issues early. In cases 
of  identified  shortages  or  bottlenecks,  the  Ministry  coordinates  with  relevant  stakeholders,  including 
manufacturers, distributors, and healthcare facilities, to address these issues. 

177 

 
 
 
 
 
 
 
 
 
Procurement of MCMs 
The Ministry is responsible for regulating with regards to procurement and stockpiling of MCMs. The 
Health Emergency Situations Centre follows the Ministry’s guidelines and regulations in delivering on 
its role of primary responsible for the operational management of the procurement of MCMs. All MCMs 
in Lithuania, regardless of the executor, are procured through public procurement processes. During 
emergencies,  Lithuanian  legislation  permits  procurement  under  simplified  conditions,  enabling  swift 
public  procurement  procedures.  The  Ministry  has  been  involved  in  both  national  and  EU-level 
procurement initiatives to ensure adequate supplies of medicines and health products.  

Stockpiling and Distribution Capacities 
The Ministry oversees and coordinates the activities of various health institutions, including the HESC, 
to ensure compliance with national health policies. This includes monitoring the adequacy of stockpiles 
maintained  by  medical  institutions.  On  the  other  hand,  the  HESC  handles  the  practical  aspects  of 
maintaining and distributing stockpiles. 

International Cooperation 
Lithuania’s Ministry of Health actively participates in EU health initiatives and programs. This includes 
involvement in the European Centre for Disease Prevention and Control (ECDC), cooperation on EU-
wide  health  policies,  such  as  the  Health  Security  Committee,  as  well  as  on  the  Joint  Procurement 
Agreement.  It  cooperates  with  the  WHO  and  international  partners  to  enhance  emergency 
preparedness and response capabilities worldwide.  

Health Emergency Situations Centre (HESC) 
The  Health  Emergency  Situations  Centre  (HESC)  in  Lithuania  plays  a  pivotal  role  in  the  country's 
preventative health care strategy. A core responsibility of the HESC is to establish and implement a 
national health emergencies management system. This system is designed to ensure that all institutions 
within the National Health System are thoroughly prepared and coordinated to effectively respond to 
any health emergency that may arise. 

Mode of operation 
During  preparedness,  the  HESC  in  Lithuania  meticulously  coordinates  the  activities  of  the  National 
Health  System  institutions,  ensuring  they  are  well-equipped  and  prepared  for  emergencies.  This 
includes  providing  Personal  HealthCare  institutions  with  necessary  tools  for  potential  radiological 
emergencies, monitoring their preparedness, making recommendations for improvement, and offering 
methodological  guidance.  The  HESC  also  accumulates  and  analyses  information  on  health 
emergencies,  their  consequences,  and  the  effectiveness  of  public  health  protection  measures, 
contributing  to  a  comprehensive  understanding  of  emergency  situations.  Additionally,  the  centre 
actively participates in the drafting of legislation related to health emergencies, providing expertise and 
recommendations to strengthen the legal framework.  

During crisis response mode, the HESC swiftly disseminates vital information to national authorities, 
detailing the crisis, its consequences, implemented public health measures, and mitigation strategies. 
The  centre  collaborates  with  various  sectors,  consolidating  input  from  surveillance,  public  health 
services, and government departments, to ensure a coordinated and effective response to the crisis, 
thereby safeguarding public health. 

Procurement of MCMs 
As part of its role of administrator of the State Medical Reserve, the HESC has responsibilities with 
regards to procurement of MCMs. The HESC is directly responsible for the operational management of 
the procurement of MCMs and is involved in conducting public procurement processes, including under 
simplified conditions during emergencies, to quickly secure necessary medical supplies. 

Stockpiling and Distribution Capacities 
An  essential  function  of  the  HESC  is  the  administration  of  the  State  Medical  Reserve.  This  entails 
strategic planning, stockpiling, management, and deployment of vital medical supplies and equipment 
crucial for crisis and emergency response. The HESC ensures that these medical supplies are readily 
available and targeted for use during crises, which is essential for efficient response and recovery during 
health emergencies. The State Reserve system in Lithuania ensures that medical stockpiles are issued 
during emergencies or crises as needed, in accordance with established regulations and procedures 
established by the Ministry of Health. Presently, medical institutions are mandated by law to maintain 

178 

 
 
 
 
 
 
 
 
an adequate amount of stockpiles necessary for their operations, as stipulated by the Minister of Health. 
Some institutions store stockpiles for periods exceeding three months in their warehouses. 

National Crisis Management Centre (NCMC) 
The National Crisis Management Centre (NCMC) in Lithuania, operating within the Government's Office 
is tasked with continuous monitoring of threats to national security. The NCMC serves as an operational 
institution responsible for coordinating responses to various crises, including health emergencies.  

Monitoring, Intelligence Gathering and Analysis 
The  NCMC  monitors  potential  threats  to  national  security,  including  health-related  risks.  Drawing 
intelligence  from  diverse  sources  such  as  domestic  agencies  and  international  partners,  the  NCMC 
conducts comprehensive analyses to identify emerging risks and assess the severity of various threats. 
This data-driven approach enables informed decision-making and the development of effective crisis 
response strategies. Regular risk assessments, including a focus on health risks, ensure a proactive 
stance in identifying and preparing for potential health emergencies. 

Health Security Coordination 
During public health crises, the NCMC disseminates information to national authorities regarding the 
health  emergency,  its  consequences,  and  the  public  health  protection  measures  being  taken.  The 
centre also consolidates input from various sectors, including surveillance and reporting entities, public 
health services, clinics, hospitals, and other government departments. This coordination aims to ensure 
a cohesive and effective response to health emergencies at the national lev

179 

 
 
 
 
 
 
r.  Luxembourg 

Overview of approach to preparedness and response to public health emergency in MCMs 

Monitoring, Intelligence Gathering, and Analysis  
In Luxembourg, The emergency preparedness and response unit is part of the Directorate of Health, 
under the authority of the Ministry of Health and Social Security. The Emergency Preparedness and 
Response unit, along with the High Commission for National Protection (HCPN) and the Laboratoire 
National de Santé (LNS), are key players in monitoring and intelligence gathering. The Ministry’s unit 
focuses on identifying medical countermeasures and prioritizing threats, developing capabilities through 
training and coordination with national and international stakeholders. The HCPN conducts continuous 
risk analysis of potential threats, including health risks, and collaborates with health experts to develop 
emergency  response  plans.  The  LNS  provides  critical  epidemiological  surveillance,  diagnosis,  and 
tracking of infectious diseases.  

Advanced Research and Development Capacities  
The Ministry of Health supports and facilitates research initiatives, partnering with institutions such as 
the Luxembourg Institute of Health and the Luxembourg Institute of Science and Technology. The LNS 
conducts advanced research to improve diagnostics, genomic surveillance, and pandemic response.  

Production / Manufacturing Capacities  
The Ministry of Health's Emergency Preparedness and Response unit works in cooperation with other 
units on critical medicines and reviews national stockpiling strategies to ensure an adequate supply 
during emergencies. It is also involved in establishing a national purchasing and storage centre (CNAL), 
which will centralize procurement and storage operations.  

Procurement of MCMs  
Procurement  of  MCMs  in  Luxembourg  involves  several  entities  within  the  Ministry  of  Health.  The 
Service ‘Risques de Santé’ handles the procurement of vaccines and antidotes, while the Luxembourg 
Hospital  Federation  (FHL)  is  responsible  for  purchasing  personal  protective  equipment  (PPE)  and 
medical  devices.  The  Ministry’s  strategy  includes  plans  for  the  CNAL  to  streamline  procurement 
processes  by  centralizing  purchasing  and  stockpiling  activities.  Additionally,  the  HCPN  allocates 
budgetary  provisions  for  acquiring  strategic  equipment  and  supplies  during  crises,  ensuring  that 
necessary MCMs are procured swiftly under emergency conditions.  

Stockpiling and Distribution Capacities  
In  collaboration  with  other  units  and  entities,  the  unit  reviews  and  optimizes  national  stockpiling 
strategies,  developing  protocols  for  the  storage  and  distribution  of  essential  medicines.  The 
establishment  of  the  CNAL  will  further  bolster  Luxembourg's  capacity  for  efficient  stockpiling  and 
distribution of MCMs. The logistical support cell, activated during crises, addresses challenges related 
to  transportation,  storage,  and  distribution  of  these  critical  supplies,  ensuring  their  timely  delivery  to 
healthcare facilities.  

International Cooperation  
Luxembourg’s Ministry of Health’s Emergency Preparedness and Response unit actively engages in 
international  cooperation,  maintaining  close  ties  with  neighbouring  countries,  the  EU,  and  global 
organisations such as the WHO. The LNS also contributes to international cooperation through EU-
funded projects, collaborating with the ECDC and WHO to share best practices and expertise. 

180 

 
 
 
 
 
 
 
 
 
Health Security Coordination  
Health  security  coordination  in  Luxembourg  involves  several  entities,  including  a  collaborative  effort 
between the Ministry of Health’s Emergency Preparedness and Response unit and the HCPN. The unit 
develops and implements health crisis strategies and policies. The HCPN coordinates national crisis 
response, activating an evaluation cell comprising sector experts to assess situations and inform the 
Prime Minister for crisis cell activation. The LNS, as the National Reference Laboratory, provides critical 
guidance and expertise, supporting the development and implementation of health crisis strategies.  

Comprehensive mapping of identified entities 

Ministry of Health - Unit on Emergency Preparedness and Response 
The Ministry of Health is responsible for setting national health crisis strategies and policies. Within the 
Health Directorate, the Emergency Preparedness and Response unit is responsible for coordinating 
preparedness  and  response  to  health  crises.  The  department  works  closely  with  the  national  and 
international authorities, adopting an all-hazards, cross-sectoral approach.  The unit works closely with 
the other departments of the Health Department responsible for purchasing MCMs. 

Mode of operation 
During  preparedness,  the  Ministry  of  Health's  Emergency  Preparedness  and  Response  unit 
collaborates  with  national  and  international  stakeholders  to  develop  and  refine  preparedness  plans. 
This involves identifying gaps, areas for improvement, and coordination needs in Luxembourg's health 
preparedness  strategies.  Actively  working  to  establish  a  community  of  practice  at  both  national  and 
international levels, the unit fosters a network for sharing best practices, resources, and expertise in 
anticipation of potential health crises. 

. 
During  crisis  response  times,  the  unit  takes  on  a  pivotal  role  as  the  primary  liaison  with  the  Health 
Emergency Response Authority (HERA) and other national crisis units. In the event of a public health 
crisis, the unit provides crucial support and expertise, both domestically and potentially at European 
and international levels, depending on the severity and scale of the emergency. This includes actively 

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participating in crisis coordination efforts and participating to the elaboration of guidance on deploying 
MCMs such as vaccines and antiviral drugs.  

Monitoring, Intelligence Gathering and Analysis  
The Ministry of Health's Emergency Preparedness and Response unit, in collaboration with other units 
and entities, including CNAL and the “Risques sanitaires” unit is currently developing capabilities for 
identifying medical countermeasures and prioritising threats. Training in MCMs is also a project that will 
be  carried  out  by  several  entities  within  the  Ministry  of  Health  and  Social  Security  and  the  Health 
Directorate.  

Advanced Research and Development Capacities  
The Ministry of Health's Emergency Preparedness and Response unit maintains links with Luxembourg 
research institutes. These collaborations, particularly with the Luxembourg Institute of Health and the 
Luxembourg Institute of Science and Technology, serve as a foundation for future advancements in 
MCM research and development.  

Production / Manufacturing Capacities  
The Ministry of Health's Emergency Preparedness and Response unit is actively involved, along with 
several  other  units  in  the  Directorate  of  Health,  in  coordinating  efforts  related  to  the  production  and 
manufacturing  capacities  of  medical  countermeasures.  Efforts  are  underway  to  identify  critical 
medicines and review national stockpiling strategies to ensure an adequate supply during emergencies. 
Additionally, the unit is contributing to the establishment of a national purchasing and storage centre 
(CNAL), which will centralize procurement and storage operations, enhancing Luxembourg's readiness 
and response capabilities.  

Procurement of MCMs 
Procurement  of  medical  countermeasures,  including  vaccines  and  antidotes,  is  the  responsibility  of 
several units within the Ministry of Health. The Service ‘Risques de Santé’ handles the procurement of 
vaccines and antidotes, while the Luxembourg Hospital Federation (FHL) is responsible for purchasing 
personal  protective  equipment  (PPE)  and  medical  devices.  The  Ministry's  broader  strategy  includes 
plans  for  the  CNAL,  which  will  streamline  the  procurement  process  by  centralizing  purchasing  and 
stockpiling activities.  

Stockpiling and Distribution Capacities 
Effective stockpiling and distribution of medical countermeasures are essential for ensuring readiness 
during  health  crises.  The  Ministry  of  Health's  Emergency  Preparedness  and  Response  unit,  in 
collaboration with other Health Directorate units, is actively involved in reviewing and optimizing national 
stockpiling strategies. This includes identifying essential medicines and developing protocols for their 
storage and distribution. The establishment of the CNAL will further enhance Luxembourg's capacity 
for stockpiling and efficient distribution of MCMs. Safe and timely distribution channels, from the CNAL 
to healthcare facilities, are crucial components of Luxembourg's preparedness framework. 

International Cooperation 
The  Ministry  of  Health's  Emergency  Preparedness  and  Response  unit  maintains  close  ties  with 
international partners, engaging in regular exchanges, workshops, and contacts. Regionally, the unit 
collaborates  with  neighbouring  countries  and  participates  in  discussions  on  regional  health  security 
initiatives. At  the European level, Luxembourg actively contributes to discussions on EU regulations 
and the HERA strategy. Globally, the unit maintains regular contact with the WHO Headquarters and 
WHO  Regional  Office  for  Europe  (WHO  EURO),  aligning  Luxembourg's  efforts  with  global  health 
security standards. 

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Health Security Coordination 
The  Emergency  Preparedness  and  Response  unit  works  closely  with  national  and  international 
authorities to develop and implement health crisis strategies and policies. By coordinating with various 
stakeholders and entities within the Ministry of Health, the unit ensures a comprehensive and integrated 
approach to health security coordination in Luxembourg. 

High Commission for National Protection (HCNP) 
The  High  Commission  for  National  Protection  (HCPN)  is  in  charge  of  coordinating  the  Civil 
Preparedness  Policy.  The  HCPN  is  in  charge  to  prevent,  anticipate  and  manage  all  kind  of  crisis 
harming the vital interests or the essential needs for all or part of the country or for the population, which 
requires urgent decisions, and which necessitates a coordination at the national level of the actions of 
the Government and the public administrations, services and departments. One of its main missions 
consists in drafting emergency response plans in collaboration with the competent public and/or private 
authorities. The HCPN is placed under the authority of the Minister responsible for national protection, 
in this case the Prime Minister. 

Monitoring, Intelligence Gathering and Analysis 
The HCPN operates as a key institution responsible for conducting risk analysis of potential threats that 
could impact the country or its population. Among the major risks identified, health risks hold significant 
importance.  This  risk  analysis  is  a  continual  process,  reviewed  regularly  to  ensure  relevance  and 
accuracy. The HCPN relies on expert input from the health sector to conduct thorough risk assessments. 
Based on these analyses, the HCPN collaborates closely with experts to develop emergency response 
plans  (ERP).  Additionally,  the  HCPN  is  responsible  for  ongoing  monitoring  of  risks  and  identifying 
emerging threats to public health. 

Procurement of MCMs 
In  line  with  its  emergency  response  plans,  the  HCPN  engages  in  acquiring  strategic  equipment  to 
complement  existing  stocks  held  by  relevant  authorities.  This  includes  a  designated  budgetary 
allocation that covers acquisitions and operational costs during crises. This financial provision ensures 
swift procurement of MCMs such as personal protective equipment, vaccines, ventilators, and other 
essential supplies needed during emergencies. 

Stockpiling and Distribution Capacities 
During  a  crisis,  the  logistical  support  cell,  activated  concurrently  with  the  crisis  cell,  assumes 
responsibility  for  managing  the  assessment  and  stockpiling  of  MCMs.  This  process  occurs  in  close 
collaboration with both public entities (such as the Army, the Grand-ducal fire and rescue corps, and 
the  Health  Directorate)  and  private  entities.  Challenges  related  to  transportation,  storage,  and 
distribution of these critical supplies are also addressed by the logistical support cell.  

International Cooperation 
Prior  to  and  during  a  crisis,  the  HCPN  fosters  close  cooperation  and  information  exchange  with  its 
counterparts in other countries. This collaborative approach allows for the alignment of cross-border 
protection measures, ensuring a cohesive and unified response to shared health threats.  

Health Security Coordination 
In the event of a crisis, such as a pandemic, the evaluation cell is activated within the HCPN. Comprising 
sector  experts,  this  evaluation  cell  assesses  the  situation  and  reports  its  findings  to  the  High 
Commissioner.  The  High  Commissioner  then  informs  the  Prime  Minister,  who  ultimately  decides  to 
activate  the  crisis  cell.  The  crisis  cell,  chaired  by  the  government  member  responsible  for  the  most 
affected  sector,  includes  representatives  from  all  relevant  ministries  and  administrations.  Under  the 
government's authority, the crisis cell initiates, coordinates, and monitors the implementation of crisis 
response  measures  and  prepares  necessary  decisions  for  government  approval.  This  crisis 

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management  structure  operates  on  a  three-tier  system:  the  strategic  level,  the  interministerial 
operational  coordination  level,  and  the  tactical  command  level.  Each  level  plays  a  distinct  role  in 
providing leadership, operational control, and on-ground direction during a crisis. Additionally, public 
information  management  and  coordination  are  overseen  by  the  national  interministerial  crisis 
communication  cell,  ensuring  transparent  and  effective  communication  with  the  public  during 
challenging times. 

National Health Laboratory (LNS) 
Within its Division of Virology and Serology, the National Health Laboratory (LNS) of Luxembourg has 
a role in diagnosing, monitoring, and surveilling infectious diseases. Recognized internationally as the 
World  Health  Organisation's  national  reference  laboratory  for  influenza,  the  LNS  is  a  beacon  of 
excellence in disease surveillance and research. The Department of Microbiology within the LNS is a 
hub of innovation, conducting advanced research and development activities to enhance Luxembourg's 
capacity to respond to health threats.  

Mode of operation 
During  preparedness  phases,  the  LNS  operates  as  a  crucial  public  institution  under  the  Ministry  of 
Health  in  Luxembourg.  Its  primary  responsibilities  involve  close  collaboration  with  national  health 
authorities  to  ensure  a  coordinated  and  effective  response  to  potential  health  crises.  As  part  of  its 
preparedness efforts, the LNS integrates itself into EU networks for pandemic preparedness, allowing 
it to stay abreast of the latest diagnostic and epidemiological tools. This integration serves to enhance 
Luxembourg's readiness to respond swiftly and comprehensively to any public health emergency that 
may arise. Additionally, the LNS focuses on building and consolidating its capacity to provide necessary 
diagnostic measures during such emergencies, ensuring timely and accurate identification of pathogens 
and infectious diseases. 

During  crisis  times,  the  LNS's  continuous  surveillance  efforts  come  to  the  forefront,  enabling  the 
monitoring  of  the  distribution  and  emergence  of  variants  of  concern.  This  proactive  surveillance 
approach is instrumental in supporting decision-making processes regarding timely implementation of 
public health measures. By constantly monitoring epidemiological trends and emerging threats, the LNS 
plays a critical role in informing authorities on the need for specific interventions and adjustments to 
existing preparedness strategies.  

Monitoring, Intelligence Gathering and Analysis 
The LNS, particularly its Division of Virology and Serology, serves as the national reference laboratory 
for  influenza  and  acute  respiratory  infections,  the  LNS  conducts  epidemiological  surveillance, 
diagnosing, and tracking infectious diseases, as well as identification and implementation of medical 
countermeasures in the context of infectious diseases. Through its Department of Microbiology, which 
encompasses  services  in  bacteriology,  mycology,  virology,  serology,  and  pathogen  sequencing,  the 
LNS provides essential data on disease trends. This includes operating a sentinel network for seasonal 
pathogens like Influenza, Respiratory Syncytial Virus, and SARS-CoV-2. Weekly reports issued by the 
LNS  to  the  Ministry  of  Health  and  the  public  offer  vital  insights  into  disease  prevalence  and  trends. 
Furthermore, the LNS actively participates in EU-funded projects to enhance pandemic preparedness, 
surveillance, and data sharing, such as PANDOMIC and END-VOC. 

Advanced Research and Development Capacities 
The  LNS's  Department  of  Microbiology  is  deeply  engaged  in  advanced  research  and  development 
efforts related to infectious diseases. Through collaborations with local and international partners, the 
LNS conducts research aimed at improving diagnostics, genomic surveillance, and pandemic response. 
Specifically, the LNS is implementing state-of-the-art diagnostic tools to enhance genomic surveillance, 
particularly  through  the  EU-funded  PANDOMIC  project.  This  initiative  expands  the  LNS's  Whole 
Genome  Sequencing  capabilities  beyond  SARS-CoV-2  to  include other  pathogens.  Additionally,  the 

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LNS  is  involved  in  the  CoVaLux  project,  funded  by  Fonds  National  de  la  Recherche,  Luxembourg, 
focusing on addressing COVID-19-related questions, such as vaccination and long-term health impacts. 

Procurement of MCMs 
The LNS's role is pivotal in providing data and expert advice to inform procurement decisions, ensuring 
that Luxembourg's healthcare system has access to necessary MCMs. 

Stockpiling and Distribution Capacities 
As the National Reference Laboratory for Acute Respiratory Infections and other pathogens, the LNS 
works in coordination with other units within the Ministry of Health to identify critical medicines, review 
national  stockpiling  strategies,  and  participate  in  the  establishment  of  a  European  strategic  stock. 
Through its surveillance and diagnostic activities, the LNS helps identify priority MCMs for stockpiling 
and ensures their efficient distribution during health emergencies. 

International Cooperation 
The  LNS  actively  engages  in  international  cooperation  efforts  to  strengthen  Luxembourg's 
preparedness and response to health threats. Through participation in EU-funded projects such as BE 
READY,  END-VOC,  UNITED4Surveillance,  and  EU-JAMRAI  2,  the  LNS  contributes  to  the 
harmonization  of  EU-wide  responses  to  pandemics  and  health  emergencies.  Additionally,  the  LNS 
collaborates with international bodies like the ECDC and the WHO. This collaboration involves sharing 
best  practices,  data,  and  expertise,  as  well  as  participating  in  workshops  and  training  programs  to 
enhance global health security. 

Health Security Coordination 
As the National Reference Laboratory for Acute Respiratory Infections, HIV, Hepatitis, and an expert 
laboratory for Enterovirus and Poliovirus, the LNS provides essential guidance and expertise during 
health emergencies. In collaboration with national crisis units and international stakeholders like HERA 
and the ECDC, the LNS contributes to the development and implementation of health crisis strategies. 
Additionally,  the  LNS's  involvement  in  various  EU-funded  projects  underscores  its  commitment  to 
advancing health security and preparedness at both national and international levels. 

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s. Malta 

Overview of approach to preparedness and response to public health emergency in MCMs 

Monitoring, Intelligence Gathering, and Analysis 
In Malta, the Ministry of Health, through Directorate for Health Information and Research, is responsible 
for  collecting  and  analysing  epidemiological  data  to  inform  health  policies  and  identify  medical 
countermeasures.  Meanwhile,  the  IDCU  focuses  on  the  surveillance,  prevention,  and  control  of 
infectious  diseases,  monitoring  disease  trends,  investigating  outbreaks,  and  implementing  control 
measures.  

Advanced Research and Development Capacities 
The Ministry of Health promotes research initiatives and collaborates with research institutes to develop 
new medical countermeasures. The IDCU engages in research to deepen understanding of infectious 
diseases,  their  transmission  dynamics,  and  potential  interventions.  This  includes  studies  on  new 
vaccines, antiviral drugs, and other medical countermeasures to combat emerging health threats.  

Production / Manufacturing Capacities 
While  Malta  does  not  have  significant  local  production  of  medical  countermeasures,  the  Ministry  of 
Health’s  Central  Procurement  and  Supplies  Unit  (CPSU)  ensures  the  availability  of  these  critical 
supplies.  

Procurement of MCMs 
The procurement of MCMs in Malta is managed by the Central Procurement and Supplies Unit (CPSU) 
within the Ministry of Health. The CPSU handles the procurement of vaccines, antiviral medications, 
and other essential supplies, adhering to public procurement regulations.  

Stockpiling and Distribution Capacities 
The Central Procurement and Supplies Unit (CPSU) is also responsible for managing and maintaining 
special  stockpiles  of  medical  countermeasures.  These  stockpiles  include  vaccines,  antiviral 
medications, and other essential medical supplies. The CPSU collaborates with the Superintendent of 
Public  Health  (SPH)  office  and  other  health  entities  to  develop  and  implement  distribution  plans, 
prioritizing areas of need and ensuring equitable access to MCMs during health crises. 

International Cooperation 
The  International  Affairs  and  Policy  Development  Directorate  (IAPD),  within  the  Ministry  of  Health, 
maintains vital links with EU institutions, member states, and international bodies such as DG SANTE, 
ECDC, and WHO.  

Health Security Coordination 
Health security  coordination  in  Malta  is overseen by the  Ministry of  Health,  in collaboration with  the 
Chief  Medical  Officer  (CMO)  and  the  Superintendent  of  Public  Health  (SPH).  These  entities  work 
together to detect and evaluate health threats, conduct epidemic surveillance, and coordinate health 
security  measures.  The  Health  Promotion  and  Disease  Prevention  Directorate  (HPDP)  and  its 
Infectious Disease Prevention and Control Unit (IDCU) lead efforts to mitigate and contain infectious 
diseases.  The  IDCU  works  closely  with  other  governmental  agencies,  including  the  Civil  Protection 
Department  (CPD),  to  develop  emergency  response  plans,  conduct  simulations  and  exercises,  and 
ensure effective communication during health emergencies.  

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Comprehensive mapping of identified entities 

Ministry of Health 
The Ministry of Health of Malta stands out in the nation's public health landscape, particularly concerning 
its  role  in  preparedness  and  response  to  public  health  emergencies.  In  this  context,  the  Ministry's 
multifaceted approach involves several key directorates and units.  

Monitoring, Intelligence Gathering and Analysis 
The Ministry of Health of Malta, through its Directorate for Health Information and Research, plays a 
critical role in monitoring, intelligence gathering, and analysis of health-related data. This Directorate 
serves as the central authority responsible for collecting and analysing epidemiological information and 
indicators.  The  Ministry  of  Health  is  also  involved  in  various  activities  related  to  the  identification  of 
medical countermeasures. This includes health technology assessments (HTA) and the development 
of  pharmaceutical  policies.  These  efforts  involve  systematic  analysis  and  monitoring  of  new  and 
emerging medical products before they reach the market. 

Production / Manufacturing Capacities 
Although Malta does not have any major production of MCMs on the island, the Central Procurement 
and Supplies Unit (CPSU), within the Ministry of Health, plays a crucial role in ensuring the availability 
of  MCMs.  This  unit  is  responsible  for  sourcing  MCMs  from  reputable  manufacturers  and  suppliers, 
ensuring quality and safety standards are met.  

Procurement of MCMs 
The CPSU is directly involved in the procurement of MCMs. The CPSU procures vaccines and other 
necessary  supplies,  following  public  procurement  regulations,  especially  during  public  health 
emergencies. 

Stockpiling and Distribution Capacities 
The CPSU is responsible for managing and maintaining special stocks of MCMs. This includes vaccines, 
antiviral medications, and other essential medical supplies. These stockpiles are strategically located 
to ensure quick and efficient distribution to healthcare facilities across the country. The CPSU works in 

187 

 
 
 
 
 
 
 
 
coordination with the Superintendent of Public Health (SPH) office and other relevant health entities to 
develop distribution plans that prioritize areas of need and ensure equitable access to MCMs. 

International Cooperation 
The  International  Affairs  and  Policy  Development  Directorate  (IAPD),  within  the  Ministry  of  Health, 
serves as a vital link for exchanging health-related information with EU institutions, member states, and 
international  bodies.  Through  these  collaborations,  Malta  can  access  global  expertise,  share  best 
practices, and coordinate responses to cross-border health threats. The Ministry actively participates in 
international forums and initiatives to strengthen its capacity for MCM procurement, stockpiling, and 
distribution. 

Health Security Coordination 
Effective  health  security  coordination  is  essential  for  Malta's  preparedness  and  response  to  public 
health emergencies. The Ministry of Health, in collaboration with the Chief Medical Officer (CMO) office 
and the Superintendent of Public Health (SPH) office, plays a central role in coordinating health security 
measures. This includes detecting and evaluating health threats, prioritizing awareness campaigns, and 
conducting epidemic surveillance. The Ministry's Health Promotion and Disease Prevention Directorate 
(HPDP), particularly the Infectious Disease Prevention and Control Unit (IDCU), leads efforts to mitigate 
and contain infectious diseases.  

Infectious Disease Prevention and Control Unit (IDCU) 
The Infectious Disease Prevention and Control Unit (IDCU) within the Health Promotion and Disease 
Prevention Directorate (HPDP) has a mandate focused on the surveillance, prevention, and control of 
infectious diseases, the IDCU plays a critical role in safeguarding the health of Malta's population. 

Monitoring, Intelligence Gathering and Analysis 
The  IDCU  conducts  surveillance,  prevention,  and  control  of  infectious  diseases.  The  IDCU's  work 
includes  monitoring  the  spread  of  infectious  diseases  across  the  Maltese  islands,  providing  crucial 
insights  for  timely  intervention  and  containment  efforts,  including  with  the  identification  of  specific 
countermeasures. With a focus on public health emergencies, the IDCU's responsibilities are diverse 
and  vital.  Foremost  among  these  duties  is  the  meticulous  monitoring  of  disease  trends  within  the 
population,  enabling  the  unit  to  detect  potential  outbreaks  swiftly.  When  outbreaks  occur,  the  IDCU 
leads  thorough  investigations  to  determine  the  source  and  scope,  implementing  necessary  control 
measures to contain and prevent further infections. 

As  Malta's  primary  surveillance  unit,  the  IDCU  collaborates  closely  with  other  entities  involved  in 
detecting  health  threats,  ensuring  a  coordinated  and  comprehensive  approach  to  monitoring  public 
health. This collaboration extends to working with the Civil Protection Department (CPD) on various 
threats, including those related to Chemical, Biological, Radiological, and Nuclear (CBRN) incidents, 
showcasing the unit's versatility and adaptability to diverse emergency scenarios. 

Advanced Research and Development Capacities 
In  its  role  as  a  centre  for  infectious  disease  prevention  and  control,  the  IDCU  also  contributes  to 
advanced research and development efforts. The unit engages in studies and investigations to deepen 
understanding  of  infectious  diseases,  their  transmission  dynamics,  and  potential  interventions.  This 
includes research into new vaccines, antiviral drugs, and other medical countermeasures to combat 
emerging threats. 

Production / Manufacturing Capacities 
Drawing on its expertise in infectious diseases and public health, the unit provides recommendations 
on the types of MCMs needed to address specific health threats. These recommendations are based 
on careful assessment of disease patterns, transmission risks, and population vulnerabilities. By liaising 

188 

 
 
 
 
 
 
 
 
with  pharmaceutical  companies  and  regulatory  bodies,  the  IDCU  ensures  that  the  MCMs  produced 
meet the highest standards of safety and efficacy. 

International Cooperation 
Recognizing  the  global  nature  of  infectious  diseases,  the  IDCU  actively  engages  in  international 
cooperation  initiatives.  The  unit  participates  in  meetings  organized  by  entities  such  as  DG  SANTE, 
ECDC, and WHO to share information, best practices, and lessons learned.  

Health Security Coordination 
The  unit  works  closely  with  other  governmental  agencies,  including  the  Civil  Protection  Department 
(CPD),  to  coordinate  efforts  in  responding  to  health  security  threats.  This  includes  developing 
comprehensive plans and protocols for emergency response, conducting simulations and exercises to 
test readiness, and ensuring effective communication channels are in place. The IDCU's coordination 
efforts extend to liaising with international partners, sharing information, and aligning strategies for a 
cohesive and effective response to health security challenges.

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t.  Netherlands 

Overview of approach to preparedness and response to public health emergency in MCMs 

Monitoring, Intelligence Gathering, and Analysis 
In the Netherlands, the National Institute for Public Health and the Environment (RIVM), operating under 
the Ministry of Health, and in specific RIVM's Centre for Infectious Disease Control, coordinates efforts 
to  control  infectious  diseases  and  conducts  continuous  monitoring,  surveillance  and  identification  of 
medical countermeasures for health threats. Additionally, the Health Council of the Netherlands plays 
a critical role in analysing epidemiological data and emerging health threats, providing evidence-based 
advice to the government on necessary preventive measures and public health risks. 

Advanced Research and Development Capacities 
The Ministry of Health and the RIVM, along with other entities such as the Dutch Research Council 
(NWO),  ZonMw,  and  TNO,  play  a  role  in  funding  and  conducting  research  for  the  development  of 
medical countermeasures. The Centre for Infectious Diseases Research, Diagnostics and Laboratory 
Surveillance  at  RIVM  conducts  research  to  enhance  the  understanding  of  infectious  diseases  and 
develop vaccines and other MCMs. The Centre for Immunology of Infectious Diseases and Vaccines 
provides specialized expertise, contributing to the development and deployment strategies of MCMs.  

Production / Manufacturing Capacities 
The  production  and  manufacturing  capacities  for  MCMs  in  the  Netherlands  are  supported  by 
cooperation between the Ministry of Health and the Ministry of Economic Affairs. The RIVM collaborates 
with entities like ZonMw through initiatives such as PharmaNL, which aims to stimulate MCM production. 
Additionally, the Ministry of Health has established continuous production arrangements for personal 
protective  equipment  (PPE)  and  mouth  masks  within  the  country,  ensuring  a  steady  supply  during 
emergencies. 

Procurement of MCMs 
The  RIVM's  Department  for  Vaccine  Supply  and  Prevention  Programmes  is  responsible  for  the 
procurement of vaccines and other MCMs. RIVM manages the supply chain, ensures timely availability, 
and  coordinates  with  relevant  stakeholders.  The  institute  holds  a  wholesaler  license,  allowing  it  to 
centrally  procure  MCMs  needed  for  public  health  threats.  Hospitals  in  the  Netherlands  also  have  a 
decentralized role in procuring commonly used MCMs, such as PPEs, to meet their immediate needs. 

Stockpiling and Distribution Capacities 
RIVM is also tasked with managing the stockpiling and distribution of MCMs, particularly vaccines and 
serums. The institute ensures that these stockpiles are maintained and can be quickly distributed to 
healthcare facilities as needed. Hospitals maintain their own stockpiles for direct usage, ensuring they 
are prepared for immediate needs. The Health Council of the Netherlands provides advisory support, 
recommending stockpiling strategies and distribution protocols. 

International Cooperation 
RIVM actively participates in international cooperation through its involvement in the HERA steering 
board and collaborations with various international counterparts. This includes sharing information on 
epidemiological  surveillance  with  countries  like  India  or  the  US  and  contributing  to  pandemic 
preparedness and public health initiatives.  

Health Security Coordination 
Health security coordination in the Netherlands is facilitated by RIVM in collaboration with the Ministry 
of Health. The institute advises the government on immunology, vaccinology, and MCM development, 

190 

 
 
 
 
 
 
 
 
 
ensuring  a  cohesive  and  informed  approach  to  public  health  crises.  The  Health  Council  of  the 
Netherlands supports  this  coordination  by  providing  strategic advice  on risk assessments,  response 
plans, and communication strategies. Public health law provisions allow for the rapid activation of RIVM 
activities during crises, ensuring a swift and effective response. 

Comprehensive mapping of identified entities 

National Institute for Public Health and the Environment - RIVM (Ministry of Health) 
The National Institute for Public Health and the Environment (RIVM) of the Netherlands, operating under 
the Ministry of Health, holds critical responsibilities across various fronts in safeguarding public health. 
Within its multifaceted structure, RIVM houses specialized centres focused on infectious diseases and 
vaccine management, each playing a distinct role in the nation's health security framework.  

Monitoring, Intelligence Gathering and Analysis 
RIVM's  Centre  for  Infectious  Disease  Control  serves  as  a  linchpin  in  coordinating  efforts  to  control 
infectious diseases, a pivotal function during public health crises. The Centre for Infectious Diseases 
Epidemiology and Surveillance is dedicated to continuous monitoring and surveillance, providing vital 
insights  into  emerging  trends  and  threats  posed  by  infectious  diseases.  Besides,  the  RIVM  has  an 
important  advisory  role  to  the  Ministry  of  Health  when  it  comes  to  countermeasures’  detection, 
evaluation and identification for health threats. 

Advanced Research and Development Capacities 
The RIVM plays a role in both funding and conducting research for the development of MCMs. The 
Centre for Infectious Diseases Research, Diagnostics and Laboratory Surveillance at RIVM conducts 
research into infectious diseases. This research not only enhances understanding but also contributes 
to the development of MCMs, including vaccines, crucial for combating infectious diseases. Additionally, 
the  Centre  for  Immunology  of  Infectious  Diseases  and  Vaccines  offers  specialized  expertise  in 
Immunology  and  Vaccinology,  providing  valuable  guidance  on  MCM  development  and  deployment 
strategies. The RIVM has a role in funding research for MCM development, together with other actors 
in the Netherlands including the Dutch Research Council (NWO), ZonMw and TNO.  

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Production / Manufacturing capacities 
Support to production of MCMs is carried out directly by the Ministry of Health in cooperation with the 
Ministry of Economic Affairs in the Netherlands. The RIVM has established cooperation to support the 
development of MCMs and manufacturing capacities, namely with the ZonMw. In specific, the project 
PharmaNL has an MCM production stimulating component. The Ministry also has arrangements for the 
continuous production of PPE and mouth masks in the Netherlands.  

Procurement of MCMs 
As part of its responsibilities, RIVM's Department for Vaccine Supply and Prevention Programmes is 
directly engaged in the procurement of vaccines. This involves managing the supply chain, ensuring 
timely availability, and coordinating with relevant stakeholders. The RIVM has a wholesaler licence and 
is able to centrally procure MCMs. In specific, RIVM procures all MCMs that are needed for public health 
threats  in  the  Netherlands.  Hospitals  have  also  a  decentralised  role  in  procuring  MCMs  in  the 
Netherlands for what concerns the countermeasures that they commonly use (e.g., PPEs). 

Stockpiling and Distribution Capacities 
In tandem with its procurement role, RIVM manages the stockpiling and distribution of MCMs in the 
Netherlands, and in particular of vaccines and serums. As it applies to procurement, hospitals stockpile 
countermeasures for their direct usage (e.g., PPEs). 

International Cooperation 
RIVM's involvement in the HERA steering board underscores its active role in international cooperation. 
Through this platform, the institute collaborates with diverse units within the Ministry of Health, as well 
as  with  international  counterparts,  on  pandemic  preparedness,  public  health  initiatives,  and 
pharmaceutical matters. The RIVM established cooperation with specific countries, e.g., India and the 
US, for sharing information on epidemiological surveillance.  

Health Security Coordination 
As an integral part of the Ministry of Health, RIVM contributes significantly to health security coordination 
within  the  Netherlands.  Its  expertise  in  infectious  diseases,  vaccine  management,  and  surveillance 
feeds  into  national  strategies  for  health  security.  The  institute's  role  in  advising  the  government  on 
immunology,  vaccinology,  and  MCM  development  ensures  a  cohesive  and  informed  approach  to 
safeguarding public health in times of crisis. Netherlands’ public health law provides for the activation 
of RIVM activities in case of crisis, enabling the institute to quickly scaling up the distribution of MCMs 
to patients. 

Health Council of the Netherlands 
The Health Council of the  Netherlands, as an independent advisory body, stands at the forefront of 
advising the government on matters concerning public health and healthcare research. In the context 
of  public  health  emergency  preparedness  and  response,  the  Health  Council’s  mission  is  to  provide 
evidence-based advice to ministers and Parliament. The Council's expertise spans monitoring, research, 
and strategic guidance.  

Monitoring, Intelligence Gathering and Analysis 
The  Health  Council  of  the  Netherlands  plays  a  crucial  role  in  monitoring  public  health  trends  and 
intelligence  gathering.  Through  its  expert  committees  and  research  capabilities,  the  Council 
continuously  analyses  epidemiological  data,  disease  patterns,  and  emerging  health  threats.  This 
monitoring  and  analysis  enable  the  Council  to  provide  evidence-based  advice  to  ministers  and 
Parliament on potential health risks and necessary preventive measures.  

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Procurement of MCMs 
As an advisory body, the Health Council advises ministers and Parliament on the procurement of MCMs 
during public health emergencies. Ministers may seek the Council's guidance on optimal procurement 
strategies,  considering  factors  such  as  effectiveness,  availability,  and  affordability  of  MCMs.  The 
Council's recommendations on procurement contribute to ensuring the timely acquisition of essential 
medical  countermeasures,  such  as  vaccines  and  antiviral  treatments,  to  address  emerging  health 
threats effectively. 

Stockpiling and Distribution Capacities 
The Health Council's role in stockpiling and distribution of MCMs is primarily advisory. In the context of 
public health emergencies, the Council provides recommendations on stockpiling strategies to ensure 
adequate reserves of essential MCMs. This includes advising on the types and quantities of MCMs to 
stockpile, storage conditions, and distribution protocols. By offering guidance on efficient and equitable 
distribution  practices,  the  Council  supports  the  preparedness  and  response  efforts  of  relevant 
authorities. 

Health Security Coordination 
In the realm of health security coordination, the Health Council serves as a key advisor to policymakers 
and government agencies. The Council's expertise in public health emergencies and MCMs allows it to 
contribute to the development of comprehensive health security strategies. This includes advising on 
risk assessments, response plans, and communication strategies during crises. By providing timely and 
evidence-based  recommendations,  the  Council  enhances  the  country's  capacity  to  coordinate  and 
implement effective health security measures, safeguarding the well-being of the population.

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u. Poland 

Overview of approach to preparedness and response to public health emergency in MCMs 

Monitoring, Intelligence Gathering and Analysis 
In Poland, the Ministry of Health, through its Department of Analysis and Strategy conducts thorough 
monitoring and analysis of health data, aiding in strategic planning and decision-making by identifying 
trends, patterns, potential health threats and related countermeasures. The Chief Sanitary Inspectorate 
(CSI) operates across various organisational levels, including central, regional, and local stations, to 
monitor the epidemiological situation both nationally and globally.  

Advanced Research and Development Capacities 
The  Ministry  of  Health,  through  the  Medical  Research  Agency  (MRA),  significantly  contributes  to 
Poland's advanced research and development capacities. The MRA funds research projects focusing 
on  vaccine  development,  antiviral  therapies,  diagnostic  tools,  and  medical  devices,  stimulating 
innovation and facilitating collaboration between academic institutions and the pharmaceutical industry. 
Additionally, the National Institute of Public Health, particularly through its Laboratory of Epidemiology 
of Vaccine-Preventable Diseases, conducts research into vaccines, contributing to the development of 
effective MCMs. 

Production / Manufacturing Capacities 
The  Chief  Pharmaceutical  Inspectorate  (CPI)  monitors  and  controls  the  distribution  of  medicinal 
products,  the  manufacturing  and  import  of  medicinal  products  as  well  as  manufacturing,  import  and 
distribution of active substances. CPI is further responsible for issuing permits for the import and export 
of narcotics and psychotropic substances.  

The Chief Pharmaceutical Inspectorate (CPI) of Poland is an authority tasked with ensuring the safety, 
quality, and availability of medicinal products (including controlled substances). 

Procurement of MCMs 
The  CPI  plays  a  crucial  role  in  monitoring  and  controlling  the  distribution  of  medicinal  products  and 
supervising entrepreneurs involved in manufacturing, import and distribution of medicinal products as 
well as manufacturing, import and distribution of active substances. The CPI issues permit for the import 
and  export  of  narcotic  and  psychotropic  substances,  as  well  as  permits  for  the  use  of  controlled 
substances  for  personal  medical  purposes  during  international  travel.  At  the  national  level,  the  CPI 
cooperates with domestic and foreign institutions, including the Ministry of Health, the Chief Sanitary 
Inspectorate,  and  law  enforcement  agencies,  to  ensure  the  effective  regulation  and  control 
manufacturing  and  distribution  of  medicinal  products.  The  CPI  submits  regular  reports  on  product 
availability  to  the  Minister  responsible  for  health  and  analyses  the  causes  and  effects  of  product 
shortages.  It  also  controls  the  export  of  products  that  are  at  risk  of  being  unavailable  in  Poland, 
contributing to the availability of essential medical products within the country. 

Stockpiling and Distribution Capacities 
Stockpiling and distribution capacities in Poland are managed by both the Ministry of Health and the 
RARS.  The  Ministry  manages  the  stockpiling  and  distribution  of  vaccines  for  mandatory  and 
recommended vaccinations, ensuring their availability through provincial and district sanitary stations. 
RARS  oversees  the  storage  and  maintenance  of  extensive  reserves  of  medical  countermeasures, 
ensuring their readiness for deployment during health emergencies. The agency handles the logistics 
of storing these supplies and facilitates their rapid distribution to healthcare facilities and affected areas 
during crises. 

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International Cooperation 
The  Ministry  of  Health  and  the  Chief  Sanitary  Inspectorate  (CSI)  engage  actively  in  international 
cooperation  to  strengthen  global  health  security  efforts,  share  best  practices,  harmonize  regulatory 
standards, and coordinate responses to cross-border health threats.  

Health Security Coordination 
The  Ministry  of  Health  activates  a  crisis  management  centre  during  public  health  crises,  ensuring 
information flow and coordination across all levels of government. The CSI's Crisis Management Plan 
guides  the  agency's  response  to  health  threats,  ensuring  efficient  monitoring,  notification,  and 
implementation of non-pharmaceutical countermeasures. RARS supports these efforts by maintaining 
strategic reserves and facilitating the distribution of medical countermeasures. Together, these entities 
ensure a comprehensive and coordinated approach to safeguarding public health in Poland. 

Comprehensive mapping of identified entities 

Ministry of Health 
The Ministry of Health of Poland is entrusted with health protection, organisation of healthcare services, 
and supervision of medicinal products and medical devices.  

Mode of operation 
During preparedness phases, the Ministry of Health of Poland establishes a crisis management team, 
comprising heads of relevant organisational units and other designated individuals. This team is tasked 
with periodic risk assessment, providing opinions on draft crisis management plans, issuing opinions 
on critical infrastructure, and developing proposals for threat prevention and counteraction. Additionally, 
the Minister of Health participates in the Government Crisis Management Team, which advises on crisis 
management actions at the Council of Ministers. Within the Ministry, tasks related to crisis management 
are  executed,  including  the  development  of  a  crisis  management  plan.  This  plan  entails  analysing 
threats  to  critical  infrastructure,  detailing  response  methods,  organizing  threat  monitoring,  and 
implementing tasks to enhance the state's defence readiness. The plan, created by the Department of 
Security  in  collaboration  with  Ministry  units,  serves  as  a  functional  annex  to  the  National  Crisis 
Management Plan. 

In times of crisis, such as epidemic threats, the Ministry of Health activates a crisis management centre. 
This centre operates 24/7 to ensure the flow of crucial information for crisis management purposes. It 
collaborates  with  other  crisis  management  centres  in  public  administration  bodies,  oversees  the 
detection  and  alarm  systems,  and  works  with  entities  conducting  environmental  monitoring,  rescue, 
search, and humanitarian operations. The centre documents its activities, implements permanent duty 

195 

 
 
 
 
 
 
 
 
tasks  to  enhance  the  state's  defence  readiness,  and  cooperates  across  all  levels  of  government 
administration to provide information and transmit orders.  

Monitoring, Intelligence Gathering and Analysis 
The Ministry of Health of Poland oversees the monitoring, intelligence gathering, and analysis of health-
related data, focusing on the needs for health care services. The Department of Analysis and Strategy 
conducts thorough analyses using health maps compiled from secondary health data, aiding in strategic 
planning  and  decision-making.  These  analyses  help  identify  trends,  patterns,  and  potential  health 
threats, allowing for the identification and prioritization of countermeasures. Additionally, the Security 
Department collaborates with other units within the Ministry and supervised entities to gather necessary 
information for strategic reserves and cooperation with competent authorities. 

Advanced Research and Development Capacities 
In  Poland,  on  the  mandate  of  the  Ministry  of  Health,  the  Medical  Research  Agency  (MRA)  funds 
research projects in vaccine development, antiviral therapies, diagnostic tools, and medical devices. 
This agency stimulates innovation and facilitates collaboration between academic institutions and the 
pharmaceutical industry, contributing significantly to the country's research and development capacities 
for medical countermeasures. 

Procurement of MCMs 
While  the  Minister  of  Health  generally  does  not  have  direct  competence  to  purchase  and  stockpile 
medicines, there are exceptions. The Ministry purchases vaccines for mandatory and recommended 
vaccinations and for the country's anti-epidemic reserve. These purchases follow public procurement 
regulations and are usually part of an unlimited tender process. The Security Department of the Ministry 
is involved in obtaining necessary information for strategic reserves and cooperation with competent 
authorities. The Ministry of Health, through its Department of Drug Policy and Pharmacy, coordinates 
the purchase process of vaccines against COVID-19 disease, as well as vaccines for mandatory and 
recommended vaccinations financed from public funds. These vaccines are not only acquired but also 
stored and distributed through the Central Distributor to provincial and district sanitary stations, ensuring 
safe storage and distribution at various levels. 

Stockpiling and Distribution Capacities 
The  Ministry  of  Health  manages  the  stockpiling  and  distribution  of  vaccines  for  mandatory  and 
recommended vaccinations, as well as for the country's anti-epidemic reserve. After procurement, these 
vaccines are sent to the Central Distributor and then distributed according to demand through provincial 
and district sanitary stations to medical facilities.  

International Cooperation 
The Ministry of Health engages in international cooperation to strengthen global health security efforts. 
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products collaborates 
with  international  partners  to  share  best  practices,  harmonize  regulatory  standards,  and  coordinate 
responses to cross-border health threats. This includes participation in international meetings, sharing 
of knowledge, and working towards common regulatory goals. 

Health Security Coordination 
In times of crisis, the Ministry of Health plays a critical role in health security coordination. The Security 
Department  is  involved  in  the  circulation  of  information  about  threats  and  the  activities  of  relevant 
entities.  The  Office  for  Registration  of  Medicinal  Products,  Medical  Devices  and  Biocidal  Products 
participates in the assessment procedures of documentation and issuing marketing authorizations of 
medicinal products in crisis situations.  

Chief Sanitary Inspectorate (CSI) 
The Chief Sanitary Inspectorate (CSI) of Poland is responsible for overseeing public health measures 
and disease control within the country. Operating at various levels, from the central CSI to regional and 
local  stations,  the  agency  conducts  continuous  monitoring  to  detect  and  manage  communicable 
diseases that could endanger public health.  

Mode of operation 
The CSI undertakes extensive preparedness activities to ensure the country's readiness for potential 
health  crises.  This  includes  continual  monitoring  of  epidemiological  situations  both  nationally  and 

196 

 
 
 
 
 
 
 
 
 
globally to stay informed about emerging health threats. CSI identifies and assesses potential biological 
threats, ensuring the efficiency of notification systems to quickly disseminate vital information during 
emergencies.  The  agency  determines  feasible  diagnostics  for  implementation  in  State  Sanitary 
Inspection laboratories, evaluates prophylaxis possibilities based on guidelines from superior units, and 
strategizes effective non-pharmaceutical countermeasures. CSI also participates in facility typing and 
surveillance for isolation or quarantine readiness, collaborates on community communication strategies, 
works closely with authorities for coordinated response efforts, maintains national focal points for IHR 
and EWRS, and conducts exercises to enhance operational readiness. 

In  times  of  crisis,  the  Inspectorate  swiftly  transitions  its  preparedness  activities  into  crisis  response 
mode.  This  includes  amplifying  monitoring  efforts  to  intensively  track  epidemiological  situations, 
promptly identifying and assessing potential biological threats for rapid response and containment. CSI 
ensures the notification system's efficiency for immediate dissemination of critical information, rapidly 
implements diagnostics in State Sanitary Inspection laboratories, and proactively initiates passive or 
active prophylaxis measures following crisis guidelines. Effective non-pharmaceutical countermeasures 
are  deployed  swiftly  to  mitigate  health  risks,  while  facilities  are  adapted  for  efficient  isolation  or 
quarantine. CSI executes crisis communication strategies, maintains close collaboration with relevant 
authorities at all levels for coordinated response actions, ensures the activity of national focal points for 
IHR and EWRS to facilitate international coordination, and conducts expedited exercises to enhance 
crisis response capabilities, ensuring readiness for any scenario. 

Monitoring, Intelligence Gathering and Analysis 
The Chief Sanitary Inspectorate (CSI) of Poland plays a vital role in continuous monitoring activities 
aimed at early detection and efficient control of communicable diseases that may threaten public health. 
This monitoring spans various levels of organisation, including the central level of CSI, 16 Provincial 
Sanitary-Epidemiological  Stations  at  the  regional  level,  and  318  District  Sanitary-Epidemiological 
Stations  and  9  Border  Sanitary-Epidemiological  stations  at  the  local  level.  CSI's  monitoring  efforts 
encompass monitoring the epidemiological situation both nationally and globally, identifying potential 
biological  threats,  ensuring  an  efficient  notification  system,  and  determining  diagnostic  procedures 
feasible at the State Sanitary Inspection laboratories, including the identification of countermeasures. 

International Cooperation 
CSI maintains an active role in maintaining the activity of the national focal point of the International 
Health Regulations (IHR) and Early Warning and Response System (EWRS). The agency collaborates 
with international counterparts and participates in initiatives aimed at global health security and disease 
surveillance, including in the field of MCMs. 

Health Security Coordination 
CSI's  Crisis  Management  Plan  is  an  integral  part  of  the  agency's  preparedness  activities.  This  plan 
guides CSI in monitoring, planning, and responding to threats within its purview, particularly in epidemic 
prevention. During crises, all preparedness activities can be scaled up ad hoc, including monitoring the 
epidemiological situation, identifying potential threats, ensuring an efficient notification system, planning 
non-pharmaceutical countermeasures, and maintaining communication strategies for the community. 
The Ministry of Health also has its Crisis Management Plan on a larger scale, which includes CSI's 
Crisis Management Plan as a component. 

Chief Pharmaceutical Inspectorate 
The  Chief  Pharmaceutical  Inspectorate  (CPI)  monitors  and  controls  the  distribution  of  medicinal 
products,  the  manufacturing  and  import  of  medicinal  products  as  well  as  manufacturing,  import  and 
distribution of active substances. CPI is further responsible for issuing permits for the import and export 
of narcotics and psychotropic substances. The Chief Pharmaceutical Inspectorate (CPI) of Poland is 
an authority tasked with ensuring the safety, quality, and availability of medicinal products (including 
controlled substances).  

Production / Manufacturing Capacities 
The  CPI  plays  a  crucial  role  in  monitoring  and  controlling  the  distribution  of  medicinal  products  and 
supervising entrepreneurs involved in manufacturing, import and distribution of medicinal products as 
well  as  manufacturing,  import  and  distribution  of  active  substances.  The  CPI  issues  permits  for  the 

197 

 
 
 
 
 
 
 
import and export of narcotic and psychotropic substances, as well as permits for the use of controlled 
substances  for  personal  medical  purposes  during  international  travel.  At  the  national  level,  the  CPI 
cooperates with domestic and foreign institutions, including the Ministry of Health, the Chief Sanitary 
Inspectorate,  and  law  enforcement  agencies,  to  ensure  the  effective  regulation  and  control 
manufacturing  and  distribution  of  medicinal  products.  The  CPI  submits  regular  reports  on  product 
availability  to  the  Minister  responsible  for  health  and  analyses  the  causes  and  effects  of  product 
shortages.  It  also  controls  the  export  of  products  that  are  at  risk  of  being  unavailable  in  Poland, 
contributing to the availability of essential medical products within the country. 

National Institute of Public Health 
Through its various laboratories and departments, the National Institute of Public Health of Poland is 
central in detecting emerging health threats, advancing research into vaccine-preventable diseases, 
and providing expert guidance on MCMs.  

Monitoring, Intelligence Gathering and Analysis 
The National Institute of Public Health of Poland, through its Laboratory for Monitoring and Analysis of 
the  Epidemiological  Situation,  plays  a  central  role  in  monitoring  public  health  trends  and  disease 
patterns. This laboratory is instrumental in early detection of public health threats, providing valuable 
data for policy decisions and control measures. By closely monitoring epidemiological data, the Institute 
can  swiftly  identify  emerging  health  risks,  outbreaks  of  infectious  diseases,  and  other  public  health 
concerns. This proactive approach allows for timely interventions and effective strategies to mitigate 
the spread of diseases. 

Advanced Research and Development Capacities 
The Institute's Laboratory of Sera and Vaccines Evaluation is a key component of Poland's research 
and development capacities in the field of MCM. This laboratory focuses on research into vaccines to 
combat  infectious  diseases,  contributing  to  the  advancement  of  preventive  medicine.  Through  its 
scientific  research,  the  Institute  explores  new  vaccine  formulations,  evaluates  their  efficacy,  and 
assesses  their  safety.  These  research  efforts  are  crucial  for  the  development  of  effective  vaccines 
against emerging pathogens and for maintaining immunity against known diseases. 

Government Agency for Strategic Reserves (RARS) 
The  Government  Agency  for  Strategic  Reserves  (RARS)  in  Poland  is  the  entity  responsible  for 
maintaining  and  managing  strategic  reserves  for  the  nation.  Established  under  the  Act  on  Strategic 
Reserves of December 17, 2020, RARS operates under the supervision of the Prime Minister’s Office. 
Its primary mission is to ensure the availability of essential goods and materials, including food, fuel, 
and medical supplies, to address emergencies and crises that may disrupt supply and demand, thereby 
safeguarding national security and public health. 

Procurement of MCMs 
The  agency  is  tasked  with  purchasing essential  medical supplies  such  as  medicines, vaccines,  and 
personal protective equipment. These items are procured based on anticipated needs to prepare for 
and respond to public health emergencies. RARS works in coordination with other government bodies, 
in particular the Ministry of Health, as well as international partners to ensure the timely and efficient 
procurement of these crucial supplies. 

Stockpiling and Distribution Capacities 
RARS  manages  extensive  reserves  of  medical  countermeasures.  These  reserves  are  strategically 
stored and maintained to ensure their readiness for deployment during health emergencies. The agency 
is responsible for the logistics of storing these supplies, including ensuring proper conditions to preserve 
their  efficacy.  During  a  crisis,  RARS  facilitates  the  rapid  distribution  of  medical  countermeasures  to 
healthcare  facilities  and  affected  areas,  supporting  both  public  health  institutions  and  the  general 
population.  This  logistical  capability  was  notably  demonstrated  during  the  COVID-19  pandemic, 
highlighting the agency's vital role in national health security.

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v. Portugal 

Overview of approach to preparedness and response to public health emergency in MCMs 

Monitoring, Intelligence Gathering and Analysis 
The Directorate-General of Health (DGS) and the National Institute of Health (INSA) are the primary 
entities  responsible  for  monitoring  and  intelligence  gathering  to  inform  medical  countermeasures 
strategies  and  policymaking  in  public  health  crisis  preparedness  and  response.  DGS  leads  in 
coordinating national epidemiological surveillance, tracking disease outbreaks, vaccination coverage, 
and  other  health  indicators.  Similarly,  INSA  conducts  epidemiological  surveillance  for  both 
communicable and non-communicable diseases, analysing health data to detect, monitor, and respond 
to health threats. 

Advanced Research and Development Capacities 
DGS collaborates with academic institutions like the Institute of Molecular Pathology and Immunology 
at the University of Porto (IPATIMUP) to promote and support research initiatives aimed at developing 
new MCMs. INSA focuses on infectious diseases and other public health threats, conducting research 
to  develop  and  evaluate  diagnostics,  vaccines, 
therapeutics,  and  other  critical  medical 
countermeasures.  

Production / Manufacturing Capacities 
DGS facilitates the enhancement of local production capabilities for MCMs by negotiating contracts and 
partnerships with pharmaceutical companies and suppliers. This role is crucial in maintaining a steady 
supply of essential MCMs within the country. The National Authority of Medicines and Health Products 
also plays a role in managing the supply of MCMs, working closely with manufacturers, distributors, and 
other stakeholders to secure and authorize the usage of these critical products. 

Procurement of MCMs 
As  the  lead  coordinator  of  Portugal’s  Public  Health  Emergencies  System,  DGS  handles  the  central 
procurement of MCMs to ensure their availability during health crises.  

Stockpiling and Distribution Capacities 
DGS ensures the strategic stockpiling of essential medical supplies, including MCMs and vaccines.  

International Cooperation 
DGS is the primary coordinator for Portugal’s European and international health relations. During cross-
border  or  global  health  emergencies,  DGS’s  role  in  fostering  partnerships,  sharing  information,  and 
participating in international networks becomes crucial.  

Health Security Coordination 
DGS leads the coordination of the Public Health Emergencies System, ensuring swift and coordinated 
responses to public health emergencies by activating protocols and mobilizing resources. The National 
Authority of Medicines and Health Products ensures the availability of safe and effective MCMs and 
provides expertise on regulatory matters during such crises. 

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Comprehensive mapping of identified entities 

Directorate-General of Health (DGS) 
The Directorate-General of Health (DGS) in Portugal serves as a central authority in the country's public 
health  system,  with  key  responsibilities  in  coordinating  national  epidemiological  surveillance,  public 
health emergencies, European and international relations. 

Monitoring, Intelligence Gathering and Analysis 
DGS  plays  a  pivotal  role  in  monitoring  disease  trends  and  public  health  data.  The  institute  leads  in 
coordinating  national  epidemiological  surveillance.  This  information  is  crucial  in  developing  effective 
health policies and responses to public health emergencies. The surveillance includes tracking disease 
outbreaks, vaccination coverage, and other health indicators to inform MCM strategies. 

Advanced Research and Development Capacities 
DGS supports and promotes research initiatives aimed at developing new medical countermeasures. 
This  includes  collaboration  with  academic  institutions  and  research  organisations  to  innovate  and 
improve  MCMs,  this  includes  an  active  cooperation  with,  for  instance,  the  Institute  of  Molecular 
Pathology and Immunology at the University of Porto (IPATIMUP) on various health research projects. 

Production / Manufacturing Capacities 
DGS facilitates the enhancement of local production capabilities for MCMs by negotiating contracts and 
partnerships  with  pharmaceutical  companies  and  other  suppliers  to  maintain  a  steady  supply  of 
essential MCMs. 

Procurement of MCMs 
As  the  lead  coordinator  of  Portugal’s  Public  Health  Emergencies  System,  DGS  handles  central 
procurement  of  medical  countermeasures  to  ensure  the  availability  of  essential  medical  products  to 
respond swiftly to health crises.  

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Stockpiling and Distribution Capacities 
Through  the  coordination  of  the  Public  Health  Emergencies  System,  DGS  ensures  the  strategic 
stockpiling of essential medical supplies, including MCMs and vaccines. The DGS collaborates with 
relevant  agencies  and stakeholders  to develop and maintain stockpiles,  ensuring  rapid  and  efficient 
distribution of critical resources when needed. 

International Cooperation 
DGS coordinates the European and international relations of the Ministry of Health. This role becomes 
crucial during cross-border or global health emergencies, where collaboration and information sharing 
with other countries and international organisations are vital. DGS fosters partnerships, exchanges best 
practices,  and  participates  in  international  networks  to  strengthen  Portugal's  preparedness  and 
response to global health threats. 

Health Security Coordination 
DGS is the lead coordinator of the Public Health Emergencies System. This system enables swift and 
coordinated responses to public health emergencies, activating protocols and mobilizing resources as 
needed. DGS ensures that emergency response plans are in place, conducts drills and exercises, and 
coordinates  with  regional  health  authorities  and  other  stakeholders  to  enhance  health  security  and 
resilience. 

National Institute of Health (INSA) 
The National Institute of Health (INSA) in Portugal is a crucial institution dedicated to maintaining public 
health through a range of responsibilities, including epidemiological surveillance and research.  

Monitoring, Intelligence Gathering and Analysis 
INSA  has  fundamental  responsibilities  in  public  health  surveillance.  The  institute  undertakes 
epidemiological surveillance for both communicable and non-communicable diseases. This surveillance 
is pivotal in detecting, monitoring, and responding effectively to health threats. By analysing health data 
and  trends,  INSA  provides  valuable  insights  into  disease  patterns,  helping  guide  policy-making  and 
targeted interventions, including with regards to the identification of medical countermeasures. 

Advanced Research and Development Capacities 
INSA maintains advanced research, particularly in the field of infectious diseases. The institute is tasked 
with promoting, coordinating, and carrying out research activities and projects on infectious diseases. 
As  part  of  their  broader  mission,  INSA  focuses  on  various  aspects  of  public  health,  including  the 
development and evaluation of medical countermeasures against a range of health threats, such as 
infectious diseases, chemical, biological, radiological, and nuclear (CBRN) hazards. Its work includes 
developing diagnostics, vaccines, therapeutics, and other critical medical countermeasures. 

National Authority of Medicines and Health Products 
The  National  Authority  of  Medicines  and  Health  Products  in  Portugal  serves as  the  regulatory  body 
responsible  for  the  oversight  and  regulation  of  medicines  and  health  products.  During  public  health 
emergencies, the authority plays a crucial role in managing the supply, authorizing usage, and ensuring 
the safety, efficacy, and quality of MCMs. 

Production / Manufacturing Capacities 
The authority has responsibilities with regards to managing the supply of MCMs as well as in evaluating 
the authorization and usage of MCMs and ensuring their availability. This involves working closely with 
manufacturers, distributors, and other stakeholders to secure a sufficient supply of MCMs to meet the 
country's needs. 

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Health Security Coordination 
The National Authority of Medicines and Health Products plays a role in ensuring the availability of safe 
and effective MCMs during public health emergencies. The authority coordinates with other national 
health entities, such as the Directorate-General of Health (DGS), to develop emergency response plans 
and protocols. It also provides expertise on regulatory matters related to MCMs.

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w. Romania 

Overview of approach to preparedness and response to public health emergency in MCMs 

Monitoring, Intelligence Gathering and Analysis 
In Romania, the National Institute for Public Health (INSP), through its National Centre for Surveillance 
and  Control  of  Communicable  Diseases  (CNSCBT),  monitors  disease  patterns,  gathers  data  on 
outbreaks, and analyses trends to identify public health threats and related medical countermeasures. 
The DSU, particularly through the National Centre for Coordination and Management of the Intervention 
(CNCCI), supports data centralization and analysis for risk assessment, providing strategic decision-
makers with vital information to formulate effective response strategies during health crises. 

Advanced Research and Development Capacities 
The  Ministry  of  Health  in  Romania  supports  biomedical  research  to  develop  new  medical 
countermeasures in cooperation with the European Union.  

Production / Manufacturing Capacities 
The Ministry of Health collaborates with local and international companies to ensure the availability and 
production of essential medical countermeasures.  

Procurement of MCMs 
Both  the  Ministry  of  Health  and  the  DSU  are  actively  involved  in  the  procurement  of  medical 
countermeasures. The Ministry conducts market analyses to identify needs and capacities, participating 
in EU’s joint procurement initiatives to acquire essential medical supplies. The Inspectorate General for 
Emergency Situations (IGSU), under the DSU, handles centralized procurement of MCMs, including 
PPE and medical equipment. 

Stockpiling and Distribution Capacities 
The  Ministry  of  Health  is  responsible  for  developing  and  maintaining  strategic  reserves  of  critical 
medical countermeasures, such as vaccines, antiviral drugs, antibiotics, and PPE. The DSU, equipped 
with  its  own  storage,  transportation,  and  distribution  means,  ensures  the  readiness  and  efficient 
deployment of essential supplies.  

International Cooperation 
The Ministry of Health collaborates with the EU and HERA on joint procurement and production capacity 
enhancement. It also engages in global initiatives like COVAX and EU4Health, promoting vaccine equity 
and health system resilience. The DSU, as a national focal point for EU’s ERCC and NATO’s EADRCC, 
facilitates international assistance, deploying medical teams, and donating medical supplies.  

Health Security Coordination 
The  Ministry  of  Health  develops  national  health  strategies  and  emergency  response  plans,  working 
closely with INSP and the Romanian Agency for Medicines and Medical Devices. The DSU operates 
within  a  legal  framework  for  public  health  measures,  implementing  a  national  contingency  plan  for 
epidemic  response.  This  plan  delineates  roles  and  responsibilities  for  stakeholders,  ensuring 
preparedness and effective coordination during health crises.  

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Comprehensive mapping of identified entities 

Ministry of Health 
The Ministry of Health of Romania (Ministerul Sănătății) is the national authority responsible for public 
health  policy,  healthcare  services,  and  health  sector  regulations.  It  oversees  the  development  and 
implementation  of  health  strategies  and  coordinates  with  other  national  and  international  health 
organisations.  

Advanced Research and Development Capacities 
The Ministry supports biomedical research to develop new medical countermeasures for health threats 
in cooperation with the EU. 

Production / Manufacturing Capacities 
The Ministry cooperates with local and international companies involved in the production of various 
medical countermeasures to ensure the availability of essential medicines and to expand production 
capacities during health crises. 

Procurement of MCMs 
The Ministry of Health in Romania is actively engaged in the procurement of medical countermeasures. 
It conducts market analyses to identify needs and capacities for acquiring medical equipment. Recent 
initiatives include the procurement of medical equipment to boost post-stroke recovery capacities and 
intensive care unit (ICU) response capabilities. The Ministry participates in the EU’s joint procurement 
initiatives  to  purchase  essential  medical  supplies,  including  vaccines,  medicines,  and  personal 
protective equipment. 

Stockpiling and Distribution Capacities 
The  Ministry  is  involved  in  developing  and  maintaining  strategic  reserves  of  critical  medical 
countermeasures, which includes vaccines, antiviral drugs, antibiotics, and PPE. 

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International cooperation 
The  Ministry  cooperates  with  the  EU  and  HERA  to  identify  needs,  procure  supplies,  and  enhance 
production  capacities  for  critical  medical  items.  This  includes  participation  in  joint  procurement 
agreements to secure vaccines and PPE. Additionally, Romania is represented by the Ministry at the 
EU  Health  Security  Committee,  facilitating  coordinated  responses  to  health  threats.  The  Ministry 
partners with WHO Europe to improve digital health services and emergency preparedness, aligning 
national  strategies  with  international  standards.  Regional  collaborations  through  networks  like  the 
South-East European Health Network (SEEHN) and bilateral agreements with various countries further 
support  the  exchange  of  medical  countermeasures  and  expertise.  The  Ministry  also  participates  in 
global  initiatives  such  as  the  COVAX  program  for  vaccine  equity  and  the  EU4Health  program  to 
strengthen health system resilience and crisis preparedness. 

Health Security Coordination 
The Ministry develops national health strategies and emergency response plans and collaborates with 
agencies  like  the  National  Institute  of  Public  Health  and  the  Romanian  Agency  for  Medicines  and 
Medical Devices to coordinate health crisis response.  

National Institute for Public Health (INSP) 
The  National  Institute  for  Public  Health  (INSP)  stands  as  a  cornerstone  of  Romania's  public  health 
infrastructure, comprising various units dedicated to disease surveillance, immunization programs, and 
health security.  

Monitoring, Intelligence Gathering and Analysis 
The  INSP  through  its  National  Centre  for  Surveillance  and  Control  of  Communicable  Diseases 
(CNSCBT)  takes  on  the  vital  role  of  monitoring  and  controlling  infectious  diseases.  This  involves 
continuous  surveillance  of  disease  patterns,  gathering  data  on  outbreaks,  and  analysing  trends  to 
identify potential threats to public health, as well as the related medical countermeasures.  The results 
of these activities are used to inform the recommendations (including awareness) and the public health 
interventions proposed to the Ministry of Health. 

Department of Emergency Situations (DSU) – Ministry of Internal Affairs 
The  Department  for  Emergency  Situations  (DSU)  in  Romania  serves  as  the  operational  arm  of  the 
Ministry of Internal Affairs with permanent national coordinating powers for prevention and management 
of  emergencies,  providing  and  coordinating  the  human,  material,  financial  and  other  resources 
necessary to cope with emergencies, including qualified first aid, emergency medical care/aerial rescue 
services,  emergency  medical  assistance  within  emergency  units.  In  public  health  crises,  the  DSU 
operates at all three levels of coordination (strategic, operational, and tactical), including on-the-ground 
responses. Their multifaceted role encompasses the physical distribution of MCMs, coordination with 
healthcare  services  for  effective  utilization,  and  direct  support  for  national  and  local  authorities  in 
affected  areas.  This  involves  ensuring  that  MCMs  are  efficiently  deployed  where  needed  and 
overseeing their proper utilization in the field. 

Monitoring, Intelligence Gathering and Analysis 
In the context of a health crisis, the DSU's role includes providing support through the National Centre 
for Coordination and Management of the Intervention (CNCCI). This involves centralizing and analysing 
data for risk assessment even in public health, assisting strategic decision-makers with vital information 
for effective response strategies, including with regards to medical countermeasures.  

Procurement of MCMs 
The Inspectorate General for Emergency Situations (IGSU), under the DSU's umbrella, is designated 
as the national authority for centralized procurement of MCMs, particularly PPE and medical equipment, 

205 

 
 
 
 
 
 
 
like  injectomats  and  ventilators.  This  responsibility  involves  assessing  requirements,  selecting 
appropriate suppliers, and ensuring the timely acquisition of essential supplies.  

Stockpiling and Distribution Capacities 
With its own means for storage, transportation, and distribution of MCMs, the DSU ensures readiness 
to  deploy  essential  supplies  when  required.  During  the  pandemic,  Romania  established  a  legal 
framework  to  facilitate  cooperation  between  national  and  international  stakeholders,  enhancing  the 
efficiency of stockpiling and distribution efforts.  

International Cooperation 
The DSU and its subunit IGSU are integral to Romania's international cooperation efforts during health 
emergencies.  They  facilitated  international  support  and  assistance  to  other  countries,  deploying 
emergency  medical  teams,  donating  PPE,  medication,  and  vaccines,  and  participating  in  the 
repatriation of EU citizens. As national focal points for EU's Emergency Response Coordination Centre 
(ERCC)  and  NATO's  Euro-Atlantic  Disaster  Response  Coordination  Centre  (EADRCC),  the  DSU 
ensures Romania's active participation in international emergency response mechanisms. 

Health Security Coordination 
At  the  national  level,  the  DSU  operates  within  a  legal  framework  for  implementing  public  health 
measures during epidemiological and biological risk situations. It has developed a national contingency 
plan for epidemic response, outlining roles and responsibilities for all stakeholders. This comprehensive 
plan includes a dedicated chapter for preparedness, emphasizing the DSU's commitment to readiness 
and effective coordination in managing health crises. Through the activation of specialized cells within 
CNCCI,  the  DSU  supports  strategic  decision-makers  with  expert  advice  and  coordination  during 
emergencies, enhancing Romania's health security coordination capabilities

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x. Slovakia 

Overview of approach to preparedness and response to public health emergency in MCMs 

Monitoring, Intelligence Gathering and Analysis 
In  Slovakia,  the  Ministry  of  Health  collaborates  with  national  and  international  bodies  to  detect  and 
evaluate  emerging  health  threats  and  countermeasures.  The  Public  Health  Authority  of  the  Slovak 
Republic (PHA SR), particularly through its Department of Epidemiology, oversees disease surveillance, 
analysing disease patterns, identifying trends, and assessing potential risks. Additionally, the Regional 
Public Health Authorities (RPHA SR) conduct regular monitoring of the epidemiological situation and 
general morbidity within their regions, providing localized responses to health threats. 

Advanced Research and Development Capacities 
Slovakia's  Ministry  of  Health  promotes  advanced 
in  medical 
countermeasures  by  supporting  innovation  and  facilitating  partnerships  between  public  health 
institutions,  universities,  and  private  sector  entities.  This  includes  funding  research  projects, 
encouraging clinical trials, and adopting new technologies to improve MCM efficacy and safety.  

research  and  development 

Production / Manufacturing Capacities 
The Ministry of Health supports local manufacturing capacities through regulatory facilitation, financial 
incentives,  and  infrastructural  support.  This  support  enhances  the  production  capabilities  of 
pharmaceuticals and other medical supplies within Slovakia.  

Procurement of MCMs 
The procurement of MCMs in Slovakia is primarily handled by the Ministry of Health through transparent 
and  competitive  processes.  The  Office  for  Public  Procurement  (Úrad  pre  verejné  obstarávanie) 
oversees regulatory and procedural aspects, while the Ministry carries out the actual procuring. The 
Ministry  also  participates  in  joint  procurement  initiatives  with  other  EU  countries  to  leverage  better 
pricing  and  supply  conditions.  During  health  emergencies,  the  Ministry  coordinates  the  purchase 
process  for  vaccines  and  other  essential  MCMs,  ensuring  their  availability  through  a  centralized 
procurement system. 

Stockpiling and Distribution Capacities 
The Ministry of Health manages the stockpiling and distribution of essential MCMs, maintaining strategic 
reserves and ensuring timely distribution across healthcare facilities. Coordination with regional health 
authorities  optimizes  storage  and  delivery  processes.  During  the  COVID-19  pandemic,  regional 
authorities were instrumental in distributing vaccines, PPE, and other supplies, ensuring effective local 
response and coverage. 

International Cooperation 
The Ministry of Health participates in EU health initiatives, cooperates with the WHO, and entertains 
bilateral  agreements  with  other  countries.  The  PHA  SR  maintains  active  communication  with  the 
European  Early  Warning  and  Response  System  (EWRS)  and  WHO,  ensuring  Slovakia  is  well-
integrated into global health security networks.  

Health Security Coordination 
Health security coordination in Slovakia is managed by the Ministry of Health. The Ministry integrates 
MCM strategies into national health security frameworks, conducts regular drills and simulations, and 
ensures  seamless  coordination  among  various  stakeholders,  including  governmental  agencies, 
healthcare providers, and international partners.  

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Comprehensive mapping of identified entities 

Ministry of Health 
Monitoring, Intelligence Gathering, and Analysis 
The  Ministry  of  Health  is  involved  in  the  systematic  monitoring  and  intelligence  gathering  related  to 
health  threats  and  the  effectiveness  of  MCMs.  This  involves  collaboration  with  various  national  and 
international bodies to detect and evaluate emerging health threats and countermeasures, ensuring a 
robust  early  warning  and  response  system.  The  Ministry  uses  comprehensive  data  collection  and 
analysis  to  inform  policy  and  operational  decisions,  thereby  enhancing  the  readiness  and 
responsiveness to public health emergencies. 

Advanced Research and Development Capacities  
Slovakia's Ministry of Health promotes advanced research and development in the field of MCMs by 
supporting innovation and facilitating partnerships between public health institutions, universities, and 
private sector entities. This includes funding research projects, encouraging clinical trials, and adopting 
new technologies to improve the efficacy and safety of MCMs. 

Production/Manufacturing Capacities  
To ensure a stable supply of MCMs, the Ministry provides support to local manufacturing capacities. 
This support includes regulatory facilitation, financial incentives, and infrastructural support to enhance 
the production capabilities of pharmaceuticals and other medical supplies within the country. 

Procurement of MCMs 
While  the  Office  for  Public  Procurement  (Úrad  pre  verejné  obstarávanie)  in  Slovakia  handles  the 
regulatory and procedural aspects of procurement, The Ministry is responsible for the procurement of 
MCMs  through  transparent  and  competitive  processes.  This  involves  negotiating  with  suppliers, 
ensuring the quality and affordability of medical products, and maintaining a steady supply to meet the 
national healthcare needs. The Ministry also participates in joint procurement initiatives with other EU 
countries to leverage better pricing and supply conditions. 

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Stockpiling and Distribution Capacities 
Effective stockpiling and distribution are crucial components managed by the Ministry of Health. This 
includes  maintaining  strategic  reserves  of  essential  MCMs,  ensuring  their  timely  distribution  across 
healthcare facilities, and managing logistics during emergencies. The Ministry coordinates with regional 
health authorities to optimize the storage and delivery processes. 

International Cooperation  
The Ministry of Health actively engages in international cooperation to enhance the country’s capacity 
to respond to health emergencies. This includes participation in EU health initiatives, collaboration with 
the WHO, and bilateral agreements with other countries. Such cooperation facilitates the exchange of 
knowledge, resources, and best practices in the management of MCMs. 

Health Security Coordination  
Health security is a critical area where the Ministry of Health coordinates efforts to protect the population 
from health threats. This involves integrating MCM strategies into national health security frameworks, 
conducting  regular  drills  and  simulations,  and  ensuring  seamless  coordination  among  various 
stakeholders, including governmental agencies, healthcare providers, and international partners. 

Public Health Authority of the Slovak Republic (PHA SR) 
The Public Health Authority of the Slovak Republic (PHA SR) serves as the central body overseeing 
public health matters in Slovakia. Under its umbrella, the Department of Epidemiology plays a pivotal 
role in emergency preparedness and response. The PHA SR, through its Department of Epidemiology, 
coordinates  the  national  immunization  program,  a  critical  aspect  of  disease  prevention  and  control. 
Responsibilities include issuing vaccination schedules, monitoring vaccination rates, and collaborating 
with international organisations. While the PHA SR plans, coordinates, and determines the scope of 
vaccination programs, it does not have the authority for vaccine approval, distribution, or application. 
Instead,  its  focus  lies  in  shaping  vaccination  strategies,  determining  vaccine  antigens,  and  ordering 
emergency vaccinations when necessary. 

Mode of operation 
During  preparedness,  PHA  SR  monitors  the  epidemiological  situation,  conducts  inquiries  to  identify 
outbreaks, and ensures the operation of National Reference Centers. They serve as the contact point 
for  EWRS  and  WHO,  evaluating  and  communicating  public  health  threats,  informing  the  population 
about health protection measures, and proposing actions to the civil protection authority. 

In  a  crisis,  PHA  SR  swiftly  conducts  field  and  laboratory  analyses  to  identify  threats,  investigates 
diseases, and maintains monitoring systems. They disseminate crucial information to the public, impose 
fines for non-compliance with health measures, and order measures such as quarantine, isolation, and 
hygiene protocols to prevent disease spread. For significant threats, they propose the declaration of an 
emergency situation, including actions like evacuation and hygiene protocols. PHA SR's role is critical 
in monitoring, responding to, and mitigating public health threats in Slovakia. 

Monitoring, Intelligence Gathering and Analysis 
The Department of Epidemiology oversees disease surveillance, analysing and evaluating results for 
early  detection  of  health  threats.  This  includes  monitoring  disease  patterns,  identifying  trends,  and 
assessing  potential  risks  to  public  health.  By  analysing  factors  influencing  disease  origination  and 
spread,  the  department  shapes  strategies  and  protocols  for  preventing,  controlling,  and  managing 
infectious  disease  outbreaks.  Additionally,  the  PHA  SR  connects  Slovakia  with  the  European  Early 
Warning  and  Response  System  (EWRS),  enabling  regular  monitoring  and  evaluation  of  exceptional 
epidemiological situations. 

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Advanced Research and Development Capacities 
The  PHA  SR  introduces  new  progressive  laboratory  diagnostic  methods  for  infectious  agents  and 
collaborates  with  scientific  research  and  university  institutions.  However,  the  identification  of 
countermeasures remains within the competence of the Ministry of Health of the Slovak Republic. 

Regional Public Health Authorities in the Slovak Republic (RPHA SR) 
The Regional Public Health Authorities in the Slovak Republic (RPHA SR) serve as vital components 
of the country's public health infrastructure, working in tandem with the Public Health Authority of the 
Slovak Republic (PHA SR) to ensure regional health security and response capabilities. 

Mode of operation 
The RPHA SR work alongside the Public Health Authority during preparedness and crisis situations. 
During  preparedness,  RPHA  SR  conducts  regular  monitoring  of  the  population's  health  status  and 
epidemiological situation. They perform epidemiological inquiries, identify biological factors, and ensure 
the operation of National Reference Centers. Additionally, they collaborate with PHA SR on EWRS and 
WHO communications, assess public health threats, and inform the population about health protection 
measures. 

In a crisis, RPHA SR swiftly provides field and laboratory analyses, investigates biological and chemical 
agents, and participates in public health threat assessments. They utilize the rapid alert system, inform 
the  public  about  protection  measures,  and  cooperate  at  national  and  international  levels  during 
emergencies. RPHA SR is authorized to order measures like quarantine, hygiene protocols, and safe 
disposal  of  contaminated  materials.  In  cases  of  significant  public  health  threats,  they  propose  the 
declaration of an emergency situation, including actions such as evacuation and hygiene protocols. The 
Regional Public Health Authorities' role complements PHA SR's efforts, ensuring a coordinated and 
effective response to public health emergencies at the regional level in Slovakia. 

Monitoring, Intelligence Gathering and Analysis 
RPHA  SR  orders  disease  prevention  measures  and  countermeasures  against  public  health  threats 
within  their  territorial  competence.  They  conduct  regular  monitoring  of  the  epidemiological  situation, 
tracking  the  general  morbidity  of  the  population  within  their  regions.  This  includes  carrying  out 
epidemiological inquiries to identify outbreak circumstances and implementing necessary measures to 
prevent the spread of communicable diseases. The regional authorities effectively implement national 
guidelines and instructions on the ground, allowing for localized responses to public health emergencies. 

Advanced Research and Development Capacities 
The  regional  authorities  introduce  new  progressive  laboratory  diagnostic  methods  for  determining 
infectious agents. They collaborate with scientific research and university workplaces to enhance their 
diagnostic  capabilities  and  stay  at  the  forefront  of  disease  detection.  However,  the  identification  of 
countermeasures remains within the competence of the Ministry of Health of the Slovak Republic. 

Stockpiling and Distribution Capacitites 
Once MCMs are procured and stockpiled by the Ministry of Health, regional authorities manage the 
distribution  of  these  supplies  to  local  healthcare  facilities.  During  the  COVID-19  pandemic,  regional 
health  authorities  played  a  critical  role  in  the  local  distribution  of  vaccines,  personal  protective 
equipment (PPE), and other medical supplies. They coordinated vaccination campaigns and managed 
local healthcare responses to the pandem

210 

 
 
 
 
 
 
 
 
 
y. Slovenia 

Overview of approach to preparedness and response to public health emergency in MCMs 

Monitoring, Intelligence Gathering, and Analysis 
In Slovakia, the Ministry of Health engages in continuous surveillance and data analysis to identify and 
evaluate  health  risks  and  countermeasures.  This  process  includes  cooperation  with  both  national 
entities, such as the National Institute of Public Health (NIJZ), and international health institutions. NIJZ 
plays a pivotal role by providing essential public health functions. 

Advanced Research and Development Capacities 
The Ministry of Health supports advanced research and development for MCMs in Slovakia by fostering 
collaborations with universities, research institutions, and international bodies. This involves developing 
new medical technologies and therapeutic solutions to enhance national preparedness and response 
capabilities.  

Production/Manufacturing Capacities 
The  Ministry  of  Health  assists  local  pharmaceutical  companies  and  manufacturers  by  providing 
regulatory support and funding for R&D.  

Procurement of MCMs 
The procurement of medical countermeasures in Slovakia is managed by the Ministry of Health. The 
Ministry  also  participates  in  joint  procurement  initiatives  with  other  EU  countries.  NIJZ  supports  this 
process by assessing vaccine needs, providing crucial information to inform procurement decisions, 
particularly during joint European procurements. 

Stockpiling and Distribution Capacities 
The Ministry of Health oversees the stockpiling and distribution of essential medical supplies in Slovakia. 
This includes ensuring that supplies are adequately stored and maintained, with protocols in place for 
rapid distribution during public health emergencies.  

International Cooperation 
The  Ministry  of  Health  collaborates  with  international  organisations  such  as  the  World  Health 
Organisation  (WHO)  and  the  European  Centre  for  Disease  Prevention  and  Control  (ECDC).  These 
partnerships facilitate the sharing of knowledge, best practices, and resources on MCMs. 

Health Security Coordination 
The  Ministry  of  Health  coordinates  national  health  security  efforts  in  Slovakia,  integrating  various 
stakeholders, including public health agencies, healthcare providers, and emergency response teams. 
This  coordinated  approach  ensures  a  unified  and  effective  response  to  health  emergencies, 
encompassing planning, preparedness, and crisis management.  

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Comprehensive mapping of identified entities 

Ministry of Health 
The Ministry of Health of Slovenia is pivotal in national crisis preparedness and response. It coordinates 
health  security  efforts,  oversees  public  health  surveillance,  supports  research  and  development  of 
medical  technologies,  ensures  the  production  and  procurement  of  essential  medical  supplies,  and 
manages stockpiling and distribution during emergencies. The Ministry collaborates with international 
organisations to enhance Slovenia's capacity to respond to global health threats effectively 

Monitoring, Intelligence Gathering, and Analysis 
The Ministry engages in continuous monitoring and data analysis to detect health threats early. This 
includes  evaluating  the  impacts  of  these  threats  and  identifying  potential  MCMs.  The  Ministry 
cooperates with national and international health institutions to gather and analyse relevant data. In 
specific, the National Institute of Public Health (NIJZ) plays a crucial role in supporting the Ministry by 
providing essential public health functions and aiding in health system governance. 

Advanced Research and Development Capacities  
The Ministry supports research initiatives through collaborations with universities, research institutions, 
and international bodies. This includes developing new medical technologies and therapeutic solutions 
to  enhance  the  country's  preparedness  and  response  to  health  emergencies.  The  Ministry  also 
oversees the strategic planning and infrastructure necessary for advanced research. 

Production/Manufacturing Capacities  
The  Ministry  assists  local  pharmaceutical  companies  and  manufacturers  by  providing  regulatory 
support, funding for research and development, and fostering public-private partnerships.  

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Procurement of MCMs 
The Ministry is responsible for the procurement of necessary MCMs, ensuring they are available during 
health  crises.  This  involves  strategic  sourcing,  maintaining  supplier  relationships,  and  ensuring 
compliance with international standards. Joint procurement initiatives with other EU countries are also 
undertaken to leverage better pricing and supply stability. 

Stockpiling and Distribution Capacities  
The Ministry oversees the stockpiling of essential medical supplies, ensuring they are adequately stored 
and maintained. Protocols are in place for the rapid distribution of these supplies during public health 
emergencies, ensuring timely delivery to affected areas. 

International Cooperation  
The Ministry collaborates with international organisations, such as the WHO and the European Centre 
for  Disease  Prevention  and  Control  (ECDC),  to  share  knowledge,  best  practices,  and  resources  on 
MCMs.  

Health Security Coordination 
The  Ministry  coordinates  national  health  security  efforts,  integrating  various  stakeholders,  including 
public  health  agencies,  healthcare  providers,  and  emergency  response  teams.  This  coordinated 
approach  ensures  a  unified  and  effective  response  to  health  emergencies,  encompassing  planning, 
preparedness, and crisis management. 

National Institute of Public Health (NIJZ) 
The National Institute of Public Health (NIJZ) in Slovenia serves as a crucial research and professional 
institution  responsible  for  a  range  of  public  health  activities,  particularly  in  the  realm  of  infectious 
diseases.  

Mode of operation 
NIJZ in Slovenia maintains a robust system for preparedness by continuously monitoring public health 
risks through its Epidemic Intelligence framework. This includes analyzing data, assessing risks, and 
ensuring  evidence-based  responses  guided  by  professional  guidelines  and  a  qualified  team.  With  a 
24/7 contact point, NIJZ meets legal obligations set by the EC and WHO, ensuring readiness within the 
EU framework. The establishment of the Operations Center for Crisis Management enables coordinated 
responses to significant health risks, optimizing resources and facilitating intersectoral cooperation for 
effective preparedness. In times of crisis, NIJZ follows predefined protocols outlined in the Health Action 
Plan and state Civil Protection plans. These plans define mechanisms, activate response groups, and 
ensure  clear  communication  channels  for  efficient  crisis  management,  emphasizing  defined 
responsibilities and cooperation among stakeholders for a swift and organized response. 

Monitoring, Intelligence Gathering and Analysis 
NIJZ  is  equipped  with  a  system  for  monitoring  public  health  risks,  often  referred  to  as  "Epidemic 
intelligence."  This  system  involves  collecting  data,  analysing  trends,  and  assessing  risks  related  to 
infectious diseases. NIJZ has qualified staff dedicated to risk assessment, developing action plans, and 
maintaining an epidemiological field service. The institute also established a 24/7 contact point at the 
national and regional levels to ensure constant vigilance and rapid response to emerging health threats. 

Advanced Research and Development Capacities 
While NIJZ does not engage in advanced research and development, it plays a role in assessing needs 
and evaluating necessary vaccines. Its focus is on using existing data and collaborating with competent 
clinics to determine vaccine requirements and contribute to the evaluation process. 

213 

 
 
 
 
 
 
 
 
 
 
Procurement of MCMs 
NIJZ is involved in the assessment of needs and the procurement of vaccines. However, during crisis 
events, joint European procurements are overseen by the Ministry of Health. NIJZ's role is in evaluating 
necessary vaccines to inform the procurement process.

214 

 
 
 
z. Spain 

Overview of approach to preparedness and response to public health emergency in MCMs 

Monitoring, Intelligence Gathering, and Analysis 
In Spain, the Coordination Centre for Health Alerts and Emergencies (CCAES) under the Ministry of 
Health, along with the Carlos III Health Institute (ISCIII), are pivotal in monitoring, intelligence gathering, 
and  analysis.  The  CCAES  detects  and  evaluates  health  threats  through  epidemic  surveillance  and 
threat  modelling,  identifying  emerging  risks,  conducting  thorough  risk  assessments,  identifying 
countermeasures and disseminating timely alerts and information to relevant stakeholders. Meanwhile, 
ISCIII enhances early detection and disease surveillance. 

Advanced Research and Development Capacities 
The CCAES and ISCIII significantly contribute to advanced research and development capacities in 
Spain. The CCAES supports research by fostering collaborations with research institutions and industry 
partners, promoting initiatives for developing effective, safe, and affordable medical countermeasures. 
ISCIII  conducts  research  to  enhance  understanding  of  disease  characteristics  and  supports  the 
development of new treatments, diagnostics, and vaccines. Finally, The AEMPS provides support and 
guidance  for  the  development  of  safe  and  effective  medical  countermeasures  and  participates  in 
initiatives led by the EU. 

Production / Manufacturing Capacities 
The  Spanish  Agency  of  Medicines  and  Medical  Devices  (AEMPS)  leads  efforts  in  production  and 
manufacturing capacities. Since 2019, AEMPS has been implementing a national plan to guarantee the 
security  of  supply  of  authorized  medicinal  products,  identifying  critical  production  sites  for  medical 
countermeasures,  and  promoting  local  production  capacities.  The  CCAES  complements  this  by 
addressing  market  challenges,  ensuring  availability,  and  resolving  bottlenecks  in  the  supply  chain. 
These initiatives collectively strengthen Spain’s strategic autonomy and resilience in the production and 
manufacturing of essential medical countermeasures. 

Procurement of MCMs 
The CCAES manages the procurement of medical countermeasures through established protocols for 
swift  acquisition  during  public  health  emergencies.  This  includes  maintaining  relationships  with 
suppliers, conducting regular market assessments, and establishing pre-negotiated contracts to ensure 
timely access to essential MCMs. By ensuring a streamlined and proactive procurement process, the 
CCAES guarantees that necessary medical supplies are readily available when needed most. 

Stockpiling and Distribution Capacities 
The Instituto Nacional de Gestión Sanitaria (INGESA) is tasked with the national stockpiling of MCMs. 
The CCAES supports this process by conducting regular evaluations of stock levels, expiration dates, 
and potential needs based on threat assessments, developing robust logistics plans, coordinating with 
relevant  agencies,  and  maintaining  strategically  located  storage  facilities.  The  AEMPS  supports  the 
national  stockpiling  initiative  by  prioritizing  medical  supplies  and  providing  technical  assistance  for 
medicines and devices included in the strategic reserve. 

International Cooperation 
The  CCAES  collaborates  with  international  organisations,  shares  surveillance  data,  participates  in 
crisis-relevant  medical  countermeasure  initiatives,  and  supports  low  and  middle-income  countries. 
AEMPS  also  engages  in  global  efforts,  participating  in  the  G20  Health  Working  Group,  OECD 
discussions,  and  the  Ibero-American  Network  of  Medicines  and  Medical  Devices  Authorities  (Red 

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EAMI).  ISCIII  collaborates  with  international  partners,  contributing  to  the  global  understanding  and 
response to infectious diseases.  

Health Security Coordination 
Health security coordination in Spain is managed by the CCAES and ISCIII, with support from AEMPS. 
The CCAES maintains  updated  emergency response  plans,  conducts  regular  drills, and establishes 
clear communication channels for rapid decision-making. It ensures swift access to MCMs through pre-
negotiated contracts, established distribution networks, and coordination with relevant agencies. ISCIII 
provides  scientific  expertise  and  support  during  public  health  emergencies,  contributing  to  the 
development of response plans and coordination efforts.  

Comprehensive mapping of identified entities 

Ministry of Health 
The  Ministry  of  Health  in  Spain,  specifically  through  the  Coordination  Centre  for  Health  Alerts  and 
Emergencies  (CCAES),  undertakes  crucial  responsibilities  across  various  facets  of  public  health 
emergency management.  

Mode of operation 
In  times  of  preparedness,  the  entity,  through  the  CCAES,  operates  by  overseeing  and  coordinating 
various efforts. This includes developing and updating emergency response plans based on thorough 
risk assessments, conducting training sessions and drills for readiness, monitoring health data for early 
threat  detection,  and  procuring  and  maintaining  stockpiles  of  essential  medical  countermeasures. 
Collaboration  with  relevant  agencies,  effective  communication  channels  for  alerts,  establishment  of 
rapid  decision-making  protocols,  and  resource  identification  for  an  effective  response  are  also  key 
aspects.  During  this  phase,  the  focus  is  on  ensuring  all  elements  are  in  place  to  mount  a  swift  and 
effective response to potential public health emergencies. 

During  a  public  health  crisis  response,  the  CCAES  immediately  activates  its  emergency  response 
protocols.  This  includes  close  collaboration  with  national  and  international  health  organisations, 
government agencies, and stakeholders. The entity manages and disseminates accurate and timely 
information  to  the  public,  healthcare  providers,  and  authorities.  It  adjusts  and  implements  response 
plans based on the evolving crisis, ensures the availability and allocation of necessary resources like 

216 

 
 
 
 
 
 
 
 
medical  supplies  and  personnel,  intensifies  surveillance  efforts  to  track  the  crisis's  spread,  and 
maintains transparent communication with stakeholders and media.  

Monitoring, Intelligence Gathering and Analysis 
The CCAES is instrumental in detecting and evaluating health threats through comprehensive epidemic 
surveillance and threat modelling. This includes identifying emerging risks, conducting thorough risk 
assessments and disseminating timely alerts and information to relevant stakeholders. Additionally, it 
focuses  on  countermeasure  identification,  risk  prioritization,  and  awareness  programs,  along  with 
training to enhance knowledge and skills related to MCMs. 

Advanced Research and Development capacities 
The CCAES supports advanced research, innovation, and development by fostering collaborations with 
research institutions and industry partners. This includes promoting initiatives for the development of 
effective,  safe,  and  affordable  medical  countermeasures  through  funding  support,  facilitating  clinical 
trials, and encouraging technological advancements in the field. 

Production / Manufacturing capacities 
The  CCAES  addresses  market  challenges  and  enhances  the  country's  strategic  autonomy  by 
identifying critical production sites for medical countermeasures and working to ensure their availability. 
This includes actively resolving bottlenecks and dependencies in the supply chain, establishing new 
industrial partnerships, and promoting local production capacities for MCMs. 

Procurement of MCMs  
The CCAES carries out procurement of MCMs by following established protocols and procedures for 
swift  acquisition  during  preparedness  for  a  public  health  emergency.  This  includes  maintaining 
relationships with suppliers, conducting regular market assessments, and establishing pre-negotiated 
contracts to ensure timely access to essential medical countermeasures when needed. 

Stockpiling and distribution capacities 
The CCAES conducts regular evaluations of stock levels, expiration dates, and potential needs based 
on threat assessments. To overcome challenges related to transportation, storage, and distribution, the 
entity develops robust logistics plans, coordinates with relevant agencies for secure transportation, and 
maintains strategically located storage facilities. In emergencies, swift deployment is ensured through 
pre-established protocols, efficient distribution channels, and coordination with regional authorities for 
timely access to MCMs. 

International Cooperation 
The  CCAES  contributes  to  reinforcing  global  health  emergency  preparedness  and  response 
architecture  through  various  avenues.  This  includes  collaborations  with  international  organisations, 
sharing  surveillance  data,  and  participating  in  crisis-relevant  medical  countermeasure  cooperation 
initiatives. Additionally, the entity supports low and middle-income countries through capacity-building 
efforts,  knowledge  sharing,  and  facilitating  access  to  medical  countermeasures.  The  CCAES  also 
actively  participates  in  EU-joint  activities  on  medical  countermeasures  to  ensure  alignment  with 
European initiatives and standards. 

Health security coordination 
The  entity  ensures  effective  deployment  of  pre-established  preparations  by  maintaining  updated 
emergency response plans and conducting regular drills and simulations. To facilitate rapid decision-
making, it establishes clear communication channels, assigns roles and responsibilities in advance, and 
empowers designated personnel to make quick, informed decisions. Swift access to MCMs is ensured 
by  pre-negotiated  contracts  with  suppliers,  established  distribution  networks,  and  close  coordination 
with relevant agencies for timely procurement and delivery. In crisis situations, the entity's focus is on 

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efficient  implementation  of  emergency  measures,  such  as  activating  response  teams,  deploying 
resources as needed, and ensuring safe and effective deployment of MCMs at the necessary scale. 

The Spanish Agency of Medicines and Medical Devices (AEMPS) 
The  AEMPS  plays  a  central  role  in  prevention  and  management  of  medicines  and  medical  devices 
shortages. At national level, both in times of preparedness and during a public health emergency, the 
Spanish Agency coordinates actions which may involve various actors in the supply chain and (regional) 
healthcare  providers,  in  order  to  secure  the  supply  of  critical  medicines  and  medical  devices.  The 
AEMPS is also involved in actions and initiatives coordinated at EU and at global level to guarantee 
medicines and medical devices supply. 

Advanced Research and Development capacities 
The  AEMPS  provides  support  and  guidance  for  the  development  of  safe  and  effective  medical 
countermeasures (including medicinal products, medical devices, and in vitro diagnostics), particularly 
during public health emergencies (PHE). At the EU level, the AEMPS participates in initiatives led by 
the  EU,  such  as  promoting  collaboration  with  researchers,  developing  guidelines,  conducting  pilot 
projects,  and  engaging  in  horizon  scanning.  However,  these  efforts  are  not  specifically  focused  on 
emergency preparedness and response. 

Production / Manufacturing capacities 
The AEMPS has been implementing the national plan to guarantee the security of supply of authorised 
medicinal products since 2019. This plan encompasses prevention, management and communication 
measures against medicine shortages. The AEMPS also identified a list of strategic medicines (critical 
medicines that require additional measures in order to guarantee their availability), regularly updated, 
that have served as a basis, among other national list to elaborate the EU list of critical medicines. The 
Spanish Agency is implementing some specific regulatory measures to promote strategic medicines 
availability, including mechanisms to speed up the administrative procedures and the assessment of 
variations of the marketing authorisation of these medicinal products, scientific and regulatory advice 
to the pharmaceutical company that intends to submit a registration dossier for a product included in 
the list, as well as measures to favour internationalisation of these medicines. The AEMPS is currently 
mapping  Spain’s  dependencies  from  third  countries  regarding  the  manufacture  of  the  strategic 
medicines  identified,  as  well  as  other  vulnerability  indicators  related  to  medicines  shortages.  This 
analysis  will  serve  as  basis  for  an  inter-ministerial  project  (RECAPI),  supported  by  the  European 
Commission  (TSI)  that  aims  to  mitigate  the  country’s  dependence  on  foreign  supply  of  strategic 
resources and materials, including medicines and their raw materials. 

Stockpiling and distribution capacities 
The  AEMPS  is  actively  involved  in  the  national  stockpiling  initiative  led  by  INGESA,  particularly  in 
determining the prioritization of medicines, medical devices, and in vitro diagnostics for inclusion in the 
strategic national stockpile. Additionally, the AEMPS provides technical support as needed in relation 
to medicines and medical devices designated for stockpiling purposes. 

International Cooperation 
The entity engages in extensive international cooperation efforts across various platforms. At the global 
level, it participates in discussions within the G20 Health Working Group and OECD to secure medical 
supply chains and promote regional production and innovation alliances. Particularly noteworthy is its 
collaboration  with  Latin  American  countries  through  the  Red  EAMI  (Ibero-American  Network  of 
Medicines  and  Medical  Devices  Authorities),  where  AEMPS  serves  as  the  network's  permanent 
secretariat. This network of 22 countries focuses on collaborative actions, sharing technical information, 
and best practices related to medicines and medical devices. The Red EAMI launched "en Red contra 
COVID-19" in 2020, facilitating rapid information sharing among health authorities and professionals 
during  the  pandemic,  hosting  meetings  to  discuss  crisis  measures  and  scientific  knowledge  about 

218 

 
 
 
 
 
 
SARS-CoV-2. Additionally, AEMPS plays an active role in EU joint activities, with its executive director 
serving  in  key  positions  like  the  Vaccines  Steering  Board,  HERA  Board,  MSSG,  SPOC  WP,  and 
CHESSMEN JA, focusing on medicine shortages prevention and management. In the realm of medical 
devices, AEMPS participates in the CAMD TF for shortages and is involved in proposals to enhance 
notification requirements for manufacturers about critical shortages.  

Health security coordination 
The AEMPS may play a key role in ensuring access to medicines and medical devices during crisis 
situations by coordinating actions among various stakeholders in the medicinal products and medical 
devices supply chain. The agency is well-positioned for this role due to its ongoing engagement with all 
relevant actors in the supply chain. For example, during a public health emergency (PHE), AEMPS can 
support manufacturers and importers of essential medical countermeasures (MCMs) as well as health 
institutions producing necessary medical devices and/or in vitro diagnostic devices (IVDs). Additionally, 
AEMPS may issue exceptional authorizations for the import and use of medicinal products without a 
marketing  authorization  in  Spain  to  ensure  the  availability  of  critical  medicines  in  extraordinary 
circumstances, such as PHEs. If required, AEMPS can also apply the derogations outlined in Article 59 
of Regulation (EU) 2017/745 concerning medical devices in exceptional situations. 

Carlos III Health Institute (ISCIII) 
The Carlos III Institute (ISCIII), an institution under the Ministry of Science, Innovation and Universities, 
holds significant responsibilities across various areas related to infectious diseases.  

Monitoring, Intelligence Gathering and Analysis 
The institute plays a crucial role in disease surveillance and early detection through its participation in 
the  RE-LAB  network.  This  involves  monitoring  disease  trends,  conducting  laboratory  testing,  and 
genetic sequencing of pathogens during outbreak situations.  

Advanced Research and Development capacities  
The  ISCIII  conducts  research  to  enhance  understanding  of  disease  characteristics,  supporting  the 
development of new treatments, diagnostics, and vaccines. 

Stockpiling and distribution capacities 
The ISCIII contributes to the knowledge base necessary for effective stockpiling strategies.  

International Cooperation 
The Carlos III Institute engages in collaborations with international partners, contributing to the global 
understanding  and  response  to  infectious  diseases.  Their  participation  in  networks  like  RE-LAB 
indicates a commitment to sharing knowledge and resources on a global scale. 

Health security coordination 
The institute's role is vital in providing scientific expertise and support during public health emergencies. 
They  likely  contribute  to  the  development  of  response  plans,  coordination  efforts  with  other  health 
authorities, and providing scientific advice to decision-makers. 

National Institute of Health Management (INGESA) 
The  National  Institute  of  Health  Management  (INGESA)  is  a  public  institution  under  the  Ministry  of 
Health,  Consumer  Affairs,  and  Social  Welfare  in  Spain.  Its  primary  responsibility  is  to  manage  and 
ensure the provision of healthcare services, especially in Spain's autonomous cities of Ceuta and Melilla, 
as well as in other regions where it operates. 

219 

 
 
 
 
 
 
 
 
 
 
Stockpiling and distribution capacities  
INGESA has been tasked with the lead of the national stockpiling of MCMs. INGESA's involvement in 
stockpiling includes the strategic storage and management of essential medical supplies like medicines, 
vaccines, personal protective equipment (PPE), and other critical healthcare materials.  

220 

 
 
 
aa.  Sweden 

Overview of approach to preparedness and response to public health emergency in MCMs 

Monitoring, Intelligence Gathering, and Analysis 
The Public Health Agency of Sweden (PHAS) and the National Board of Health and Welfare (NBHW) 
collaboratively  handle  monitoring,  intelligence  gathering,  and  analysis  of  health  threats  and 
identification of countermeasures in Sweden. PHAS is responsible for monitoring notifiable diseases 
reported  by  the  healthcare  system.  Complementing  these  efforts,  NBHW  collaborates  closely  with 
PHAS  to  identify  and  assess  health  threats  and  issues  publications  on  healthcare  prioritization  and 
preparedness training programs. 

Advanced Research and Development Capacities 
Sweden’s advanced research and development capacities in medical countermeasures (MCMs) are 
primarily driven by the Karolinska Institute (KI) and the Swedish Civil Contingencies Agency (MSB). KI 
works  closely  with  pharmaceutical  and  biotech  companies  to  translate  research  into  therapies  and 
MCMs. MSB funds research in civil security, disasters, crises, and war, providing significant financial 
support for research initiatives that may include health-related studies. 

Production / Manufacturing Capacities 
The NBHW, along with the Swedish Medical Products Agency, plays a pivotal role in ensuring robust 
production  and  supply  of  MCMs.  The  NBHW  conducts  investigations  to  secure  safe  production 
capacities and collaborates on mapping and developing Sweden’s manufacturing capabilities.  

Procurement of MCMs 
Procurement  of  MCMs  in  Sweden  is  managed  by  the  NBHW,  which  is  responsible  for  national 
stockpiling and ensuring the availability of vital healthcare products during emergencies, such as mass 
casualty  situations  and  chemical,  biological,  radiological,  and  nuclear  (CBRN)  events.  The  NBHW 
represents  Sweden  in  EU  joint  procurement  agreements  and  has  published  recommendations  on 
necessary  MCMs  to  stockpile  at  local,  regional,  and  national  levels,  aiming  to  enhance  national 
resilience and access to essential medical supplies. 

Stockpiling and Distribution Capacities 
Stockpiling and distribution of MCMs involve multiple entities. PHAS guarantees distribution routes and 
collaborates  with  regions  responsible  for  warehousing  and  transporting  MCMs  to  end-users.  The 
regions manage large MCM stocks, funded through regional taxation, ensuring proximity to where they 
are needed. NBHW oversees national stockpiling of critical healthcare products and faces challenges 
in finding appropriate storage spaces. MSB hosts a RescEU medical stockpile, coordinating allocation 
during  emergencies,  which  includes  vital  supplies  such  as  personal  protective  equipment  and 
respiratory equipment. 

International Cooperation 
International cooperation in health security is a collaborative effort among Swedish agencies. PHAS 
acts as the National Focal Point for the International Health Regulations, disseminating information and 
coordinating with WHO channels. It also managed the participation of Norway and Iceland in EU vaccine 
procurement during the pandemic. NBHW is actively engaged in various international entities, such as 
NATO committees, WHO working groups, and EU health security initiatives, representing Sweden in 
global  health  security  discussions.  MSB  coordinates  international  responses  to  civil  protection  and 
humanitarian aid requests. 

221 

 
 
 
 
 
 
 
 
 
Health Security Coordination 
Health  security  coordination  in  Sweden  is  overseen  by  NBHW,  particularly  during  heightened  alert 
states.  NBHW  aligns  actions  with  the  Armed  Forces,  other  preparedness  agencies,  and  County 
Administrative Boards, ensuring civilian healthcare and welfare preparedness. It coordinates the supply 
of  medicines  and  medical  products  and  maintains  expertise  in  disaster  medicine  and  emergency 
preparedness. PHAS supports these efforts by coordinating nationwide disease control during public 
health emergencies, arranging vaccination programs, and managing national stockpiles. 

Comprehensive mapping of identified entities 

Public Health Agency of Sweden (PHAS) 
The  Public  Health  Agency  (PHAS)  oversees  the  prevention  and  control  of  communicable  diseases. 
During a public health emergency, they would take charge of coordinating nationwide disease control 
efforts, which could include arranging mass vaccination programs, utilizing national stockpiles of MCMs, 
and providing expert support for disease investigations. 

Monitoring, Intelligence Gathering and Analysis 
PHAS  monitors  and  conducts  risk  assessments  of  communicable  diseases  based  on  all  notifiable 
diseases  being  reported  from  the  healthcare  system  to  PHAS.  PHAS  also  has  national  laboratory 
capacity that allows highly pathogenic samples to be analysed. 

Stockpiling and distribution capacities 
PHA guarantees distribution routes to regions and recipient units in Sweden. Regions, responsible for 
healthcare,  transport  MCMs  to  end-users.  Regions  also  warehouse  large  MCM  stocks,  ensuring 
proximity to where needed. Regional financing, via taxation, supports procurement and stockpiling. This 
model  aligns with  local  responsibility, with  regions managing  resources,  including  MCMs,  efficiently. 
The ultimate responsibility for having good inventory management lies with the regions. What is stocked 
nationally at PHA is appointed on behalf of the government. 

International Cooperation 
PHA  serves  as  the  National  Focal  Point  (NFP)  for  the  International  Health  Regulations  (IHR), 
disseminating  information  and  potentially  medicines  through  WHO  channels.  During  the  pandemic, 
PHA  facilitated  Norway  and  Iceland's  participation  in  EU  vaccine  procurement,  requiring  significant 
additional effort from PHA to manage this process. 

222 

 
 
 
 
 
 
 
 
 
The National Board of Health and Welfare (NBHW) 
The  National  Board  of  Health  and  Welfare  (NBHW)  in  Sweden  is  a  government  agency  under  the 
Ministry of Health and Social Affairs. It has a diverse range of responsibilities within social services, 
health, medical services, patient safety, and epidemiology. The NBHW supports staff, managers, and 
decision-makers by collecting and analysing information, developing best practices, setting standards 
based on legislation, and maintaining health data registers. Within the national emergency management 
system, the NBHW strengthens preparedness in health and social services organisations to respond to 
adverse events and minimize their impact. It collaborates closely with other agencies in the health sector 
and coordinates civil defence planning. Additionally, during heightened alert states, the NBHW plays a 
crucial role in coordinating actions, aligning efforts with other agencies and armed forces, and ensuring 
the availability of medicines and medical supplies. 

Monitoring, Intelligence Gathering and Analysis 
NBHW plays a crucial role in monitoring, intelligence gathering, and analysis related to health threats 
and emergencies. Through weekly meetings with regional preparedness organisations and a technical 
solution  for  information  sharing,  NBHW  maintains  a  comprehensive  view  of  national  readiness  and 
potential threats. This includes collaborating with the Public Health Agency to identify and assess health 
threats and countermeasures. Additionally, NBHW issues publications on healthcare prioritization and 
training programs for preparedness and civil defence.  

Production / Manufacturing Capacities 
The Board reported several investigations on how to ensure safe and robust supply and production on 
different MCMs. The Board also collaborates with the Swedish Medical Products Agency on mapping 
and developing Sweden’s production capabilities regarding different MCM 

Procurement of MCMs 
The  NBHW  is  responsible  for  ensuring  procurement  of  several  essential  MCMs,  mainly  by  national 
stockpiling of MCMs and other health care products that are of vital importance in e.g. mass casualty 
situations  and  CBRN  events.  During  the  pandemic,  the  Board  represented  Sweden  in  the  joint 
procurement  agreement  mechanism  of  the  EU.  The  Board  has  published  several  recommendations 
regarding which MCMs and related health care products that should be stockpiled on local, regional 
and national level in order to increase national robustness and resilience vis-à-vis access to essential 
MCMs. 

Stockpiling and Distribution Capacities 
The NBHW is responsible for national stockpiling of essential MCMs and healthcare products critical in 
mass casualty situations and CBRN events. The agency faces challenges in finding appropriate storage 
spaces  that  meet  safety  requirements  and  purchasing  MCMs  to  avoid  significant  market  impact. 
Regions are primarily responsible for warehousing in Sweden, ensuring proximity to users and regional 
financing. 

International Cooperation 
The  NBHW  is  actively  engaged  in  international  entities  concerning  preparedness  and  international 
health threats. This includes representation in NATO committees such as the Civil Emergency Planning 
Committee and JHAFG Health, Nordic Council of Ministers' Svalbardgruppen, WHO working groups on 
pandemic treaties and IHR revision, EU-KOM's Health Security Committee, and the HERA Advisory 
Forum.  It  also  serves  as  Sweden's  point  of  contact  for  WHO's  work  on  Emergency  Medical  Teams 
(EMTs). 

Health Security Coordination 
In a state of heightened alert, the NBHW coordinates actions within the preparedness sector and aligns 
them  with  the  Armed  Forces,  other  preparedness  agencies,  and  County  Administrative  Boards.  It 

223 

 
 
 
 
 
 
 
supervises civilian healthcare and welfare preparedness and coordinates preparations for medicine and 
medical product supply during heightened alert states. The agency also maintains expertise in disaster 
medicine  and  emergency  preparedness,  disseminating  knowledge  to  support  the  Swedish  health 
system and social services during emergencies and disasters. 

Swedish Civil Contingencies Agency (MSB)  
The Swedish Civil Contingencies Agency (MSB) plays a critical role in ensuring civil protection, public 
safety, emergency management, and civil defence within Sweden.  

Mode of operation 
In  terms  of  preparedness,  MSB  undertakes  cross-sectoral  resilience  building  and  military  support 
measures. Its responsibilities include specific areas such as civil protection and cybersecurity within the 
Swedish  context.  MSB  is  actively  involved  in  supporting  the  development  of  national  capacity  for 
security  of  supply  preparedness,  focusing  on  flexible  preparedness  strategies  and  adaptability  in 
production to meet evolving demands during emergencies and crises. When public health crises arise, 
MSB  is  tasked  with  stepping  in  to  oversee  emergency  measures  and  coordination  when  no  other 
authority is responsible. 

Advanced Research and Development Capacities 
MSB holds the mandate to finance research within its area of responsibility, providing approximately 10 
million Euros for research initiatives. Research topics primarily revolve around civil security concerning 
disasters, crises, and war. Although not directly involved in healthcare-specific research, MSB's funding 
supports broader research efforts that may encompass healthcare and health-related studies. 

Stockpiling and Distribution Capacities 
MSB  hosts  one  of  the  RescEU  medical  stockpiles.  This  stockpile  comprises  vital  supplies  such  as 
personal  protective  equipment  and  respiratory  equipment.  Stockpiling  activities  and  the  associated 
logistics are primarily managed by other entities, whereas MSB's role lies in coordinating and facilitating 
the allocation of these stockpiles during emergencies and crises. 

International Cooperation 
As an agency involved in civil protection and humanitarian aid, MSB serves as a crucial point of contact 
for  requests  for  assistance,  particularly  in  health-related  emergencies.  The  agency  coordinates 
responses with relevant national authorities, ensuring efficient and effective international cooperation. 
MSB also participates in international initiatives such as hosting one of the RescEU medical stockpiles, 
which enhances Sweden's preparedness and response capabilities in collaboration with EU partners. 

Karolinska Institute 
The  Karolinska  Institute  (KI)  is  a  leader  in  medical  research,  accounting  for  a  substantial  share  of 
academic medical research in Sweden. 

Advanced Research and Development Capacities on MCMs 
KI's  research  spans  numerous  medical  fields,  from  molecular  biology  to  clinical  neuroscience.  It 
collaborates  closely  with  pharmaceutical  and  biotech  companies  to  foster  the  translation  of  basic 
research  into  novel  therapies.  This  approach  enhances  its  capacity  to  develop  advanced  MCMs, 
particularly in areas like cancer therapy and infectious diseases. 

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2) Supranational organisation - BeNeLuxA 

Key contextual elements 

Date of creation: 
2015  

Member States: 
5  EU  countries:  Austria,  Belgium, 
Netherlands, Ireland, and Luxembourg 

the 

Main mission  
The  mission  of  the  BeNeLuxA  initiative  is  to  ensure  sustainable  access  to  and  appropriate  use  of 
medicines  in  the  participating  countries.  The  BeNeLuxA  initiative  identified  four  domains  for 
cooperation: 

-  Horizon scanning, 
-  Health technology assessment, 
- 
-  Pricing and reimbursement, including joint price negotiations. 

Information sharing and policy exchange, 

The  Initiative  is  managed  by  a  Steering  Committee  that  supervises  the  overall  collaboration.  This 
committee is supported by technical Domain Task Forces dedicated to specific areas of cooperation. 
Each participating country is represented on the Steering Committee, which also includes the leaders 
of the Domain Task Forces. 

Contextual elements regarding the global situation 
During the meeting of European Ministers for Employment, Social Policy, Health, and Consumer Affairs 
in Latvia in 2015, the health ministers of Belgium and the Netherlands announced their initiative to 
explore  possible  collaboration  on  pharmaceutical  policy.  This  included  price  negotiations  with 
pharmaceutical companies for orphan medicinal products. 
A few months later, the Grand Duchy of Luxembourg joined the Belgium-Netherlands project. 
Austria  joined  the  cooperation  initiative  in  June  2016,  and  since  then  this  project  has  been  named 
‘BeNeLuxA’. 
In 2018, Ireland also joined the BeNeLuxA initiative. 

Activities and tasks 

225 

 
 
 
 
 
 
 
 
 
 
 
Monitoring, Intelligence gathering and analysis 
One of the 4 activities of BeNeLuxA is horizon scanning. 
After having experimented with joint Horizon Scanning, Belgium, The Netherlands, Luxembourg, and 
Austria  have  started  an  open  joint  initiative,  on  Horizon  Scanning.  The  aim  is  to  highlight  important 
pharmaceutical innovations before they reach the market. 
Nevertheless,  many  countries  have  expressed  a  need  for  early  access  to  information  on  the 
development of innovative pharmaceutical products. Thus, BeNeLuxA launched in 2022 a new Horizon 
Scanning Initiative, with the aim of involving as many countries as possible (EU member states, non-
EU countries, as well as representatives of the European Commission, the OECD and the WHO). 
In the context of the BeNeLuxA, during the Covid-19 crisis, the Austrian Institute for Health Technology 
Assessment GmbH established a Horizon Scanning System for COVID-19 medicines and vaccines. 

Advanced Research and Development capacities 
- 

Production / Manufacturing capacities 
- 

Procurement of MCMs 
One of the 4 activities of BeNeLuxA is pricing and reimbursement. 
Participants  in  the  BeNeLuxA  initiative  agree  that  collaborating  on  price  negotiations  for  specific 
pharmaceuticals  enhances  their  strategic  position  with  the  industry.  They  share  information  and 
experiences on pharmaceuticals that are part of past, current, or anticipated reimbursement procedures. 
Currently, pilots are underway, and the initiative is open to new pilot applications. The pilots focus on 
pharmaceutical with unmet medical need, expected added value and satisfactory degree of evidence. 

Stockpiling and distribution capacities 
- 

International cooperation 
The Horizon Scanning initiative aims to involve as many countries as possible (EU member states, non-
EU countries, as well as representatives of the European Commission, the OECD and the WHO). 

Health security coordination 
- 

226 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
II.  Third countries 

1) Africa 

Monitoring, Intelligence Gathering and Analysis 

Entity 

The Ministry of Health and Population (MoHP) 

Ethiopian Public Health Institute 

Ministry of Health 

Ministry of Health, Public Hygiene, and Universal Health 
Coverage 

The National Institute of Public Health 

The Ministry of Health 

The Ministry of Health and Social Protection 

The Federal Ministry of Health and Social Welfare 

Nigeria Centre for Disease Control and Prevention (NCDC) 

Rwandan Ministry of Health 

Ministry of Health and Social Action 

COUS – Centre for Health Emergency Operations 

the Institute Pasteur Dakar  

Country 

Egypt 

Ethiopia 

Ethiopia 

Ivory Coast 

Ivory Coast 

Kenya 

Morocco 

Nigeria 

Nigeria 

Rwanda 

Senegal 

Senegal 

Senegal 

The National Department of Health (NDoH) 

South Africa 

The Ministry of Health 

Zambia National Public Health Institute (ZNPHI) 

Zambia 

Zambia 

Advanced Research and Development Capacities  

Entity 

Ethiopian Public Health Institute 

The National Institute of Public Health 

The Kenya Medical Research Institute (KEMRI) 

The Ministry of Health and Social Protection 

MAScIR - Moroccan Foundation for Advanced Science, 
Innovation and Research 

Country 

Ethiopia 

Ivory Coast 

Kenya 

Morocco 

Morocco 

227 

 
 
 
 
 
 
The Ministry of Industry and Trade 

The Federal Ministry of Health and Social Welfare 

Nigeria Centre for Disease Control and Prevention (NCDC) 

the National Institute for Pharmaceutical Research and 
Development 

Rwanda Biomedical Center (RBC) 

National Council for Science and Technology 

the Institute Pasteur Dakar  

The National Department of Health (NDoH) 

National Institute for Communicable Diseases (NICD) 

Zambia National Public Health Institute (ZNPHI) 

Production / Manufacturing Capacities 

Entity 

Ministry of Health, Public Hygiene, and Universal Health 
Coverage 

The Ministry of Health 

The Ministry of Industrialization, 
Trade and Enterprise Development  

The Ministry of Health and Social Protection 

The Ministry of Industry and Trade 

the National Institute for Pharmaceutical Research and 
Development 

Rwandan Ministry of Health 

Ministry of Health and Social Action 

National Procurement Pharmacy 

the Institute Pasteur Dakar  

The National Department of Health (NDoH) 

The Ministry of Health 

Morocco 

Nigeria 

Nigeria 

Nigeria 

Rwanda 

Rwanda 

Senegal 

South Africa 

South Africa 

Zambia 

Country 

Ivory Coast 

Kenya 

Kenya 

Morocco 

Morocco 

Nigeria 

Rwanda 

Senegal 

Senegal 

Senegal 

South Africa 

Zambia 

228 

 
 
 
 
 
 
Procurement of MCMs  

Entity 

The Egyptian Authority for Unified Procurement, Medical Supply 
and The Management of Medical Technology 

Ethiopian Pharmaceuticals Supply Agency (EPSA) 

Ministry of Health 

Country 

Egypt 

Ethiopia 

Ethiopia 

The New Public Health Pharmacy of Ivory Coast 
(NPSP-CI) 

Ivory Coast 

the Kenya Medical Supplies Agency (KEMSA) 

The Ministry of Health and Social Protection 

Nigeria Centre for Disease Control and Prevention (NCDC) 

Rwandan Ministry of Health 

Rwanda Biomedical Center (RBC) 

Rwanda Medical Supply Ltd 

National Procurement Pharmacy 

Kenya 

Morocco 

Nigeria 

Rwanda 

Rwanda 

Rwanda 

Senegal 

The National Department of Health (NDoH) 

South Africa 

The Zambia Medicines and Medical Supplies Agency 
(ZAMMSA) 

Zambia 

Stockpiling and Distribution Capacities 

Entity 

The Egyptian Authority for Unified Procurement, Medical Supply 
and The Management of Medical Technology 

The Egyptian Drug Authority 

Ethiopian Public Health Institute 

Country 

Egypt 

Egypt 

Ethiopia 

229 

 
 
 
 
 
 
 
Ethiopian Pharmaceuticals Supply Agency (EPSA) 

Ethiopia 

The New Public Health Pharmacy of Ivory Coast 
(NPSP-CI) 

Ivory Coast 

the Kenya Medical Supplies Agency (KEMSA) 

The Ministry of Health and Social Protection 

Nigeria Centre for Disease Control and Prevention (NCDC) 

Rwandan Ministry of Health 

Rwanda Biomedical Center (RBC) 

Rwanda Medical Supply Ltd 

COUS – Centre for Health Emergency Operations 

National Procurement Pharmacy 

Kenya 

Morocco 

Nigeria 

Rwanda 

Rwanda 

Rwanda 

Senegal 

Senegal 

The National Department of Health (NDoH) 

South Africa 

The Zambia Medicines and Medical Supplies Agency 
(ZAMMSA) 

Zambia 

230 

 
 
 
 
International Cooperation  

Entity 

The Ministry of Health and Population (MoHP) 

Ethiopian Public Health Institute 

Ministry of Health, Public Hygiene, and Universal Health 
Coverage 

The Ministry of Health 

The Kenya Medical Research Institute (KEMRI) 

the Kenya Medical Supplies Agency (KEMSA) 

The Ministry of Health and Social Protection 

The Federal Ministry of Health and Social Welfare 

Nigeria Centre for Disease Control and Prevention (NCDC) 

Rwandan Ministry of Health 

COUS – Centre for Health Emergency Operations 

the Institute Pasteur Dakar  

The National Department of Health (NDoH) 

Zambia National Public Health Institute (ZNPHI) 

Health Security Coordination 

Entity 

The Ministry of Health and Population (MoHP) 

Ethiopian Public Health Institute 

Ministry of Health 

Ministry of Health, Public Hygiene, and Universal Health 
Coverage 

The Ministry of Health 

The Ministry of Health and Social Protection 

The Federal Ministry of Health and Social Welfare 

Nigeria Centre for Disease Control and Prevention (NCDC) 

Rwandan Ministry of Health 

Country 

Egypt 

Ethiopia 

Ivory Coast 

Kenya 

Kenya 

Kenya 

Morocco 

Nigeria 

Nigeria 

Rwanda 

Senegal 

Senegal 

South Africa 

Zambia 

Country 

Egypt 

Ethiopia 

Ethiopia 

Ivory Coast 

Kenya 

Morocco 

Nigeria 

Nigeria 

Rwanda 

231 

 
 
 
 
 
Ministry of Health and Social Action 

COUS – Centre for Health Emergency Operations 

Senegal 

Senegal 

The National Department of Health (NDoH) 

South Africa 

National Institute for Communicable Diseases (NICD) 

South Africa 

The Ministry of Health 

Zambia National Public Health Institute (ZNPHI) 

Zambia 

Zambia 

232 

 
 
 
 
a. Egypt 

Key contextual elements 

Population: 
107 million 

Current health expenditure (% of GDP) : 
5% 

Socio-demographic and public health situation 
Egypt is classified as "lower middle income" by the World Bank, with 29.7% of the population living 
below the national poverty line and an inequality estimated at 0.32 on the Gini coefficient1 in 20192. 

Egypt is known as one of the pioneering countries in the establishment of a national surveillance system 
for  monitoring  infectious  diseases,  his  system  has  been  operational  for  about  a  century.  A 
comprehensive  network  of  epidemiological  and  laboratory  vertical  systems  for  reporting  acute 
respiratory infections was implemented in 2009, along with an alert system for early detection of novel 
respiratory viruses. The network covers the entire country and comprises surveillance systems targeting 
severe acute respiratory infections, influenza-like illness, pneumonia, avian influenza, and Middle East 
respiratory syndrome coronavirus (MERS-CoV)3. 
Egypt made significant progress regarding public health in the recent years, becoming the first country 
to achieve WHO validation on the path to elimination of hepatitis C in 20234.  

Key information regarding medical countermeasures 
Egypt is the largest producer and consumer of pharmaceuticals in the MENA region, holding a market 
value estimated at $ 56.6 billion. It is a significant player in the global supply chains of pharmaceutical 
products5. 
Egypt also is the host country of Northern Africa RCC (regional coordination centre of the Africa CDC). 

Comprehensive mapping of identifies entities 

1 The Gini index is a measure of statistical dispersion intended to represent the income inequality within a country. The Gini coefficient measures 
the inequality among the values of a frequency distribution, such as levels of income. It takes a value between 0 and 1. A Gini coefficient of 1 
reflects maximal inequality among values, a situation where a single individual has all the income while all others have none. 
2 Poverty & Equity Brief, Arab Republic of Egypt, data calculated in 2019 
3 The Impact of Implementing the Egypt Pandemic Preparedness Plan for Acute Respiratory Infections in Combating the Early Stage of the COVID-
19 Pandemic, JMIR Public Health Surveill. 2021 May; 7(5): e27412. 
4 Egypt becomes the first country to achieve WHO validation on the path to elimination of hepatitis C, WHO Eastern Mediterranean region, Media 
Centre, October 2023 
5 A new collaborative approach in business development, The African development bank group, October 2023 

233 

 
 
 
 
 
 
 
 
 
The  Egyptian  Authority  for  Unified  Procurement,  Medical  Supply  and  The  Management  of  Medical 
Technology 
Governmental  entity,  the  Egyptian  Authority  for  Unified  Procurement,  Medical  Supply  and  The 
Management of Medical Technology (UPA) aims to ensure “an equitable access of medicinal and health 
technology  products  through  conducting  evidence-based  technology  assessments,  strategic  value 
driven procurement methods and establishing a robust and sustainable supply chain”. 
Regarding HERA’s tasks, UPA is in charge of the centralized procurement of medical supplies for Egypt 
and the distribution of MCMs. 

The Egyptian Drug Authority 
The Egyptian Drug Authority is the pharmaceutical regulatory body, working under supervision of the 
Ministry  of  Health  and  Population.  Established  in  September  2019,  in  replacement  of  the  General 
Authority for Pharmaceutical Research and Control and the National Authority for Research and Control 
of Biopharmaceuticals, its mandate is to monitor unified drug procurement, medical supply, and medical 
technology management. 

The EDA monitors and manages the stockpiling of medicines. 
There is insufficient publicly available evidence that Egypt has a stockpile of other MCMs (vaccines, 
medical equipment, PPE) for national use during a public health emergency. 

The Ministry of Health and Population 
The  Ministry  of  Health  and  Population  is  charged  with  the  oversight  and  regulation  of  the  Egyptian 
healthcare system. 
The publicly available information was limited; however, the Study Team was able to identify that the 
MoHP coordinates responses to outbreaks of infectious diseases in healthcare facilities and provides 
necessary guidelines to address such public health crises, as well as international cooperation. 

234 

 
 
 
 
 
 
 
 
b. Ethiopia 

Key contextual elements 

Population: 
123 million 

Current health expenditure (% of GDP): 
3% 

Socio-demographic and public health situation 
The World Bank ranks Ethiopia as a low-income country, although it aims to reach lower middle-income 
status by 2025. 
Over  the  past  years,  Ethiopia’s  health  indicators  have  improved  considerably  as  for  instance  the 
decrease of its malaria incidence rate since 2015. Nevertheless, significant challenges remain from a 
continuing burden of communicable diseases (malaria, tuberculosis, and neglected tropical diseases6) 
to the increasing impact of noncommunicable diseases and persistent high levels of malnutrition. These 
difficulties are compounded by conflict and natural disasters, inadequate service coverage and quality, 
gaps  in  disease  surveillance  and  monitoring,  and  shortfalls  in  preparedness  for  future  health 
emergencies7. 

Key information regarding medical countermeasures 
Ethiopia had received significant support from the World Bank to fill critical resource gaps in its public 
health emergency preparedness in 2020, during the Covid-19 crisis.  
Although some difficulties persist in the country, important efforts are being made. For example, the 
Government seeks to establish a pharmaceutical hub through developing industrial parks to realize the 
vision of strengthening and transforming the Ethiopian pharmaceutical industry along the entire value 
chain to an internationally competitive and compliant industry. 

Comprehensive mapping of identifies entities 

Ethiopian Public Health Institute (EPHI) 
The  Ethiopian  Public  Health  Institute  is  an  autonomous  public  authority,  accountable  to  the  Federal 
Ministry  of  Health.  The  Institute  aims  to  conduct  research  on  the  caused  and  spread  of  diseases, 
nutrition, traditional medicine and medical practices and drugs. It also contributes to the promotion and 
development of health science and technology. 

6 Country Disease Outlook - Ethiopia, WHO Africa, August 2023 
7 Ethiopia 2030 : A country transformed ? Options for A Next Generation of Reforms, UNDP, Feb. 2023 

235 

 
 
 
 
 
 
 
 
 
Regarding vaccines and diagnostics, its mission is to serve as a focal point within Ethiopia for human 
vaccine  research  and  development  in  collaboration  with  external  partners  and  organisations. 
Additionally,  it  aims  to  promote,  initiate,  and  implement  collaborative  research  and  development 
platforms for vaccines. 
The EPHI also works with international partners, with bilateral agreements with the Finlay Institute of 
Vaccines (Cuba) regarding staff training and transfer of technology for the production of vaccines. 

Besides  its  R&D  activities,  EPHI  manages  the  national  stockpile  of  MCMs  in  collaboration  with  the 
EPSA and cooperates with the MoH to ensure the health security coordination in establishing guidelines 
regarding public health emergency management. 

Finally, the EPHI has been given the mandate to serve as a referral medical laboratory service and to 
establish and support National Laboratory Quality Assurance programs and systems. 

Ethiopian Pharmaceuticals Supply Agency (EPSA) 
The EPSA is a public procurement agency, under the Ethiopian Ministry of Health. 
Its  mandate  is  to  ensure  the  procurement,  inventory  and  distribution  of  pharmaceuticals,  medical 
supplies, and equipment in Ethiopia. 
The  EPSA  also  manages  the  inventory  and  distribution  of  the  national  stockpile  of  MCMs  in 
collaboration  with  the  EPHI.  In  pursuit  of  efficiency,  EPSA  has  developed  a  suite  of  applications  to 
ensure the proximity of EPSA distribution hubs to health facilities across Ethiopia and establish efficient 
systems for inventory, fleet, and information management8. 

Ethiopian Ministry of Health 
The Ethiopian Ministry of Health’s mandate is ‘to promote health and wellbeing of Ethiopians through 
providing and regulating a comprehensive package of promotive, preventive, curative and rehabilitative 
health services in an equitable manner’. 
In  practice,  the  Ministry  decides  the  health  policy and  guidelines,  defines  intervention  priorities,  and 
finds financial resources. 

In  terms  of  MCMs  in  health  crisis  preparedness  and  response,  the  MoH,  along  with  EPSA,  is 
responsible for managing the national procurement of medical supplies, laboratory equipment, reagents, 
and consumables. 
It is also responsible for the health security coordination with relevant stakeholders. 

In  addition,  the  Ministry  of  Health  implement  the  Government  strategy  aiming  to  establish  a 
pharmaceutical  hub  through  developing  industrial  parks  to  realize  the  vision  of  strengthening  and 
transforming the Ethiopian pharmaceutical industry along the entire value chain to an internationally 
competitive and compliant industry. 

8 International Trade Administration, US Department of Commerce: Ethiopia - Healthcare 

236 

 
 
 
 
 
 
 
 
 
 
 
 
c. Ivory Coast 

Key contextual elements 

Population: 
28.2 million 

Current health expenditure (% of GDP): 
3,1% 

Socio-demographic and public health situation 
According to the World Bank, Ivory Coast is a lower-middle income country with a Gini index estimated 
at  0.35.  It  is  the  largest  economy  in  the  UEMOA  (West  African  Economic  and  Monetary  Union), 
accounting for 40% of its GDP. However, social indicators such as child and maternal mortality remain 
below the sub-Saharan average. 

Ivory  Coast  faces  challenges  with  communicable  diseases  and  outbreaks.  While  the  incidence  of 
tuberculosis and HIV is decreasing, it remains high, and the malaria rate has been steady since 2015 
after  two  decades  of  decline.  The  national  malaria  control  programme  (NMCP)  aims  to  reduce  the 
mortality rate and the incidence rate by 75% by 20259. Neglected tropical diseases are still endemic in 
the country10. Despite its proximity to countries heavily affected by the Ebola epidemic (Guinea and 
Liberia), Ivory Coast has recorded only one confirmed case of Ebola virus disease since 199411 12.  

Despite improvements, more than half of the population lives in slums13 which enhance the propagation 
of disease. The child survival rate remains high, and nearly 22% of children under five are stunted14. 
35.7% of children are fully vaccinated (basic antigens), and 8% have not received any vaccines15. There 
is no vaccination strategy in the country according to the WHO. 

Moreover, as its neighbours, Ivory Coast deals with the issue of counterfeit medicines being sold in the 
streets due to the high cost of genuine ones in pharmacies16. 

Key information regarding medical countermeasures 
Ivory Coast has notably received support from the WHO for the preparation and response to the COVID-
19 health crisis. This support included assistance with the logistics of MCMs17. 
In  2021,  the  country  also  conducted  a  response  to  the  outbreak of  Ebola  cases;  the  country  swiftly 
initiated  the  vaccination  of  frontline  healthcare  workers  and  contacts  of  confirmed  cases,  with  the 
support of the WHO18. 

In parallel, Ivory Coast is seeking to enhance its local production of pharmaceutical products to cover 
20% of national needs by 2025 and 30% by 2030, up from the current 6%. To achieve this goal, the 
Ivorian government aims to mobilize €15 million from private sector partners19. 

9 The National Program for Malaria Control, 2020 
10 Country Disease Outlook – Ivory Coast, WHO Africa, August 2023 
11 Ivory Coast: Start of Ebola vaccination for high-risk individuals, UN Info, August 2021 
12 Ivory Coast declares the first Ebola outbreak in over 25 years, WHO, August 2021 
13 World Bank – Population living in slums  
14 Our World in Data – Malnutrition: Share of children who are stunted 
15 Côte d’Ivoire Enquête démographique et de santé 2021 – Indicateurs clés  
16 Nouvelle pharmacie de la santé publique de Côte d’Ivoire 
17 Covid-19 in Ivory Coast, Support and Partnership: An experience to share, WHO, November 2020 
18 Ivory Coast begins Ebola vaccination for frontline healthcare workers and contacts, WHO, August 2021 
19 Ivory Coast: Objective of 20% national pharmaceutical coverage by 2025, Business France, July 2023 

237 

 
 
 
 
 
 
 
 
 
 
Comprehensive mapping of identifies entities 

The Ministry of Health, Public Hygiene, and Universal Health Coverage 
The mission of the Ministry of Health, Public Hygiene and Universal Health Coverage to provide and 
continually improve the health services of Cote d'Ivoire through the provision of preventive, curative and 
rehabilitative health care thereby contributing to the reduction of poverty and enhancing the general 
well-being of the population. 

In terms of preparedness and response to health crisis, the Ministry realizes health threats analysis and 
evaluate the consequences. Specifically, within the context of the COVID-19 crisis, in June 2020, in 
collaboration with the WHO and implementation partners (CDC, USAID, UNICEF…), it conducted an 
assessment  mission  on  the  Preparedness  and  Response  to  the  COVID-19  Pandemic  in  the  health 
regions and districts of Ivory Coast20. 
It is also in charge the health security coordination with relevant stakeholders. 

Furthermore, the Ministry is dedicated to promoting local drug manufacturing with the goal of increasing 
the local drug production rate from 6% to 30% by 2030. In pursuit of this objective, it commenced the 
process of establishing a new local production and distribution facility for essential medicines in the 
country in early 202321. 
The Ministry also cooperates with other countries to reinforce the international health architecture for 
preparedness and response to health crisis. 

The New Public Health Pharmacy of Ivory Coast (NPSP-CI) 
Public structure established as a National Public Institution with an Industrial and Commercial Character 
(EPIC); the New Public Health Pharmacy of Ivory Coast (NPSP-CI) was created in 2013. 
This  entity  is  in  charge  of  the  centralised  public  procurement  and  distribution  of  medicines  and 
pharmaceuticals. 

Regarding procurement, especially during times of health crisis, the NPSP-CI centralizes procurement 
of MCMs, and strives to combat fraud involving counterfeit medicines or, in the case of the COVID crisis, 
counterfeit masks. 

20 Covid-19 in Ivory Coast, Support and Partnership: An experience to share, WHO, November 2020 
21 Local drug manufacturing: Ivory Coast moving towards establishment of a new production facility, Government official press release, January 
2023 

238 

 
 
 
 
 
 
 
 
 
The NPSP-CI also oversees stockpiling essentials medicines and medical supplies and ensures stock 
control through regular inventories. The entity is responsible for the distribution to all healthcare facilities 
in the country22. 
For example, during the preparation of the response to SARS-CoV-2, WHO supported the inventory of 
all PPE stocks in the country. This inventory revealed sufficient availability of most items except for N95 
and FFP2 masks, for which an additional order was placed23. 

The National Institute of Public Health 
The  National  Institute  of  Public  Health  is  a  public  institution  under  the  technical  supervision  of  the 
Minister of Health and under the financial supervision of the Minister of Economy and Finance and the 
Minister of Budget. Its missions are research and training in the medical, pharmaceutical, and medical 
biology fields. 

Regarding HERA’s tasks, the National Institute of Public Health ensures knowledge management and 
sharing  of  best  practices  in  preparedness  and  response  against  public  health  emergencies.  It  also 
supervises and develops operational research and applied research in public health, particularly in the 
pharmaceutical field. 

In  addition,  the  Institute  promotes  R&I,  supervises  and  develops  operational  research  and  applied 
research in public health, particularly in the pharmaceutical field. 

22 NPSP-CI Official website 
23 Covid-19 in Ivory Coast, Support and Partnership: An experience to share, WHO, November 2020 

239 

 
 
 
 
 
 
 
d. Kenya 

Key contextual elements 

Population: 
53 million 

Current health expenditure (% of GDP): 
5% 

Socio-demographic and public health situation 
East African country, Kenya is a lower middle-income country24, with an inequality estimated at 0.39 on 
the Gini coefficient in 202125. 
Communicable diseases are reported in the country as the leading cause of outpatient clinic visit and 
inpatient admissions. By 2021, Kenya was one of the seven high tuberculosis burden countries that had 
reached or passed the 1st milestone of a 20% reduction in the TB incidence rate compared with 2015. 
Malaria also represents a threat in Kenya: approximately 70% of the population is at risk26. 

Regarding health emergency preparedness and response, in 2014, the Ebola Virus Disease outbreak 
in West Africa highlighted key challenges in emergency preparedness and coordination of responses 
in Kenya. 
Following  this,  the  Kenyan  government  has  progressively  implemented  initiatives  to  improve  its 
preparedness  and  response  capacities.  It  notably  collaborated  with  the  US  CDC  to  form  the  Global 
Rapid Response Team, which led to the formation of county-specific response teams27. 
More  recently,  in  2023,  the  Government  launched  the  “Kenya  Health  Emergency  Preparedness, 
Response, and Resilience Project” in collaboration with the World Bank, aiming at fostering local health 
systems and advance UHC28. 

Key information regarding medical countermeasures 
Currently,  Kenya  imports  70%  of  its  pharmaceutical  requirements,  including  vaccines  and  other 
biological products. Nevertheless, in the context of the 'Bottom-Up Economic Transformation Agenda'29, 
the  Kenyan  government  is  committed  to  promoting  local  pharmaceutical  production  and  aims  to 
become a leading regional hub in the production of medicines and healthcare supplies30. One of 
the major objectives is to achieve a production of at least 50% of health products and technologies 
listed in the Kenya Essential Medicines List locally by 202631. 

Moreover, Kenya is the host country of the Eastern Africa Regional Coordination Centre (EA-RCC) of 
Africa CDC. 

24 Kenya – Overview, The World Bank 
25 The World Bank 
26 Country Disease Outlook – Kenya, WHO, August 2023 
27 National Strategic Plan 2021 – 2026, Kenya Public Health Emergency Operations Centre, Ministry of Health 
28 Cabinet Advances Healthcare Resilience: Approves Kenya Health Project and Pandemic Treaty Negotiations, Ministry of Health, Press release, 
October 2023 
29 The  "Bottom-Up  Economic  Transformation  Agenda"  (BETA)  in  Kenya  is  an  economic  strategy  which  aims  to  shift  the  focus  from  top-down 
economic policies to grassroots development, targeting the lower socioeconomic segments of society to foster inclusive economic growth. Here are 
the key aspects of the agenda. It includes targeted investments in five pillars: Agriculture, MSME Economy, Housing and Settlement, Healthcare, 
Digital Superhighway and Creative Economy. Source: The Kenya Institute for Public Policy Research and Analysis. 
30 Kenya strives to become regional pharmaceutical hub, Pharmacy and Poisons board, Press release, May 2023 
31 Empowering Health through local manufacturing: a path to UHC, Ministry of Health news, January 2024 

240 

 
 
 
 
 
 
 
 
Comprehensive mapping of identifies entities 

The Ministry of Health 
The Ministry of Health seeks to build progressive, responsive, and sustainable technologically driven, 
evidence-based  and  client-centred  health  system  for  accelerated  attainment  of  highest  standard  of 
health  to  all  Kenyans.  Its  mandate  includes  health  policy,  health  regulation,  national  referral  health 
facilities, capacity building, and technical assistance to counties. 

Concerning health crises, the Ministry of Health conducts health intelligence gathering and assesses 
potential  consequences  and  impacts  on  public  health  with  the  aim  of  ensuring  swift  and  informed 
decision-making.  Within  the  ministry,  this  task  falls  particularly  to  the  Public  Health  Emergency 
Operations Centre (PHEOC). 
The Ministry also is the central body in Kenya for health security coordination. Its Public Health 
Emergency  Operations  Centre  as  well  as  some  of  its  departments  play  key  roles  in  emergency 
preparedness  and  response:  the  Department  of  Disease  Surveillance  and  Epidemic  Response;  the 
Division of Zoonotic Diseases (which also has connections with the Ministry of Agriculture, Livestock, 
and  Fisheries,  and  the  Ministry  of  Water,  Sanitation,  and  Irrigation);  the  Division  of  National  Public 
Health Laboratories; and the Department of Environmental Health. 

In line with the Bottom-Up Economic Transformation Agenda (BETA), the Ministry of Health seeks to 
increase pharmaceutical local manufacturing. It has set the objective of producing a minimum of 
50% of health products and technologies listed in the Kenya Essential Medicines List locally by 
2026.  To  achieve  this,  the  Pharmacy  and  Poisons  Board  (under  the  Ministry  of  Health)  prioritizes 
continuous capacity building for local manufacturing and ensuring global competitiveness in the quality, 
safety, and efficacy of medicines and other products, devices, and technologies32. 
More specifically regarding MCMs, PPE was primarily imported prior to the COVID-19 pandemic. Their 
necessity  and  shortfall  during  the  pandemic  provided  an  opportunity  for  capacity  and  technological 
leapfrogging.  The  ministry  implemented  initiatives  to  boost  local  production.  In  2021,  PPEs  were 
manufactured locally in Kenya and exported to the wider East African region33. 

Regarding international cooperation, the Kenyan Ministry of Health aims to contribute to reinforcing the 
global  health  emergency  preparedness  and  response  architecture.  It  has  particularly  established 
collaborations with: 

32 Empowering Health through local manufacturing: a path to UHC, Ministry of Health news, January 2024 
33 Kenya’s  response  to  the  COVID-19  pandemic:  a  balance  between  minimising  morbidity  and  adverse  economic  impact,  African  Academy  of 
Sciences, 2021, doi: 10.12688/aasopenres.13156.2 

241 

 
 
 
 
 
 
 
 
►  Egypt: collaboration with the Egyptian Authority for Unified Procurement, Medical Supply, and the 
Management  of  Medical  Technology,  and  the  Egyptian  Drug  Authority  to  strengthen  pooled 
procurement, facilitate bilateral trade in health products and technology, and build capacity for local 
manufacturing in the healthcare sector34.  
Italy: The Memorandum of Understanding between Kenya and Italy encompasses various areas, 
including  strengthening  local  production  of  pharmaceuticals  and  medical  supplies  to  improve 
healthcare self-sufficiency and global health security (disease control)35. 

► 

►  South Korea: The Kenyan Government has signed a cooperation framework with South Korea in 
the  area  of  vaccine  production.  This  will  allow  for  the  exchange  of  technology,  expertise,  and 
finances36. 

The Kenya Medical Research Institute (KEMRI) 
KEMRI is the Kenyan national body responsible for carrying out research in human health. It provides 
advice to the Ministry on national diseases surveillance and rapid response capacity for major disease 
outbreaks (Cholera, Chikungunya Virus, Yellow Fever, Rift Valley Fever, Ebola, Aflatoxicosis, etc.). 

Regarding HERA’s tasks, KEMRI promotes and coordinates advanced R&D on MCMs. Notably, the 
Institute  has  developed  the  Infectious  and  Parasitic  Diseases  Research  Programme,  which  aims  to 
develop  tools  and  technologies  for  the  reduction  of  disease  burden  due  to  infectious  and 
parasitic agents. In this regard, research is conducted on vector control, bacterial, fungal, and viral 
infections  such  as  HIV/AIDS,  tuberculosis,  Ebola,  malaria,  chikungunya,  Dengue  Fever,  and  other 
neglected tropical diseases. 

KEMRI is involved in international cooperation to promote research on MCMs. Over the years, KEMRI 
has led the way in the region by sharing research findings through the East African Health Research 
Commission and hosts several regional programmes, including the Laboratory Training on the Control 
of Emerging and Re-emerging Diseases in Africa. 
Especially  in  terms  of  emergency  preparedness  and  response,  KEMRI  collaborates  with  the  Japan 
International  Cooperation  Agency  (JICA)  since  1979.  This  partnership  focuses  on  health  research 
development through various means, including technical cooperation, capacity building, and supports 
the construction of laboratories, the procurement of medical equipment, and the provision of specialized 
training…  For  instance,  KEMRI/JICA  collaborations  were  instrumental  in  supplying  resources  and 
equipment  like  testing  kits  and  consumables  during  the  COVID-19  pandemic.  Furthermore,  the 
collaboration between KEMRI and JICA facilitated: 

- 

the  implementation  of  the  Science  and  Technology  Research  Partnership  for  Sustainable 
Creation (SATREPS) Project, resulting in the development of rapid diagnostic tests between 
2012 and 2017. 

-  The  development  of  a  training  initiative  named  "Strengthening  Laboratory  Preparedness  for 
Building  Resilience  Against  Public  Health  Emergencies  in  Eastern  Africa"  which  aims  to 
improve  Africa’s  ability  to  respond,  prepare,  and  prevent  epidemics,  pandemics,  and  other 
critical health crises. 

The Kenya Medical Supplies Agency (KEMSA) 
State agency under the Ministry of Health, KEMSA mandate is to procure, warehouse and distribute 
drugs and medical supplies. KEMSA ensures the centralized purchasing and procurement of drugs and 
medical supplies for both public and private hospitals in Kenya. 
Regarding warehousing, KEMSA has policies and procedures in place to ensure that stocks are well 
managed. The Authority is responsible for the management of the national strategic stock reserve. 
For distribution, KEMSA delivers medical supplies to each health facility in Kenya. It has established a 

34 Kenya and Egypt forge collaboration to enhance healthcare systems, Ministry of Health news, July 2024 
35 Kenya and Italy advance healthcare collaboration go Universal Coverage and Pharmaceutical Production, Ministry of Health news, September 
2023 
36 Zambia Association of Manufacturers, The Zambian Pharmaceutical Sector: Lessons from the Region, August 2023 

242 

 
 
 
 
 
 
distribution network with the capacity to reach all Public Hospitals, Health Centers and Dispensaries 
countrywide. 
During Covid-19 crisis, the Authority had constituted a “Covid-19 management Rapid Response Team” 
to ensure the efficient supply of PPE and other medical countermeasures across the country. 

KEMSA  cooperates  with  different  stakeholders  in  this  objective  of  reinforcing  the  global  health 
emergency preparedness and response architecture. Indeed, the agency works with USAID, the World 
Bank, the Danish International Development Agency (DANIDA) to improve supply management in the 
region. 

The Ministry of Industrialization, Trade and Enterprise Development 
The  State  Department  for  Industry  has  set  several  priority  areas,  including  the  promotion  of  local 
pharmaceutical  manufacturing.  The  Ministry  of  Industrialization,  Trade  and  Enterprise  Development 
cooperates  with  the  Ministry  of  Health  to  realize  Kenya’s  goal  of  becoming  a  regional  hub  for  the 
manufacture and distribution of pharmaceutical products. 

243 

 
 
 
 
 
 
 
 
 
e. Morocco 

Key contextual elements 

Population: 
37 million 

Current health expenditure (% of GDP): 
5% 

Socio-demographic and public health situation 
Classified as a lower middle-income country, Morocco with a Gini Coefficient of 0.5137. 
Morocco  is  witnessing  a  major  shift  in  its  epidemiologic  profile  with  an  increasing  burden  of 
noncommunicable diseases, NCDs account for over 80% of deaths in Morocco38. 

In terms of health crisis management, Morocco is often cited as an example by neighbouring countries 
for its handling of the health crisis. The government quickly deployed a series of actions to raise its level 
of vigilance in monitoring the epidemiological situation in real-time. It established a special fund of 10 
billion  dirhams  (equivalent  to  934  million  euros)  for  pandemic  management  and  encouraged  its 
companies to participate in the production of MCMs39. 

Key information regarding medical countermeasures 
Morocco is one of the major pharmaceutical producers in Africa. In 2022, Morocco and South Africa 
collectively met over 70% of pharmaceutical product demand through local production. 
The Moroccan healthcare system has undergone strengthening measures in recent years, notably the 
generalization of social coverage for the benefit of all Moroccans, launched on July 29, 2020, by King 
Mohammed VI. Additionally, the Moroccan government is actively pursuing the development of self-
reliance and local production of pharmaceuticals, vaccines, and PPE, including masks, gloves, gowns, 
overshoes, and head coverings. 
In 2022, the Government launched a new program for the pharmaceutical sector for the period 2022-
2027,  which  sets  objectives  for  job  creation  and  revenue  figure  within  the  sector 40.  To  date,  the 
pharmaceutical industry enables the satisfaction of 70% of the national demand for drugs41. 

In parallel to the actions implemented, it should be noted that Morocco is currently facing a significant 
drug shortage. In April 2024, approximately 1200 products were affected, the vast majority of which are 
imported42. 

37 The World Bank 
38 WHO 
39 Coronavirus and Africa - Morocco, a Model for Crisis Management ?, Institut Montaigne, 2020 
40 Is 'Made in Morocco' a lever for Morocco's industrial sovereignty?, Atlas Capital, July 2023 
41 Morocco’s Healthcare System : Achievements, Challenges, and Perspectives, Cureus, June 2023 
42 Morocco faces a shortage of imported medications, Maroc Diplomatique, April 2024 

244 

 
 
 
 
 
 
 
 
Comprehensive mapping of identifies entities 

The Ministry of Health and Social Protection 
In terms of health emergency preparedness and response, the Ministry of Health and Social Protection 
is  responsible  for  monitoring  and  intelligence  gathering.  It  conducts  health  threats  analysis  and 
evaluates the potential impacts. For instance, during Covid, a risk assessment was established early 
by the Ministry of Health in the aftermath of the first signals of the COVID-19 epidemic that stressed 
that Morocco was at risk of being rapidly exposed to the disease. In addition, it adjusted its mode of 
operation by establishing a technical and scientific advisory committee, one of whose missions is to 
define a protocol for the care of COVID-19 patients. 
The  Ministry  also  oversees  the  coordination  of  the  response  to  health  emergency,  with  relevant 
stakeholders.  It  develops  guidelines  and  procedures,  adapting  them  to  scientific  knowledge  and 
national epidemiological context43. 

The Ministry of Health and Social Protection promotes advanced R&I to develop effective, safe and 
affordable MCMs and aims to foster Morocco’s autonomy in MCMs production. 
Indeed, for many years, the Moroccan government has aimed to strengthen the country's autonomy in 
the field of drugs and medicines production. In 2022, the Ministry of Health launched a new program 
contract  for  the  pharmaceutical  sector  for  the  period  2022-2027,  in  partnership  with  the  Ministry  of 
Industry and Trade and other stakeholders44. This policy sets objectives for job creation and revenue 
figure within the sector45. 
More specifically, in terms of preparedness and response to health crises, the Ministry of Health and 
Social Protection has signed partnerships and cooperation agreements with a range of stakeholders in 
the  field  of  healthcare  products  and  pharmaceuticals  in  both  the  public  and  private  sectors.  These 
collaborations  seek  to  enhance  Morocco’s  capacity  in  preparedness  and  response  to  public  health 
emergencies and strive to provide the requisite technologies for drug development and clinical trials 
within Morocco46. 
The Maroc Biotechnologies project (formerly known as SENSYO Pharmatech), example of the public-
private partnerships established by the Ministry of Health and Social Protection, aimed to establish a 
manufacturing  plant  for  vaccines  in  Morocco.  This  project  seeks  to  ensure  the  Kingdom's  self-
sufficiency and position Morocco as a key biotechnology hub in Africa by integrating pharmaceutical 

43 Morocco's National Response to the COVID-19 Pandemic: Public Health Challenges and Lessons Learned, JMIR Public Health Surveillance, 
2021 
44 such as the General Confederation of Moroccan Enterprises (CGEM), Pharmaceutical Companies in Morocco (LEMM), the Moroccan Association 
of Generic Drugs (AMMG), among others. 
45 Is 'Made in Morocco' a lever for Morocco's industrial sovereignty?, Atlas Capital, July 2023 
46 Magazine of the Ministry of Health and Social Protection, Major Achievements 2022/2023, Ministry of Health and Social Protection, 2023 

245 

 
 
 
 
 
 
research,  clinical  development,  manufacturing,  and  marketing  of  biopharmaceutical  products  of 
significant necessity47. Announced and initiated in response to the COVID crisis, the production site 
was completed in 2023. 

The Ministry of Health and Social Protection is also responsible for the procurement of MCMs and the 
management of the national stockpile of medicines and pharmaceutical products. 

The  Moroccan  Ministry  of  Health  and  Social  Protection  is  involved  in  international  cooperation  to 
strengthen capacities for health crisis preparedness and response, particularly at the African continent 
level. 
It was notably the initiator of the 1st African Conference on Health Risk Reduction, which falls within 
the framework of the global health system dynamics and the increasing need for reform, particularly in 
response to the impact of the Covid-19 pandemic. This initiative aimed to encourage the adoption of a 
scientific  and  medical  approach  firmly  focused  on  Africa's  future,  emphasizing  the  necessity  of 
concerted  collaboration  to  address  health  crises.  The  conference  took  place  in  November  2022  in 
Marrakech, with the participation of national and international researchers and scientists48. 

MAScIR - Moroccan Foundation for Advanced Science, Innovation and Research 
Created  in  2007,  the  MAScIR  Foundation  is  a  non-profit  organisation  under  the  Mohammed  VI 
Polytechnic University. It seeks to promote and develop technological research hubs in the fields of 
materials  and  nanomaterials,  biotechnology,  microelectronics,  and  life  sciences.  Its  work  is  oriented 
towards applied R&I  
to meet market needs. The MAScIR Foundation also aims to capitalize on the results of its research 
and  invention  patents  through  technology  transfer  and  the  creation  of  startups,  to  contribute  to  the 
emergence of a knowledge-based economy in Morocco. 
The foundation undertakes the following activities: 

-  Serving as a development support for the mentioned sectors, 
-  Promoting the development of human resources and internationally standardized skills in these 

sectors, 

-  Conducting  applied  research  and  technological  application  development  to  generate 

intellectual and industrial property in alignment with market needs, 

-  Establishing partnerships and serving as a link between industry and academic institutions, 
-  Fostering  the  emergence  of  innovative  enterprises  based  on  technological  developments 

achieved. 

In the field of medical countermeasures, the MAScIR Foundation has developed a diagnostic RT-PCR 
test in the context of the SARS-CoV-2 crisis, which is characterized by its specificity, high degree of 
sensitivity  and  reliability,  and  controlled  cost49.  Once  these  tests  were  developed,  they  became  the 
subject of a collaborative project on the African continent led by Africa CDC. More than 36,000 of these 
Covid-19 diagnostic tests were delivered to the Pasteur Institute in Tunis, Tunisia, the Pasteur Institute 
in Dakar, Senegal, and the new public health pharmacy in Abidjan, Côte d'Ivoire50 51. 
Furthermore, in the context of the national strategic plan for the prevention and control of tuberculosis, 
the MAScIR Foundation has developed a molecular test for tuberculosis diagnosis, which offers the 
advantage of being accurate and rapid, delivering results in 30 minutes. This test has been registered 
with the Directorate of Drugs and Pharmacy52. 

47 Morocco Now – Invest and Expert, Pharmaceutical Industry, February 2022 
48 International Cooperation in Health, Ministry of Health and Social Protection, 2022 
49 Mascir Designs the First 100% Moroccan Covid-19 Diagnostic Kit, tested and validated by the Royal Armed Forces, the Royal Gendarmerie, and 
the Pasteur Institute Of Paris, MAScIR News 
50 Once produced by Moldiag, a start-up of the MAScIR Foundation. 
51 Moldiag, a spin-off of the MAScIR foundation, finalizes an export operation in Africa for the benefit of Africa CDC, MAScIR News, September 
2022 
52 Moldiag launches the first tuberculosis diagnostic test, 100% Moroccan, developed by MAScIR, MAScIR News  

246 

 
 
 
 
 
 
 
The Ministry of Industry and Trade 
The  Ministry of  Industry  and  Trade  is  responsible  for  the  design and  implementation  of  government 
policy in the areas of industry, trade, and new technologies, subject to the responsibilities assigned to 
other ministerial departments by the laws and regulations in force. 
It oversees the development of strategies for the industrial, trade, new technologies, and postal sectors, 
translating them into operational programs, and implements these strategies. 

In  Morocco,  the  Ministry  of  Industry  and  Trade  collaborates  with  the  Ministry  of  Health  to  boost  the 
production  of  medical  countermeasures  (MCMs).  As  part  of  the  response  to  the  health  crisis,  the 
Ministry implemented a proactive policy to encourage companies to produce MCMs to address Covid-
19. This particularly involved converting textile factories to produce fabric masks. 

The Ministry of Industry and Trade also encourages and coordinates the research and development of 
MCMs in times of health crisis, in collaboration with the Ministry of Health and Social Protection. 
During  the  COVID-19  crisis,  it  mobilized  a  team  of  industrialists  and  engineers  to  design  and 
manufacture  a  resuscitation  bed  in  Morocco  that  meets  international  standards  in  terms  of  safety, 
performance, and competitive pricing. The objective was to address, on one hand, the national needs 
for healthcare equipment and supplies and, on the other hand, to support the government's directives 
aimed at promoting local production, especially in sectors that have become strategic during this period 
of health crisis53. 

53 Fight against COVID-19, the Ministry of Industry and Trade website 

247 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
f.  Nigeria 

Key contextual elements 

Population: 
218.5 million 

Current health expenditure (% of GDP): 
4.1 % 

Socio-demographic and public health situation 
Lower-middle income country, Nigeria is the largest economy in Sub-Saharan Africa as well as the most 
populous country in the continent. Its GDP accounts for 25% of the African’s total and it has a Gini index 
of around 0.33. Nigeria represents 26% of health workers in the continent54. 
Nigeria regularly faces disease outbreaks, including a significant diphtheria epidemic since 2022, that 
has already killed hundreds of people55. The country also experienced a yellow fever outbreak between 
2018 and 2020 that particularly affected children56. Despite a decrease in the last decade, Nigeria bears 
the highest HIV/AIDS burden in Sub-Saharan Africa. According to the 2022 WHO Malaria report, Nigeria 
recorded the highest number of malaria cases and deaths worldwide57. 

In terms of health preparedness and response, Nigeria's effective response to the Ebola outbreak in 
2014  was  recognized  both  locally  and  internationally.  The  country  was  commended  by  WHO  for  its 
leadership  and  efficient  coordination  of  emergency  measures,  including  the  establishment  of  an 
Emergency  Operations  Centre,  which  played  a  crucial  role  in  containing  the  spread  of  the  highly 
contagious virus58. 
More recently, the response to the COVID-19 outbreak in Nigeria was initially slower, likely due to the 
complexity of the situation and the novelty of the virus. However, the country has implemented several 
response measures, including managing to increase the number of molecular laboratories in the country 
in response to the pandemic59. 
Nigeria is the host country of Africa CDC’s Regional Coordination Centre in Western Africa. 

Key information regarding medical countermeasures 
In terms of manufacturing capacities, Nigeria relies on foreign supply of medicines and vaccines, with 
imports  accounting  for  70%  of  local  drug  consumption.  Nigeria  also  imports  most  of  the  active 
pharmaceutical ingredients needed for local production60. 
In this context, the COVID-19 pandemic has highlighted certain challenges within Nigeria's healthcare 
system, leading to significant risks of shortages. For instance, during the peak of the pandemic, the 
supply of medicines for chronically ill patients and certain non-communicable diseases reached critically 
low levels due to severe bottlenecks in importation channels61. 
However, the pandemic has spurred and expedited actions towards enhancing local manufacturing of 
medicines  and  vaccines.  Nigeria  has  studied  the  feasibility  of  domestically  producing  COVID-19 
vaccines  and  was  selected  as  one  of  six  African  countries  to  receive  the  technology  required  for 
manufacturing mRNA vaccines. Moreover, the Federal government introduced a national vaccine policy 
and updated its national drug policy62.  
Comprehensive mapping of identifies entities 

54 Eze UA, Alao A, Akinmade OV, Buowari DY, Onwuliri CD, Gbujie DC. Retrospective Comparison of Nigeria's Emergency Response Between the 
2014 Ebola Outbreak and 2020 COVID-19 Pandemic. Cureus. 2023 Aug 29 Retrospective Comparison of Nigeria’s Emergency Response Between 
the 2014 Ebola Outbreak and 2020 COVID-19 Pandemic - PMC (nih.gov) 
55 Nigeria Centre for Disease Control and Prevention – Diphtheria 
56 Nigeria Centre for Disease Control and Prevention – Yellow Fever 
57 World Malaria Report 
58 How Nigeria won the fight against Ebola, UN Office for Disaster Risk Reduction, October 2016 
59 Retrospective Comparison of Nigeria’s Emergency Response Between the 2014 Ebola Outbreak and 2020 COVID-19 Pandemic, Cureus, August 
2023 
60 Fostering local production of essential medicines in Nigeria, Bulletin of the World Health Organisation, 2020 
61 Impact of the COVID-19 Pandemic on Consumers’ Access to Essential Medicines in Nigeria, American Journal of Tropical Medicine and Hygiene, 
October 2020 
62 The Nigerian Economic Summit Group 

248 

 
 
 
 
 
 
 
The Federal Ministry of Health 
The Nigerian Federal Ministry of Health aims to develop and implement policies that strengthen the 
national health system for effective, efficient, accessible, and affordable delivery of health services in 
partnership with other stakeholders. 

In cooperation with the NCDC, it analyses health threats and evaluate their potential consequences and 
impacts on public health. The Federal Ministry of Health is also a significant actor in terms of health 
security coordination; it produces guidelines and protocols, and it coordinates the relevant stakeholders. 

The Federal Ministry of Health plays a significant role for the R&I of MCMs: it coordinates and promotes 
health  research  for  efficient  health  system  development.  One  example  is  the  establishment  of  the 
Nigeria COVID-19 Research Consortium. Formed in collaboration with the NCDC, the TETFUND63, the 
National University Commission, the Manufacturers Association of Nigeria (MAN) and the NESG64, this 
Research  Consortium  brought  together  academics  and  scientists,  to  promote  high-quality  scientific 
research on identified national priorities in line with the WHO research roadmap for COVID-19. 

Its  international  Cooperation  division  aims  to  coordinate  international  cooperation  on  health  and 
collaborations with development partners, NGOs and other health actors. 
For instance, to strengthen cross-border collaboration for health security between its neighbours from 
West and Central Africa, the Federal Ministry of Health led the design of a multi-lateral framework for 
cross-border  collaboration  between  Nigeria,  Benin,  Chad,  Cameroon,  and  Niger.  This  framework 
establishes a foundation for bilateral agreement on sharing infectious disease surveillance information. 
It  also  sets  the  stage  for  broader  collaboration  in  incident  reporting,  joint  investigations,  and  cross-
border response efforts. 

Nigeria Centre for Disease Control and Prevention (NCDC) 
The Nigeria Centre for Disease Control and Prevention (NCDC) is the national public health institute. 
Its mandate is to lead the preparedness, detection and response to infectious disease outbreaks and 
public health emergencies. 

The Nigeria CDC ensures the intelligence gathering, analyse health threats, and evaluate the potential 
consequences and impact on public health. 

63 TETFUND: the Tertiary Education Trust Fund 
64 NESG: the National Economic Summit Group 

249 

 
 
 
 
 
 
 
 
 
 
The  Nigeria  CDC  is  a  key  actor  of  the  health  security  coordination  in  the  country.  Its  Directorate  of 
Emergency Preparedness and Response oversees disaster and emergency mitigation and manages 
their impact. It leads outbreak response activities, including the deployment of Rapid Response Teams. 
During the 2016/2017 Meningitis outbreak, the Directorate oversaw the establishment of an Emergency 
Operations Centre, which coordinates outbreak response activities nationwide. 
Moreover,  its  Directorate  of  Public  Health  Laboratory  Services  manages  the  national  and  regional 
reference  laboratories.  These  laboratories  provide  diagnostic  services  for  diseases  of  public  health 
importance  in  the  country,  including  viral  haemorrhagic  fevers,  meningitis,  cholera,  measles,  yellow 
fever. 

It also promotes and encourages R&I for the development of effective and affordable MCMs. Indeed, 
the Directorate of Planning, Research & Statistics develops health promotion and disease prevention 
plans which address priority endemic infectious diseases. This Directorate conducts research to inform 
evidence-based  policies  and  works  with  other  government  agencies  to  promote  partnerships  and 
collaborations,  especially  towards  strengthening  the  One  Health  approach.  In  April  2017,  the 
Directorate coordinated the development of a National Antimicrobial Resistance Situational Analysis 
and  Action  Plan,  as  well  as  the  enrolment  of  laboratories  into  the  Global  Antimicrobial  Resistance 
Surveillance System. 
In addition, the Nigeria CDC has developed the "Alliance for Epidemic Preparedness and Response 
(A4EPR)", an innovative platform for private sector engagement, in cooperation with the Private Sector 
Health Alliance of Nigeria (PHN). The A4EPR seeks to collaborate with the private sector to strengthen 
the capacity of NCDC to prevent, detect, respond to and control epidemic-prone diseases. Its priority 
areas of focus include: 

-  Epidemic infrastructure and equipment, 
-  Direct response and logistics support, 
-  Technology and innovation, 
-  Emergency stockpile, 
-  Capacity development. 

The Nigeria CDC has also cooperated with the Federal Ministry of Health to create the Nigeria Covid-
19 Research Consortium65. 

The Nigeria CDC is also responsible for the procurement of MCMs and the management of the national 
stockpile. The national stockpile is a reserve of essential supplies including drugs, reagents, equipment, 
vaccines, antidotes, PPE. Through direct procurements and partner support, the NCDC established a 
national  strategic  stockpile  for  the  COVID-19  pandemic.  This  enabled  the  agency  to  meet  the  high 
demand  for  medical  and  laboratory  supplies  and  equipment  from  states  for  COVID-19  and  other 
diseases throughout the year. The establishment of the national stockpile helped prevent shortages of 
critical supplies, especially at the pandemic's peak. 
The Nigeria CDC also developed guidelines and Standard Operating Procedures (SOPs) for managing 
these  supplies.  Additionally,  with  support  from  eHealth  Africa,  a  Logistics  Management  Information 
System was developed to enhance the accuracy, quality of data, and visibility of the stockpile at all 
levels of the supply chain66. 

Regarding  international  cooperation,  the  Nigeria  is  tasked  to  lead  Nigeria’s  engagement  with  the 
international community on diseases of public health relevance. 

The National Institute for Pharmaceutical Research and Development (NIPRD) 
The  National  Institute  for  Pharmaceutical  Research  and  Development  is  a  Federal  Government 
Parastatal, under the Federal Ministry of Health. 

65 Refer to the paragraph on the Federal Ministry of Health for more details. 
66 Annual Report 2020, Nigeria CDC 

250 

 
 
 
 
 
 
The  Institute  is  responsible  of  the  promotion  and  coordination  of  R&D  of  MCMs:  drugs,  vaccines, 
phytomedicines, commodities, and diagnostics, in this objective of improving sustainable access to safe, 
affordable,  and  high-quality  healthcare.  The  Institute  also  seeks  for  the  development  of  contextual 
partnerships that can accelerate access to healthcare67. 

Furthermore, in terms of health crisis response, during the COVID-19 crisis, NIPRD’s primary focus has 
been  on  developing  the  nation’s  vaccine  manufacturing  capacity,  particularly  for  the  production  of 
COVID-19 vaccines68. 

67 The National Institute for Pharmaceutical Research and Development, official website 
68 An insightful public health conversation with Dr Muhammad Ali Pate, Coordinating Minister of Health and Social Welfare, Nigeria, Africa CDC 
news, December 2023 

251 

 
 
 
 
 
 
 
 
 
g. Rwanda 

Key contextual elements 

Population: 
13.1 million 

Current health expenditure (% of GDP): 
6% 

Socio-demographic and public health situation 
Rwanda is a low-income country which aspires to middle income Country status by 2035 and High-
Income Country status by 2050, according to the World Bank. 
High inequalities remain with 38% of the population living in slums. 

Regarding public health, Rwanda has been subject to several situations, mainly: 

-  Pandemic influenza A (H1N1), 2009, 
-  Covid-19, 2020, 
-  Presence of cholera, malaria, dengue, measles, schistosomiasis, influenza all year long. 

Also, the meningococcal disease is present in neighbouring countries. 

Key information regarding medical countermeasures 
Rwanda is the focal point of African efforts to strengthen regulatory harmonisation, improve access 
to and affordability of medicines, and build up sustainable domestic manufacturing capacity for drugs 
and vaccines. Significant initiatives are underway: 

- 

In December 2023, the Africa's first mRNA vaccines plant (BioNTech) have been inaugurated 
in  Kigali.  On  this  occasion,  a  €40  million  financial  agreement  of  the  EU  to  strengthen  the 
Rwandan ecosystem for manufacturing health products69, 

-  The  African  Development  Bank  approved  the  establishment  of  an  African  Pharmaceutical 
Technology Foundation (APTF) in Rwanda to help strengthen Africa’s pharmaceutical industry 
and its manufacturing and healthcare infrastructure (June 2022). 

Rwanda also hosts the headquarters and secretariat of the African Medicines Agency (AMA), which 
intends to harmonise regulatory systems for pharmaceutical products across Africa. 

Comprehensive mapping of identifies entities 

69 Global Gateway: EU increases support to vaccine production in Rwanda as first mRNA facility opens, News announcement, December 2023 

252 

 
 
 
 
 
 
 
 
 
 
Rwandan Ministry of Health 
The  mission  of  the  Rwandan  Ministry  of  Health  is  to  provide  and  continually  improve  affordable 
promotive, preventive, curative and rehabilitative health care services of the highest quality, thereby 
contributing to the reduction of poverty and enhancing the general well-being of the population. 
Regarding health crisis, the MoH oversees the procurement, stockpiling and distribution of MCMs, and 
ensures  to  health  security  coordination  through  the  establishment  and  operationalisation  of 
multisectoral  coordination  mechanisms.  More  precisely,  the  MoH  establishes  and  manages  the 
stockpile of MCMs for national use during emergency, putting in place needed infrastructures, medical 
products  and  consumables  and  signing  agreements  with  manufacturers  or  distributors  to  procure 
medical countermeasures during a public health emergency. The MoH also ensures the preparation of 
the distribution, through planned simulation exercises.  

The Ministry of Health promotes and encourages capacity-building activities for the manufacturing and 
production  of  MCMs.  Its  vision  is  to  transform  the  country  into  a  regional  hub  for  pharmaceutical 
production and vaccine manufacturing. It is in this context that the MoH has played a significant role in 
establishing the African Pharmaceutical Technology Foundation (APTF) and elevating it to the status 
of an international agency. This was achieved through collaboration with the African Development Bank 
and the signing of the Host Country Agreement for the Foundation in Kigali in December 202370. 

Rwandan Biomedical Centre (RBC) 
RBC is Rwanda's central health implementation agency. The mission of the agency is to improve the 
health  of  the  Rwandan  population  by  providing  high  quality,  affordable  and  sustainable  health  care 
services. RBC conducts scientific research, provides diagnostics services, and implements innovative 
health interventions to collaborate in the preparedness and response to health crisis. 
In case of public health crisis, RBC cooperates with the MoH to procure and distribute MCMs through 
signed agreements with manufacturers or distributors. RBC also plays a key role in the distribution of 
MCMs as the agency is responsible for the identification and recruitment of resources and staffing for 
logistics, tracking and distribution of MCMs. 

Rwandan Medical Supply Ltd 
Rwanda Medical Supply Limited is a large-scale corporation created and owned by the Government of 
Rwanda.  RMS's  primary  mission  is  to  ensure  the  availability  of  medicines,  medical  supplies,  and 
consumables in the right quantity and quality, delivered to the appropriate place and customers, at the 
right time and cost, for the benefit of the Rwandan population. 

The  main  activities  of  RMS  include  warehouse  management,  distribution,  quantification,  and  stock 
monitoring. In the event of a health crisis, RMS also collaborates with the Ministry of Health (MoH) and 
the RBC for the procurement of drugs, medical supplies, and consumables. 

The National Council for Science and Technology 
The National Council for Science and Technology (NCST) conducts studies and analyses current trends 
and future needs in science, technology, and innovation (STI), with the aim of enhancing regional and 
international collaboration in these areas. The NCST also regulates research activities in Rwanda to 
prevent potential duplications and provides policy recommendations on science, technology, research, 
and innovation. 

70 Rwanda: the African Development Fund commits $12 million to the rapid operationalization of the African Pharmaceutical Technology Foundation 
(APTF), African Development Bank Group, March 2024 

253 

 
 
 
 
 
 
 
 
 
 
 
h. Senegal 

Key contextual elements 

Population: 
17.3 million 

Current health expenditure (% of GDP): 
4.4% 

Socio-demographic and public health situation 
Senegal  is  a  lower-middle  income  country  and  the  second  largest  economy  in  the  UEMOA  (West 
African Economic and Monetary Union). It has a Gini index of 0.36.  

From an epidemiological perspective, malaria is endemic in Senegal and the incidence rate increased 
between 2015 and 2019. However, the death rate fell, and the incidence is one of the lowest in Africa71. 
The  National  Strategic  Plan  2021-2025  on  malaria  aims  to  tackle  the  incidence,  death,  and  local 
transmission rate of the disease, continuing the efforts of the 2016-2020 plan72. 
HIV prevalence is comparable to that of developed countries73, and the tuberculosis rate is below the 
African average74-75. Neglected tropical diseases remain prevalent. 

Key information regarding medical countermeasures 
In 2024, the Senegalese government presented the Plan for an Emerging Senegal': a ten-year strategy 
based on a vision of an emerging Senegal by 2035. This vision is structured around three strategic 
pillars: 

-  structural transformation of the economy and growth, 
-  human capital, social protection, and sustainable development, 
-  governance, institutions, peace, and security. 

This program specifically aims to locally manufacture 50% of the country's pharmaceutical products by 
203576. 
To date, Senegal imports over 90% of its medicines and 99% of its vaccines77. Several projects are 
being implemented to increase this capacity. One such project is MADIBA, 'Manufacturing in Africa for 
Disease Immunisation and Building Autonomy,' spearheaded by the Institute Pasteur Dakar. 

71 Our world in data – Incidence of malaria 
72 Plan stratégique national contre le paludisme 2021-2025 
73 Our world in data – HIV prevalence 2022 
74 Country Disease Outlook - Senegal, WHO 
75 TB Incidence, WHO  
76 Emerging Senegal, Presidency of the Senegal 
77 Strengthen local pharmaceutical production, particularly the production of vaccines in Senegal, GIZ, July 2023 

254 

 
 
 
 
 
 
 
 
Comprehensive mapping of identifies entities 

The Ministry of Health and Social Action 
In Senegal, the Ministry of Health and Social Action is responsible for coordinating the multisectoral 
response to health crises. This includes working with various ministries and agencies. The Ministry's 
responsibility  for  health  security  coordination  primarily  involves  governance  and  oversight,  while  the 
COUS's role is more operational and functional. 
In addition, the Ministry of Health and Social Action collaborates with the COUS to analyse threats and 
evaluation potential consequences and impact on public health. 

Finally, in the framework of the Plan for Emerging Senegal, the Ministry of Health and Social Action 
promotes local manufacturing projects78. 

COUS – Centre for Health Emergency Operations 
Agency under the Ministry of Health and Social Action, the COUS is a permanent institution responsible 
for coordinating, early detection, and managing the response to health crises. Its missions are: 

-  To  ensure  continuous  monitoring  of  events  that  could  lead  to  national-scale  health  crises, 

regardless of their origin, 

-  To conduct necessary investigations when an event that could lead to a health crisis is identified, 
-  To  prepare  operational  response  procedures  by  establishing  standardized  operating 

procedures for each of the priority risks, 

-  To  contribute  to  international  cooperation  efforts  to  improve  monitoring  and  response 

mechanisms for international health emergencies, 

-  To coordinate response activities in accordance with regulatory requirements, 
-  To provide relevant information in real-time to the Ministry of Health and Social Action, as well 

as to partner institutions. 

Regarding HERA’s tasks, the COUS conducts health intelligence gathering. It is responsible for creating 
and maintaining an updated list of health threats that could impact health in Senegal. For each risk, it 
assesses their likelihood of occurrence and potential medical impact. 

The COUS is central to health security coordination in Senegal. In case of a health emergency, the 
entity ensures the liaison between emergency response actors and the Minister of Health and Social 
Action. It is also in charge of the establishment of guidelines to respond to different health threats and, 
the definition the emergency measures to be implemented according to health emergency situations. 

78 Healthcare System: From Resilience to Emergence, Ministry of Health and Social Action, January 2024 

255 

 
 
 
 
 
 
 
 
 
The  COUS  also  coordinates  the  actions  of  various  stakeholders  involved  in  responding  to  health 
emergencies. 

Moreover,  the  COUS  oversees  the  stockpiling  of  PPE  (masks,  gloves…)  and  pharmaceuticals  and 
collaborates with the NPP to monitor and coordinate stock availability for the response. 
Finally, the COUS cooperates with the neighbouring countries to reinforce their capacities (including 
surveillance)79. 

The National Procurement Pharmacy 
The  National  Procurement  Pharmacy,  under  the  Ministry  of  Health,  has  the  status  of  “Public 
Establishment of an Industrial and Commercial Nature” since 2023. 

This agency ensures the centralized procurements of medical countermeasures in Senegal. 
It also cooperates with the COUS for the stockpiling of MCMs: the NPP is responsible for the storage 
and warehousing of the supplies, as well as the distribution. 

In addition to its existing responsibilities of procurement, stockpiling, and distribution, the NPP changed 
its status in April 2023 to become a Public Establishment of an Industrial and Commercial Nature (EPIC). 
This new status represents a significant move by the Senegalese government towards pharmaceutical 
sovereignty. With this change, the NPP now plays a larger role in enhancing manufacturing capacities, 
as  it  can  invest  in  the  share  capital  of  pharmaceutical  companies  and  focus  on  producing  certain 
essential molecules locally. 
This  aligns  with  the  government's  objective  of  meeting  60%  of  the  country's  local  pharmaceutical 
needs80. 

The Institute Pasteur of Dakar (IPD) 
The Institute Pasteur de Dakar (IPD) is a non-profit foundation of public utility, dedicated to promoting 
public  health  and  well-being  in  West  Africa.  Since  its  foundation  in  1896,  the  IPD  has  been  at  the 
forefront of the fight against infectious diseases. 
Its mandate includes:  
-  Research, 
-  Health protection and promotion, 
-  Support and expertise in public health, 
-  Education and training, 
-  Services ranging from clinical diagnosis, human vaccination, and food safety testing, 
-  Production of human vaccines. 

With regards to HERA’s tasks, the IPD promotes and encourages R&I for the development of effective 
and affordable MCMs. 
It also plays a crucial role in the diagnostic activities. For example, designated by the WHO and the 
Africa CDC as a reference laboratory for COVID-19, the Institute Pasteur of Dakar conducted genomic 
surveillance of SARS-CoV-2 both nationally and sub-regionally. 

In terms of increasing local manufacturing capacities of medical countermeasures, the Institute Pasteur 
de Dakar (IPD) is a key player in the national strategy aiming to meet one-third of its needs with local 
production by 2030 and up to 50% by 2035. 
In fact, the IPD is leading the MADIBA project, which stands for Manufacturing in Africa for Disease 
Immunisation and Building Autonomy. This project aims to enhance local production capacity through 
the  construction  of  a  messenger  RNA  vaccine  manufacturing  unit,  facilitated  by  technology  transfer 
from the Belgian biotech company Quantoom Biosciences. 

79 COUS Strategic Plan, 2016-2018, COUS and Ministry of Health and Social Action 
80 Healthcare System: From Resilience to Emergence, Ministry of Health and Social Action, January 2024 

256 

 
 
 
 
 
 
 
 
 
Additionally, this project includes a centre of excellence for training young talents, particularly young 
women, in specialized skills related to various aspects of vaccine research, manufacturing, production, 
and distribution81 82. 

The IPD is willing to contribute to reinforcing the global health emergency preparedness and response 
architecture, notably through the reinforcement of global surveillance and diagnostic capacities. 
For instance, in 2019, experts from the Pasteur Institute of Dakar were deployed to the field along with 
several microbiologist experts participating in diagnostics alongside the National Institute for Biomedical 
Research of the DRC in response to the Ebola epidemic. These researchers also supported on-site 
personnel  in  monitoring  patients  undergoing  treatment  with  confirmed  diagnoses,  as  well  as 
epidemiological work to specify transmission chains83. 

More recently, in 2023, CEPI and the IPD announced their partnership to improve vaccine access in 
Africa, aligning with the African Union's 60% vaccine self-reliance goal by 2040. CEPI is establishing a 
Global South vaccine manufacturing network, with IPD as a key member, leveraging its expertise in 
yellow fever vaccines and aspiring to become a regional vaccine hub through Project MADIBA. Initial 
funding of up to $15 million over three years, expandable to $50 million over a decade, supports IPD's 
development alongside other major funders. 
The partnership focuses on enhancing IPD's manufacturing capacity to supply vaccines within 100 days 
of identifying new pathogens, crucial for pandemic prevention84.  

The IPD has also signed an agreement with the Global Health Innovative Technology Fund to advance 
research on infectious diseases in low- and middle-income countries. Together, they aim to accelerate 
the development of medical countermeasures for infectious diseases in these regions, focusing on the 
R&D  of  therapies,  vaccines,  and  diagnostics.  Additionally,  they  will  strengthen  their  collaboration  to 
support  the  manufacturing  of  low-cost  vaccines  and  diagnostics  through  technology  transfer  and 
knowledge sharing with Japanese pharmaceutical companies and academia85. 

81 Africa will accelerate vaccine production, UN news, July 2023 
82 Senegal: The Republic of Senegal and Team Europe agree to build a vaccine factory for COVID-19 and other endemic diseases, European 
Investment Bank, July 2021 
83 The scientific teams of the International Network of Pasteur Institutes involved in the fight against the ongoing Ebola epidemic in the Democratic 
Republic of Congo, the Pasteur Network, August 2019 
84 CEPI and IPD announce 10-year partnership to boost manufacturing of affordable vaccines for the Global South, CEPI News, January 2023 
85 The  Global  Health  Innovative  Technology  Fund  and  the  IPD  announce  a  new  partnership  to  advance  research  and  development  of  new 
diagnostics and vaccines in low- and middle-income countries, Pasteur Network News, October 2023 

257 

 
 
 
 
 
 
i.  South Africa 

Key contextual elements 

Population: 
59.8 million 

Current health expenditure (% of GDP): 
9% 

Socio-demographic and public health situation 
Classified  as  an  upper  middle-income  country,  South  Africa  is  considered  a  developing  nation. 
According  to  the  most  recent  data,  South  Africa  has  one  of  the  highest  levels  of  income  inequality 
globally, with a Gini coefficient of around 0.6786. 

Regarding public health, South Africa continues to have a high prevalence of HIV among all age groups, 
with 17.8% of the adult population living with HIV87, one of the highest rates in the world. The country 
has made significant improvements in getting people to test for HIV and met the 2020 target of 90% of 
people with HIV knowing their status88. 
South  Africa  is  also  subject  to  diverse  communicable  diseases,  including  malaria,  measles, 
influenzas… 

Key information regarding medical countermeasures 
With regards to medical countermeasures, South Africa is the co-leader of the Johannesburg process: 
a cooperation initiative led by South Africa and Norway to enhance collaboration for timely and equitable 
access  to  medical  countermeasures  against  pandemic  threats,  through  a  network-of-networks 
approach89 

In  2022,  Morocco  and  South  Africa  collectively  met  over  70%  of  pharmaceutical  product  demand 
through local production. 
Additionally, there is a growing interest in developing a strong pharmaceutical and biotech production 
hub in the country to prepare adequately for the next pandemic. Partnerships between U.S. pharma 
manufacturers and local producers are being developed, focusing on technology transfer to ramp up 
local production for the continent90. 

Finally, a technology transfer hub has been established in Cape Town to enhance capacity in low- and 
middle-income  countries  for  manufacturing  mRNA  vaccines.  This  centre  of  excellence  and  training, 
supported by WHO, facilitates the sharing of technology and technical expertise with local producers. 

86 Gini coefficient by country, World Bank Open Data 
87 World population review 
88 At a glance: HIV in South Africa, Article, 2021, Be in the Know 
89 i-MCM-Net update, WHO, January 2024 
90 International Trade Administration, US Department of Commerce: South Africa – Healthcare 

258 

 
 
 
 
 
 
 
 
 
 
Comprehensive mapping of identifies entities 

The National Department of Health (NDoH) 
The National Department of Health of South Africa derives its mandate from the National Health Act 
(2003), which requires that the department provides a framework for a structured and uniform health 
system for South Africa. 
Therefore, the Department seeks to improve the population health through the prevention of illnesses 
and the promotion of healthy lifestyles. Additionally, it consistently strives to enhance the healthcare 
delivery system by prioritizing access, equity, efficiency, quality, and sustainability. 

The NDoH oversees health security coordination and develops national guidelines, such as the National 
Preparedness and Response plan to Covid-19. It is responsible for multisectoral coordination at both 
national  and  subnational  levels,  including  the  identification  of  needs  and  procurement  of  required 
supplies. 

Moreover,  the  NDoH  ensures  to  procurement  of  essential  medicines,  through  national  medicine 
contracts from which provinces and regions procure medicines for delivery to the central medical depots 
for distribution to the various healthcare facilities based on orders placed. The stockpiling of medical 
supplies is also a mission of the NDoH, thanks to a system to guarantee the availability of stockpiles 
when needed (for example, personal protective equipment and vaccines are kept in strategic areas at 
national and provincial levels, including in the private sector). 

The NDoH seeks to promote advanced R&D as indicated in its 2030 Vision: "Support the research and 
development of vaccines and medicines for the communicable and non-communicable diseases that 
primarily affect developing countries, provide access to affordable essential medicines and vaccines, in 
accordance with the Doha Declaration on the TRIPS Agreement and Public Health […]." 
The NDoH encourages and promotes local manufacturing of MCMs. 

Regarding  international  cooperation,  as  mentioned  previously,  South  Africa  and  Norway  are 
cooperating  under  the  i-MCM-nEt  initiative  of  the  WHO,  to  enhance  collaboration  for  timely  and 
equitable access to medical countermeasures against pandemic threats, through a network-of-networks 
approach: The Johannesburg Process91. 

91 To prevent the Next Pandemic, Leaders should finish what they started – A pandemic action priority list, Think Global Health, Press release, Sept. 
2023 

259 

 
 
 
 
 
 
 
 
 
 
National Institute for Communicable Diseases (NICD) 
The NICD aims to be a key source of knowledge and expertise on regionally relevant communicable 
diseases to the South African Government, the Southern African Development Community countries, 
and the African continent. It also provides contribution in the development of policies and programs and 
supports responses to communicable disease threats. 
It plays a role in the health security coordination by working with the provincial and national departments 
of Health to detect and report swiftly on communicable disease outbreaks. It cooperates with the NICD 
in preparedness and response. 

Its role is particularly significant in the promotion of R&D capacities in health crisis response, as it: 

-  Provides  advice  during  outbreak  situations  and  offers  technical  support  for  all  aspects 

surrounding communicable disease outbreaks, 

-  Seeks to optimize available laboratory services during outbreak events, 
-  Provides laboratory diagnostic services and specialized testing during outbreaks. 

260 

 
 
 
 
 
j.  Zambia 

Key contextual elements 

Population: 
20 million 

Current health expenditure (% of GDP): 
5% 

Socio-demographic and public health situation 
Zambia  is  a  low-income  country  with  a  high  burden  of  communicable  diseases,  including  malaria, 
tuberculosis, and HIV/AIDS. Bordered by eight countries, it lies in a region prone to disease outbreaks92. 
Starting with the rainy season in October 2023, the country recently experienced one of its worst cholera 
outbreaks, with more than 15,000 cases and close to 600 deaths recorded93. 

Regarding  health  emergency  preparedness  and  response,  Zambia’s  2017  Joint  External  Evaluation 
identified  gaps  in  Zambia’s  capacity  to  prevent,  detect,  and  rapidly  respond  to  public  health  risks. 
Moreover,  the  COVID-19  pandemic  has  also  highlighted  challenges.  In  response  to  these  factors, 
Zambia  is  implementing  various  initiatives  to  enhance  its  capacities.  For  instance,  The  Zambia 
Multisectoral Pandemic Preparedness and Response Project, supported by the Pandemic Fund, aims 
to strengthen the national surveillance, laboratory systems, and workforce capacity for preparedness 
and response to public health events, especially those requiring a One Health approach94. 

Key information regarding medical countermeasures 
Zambia  has  faced  drug  shortages  in  recent  years.  In  2021/2022,  some  public  hospitals  reported 
shortages of medicines and intravenous fluids, as well as consumables such as syringes, gloves, and 
swabs95. 

Local  pharmaceutical  production  represents  between  10%-15%  of  the  demand  for  pharmaceutical 
products.  Therefore,  like  several  other  developing  African  countries,  Zambia  imports  most  products 
from other countries, especially India. 
However, the government of republic of Zambia is trying to reduce costs on the importation by promoting 
the setting up of local manufacturing of essential medicines. Zambia's ambition is to become a producer 
and eventually an exporter of pharmaceutical products in the region and beyond96. 

In addition, Zambia is the host country of Africa CDC’s Regional Coordination Centre in Southern Africa. 

92 Zambia – Country Disease Outlook, WHO, August 2023 
93 Tackling cholera in Zambia: an overview of our outbreak response, UK-MED, April 2024 
94 The Pandemic Fund: Multisectoral Pandemic Preparedness and Response Project in Zambia, The World Bank, September 2023 
95 Drug shortage hits Zambia’s public hospitals, APA news, March 2022 
96 The Pharmaceutical manufacturing industry in Zambia: Challenges and Opportunities, Policy Monitoring and Research Centre, January 2022 

261 

 
 
 
 
 
 
 
 
 
Comprehensive mapping of identifies entities 

The Ministry of Health 
The Zambian Ministry of Health’s mission is to provide equitable access to cost effective and quality 
healthcare services to the Zambian population. 
In  terms  of  health  crisis  preparedness  and  response,  the  Ministry  collaborates  with  the  ZNPHI  in 
gathering information and analysing health threats. Additionally, the Ministry’s Directorate of Clinical 
Care and Diagnostics Services, Pharmacy Unit, ensures the forecasting and quantification of medicines 
required to prepare for and respond to health crises97. 

The Ministry of Health is central in the health security coordination. In cooperation with the ZNPHI, it 
coordinates the various stakeholders to respond to heath emergency. For instance, during Covid-19, 
the Ministry of Health oversaw and coordinated the vaccine deployment strategy. 

In response to the Covid-19 pandemic, which exposed Zambia’s vulnerability in ensuring access to vital 
medicines  and  medical  supplies,  the  Ministry  launched  the  “Zambian  Government's  Pharmaceutical 
Manufacturing Initiative (ZPMI)” in 2022, supported by the Team Europe Initiative on MAV+. Zambia's 
ambition  with  this  program  is  to  become  a  producer  and  eventually  an  exporter  of  pharmaceutical 
products in the region and beyond. To achieve this, the ZPMI aims to enhance access to technology in 
the  country  and  strengthen  partnership  mentorship  programs  to  help  local  pharmaceutical 
manufacturers prepare themselves for partnerships with international pharmaceutical firms, financial 
institutions, and development partners98. 

The Zambia Medicines and Medical Supplies Agency (ZAMMSA) 
The ZAMMSA is a statutory body mandated to procure, store, and distribute medicines and medical 
supplies to all public health institutions in Zambia on behalf of the Zambian Government. The scope of 
ZAMMSA includes, notably in terms of MCMs, essential medicines, medical and surgical supplies, anti-
malarial, anti-retroviral, blood commodities, and laboratory products99. 

In the context of drug shortages, ZAMMSA implemented a strategy aimed at sustainably inhibiting the 
shortages of medicines and medical supplies in our public health facilities. This strategy, announced in 
February  2024,  notably  includes  the  large-scale  supply  of  medicines  through  the  government-to-

97 The Pharmaceutical manufacturing industry in Zambia: Challenges and Opportunities, Policy Monitoring and Research Centre, January 2022 
98 Zambia : Global Gateway & Team Europe in action ! Our partnership towards local pharmaceutical production materialises, Delegation of the 
European Union to Zambia and COMESA, March 2023 
99 The Zambia Medicines and Medical Supplies Agency Act, 2019 

262 

 
 
 
 
 
 
 
 
 
government approach with the Egypt, as well as through the support of United Nations Agencies such 
as UNICEF, UNDP, and the Global Fund. This strategy also relies on the purchase of much-needed 
essential medicines and medical supplies from the local market to reduce delivery times100. 

The Zambia National Public Health Institute (ZNPHI) 
The Zambia National Public Health Institute was established in accordance with the ZNPHI Act No. 19 
of  2020,  as  a  technical  institution  specialized  in  public  health.  The  ZNPHI  is  mandated  to  lead  in 
safeguarding  Zambia’s  health  security  through  surveillance  and  disease  intelligence  systems, 
emergency  preparedness  and  response  capabilities,  specialized  laboratory  systems  and  networks, 
health  information  management  systems,  health  security  workforce  development,  and  generation  of 
scientific evidence through research. 

With regards to HERA’s tasks, the ZNPHI analyses health threats; it conducts hazard mapping and risk 
assessments for districts, to evaluate the potential consequences and impacts of health threats. The 
entity  also  provides  an  integrated  platform  for  information  collection,  collation,  and  dissemination 
regarding health threats. 

The ZNPHI is a key cornerstone in health security coordination in Zambia, as its mission is to coordinate 
public health security in Zambia by ensuring robust surveillance systems, effective preparedness, and 
emergency response mechanisms to support evidence-based decision-making. For instance, since its 
establishment in 2020: the Institute coordinated the response to scabies outbreak and developed EVD 
and Cholera contingency plans. 
The  ZNPHI  also  provides  training  of  staff,  just  as  the  training  in  eastern  province  in  terms  of 
preparedness for the threat of cholera due to the outbreak in neighbouring Malawi. 

In terms of diagnostic capacities, the ZNPHI supports laboratory capacity-building efforts through its 
National  Public  Health  Laboratory  Service  department.  For  instance,  its  initiatives  include  deploying 
mobile  labs  to  the  Eastern  Provincial  Genomic  Sequencing,  promoting,  and  expanding  AMR 
surveillance, and developing a multi-pathogen genomic surveillance strategy. 

Finally,  the  ZNPHI  is  involved  in  strengthening  the  health  emergency  preparedness  and  response 
architecture, specifically at the African continent level. Firstly, ZNPHI anchors Zambia’s designated role 
as the host of the Africa CDC Regional Collaborating Centre (RCC) for Southern Africa. 
Moreover, the Institute collaborates with Africa CDC and the World Bank to strengthen continental and 
regional infectious disease detection and response systems through a project called "The Africa CDC 
Financing  Project".  In  Zambia,  the  Project  provides  human  resource  capacity  strengthening  to  the 
ZNPHI and support operationalization of the Africa CDC Southern Africa RCC. The project includes the 
construction,  equipping,  and  staffing  of  an  office  complex  that  serves  as  a  Regional  Centre  of 
Excellence and provides additional capacity to support the Southern Africa region101. 

100 Govt moves to address drug shortages, engages 24 contractors to supply medicines worth K600 million, Zambia Monitor, Press release, Feb. 
2024 
101 ZNPHI Annual Progress Report, ZNPHI, 2022 

263 

 
 
 
 
 
 
 
 
 
 
 
2) Asia 

Monitoring, Intelligence Gathering and Analysis 

Entity 

Chinese Center for Disease Control and Prevention (China 
CDC) 

The Office of the Principal Scientific Adviser to the Government 
of India 

Ministry of Health 

Ministry of Health, Labour and Welfare 

The National Institute of Infectious Disease 

National Public Health Laboratory  

Institute for Public Health  

Ministry of Health 

Ministry of Health 

The Public Health Authority 

the Ministry of Health 

the new Communicable Diseases Agency  

A*STAR 

The National Centre for Infectious Diseases 

KCDA : Korea Disease Control and Prevention Agency 

Ministry of Food and Drug Safety (MFDS) 

Taiwan Centers for Disease Control (CDC) 

Ministry of Health 

National Institute of Hygiene and Epidemiology  

Pasteur Institutes (in Hanoi, Ho Chi Minh City, Nha Trang, and 
Da Lat) 

Country 

China 

India 

Indonesia 

Japan 

Japan 

Malaysia 

Malaysia 

Malaysia 

Saudi Arabia 

Saudi Arabia 

Singapore 

Singapore 

Singapore 

Singapore 

South Korea 

South Korea 

Taiwan 

Vietnam 

Vietnam 

Vietnam 

264 

 
 
 
 
 
Advanced Research and Development Capacities  

Entity 

Country 

Chinese Center for Disease Control and Prevention (China 
CDC) 

Ministry of Science and Technology (MOST) 

Ministry of Health and Family Welfare 

The Office of the Principal Scientific Adviser to the 
Government of India 

Indian Council of Medical Research 

Ministry of Health, Labour and Welfare 

The Japan Agency for Medical Research and Development 
(AMED) 

The National Institute of Infectious Disease 

Institute for Medical Research 

Ministry of Health 

the Ministry of Health 

A*STAR 

China 

China 

India 

India 

India 

Japan 

Japan 

Japan 

Malaysia 

Saudi Arabia 

Singapore 

Singapore 

KCDA : Korea Disease Control and Prevention Agency 

South Korea 

Korean Health Industry Development Institute (KHIDI) 

South Korea 

Ministry of Economic Affairs 

Ministry of Health 

National Institute of Hygiene and Epidemiology  

Pasteur Institutes (in Hanoi, Ho Chi Minh City, Nha Trang, 
and Da Lat) 

Taiwan 

Vietnam 

Vietnam 

Vietnam 

265 

 
 
 
 
 
 
Production / Manufacturing Capacities 

Entity 

National Health Commission of the People's Republic of China 

The Office of the Principal Scientific Adviser to the Government 
of India 

Ministry of Health 

Ministry of Health, Labour and Welfare 

Ministry of Health 

the Ministry of Health 

A*STAR 

Country 

China 

India 

Indonesia 

Japan 

Saudi Arabia 

Singapore 

Singapore 

Korean Health Industry Development Institute (KHIDI) 

South Korea 

Taiwan Centers for Disease Control (CDC) 

Ministry of Economic Affairs 

Ministry of Health 

Procurement of MCMs  

Entity 

The National Healthcare Security Administration 

The Office of the Principal Scientific Adviser to the Government 
of India 

Central Medical Services Society (CMSS) 

Ministry of Health 

Ministry of Health, Labour and Welfare 

Ministry of Health 

National Unified Company for Medical Supplies (NUPCO) 

the Ministry of Health 

Ministry of Health and Welfare of the Republic of Korea 

KCDA : Korea Disease Control and Prevention Agency 

Ministry of Food and Drug Safety (MFDS) 

Taiwan Centers for Disease Control (CDC) 

Taiwan 

Taiwan 

Vietnam 

Country 

China 

India 

India 

Indonesia 

Japan 

Malaysia 

Saudi Arabia 

Singapore 

South Korea 

South Korea 

South Korea 

Taiwan 

266 

 
 
 
 
 
Ministry of Health 

The national centralized drug procurement center 

Vietnam 

Vietnam 

Stockpiling and Distribution Capacities 

Entity 

Central Medical Services Society (CMSS) 

National Disaster Management Authority 

Ministry of Health 

Badan Nasional Penanggulangan Bencana/BNPB 
(National Disaster Management Agency) 

Ministry of Health, Labour and Welfare 

Ministry of Health 

Ministry of Health 

National Unified Company for Medical Supplies (NUPCO) 

the Ministry of Health 

KCDA : Korea Disease Control and Prevention Agency 

Taiwan Centers for Disease Control (CDC) 

Ministry of Health 

International Cooperation  

Entity 

Chinese Center for Disease Control and Prevention (China 
CDC) 

Ministry of Health and Family Welfare 

The Office of the Principal Scientific Adviser to the Government 
of India 

Indian Council of Medical Research 

Ministry of Health 

Ministry of Health, Labour and Welfare 

The National Institute of Infectious Disease 

Ministry of Health 

Ministry of Health 

Country 

India 

India 

Indonesia 

Indonesia 

Japan 

Malaysia 

Saudi Arabia 

Saudi Arabia 

Singapore 

South Korea 

Taiwan 

Vietnam 

Country 

China 

India 

India 

India 

Indonesia 

Japan 

Japan 

Malaysia 

Saudi Arabia 

267 

 
 
 
 
 
 
 
the Ministry of Health 

the new Communicable Diseases Agency  

A*STAR 

Ministry of Health and Welfare of the Republic of Korea 

KCDA : Korea Disease Control and Prevention Agency 

Taiwan Centers for Disease Control (CDC) 

Ministry of Health 

Pasteur Institutes (in Hanoi, Ho Chi Minh City, Nha Trang, and 
Da Lat) 

Health Security Coordination 

Entity 

National Health Commission of the People's Republic of China 

Chinese Center for Disease Control and Prevention (China 
CDC) 

Ministry of Health and Family Welfare 

National Disaster Management Authority 

Ministry of Health 

Ministry of Health, Labour and Welfare 

The new Cabinet Agency for Infectious Disease Crisis 
Management 

National Public Health Laboratory  

National Disaster Management Agency  

Ministry of Health 

Ministry of Health 

The Public Health Authority 

the Ministry of Health 

the new Communicable Diseases Agency  

Ministry of Health and Welfare of the Republic of Korea 

KCDA : Korea Disease Control and Prevention Agency 

Singapore 

Singapore 

Singapore 

South Korea 

South Korea 

Taiwan 

Vietnam 

Vietnam 

Country 

China 

China 

India 

India 

Indonesia 

Japan 

Japan 

Malaysia 

Malaysia 

Malaysia 

Saudi Arabia 

Saudi Arabia 

Singapore 

Singapore 

South Korea 

South Korea 

268 

 
 
 
 
Ministry of Food and Drug Safety (MFDS) 

South Korea 

Taiwan Centers for Disease Control (CDC) 

Ministry of Health 

Taiwan 

Vietnam 

269 

 
 
 
 
 
 
a. China 

Key contextual elements 

Population: 
1.41 billion 

Current health expenditure (% of GDP): 
5% 

Socio-demographic and public health situation 
Classified as an upper middle-income country, China has one of the fastest growing ageing populations 
in the world. This significant demographic shift presents many new challenges for public health and 
socioeconomic development102. Additionally, studies show that two of the biggest public health threats 
in China are currently cigarette consumption and environmental pollution103. 

In  recent  decades,  China  has  made  significant  progress  in  the  field  of  infectious  diseases,  with 
noteworthy reductions in historically prevalent illnesses (e.g., tuberculosis and viral hepatitis). However, 
the  emergence  of  new  pathogens  like  SARS,  Influenza  A,  and  SARS-CoV-2  pose  new  challenges. 
These epidemiological shifts, attributable to fast economic development, urbanization, modifications in 
the healthcare system, and an aging population, present considerable challenges to the country’s public 
health policies104. 

Key information regarding medical countermeasures 
The outbreak of COVID-19, first in China and then globally, has emphasized the critical role China plays 
in the production and supply chain of medical countermeasures. China is a major supplier of APIs to 
global manufacturers of generic pharmaceuticals, notably to India, which is itself a significant producer 
of pharmaceuticals. India imports nearly 70% of its APIs from China105. 
Moreover, China made significant progress in the field of R&D during this crisis, aiming to develop a 
vaccine:  China advanced rapidly in COVID-19 vaccine R&D, launching the world's first clinical trial in 
March 2020 and gaining regulatory approval for vaccines by December 2020. 

Chinese pharmaceutical companies and research institutions collaborated extensively, leading to the 
development and approval of several vaccines, including Sinopharm and Sinovac. These vaccines have 
been distributed globally, contributing significantly to the worldwide vaccination efforts against COVID-
19. 

However, China faces challenges in non-COVID-19 vaccine R&D and regulatory capacity compared to 
developed  countries  like  the  USA  and  UK,  reflecting  its  ongoing  efforts  to  enhance  innovation  and 
regulatory frameworks in global healthcare contexts. 

102 Ageing and health in China, WHO 
103 Columbia – Mailman School of Public Health, China - Overview 
104 Perspectives: Epidemiological Shifts in Infectious Diseases in China: Implications and Policy Recommendations, China CDC, 2023, 5(42): 948-
951 
105 Fears of US drug shortages grow as India locks down to curb the coronavirus, CNBC, March 24, 2020 

270 

 
 
 
 
 
 
 
 
 
Comprehensive mapping of identifies entities 

The National Health Commission of the People's Republic of China 
The  National  Health  Commission  of  the  PRC  is  a  cabinet-level  executive  department  of  the  State 
Council of China, responsible for formulating national health policies. 
Regarding HERA’s tasks, the NHC oversees the production capacities as it formulates and carries out 
administrative measures for medical institutions and medical services industry. 
According to the publicly available information, the NHC also ensures the health security coordination 
through  the  implementation  of  plans  of  disease  prevention  and  control,  the  development  of  guides 
prevention and control in case of public health emergency and the supervision of the prevention and 
treatment of infectious diseases.  

Regarding  international  cooperation,  it  is  worth  noting  the  trilateral  cooperation  between  China, 
Japan,  and  South  Korea  on  a  range  of  issues,  including  health.  In  terms  of  preparedness  and 
response to health crises, this collaboration was strengthened in June 2024 during the 9th Trilateral 
Summit Meeting among China, Japan, and South Korea. 
Recognizing  the  critical  role  of  trilateral  cooperation  in  the  health  field,  particularly  in  response  to 
emerging  and  re-emerging  infectious  diseases,  the  governments  adopted  the  Joint  Statement  on 
Future Pandemic Prevention, Preparedness, and Response at this summit. The statement aims to 
enhance  collaboration  in  managing  health  emergencies,  including  infectious  diseases,  among  the 
Ministries of Health and other national agencies for disease control in the three countries106. 

The Chinese Centre for Disease Control and Prevention (China CDC) 
The China CDC is a national-level technical organisation under the National Health Commission that 
specializes in disease control and prevention and public health. It aims to: 

-  Protect public health and safety by providing information to enhance health decisions, and to 
through  partnerships  with  provincial  health  departments  and  other 

promote  health 
organisations. 

-  Focus national attention on developing and applying disease prevention and control (especially 

infectious diseases), and environmental health. 

The China CDC carries out work on disease prevention and control, public health emergency response, 
and provide technical support and advice for the formulation of public health laws, regulations, policies, 
plans and programs. In the field of R&D, it also promotes scientific and technological innovation and 
development. 

106 Joint Declaration of the 9th ROK-Japan-China Trilateral Summit, Government of South Korea, Press Release, June 2024 

271 

 
 
 
 
 
 
 
 
Its role is important in the health security coordination as it guides the implementation of local plans and 
programs on disease prevention and control and provides guidance to local CDC. 

The  China  CDC  is  engaged  in  international  cooperation  to  improve  preparedness  and  response 
capabilities  for  health  crises  at  regional  level.  Indeed,  the  Japan-China-Korea  Forum  on 
Communicable Disease Control and Prevention is held annually. This forum, which is part of the 
trilateral  cooperation  between  Japan,  China,  and  South  Korea,  brings  together  infectious  disease 
experts from NIID Japan, Korea DCA, and China CDC for presentations and discussions on specific 
themes, such as Pandemic Preparedness and Response and AMR Control in each country. 
Furthermore, China CDC provides technical support to the establishment and development of Africa 
CDC since 2015. The two CDCs exchanged leadership and senior expert visits annually. 
China  CDC  also  collaborates  with  Rospotrebnadzor  on  infectious  disease  control  and  prevention, 
emergency preparedness and response, joint research on laboratory techniques, etc. under the MOU 
signed in 2020. 

The National Healthcare Security Administration 
The National Healthcare Security Administration is a sub-ministry-level government agency directly 
under the State Council of China. Its mandate is to oversee the state-backed China Healthcare 
Security including general health insurance plan, maternity insurance, and medical aid programs. 

In terms of health emergency preparedness and response, the NHSA is responsible for the 
centralized procurement of drugs and medical supplies. 

The Ministry of Science and Technology (MOST) 
The MOST is a crucial actor of the R&D sector in China, as its main missions are: 

-  To formulate and facilitate the implementation of strategies and policies for innovation-driven 

development, 

-  To coordinate the national innovation system, 
-  To formulate and implement national basic research plans, policies, and standards, and to 
organize and coordinate major national projects on basic research and application-oriented 
basic research, 

-  To lead the efforts to develop the national technology transfer system, formulate and oversee 
the implementation of policies and measures for promoting the transfer and commercialization 
of R&D outcomes and the collaboration among enterprises, universities, and research 
institutes. 

The MOST led the R&D response to the Covid-19 crisis in China. In fact, soon after the beginning of 
COVID-19  outbreak,  the  central  government  set  a  strategic  goal  to  maintain  no  or  minimal  local 
transmission until the population became protected through immunization with vaccines. To accelerate 
vaccine  R&D  and  rollout,  the  Ministry  of  Science  and  Technology  quickly  initiated  the  emergency 
response research projects, 1 day before Wuhan’s lockdown. MOST promoted and encouraged R&D 
and sponsored five technology roadmaps and 12 vaccine candidates, including some being developed 
by private companies and startups. 

272 

 
 
 
 
 
b. India 

Key contextual elements 

Population: 
1.42 billion 

Current health expenditure (% of GDP): 
3% 

Socio-demographic and public health situation 
India, classified as a lower middle-income country, with a fast-growing economy as well as persistent 
inequalities (Gini coefficient: 0.43 in 2019). 

In  terms  of  public  health,  India  is  characterised  by  a  two-sided  disease  burden,  with  a  long-term 
prevalence of communicable diseases and a fast-growing prevalence of non-communicable diseases 
(e.g., cardiovascular disease, diabetes, and respiratory diseases). 
Infectious diseases such as dengue, malaria and HIV/AIDS continue to be major public health threats, 
especially in poor and rural areas. India has the highest burden of tuberculosis in the world107 108. 
India has been significantly affected by the COVID-19 pandemic, ranking among the countries with the 
highest total estimated excess death. 

Key information regarding medical countermeasures 
India plays a significant role in the international architecture of health emergency preparedness and 
response. In 2023, India's G20 presidency had designated the strengthening of the cooperation in the 
field of medical countermeasure as one of its objectives. In this context, India has proposed the creation 
of a medical countermeasure coordination platform that will help establish norms and standards for the 
common public good, equity, and representation of the global south, enabling effective responses to 
challenges posed by pandemics like Covid-19. 

India is also known as a major vaccine innovator and producer. In fact, India's vaccine innovation and 
manufacturing capabilities were on display during the COVID-19 pandemic. The Serum Institute and 
Biological E took on production of COVID-19 vaccines owned by AstraZeneca and Johnson & Johnson. 
The Serum Institute helped resolve production problems with Novavax's vaccine. 
India was also home to vaccine innovations, such as a needle-free vaccine and a unique mRNA vaccine 
candidate that does not require ultracool storage109. 

Furthermore, India is an important pharmaceutical manufacturer and plays a major role in the global 
supply chain. For instance, India supplies approximately 40% of the generic pharmaceuticals used in 
the United States110. 

107 Population health in India: Challenges and strategies for improving public well-being, Observer Research Foundation, Article published in July 
2023 
108 WHO South-East Asia, Focus on Tuberculosis 
109 Insights from India on Expanding global vaccine production, Think Global Health, published in Feb. 2024 
110 COVID-19: China Medical Supply Chains and Broader Trade Issues, Congressional Research Service, December 2020 

273 

 
 
 
 
 
 
 
 
 
Comprehensive mapping of identifies entities 

The Ministry of Health and Family Welfare 
The MoHFW is responsible for formulating and implementing health policies and programs, including 
those related to crisis preparedness and response. It oversees the health security coordination with 
relevant stakeholders in case of health crisis. 
It also promotes advanced R&D through dedicated programs such as: 

-  The  Ayushman  Bharat  Digital  Mission  (ABDM)  aims  to  bridge  the  gap  amongst  different 

stakeholders of the healthcare ecosystem through usage of technology. 

-  The  PM-Ayushman  Bharat  Health  Infrastructure  Mission  aims  to  build  disease  surveillance 
system,  laboratory  networks,  building  of  infectious  disease  blocks  across  the  country  and 
augmenting research capacity with emphasis on "One Health approach,” he said. 

Regarding international cooperation in the field of medical countermeasures, India's G20 presidency 
focuses  on  three  priorities  in  the  health  sector,  one  of  which  is  to  strengthen  cooperation  in  the 
pharmaceutical sector with a focus on ensuring access to safe, effective, quality, and affordable medical 
countermeasures.  In  this  context,  India  has  proposed  the  creation  of  a  medical  countermeasure 
coordination platform, the G20-Chief Science Advisers' Roundtable. This initiative was led by the Office 
of the Principal Scientific Adviser (PSA)111, with the support of the MoH. 
India is involved since 2004 in a longstanding cooperation on health with the EU. The EU and India are 
working  together  to  address  common  public  health  challenges,  such  as  communicable  and  non-
communicable diseases, and antimicrobial resistance. During the EU-India Leaders' meeting of May 
2021, the partners highlighted the aim to collaborate in better preparing and responding to global health 
emergencies and advancing global health security and agreed to cooperate on resilient medical supply 
chains,  vaccines  and  APIs,  on  the  application  of  internationally  recognised  good  manufacturing 
standards to ensure high product quality and safety, as well as in R&D. 

The Office of the Principal Scientific Adviser to the Government of India 
Established in 1999, the Office of the Principal Scientific Adviser is placed under the Cabinet Secretariat. 
It aims to aims to provide pragmatic and objective advice to the Prime Minister and the cabinet in matters 
of Science and Technology. Its missions are: 
- 

To enable future preparedness in emerging domains of science and tech, 

-  To coordinate major inter-ministerial S&T missions, 
-  To provide an enabling ecosystem for technology led innovations and techno-entrepreneurship, 
-  To  drive  innovation  and  technology  delivery  towards  solving  socio-economic  challenges  for 

sustainable growth, 

111 Refer to the section dedicated to the Office of the PSA. 

274 

 
 
 
 
 
 
 
-  To foster effective public-private linkages for driving research and innovation. 

The Office of PSA conducts health intelligence gathering on science & technologies as it reviews and 
recommends  technologies  and  technology  products  to  ensure  India’s  preparedness  and  response 
capacities. 
Its role is crucial in the field of R&D: it develops strategies to influence the international discourse on 
key technologies and for furthering India's interests in those domains and gives advice to promote the 
private sector and global investment in R&D, education, and skills related to emerging technologies. 
Additionally, one of its initiatives, the Empowered Technology Group, aims: 

-  To  proactively  lay  down,  coordinate,  and  oversee  national-level  policies  relating  to  R&D  in 

technologies that require large outlays in resources, both financial and human, 

-  To  render  timely  advice  for  determining  direction  and  trajectory  of  Government's  R&D  and 

Technology Development Programmes. 

The Empowered Technology Group also intervenes to coordinate and oversee national policies related 
to the procurement and induction of technologies. 

Some  of  its  programs  also  seek  to  enhance  India’s  production  and  manufacturing  capacities.  For 
instance,  the  National  Diagnostic  Catapult  initiative,  launched  in  2023,  aims  to  boost  India’s 
preparedness for pandemics. The objective of this program is to foster the development and scaling up 
of manufacturing capacities in diagnostics, enabling the Indian diagnostic ecosystem to achieve self-
sufficiency in the manufacturing of molecular diagnostics kits for infectious diseases while also gaining 
export capabilities. 

The Office of PSA seeks to contribute in reinforcing the global health emergency preparedness and 
response architecture, through diverse international engagement. For example, the G20-Chief Science 
Advisers'  Roundtable  (G20-CSAR),  led  by  the  Office  of  the  Principal  Scientific  Adviser  to  the 
Government  of  India,  was  an  initiative  under  the  India’s  G20  Presidency.  G20-CSAR  provided  a 
platform to discuss and devise common frameworks to address some of the pressing policy challenges 
through inclusive global science advice, including pandemic preparedness and response. 

The Central Medical Services Society (CMSS) 
The Central Medical Services Society is the central procurement agency under the Ministry of Health 
and Family Welfare. It ensures the procurement of medicines, vaccines, contraceptives and medical 
equipment's  for  the  MoHFW.  CMSS  is  also  in  charge  of  the  quality  control  and  distribution  of  the 
mentioned goods. 

The Indian Council of Medical Research 
The Indian Council of Medical Research is the apex body in India for coordination and promotion of 
biomedical  research.  It  conducts,  coordinates,  and  implements  medical  research  and  supports  the 
translation  of  medical  innovations  into  products/processes  and  introduce  them  to  the  public  health 
system. 
The Council coordinates a network of 26 institutes for research involved in evaluation of new drugs, 
insecticides, vaccines, devices, diagnostic kits & other interventions for all diseases of national health 
priority. 
It was part of the collaboration in the development of Covaxin, India’s Covid-19 vaccine (developed by 
Bharat Biotech International, in collaboration with the Indian Council of Medical Research). 

As part of the international architecture in medical research, the Council has collaborative projects with 
the  US  (Workforce  development  through  field  epidemiology  training  programs),  the  UK,  Canada 
(Wastewater-based  Surveillance  for  Antimicrobial  Resistance  for  Early  Warning  and  Engendering 
Stakeholder Response Through Artificial Intelligence) … 

275 

 
 
 
 
 
 
 
 
The National Disaster Management Authority 
The NDMA is a governmental body mandated to lay down the policies, plans and guidelines for Disaster 
Management to ensure timely and effective response to disasters. 
It ensures the stockpiling and distribution of MCMs in case of CBRN and cooperates with the MoHFW 
is the health security coordination in case of a health emergency, providing advice and guidelines for 
the prevention of disaster or mitigation of its effects. 

276 

 
 
 
 
c. Indonesia 

Key contextual elements 

Population: 
275 million 

Current health expenditure (% of GDP): 
3% 

Socio-demographic and public health situation 
Indonesia  is  an  emerging  middle-income  country,  which  has  made  significant  efforts  in  poverty 
reduction over the last years. 
Although programmatic interventions and policies have significantly reduced the disease burden in the 
past  decades,  communicable  diseases  remain  a  public  health  concern  in  Indonesia,  along  with  the 
rising burden of non-communicable diseases such as diabetes112. Additionally, Indonesia is at risk for 
emerging diseases such as Zika virus, Monkey pox as well as re-emerging illnesses as tuberculosis, 
dengue, malaria…113 

Key information regarding medical countermeasures 
Indonesia is making significant efforts to improve its preparedness to health crisis, after the significant 
impact of the Covid-19 crisis. With the support of WHO, Indonesia aims to diverse initiatives such as 
policies on prevention and control of zoonosis and EIDs, updating contingency plans based on lessons 
learned  from  COVID-19,  strengthening  risk  assessment  and  risk  mapping,  improving  hospital 
preparedness 
for 
countermeasures like vaccines and medical equipment114. 

review,  and  ensuring  a  sustainable  deployment  plan 

through  periodic 

Comprehensive mapping of identifies entities 

The Ministry of Health 
In  terms of  health  crisis  preparedness and  response,  the  Indonesian  MoH conducts  the  intelligence 
gathering and oversees the monitoring, mapping, and evaluation the MCMs. 
It also ensures a centralized procurement for vaccines and logistics. An existing presidential regulation 
permits a swift procurement of MCMs (without tendering process) in case of a health emergency. 
Additionally, a plan for management and distribution of some national stockpiles is in place. 

112 The health status of Indonesia’s provinces: the double burden of diseases and inequality gap, The Lancet Global Health, Nov.2022 
113 The threat of emerging and re-emerging infections in Indonesia, Acta Med Indones, 2019 Jul;51(3):195-196. 
114 Building back better: Strengthening Indonesia's preparedness and resilience to emerging threats, WHO, March 2024 

277 

 
 
 
 
 
 
 
 
 
The PKK (PKK means Pusat Krisis Kesethan = Health Crisis Centre), under the Ministry of Health, is in 
charge of arranging and accounting for health logistics in all warehouses and carrying out monitoring 
throughout its warehouse. 

The Indonesian MoH is conducting an initiative to carry out health transformation activities that include 
6 types of transformation, such as the transformation of Primary Services, Referral Services, Health 
Resilience Systems, Health Financing Systems, Health Human Resources, and Health Technology 
The pillar "Health Resilience System Transformation" aims to maintain a robust health system amidst 
global health threats. To achieve this, it seeks to: 

- 

- 

increase the resilience of the pharmaceutical and medical device sector by promoting domestic 
production of 14 routine vaccines, the top 10 drugs, and the top 10 medical devices. 
strengthen emergency response resilience through the establishment of a national surveillance 
network,  preparation  of  backup  personnel  for  emergency  response,  and  conducting  crisis 
preparedness exercises. 

The National Disaster Management Agency (Badan Nasional Penanggulangan Bencana/BNPB) 
As the Indonesian agency for natural disaster affairs, BNPB’s missions are: 

-  To  protect  the  population  from  the  threat  of  disaster  by  building  disaster  risk  reduction  and 

disaster preparedness plans, 

-  To build a disaster emergency management system quickly, effectively, and efficiently, 
-  To  carry  out  post-disaster  recovery  of  regions  and  communities  through  coordinated 

rehabilitation and reconstruction, 

-  To organize support and management of disaster management logistics and equipment. 

Regarding health crisis preparedness and response, the Agency establishes stocks and sets minimum 
standards for logistics inventory to ensure that essential supplies are available to disaster victims within 
72 hours. This includes a minimum inventory of logistical supplies such as medicine, food packages, 
clothing packages, shelter packages, and other necessary items. 

278 

 
 
 
 
 
 
 
d. Japan 

Key contextual elements 

Population: 
125,1 million 

Current health expenditure (% of GDP): 
11% 

Socio-demographic and public health situation 
Developed country, Japan has a very densely populated cities, as well as an aging society with the 
world’s  highest  proportion  of  population  aged  65  years  or  over.  Disaster-prone  country  and  global 
economic  hub,  the  country  must  be  prepared  for  public  health  emergencies  of  all  kinds  (disease 
outbreaks, natural hazards…). 
Japan  is  also  among  the  top  ally  of  WHO  during  many  emergencies  (the  COVID-19  pandemic,  the 
Ukraine crisis, natural disasters…), and was an early supporter of the WHE. 

In  2023,  during  the  G7  Hiroshima  Summit,  with  Japan  as  the  G7  presidency,  the  development  and 
strengthening of the global health architecture for public health emergencies was one of the three health 
priorities on the agenda. Japan recalled that it will be crucial to strengthen global health architecture 
based on the lessons from the COVID-19 pandemic about health emergency prevention, preparedness, 
and response. Recognizing the necessity for a stronger governance system, the G7 leaders committed 
to  further  improve  political  momentum  towards  “more  coordinated  and  sustained  leader-level 
governance for health emergency prevention, preparedness, and response”115. 
Furthermore, Japan prioritized Health Innovation as the third agenda item, thereby reinforcing the focus 
on MCMs. In this context, the G7 leaders committed to bridging the gap in equitable access to MCMs 
by  announcing  the  G7  Hiroshima  Vision  for  Equitable  Access  to  MCMs.  This  vision  is  based  on 
principles  of  equity,  inclusivity,  efficiency,  affordability,  quality,  accountability,  agility,  and  speed 116. 
While acknowledging the progress made in developing MCMs, G7 leaders emphasized the importance 
of  ensuring  that  these  measures  are  accessible,  safe,  effective,  and  affordable,  especially  for  low-
income and middle-income countries. To support these efforts, the G7 leaders announced the MCM 
Delivery Partnership for equitable access117, an initiative informed by the lessons from the delivery of 
COVID-19 vaccines. This partnership underscores the importance of ensuring that developed MCMs 
reach the people who need them. 

Key information regarding medical countermeasures 
Japan is currently investing to enhance its capacities regarding medical countermeasures. For instance, 
following the exposure of Japan’s weaknesses in R&D capacities during the COVID-19 pandemic, the 
country is ramping up an $8.5 billion initiative. This initiative aims to enable Japan to develop a vaccine 
for a new virus within 100 days, a goal that has been adopted by many countries118. 

115 Health outcomes of the G7 Hiroshima Summit: breaking the cycle of panic and neglect and achieving UHC, The Lancet, June 2023 
116 G7 Hiroshima Vision for Equitable Access to Medical Countermeasures, G7 Leaders, June 2023 
117 G7 Hiroshima Leaders ‘Communiqué, G7 Leaders, Japanese Ministry of Foreign Affairs, June 2023 
118 Japan moves to bolster vaccine R&D after COVID-19 exposed startling weakness, science.org, Feb.2023 

279 

 
 
 
 
 
 
 
Comprehensive mapping of identifies entities 

The Ministry of Health, Labour and Welfare 
As a cabinet-level ministry within the Japanese government, the Ministry of Health, Labour and Welfare 
(MoHLW) plays a pivotal role in Japan's preparedness and response framework for public health crises. 
It  undertakes  crucial  functions  such  as  intelligence  gathering  and  analysis  to  gather  pertinent 
information  on  outbreak  situations  and  countermeasures,  both  domestically  and  internationally. 
Additionally, during emergencies and post-crisis phases, the MoHLW evaluates past countermeasures 
and revises guidelines as necessary. 

Central to health security coordination, the MoHLW develops and disseminates guidelines on health 
emergency-related  activities,  including  stockpiling,  production,  and  distribution,  to  prefectural 
governments and relevant stakeholders. According to the National Action Plan, the MoHLW is tasked 
with promoting research and development (R&D) of medical countermeasures such as vaccines and 
drugs at all stages of a pandemic. 

In  terms  of  production  capacities,  the  MoHLW  promotes  the  production  of  medical  supplies  before 
outbreaks and seeks to enhance production during pandemics, addressing supply chain bottlenecks 
and ensuring continuous operations. It has the authority to request producers and sellers of vaccines 
to suspend their classic production and shift to the production of pandemic vaccines to optimize capacity 
utilization. 

Furthermore,  the  MoHLW  is  responsible  for  stockpiling  medical  supplies  and  equipment,  including 
personal protective equipment (PPE) and respirators, and coordinates with prefectural governments to 
assess  and  maintain  necessary  stockpiles.  It  also  oversees  the  smooth  distribution  of  medical 
countermeasures such as vaccines and drugs. 

Lastly,  the  MoHLW  engages  in  international  cooperation  efforts  for  preparedness  and  response  by 
collaborating  with  international  organisations  and  providing  significant  support  to  low-  and  middle-
income countries. 
More precisely, Japan is part of the trilateral cooperation between China, Japan, and South Korea 
on a range of issues, including health. In terms of preparedness and response to health crises, this 
collaboration was strengthened in June 2024 during the 9th Trilateral Summit Meeting. As mentioned 
previously,  the  governments  adopted  the  Joint  Statement  on  Future  Pandemic  Prevention, 
Preparedness, and Response at this summit. The statement aims to enhance collaboration in managing 

280 

 
 
 
 
 
 
 
 
health emergencies, including infectious diseases, among the Ministries of Health and other national 
agencies for disease control in the three countries119. 

The Japan Agency for Medical Research and Development (AMED) 
AMED is a funding agency aiming to promote medical research and development and to become a 
pillar of Japan’s economy by fostering medicine, drugs, and medical devices as strategi industries. 
The  agency  supports  the  implementation  of  medical  research  and  development  (management, 
concentration of the medical R&D funds to one funding agency, monitoring and administration for proper 
implementation of R&D…) and the improvement of the infrastructures for clinical research. 
AMED also supports the industrialization through support to research institutes in acquiring intellectual 
property  rights,  cooperation  with  compagnies  and  support  for  cooperation  aiming  at  practical  use, 
promotion of international joint research. 

AMED  cooperates  with  a  range  of  stakeholders  to  reinforce  the  global  architecture  for  health  crisis 
preparedness  and  response  through  different  initiatives.  One  of  them  is  the  Strategic  International 
Collaborative  Research  Program  (SICORP),  which  promotes  international  collaborative  research 
projects based on inter-ministerial agreements with other countries. This initiative was launched with 
Singapore's A*STAR in 2016. There is also a international collaborative research initiative focused on 
neglected tropical diseases (NTDs) in Africa. 
AMED also collaborates with many countries on infectious diseases and AMR research projects: 

In Asia: China, Mongolia, Laos, Vietnam, Indonesia, India… 

- 
-  And beyond: the US, Nigeria, Gabon, Egypt, South Africa, Brazil, Kenya… 

HERA and AMED have signed a working arrangement to strengthen their cooperation on MCMs to step 
up prevention, preparedness and response to serious cross border health threats in October 2023. 

The National Institute of Infectious Disease 
Institution under the Ministry of Health, Labour and Welfare, the NIID is mandated to conduct research 
projects on a range of infectious diseases from a preventive medicine perspective, enhancing human 
health  and  welfare  by  controlling  infectious  diseases,  and  providing  scientific  support  for  the 
government's health and medical administration. 

The Institute conducts health threats analysis and intelligence gathering. It collects reports of detection 
of infectious agents from prefectural public health institutes and those of incidents of infectious diseases 
from sentinel clinics in the whole country. This information is accessible to the public, as weekly and 
monthly reports. 
In addition, the institute promotes and coordinates basic and applied research projects on infectious 
disease; molecular biological analyses of the etiological agents as well as development and application 
of rapid diagnostic methods and vaccines for important diseases emerging or re-emerging and other 
traditional diseases are the main projects. Research on development of recombinant and other new 
concept-based vaccines (e.g., DNA vaccines) are also being worked out actively. 

The  Japan  NIID  is  engaged  in  international  cooperation  to  improve  preparedness  and  response 
capabilities for health crises. For instance, since 2004, Taiwan CDC and Japan NIID organize an annual 
bilateral symposium. In 2011, they signed an agreement regarding joint research that enables Taiwan 
CDC and the NIID to conduct joint research on infectious disease prevention. In 2022, Taiwan CDC 
and NIID cooperated in conducting 11 joint infectious disease research projects. 

119 Joint Declaration of the 9th ROK-Japan-China Trilateral Summit, Government of South Korea, Press Release, June 2024 

281 

 
 
 
 
 
 
 
 
The Institute has also established collaborations with the following countries: 

- 

India,  collaboration  on  Antimicrobial  Resistance  Research  with  Indian  Council  of  Medical 
Research, 

-  South Korea, on Quality Control of Vaccines and Biological Products, 
-  Thailand,  on Quality Control  of  Vaccines  and  Biological  Products with  the  Ministry  of  Public 

Health, 

-  China,  collaboration  on  infectious  diseases  with  the  Wuhan  Institute  of  Virology,  Chinese 

Academy of Sciences and Quality Control of Vaccines and Biological Products, 

-  France, with the Pasteur Institute, 
-  Vietnam, with the National Institute of Hygiene and Epidemiology, 
-  Mongolia, with the Mongolian Academy of Medical Sciences. 

Furthermore, at the regional level, the Japan-China-Korea Forum on Communicable Disease Control 
and Prevention is held annually. This forum brings together infectious disease experts from NIID Japan, 
KDCA,  and  China  CDC  for  presentations  and  discussions  on  specific  themes,  such  as  Pandemic 
Preparedness and Response and AMR Control in each country. 

The Cabinet Agency for Infectious Disease Crisis Management 
The  new  Cabinet  Agency  for  Infectious  Disease  Crisis  Management  was  established  in  September 
2023 within the Cabinet Secretariat as a permanent entity for infectious disease crisis management. 
It  has  the  authority  to  plan  and  formulate  important  policies  with  the  Cabinet  and  to  coordinate  all 
administrative departments so that the agency functions as a leader during both daily operations and 
in emergency situations. 
It directly assists the Prime Minister and the Chief Cabinet Secretary. It also has centralized control 
over government-wide policy planning and comprehensive coordination of administrative departments 
related to preparations during normal operations, initial response to infectious disease crises, and the 
affairs of the Government countermeasures Headquarters during crises. 

282 

 
 
 
 
 
 
e. Malaysia 

Key contextual elements 

Population: 
33.9 million 

Current health expenditure (% of GDP): 
4% 

Socio-demographic and public health situation 
Malaysia is a rapidly developing Southeast Asian nation known for its economic growth and cultural 
diversity. Public health in Malaysia faces several challenges, including non-communicable diseases, 
health disparities between urban and rural populations, environmental pollution120… 

Over the past years, Malaysia had to deal with several pandemics. Since the Nipah virus outbreak in 
1999,  the  Malaysian  Health  Ministry  has  implemented  processes  to  enhance  the  country's 
preparedness against infectious diseases121. During the SARS situation, Malaysia effectively managed 
the threat, despite not being a SARS-affected country. It also responded promptly to the H5N1 outbreak 
in 2004 through mass culling of poultry, quarantine rooms and collaboration with FAO/WHO122.  

Key information regarding medical countermeasures 
To further strengthen its defences, the Malaysian government developed in 2006 the National Influenza 
Pandemic  Preparedness  Plan  (NIPPP).  This  plan  provides  a  comprehensive,  time-bound  guide  for 
responding  to  influenza  pandemics,  outlining  a  policy  and  strategic  framework  for  a  multisectoral 
response. It also contains specific actions to be undertaken by the Ministry of Health at various levels 
123. 

Building on this experience and preparation, Malaysia was proactive in implementing health screening 
at entry points, stockpiling 2 million doses of Tamiflu, and launching widespread vaccination campaigns 
during the H1N1 influenza pandemic in 2009124. 
In response to COVID-19, Malaysia introduced strict Movement Control Orders (MCO) from March 2020, 
significantly curbing the virus's spread125. Malaysia is considered as relatively successful in managing 
the COVID-19 pandemic, with the number of deaths and infections lower than neighbouring countries 
and many developed economies126. 

In 2024, collaborating with international partners like the CEPI, Malaysia seeks to improve its vaccine 
R&D capabilities127, while boosting its production capacity. For instance, the Malaysian pharmaceutical 
company Pharmaniaga facilitated the local fill-and-finish production of the Sinovac COVID-19 vaccine. 

120 Air pollution and its health impacts in Malaysia: a review, Soringer Nature – January 2020 
121 Lessons from the Nipah virus outbreak in Malaysia, The Malaysian Journal of Pathology - 2007 
122 Global Outbreak of Avian Influenza A (H5N1) and International Law, David P. Fidler - 2004 
123 National Influenza Pandemic Preparedness Plan, Ministry of Health Malaysia, 2006 
124 Prevention, control and eradication of avian influenza in ASEAN, ASEAN/ADB – August 2010 
125 Covid-19 outbreak in Malaysia: Actions taken by the Malaysian government, National Library of Medicine - 2020 
126 COVID-19:  Malaysia Experience and Key Lessons, Asian Economic Papers (2021) 20 (2): 73–95. 
127 CEPI-funded project to enhance scientific understanding of deadly Nipah virus strains, CEPI – June 2023 

283 

 
 
 
 
 
 
 
 
 
 
Comprehensive mapping of identifies entities 

The Ministry of Health 
Malaysia's Ministry of Health is proactive in its approach to preparing for and responding to public health 
crises, with a comprehensive strategy that encompasses surveillance, rapid response, and coordination 
at  national  and  international  levels. Central  to  these  efforts  is  the  National  Crisis  Preparedness  and 
Response Centre (CPRC), which functions as the operational hub for managing health emergencies. 
MoH  has  activated  CPRC  in  2020  to  monitor  developments  on  COVID-19  and  to  prepare  for  the 
pandemic.  

The  CPRC  coordinates  the  implementation  of  emergency  plans,  monitors  emerging  threats,  and 
ensures effective communication among various stakeholders. It conducts regular simulation exercises 
and drills to maintain readiness and enhance response capabilities. 

Additionally,  the  CPRC  oversees  the  strategic  procurement  and  stockpiling  of  essential  medical 
countermeasures, such as vaccines, antiviral drugs, and personal protective equipment, ensuring their 
availability during crises. 
The Ministry of Health is also in charge of establishing and coordinating the distribution of MCMs.  

Regarding  international  cooperation,  the  Malaysian  Ministry  of  Health  seeks  to  reinforce  the  global 
health emergency preparedness and response architecture. 
For  instance,  during  the  COVID-19  crisis,  the  Malaysian  Ministry  of  Health  led  the  "ASEAN  EOC 
Network  for  Public  Health":  a  platform  among  ASEAN  Member  States  officials  working  at  their 
respective  Crisis  Centres  and/or  in  disease  prevention  and  control,  to  share  information  in  a  timely 
manner through various communication mechanisms. This program aimed to enable rapid and daily 
communication to share information on new confirmed cases and any measures taken at the national 
level128. 

The National Public Health Laboratory  
The National Public Health Laboratory (MKAK), operating under the Disease Control Division of the 
Public  Health  Department  within  Malaysia's  Ministry  of  Health,  was  established  to  support  outbreak 
investigations and surveillance activities. 

128 ASEAN Health Sector Efforts in the Prevention, Detection and Response to Coronavirus Disease 2019, ASEAN Press Release, September 
2023 

284 

 
 
 
 
 
 
 
 
 
Currently,  there  are  five  Public  Health  Laboratories,  including  the  National  Public  Health  Laboratory 
which serves as the national reference lab, and four regional laboratories. 

The Epidemiology Division of the National Public Health Laboratory in Malaysia is divided into three 
sections: Surveillance, Outbreak and Preparedness, and Information Technology.  

-  The Surveillance Section compiles, analyses, monitors, and reports laboratory results, provides 
laboratory  support  for  public  health  concerns,  offers  technical  advisory  and  training,  and 
participates in Ministry of Health research activities.  

-  The Outbreak and Preparedness Section collaborates with public health labs and agencies for 
outbreak  investigations,  provides diagnostic and analytical  services,  and  participates  in  field 
investigations and inter-agency reporting.  

-  The Information Technology Unit manages data and communication platforms, supports ICT 

infrastructure, and ensures readiness for diagnostic and outbreak reporting. 

The Disease Division is also useful in preparation and response to public health crisis. It is responsible 
for providing the analytical and laboratory diagnostic services in the prevention of communicable and 
non-communicable diseases as well as outbreak control.  

The Institute for Public Health  
The  Institute  for  Public  Health  in  Malaysia  conducts  epidemiological  and  public  health  research  to 
provide  evidence-based  findings  to  policy  makers  and  relevant  stakeholders.  The  Institute  develops 
and  implements  training  programs  to  enhance  the  skills  of  public  health  professionals  and  ensure 
effective crisis management.  
More specifically, regarding health crisis preparedness and response, it analyses health threats and 
supports surveillance activities. It conducts health risk assessments, and the dissemination of crucial 
public health information to mitigate the impact of health crises. 

The National Disaster Management Agency  
The National Disaster Management Agency (NADMA) operates under the Prime Minister's Department 
and serves as a focal point for disaster management in Malaysia. It coordinates national efforts across 
various government agencies to ensure a unified response to emergencies.  

NADMA  oversees  disaster  preparedness  planning,  conducts  simulation  exercises,  and  manages 
resource  allocation  to  enhance  readiness.  During  a  public  health  crisis,  NADMA  facilitates  rapid 
response  measures,  supports  the  deployment  of  medical  countermeasures,  and  ensures  effective 
communication and coordination among stakeholders. 

The Institute for Medical Research 
The  Institute  for  Medical  Research  stands  as  a  cornerstone  in  Malaysia's  healthcare  landscape, 
recognized for its pioneering research and development initiatives under the Ministry of Health.  
The Institute promotes and encourages advanced R&D to develop effective and safe MCMs. In fact, 
with a primary focus on MCMs, it plays a role in advancing the nation's capacity to combat infectious 
diseases, emerging health threats, and other medical challenges.  

Leveraging  modern  technology  and  interdisciplinary  expertise,  the  Institute  conducts  innovative 
research in vaccine development, diagnostics, and therapeutic interventions. 

285 

 
 
 
 
 
 
 
 
 
 
 
 
f.  Saudi Arabia 

Key contextual elements 

Population: 
36,4 million 

Current health expenditure (% of GDP): 
6% 

Socio-demographic and public health situation 
Saudi Arabia is a high-income developing country, with a fast-growing economy. In terms of pandemic 
preparedness  and  response,  Saudi  Arabia  faces  the  unique  challenge  of  hosting  one  of  the  largest 
mass gatherings globally—the Hajj, an annual pilgrimage to holy sites in the city of Makkah—which 
makes the region susceptible to the spread of infectious diseases. In this context, significant efforts are 
made  by  the  government  of  Saudi  Arabia  to  ensure  the  health,  safety,  and  security  of  pilgrims  by 
enhancing  its  pandemic  preparedness  and  adhering  to  WHO  strategies  for  infection  prevention  and 
control129. 

Key information regarding medical countermeasures 
In its “Vision 2030”, the Kingdom of Saudi Arabia aims to enhance its pharmaceutical and bioscience 
manufacturing capacities. Its strategy seeks to prioritise local production, technology transfer, conduct 
clinical trials locally, and train the local labour force130. 

Comprehensive mapping of identifies entities 

The Ministry of Health 
The  Saudi  Arabian  Ministry  of  Health  has  diverse  missions,  including  regarding  health  crisis 
preparedness and response: “to achieve the highest levels of health preparedness to confront risks”. 
As comparison to HERA’s tasks, the Ministry supports and encourages scientific research, ensures the 
coordination with the relevant authorities to encourage medical research and clinical trials. It supports 
the cooperation with other countries for clinical studies (e.g. with China during covid-19). 
It also conducts health threats analysis and evaluation of potential consequences, in collaboration with 
the Public Health Authority. 
Additionally, the MoH plays a role in the improvement of manufacturing capacities in case of a health 
emergency, supporting initiatives of national companies to manufacture medical equipment. 

129 Coronavirus and co-infections: A Saudi Arabian perspective, Saudi J Biol Sci. 2023 Sep; 30(9): 103739. 
130 Healthcare in Saudi Arabia: An industry overview, Omnia Health, article published in Oct.2022 

286 

 
 
 
 
 
 
 
 
 
Saudi  Arabia  has  a  National  Plan  to  manage  the  stockpiling  and  distribution  of  PPEs,  under  the 
responsibility of the MoH. However, publicly available information has not enabled the Study Team for 
the identification of stockpiling or distribution of other medical countermeasures. 

Moreover, Saudi Arabia seeks to reinforce the global health architecture, by providing both national and 
international  financial  support.  As  an  example,  during  its  G20  Presidency  (2020),  Saudi  Arabia 
committed $150 million to the Coalition for Epidemic Preparedness and Innovations and $150 million 
to the GAVI Vaccine Alliance131. 
More recently, in May 2024, the Ministries of Health of Saudi Arabia and South Korea agreed to enhance 
healthcare capacity building and to continue medical cooperation between the 2 countries132. 

The National Unified Company for Medical Supplies (NUPCO) 
As  part  of  Saudi  Arabia’s  ambitious  ‘Vision  2030’  economic  transformation  plan,  the  country  has 
centralised the public procurement of medications through the National Unified Procurement Company 
for Medical Supplies (NUPCO). 
Established in 2009, NUPCO is the leading company in Saudi Arabia in procurement, storage, logistics 
and  supply  chain  management  for  pharmaceutical,  medical  devices  and  supplies  for  governmental 
hospitals in Saudi Arabia. 

The Public Health Authority 
Newly established, this authority aims to protect and promote the public health, prevent disease, and 
raise  the  public  preparedness  to  respond  to  public  health  emergencies  by  organizing  the  efforts 
between the relevant authorities. 
The Public Health Authority supports the Ministry of Health by conducting health threats analysis and 
intelligence gathering. 
The  Public  Health  Authority  intervenes  in  the  health  security  coordination  as  it  monitors,  measures, 
evaluates, controls, and prevents any risk factors related to the public health in the Kingdom of Saudi 
Arabia, including communicable and noncommunicable diseases, injuries, and other health challenges, 
and provides guidelines to relevant authorities. 

131 Public Health Challenges in Saudi Arabia during the COVID-19 Pandemic: A Literature Review, Healthcare (Basel), June 2023 
132 Korea-Saudi Arabia discuss healthcare cooperation including medical personnel training and capacity building, South Korea Ministry of Health 
and Welfare, Press Release, May 2024 

287 

 
 
 
 
 
 
 
 
 
g. Singapore 

Key contextual elements 

Population: 
5.7 million 

Current health expenditure (% of GDP): 
4% 

Socio-demographic and public health situation 
Singapore is a high-income country with one of the highest GDP per capita in the world. The Gini index 
has decreased in the last decade to reach 0.37 in 2023133. 
Infectious disease outbreaks are a continuous threat to Singapore. As an international travel hub with 
a  high  population  density,  Singapore  is  particularly vulnerable  to  imported  and  local  transmission  of 
novel infectious diseases and re-emergence of established ones. Before COVID-19, past examples of 
imported infectious disease outbreaks include Nipah (1999), SARS (2003), influenza pandemic (2009), 
and Zika (2016)134. 

Key information regarding medical countermeasures 
Singapore  ranks  high  on  the  list  as  a  manufacturing  hub  for  pharmaceutical  companies  and  is 
considered a significant technology and innovation hub. There are 60 manufacturing facilities producing 
a wide range of products, from antibiotics and flu vaccines to life-saving medicine for hypertension and 
diabetes.  The  Tuas  Biomedical  Park,  a  dedicated  hub  in  Singapore's  west,  is  home  to  13  global 
biopharmaceutical companies135. 

Additionally, Singapore's status as a small island state underscores its reliance on and advocacy for 
multilateral  cooperation  in  preparedness  and  response  to  health  crises.  Consequently,  Singapore 
actively engages in regional and international cooperation in this field. For instance, as one of the high-
income  countries  in  ASEAN,  Singapore  has  consistently  contributed  to  regional  initiatives  like  the 
COVID-19 ASEAN Response Fund, showcasing its reliability as a source of support. 
Moreover,  Singapore  has  been  a  proponent  of  regional  collaboration  in  vaccine  production  and 
distribution, citing the November 2019 ASEAN Leaders’ Declaration on ASEAN Vaccine Security and 
Self-Reliance as a reference point. 

Comprehensive mapping of identifies entities 

133 Key Household Income Trends - Singapore Department of Statistics  
134 Singapore - Ministry of Health – Infectious Diseases 
135 Influx of Pharmaceutical Investment to Singapore, Singapore Process Industries, 2022 

288 

 
 
 
 
 
 
 
 
 
The Ministry of Health 
The Singaporean Ministry of Health is mandated to lead, facilitate, and accelerate system-level changes 
needed  to  transform  healthcare  delivery,  and  the  empowerment  of  health  and  self-management  of 
disease.  Its  mission  is  to  design  and  implement  innovative  solutions  that  bring  about  these  desired 
changes. 

With  regards  to  HERA’s  tasks,  the  Ministry  of  Health  analyses  health  threats  and  conducts  health 
intelligence  gathering.  It  cooperates  with  the  new  Communicable  Diseases  Agency  to  evaluate  the 
potential consequences and impact of health threats. 

The  Singaporean  Ministry of  Health  is  very  involved  in  the  promotion  and coordination  of  advanced 
research  and  innovation  to  develop  effective,  safe,  and  affordable  MCMs  and  related  technologies. 
Indeed, it set up a national programme called PREPARE, as “Programme for Research in Epidemic 
Preparedness  and  Response”,  which  aims  to  support  and  strengthen  Singapore’s  key  essential 
research capabilities, translational platforms, and expertise to develop tools, methods and products that 
can be tapped on to detect, respond to, and contain future infectious disease threats. 
More precisely, the PREPARE’s mission is to: 

-  Draw  up  a  national  R&D  plan  that  sets  out  the  key  R&D  goals  and  strategies  that  support 

epidemic preparedness and response, 

-  Develop  strong  and  synergistic  partnerships  between  teams  in  different  disciplines,  across 

sectors, and in close collaboration with MOH, 

-  Make the necessary preparations during periods of normalcy that will enable R&D to proceed 

rapidly during an epidemic, 

-  Actively facilitate and expedite the process by which research discoveries can be developed 
into deployable products and solutions, e.g. approved diagnostic kits and therapeutic agents, 
and manufactured at scale136. 

In addition, the Ministry of Health ensures the procurement, the maintenance of a national stockpile of 
MCMs, including PPE, masks, vaccines, and medications137. 
The  Ministry  also  monitors  the  stock  levels  of  commonly  used  medicines  and  medical  supplies, 
especially  during  exceptional  surges  in  demand  or  supply  disruptions.  If  necessary,  it  will  work  with 
retailers to procure additional stocks to meet the demand. Furthermore, the Ministry of Health maintains 
stockpiles of key medicines and medical supplies to be prioritized for higher acuity patients. 
In extreme situations, where there may be global shortages, the Ministry can take additional measures 
such as imposing sales limits to prevent hoarding and ensure the medicines and medical supplies are 
timely and efficiently distributed138. 
The Ministry is also responsible for the distribution of MCMs in case of a crisis. 

The Singaporean Ministry of Health also works to strengthen the resilience of its MCM supply chain, 
particularly  through  the  diversification  of  sources  (different  countries,  different  suppliers,  etc.).  The 
Ministry also has the capacity to encourage companies to produce MCMs in the context of a health 
crisis, as was the case during the COVID-19 crisis for surgical mask production. 

The Ministry of Health coordinates the health crisis response with the relevant stakeholders. In fact, 
Singapore’s  response  management  is  spearheaded  by  a  ministerial-level  Multi-Ministry  Task  Force 
(MTF) under the responsibility of the Ministry of Health. 
The responsibilities of the MTF are to: 

136 PREPARE Official website, About us, consulted in June 2024 
137 Notice of question for oral answer for the sitting of parliament on 12 September 2022 – QUESTION N°2058, Ministry of Health Singapore, News 
Highlights 
138 Notice of question for oral answer for the sitting of parliament on or after 10 January 2023 – QUESTION N°4000 – 4066 - 2585, Ministry of 
Health Singapore, News Highlights 

289 

 
 
 
 
 
 
 
 
- 
- 

direct the national whole-of-government response to the outbreak, 
coordinate  the  community  response  to  protect  the  population  and  stay  vigilant  against  the 
spread of the disease, 

-  work with the international community to respond to the outbreak139. 

In  terms  of  internation  cooperation,  the  commitment  of  the  Singaporean  Ministry  of  Health  to 
strengthening the global health emergency preparedness and response architecture is closely linked to 
its participation within ASEAN. 
Indeed, as one of the high-income countries in ASEAN, Singapore has demonstrated its reliability as a 
source of contributions for regional initiatives such as the COVID-19 ASEAN Response Fund, to which 
the city-state contributed US$100,000 in 2020. Singapore has also advocated for regional cooperation 
in vaccine production and distribution, referencing the November 2019 ASEAN Leaders’ Declaration on 
ASEAN Vaccine Security and Self-Reliance140. 
Furthermore, the Singaporean Ministry of Health has been actively engaged to promote and encourage 
international  cooperation  in  R&D  for  treatment,  vaccines,  and  diagnostics  for  COVID-19  but  also  in 
health communication. 
Beyond its collaboration with the ASEAN Member States, the Singaporean Ministry of Health develops 
bilateral agreements. This was in the case with Australia; the two countries agreed to a dose-sharing 
arrangement of COVID-19 vaccines. This arrangement allowed both countries to support each other in 
optimizing their respective schedules for vaccinating their populations against COVID-19141. 

The Communicable Disease Agency 
Announced  in  March  2023,  the  new  Communicable  Disease  Agency  of  Singapore  aims  to  oversee 
disease preparedness, prevention, surveillance, risk assessments and outbreak response. 
Moreover, the National Public Health Laboratory will be transferred to the new Agency, and it will also 
maintain oversight of the clinical facilities in NCID. 

As of June 2024, the Communicable Disease Agency is in the interim stage (iCDA), serving as a pre-
operations structure to facilitate the transition and develop the corporate strategy and plans for the new 
Statutory Board142. 

In  May  2024,  the  iCDA  met  with  the  interim  Australian  Centre  for  Disease  Control,  also  an  agency 
established in response to COVID-19. The meeting facilitated an exchange of experiences and ideas 
between the agencies. Both agencies agreed to: 

- 
- 
- 

share updates on the planning processes completed by both agencies. 
assess the progress of the interim Australian CDC’s establishment. 
identify areas of success and challenges143. 

A*STAR, the Agency for Science, Technology and Research 
A*STAR,  the  Agency  for  Science,  Technology  and  Research  is  mandated  to  develop  Singapore's 
science, technology, and engineering capabilities to boost the nation's economic growth. 

A*STAR Infectious Disease Lab (ID Labs) was founded in 2021 in response to the Covid-19 pandemic. 
Uniting  scientists  from  around  the  world,  it  promotes  collaboration  in  R&D,  and  fosters  partnerships 
among a network of industry, clinical, and public sector collaborators. ID Labs aims to advance cutting-
edge  translational  research  in  respiratory  and  vector-borne  diseases,  antimicrobial  resistance,  and 
epidemic preparedness. Its objective is to develop new and effective technologies for the detection, 

139 Decision making for social and movement measures in the context of COVID-19, WHO, November 2020 
140 ASEAN  Leaders’  Declaration  on  ASEAN  Vaccine  Security  and  Self-Reliance  (AVSSR),  ASEAN  Secretariat,  November  2019,  adopted  in 
Bangkok, Thailand 
141 Dose Sharing Arrangement of COVID-19 Vaccines Between Singapore and Australia to Support Efforts to Combat COVID-19, Ministry of Foreign 
Affairs Singapore, August 2021 
142 Parliamentary Debate on the White Paper on Singapore’s Response to COVID-19, March 2023 
143 Successful bilateral meeting with Singapore’s interim Communicable Diseases Agency, Australian Centre for Disease Control News, May 2024 

290 

 
 
 
 
 
 
 
 
intervention, and prevention of new and emerging pathogens, ultimately delivering better health and 
economic outcomes. 
The  Epidemic  Preparedness  Horizontal  Technology  Coordinating  Office  (EP  HTCO)  is  a  dedicated 
Programme  Office  set  up  to  coordinate  research  and  capabilities  in  A*STAR  around  surveillance, 
detection,  intervention,  prevention.  EP  HTCO’s  goal  is  to  develop  an  integrated  response  to  better 
manage  infectious  disease  outbreaks.  The  HTCO  is  housed  under  ID  Labs  and  is  dedicated  to 
developing multi-disciplinary research, opening new opportunities for collaboration, and ensuring active 
communication and synergy among researchers. The EP HTCO has 4 focus areas: 

-  Surveillance:  detection  of  unknown  pathogens,  analytics  for  surveillance,  environmental 

transmission… 

-  Detection: screening and triaging, detection of identified pathogens, 
- 

Intervention:  research  on  drug  repurposing,  novel  drug  discovery,  therapeutic  monoclonal 
antibodies, 

-  Prevention:  vaccines,  production  of  PPE  /  Healthcare  equipment,  antimicrobial  /  antiviral 

coating and disinfectants. 

Beyond advanced R&D activities, A*STAR is also involved in enhancing and strengthening production 
and  manufacturing  capabilities,  notably  through  the  Advanced  Remanufacturing  and  Technology 
Centre  (ARTC).  The  ARTC  is  a  platform  built  upon  public-private  partnerships  with  expertise  in 
advanced  manufacturing  and  remanufacturing,  aiming  to  accelerate  the  transfer  of  innovation  from 
applied research to industrial applications and solutions, and building capabilities through collaboration 
with industry members. 
Within  the  ARTC,  the  MedTech  Manufacturing  Alliance  is  a  collaborative  platform  with  research 
institutes,  institutes  of  higher  learning,  multinational  corporations,  equipment  manufacturers,  global 
medical  equipment  providers.  The  alliance  aims  to  develop  R&D  solutions  based  on  real  problem 
statements in the medical and healthcare industry and accelerate technology deployment. 

In  terms  of  international  cooperation,  A*STAR  has  distinguished  itself  as  a  central  actor  in 
Singapore's role within ASEAN in the preparedness and response to the COVID-19 crisis. Indeed, 
A*STAR has been actively involved in ASEAN's R&D dynamics with three major projects144: 

-  The  Singapore-Malaysia  collaboration  to  enhance  ASEAN’s  epidemic  preparedness  with 

genomic surveillance: 
This  partnership  between  Singapore’s  Bioinformatics  Institute,  A*STAR  ID  Labs,  and 
Malaysia’s  Institute  for  Biotechnology  aimed  at  providing  accurate  and  up-to-date  genomic 
information on virus strains detected in the region, leveraging the Global Initiative on Sharing 
All Influenza Data (GISAID3) platform145 to enable rapid and open access to virus information, 

-  The  Philippines-Singapore  regional  study  to  assess  the  levels  of  immunity  within  ASEAN 
communities  at  different  stages,  including  before  vaccination  and  the  longevity  of  immunity 
conferred through vaccination. Leb by the Research Institute of Tropical Medicine & Council of 
Health Research and Development of the Philippines and the A*STAR, this study included the 
participation of  other  entities within  ASEAN  Members  states:  Indonesia,  Malaysia,  Thailand, 
and Vietnam. 

- 

the Strategic International Collaborative Research Program (SICORP), in collaboration with the 
AMED  (Japan),  to  promote  international  collaborative  research  projects  based  on  inter-
ministerial agreements with other countries. 

A*STAR is also involved in bilateral technology transfers as part of the country's health diplomacy. 
This was evident during the COVID-19 crisis with the Fortitude Kit 2.0: the first complete diagnostic kit 
to  be  approved  and produced at  scale in  Singapore.  Developed  by  A*STAR,  the  technology  for  the 

144 Singapore To Advance Covid-19 Research Collaboration with Asean And Strengthen Regional Capabilities To Combat Pandemics, A*STAR 
Press release, June 2021 
145 International data initiative for sharing of virus genomes, including the coronavirus causing COVID-19, to enable rapid and open access to virus 
information. 

291 

 
 
 
 
 
 
 
 
Fortitude Kit 2.0 was transferred through a non-exclusive license for manufacturing to meet local and 
regional demands, to help fulfil international demand for kits to detect the novel virus, especially in low- 
and middle-income countries. 

The National Centre for Infectious Diseases 
The  NCID  is  a  purpose-built  facility  with  330  beds,  aimed  at  enhancing  Singapore’s  capabilities  in 
managing and preventing infectious diseases. 
NCID  integrates  clinical  services,  public  health,  research,  training  and  education,  and  community 
engagement within a single framework. Alongside its role as a treatment centre for infectious diseases 
and outbreak management, NCID comprises various missions. 
More specifically, with regards to HERA’s tasks, the National Centre for Infectious Diseases assists the 
Ministry  of  Health  in  preventing,  detecting,  responding  to,  and  preparing  for  communicable  disease 
threats by: 

-  Establishing  the  evidence  base  for  national  strategies  for  preventing  and  controlling 

communicable diseases, 

-  Conducting long-term horizon scanning and risk assessments on infectious threats to provide 

guidance for clinical and public health practices, 

-  Performing national surveillance and audits on healthcare-associated infections, antimicrobial 

stewardship, and infection prevention and control, 

-  Strengthening the connection between expertise in public health and epidemiology and policy 

development. 

292 

 
 
 
 
 
h. South Korea 

Key contextual elements 

Population: 
51,6 million 

Current health expenditure (% of GDP): 
8% 

Socio-demographic and public health situation 
South Korea is a developed country, with one of the fastest ageing populations and the lowest birth rate 
in the world. In terms of public health, South Korea, together with Japan and Singapore, ranks in the 
top 25 healthiest nations in the world in terms of life expectancy, environmental factors, and health risks. 
Like other countries in the Western Pacific region, non-communicable disease contributes the most to 
disease burden146. 
Relatively to its geographical situation, South Korea is frequently exposed to public health threats like 
the typhoon season, large-scale fires, natural hazards, and infectious disease outbreaks (MERS, Covid-
19…). 

Key information regarding medical countermeasures 
Korea is a leading exporter of medical devices, with important manufacturing capacities. However, the 
Covid-19  pandemic  exposed  some  difficulties  in  vaccine  R&D.  In  reaction,  Korea  aims  to  embrace 
principles  proposed  by  the  CEPI  in  its  so-called  “100  Days  Mission” where safe,  effective  vaccines, 
therapeutics, and diagnostics would be available within 100 days of identifying the next “Disease X”. 
To achieve this, South Korea is building a vaccine library of prototypes to treat target pathogens within 
100 days, and which could be adapted within 200 days to tackle related pathogens. 

Comprehensive mapping of identifies entities 

The Ministry of Health and Welfare of Republic of Korea 
The Ministry of Health and Welfare (MoHW) coordinates and oversees health and welfare related affairs 
and policies. In the preparedness and response to health emergencies, it ensures to health security 
with relevant stakeholders. 
The  MoHW  also  oversees  the  procurement  of  MCMs.  For  instance,  during  the  Covid-19  crisis,  the 
Ministry of Health and Welfare had entered into agreements with AstraZeneca, Pfizer, Moderna, and 
Janssen Pharmaceutica (US) to procure Covid-19 vaccines. 

146 South Korea’s population shift: challenges and opportunities, The Lancet Regional Health – Western Pacific, July 2023 

293 

 
 
 
 
 
 
 
 
 
 
Additionally,  the  Ministry  intervenes  to  improve  and  enhance  the  global  health  architecture  through 
partnerships.  
Korea joined the WHO Executive Board in 2020 and served from 2020 through 2023, taking a more 
proactive role in discussions on health agenda. It also engaged in initiatives including ACT-A to lead 
the efforts to resolve global health issues, including the equitable distribution of vaccines, therapeutics 
and tests. 
Regarding the regional cooperation, South Korea is part of the trilateral cooperation between China, 
Japan,  and  South  Korea  on  a  range  of  issues,  including  health.  In  terms  of  preparedness  and 
response to health crises, this collaboration was strengthened in June 2024 during the 9th Trilateral 
Summit Meeting. As mentioned previously, the governments adopted the Joint Statement on Future 
Pandemic Prevention, Preparedness, and Response at this summit. The statement aims to enhance 
collaboration in managing health emergencies, including infectious diseases, among the Ministries of 
Health and other national agencies for disease control in the three countries147. 

In May 2023, HERA and the MOHW signed an Administrative Agreement, to strengthen cooperation in 
their  joint  efforts  to  address prevention,  preparedness,  and  response  to  serious cross  border  health 
threats in the area of medical countermeasures. 

KCDA: Korea Disease Control and Prevention Agency 
The  KCDA  is  the  central  agency,  under  the  MoHW,  specializing  in  scientific  evidence-based  public 
health management and healthcare R&D. It performs a wild range of HERA-like tasks: 

- 

- 
- 

- 

In monitoring intelligence, the KDCA analyses threats and produces guidelines (including about 
the MCMs), 
It purchases vaccines and manages vaccination safety, 
It  cooperates  with  the  MoHW  on  the  Health  security  coordination,  producing  guidelines  for 
outbreaks  of  different  infectious  diseases,  including  annual  guidelines  and  disease-specific 
guidelines,  and  led  the  task  force  aiming  to  coordinate  emergency  measures  to  respond  to 
Covid-19, 
It participates in collaborative research with international partners. 

The  KDCA  plays  a  significant  role  in  the  promotion  of  advanced  R&D  capacities.  Since  covid-19 
highlighted South Korea’s weaknesses in R&D, the KDCA intends to ramp up its investment in research 
and development, building on a 2021 pledge by then President Moon Jae-in to invest $1.9 billion to 
place South Korea among the world’s top five vaccine producers by 2025 and achieve the “100 Days” 
objective. 

The  KCDA  is  also  tasked  with  the  collection,  storage,  and  distribution  of  medication  and  medical 
resources to address infectious diseases. Specifically, the KCDC has identified 11 priority infectious 
diseases,  serving  as  the  foundation  for  strategic  planning  and  resource  allocation.  To  this  end,  the 
KCDA has established a Strategic National Stockpile comprising medical countermeasures pertinent to 
these 11 diseases. Additionally, a long-term plan is reviewed and updated biennially to augment this 
stockpile. Similar reserves are maintained to address chemical and radiation emergencies. 

Finally,  the  KCDA  is  involved  in  international  cooperation  to  improve  preparedness  and  response 
capabilities for health crises. At the regional level, it participates in the Japan-China-Korea Forum on 
Communicable  Disease  Control  and  Prevention  which  is  held  annually.  This  forum  brings  together 
infectious  disease  experts  from  NIID  Japan,  Korea  DCA,  and  China  CDC  for  presentations  and 
discussions on specific themes, such as Pandemic Preparedness and Response and AMR Control in 
each country. 

147 Joint Declaration of the 9th ROK-Japan-China Trilateral Summit, Government of South Korea, Press Release, June 2024 

294 

 
 
 
 
 
 
 
 
The Ministry of Food and Drug Safety (MFDS) 
The Ministry of Food and Drug Safety is in charge of ensuring the safety of food and medical products 
used in daily life. 
In  the  context  of  health  emergencies,  the  MFDS  oversees  the  collection  of  pertinent  information  on 
Medical  Countermeasures  (MCMs).  It  can  authorize  the  urgent  introduction  or  steady  provision  of 
medical devices recognized by the Minister of Food and Drug Safety, or those requested by relevant 
central administrative agencies, for public health purposes. 
Additionally, the Central Pharmaceutical Affairs Council, under the MFDS, manages the procurement 
of essential drugs. 

The Korean Health Industry Development Institute (KHIDI) 
The  KHIDI,  under  the  Ministry  of  Health  and  Welfare,  aims  to  foster  the  domestic  health  industry, 
strengthen  its  international  competitiveness,  and  consequently  improve  people’s  quality  of  life  to 
contribute to the advancement of Korea as a global bio and digital health hub. It has 4 major activities: 
policy development for the healthcare industry, support for healthcare R&D, fostering the healthcare 
industry and supporting business, supporting efforts to promote the global healthcare industry. 
KHIDI  is  specialised  in  the  planning,  evaluation,  management  of  domestic  R&D  projects  related  to 
healthcare. It invests mainly in promising, next-generation technologies such as new drugs, medical 
devices, and regenerative medicine and supports the development of medical technologies, such as 
big data and AI.  
The Institute also seeks to boost the domestic health industry. For instance, in 2020, the KHIDI 
operated a support centre to alleviate problems faced by companies developing Covid-19 treatments 
and vaccines. 

295 

 
 
 
 
 
i.  Taiwan 

Key contextual elements 

Population: 
23,6 million 

Current health expenditure (% of GDP): 
6% 

Socio-demographic and public health situation 
Taiwan,  significantly  impacted  by  the  2003  severe  acute  respiratory  syndrome  (SARS)  outbreak, 
implemented various surveillance systems, both event- and indicator-based, to monitor disease trends 
and detect potential emerging and re-emerging diseases. 
Additionally, Taiwan revised the Communicable Disease Control Act, granting public health authorities 
the authority to enforce control measures and establish an efficient central epidemic control command 
structure  for  swift  response  to  emergent  epidemics.  Following  the  COVID-19  outbreak,  Taiwan's 
successful response to the epidemic has been highlighted. 

Key information regarding medical countermeasures 
Due to its restricted domestic manufacturing capacity, Taiwan experiences a significant need to import 
advanced medical devices. In the realm of research and development, the government is spearheading 
efforts to transform Taiwan's biomedical sector into a global centre for innovative biotechnology and 
medical research and development148. 

Comprehensive mapping of identifies entities 

Taiwan Centre for Disease Control 
The Taiwan CDC, agency under the Ministry of Health and Welfare of Taiwan, plays a crucial role in 
preparing  for  and  responding  to  health  emergencies.  Serving  as  the  cornerstone  of  health  security 
coordination, Taiwan CDC oversees outbreak preparedness and response by collaborating with local 
health departments, food and agricultural authorities, and universities. 
It also in charge of intelligence gathering to address emerging and re-emerging communicable diseases, 
through extensive international collaboration focused on information exchange, experience sharing, and 
technological advancements. 

148 Guide to Taiwan’s health industries, Sept. 2022, PWC 

296 

 
 
 
 
 
 
 
 
 
 
Taiwan CDC also holds authority over policies governing vaccine manufacturing (in both preparedness 
and emergency phases) and collaborates with the Ministry of Economic Affairs to bolster capacities in 
case of a public health crisis. 
In  terms  of  procurement,  during  the  preparedness  phase,  Taiwan  CDC  manages  and  maintains 
stockpiles, procuring new products when necessary. The "Influenza Pandemic Strategy Plan" outlines 
pre-pandemic  negotiations  with  vaccine  manufacturers  to  ensure  sufficient  supply  during  future 
pandemics.  In  health  emergencies,  Taiwan  CDC  implements  an  "urgent  procurement  of  pandemic 
vaccine" strategy and procures other medical countermeasures (MCMs), such as medical face masks, 
surgical  masks,  N95  respirators,  isolation  gowns,  and  coveralls,  from  domestic  manufacturers  for 
professional use in healthcare settings or public health. 

Regarding stockpiling, Taiwan CDC maintains national reserves of antiviral drugs, including Tamiflu, 
Relenza,  Eraflu,  Rapiacta,  and  Avigan,  sufficient  to  supply  at  least  10%  of  the  population.  It  also 
manages  stockpiles  of  vaccines  and  PPE,  such  as  surgical  masks,  N95  respirators,  and  coveralls, 
ensuring an adequate supply for personnel engaged in epidemic control and healthcare services during 
the early phases of an epidemic. 
In terms of distribution, Taiwan CDC has established detailed allocation strategies and is responsible 
for distributing MCMs in the event of a health emergency. 

Lastly,  internationally,  during  the  COVID-19  crisis,  Taiwan  CDC  has  actively  enhanced  health 
exchanges  by  strengthening  bilateral  and  multilateral  relationships,  sharing  experiences  and 
information  with  other  countries,  and  participating  in  or  hosting  online  international  public  health 
conferences and workshops. 
For  instance,  since  2004, Taiwan  CDC  and  Japan NIID  organize  an  annual bilateral symposium.  In 
2011, they signed an agreement regarding joint research that enables Taiwan CDC and the NIID to 
conduct joint research on infectious disease prevention. In 2022, Taiwan CDC and NIID cooperated in 
conducting 11 joint infectious disease research projects149. 

Ministry of Economic Affairs 
The Ministry of Economic Affairs (MOEA) is tasked with crafting policies and legislation pertaining to 
industry  and  trade,  foreign  direct  investment,  energy,  minerals,  measurement  standards,  intellectual 
property, and state-owned enterprises. Operating at the cabinet level, the ministry plays a pivotal role 
in bolstering the nation's research and development and manufacturing capabilities. 
In  fact,  in  2016,  the  MOEA  initiated  the  Biomedical  Industry  Innovation  Program  to  boost  the 
development of Taiwan's biomedical sector. This program aims to foster industry growth within Taiwan, 
cultivate  innovation  clusters,  establish  connections  with  global  markets,  and  promote  key  specialty 
industries. 

Furthermore, in times of health crises, the Ministry of Economic Affairs can engage in negotiations with 
domestic manufacturers to ramp up production capacities of medical countermeasures, as outlined in 
the "Influenza Pandemic Strategic Plan". For instance, during the COVID-19 pandemic, the government 
collaborated with domestic manufacturers to increase the production capacities of COVID-19 rapid tests 
and masks. 

149 2023 Annual Report, Taiwan CDC 

297 

 
 
 
 
 
 
 
 
j.  Vietnam 

Key contextual elements 

Population: 
98 million 

Current health expenditure (% of GDP): 
5% 

Socio-demographic and public health situation 
Vietnam  is  a  developing  nation  with  one  of  the  most  rapidly  ageing  population  in  the  world150.  The 
country  has  made  impressive  strides  in  healthcare,  reducing  infectious  diseases,  and  improving 
maternal  and  child  health.  However,  Vietnam  faces  public  health  challenges,  including  the  rising 
prevalence of non-communicable diseases such as diabetes and hypertension. 

More  specifically  regarding  infectious  diseases,  Vietnam  is  considered  a  hotspot  for  influenza  virus 
evolution, both for human seasonal influenza strains, as well as the emergence of zoonotic variants 
with pandemic potential arising from the interaction of humans, livestock, wild animals, and ecosystems. 

In terms of preparedness and response, Vietnam has a strong track record in managing pandemics. At 
the beginning of the 2000s, it was the second country, after China, to confront SARS and became the 
first country to be declared SARS-free by the WHO after reporting 63 cases and five deaths151. In recent 
years, the country  has  addressed outbreaks  of  diseases such as mumps,  polio,  and plague152.  The 
strategies Vietnam developed during the SARS outbreak have been utilized to combat COVID-19. 
Additionally, the country's extensive experience with epidemic preparedness and response has likely 
contributed to a higher level of public compliance with centralized health directives153. 

Key information regarding medical countermeasures 
During the Covid-19 pandemic, the country has been proactive in vaccine R&D, leveraging partnerships 
with international organisations and local biotechnology firms. For instance, Nanogen, a Vietnamese 
company, developed the Nanocovax vaccine, which was one of the first locally produced COVID-19 
vaccines to undergo clinical trials.  

Furthermore, the Vietnamese government has focused on building a robust healthcare infrastructure to 
manage future pandemics. This includes strengthening laboratory capacities for rapid diagnostic testing 
and enhancing the supply chain for essential medical supplies154. 
The Ministry of Health also prioritizes the development of a national production of vaccines and drugs 
to reduce dependency on imports and increase self-sufficiency in MCMs availability. For instance, the 
Decision 1286/QD-TTg sets the target to master the production technology for 15 vaccines and be able 
to domestically produce 5 vaccines at international standards by 2030. 

150 UNFPA Vietnam  
151 Viet Nam SARS-free, WHO, published in 2023 
152 Việt Nam's health sector paves the way for quality and affordable medications, Viet Nam news, January 2024 
153 Emerging Covid-19 Success Story: Vietnam’s Commitment To Containment, Exemplars in Global Health, 2022 
154 Vietnam aims to ease medicine supply shortage with new regulation, Fitch Solutions – May 2023 

298 

 
 
 
 
 
 
 
 
 
 
Comprehensive mapping of identifies entities 

The Ministry of Health 
The Vietnamese Ministry of Health focuses on boosting the country’s readiness and response to public 
health crises through  solid  planning  and  infrastructure.  It  crafts national  policies  and  action  plans  to 
handle emergencies, ensuring quick detection and surveillance of health threats. 

During  public  health  crises,  the  Ministry  of  Health,  through  the  General  Department  of  Preventive 
Medicine  (GDPM),  implements  comprehensive  response  strategies.  GDPM  is  responsible  for  the 
development  and  execution  of  action  plans  for  disease  prevention  and  control.  It  coordinates  with 
domestic and international partners to strengthen surveillance systems, conduct risk assessments, and 
ensure stockpiling and rapid deployment of resources such as MCMs. GDPM also leads emergency 
response teams in the field, providing crucial support in outbreak investigations, sampling, analysis, 
and reporting. 

In  addition,  the  Ministry  of  Health  seeks  to  reinforce  the  country’s  autonomy  in  research  and 
production of MCMs. In October 2022, it launched a program aimed at ensuring the supply of vaccines 
for vaccination through 2030 (via Decision 1286/QĐ-TTg). In this objective of satisfying the demand 
for  vaccines  against  infectious  diseases  that  are  required  to  be  deployed  in  the  Expanded 
Immunization  Program,  this  programme  sets  the  objective  of  to  master  the  technology  needed  to 
produce 15 types of vaccines and to manufacture at least 5 of these vaccines domestically by 2030. In 
addition,  this  programme  aims  to  promote  and  encourages  research  and  production  of  vaccines, 
especially for vaccines against emerging, dangerous, and highly infectious disease, new vaccines that 
are  not  available  in  Vietnam,  combination  vaccines,  vaccines  against  diseases  that  have  not  been 
implemented in the Expanded Program on Immunization155. 
Furthermore, in October 2023, the government approved the ‘National Strategy for Development of 
Vietnam’s Pharmaceutical Industry to 2030’ with a Vision to 2045 which aims to ensure Vietnamese 
have access to the medicines needed at reasonable prices, to improve the country’s research capacity 
and to produce original brand-name drugs. With this strategy, the country seeks to become a regional 
centre  for  manufacturing,  processing,  and  the  development  of  brand-name  drugs.  One  of  the  set 
objectives is to manufacture 80 percent of the drugs consumed domestically in Vietnam, and for those 
drugs to account for 70 percent of the market value of all drugs sold in Vietnam156. 

155 To prioritize research and production of vaccines for emerging and infectious diseases in Vietnam, Law Net, October 2022 
156 The Future of Vietnam’s Pharmaceutical Industry, Vietnam Briefing, November 2023 

299 

 
 
 
 
 
 
 
 
In terms of procurement, the Vietnamese Ministry of Health do not ensure the procurement of MCMs 
as this activity is centralised under the National Centralized Drug Procurement Centre. 
However, the Ministry defines guidelines and policies for procurement. It recently announced its strategy 
"Solutions to Overcoming Shortage of Medicines and Medical Supplies," implemented in response to 
significant shortages encountered since 2020 due to the COVID-19 crisis. According to the Ministry of 
Health, these shortages could be attributed in part to complex and lengthy bidding processes. A new 
legislation  published  in  2022  by  the  Ministry  aimed  to  address  these  shortages  by  simplifying  and 
expediting the bidding process157-158. 

Finally, the Vietnamese Ministry of Health promotes the reinforcement of the global health emergency 
preparedness and response architecture. During the 77th World Health Assembly, which took place in 
Geneva from May 28 to June 1, 2024, the Minister of Health of Vietnam reiterated and emphasized the 
need for cooperation to best respond to and minimize global health security threats. Additionally, there 
was an emphasis on responding quickly and effectively to all possible health risks159. 

The National Institute of Hygiene and Epidemiology  
The National Institute of Hygiene and Epidemiology (NIHE) focuses on research and development in 
the fields of epidemiology, microbiology, and immunology, and supports the production of vaccines and 
other biological products. 
It  also  provides  the  Minister  of  Health  technical  advice,  policy,  strategies,  national  guidelines  and 
planning for prevention and control of infectious epidemics nationwide. 

The Pasteur Institute 
Institute Pasteur is a private, non-profit foundation. Its mission is to help prevent and treat diseases, 
mainly those of infectious origin, through research, teaching, and public health initiatives.  

Pasteur  Institutes  in  Vietnam  contribute  to  the  research  and  development  of  MCM,  conducts 
epidemiological  surveillance  of 
training,  and 
collaborates with global entities for joint research and information sharing. It also provides expertise 
and advice during public health emergencies. 

infectious  diseases,  provides  capacity-building 

The National Centralized Drug Procurement Center 
The National Centralized Drug Procurement Centre, under the Ministry of Health, is tasked with 
organizing bidding for procurement of the drugs on the list subject to national centralized procurement 
promulgated by the Health Ministry and organizing price negotiation for the drugs on the list subject to 
price negotiation in accordance with the law. 

157 Vietnam Health Sector Ordered to Solve Drugs, Medical Supplies Shortage, VUFO-NGO Resource Centre, Vietnam, 2022 
158 Removing legal bottlenecks to put an end to shortage of medical supplies, Vietnam Law and Legal Forum, December 2022 
159 Vietnam attends 77th World Health Assembly, Vietnam Plus, June 2024 

300 

 
 
 
 
 
 
 
 
 
3) Europe 

Monitoring, Intelligence Gathering and Analysis 

Entity 

 Ministry of Health and Social Protection 

Instituti i Shëndetit Publik (Institute of Public Health) 

Country 

Albania 

Albania 

Federal Ministry of Health 

Bosnia and Herzegovina 

Agency for Medical Products and Medical Devices 

Bosnia and Herzegovina 

Ministry of Internally Displaced Persons from the Occupied 
Territories, Health, Labour and Social Affairs of Georgia 

National Center for Disease Control and Public Health 

National Institute of Public Health (IKShPK) 

Ministry of Health  

Ministry of Health of the Republic of Moldova 

Institute of Public Health of Montenegro 

Ministry of Health  

Institute for Public Health of the Republic of North Macedonia 
(IPH) 
Ministry of Health (State Sanitary and Health Inspectorate, 
Medicines Bureau) 

The Norwegian Medicines Agency 

Ministry of Health of the Russian Federation 

Ministry of Civil Defense, Emergencies and Elimination of the 
Consequences of Natural Disasters 

The Smorodintsev Research Institute of Influenza 

Rospotrebnadzor - the Russian Federal Service for Surveillance 
on Consumer Rights Protection and Human Wellbeing 

Ministry of Health  

Institute of Public Health of Serbia 

Turkish Ministry of Health 

UK Health Security Agency (UKHSA) 

Centre for Public Health (part of Ministry of Health) 

Georgia 

Georgia 

Kosovo 

Kosovo 

Moldova 

Montenegro 

Montenegro 

North Macedonia 

North Macedonia 

Norway 

Russia 

Russia 

Russia 

Russia 

Serbia 

Serbia 

Türkiye 

UK 

Ukraine 

301 

 
 
 
 
 
 
 
 
 
Advanced Research and Development Capacities  

Entity 

 Ministry of Health and Social Protection 

Instituti i Shëndetit Publik (Institute of Public Health) 

National Center for Disease Control and Public Health 

National Institute of Public Health (IKShPK) 

The Research Council of Norway 

Innovation Norway 

Ministry of Health of the Russian Federation 

The Smorodintsev Research Institute of Influenza 

Turkish Ministry of Health 

UK Health Security Agency (UKHSA) 

ARIA : Advanced Research and Invention Agency 

Ukrainian Academy of Sciences 

Production / Manufacturing Capacities 

Entity 

 Ministry of Health and Social Protection 

Ministry of Internally Displaced Persons from the Occupied 
Territories, Health, Labour and Social Affairs of Georgia 

The Research Council of Norway 

Innovation Norway 

Ministry of Health of the Russian Federation 

Turkish Ministry of Health 

UK Health Security Agency (UKHSA) 

State Service of Ukraine on Medicines and Drugs Control 

Country 

Albania 

Albania 

Georgia 

Kosovo 

Norway 

Norway 

Russia 

Russia 

Türkiye 

UK 

UK 

Ukraine 

Country 

Albania 

Georgia 

Norway 

Norway 

Russia 

Türkiye 

UK 

Ukraine 

302 

 
 
 
 
 
 
Procurement of MCMs  

Entity 

 Ministry of Health and Social Protection 

Ministry of Internally Displaced Persons from the Occupied 
Territories, Health, Labour and Social Affairs of Georgia 

Ministry of Health of the Republic of Moldova 

Institute of Public Health of Montenegro 

Ministry of Health  

Country 

Albania 

Georgia 

Moldova 

Montenegro 

Montenegro 

Ministry of Health (State Sanitary and Health Inspectorate, 
Medicines Bureau) 

North Macedonia 

The Norwegian Medicines Agency 

Ministry of Health of the Russian Federation 

The Ministry of Industry and Trade 

Ministry of Health  

Turkish Ministry of Health 

Turkish Federation of Medical Device Manufacturers and 
Suppliers (TUMDEF) 

the Department of Health and Social Care (DHSC) 

Medical procurement of Ukraine  

Norway 

Russia 

Russia 

Serbia 

Türkiye 

Türkiye 

UK 

Ukraine 

303 

 
 
 
 
 
Stockpiling and Distribution Capacities 

Entity 

 Ministry of Health and Social Protection 

Ministry of Internally Displaced Persons from the Occupied 
Territories, Health, Labour and Social Affairs of Georgia 

Ministry of Health of the Republic of Moldova 

General Inspectorate for Emergency Situations (IGSU) 

Country 

Albania 

Georgia 

Moldova 

Moldova 

Ministry of Health  

Montenegro 

The Norwegian Medicines Agency 

Ministry of Health of the Russian Federation 

The Ministry of Industry and Trade 

Ministry of Health  

Turkish Ministry of Health 

the Department of Health and Social Care (DHSC) 

UK Health Security Agency (UKHSA) 

The State Emergency Service of Ukraine 

Medical procurement of Ukraine  

International Cooperation  

Entity 

 Ministry of Health and Social Protection 

Instituti i Shëndetit Publik (Institute of Public Health) 

Norway 

Russia 

Russia 

Serbia 

Türkiye 

UK 

UK 

Ukraine 

Ukraine 

Country 

Albania 

Albania 

Federal Ministry of Health 

Bosnia and Herzegovina 

Ministry of Internally Displaced Persons from the Occupied 
Territories, Health, Labour and Social Affairs of Georgia 

Georgia 

304 

 
 
 
 
 
National Center for Disease Control and Public Health 

National Institute of Public Health (IKShPK) 

Ministry of Health  

Ministry of Health of the Republic of Moldova 

Ministry of Health  

Institute for Public Health of the Republic of North Macedonia 
(IPH) 

Ministry of Health (State Sanitary and Health Inspectorate, 
Medicines Bureau) 

The Norwegian Directorate of Health 

The Norwegian Medicines Agency 

The Research Council of Norway 

The Smorodintsev Research Institute of Influenza 

Rospotrebnadzor - the Russian Federal Service for Surveillance 
on Consumer Rights Protection and Human Wellbeing 

Ministry of Health  

Institute of Public Health of Serbia 

Turkish Ministry of Health 

UK Health Security Agency (UKHSA) 

ARIA : Advanced Research and Invention Agency 

National Security and Defence Council 

Ukrainian Academy of Sciences 

Medical procurement of Ukraine  

Georgia 

Kosovo 

Kosovo 

Moldova 

Montenegro 

North Macedonia 

North Macedonia 

Norway 

Norway 

Norway 

Russia 

Russia 

Serbia 

Serbia 

Türkiye 

UK 

UK 

Ukraine 

Ukraine 

Ukraine 

305 

 
 
 
 
Health Security Coordination 

Entity 

Ministry of Health and Social Protection 

Instituti i Shëndetit Publik (Institute of Public Health) 

National Emergency Medical Center (QKUM) 

Country 

Albania 

Albania 

Albania 

Federal Ministry of Health 

Bosnia and Herzegovina 

The Federal Civil Protection Headquarters (FŠCZ)  

Bosnia and Herzegovina 

Ministry of Internally Displaced Persons from the Occupied 
Territories, Health, Labour and Social Affairs of Georgia 

National Center for Disease Control and Public Health 

National Institute of Public Health (IKShPK) 

Ministry of Health  

Ministry of Health of the Republic of Moldova 

General Inspectorate for Emergency Situations (IGSU) 

Institute of Public Health of Montenegro 

Ministry of Health  

Institute for Public Health of the Republic of North Macedonia 
(IPH) 

Ministry of Health (State Sanitary and Health Inspectorate, 
Medicines Bureau) 

The Norwegian Directorate of Health 

The Norwegian Medicines Agency 

Ministry of Health of the Russian Federation 

Ministry of Civil Defense, Emergencies and Elimination of the 
Consequences of Natural Disasters 

Ministry of Health  

Institute of Public Health of Serbia 

Turkish Ministry of Health 

the Department of Health and Social Care (DHSC) 

National Security and Defence Council 

Centre for Public Health (part of Ministry of Health) 

Georgia 

Georgia 

Kosovo 

Kosovo 

Moldova 

Moldova 

Montenegro 

Montenegro 

North Macedonia 

North Macedonia 

Norway 

Norway 

Russia 

Russia 

Serbia 

Serbia 

Türkiye 

UK 

Ukraine 

Ukraine 

306 

 
 
 
 
 
a. Albania 

Key contextual elements 

Population: 
2.7 million 

Current health expenditure (% of GDP): 
6% 

Socio-demographic and public health situation 
The demographic profile of Albania has been marked by a historically young population, although it is 
now  facing  the  challenges  of  an  aging  demographic  and  emigration  that  may  affect  its  population 
structure. The healthcare system, which underwent reforms in the post-communist era, is striving to 
meet the health needs of its citizens, with improvements in health indicators such as life expectancy 
and  infant  mortality  rates 160 .  However,  Albania  still  contends  with  issues  common  to  transition 
economies, such as limited healthcare resources, rural-urban health disparities, and the burden of non-
communicable diseases. 

Albania is an EU candidate and, as part of the Western Balkans, it benefits from the New Growth Plan 
the  Western  Balkans,  adopted  by  the  European  Commission.  The  goal  is  to  integrate  the  Western 
Balkan partners more closely with the EU by granting them certain benefits of EU membership ahead 
of  accession.  This  initiative  aims  to  stimulate  economic  growth  and  accelerate  socio-economic 
convergence.  Collaboration  with  these  countries  through  strategic  partnerships  is  also  underway  to 
bolster the security of critical medicine supplies. 

Key information regarding medical countermeasures 
Due to the Covid-19 pandemic, Albania has made significant strides in enhancing its health facilities 
thanks to investments targeted in infrastructure, equipment, and skilled personnel. A UNFPA report161 
shows the steady improvement of many health indicators in recent years, but also the need to grow the 
stockpiles of MCMs. It calls for a government commitment to increased sustainable financing for MCMs 
and hospitals as heavy co-payments undermine protection162.   

160 Albania - Health Indicators, WHO 

161  Demographic and Health Challenges Facing Albania in the 21st Century: In-depth secondary analysis of demographic and health trends and 

challenges     in Albania, Dr Arjan Gjonça, Dr Genc Burazeri, Dr Alban Ylli, 2021 
125  Albania needs to expand population coverage to move towards universal health coverage, WHO 

307 

 
 
 
 
 
 
 
 
Comprehensive mapping of identifies entities 

Ministry of Health and Social Protection 
The Ministry of Health and Social Protection (MHSP) in Albania carries out most of HERA’s main tasks, 
excluding R&D capacities. At the core of the Ministry's approach to preparedness for public health crises 
is the development and maintenance of robust surveillance systems. These systems are designed to 
promptly  identify  potential  health  threats,  whether  they  are  outbreaks  of  infectious  diseases, 
environmental hazards, or bioterrorism events. By monitoring health indicators and patterns across the 
country, the Ministry aims to detect any anomalies early on, enabling swift action to be taken before 
these threats escalate into more widespread crises. 

In addition to surveillance, the Ministry focuses on strengthening Albania's health infrastructure. This 
involves  ensuring  that  hospitals  and  health  facilities  are  equipped  to  handle  a  surge  in  patients, 
developing and stockpiling necessary medical supplies and pharmaceuticals, and maintaining a trained 
workforce ready to mobilize in emergency situations. The Ministry is also responsible for maintaining a 
comprehensive contingency plan that outlines clear roles and procedures during a crisis. 

Regarding response, the Ministry of Health and Social Protection is committed to deploying rapid and 
coordinated actions. In the event of a public health emergency, the Ministry coordinates the efforts of 
various stakeholders, including government agencies, international partners, and the private sector, to 
provide an effective response. 

During a crisis, decisions are taken in consultation with the Central Committee of Experts, which is set 
up in cases of epidemics or national medical emergencies and serves as a consultative body under the 
Ministry of Health. 
MHSP is also responsible for implementing recovery programs post-crisis to restore the health system's 
functioning and address the psychosocial and economic impacts. It evaluates the response to identify 
lessons learned and areas for improvement to strengthen resilience for future events. 

Instituti i Shëndetit Publik (Institute of Public Health) 
The Public Health Institute of Albania operates within the framework of the Ministry of Health and Social 
Protection. At the core of the Institute's mission is the establishment and continuous maintenance of 
public health surveillance systems aimed at monitoring the health status of the general population. 

Beyond  surveillance,  the  Institute  invests  significant  effort  into  planning  and  preparedness.  This 
involves  the  development  of  national  guidelines  and  protocols  for  crisis  management  falls  under  its 
purview. It also includes conducting simulations and drills that test the readiness of the health system 
and its practitioners.  

308 

 
 
 
 
 
 
 
When  a  public  health  emergency  does  occur,  the  Institute  can  mandate  its  research  teams  to 
understand  the  nature  of  the  crisis  and  the  best  methods  for  dealing  with  it.  During  the  Covid-19 
pandemic, it worked closely with MoHSP to coordinate an effective response, deploying specialized 
teams, and advising on the implementation of vaccination campaigns and quarantine protocols. Finally, 
the Committee of Experts, consultative body described above, is composed of experts from the Institute 
of Public Health among others public health entities, giving it a major power to influence and strengthen 
crisis response plans.   

National Emergency Medical Center (QKUM) 
The National  Emergency  Center  of  Albania (Qendra  Kombëtare  Urgjencës  Mjekësore) manages 
emergency calls and dispatches vehicles. It coordinates with hospitals across Albania to ensure efficient 
response to health emergencies. It therefore has an important role in health security coordination as he 
oversees  regional  emergency  centers.  Moreover,  the  Committee  of  Experts,  consultative  body 
described above, is composed of experts from QKUM among others public health entities, giving it a 
major power to influence and strengthen crisis response plans.   
The center also collaborates with international organisations such as the European Centre for Disaster 
Medicine. This alliance aims to strengthen disaster response strategies, focusing on comprehensive 
risk reduction and management in the Balkans and the Mediterranean region. 

309 

 
 
 
b. Bosnia and Herzegovina 

Key contextual elements 

Population: 
3.2 million 

Current health expenditure (% of GDP): 
9% 

Socio-demographic and public health situation 
Bosnia and Herzegovina is now facing the challenges of an aging demographic and emigration that will 
probably  affect  its  population  structure.  Projections  suggests  a  55%  population  decline  by  2070163, 
which questions on the sustainability of the social system. While progress has been made in child health 
and population health care coverage, the country faces a high burden of noncommunicable diseases, 
including stroke, ischemic heart disease, and cancer. Tobacco use is a major public health concern as 
an alarming 25% of all deaths in the country are attributable to cigarettes164. 

Like  Albania,  Bosnia  and  Herzegovina  is  an  EU  candidate  and,  as  part  of  the  Western  Balkans,  it 
benefits for the New Growth Plan the Western Balkans, adopted by the European Commission, which 
includes collaboration to bolster the security of critical medicine supplies. 

Key information regarding medical countermeasures 
Bosnia  and  Herzegovina  has  two  AMR  surveillance  networks  in  place  with  good  geographical  and 
population coverage, and expanded its surveillance networks to cover all hospital types. Besides, partly 
because  access  to  medical  supplies,  protective  equipment  and  digital  infrastructure  to  maintain 
essential services was disrupted, Bosnia and Herzegovina signed the Joint Procurement Agreement in 
2020.  To  improve  pandemic  preparedness  in  the  future,  the  Ministry  of  Civil  Affairs  of  Bosnia  and 
Herzegovina  and  health  authorities  are  committed  to  review  their  emergency  preparedness  and 
response capacities through the Joint External Evaluation of IHR Core Capacities. 

Comprehensive mapping of identifies entities 

Bosnia and Herzegovina has a complicated and decentralized system of governance. It consists of two 
entities, each with a high degree of autonomy: the Federation of Bosnia and Herzegovina (FBiH) and 
the Republika Srpska (RS), as well as the self-governing District of Brčko (DB) under the direct authority 
of  the  state  level  government.  The  FBiH  is  further  divided  into  10  cantons  that  have  their  own 

163 Demographic Development in Bosnia and Herzegovina, Sven Petke, Jan Petzke, Sebastian Kalbe, 2023 
164 The Tobacco Atlas – Country Factsheets, Bosnia and Herzegovina 

310 

 
 
 
 
 
 
 
 
governments  and  administrative  structure.  As  a  result,  the  country  is  governed  by  14  executive 
governments and 14 prime ministers (one at the state level, two at the entity level, 10 at the cantonal 
level  and  one  for  Brčko  District).  Health  system  administration  is  decentralized  and  very  often 
fragmented, with lacking coordination between health care “sub-systems”.  

Federal Ministry of Health 
The Federal Ministry of Health analyses and monitors the health status and needs of the population 
through data gathering, health trends assessments, and identification of health risks. 
The Ministry is also greatly involved in international representation and cooperation. It collaborates with 
organisations  such  as  the WHO, European  Centre  for  Disease  Prevention  and  Control,  and United 
Nations (UN) agencies on various perspectives such as knowledge exchange and capacity building.  

Finally, Ministry of Health is an important actor of coordination. During the Covid-19 crisis, the entity 
was the main advisory body of the government and acted as point of contact for various requests and 
cooperative projects. 

Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina (ALMBIH) 
The Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina (ALMBIH) was 
established by the Act of Medicinal Products and Medical Devices in 2008. Its mission is to protect and 
promote  public  health  by  ensuring  the  supply  of quality,  safe,  and  efficient medicinal  products  and 
medical devices for use in human medicine. 
Regarding  HERA’s  functions,  ALMBIH  is  mainly  responsible  for  ensuring  availability  of  medicinal 
products across Bosnia and Herzegovina. It supports the Federal Ministry of Health in the monitoring 
and intelligence gathering of MCMs. 

Ministry of Civil Affairs 
The Ministry of Civil Affairs of Bosnia and Herzegovina is responsible of the coordination between the 
different levels of government described above (state, entity, cantonal, and municipal authorities) and 
oversees  harmonization  efforts  across  these  levels  in  preparing  for  and  responding  to  public  health 
emergencies.  The  ministry  is  for  instance  in  charge  for  the  creation  of  policies  and  strategies  that 
address public health crises, from gathering arguments of public partners nationwide to ensuring the 
effectiveness of the implementation of the measures.   

The  Ministry  oversees  also  the  allocation  of  resources  necessary  for  an  effective  response,  but  the 
distribution  of  MCMs  is  managed  by  the  government  of  the  Federation  and  further  devolved  to  the 
cantonal health ministries within the Federation. 

The Federal Civil Protection Headquarters (FŠCZ)  
The Federal Civil Protection Headquarters (FŠCZ) studies, analyses, and proposes solutions related to 
the development, construction, and functioning of protection and rescue systems within the territory. 

Additionally, it organizes activities such as vulnerability assessments, development of protection and 
rescue  plans,  and  coordination  during  emergencies.  Even  though  FSCZ  is  not  specialized  in  public 
health  crisis  and  participates  in  a  large  array  of  missions  (ranging  from  fire  rescuing  to  citizen  self-
protection), it played a coordinating role during the Covid-19 outbreak.  Therefore, it participates actively 
in two of the seven HERA’s tasks that are health data analysis and health security coordination. 

311 

 
 
 
c. Georgia 

Key contextual elements 

Population: 
3.7 million 

Current health expenditure (% of GDP): 
7% 

Socio-demographic and public health situation 
As a lower middle-income country, Georgia has undergone significant transformations since regaining 
independence  in  1991.  Despite  facing  challenges  related  to  poverty  and  inequality,  the  country  has 
made considerable progress in healthcare reform, aiming to modernize infrastructures and improve the 
quality and accessibility of medical services165. Yet the nation still contends with prevalent issues such 
as  non-communicable  diseases.  For  instance,  cardiovascular  diseases  remain  a  leading  cause  of 
mortality166, reflecting broader public health concerns that include lifestyle-related risk factors.  

Key information regarding medical countermeasures 
During  the  COVID-19  pandemic,  Georgia  implemented  early  and  stringent  measures,  including 
international  travel  restrictions,  quarantine  protocols,  and  widespread  testing,  which  successfully 
delayed  the  virus's  spread  and  minimized  initial  cases 167 .  Georgia  is  also  very  committed  to 
strengthening its biodefense systems amid concerns about bioterrorism and has implemented rigorous 
training programs for healthcare professionals in this domain168. 

Comprehensive mapping of identifies entities 

Ministry of Internally Displaced Persons from the Occupied Territories, Health, Labour and Social Affairs 
of Georgia 
The  Ministry  of  Internally  Displaced  Persons  from  the  Occupied  Territories  (MoIDPLHSA),  Health, 
Labour and Social Affairs of Georgia is a government body responsible for a broad range of social and 
health policies and services, including the nation's healthcare system and its response to public health 
crises.  

The Ministry plays a pivotal role in coordinating national efforts to prepare for, detect, and respond to 
health emergencies. It assesses the country's needs for MCMs based on potential health threats and 

165 Health Systems in Action – Georgia, European Observatory on Health Systems and Policies, 2021 
166 cardiovascular disease statistics 2021, European Society of Cardiology 
167 Health Systems in Action – Georgia, European Observatory on Health Systems and Policies, 2021 
168  “Establishment  of  a  Western  Asian  Network  for  the  Improvement  of  Biosecurity  in  the  Caucasus  Region”  Program,  in  partnership  with 
Bundeswehr Institute of Microbiology (BwIM) (2017-2019) 

312 

 
 
 
 
 
 
 
 
 
 
manages the tendering process. The Ministry also oversees the development and maintenance of a 
strategic national stockpile of MCMs. 

In times of health crises, like the COVID-19 pandemic, MoIDPLHSA is instrumental in crafting national 
health emergency strategies, fostering prevention and control mechanisms, ensuring healthcare service 
continuity, and guiding the national response. One of its core missions is to scale up the public health 
infrastructure to swiftly address and manage emergent health issues effectively.  

The Ministry actively represents the country internationally and seeks partnerships and guidance from 
global health organisations, such as the World Health Organisation, the European Union, and the United 
States Centers for Disease Control and Prevention to strengthen the health sector's capacity. 

National Centre for Disease Control and Public Health (NCDC) 
The  National  Centre  for  Disease  Control  and  Public  Health  (NCDC)  is  an  operational  governmental 
agency under the Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health, 
and  Social  Affairs.  It  plays  a  crucial  role  in  emergency  preparedness,  conducts  rigorous  disease 
surveillance,  and  coordinates  response  measures.  Critical  functions  of  the  NCDC  include  the 
development of health crisis strategies, maintenance of early warning systems, engagement in public 
health research and innovation, and risk assessment and management. 

Furthermore, the NCDC prioritizes international collaboration with global health entities to bolster their 
emergency  preparedness  and  response  framework.  It  ensures  effective  dissemination  of  health 
information  to  the  public  and  strengthens  capacity  building  through  comprehensive  training  for 
healthcare professionals. 

313 

 
 
 
 
 
 
 
 
 
d. Kosovo 

Key contextual elements 

Population: 
1.8 million 

Current health expenditure (% of GDP): 
3.5%   

Socio-demographic and public health situation 
With a population predominantly composed of young individuals and a high urbanization rate, Kosovo 
faces  ongoing  demographic  shifts  and  socio-economic  disparities.  Despite  progress  in  rebuilding 
infrastructure  and  improving  access  to  healthcare  services  since  the  conflict  in  the  late  1990s,  the 
healthcare system still contends with challenges such as limited resources, unequal access to care, 
and  insufficient  infrastructure  in  rural  areas.  Public  health  concerns  include  high  rates  of  non-
communicable diseases169, inadequate sanitation and hygiene facilities, and disparities in healthcare 
access among marginalized populations. 

Kosovo is an potential EU candidate and, as part of the Western Balkans, it benefits for the New Growth 
Plan  the  Western  Balkans,  adopted  by  the  European  Commission,  which  includes  collaboration  to 
bolster the security of critical medicine supplies. 

Key information regarding medical countermeasures 
The  COVID-19  pandemic  led  to  a  significant  decline  in  basic  immunization  coverage  in  Kosovo, 
dropping from 92 percent in 2020 to 87 percent in 2021170. Moreover, Kosovo still faces challenges in 
effectively utilizing medical countermeasures during emergencies. One major challenge is the limited 
capacity  for  timely  procurement  and  distribution  of  medical  supplies  and  medications,  including 
vaccines, during crises. Additionally, logistical difficulties, inadequate funding, and gaps in healthcare 
infrastructure pose further obstacles to the efficient deployment of medical countermeasures. 

Comprehensive mapping of identifies entities 

Ministry of Health  

169 Management of Non-Communicable Diseases in Kosovo: A Scoping Review, Ilir Hoxha, 2023 
170 USAID, World Immunization Week campaign, 2023 

314 

 
 
 
 
 
 
 
 
 
 
 
 
 
Tasked  with  developing  policies,  guidelines,  and  protocols,  the  Ministry  of  Health  conducts  risk 
assessments,  surveillance,  and  monitoring  to  detect  and  manage  potential  health  threats,  including 
infectious disease outbreaks, natural disasters, and other emergencies. 
During  crises, 
it  coordinates  government  response  efforts,  mobilizes  resources,  conducts 
epidemiological  investigations,  and  disseminates  crucial  information  to  healthcare  professionals  and 
the public. The Ministry of Health also engages in international cooperation through joint initiatives with 
the WHO and the European Union. 

National Institute of Public Health (IKShPK) 
As the leading authority in public health matters, the National Institute of Public Health (IKShPK) plays 
a  crucial  role  in  Kosovo's  preparedness  and  response  efforts  to  public  health  crises.  Its  missions 
encompass a wide range of activities, including disease surveillance, epidemiological monitoring, and 
health promotion initiatives aimed at preventing diseases and promoting healthy lifestyles. During public 
health  crises,  IKShPK  coordinates  with  relevant  stakeholders,  including  governmental  agencies, 
healthcare providers, and international partners, to mobilize resources, conduct risk assessments, and 
implement control measures to mitigate the impact of the crisis. Additionally, IKShPK conducts research, 
provides training, and disseminates information to healthcare professionals and the public to enhance 
overall preparedness and resilience against health emergencies in Kosovo. 

The entity in charge of production, stockpiling, distribution, and procurement of MCMs in Kosovo could 
not be defined with total accuracy. The missions of the Kosovo Medicines Agency are unclear but may 
incorporate these prerogatives regarding medicines. The United States of America and international 
health entities, through various programs, may also play partially this role.  

315 

 
 
 
 
 
 
 
 
e. Moldova 

Key contextual elements 

Population: 
2.6 million 

Current health expenditure (% of GDP): 
6%  

Socio-demographic and public health situation 
Moldova faces challenges such as emigration, aging, and a high prevalence of poverty. A significant 
portion of its population works abroad, leading to a drain on the workforce and impacting the country's 
economy.  The  healthcare  system  in  Moldova  also  faces  hurdles,  including  limited  access  to  quality 
healthcare services, inadequate infrastructure, and insufficient funding. As a result, the population often 
experiences  disparities  in  health  outcomes,  with  prevalent  issues  such  as  cardiovascular  diseases, 
tuberculosis,  and  alcohol-related  illnesses 171 .  Additionally,  Moldova  contends  with  environmental 
factors contributing to health concerns, including pollution and inadequate sanitation infrastructure. 

Key information regarding medical countermeasures 
The  COVID-19  pandemic  has  resulted  with  substantial  excess  mortality  in  Moldova,  exceeding  the 
WHO  European  Region  average.  Antimicrobial  resistance  has  been  recognized  as  a  challenge,  but 
development of a national action plan was delayed by the pandemic172. In 2023, Moldova expressed 
interest  to  join the EU  mechanism  for  Joint  Procurement of  Medical  Countermeasures  and  joined  in 
2024 the EU Civil Protection Mechanism.  

Comprehensive mapping of identifies entities 

Ministry of Health of the Republic of Moldavia   
The Ministry of Health of the Republic of Moldova is tasked with safeguarding public health, ensuring 
access to quality healthcare services, and implementing health policies and programs. 
Its mission encompasses disease prevention, healthcare regulation, health security coordination both 
within Moldova and with international partners. 
The Ministry is in charge of the procurement and stockpiling of a 3-months reserves of medicines and 
medical device through its “Centre for centralised procurement in the health sector”.  

171 Tuberculosis and Cardiovascular Complications: An Overview, Mayowa A Adefuye, 2022 
172 Health Systems in Action – Moldova, European Observatory on Health Systems and Policies, 2021 

316 

 
 
 
 
 
 
 
 
 
 
General Inspectorate for Emergency Situations (IGSU) 
The General Inspectorate for Emergency Situations (IGSU) in Moldova plays a critical role in ensuring 
public health and safety during emergencies. Its core missions include rapid response to accidents, 
disaster management, and saving lives. 
Through cross-border projects, it also enhances Moldova's preparedness to health crisis. IGSU is in the 
scope of HERA’s missions as it helps coordinate logistics, such as distributing medical supplies, PPE, 
and coordinating transportation for healthcare workers. 

317 

 
 
 
 
 
 
 
 
f.  Montenegro 

Key contextual elements 

Population: 
600 k 

Current health expenditure (% of GDP): 
11%  

Socio-demographic and public health situation 
Montenegro  confronts  the  hurdles  of  an  aging  demographic  alongside  healthcare  accessibility  and 
infrastructure issues, especially in its rural areas.  Major health threats include unhealthy diets, tobacco 
and alcohol consumption, and relatively poor air quality, with poverty and unemployment aggravating 
ill health. 
Nonetheless, the country implemented a significant shift in health financing in 2022, transitioning to a 
tax-funded health insurance system covering all residents. Despite this broad coverage, out-of-pocket 
payments  remain  substantial,  comprising  39% 173 of  health  spending  in  2019,  with  nearly  10%  of 
households facing catastrophic health expenditures in 2017174. 

Montenegro is an EU candidate and, as part of the Western Balkans, it benefits for the New Growth 
Plan  the  Western  Balkans,  adopted  by  the  European  Commission,  which  includes  collaboration  to 
bolster the security of critical medicine supplies. 

Key information regarding medical countermeasures 
During Covid-19, Montenegro received great help of international partners to faces the challenges of 
limited  stock  and  the  cost  of  MCMs  financing.  For  example,  countries  such  as  the  United  States, 
European Union member states, and COVAX provided doses of COVID-19 vaccines to Montenegro to 
bolster its vaccination efforts. 
Regarding antimicrobial resistance, Montenegro has a well-developed AMR action plan, but rates of 
antimicrobial consumption are high175. 

Comprehensive mapping of identifies entities 

Ministry of Health  
The  Ministry  establishes  and  maintains  robust  surveillance  systems,  mirroring  HERA's  role,  to 
continuously monitor and detect disease outbreaks or other health emergencies. These systems enable 

173 Health Systems in Action – Montenegro, European Observatory on Health Systems and Policies, 2022 
174 WHO data, 2017 
175 Health Systems in Action – Montenegro, European Observatory on Health Systems and Policies, 2022 

318 

 
 
 
 
 
 
 
 
 
 
 
early warning and rapid response, crucial for containing and mitigating the spread of infectious diseases 
or other public health crises. 
Furthermore,  akin  to  HERA's  responsibilities,  the  Ministry  ensures  the  availability  and  adequacy  of 
medical  supplies,  equipment,  and  infrastructure  necessary  for  an  effective  response  to  health 
emergencies. This includes maintaining stockpiles of essential medical resources and coordinating with 
relevant  stakeholders  to  streamline  logistics  and  distribution  processes.  Additionally,  it  collaborates 
closely with other governmental agencies and international partners to foster a unified and coordinated 
response to health emergencies. 

The Institute of Public Health of Montenegro 
Institute of Public Health of Montenegro’s missions include implementation of proactive measures such 
as  epidemiological  surveillance,  risk  assessment,  and  the  establishment  of  robust  communication 
channels with relevant stakeholders. 
Additionally,  the  Institute  is  entrusted  with  coordinating  emergency  response  efforts  and  mobilizing 
resources. It aims to ensure efficient allocation of personnel, medical supplies, financial support, and 
logistical assets to effectively address emerging public health crises. This entails strategic planning to 
ensure the availability and accessibility of essential resources, such as vaccines, medical equipment, 
and trained personnel, in a timely manner to support response efforts. 

319 

 
 
 
 
 
 
 
g. North Macedonia 

Key contextual elements 

Population: 
2 million 

Current health expenditure (% of GDP): 
7%  

Socio-demographic and public health situation 
North  Macedonia  faces  socio-demographic  challenges  such  as  aging  population  and  economic 
disparities,  impacting  access  to  healthcare  and  public  health  outcomes.  North  Macedonia’s  health 
system provides a relatively comprehensive basic benefits package, with about 90% of the population 
being covered under the social health insurance scheme. Public spending on health has declined in 
recent  years  and  is  among  the  lowest  in  South-Eastern  Europe.  There  is  strong  reliance  on  out-of-
pocket payments which represent 42% of total health spending and are among the highest in South-
Eastern Europe176. 

Like Albania and Bosnia and Herzegovina, North Macedonia is an EU candidate and, as part of the 
Western Balkans, it benefits for the New Growth Plan the Western Balkans, adopted by the European 
Commission, which includes collaboration to bolster the security of critical medicine supplies. 

Key information regarding medical countermeasures 
North Macedonia was hit harder by the COVID-19 pandemic than many other countries, particularly 
during the second and third waves. Essential health services were disrupted, but e-health interventions 
were leveraged as part of the emergency response. In 2024, North Macedonia has become the first 
country in the Western Balkans to officially adopt a national action plan for health security (NAPHS)177, 
ensuring that the country’s health system can protect its people from disease threats. 

Comprehensive mapping of identifies entities 

Ministry of Health (State Sanitary and Health Inspectorate, Medicines Bureau) 
The Ministry of Health of North Macedonia plays a pivotal role in coordinating health security within the 
country's  borders.  Through  close  collaboration  with  IPH  and  other  relevant  governmental  agencies, 

176 Health systems in action: North Macedonia, European Observatory on Health Systems and Policies, 2021 
177 North Macedonia: First country in the Western Balkans to adopt a national action plan for health security, WHO, 2024 

320 

 
 
 
 
 
 
 
 
 
 
healthcare institutions, and local authorities, the Ministry orchestrates a unified response framework to 
safeguard public health. 
This  coordination  encompasses  surveillance,  drill  conduction  and  early  warning  systems,  resource 
mobilization, risk assessment, and the implementation of response measures. It also ensures MCMs 
procurement, as vaccine procurement in North Macedonia is coordinated by the MoH, together with the 
national Government. MoH has been granted by the European Union for the delivery of vaccines and 
MCMs within the scope of the EU4Health project. 

Institute for Public Health of the Republic of North Macedonia  
The  Institute  for  Public  Health  of  the  Republic  of  North  Macedonia  (IPH)  employs  a  comprehensive 
strategy for preparedness and response to public health crises. Firstly, in terms of proactive surveillance, 
IPH  utilizes  various  surveillance  systems  to  detect  potential  health  threats  early.  For  instance,  it 
maintains a network of sentinel healthcare facilities that report unusual patterns of diseases, such as 
spikes  in  respiratory  illnesses  or  unusual  clusters  of  symptoms.  Additionally,  IPH  conducts  regular 
monitoring of infectious disease trends through laboratory surveillance, where samples are tested for 
pathogens like influenza or COVID-19. 

Secondly, IPH places great emphasis on data collection and analysis to identify emerging risks and 
vulnerabilities.  For  example,  it  gathers  demographic  and  health-related  data  from  various  sources, 
including  hospitals,  clinics,  and  community  health  centers.  By  analyzing  this  data,  IPH  can  pinpoint 
populations at higher risk of certain diseases or assess the effectiveness of public health interventions. 

Lastly,  IPH  fosters  collaboration  and  coordination  among  stakeholders  at  national  and  international 
levels. It actively participates in inter-agency meetings, task forces, and working groups dedicated to 
public health emergency preparedness and response. For example, IPH collaborates with the Ministry 
of Health and the World Health Organisation (WHO) to develop joint action plans, share resources, and 
coordinate response efforts during cross-border health threats. 

321 

 
 
 
 
 
 
 
 
h. Norway 

Key contextual elements 

Population: 
5.5 million 

Current health expenditure (% of GDP): 
19% 

Socio-demographic and public health situation 
Like other Nordic countries, Norway is an advanced, high income and highly connected country. Three 
quarters of people reported being in good health in 2019, which is a higher proportion than in most EU 
countries. Nevertheless, more than 1/3 of Norwegian adults (37 %) reported having at least one chronic 
condition in 2019178. 

Key information regarding medical countermeasures 
Throughout the pandemic, Norway played a leading role in the international effort to promote equitable 
access  to  Covid-19  vaccines,  medicines,  tests,  and  protective  equipment.  Norway  and  South  Africa 
have co-chaired the Facilitation Council of the Access to Covid-19 Tools Accelerator (ACT-A)179. 
Norway is also a member of the Nordic Pharmaceutical Forum, which aims to ensure ‘timely access to 
the right pharmaceuticals to the right price for patients in the five Nordic countries’180. 

Comprehensive mapping of identifies entities 

The Norwegian Directorate of Health 
The Norwegian Directorate of Health is the technical agency and public authority under the Ministry of 
Health  and  Care  Services  and  reports  to  the  Ministry  of  Health  and  Care  Services.  It  implements 
government policies and has other responsibilities delegated by the ministry, including the authority to 
apply and interpret laws and regulations about public health and the health and care sector. 

In terms of preparedness and response to health crises, the Directorate ensures governance and health 
security coordination with relevant stakeholders. 

The Norwegian Directorate of Health is actively involved in international cooperation to reinforce the 
global architecture in preparedness and response to health crises. In fact, it is a member of the Nordic 

178 Norway – Country Health Profile 2021, OCDE 
179 Norway strengthens global pandemic preparedness efforts, Government of Norway, Press release, September 2022 
180 The Nordic Pharmaceutical Forum official website 

322 

 
 
 
 
 
 
 
 
 
 
 
Pharmaceutical  Forum  and  co-led  the  Johannesburg  agreement  with  South  Africa.  Additionally,  its 
Health Industry roadmap, published in 2022, outlines its objective to negotiate with the EU to achieve 
an  agreement  on  Norwegian  affiliation  to  the  strengthened  European  cooperation  on  health 
preparedness,  including  with  HERA.  Efforts  will  be  made  to  find  a  solution  that  gives  Norway  the 
greatest possible influence through full participation rights. 

The Norwegian Medicines Agency 
As the national regulatory authority for new and existing medicines and the supply chain, the Norwegian 
Medicines Agency (NOMA) assumes overall responsibility for the security of supply and emergency 
preparedness  of  medical  products  (since  January  2024).  This  responsibility  includes  monitoring  the 
supply chains, an enhanced role in product procurement, and management of emergency stockpiles. 

In  preparedness  and  response  to  health  emergencies,  NOMA  oversees  intelligence  gathering  and 
analysis regarding medicines. The entity collaborates closely with the Directorate of Health in health 
security coordination as it aims to ensure the security of supply of medical products. 
Additionally, NOMA plays a significant role in international coordination, maintaining close dialogue with 
international stakeholders such as the EMA and HERA. 

The Research Council of Norway 
Established in 1993, the Research Council is a Norwegian government agency that funds research and 
innovation projects. It is responsible for promoting basic and applied research as well as innovation by 
managing  research  funding  and  advising  the  authorities  on  research  policy.  This  includes  making 
proposals for the research budget in the National Budget. 

The Research Council also plays an important role in enhancing Norway's production capacities. In 
2022/2023, it was tasked with evaluating potential strategies, arrangements, and actions to implement 
the  objectives  outlined  in  the  Government’s  policy  platform,  referred  to  as  ‘the  Hurdal  Platform’,  in 
cooperation with Innovation Norway. This initiative aims to facilitate the production of critically important 
drugs  in  Norway,  including  vaccines,  biopharmaceuticals,  and  pharmaceutical  raw  materials.  The 
assignment  also  involved  assessing  measures  that  could  contribute  to  the  profitable  production  of 
pharmaceuticals in Norway, potentially including the establishment of a central facility. 
The resulting report, submitted in Spring 2023, outlined three potential courses of action: 

- 

- 
- 

establishing a collaborative physical centre for biopharmaceutical production with a strategic 
focus, 
creating a decentralized centre of expertise utilizing a virtual structure, 
launching a national initiative connected to the Nordic region, involving the construction of a 
national  pharmaceutical  production  centre  through  various  subsidiary  initiatives.  This  could 
involve  setting  up  a  decentralized  hub  of  expertise,  followed  by  a  rapid  expansion  where 
multiple projects are connected to the hub, such as a national catalyst centre. 

In addition to its domestic initiatives, the Research Council works to promote international research and 
innovation cooperation. It has several schemes to mobilize Norwegian applicants for the EU Research 
and  Innovation  Program.  Other  tasks  include  creating  meeting  places  for  researchers,  trade  and 
industry representatives, public administration officials, and other users of research. 

Innovation Norway 
Innovation Norway is the Norwegian Government's instrument for innovation and development of 
Norwegian enterprises and industry. It supports companies in developing their competitive advantage 
and to enhance innovation, through grants and loans. 

Innovation Norway also cooperated with The Research Council in 2022/2023 to evaluate potential 
strategies, arrangements, and actions to implement ‘the Hurdal Platform’ which aims to facilitate the 

323 

 
 
 
 
 
 
 
production of critically important drugs in Norway, including vaccines, biopharmaceuticals, and 
pharmaceutical raw materials. 

The Norwegian Institute of Public Health 
The Norwegian Institute of Public Health (NIPH) is a Norwegian government agency under the 
Ministry of Health and Care Services, serving as the national public health institute. It functions as a 
key competence centre in public health for various stakeholders, including governmental authorities, 
health services, and international organisations. 

NIPH's primary activities include health surveillance, research, and prevention. It comprises 
divisions focused on infection control and environmental health, mental and physical health, health 
data and digitalization, and a Knowledge Centre for Public Health. 

The Institute also participates in the UNITED4Surveillance project, an EU4Health Joint Action with 
over 40 partners from across Europe. Coordinated by the Dutch National Institute for Public Health 
and the Environment (RIVM), this project aims to integrate existing and new data sources for more 
comprehensive EU/EEA infectious disease surveillance, prevention and control. 

324 

 
 
 
 
 
i.  Russia 

Key contextual elements 

Population: 
144 million 

Current health expenditure (% of GDP): 
6% 

Socio-demographic and public health situation 
Russia is part of the BRICS countries, with a Gini index of 0.36 in 2020181. 
The  current  state  of  the  national  healthcare  system  raises  justified  concern  as  high  morbidity  and 
mortality of the population of Russia persist182. 
The ongoing conflict between Russia and Ukraine restricts the available information on the impacts on 
public health and capacities related to preparedness and response to health crises. 

Key information regarding medical countermeasures 
During the Covid-19 crisis, innovative drugs have been developed and registered for the treatment of 
COVID-19,  produced  in  full  cycle  by  the  Russian  companies,  such  as  antiviral  drugs.  Russia  also 
developed and produced Sputnik V, an adenovirus viral vector vaccine for COVID-19 developed by the 
Gamaleya Research Institute of Epidemiology and Microbiology in Russia183. 

Comprehensive mapping of identifies entities 

The Ministry of Health 
The Russian Ministry of Health is Responsible for: 

- 

- 
- 

drafting  and  implementing  government  policy  and  legal  regulation  in  healthcare,  mandatory 
health insurance, 
production and distribution of pharmaceuticals and medical products, 
pharmaceuticals activities such as ensuring the quality, efficacy and safety of pharmaceuticals 
for medical use, 

-  medical-biological  assessment  of  the  health  hazards  associated  with  hazardous  physical  or 

chemical factors, 

-  management of state property and provision of state services related to healthcare, such as 

- 

medical services, 
introduction  of  modern  medical  technology,  new  disease  prevention  methods,  diagnostics, 
treatment and rehabilitation methods, forensic tests and psychiatric appraisals. 

181 The World Bank 
182 Modern Development Problems of Russian Healthcare, Stud Russ Econ Dev. 2021; 32(6): 631–639. 
183 The Russian Federation’s response to Covid-19, Ministry of Heatlh, 2020 

325 

 
 
 
 
 
 
 
 
 
According  to  publicly  available  information,  the  Ministry  of  Health  is  responsible  for  intelligence 
gathering and analysis of Medical Countermeasures in the event of a health crisis. It is also in charge 
of managing MCMs: procurement, production, stockpiling, and distribution. 
The Ministry also promotes and encourages advanced R&D. 

The Ministry of Civil Defence, Emergencies and Elimination of the Consequences of Natural Disasters 
According to publicly available information, The Ministry of Civil Defence, Emergencies and Elimination 
of the Consequences of Natural Disasters is responsible for cooperating with the Ministry of Health on 
intelligence gathering and analysis, as well as health security coordination in the event of a health crisis. 

The Ministry of Industry and Trade 
According to publicly available information, the Ministry of Industry and Trade is responsible for: 

- 
- 

- 

- 

drafting and implementing government policy and legal regulation in various sectors, 
providing government services and managing state property in a wide range of industries such 
as pharmaceutical, biotechnological, medical, 
supporting  industrial  exports,  ensuring  market  availability  of  goods  and  services,  organizing 
exhibitions and fairs, conducting investigations prior to the introduction of special protective, 
anti-dumping,  or  compensatory  measures  for  imported  goods,  implementing  non-tariff 
regulation measures, 
serving as the authorized federal executive body for government regulation in foreign trade, 
excluding customs and tariff regulation matters and issues related to the accession of Russia 
to the World Trade Organisation. 

Regarding the management of MCMs, the Ministry of Industry and Trade collaborates with the Ministry 
of Health for the procurement and the distribution. 

The Smorodintsev Research Institute of Influenza 
The Smorodintsev Research Institute of Influenza is a Federal Government Budgetary Institution under 
the Russian Ministry of Health. 
The Institute is mandated to focus on finding solutions to fundamental and applied problems in the fields 
of virology, epidemiology, and infectious disease. 

It  conducts  health  threats  analysis  and  evaluates  the  potential  consequences  and  impact  on  public 
health. 
It also promotes and coordinates R&D on medical countermeasures, including the development of viral 
infection diagnostic reagents, development of approaches to the creation of new generation influenza 
vaccines, search for new antiviral drugs… 
The  Institute  also  works  on  the  development  of  biological  repository  systems  to  reinforce  the 
preparedness and response capacities. 
The Smorodintsev Research Institute of Influenza is involved in international scientific and technical 
cooperation.  
For instance, the Russian-Chinese Symposium on Infectious Diseases has been held annually for 6 
years. This collaboration consists in discussions and exchanges between researchers of the Institute 
and the China CDC. 
The Institute is also part of the WHO’s Global Influenza Surveillance and Response System (GISRS). 

Rospotrebnadzor - the Russian Federal Service for Surveillance on Consumer Rights Protection and 
Human Wellbeing 
Rospotrebnadzor  is  a  Federal  Agency  dedicated  to  overseeing  and  controlling  the  wellbeing  and 
consumer rights of the citizens of Russia. 

326 

 
 
 
 
 
 
 
 
 
With regards to HERA’s tasks, Rospotrebnadzor supports the Ministry of Health in the monitoring and 
analysis  of  health  threats  as  it  is  responsible  for  carrying  out  the  federal  state  sanitary  and 
epidemiological surveillance. 
Furthermore,  Rospotrebnadzor  is  involved  in  international  cooperation  to  reinforce  the  global  health 
emergency preparedness and response architecture. The entity develops cooperation agreements and 
supports other nations in responding to infectious diseases on bilateral basis. In this context priority is 
given to the CIS184 region where a variety of programs on the fight against measles, poliomyelitis, and 
HIV/AIDS are carried out. 
Administrative  agreements  of  cooperation  have  been  signed  between  Rospotrebnadzor  and  the 
Ministries of Health of Armenia, Azerbaijan, Belarus, Kyrgyzstan, Tajikistan, Uzbekistan, Vietnam, and 
Mongolia. 
In addition, China CDC and Rospotrebnadzor collaborate on infectious disease control and prevention, 
emergency preparedness and response, joint research on laboratory techniques, etc. under the MOU 
signed in 2020. 

184 Commonwealth of Independent States 

327 

 
 
 
 
 
 
 
j.  Serbia 

Key contextual elements 

Population: 
6.7 million 

Current health expenditure (% of GDP): 
8% 

Socio-demographic and public health situation 
Serbia contends with an aging population185 and regional disparities particularly in rural areas where 
healthcare  services  are  often  inadequate.  Circulatory  diseases  and  cancers  are  the  most  important 
causes of adult mortality and morbidity, and uncontrolled hypertension is by far the leading risk factor 
affecting population health186. Besides, if life expectancy has increased within the last years, it remains 
below  the  average  of  the  WHO  European  Region 187.  However,  the  country  has  made  significant 
progress in coverage and infrastructure: Public spending on health as a share of GDP is above the 
average  for  South-Eastern  European  countries  and  the  benefits  package  covers  a  wide  scope  of 
services and 98% of the population. 

Serbia is an EU candidate and, as part of the Western Balkans, it benefits for the New Growth Plan the 
Western Balkans, adopted by the European Commission, which includes collaboration to bolster the 
security of critical medicine supplies. 

Key information regarding medical countermeasures 
Serbia has made progress towards combating antimicrobial resistance (AMR) by taking a One Health 
approach, and the sale of antibiotics in community pharmacies is now closely regulated. 
In terms of medical countermeasures during health crises, Serbia faced shortages during the COVID-
19 pandemic, but promptly secured various equipment and medicines through proactive procurement 
strategies.  Concerning  the  vaccines,  Serbia  ensured  a  diverse  portfolio  including  Pfizer-BioNTech, 
Sinopharm, and Sputnik V. 

Comprehensive mapping of identifies entities 

Ministry of Health 

185 Serbia: Age structure from 2021 to 2022, Statista  
186 Health systems in action: North Macedonia, European Observatory on Health Systems and Policies, 2022 
187 European Health for All database, WHO Regional Office for Europe, 2022 

328 

 
 
 
 
 
 
 
 
 
 
Serbia’s  Ministry  of  Health  missions  encompass  comprehensive  preparation  and  swift  response  to 
emergent health threats. This entails continual surveillance and assessment of potential risks, ensuring 
robust  healthcare  infrastructure  and  supply  chains,  and  implementing  effective  communication 
strategies  to  disseminate  accurate  information  to  the  public.  Additionally,  the  ministry  coordinates 
closely  with  national  and  international  health  agencies,  facilitates  collaboration  among  healthcare 
providers,  and  conducts  research  to  inform  evidence-based  strategies.  Furthermore,  the  Ministry  of 
Health  of  Serbia  is  in  charge  of  MCMs  procurement  and  mobilizes  resources  to  ensure  rapid 
deployment of medical personnel and supplies in affected areas, fostering a proactive approach to crisis 
management. 

Institute of Public Health 
The  Institute  of  Public  Health  of  Serbia  is  committed  to  safeguarding  the  nation's  well-being  by 
proactively  addressing  public  health  crises.  Central  to  its  mission  is  the  development  and 
implementation of robust preparedness and response strategies tailored to various emergent situations. 
This entails the continuous monitoring of health indicators, rapid identification of potential threats, and 
the dissemination of accurate information to both the public and relevant stakeholders. Furthermore, 
the institute plays a pivotal role in coordinating collaborative efforts among healthcare professionals, 
governmental  agencies,  and  international  partners  like  the  European Centre  for Disease  Prevention 
and Control. 

329 

 
 
 
 
 
 
 
 
k. Türkiye 

Key contextual elements 

Population: 
85 million 

Current health expenditure (% of GDP): 
4% 

Socio-demographic and public health situation 
Türkiye is an upper-middle-income and emerging country. 
Due to its geological position and geomorphological structure, Türkiye is very prone to experiencing 
natural disasters such as earthquakes, wildfires, landslides, and floods which can represent significant 
health threats. Moreover, the country is exposed to health risks arising from climate change including 
waterborne, vector-borne and foodborne diseases; respiratory diseases caused by air pollution; and 
heat stress188. 

Key information regarding medical countermeasures 
Türkiye has an important pharmaceutical production capacity with medicinal production facilities and 
raw material manufacturing plants189. 
In  terms of  medical  countermeasures during  health  crises,  Türkiye  has  faced  shortages  of  personal 
protective equipment (PPE) during the COVID-19 crisis. More recently, due to the severe depreciation 
of  the  Turkish  lira,  some  international  pharmaceutical  companies  have  withdrawn  certain  medicines 
from the Turkish market, potentially leading to significant shortages190 191. 

Comprehensive mapping of identifies entities 

The Ministry of Health 
The Ministry of Health’s mission is to safeguard human and community health at the highest standards, 
and delivering timely, relevant, and effective solutions to health issues through superior care. 
Aligned with this mission, regarding preparedness and response to health crises, the Ministry of Health 
conducts health threats analysis and ensures health security coordination with relevant stakeholders. 
In  its  strategy,  it  seeks  the  promotion  of  R&D  and  innovation  in  the  health  sector,  as  well  as  the 

188 TÜRKIYE – Health and Climate change, Country Profile, 2022, WHO 
189 Early Results of Transformation of Pharmaceutical Industry in Turkey: Scope of Localization, GMJ 2022; 33: 325-328 Vural et al. 
190 Novartis withdraws medicines in Turkey in response to unfavourable exchange rate, BNE, Jan. 2024 
191 Three international pharmaceutical companies withdraw medicines from Turkish market over lira depreciation, duvaR. English, Jan. 2024 

330 

 
 
 
 
 
 
 
 
 
enhancement of domestic production within health industries. The Ministry of Health also oversees the 
procurement of medical devices and supplies, participating in long-term and centralized procurement 
schemes. Additionally, it plays a crucial role in ensuring that the stock level of medical supplies is kept 
at an optimal level and creates emergency supply plans taking into consideration natural disasters and 
emergencies. 
Finally,  in  its  strategic  vision,  the  ministry  emphasizes  international  cooperation,  aiming  to  leverage 
participation in international networks to increase support for clinical trials, such as those funded by the 
EU and NIH, and enhance Türkiye's global visibility in the healthcare arena. 

Turkish Federation of Medical Device Manufacturers and Suppliers (TUMDEF) 
The mission of the Federation is to develop professional unity, assistance, social solidarity, harmony 
and discipline among the existing 'Medical Device Manufacturer, Importer and Supplier Associations' in 
Türkiye and their members. 
The  Turkish  Federation  of  Medical  Device  Manufacturers  and  Suppliers  (TUMDEF)  is  a  non-
governmental organisation operating within the medical device industry in Türkiye. Its mission revolves 
around developing professional unity, assistance, social solidarity, harmony and discipline among the 
existing  'Medical  Device  Manufacturer,  Importer  and  Supplier  Associations'  in  Türkiye  and  their 
members.  

TUMDEF plays a pivotal role in facilitating communication and collaboration between the government 
and the private sector. Through close liaison with both sectors, TUMDEF ensures effective procurement 
processes, thereby contributing to the nation's healthcare preparedness and response capabilities. 

331 

 
 
 
 
 
 
 
l.  Ukraine 

Key contextual elements 

Population: 
36 million 

Current health expenditure (% of GDP): 
7% (2020)  

Socio-demographic and public health situation 
In the intricate socio-demographic landscape of Ukraine, characterized by urbanization, low fertility rate, 
an aging population, and significant emigration, the ongoing conflict in the east adds further strain to 
public health systems192. Historical legacies intertwine with geopolitical tensions, contributing to high 
rates of infectious diseases and mental health disorders193. Despite ongoing healthcare reforms, issues 
of  underfunding  and  inefficiencies  persist,  requiring  comprehensive  approaches  and  international 
collaboration to address pressing public health imperatives and provide essential humanitarian aid in 
conflict-affected areas. 

The  ongoing  conflict  between  Russia  and  Ukraine  results  in  disrupted  access  to  healthcare  and 
availability of drugs is particularly limited in some regions. 

Key information regarding medical countermeasures 
During the COVID-19 pandemic, the country conducted nationwide vaccination drives and established 
temporary  field  hospitals  to  accommodate  surges  in  patient  number.  However,  Ukraine  has  faced 
shortages  of  medical  countermeasures  including  medications,  and  personal  protective  equipment 
(PPE), during the COVID-19 pandemic. Challenges such as ensuring equitable access to healthcare 
resources across regions and addressing healthcare disparities persist. 

Comprehensive mapping of identifies entities 

The State Emergency Service of Ukraine  
The State Emergency Service of Ukraine (SESU), operating under the Ministry of Internal Affairs, is 
responsible  for  managing  emergencies  and  disaster  response  nationwide.  With  regional  branches 
across  the  country,  SESU  personnel  are  trained  in  various  fields,  including  search  and  rescue  and 
disaster  management.  Specifically,  regarding  public  health  crises,  SESU  collaborates  with  relevant 
agencies and international partners to develop preparedness strategies and response plans. During 
emergencies, SESU coordinates the deployment of resources, establishes temporary medical facilities, 
and  supports  public  health  measures  such  as  vaccination  campaigns  and  quarantine  enforcement. 
Close  collaboration  with  the  Ministry  of  Health  and  other  government  bodies  ensures  a  cohesive 

192 UNFPA – Ukraine data, 2021 
193 Health Situation Update in Ukraine – Report by the Director General, WHO, 2022 

332 

 
 
 
 
 
 
 
 
 
 
response to health emergencies, while engagement with international organisations (such as the United 
Nations Office for the Coordination of Humanitarian Affairs) facilitates access to expertise and resources. 

National Security and Defence Council 
The  National  Security  and  Defense  Council  of  Ukraine  (NSDC),  chaired  by  the  President,  is  a  key 
governmental  body  overseeing  national  security  policies.  While  primarily  focused  on  security  and 
defense, it also plays a crucial role in coordinating responses to public health crises. Responsible for 
policy  formulation  and  coordination,  the  NSDC  collaborates  with  relevant  government  agencies  and 
international  partners  to  enhance  Ukraine's  preparedness  for  health  emergencies.  During  crises,  it 
mobilizes resources, deploys personnel, and coordinates with regional authorities to ensure an effective 
response. Additionally, the NSDC engages in international cooperation with organisations like the World 
Health Organisation (WHO) and bilateral partners to share expertise and resources, safeguarding the 
health and safety of Ukraine's population. 

Centre for Public Health (part of Ministry of Health) 
The  Centre  for  Public  Health  (CPH)  operates  as  a  crucial  arm  of  the  Ministry  of  Health  in  Ukraine, 
dedicated to safeguarding public health and ensuring effective responses to health crises. Its missions 
encompass a comprehensive range of activities, with a primary focus on enhancing preparedness and 
response  to  public  health  emergencies.  Tasked  with  developing  strategies  and  protocols,  the  CPH 
conducts risk assessments, surveillance, and monitoring to detect and manage potential health threats, 
including  infectious  disease  outbreaks  and  environmental  hazards.  During  crises,  it  coordinates 
government  response  efforts,  mobilizes  resources,  conducts  epidemiological  investigations,  and 
disseminates  vital  information  to  healthcare  professionals  and  the  public.  Additionally,  the  CPH 
engages  in  health  promotion  and  education  initiatives  to  prevent  diseases  and  promote  healthy 
behaviours, contributing to overall public health resilience and preparedness in Ukraine. 

Ukrainian Academy of Sciences 
The Ukrainian Academy of Sciences (UAS) serves as a prestigious institution dedicated to advancing 
scientific  research  and  innovation  across various  disciplines,  including public health.  While  the  UAS 
primarily  focuses  on  scientific  inquiry  and  knowledge  dissemination,  its  role  in  preparedness  and 
response  to  public  health  crises  is  indirect  but  significant.  Through  its  network  of  researchers  and 
experts in fields such as epidemiology, virology, and healthcare systems, the UAS contributes to the 
development of evidence-based strategies and interventions to address public health challenges. Its 
research outputs inform government policies, healthcare practices, and public health initiatives aimed 
at enhancing preparedness and response to crises such as infectious disease outbreaks. Additionally, 
the  UAS  collaborates  with  national  and  international  partners,  including  government  agencies, 
universities, and research institutions, to share expertise, conduct joint studies, and develop innovative 
solutions to mitigate the impact of health emergencies. 

Medical procurement of Ukraine  
As an integral part of the healthcare system, the medical procurement of Ukraine’s status is critical for 
the  timely  procurement  and  distribution  of  pharmaceuticals,  vaccines,  medical  devices,  and  other 
healthcare  necessities.  The  Medical  Procurement  of  Ukraine  coordinates  procurement  processes, 
establishes supply chains, and negotiates contracts with suppliers to ensure the availability of medical 
resources.  During  emergencies  such  as  pandemics  or  natural  disasters,  it  accelerates  procurement 
efforts,  prioritizing  the  acquisition  of  vital  supplies  to  support  healthcare  providers  and  emergency 
responders. Additionally, it collaborates with international organisations, engages in strategic planning, 
and  implements  measures  to  address  potential  shortages  and  ensure  uninterrupted  access  to 
healthcare  resources,  thereby  enhancing  Ukraine's  resilience  and  capacity  to  effectively  respond  to 
public health crises. 

333 

 
 
 
 
 
 
State Service of Ukraine on Medicines and Drugs Control 
The State Service of Ukraine on Medicines and Drugs Control (SSUDC) plays a pivotal role in ensuring 
the  safety,  quality,  and  accessibility  of  pharmaceuticals  and  medical  products  in  Ukraine.  As  the 
regulatory  authority  overseeing  the  pharmaceutical  sector,  SSUDC  is  responsible  for  licensing, 
registration, and monitoring of drugs, medical devices, and other healthcare products. In times of public 
health  crises,  such  as  pandemics  or  epidemics,  SSUDC's  missions  expand  to  include  enhancing 
preparedness  and  response  efforts.  This  involves  expedited  review  and  approval  processes  for 
essential medications and vaccines, ensuring timely access to critical healthcare resources. SSUDC 
also collaborates with national and international partners to monitor supply chains, prevent shortages, 
and combat counterfeit drugs, thereby safeguarding public health during emergencies. 

National Health Service of Ukraine 
The  National  Health  Service  of  Ukraine  (NHSU)  missions  encompass  various  activities  aimed  at 
enhancing readiness, such as developing and implementing emergency response plans, coordinating 
with regional health authorities, and facilitating the allocation of resources to areas most in need during 
crises. Additionally, the NHSU works closely with international partners and organisations to leverage 
expertise, resources, and best practices in public health emergency management.  

334 

 
 
 
m. United Kingdom 

Key contextual elements 

Population: 
67 million 

Current health expenditure (% of GDP): 
10% 

Socio-demographic and public health situation 
The United Kingdom is a highly developed nation, with a Gini coefficient of 0.34. 
Smoking, poor diet, physical inactivity and harmful alcohol use are the leading risk factors of preventable 
ill health and mortality in the UK194. 

Brexit had an impact on public health, including the supply chain, over the past few years. Indicators 
show  that  2022-2023  have  seen  consistently  elevated  medicine  shortages,  worsening  in  2023.  The 
English NHS had to increase medicine prices to address supply problems, costing £220 million more in 
one year than at previous costs. 
These shortages reflect significant global market issues, also impacting EU countries. However, Brexit 
has  exacerbated  difficulties  by  lowering  the  value  of  sterling  and  removing  the  UK  from  EU  supply 
chains195. 

Key information regarding medical countermeasures 
The UK Government has the ability to intervene to enhance manufacturing capacities in the event of a 
health  crisis.  For  instance,  during  the  Covid-19  pandemic,  it  bolstered  its  manufacturing  capabilities 
through a significant agreement with the pharmaceutical and biotech organisation Wockhardt196. 

Furthermore, as part of its objective to enhance advanced research and development capabilities, the 
UK  government  founded  a  new  research  funding  agency  in  2023:  The  Advanced  Research  and 
Invention Agency, or ARIA. ARIA aims to fund and support "high-risk" R&D projects. 

Comprehensive mapping of identifies entities 

194 Addressing the leading risk factors for ill health: A review of government policies tackling smoking, poor diet, physical inactivity and harmful 
alcohol use in England. The Health Foundation; 2022 
195 The future of health after Brexit, Nuffield Trust, April 2024 
196 Government further boosts UK vaccine manufacturing capacity, Gov.uk press release, Aug. 2020 

335 

 
 
 
 
 
 
 
 
 
 
 
The Department of Health and Social Care 
The Department of Health and Social Care (DHSC), a ministerial department of the Government of the 
United  Kingdom,  leads  the  nation’s  health  and  social  care  to  help  people  live  more  independent, 
healthier lives for longer. 
The DHSC is the lead government department and owner for the National Security Risk Assessment 
(NSRA)  related  to  the  management  of  emerging  infectious  diseases  and  the  preparedness  for, 
response  to,  and  recovery  from  pandemics.  DHSC  works  closely  with  its  executive  agencies,  other 
government  departments  and  the  devolved  nations  to  collectively  prevent,  prepare,  and  respond  to 
pandemics. 

Regarding HERA’s missions, the DHSC ensures the procurement of medical supplies and PPE. 
In  addition,  the  DHSC  collaborates  with  the  UKHSA  to  maintain  a  centralised  stockpile  of  relevant 
clinical and non-clinical products stored on a ‘Just-In-Case’ basis and a contract for the provision of a 
pandemic specific influenza vaccine at the time of a pandemic. These products include PPE, hygiene 
consumables, and therapeutics, such as antivirals and antibiotics. They also have several storage and 
distribution contracts  to  ensure  that  the  right  product  can be  delivered  to  the right  place  in  the  right 
quantity when needed. 
Additionally, in response to Covid-19, the DHSC created in 2020 a stockpile of PPE equivalent to "the 
120-day demand". 

The DHSC is responsible for the health security coordination with the relevant stakeholders. 

In terms of international cooperation, the DHSC is part of the Medical Countermeasure Consortium, a 
four-nation partnership involving the Defence and Health Departments of Australia, Canada, the United 
Kingdom, and the United States. The Consortium seeks to develop medical countermeasures to assist 
with all-hazard preparedness and response for the participant countries. 

UK Health Security Agency (UKSHA) 
The UK Health Security Agency (UKHSA), executive agency sponsored by the DHSC, is responsible 
for  protecting  every  member  of  every  community  from  the  impact  of  infectious  diseases,  chemical, 
biological, radiological and nuclear incidents and other health threats. 
Concerning  pandemics,  UKHSA  oversees  the  management  of  emerging  infectious  diseases, 
implementing  various  pandemic  preparedness  measures,  which  include  but  are  not  limited  to 
surveillance and the provision of medical countermeasures. 

In terms of monitoring, intelligence gathering and analysis, the UKHSA collects information and provides 
evidence-based  analysis  and  advice  on  the  safety  and  effectiveness  of  vaccines,  data  on  disease 
incidence, vaccine coverage, and vaccine safety. 

UKHSA plays a crucial role in enhancing R&D and manufacturing capacities in the UK by promoting 
and coordinating R&D efforts to develop effective, safe, and accessible medical countermeasures. For 
instance,  UKHSA  is  currently  overseeing  research  aimed  at  developing  vaccines  against  deadly 
henipaviruses. 
Regarding the manufacturing capacities, UKHSA seeks to maintain critical national infrastructure and 
specialist capabilities required to respond to emerging and high consequence infectious diseases, such 
as  high  containment  laboratories  and  specialist  diagnostic  equipment.  During  COVID-19  pandemic, 
UKHSA  has  worked  with  Moderna  and  other  stakeholders  to  ensure  early  vaccine  development, 
supporting the G7 mission to get from variant to vaccine in 100 days and greater UK manufacturing 
capacity. 

336 

 
 
 
 
 
 
 
 
 
In  addition,  the  UKSHA  collaborates  with  the  DHSC  to  maintain  a  centralised  stockpile  of  relevant 
clinical and non-clinical products stored on a ‘Just-In-Case’ basis and a contract for the provision of a 
pandemic specific influenza vaccine at the time of a pandemic. These products include PPE, hygiene 
consumables, and therapeutics, such as antivirals and antibiotics. They also have several storage and 
distribution contracts  to  ensure  that  the  right  product  can be  delivered  to  the right  place  in  the  right 
quantity when needed. 

The UKSHA is involved in several initiatives aiming to reinforce the global preparedness and response 
architecture. For instance, UKHSA has worked directly with WHO to support development of the WHO 
Berlin  Hub  and  is  invited  to  join  future  leadership  of  the  new  International  Pathogen  Surveillance 
Network. 
In 2021, the UKSHA signed a MoU with the ECDC aimed to strengthen the collaboration between the 
two agencies on matters of communicable diseases prevention and control. 

ARIA: Advanced Research and Invention Agency 
Created in 2022, ARIA is a non-departmental public body, sponsored by the department for Science, 
Innovation & Technology. It is mandated to:  

-  Conduct scientific research, 
-  Develop and exploit scientific knowledge, 
-  Collect, share, publish and advance scientific knowledge. 

ARIA  plays  a  pivotal  role  in  enhancing  advanced  R&D  capacities  in  the  UK.  Indeed,  the  Agency 
encourages, facilitates and provides advice regarding R&D and provides financial support by way of 
grants, loans, investments in companies or other entities, or in any other form (including prizes). It also 
aims to make available rights or other property (including by way of loan, licence or gift or other transfer). 
ARIA gives particular weight to the potential for significant benefits to be achieved or facilitated through 
scientific research, or the development and exploitation of scientific knowledge, that carries a high risk 
of failure. 

337 

 
 
 
 
 
 
4) North America 

Monitoring, Intelligence Gathering and Analysis 

Entity 

Health Canada 

The Public Health Agency of Canada (PHAC) 

The Ministry of Public Health 

Secretariat of Health (SSA) 

The Administration for Strategic Preparedness and Response 
(ASPR) 

Biomedical Advanced Research and Development Authority 
(BARDA) 

Centers for Disease Control and Prevention 

Advanced Research and Development Capacities  

Entity 

National Research Council Canada (NRC) 

The Ministry of Public Health 

BioCubaFarma 

The National Institute of Public Health 

The Administration for Strategic Preparedness and Response 
(ASPR) 

Biomedical Advanced Research and Development Authority 
(BARDA) 

National Institutes of Health (NIH) 

Production / Manufacturing Capacities 

Entity 

Health Canada 

The Ministry of Public Health 

BioCubaFarma 

Biomedical Advanced Research and Development Authority 
(BARDA) 

Country 

Canada 

Canada 

Cuba 

Mexico 

USA 

USA 

USA 

Country 

Canada 

Cuba 

Cuba 

Mexico 

USA 

USA 

USA 

Country 

Canada 

Cuba 

Cuba 

USA 

338 

 
 
 
 
 
 
 
 
 
Procurement of MCMs  

Entity 

Public Services and Procurement Canada (PSPC) 

The Ministry of Public Health 

MediCuba 

Secretariat of Health (SSA) 

The Administration for Strategic Preparedness and Response 
(ASPR) 

Biomedical Advanced Research and Development Authority 
(BARDA) 

Stockpiling and Distribution Capacities 

Entity 

The Public Health Agency of Canada (PHAC) 

The Ministry of Public Health 

EMCOMED 

Secretariat of Health (SSA) 

The Administration for Strategic Preparedness and Response 
(ASPR) 

Biomedical Advanced Research and Development Authority 
(BARDA) 

International Cooperation  

Entity 

Health Canada 

The Public Health Agency of Canada (PHAC) 

National Research Council Canada (NRC) 

The Ministry of Public Health 

BioCubaFarma 

Secretariat of Health (SSA) 

Country 

Canada 

Cuba 

Cuba 

Mexico 

USA 

USA 

Country 

Canada 

Cuba 

Cuba 

Mexico 

USA 

USA 

Country 

Canada 

Canada 

Canada 

Cuba 

Cuba 

Mexico 

339 

 
 
 
 
 
 
 
 
 
The Administration for Strategic Preparedness and Response 
(ASPR) 

Biomedical Advanced Research and Development Authority 
(BARDA) 

Centers for Disease Control and Prevention 

Health Security Coordination 

Entity 

Health Canada 

The Public Health Agency of Canada (PHAC) 

Public Safety Canada 

The Ministry of Public Health 

Secretariat of Health (SSA) 

The Administration for Strategic Preparedness and Response 
(ASPR) 

Biomedical Advanced Research and Development Authority 
(BARDA) 

Centers for Disease Control and Prevention 

USA 

USA 

USA 

Country 

Canada 

Canada 

Canada 

Cuba 

Mexico 

USA 

USA 

USA 

340 

 
 
 
 
 
 
 
a. Canada 

Key contextual elements 

Population: 
39 million 

Current health expenditure (% of GDP): 
11% 

Socio-demographic and public health situation 
Canada is a highly developed nation with one of the largest economies in the world. 
Regarding public health, some of the major challenges in public health include combating the opioid 
crisis and substance abuse, addressing mental health concerns, and reducing the burden of chronic 
diseases such as diabetes and heart disease. Canada also faces significant health disparities between 
indigenous and nonindigenous Canadians197. 

Canada is also subject to natural hazards which can cause health emergencies such as hurricanes, 
extreme cold, wildfires…198 

Key information regarding medical countermeasures 
Canada possesses robust R&I capabilities in the development of medical countermeasures (MCMs), 
with  a  strong  emphasis  on  vaccine  development,  therapeutics,  and  diagnostic  tools,  as  well  as 
significant production capacities.  
However, ensuring access to critical vaccines, therapeutics and other life-saving medicines remains a 
priority for the Government of Canada. It has already invested over $1.2 billion to re-build Canada's 
vaccine, therapeutics and biomanufacturing capacity and it is also implementing its biomanufacturing 
and life sciences strategy. 
This Strategy consists of 5 pillars to strengthen Canada's biomanufacturing and life sciences sector and 
is driven by 2 objectives: 

-  Growing a strong, competitive domestic life sciences sector with cutting edge biomanufacturing 

capabilities 

-  Ensuring preparedness for pandemics or other health emergencies199. 

Comprehensive mapping of identifies entities 

197 A vision to transform canada’s public health system, PHAC, 2021 
198 Hazards and Emergencies, Government of Canada 
199 Overview of Canada’s Biomanufacturing and Life Sciences Strategy, Government of Canada, April 2024 

341 

 
 
 
 
 
 
 
 
 
Health Canada 
As  the  federal  department  responsible  for  safeguarding  the  health  of  Canadians,  Health  Canada  is 
dedicated to enhancing the nation's overall health and well-being. This commitment includes ensuring 
Canada's population ranks among the healthiest globally in terms of longevity, lifestyle, and access to 
effective healthcare. 

Regarding medical countermeasures, Health Canada engages in various activities aimed at monitoring 
and analysing medications. This involves closely tracking the distribution and uptake of medications 
across  the  country  and  collaborating  with  stakeholders  to  ensure  the  safety  and  efficacy  of  these 
products. 
Moreover, recognizing the importance of addressing drug shortages and aiming to improve access to 
health products, Health Canada established a Drug Shortages Task Force. This task force is tasked 
with identifying challenges and exploring solutions to enhance the availability and accessibility of drugs 
and other health products for all Canadians. Through consultations involving diverse stakeholders such 
as healthcare providers, patient advocacy groups, retailers, distributors, manufacturers, and indigenous 
communities,  Health  Canada  seeks  to  develop  comprehensive  strategies  to  address  these  issues 
effectively. 
Health  Canada  also  collaborates  with  the  PHAC  in  coordinating  health  security  efforts,  ensuring  a 
coordinated and effective response to health emergencies across the country. 

Lastly, Health Canada cooperates with PAHO and its member states in the objective of reinforcing the 
global health emergency preparedness and response architecture. 
Health  Canada  is  also  part  of  the  Medical  Countermeasure  Consortium,  a  four-nation  partnership 
involving  the  Defence  and  Health  Departments  of  Australia,  Canada,  the  United  Kingdom,  and  the 
United States. 
The Consortium seeks to develop medical countermeasures to assist with all-hazard preparedness and 
response for the participant countries. 

The Public Health Agency of Canada 
The  Public  Health  Agency  of  Canada  (PHAC)  is  the  primary  federal  authority  addressing  pandemic 
influenza preparedness and response, with support from Public Safety (PS) and Health Canada. 
As part of its mandate, PHAC prepares for and responds to public health emergencies, playing a pivotal 
role in intelligence gathering and analysis of health threats nationwide. It is responsible for developing 
timely and credible risk assessments to inform decision-making processes. 

PHAC also manages the National Emergency Strategic Stockpile (NESS), which encompasses a range 
of  essential  items  such  as  PPE,  medical  supplies  (including  ventilators  and  cardiac  monitors), 
pharmaceuticals (vaccines and therapeutics), and social services supplies (such as beds and blankets). 
Furthermore, the NESS includes emergency triage units, equipped with medical resources to adapt to 
various health emergencies and provide primary care to non-critical patients. 
PHAC is responsible for overseeing the whole process of management of the NESS: 

-  Definition of the MCM Requirements, which includes the MCM capability analysis, identification 
of gaps by comparing MCMs needs and the NESS holdings, prioritization of MCM requirements 
in  consultation  with  Subject  Matter  Experts  (Health  Canada,  pharmaceutical  experts,  other 
government departments, international partners such as the MCM Consortium…) 
Identification  of  product  candidates,  through  MCM  market  assessment  by  scanning  drug 
databases, 

- 

-  Acquisition Planning, 
-  Stockpiling, including inventory management and reporting, 
-  Deployment. 

342 

 
 
 
 
 
 
 
PHAC collaborates closely with Health Canada to ensure coordinated health security efforts across the 
country.  In  addition  to  its  domestic  efforts,  it  also  engages  and  coordinates  with  both  domestic  and 
international health partners to enhance preparedness and response capabilities. 

Public Safety Canada 
Public Safety Canada is a governmental agency established in 2003 with the mission to enhance the 
safety and resilience of Canada. In the context of health emergencies, Public Safety Canada plays a 
key role in coordinating the overall government response when the federal government is involved in 
emergency response efforts. 

Public Services and Procurement Canada (PSPC) 
As  a  federal  department  of  the  Government  of  Canada,  Public  Services  and  Procurement  Canada 
(PSPC) holds a significant position in facilitating the daily operations of the government. PSPC provides 
essential support to federal departments and agencies to help them achieve their mandated objectives 
by serving as: 

-  The central purchasing agent, 
-  The manager of real property, 
-  The linguistic authority, 
-  The treasurer, 
-  The accountant, 
-  The administrator for pay and pensions, 
-  The common service provider. 

In terms of preparedness and response to health crises, PSPC, as the central purchasing agent of the 
Federal  Government,  is  responsible  for  procuring  vaccines,  therapeutics,  personal  protective 
equipment (PPE), and medical supplies. 

The National Research Council Canada (NRC) 
The National Research Council Canada is a Government of Canada organisation with the main mission 
of making an impact by advancing knowledge, applying cutting-edge technologies, and collaborating 
with innovators to find creative, relevant, and sustainable solutions to Canada's economic, social, and 
environmental challenges. 

In  the  field  of  health  preparedness  and  response,  the  NRC  focuses  on  supporting  the  Canadian 
ecosystem  in  developing,  translating,  and  implementing  medical  device  innovations.  Leveraging 
scientific  fundamentals  and  expertise  in  biomedical  engineering,  it  seeks  to  maintain  a  deep 
understanding of the research path from conception to market, facilitated by an extensive collaborative 
network of industry, clinicians, academics, and government partners. 

About the MCMs, during the COVID-19 crisis, the NRC launched the "Pandemic Response Challenge 
Program," aimed at accelerating research and development to address specific gaps and challenges 
identified by Canada's health experts. This initiative brought together teams comprising government 
agencies, universities, and Canadian businesses to accelerate the development of diagnostic tools and 
MCMs, ensuring a rapid frontline response to protect and treat Canadians affected by the pandemic. 

Additionally,  the  NRC  engages  in  international  cooperation  through  collaborations  and  funding 
partnerships with other countries, including Germany, Japan, India, and others. 

343 

 
 
 
 
 
 
 
 
 
 
b. Cuba 

Key contextual elements 

Population: 
11.2 million 

Current health expenditure (% of GDP): 
11% 

Socio-demographic and public health situation 
Cuba is classified as an upper-middle income country by the World Bank, but it has been experiencing 
a severe economic crisis since Covid-19. 
In terms of public health, a few cases of cholera and tuberculosis have been recorded in the last decade, 
and dengue fever, chikungunya and Zika virus are present200. Cuba’s HIV prevalence is equals to the 
Latin America and Caribbean average, but the country faces condom shortages. 

In terms of health crisis preparedness and response, Cuba spearheaded the response to Covid through 
a national intersectoral government plan, including research in diagnosis and case tracing, and the use 
of  a  universal  protocol  for  prevention  and  treatment 201.  In  addition,  during  this  pandemic,  Cuban 
assistance  has  been  present  in  Europe  and  Mexico,  with  over  a  thousand  healthcare  workers 
contributing  to  the  response  to  the  coronavirus  disease.  This  is  part  of  Cuba's  tradition  that  healthy 
populations form the foundation of the global community, making cooperation in this area crucial for 
order202. 

Key information regarding medical countermeasures 
In response to the embargo imposed on Cuba by the USA, the government has implemented initiatives 
to foster the local production of biomedical products and significant investments have been made by 
the Cuban state into R&D to ensure access to medicines in the event of an outbreak. For example, this 
has included the development of vaccines for dengue fever, meningitis B, hepatitis B… 

Today, the Cuban biotechnology industry is driven by the state entity BioCubaFarma, which is a major 
player in the R&D and production of MCMs. This was particularly the case for the COVID vaccines203. 
Furthermore, Cuba has fully committed to local vaccine development and self-sufficiency, even opting 
out of the COVAX mechanism by Gavi. The national institutes were responsible for producing 8 out of 
the 10 vaccines in the island's national vaccination program and exporting hundreds of millions of doses 
worldwide204. 

200 Country Profile - Cuba, PAHO  
201 Preparedness,  impacts,  and  responses  of  public  health  emergencies  towards  health  security:  qualitative  synthesis  of  evidence,  Arch  Public 
Health, November 2023 
202 Development, distribution, and supply chain of COVID-19 vaccines in Chile, Cuba, and Mexico, UN, 2022 
203 Cuba y seguridad sanitaria mundial: Cuba’s role in global health security, BMJ Global Health, 2020 
204 Development, distribution, and supply chain of COVID-19 vaccines in Chile, Cuba, and Mexico, UN, 2022 

344 

 
 
 
 
 
 
 
 
Comprehensive mapping of identifies entities 

The Ministry of Public Health (MINSAP) 
Central  State  Administration,  the  Ministry  of  Public  Health  is  responsible  for  proposing,  and  once 
approved, overseeing, and controlling the implementation of State and Government policy regarding 
Public Health and the development of Medical Sciences careers. 

The  MINSAP  is  a  central  body  for  health  crisis  preparedness  and  response  in  Cuba.  The  Ministry 
ensures the analysis of health threats and evaluate the potential consequences and impact on public 
health. It is also responsible for intelligence gathering regarding MCMs and produces a 'basic drug list' 
each year, classifying the drugs as essential, non-essential, or special. This list serves as the basis for 
public policy on drugs (procurement, production, etc.) in the following year. 
The MINSAP also ensures health security coordination in the event of a health crisis, in collaboration 
with relevant stakeholders. It establishes protocols and guidelines. For instance, it formalized disease-
specific plans in 2005 and 2009 for Influenza A, as well as a comprehensive COVID-19 plan involving 
measures such as three-layer screening for travellers, mandatory quarantine/isolation for possible or 
confirmed cases, scaling up of testing and treatment facilities, among others. 

In Cuba in 2018, approximately 26% of all Cuban scientific institutions are dedicated to health-related 
research, development, and innovation. The MINSAP sets the sector’s R&D priorities in accordance 
with the country’s economic and social policy guidelines and promotes these research activities205. 

In Cuba, the state owns the domestic enterprises responsible for manufacturing and distributing MCMs. 
The MINSAP is tasked with defining the policies and guidelines for procurement. It also oversees the 
procurement ensured by MEDICUBA. 
For  distribution  of  drugs  and  pharmaceuticals,  the  Ministry  collaborates  with  EMCOMED  and  the 
BioCubaFarma. More broadly, the Ministry sets the strategy and guidelines for the distribution of all 
MCMs in the event of a health crisis. 
However, Cuba's system for responding to public health emergencies does not include a stockpile of 
Medical Countermeasures for national use during such events. 

The MINSAP also plays a role in setting priorities for the local production of medicines and other medical 
supplies in Cuba. In fact, the MINSAP cooperates with BioCubaFarma on this point. Both entities are 
responsible for preparing an annual plan for domestically manufactured and imported drugs, utilizing 

205 Science and technological innovation in health in Cuba: results in selected problems, Pan American Journal of Public Health, 2018 

345 

 
 
 
 
 
 
 
 
 
analyses at the provincial level that consider demand and follow epidemiological data in the event of 
health crises206. 
Furthermore,  during  health  crises,  the  MINSAP  has  the  capability  to  facilitate  the  redirection  of 
companies towards local manufacturing of MCMs. For instance, amidst the Covid-19 pandemic, certain 
companies were mobilized to produce masks. 

Lastly,  the  MINSAP  is  also  involved  in  international  cooperation  to  strengthen  the  global  health 
emergency preparedness and response architecture. It has notably established bilateral cooperation 
agreements regarding the research and development of MCMs with Portugal207. 

MediCuba 
MEDICUBA  ensures  the  central  procurement  of  MCMs,  drugs,  reagents  and  disposable  materials, 
servicing the national health system. 

BioCubaFarma 
BioCubaFarma  is  a  Cuban  state-run  biotechnology  organisation  mandated  to  research,  develop, 
manufacture,  and  commercialize  biopharmaceuticals  for  the  prevention,  diagnosis,  and  treatment  of 
infectious diseases, cardiovascular diseases, neurodegenerative diseases, autoimmune diseases, and 
cancer,  as  well  as  medical  equipment,  medical  devices,  and  other  products  for  the  Cuban  National 
Healthcare System. 

One of BioCubaFarma's primary tasks is to promote and coordinate the research and development of 
MCMs to enhance the preparedness and response capacities. 
In  addition,  BioCubaFarma  promotes  and  encourages  local  manufacturing  of  MCMs.  To  boost  the 
capacities,  it  collaborates  with  the  MINSAP  to  set  priorities  in  local  drug  manufacturing  through  an 
annual plan for domestically manufactured and imported drugs208. 

BioCubaFarma collaborates with international stakeholders, particularly in a commercial capacity, to 
facilitate access to markets for its products, such as in Türkiye and Mexico. 

EMCOMED 
EMCOMED, the Drug Marketing and Distribution Company, is responsible for setting the retail price of 
drugs and cooperates with the MINSAP and BioCubaFarma for the distribution of drugs, reagents and 
raw materials. 

206 Cuban experience with local production of medicines, technology transfer and improving access to health, WHO, 2015 
207 Cuba: Expansion of International Cooperation in the Biopharmaceutical Sector, German Office for the Promotion of Trade and Investment in 
Cuba, February 2023 
208 Cuban experience with local production of medicines, technology transfer and improving access to health, WHO, 2015 

346 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
c. Mexico 

Key contextual elements 

Population: 
128 million 

Current health expenditure (% of GDP): 
5% 

Socio-demographic and public health situation 
Developing country with the second-largest economy in Latin America, Mexico has underperformed in 
terms  of  growth,  inclusion,  and  poverty  reduction  compared  to  similar  countries  over  the  last  three 
decades209.  
The major health concern in Mexico is Obesity. In Mexico, 32.4% of the population is obese, making it 
the country with the 2nd highest prevalence of obesity, behind the US210. 
Regarding  infectious  diseases,  measles  and  mumps  outbreaks  in  Mexico  have  coincided  with 
worldwide and regional outbreaks. Hepatitis A is also endemic to Mexico211. 
Additionally, due to its geographical situation, Mexico is exposed to natural hazards such as floods, 
earthquakes… which can be important health threats212. 

Key information regarding medical countermeasures 
Mexico is an important pharmaceutical industry, with a solid production network and strong supply 
capabilities. Mexico in the 8th largest exporter of medical devices globally213. 

However, in terms of health crisis preparedness, the Council of the Americas assesses that the Mexican 
healthcare  system  was  inadequately  equipped  and  unprepared  to  handle  the  scale  of  the  Covid-19 
pandemic, resulting in the collapse of the primary care system214. 
Mexico  often  experiences  shortages  of  medicines  and  essential  supplies  in  its  hospitals,  along  with 
challenges in the government procurement process for medications, complicating the management of 
the Covid crisis215. 

Comprehensive mapping of identifies entities 

209 Mexico Overview, The World Bank 
210 Mexico – Public Health summary, Columbia Mailman School of Public Health 
211 Mexico - CDC Yellow Book 2024, US CDC 
212 Natural Hazard Statistics – Mexico, World Bank Group 
213 Ivemsa official website 
214 Rountable: integrating Covid-19 management into the Health Agenda in Mexico, AS/COA, Jan. 2024 
215 Evaluating the Impact of COVID-19 in Mexico, Wilson Center, March 2020 

347 

 
 
 
 
 
 
 
 
 
The Secretariat of Health 
The  Secretariat  of  Health  in  Mexico  serves  as  the  executive  agency  chiefly  tasked  with  disease 
prevention and the advancement of population health. Its mission revolves around establishing state 
policies to enable the population to exercise their right to health protection. 

Additionally,  it  is  responsible  for  monitoring  and  analysing  health  threats  and  coordinating  health 
security coordination. 
The Secretariat also manages the storage, distribution, and administration of the Federal Reserve of 
medicines  and  supplies  and  oversees  procurement  activities.  Furthermore,  the  Secretariat  seeks  to 
collaborate with international partners to further its public health objectives. 

The National Institute of Public Health 
The  National  Institute  of  Public  Health  is  dedicated  to  advancing  social  equity  and  ensuring  the  full 
realization of the right to health protection. It achieves this by generating and disseminating knowledge, 
training high-quality human resources, and fostering innovation through multidisciplinary research to 
inform  evidence-based  public  policies.  Specifically  addressing  HERA’s  tasks  related  to  medical 
countermeasures  (MCMs),  the  institute  actively  promotes  and  supports  advanced  research  and 
development efforts. 

348 

 
 
 
 
 
 
d. United States of America 

Key contextual elements 

Population: 
333 million 

Current health expenditure (% of GDP): 
17% 

Socio-demographic and public health situation 
The USA is a highly developed country, with a Gini index of 0.40216. 
Some  of  the  most  important  health  challenges  in  the  United  States  include  chronic  diseases  (heart 
disease, cancer, diabetes…), and the opioid epidemic, with high rates of opioid addiction, overdose 
deaths, and related social and economic impacts across the country. 
The USA also has a significant level of health inequity, with disparities in health outcomes remaining 
among different racial and ethnic groups, and socioeconomic statuses.217 

Key information regarding medical countermeasures 
During the COVID-19 pandemic, the US demonstrated its robust R&D capabilities in the development 
of  MCMs.  American  researchers,  academic  institutions,  and  pharmaceutical  companies  swiftly 
mobilized to conduct cutting-edge research aimed at developing vaccines, therapeutics, and diagnostic 
tools  to  combat  the  virus.  The  rapid  development  of  multiple  COVID-19 vaccines within  record  time 
exemplified  the  nation's  scientific  prowess  and  collaborative  efforts  between  government  agencies, 
private sector entities, and academia. 
Additionally, the US pharmaceutical industry played a crucial role in scaling up production capacities to 
meet the unprecedented demand for MCMs, ensuring widespread access to vaccines and treatments 
across the country218. 

Comprehensive mapping of identifies entities 

216 World Bank, 2021 
217 Our biggest health challenges, The National Institute of Health, Nov. 2023 
218 National COVID-⁠19 Preparedness Plan, The White House 

349 

 
 
 
 
 
 
 
 
 
 
The Administration for Strategic Preparedness and Response (ASPR) 
ASPR  operates  within  the  US  Department  of  Health  and  Human  Services  and  leads  the  nation's 
preparedness, response, and recovery efforts for medical and public health emergencies. Collaborating 
with various stakeholders, including hospitals, healthcare coalitions, and government agencies, ASPR 
works to enhance readiness and response capabilities nationwide. 

The Public Health Emergency Medical Countermeasure Enterprise (PHEMCE), under the leadership of 
ASPR,  functions  as  an  interdepartmental  governance  body  responsible  for  researching,  developing, 
procuring,  and  stockpiling  MCMs  essential  for  addressing  infrequent  yet  high-consequence  public 
health and medical emergencies. Additionally, PHEMCE plays a crucial role in monitoring, gathering 
intelligence,  and  analysing  data  to  identify  national  health  security  needs,  assess  gaps  in  MCM 
preparedness and response, and address challenges associated with meeting these needs. 

In  terms  of  stockpiling  and  distribution,  ASPR  oversees  the  management  of  the  Strategic  National 
Stockpile, which encompasses the full life cycle of stockpile assets, including acquisition, storage, and 
transportation of supplies. The PHEMCE is dedicated to optimizing the U.S. government’s portfolio of 
medical countermeasures by addressing logistics, deployment, distribution, dispensing, and utilization 
of these measures. 

Regarding health security coordination, ASPR takes the lead in federal efforts to bolster preparedness 
against chemical, biological, radiological, and nuclear threats, as well as emerging infectious diseases, 
focusing  on  MCMs  strategies  through  the  PHEMCE.  This  entails  providing  recommendations  to  the 
Secretary of HHS on various aspects such as research and development, procurement, stockpiling, 
distribution, and utilization of MCMs. Additionally, the PHEMCE identifies national health security needs 
and  develops  strategies  for  logistics,  deployment,  distribution,  and  dispensing  of  countermeasures, 
particularly in relation to the Strategic National Stockpile. 

Lastly,  ASPR  plays  a  significant  role  in  strengthening  the  global  architecture  for  health  emergency 
preparedness and response. For instance, it participates in initiatives such as the Global Health Security 
Agenda, which involves partnerships between U.S. government agencies, international organisations, 
and  stakeholders.  This  program  seeks  to  accelerate  efforts  towards  ensuring  global  safety  from 
infectious  disease  threats  and  elevating  global  health  security  as  a  priority  in  international  security 
agendas, with the goal of preventing, detecting, and responding to public health threats worldwide. 

ASPR is also part of the Medical Countermeasure Consortium, a four-nation partnership involving the 
Defence and Health Departments of Australia, Canada, the United Kingdom, and the United States. 
The Consortium seeks to develop medical countermeasures to assist with all-hazard preparedness and 
response for the participant countries. 

The Biomedical Advanced Research and Development Authority (BARDA) 
BARDA  is  an  office  within  the  U.S.  Department  of  Health  and  Human  Services  (HHS),  which  was 
founded in 2006. It operates under the supervision of  and reports to ASPR. 
The  mission  of  BARDA  is  to  develop  medical  countermeasures  that  address  the  public  health  and 
medical consequences of CBRN accidents, incidents and attacks, pandemic influenza, and emerging 
infectious diseases. 

BARDA plays a pivotal role in monitoring and analysing MCMs, primarily by ensuring effective portfolio 
management. 
In phase of preparedness, BARDA evaluates its capacity to address public health emergencies and 
identifies  opportunities  to  innovate  through  additional  product  development.  During  health  crises, 
BARDA  swiftly  assesses  its  portfolio  to  identify  MCMs  suitable  for  response.  Despite  maintaining  a 
diverse pipeline of products, some threats may not be anticipated beforehand, and not all MCMs can 

350 

 
 
 
 
 
 
 
 
be  readily  deployed.  BARDA's  Incident  Management  Team  (IMT)  has  been  activated  to  support 
response efforts during various public health emergencies, including the H1N1 influenza, Zika virus, 
Ebola virus, and SARS-CoV-2 outbreaks. 
Moreover, BARDA seeks to gather intelligence and understand operational challenges that users may 
face when administering an MCM. BARDA actively collaborates with patients, healthcare providers, and 
professional  societies  to  gain  insights  into  end-user  needs  and  to  devise  solutions  for  operational 
challenges.  For  instance,  BARDA  has  partnered  with  organisations  such  as  the  American  Burn 
Association and American College of Surgeons to develop thermal burn MCMs, and the Radiation Injury 
Treatment Network to create acute radiation syndrome MCMs. 

To bolster R&D capabilities, BARDA pursues two key strategies. Firstly, it develops partnerships with 
the private sector to advance the development of life-saving Medical Countermeasures. BARDA directs 
investments  toward  technologies  with  the  potential  to  accelerate  the  availability  of  MCMs  while 
enhancing their safety and accessibility. Secondly, BARDA is tasked with identifying opportunities for 
product development aimed at filling preparedness gaps, collaborating closely with partner agencies 
within the PHEMCE (ASPR). 

To boost manufacturing capacities, BARDA aims at establishing a resilient, flexible ecosystem capable 
of  managing  surges  in  demand  and  prioritizing  increased  domestic  capacity.  BARDA  fosters 
partnerships to ensure the long-term sustainability of critical manufacturing capabilities, utilizing new 
infrastructure lending authorities as necessary. Through initiatives like the National Biopharmaceutical 
Manufacturing  Partnership  (BioMaP),  BARDA  promotes  not  only  capacity  but  also  manufacturing 
capabilities,  ensuring  facilities  are  adequately  staffed,  trained,  and  actively  producing  high-quality 
products. 

To  facilitate  the  procurement  of  MCMs,  BARDA  develops  partnerships  with  private  stakeholders. 
BARDA also aims to leverage acquisition vehicles that facilitate swift responses. Thus, the agency is 
focused on designing and implementing new acquisition methods that can be promptly employed to 
procure MCMs during public health emergencies. 

Regarding stockpiling  and  distribution, BARDA  oversees  the  management  of the  U.S.  National  Pre-
Pandemic Influenza Vaccine Stockpile (NPIVS) and collaborates with FDA-licensed influenza vaccine 
manufacturers  to  bolster  pandemic  readiness,  maintain  and  enhance  stockpile  management.  The 
agency  also  partners  with  industry  stakeholders  to  guarantee  the  availability  of  drug  substance 
manufacturing,  fill/finish,  distribution,  and  administration  capacities  to  respond  effectively  to  public 
health emergencies. 

Lastly,  regarding  international  cooperation,  BARDA  engages  in  collaborations  with  international 
partners,  including  HERA.  For  instance,  BARDA  assisted  in  devising  an  access  protocol  for  Ebola 
vaccines in West Africa through partnerships with local entities, participates as a member of the Trans-
Atlantic Task Force on Antimicrobial Resistance… 

The Centres for Disease Control and Prevention 
The  Centres  for  Disease  Control  and  Prevention  (CDC)  is  the  national  public  health  agency  of  the 
United States, operating under the US Department of Health and Human Services. The CDC's primary 
focus is on disease control and prevention, with particular attention to infectious diseases, foodborne 
pathogens, environmental health, occupational safety and health, health promotion, injury prevention, 
and educational initiatives aimed at improving the health of US citizens. Additionally, the CDC conducts 
research and disseminates information on non-infectious diseases such as obesity and diabetes, and 
it is a founding member of the International Association of National Public Health Institutes. 

351 

 
 
 
 
 
 
 
 
In relation to HERA's tasks, the CDC is involved in: 

-  Monitoring  and  health  threats  analysis:  the  CDC  monitors  health  threats  and  ensures  the 

disease outbreak surveillance, 

-  Health security coordination: The Division of State and Local Readiness (DSLR) assists state, 
local, and territorial health departments in preparing for, responding to, and recovering from 
emergencies and disasters. DSLR monitors and evaluates public health capabilities, plans, and 
operational  readiness,  providing  funding  and  technical  expertise  to  support  nationwide 
preparedness and response efforts. The CDC has established a framework for preparedness 
and response capabilities, including the dispensing and distribution of MCMs, 
International cooperation: The CDC maintains regional offices worldwide to support its Global 
Health  Strategy,  advancing  programs  and  fostering  collaboration  within  regions  to  build 
capacity across borders. 

- 

The National Institutes of Health (NIH) 
The NIH is the US’s medical research agency, part of the US Department of Health and Human Services. 
Its mission is to pursue fundamental knowledge about living systems' nature and behaviour and apply 
that knowledge to improve health, extend life, and lessen illness and disability. 
The  NIH  supports  various  research  initiatives,  including  those  related  to  medical  countermeasures 
(MCMs), such as the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-
private partnership, which aims to develop a coordinated research strategy to prioritize and expedite 
the development of the most promising treatments and vaccines. 

The Advanced Research Projects Agency for Health (ARPA-H) 
Established in 2022, the ARPA-H is a research funding agency that supports transformative biomedical 
and  health  breakthroughs.  ARPA-H  operates  as  a  lean  organisation:  it  makes  investments  in 
breakthrough technologies and broadly applicable platforms, capabilities, resources, and solutions with 
the potential to transform important areas of medicine and health that cannot readily be accomplished 
through traditional research or commercial activity. 

In a proactive approach, ARPA-H is modelled after DARPA in several respects. ARPA-H does not have 
its  own  laboratories  or  research  facilities.  Its  organisational  structure  is  organized  around  Program 
Managers who design, launch, and run an ever-changing portfolio of programs. to foster a continual 
flow  of  new  ideas,  Program  Managers  have  a  term  limit  of  up  to  six  years,  and  the  programs  they 
develop will not align with their tenure. 

One of the programs is the APECx (Antigens Predicted for Broad Viral Efficacy through Computational 
Experimentation) aims to eliminate viruses as future health threats. To achieve this, APeX intends to 
create  broadly  effective  antigens  that  can  target  entire  viral  families  by  developing  advanced 
computational  toolkits.  This  initiative  will  facilitate  quicker  and  more  efficient  vaccine  development, 
potentially  enabling  vaccines  that  can  combat  multiple  viruses  simultaneously,  thereby  addressing 
chronic illnesses, pandemics, and other viral threats more effectively. 
ARPA-H  also  launched  a  project  to  combat  AMR.  The  Defeating  Antibiotic  Resistance  through 
Transformative Solutions (DARTS) project focuses on developing a set of diagnostic and experimental 
platforms that can reveal insights into how antibiotic resistance starts, search for new antibiotics, and 
rapidly identify the right antibiotic to prescribe for a particular infection in real time. 

As the US research funding agency, ARPA-H prioritizes awards to entities (organisations or individuals) 
that will conduct funded work in the United States. For clinical trials, ARPA-H has a strong preference 
that they be performed within the United States. 
However, ARPA-H recognizes the importance of international cooperation and coordination. Therefore, 
the Agency indicates that trials in other countries will be considered on a case-by-case basis at ARPA-
H's discretion. 

352 

 
 
 
 
 
 
 
5) South America 

Monitoring, Intelligence Gathering and Analysis 

Entity 

The Ministry of Health (Ministerio de Salud de la Nación) 

Ministério da Saúde (MS) (Ministry of Health) 

The Oswaldo Cruz Foundation 

Ministry of Health and Social Protection 

National Food and Drug Surveillance Institute (INVIMA) 

Ministry of Public Health (Ministerio de Salud Publica) 

Ministry of Public Health and Social Welfare 

National Council for Science and Technology - CONACYT 

Ministry of Health (MINSA) 

National Institute of Health 

Advanced Research and Development Capacities  

Entity 

The National Institute of Industrial Technology (INTI - Instituto 
Nacional de Tecnologia Industrial) 

Ministério da Saúde (MS) (Ministry of Health) 

The Oswaldo Cruz Foundation 

National Council for Science and Technology - CONACYT 

National Institute of Health 

Production / Manufacturing Capacities 

Entity 

The National Institute of Industrial Technology (INTI - Instituto 
Nacional de Tecnologia Industrial) 

Ministério da Saúde (MS) (Ministry of Health) 

Country 

Argentina 

Brazil 

Brazil 

Colombia 

Colombia 

Ecuador 

Paraguay 

Paraguay 

Peru 

Peru 

Country 

Argentina 

Brazil 

Brazil 

Paraguay 

Peru 

Country 

Argentina 

Brazil 

353 

 
 
 
 
 
 
 
 
 
The Oswaldo Cruz Foundation 

Ministry of Health and Social Protection 

National Food and Drug Surveillance Institute (INVIMA) 

Ministry of Public Health and Social Welfare 

Ministry of Industry and Commerce 

Procurement of MCMs  

Entity 

The Ministry of Health (Ministerio de Salud de la Nación) 

Ministério da Saúde (MS) (Ministry of Health) 

Colombia Compra Eficiente - National Public Procurement 
Agency 

Ministry of Public Health (Ministerio de Salud Publica) 

Ministry of Public Health and Social Welfare 

Ministry of Health (MINSA) 

Perú Compras 

Stockpiling and Distribution Capacities 

Entity 

The Ministry of Health (Ministerio de Salud de la Nación) 

Ministério da Saúde (MS) (Ministry of Health) 

ANVISA - Brazilian Health Regulatory Agency 

Ministry of Health and Social Protection 

Ministry of Public Health (Ministerio de Salud Publica) 

Ministry of Public Health and Social Welfare 

Ministry of Health (MINSA) 

Brazil 

Colombia 

Colombia 

Paraguay 

Paraguay 

Country 

Argentina 

Brazil 

Colombia 

Ecuador 

Paraguay 

Peru 

Peru 

Country 

Argentina 

Brazil 

Brazil 

Colombia 

Ecuador 

Paraguay 

Peru 

354 

 
 
 
 
 
 
 
 
 
International Cooperation  

Entity 

The Ministry of Health (Ministerio de Salud de la Nación) 

Ministério da Saúde (MS) (Ministry of Health) 

The Oswaldo Cruz Foundation 

Ministry of Health and Social Protection 

Ministry of Public Health (Ministerio de Salud Publica) 

Ministry of Public Health and Social Welfare 

Ministry of Health (MINSA) 

Health Security Coordination 

Entity 

The Ministry of Health (Ministerio de Salud de la Nación) 

Ministério da Saúde (MS) (Ministry of Health) 

ANVISA - Brazilian Health Regulatory Agency 

Ministry of Health and Social Protection 

National Food and Drug Surveillance Institute (INVIMA) 

Ministry of Public Health (Ministerio de Salud Publica) 

Ministry of Public Health and Social Welfare 

Ministry of Health (MINSA) 

Country 

Argentina 

Brazil 

Brazil 

Colombia 

Ecuador 

Paraguay 

Peru 

Country 

Argentina 

Brazil 

Brazil 

Colombia 

Colombia 

Ecuador 

Paraguay 

Peru 

355 

 
 
 
 
 
 
 
 
a. Argentina  

Key contextual elements 

Population: 
46.2 million 

Current health expenditure (% of GDP): 
10% 

Socio-demographic and public health situation 
Developing country, Argentina is one of the largest economies in Latin America. 
Concerning public health, non-communicable diseases (NCDs) constitute the primary causes of both 
death and disability. Specifically, cardiovascular diseases and cancer, together, account for half of all 
fatalities219. Additionally, Argentina, like many other Latin American countries, contends with infectious 
and neglected tropical diseases. 
In the first months of 2024, Brazil, Argentina, and Paraguay have been the worst hit, in what PAHO 
officials have described as potentially the worse outbreak in the Americas to date. These three countries 
have made up 98% of all cases and 87% of deaths from the virus. Argentina, facing one of its largest 
dengue outbreaks, recording over 180,500 cases in the 2023/24 season220.  

Key information regarding medical countermeasures 
Argentina has significant pharmaceutical manufacturing capabilities, supported by an extensive network 
of pharmaceutical plants, public laboratories, and R&D centres. However, the country often struggles 
with shortages of essential medicines, vaccines, and medical supplies and equipment221. 

In  the  context  of  the  significant  dengue  outbreak  across  Latin  America  in  the  first  quarter  of  2024, 
Argentina is facing a shortage of insect repellents. The government attributes this issue to a bottleneck 
in the supply chain222. 

Comprehensive mapping of identifies entities 

The Ministry of Health (Ministerio de Salud de la Nación) 
The primary mandate of the Ministry of Health is to provide support to the President of the Nation and 
the Chief of the Cabinet of Ministers in matters pertaining to public health and the promotion of healthy 

219 Chronic non-communicable diseases in Argentina: Model and forecast by sex and age, PSM [online]. 2022, vol.20, n.1, pp.99-116 
220 Argentina battles dengue surge and repellent shortage, BBC, April 2024 
221 Public and private capacities for local manufacturing of pharmaceuticals: Argentina, Ministry of Health, April 2023 
222 Argentina battles dengue surge and repellent shortage, BBC, April 2024 

356 

 
 
 
 
 
 
 
 
 
 
behaviors within the community. Specifically, it is entrusted with the implementation of plans, programs, 
and  projects  within  its  jurisdiction  aimed  at  enhancing  the  quality  and  ensuring  equity  in  healthcare 
systems, as well as facilitating access to healthcare goods and services for the populace. 

In terms of preparedness and response to health crises, the Ministry is responsible for monitoring and 
gathering intelligence on Medical Countermeasures (MCMs). It also oversees the coordination of crisis 
response  activities  with  national  stakeholders,  exemplified  during  events  such  as  the  COVID-19 
pandemic. 

The Ministry manages the procurement, stockpiling, and distribution of essential healthcare resources. 
In  fact,  the  National  Directorate  of  Health  Emergencies  (DINESA)  within  the  Ministry  oversees  the 
storage  and  distribution  of  materials  necessary  for  immediate  healthcare  response  to  emergencies 
affecting the population, ensuring that supplies reach local levels where they can be effectively utilized. 

Additionally, the Ministry participates in the preparedness and response globally, through collaborations 
with international partners such as Chile, PAHO, etc. 

The National Institute of Industrial Technology (INTI - Instituto Nacional de Tecnologia Industrial) 
As the federal agency tasked with the advancement of industrial technology, the National Institute of 
Industrial  Technology  (INTI)  serves  as  Argentina's  foremost  authority  in  industrial  technology  and 
metrology. With a mission to foster industry development, INTI focuses on innovation and technology 
transfer, process and product certification, and the quality assurance of goods and services nationwide. 
In its pursuit of research and development (R&D) capabilities and manufacturing excellence, INTI is 
committed  to  bolstering  the  growth  of  Argentine  small  and  medium-sized  enterprises  (SMEs)  and 
promoting  the  expansion  of  the  national  industry.  This  involves  fostering  innovation,  facilitating 
technology transfer, and spearheading initiatives such as the Strategic Projects in Public Production of 
Medicines (PE PPM 2021) aimed at enhancing pharmaceutical production. 

357 

 
 
 
 
 
 
b. Brazil 

Key contextual elements 

Population: 
215 million 

Current health expenditure (% of GDP) : 
10% 

Socio-demographic and public health situation 
Classified  as  an  emerging  upper-middle  income  economy,  Brazil  has  made  significant  progress  in 
recent years to improve its healthcare system, but it remains behind many other countries in terms of 
population coverage, quality metrics, and overall and efficient spending223. 

Brazil, like many other Latin American countries, is subject to infectious and neglected tropical diseases, 
and  mosquito-borne  diseases  (chikungunya,  dengue,  malaria,  yellow  fever,  and  Zika)  are  endemic 
throughout the Amazon224. 
Since the start of 2024, Brazil is facing the accelerated spread of the dengue fever, with more than 2 
million cases225. PAHO officials have described the situation as potentially the worse outbreak in the 
Americas to date. 

Key information regarding medical countermeasures 
During the COVID-19 pandemic, Brazilian healthcare services faced challenges with drug shortages, 
including neuromuscular blocking agents, sedatives, vasoactive drugs, and anti-infective agents226. In 
the context of the current dengue crisis, there is no evidence of shortages. 

Comprehensive mapping of identifies entities 

The Ministry of Health 
The Ministry of Health, as a core entity within the Federal Executive Branch, holds the responsibility for 
formulating  and  implementing  public  strategies  and  policies  aimed  at  promoting,  preventing,  and 
providing healthcare services to the Brazilian populace. 

223 A Closer Look Into Brazil’s Healthcare System: What Can We Learn?, Cureus. 2023 May; 15(5): e38390. 
224 US CDC, Brazil, consulted in April 2024 
225 Brazil registers over 2 mi cases of dengue in 2024, Agencia Brazil, 22 March 2024 
226 Drug  and  others  products  shortage  in  Brazilian  health  services  in  the  scenario  imposed  by  COVID-19,  Apr  2022,  Research,  Society  and 
Development-Vol. 11, Iss: 5, pp e26711527928-e26711527928 

358 

 
 
 
 
 
 
 
 
 
 
Central to its mission is the provision of a conducive environment for safeguarding and enhancing the 
health  of  the  population,  efforts  to  reduce  illnesses,  control  endemic  and  parasitic  diseases,  and 
strengthen  health  surveillance  systems,  ultimately  contributing  to  an  improved  quality  of  life  for 
Brazilians. 

The Ministry of Health assumes a critical role in coordinating health security, notably through the Public 
Health Emergency Operations Centre for Dengue and other Arboviruses, established in February 2024 
within  the  MoH.  This  initiative  is  geared  towards  ensuring  a  synchronized  and  efficient  response  to 
epidemiological challenges associated with these diseases nationwide. Its goal is to enhance planning 
and coordination efforts with state and municipal authorities against arboviruses. 
The Ministry is also responsible for monitoring and analysing health threats. 

In  terms  of  Brazil's  capacity  for  research  and  development  and  manufacturing  in  preparedness  and 
response to health crisis, the Ministry has allocated nearly USD 9.3 million in R&D initiatives in response 
to  Covid-19,  with  a  particular  focus  on  treatments,  vaccines,  diagnostics,  disease  pathogenesis, 
healthcare, prevention, and control227. 
Additionally, it launched the National Development Strategy for the Health Economic-Industrial Complex 
in October 2023, aimed at expanding Brazil's capacity to produce essential items for its Unified Health 
System.  This  strategy  entails  the  implementation  of  structural  programs,  including  new  sanitary 
regulations to foster the development of vaccines for emerging pandemics. 

The Ministry oversees the procurement, storage, and distribution of MCMs such as vaccines, PPE, and 
ventilators, and manages national stockpiles. 

In terms of international cooperation, the Ministry of Health is part of the Immunization Capacity Scaling 
Project  in  the  countries  of  PROSUR,  with  the  Ministries  of  Health  of  Ecuador,  Peru,  Paraguay,  and 
Chile. This initiative aims to foster regional capacities for vaccine research, development, production, 
and distribution, thereby enhancing preparedness and response capabilities across PROSUR member 
countries. 

The ANVISA - Brazilian Health Regulatory Agency 
The Brazilian Health Regulatory Agency (Anvisa) is an entity linked to the Ministry of Health, part of the 
Brazilian National Health System (SUS), serving as the coordinator of the Brazilian Health Regulatory 
System (SNVS). 
Its role it to promote the protection of the population’s health by implementing sanitary control over the 
production, marketing, and use of products and services subject to health regulation. 

ANVISA cooperates with the Ministry of Health on the health security coordination and the management 
of MCMs stockpiles, through the elaboration of guidelines. 

FIOCRUZ - The Oswaldo Cruz Foundation 
FIOCRUZ is a scientific institution for research and development in biological sciences. Linked to the 
Ministry  of  Health,  the  foundation  aims  to  promote  health  and  social  development,  generate  and 
disseminate scientific and technological knowledge. 
FIOCRUZ  analyses  health  threats  and evaluates  their  potential  consequences.  The  Foundation  has 
units  dedicated  to  health  surveillance  and  epidemiology.  It  conducts  studies  on  the  prevention  and 
control of diseases through computational and simulation methods. 

FIOCRUZ in a major player in the promotion of R&I to develop safe and effective MCMs in Brazil. It 
conducts and coordinates research projects to produce knowledge for the control of diseases (AIDS, 

227 Brazil’s response to the COVID-19 pandemic, WHO 

359 

 
 
 
 
 
 
 
 
 
 
malaria,  Chagas,  tuberculosis,  leprosy,  rubella,  etc),  innovation  projects  to  develop  products,  and 
processes with potential applications such as vaccines, diagnostic methods… 
Some examples of technologies developed by the Institution are: 

-  A rapid test for diagnosing Zika virus, which aims to be more affordable and more sensitive and 

specific (development stage: prototype), 

-  An optimized therapy for infectious diseases using nanopedtide carrier, aiming to have fewer 

side effects (development stage: prototype). 

Its  technological  management  coordination  centre  (Gestec)  ensures  the  guidance,  protection, 
negotiation and transfer of the Institution's intellectual assets. 

FIOCRUZ also cooperates with the Ministry of Health to foster local manufacturing capabilities. In 2021, 
they  launched  the  construction  of  the  Industrial  Complex  of  Biotechnology  in  Health  (Cibs),  a  new 
complex  of  FIOCRUZ.  This  project  aims  to  increase  the  production  capacity  of  vaccines  and 
biopharmaceuticals thus reinforcing the country's self-sufficiency in the field of immunobiological and 
reducing external technological dependence228. 

Finally,  FIOCRUZ  seeks  to  contribute  to  reinforcing  the  global  health  emergency  preparedness  & 
response architecture, particularly in advanced R&D capacities. Its unit in Africa (Mozambique) aims to 
coordinate,  monitor,  and  evaluate  cooperation  programs  in  health  with  African  countries.  This  unit 
ensures technology transfer to boost local production and supports the strengthening of health systems 
in  the  countries  of  the  Community  of  Portuguese-Speaking  Countries.  Within  this  South-South 
cooperation  dynamic,  FIOCRUZ  also  has  partnerships  with  entities  in  Latin  America  (Argentina, 
Ecuador, etc.) to strengthen production chains, reduce external dependence, and promote mutual aid. 
Additionally, FIOCRUZ establishes bilateral partnerships, such as with the China CDC for joint research 
and laboratory diagnosis development. FIOCRUZ is also the only Brazilian institution that belongs to 
the Pasteur World Network. 

228 Fiocruz and MoH publish notice for construction of the largest vaccine factory in Latin America, Fiocruz News, February 2021 

360 

 
 
 
 
 
c. Colombia 

Key contextual elements 

Population: 
52 million 

Current health expenditure (% of GDP): 
9% 

Socio-demographic and public health situation 
Colombia is an upper-middle income country with significant inequalities, as indicated by the 0.55 Gini 
index, the second highest in Latin America. 43% of the population lives below the national poverty line 
and, informal employment is very high229. 

Covid  killed  143 000  people  in  Colombia  and  led  to  a  historic  economic  recession.  Additionally,  the 
country has experienced a rising number of dengue and severe dengue cases over the last two years230. 
HIV and tuberculosis statistics are on par with the Latin American average. Malaria remains a challenge 
in Colombia despite a low death rate, prompting the Ministry of Health and Social Protection to establish 
the  Malaria  Strategic  Plan  for  2019-2022231.  A  National  Plan  for  the  Elimination  and  Eradication  of 
Communicable  Diseases  was  also  launched  in  May  2024,  including  HIV,  tuberculosis,  malaria,  and 
tropical diseases in a One Health approach232.  

Key information regarding medical countermeasures 
During the COVID crisis, Colombia faced medication shortages due to a combination of factors: 

- 

- 

- 

- 

the  pandemic  exposed  medication  shortages,  such  as  increased  demand  for  medications 
(antibiotics, muscle relaxants, painkillers, etc.), 
reduced  supply  as  Colombia  shifted  from  domestic  production  to  reliance  on  imported 
medications, 
the  lack  of  raw  materials  to  produce  medications  due  to  lockdowns,  impacting  the  already 
limited local production, 
the price control established by the Colombian Ministry of Health and Social Protection; a policy 
aimed  at  ensuring  access  to  medications  at  reasonable  prices,  but  which  reduces 
attractiveness for the pharmaceutical industry233. 

In response to these challenges, the Ministry and other concerned entities are implementing initiatives 
to improve their preparedness and response capacities. 

229 Poverty and Equity Brief – Colombia, the World Bank, April 2022 
230 Reported Cases of Dengue Fever in The Americas, PAHO, 2022 to 2024 
231 Malaria strategic plan 2019-2022, Ministry of Health and Social Protection, April 2020 
232 Colombia launches national plan for the elimination and eradication of communicable diseases, PAHO, May 2024  
233 The shortage of medications in Colombia and the role of several sectors in this issue, National University of Colombia, November 2023 

361 

 
 
 
 
 
 
 
Comprehensive mapping of identifies entities 

The Ministry of Health and Social Protection 
The Ministry of Health and Social Protection is a central public entity of the National Government and 
the head of the health sector. It is responsible for overseeing, directing, evaluating, and guiding the 
social  health  security  system  through  the  formulation  of  policies,  plans,  and  programs,  as  well  as 
intersectoral  coordination  and  the  integration  of  health  actors.  The  aim  is  to  improve  the  quality, 
timeliness, and accessibility of health services and the sustainability of the system, thereby increasing 
the satisfaction levels of patients, families, communities, and residents across the national territory. 

In terms of preparedness and response to health crisis, it conducts health threats analysis and evaluate 
their impact. It also cooperates with INVIMA to identify the medicines and medical supplies at risk of 
shortages234. 
The Ministry is also central to heath security coordination in the country as it coordinates to response 
to health crisis with the relevant stakeholders. 

Moreover, it encourages and promotes the local manufacturing of MCMs, particularly vaccines, as part 
of its policy to achieve health sovereignty. To this end, two local vaccine production initiative projects 
are currently underway, led by the Ministry in coordination with other entities. 
These initiatives aim to restore the local capacity of institutions (such as the INS and Vecol) in vaccine 
production. Additionally, the Ministry is implementing an advantageous patent policy: protection granted 
by the state to an inventor to ensure a monopoly that encourages research and development235. 

The Ministry develops the distribution policy and oversees the distribution of MCMs. However, there is 
no national stockpiling strategy in place. 

The Colombian Ministry of Health and Social Protection aims to contribute to reinforcing global health 
emergency  preparedness  and  response.  It  establishes  bilateral  agreements  with  foreign  countries, 
including one with Denmark focused on access to medicines236. 
Moreover, it is part of the Andean Regional Health Agency (ORAS) and contributes in this framework 
to  a  set  of  initiatives  and  policies,  including  projects  aimed  at  improving  access  to  medications  and 
promoting  R&D  for  MCMs  in  the  region.  Still  within  this  framework,  the  Ministry  has  contributed  to 

234 Colombia advances in the supply of medicines, Colombian government news, January 2021 
235 Medicines: Minsalud works to achieve health sovereignty, Colombian government news, October 2023 
236 Denmark and Colombia strengthen bilateral cooperation in health, Colombian government news, March 2017 

362 

 
 
 
 
 
 
 
 
 
strengthening decision-making in the control of the Covid-19 pandemic through genomic surveillance 
in collaboration with its neighbours (Bolivia, Peru, Ecuador). 

Colombia Compra Eficiente - National Public Procurement Agency 
Colombia  Compra  Eficiente  is  the  national  public  procurement  Agency,  mandated  to  develop  and 
promote public policies and tools for state procurement processes, aiming to generate greater efficiency, 
transparency, and optimization of state resources. 
For the preparedness and response to health emergencies, the agency ensures the procurement of 
MCMs. 

The National Food and Drug Surveillance Institute - INVIMA 
The  National  Food  and  Drug  Surveillance  Institute  –  INVIMA  is  a  national  technical  and  scientific 
institute, under the Ministry of Health and Social Protection. Its mission is to implement government 
policies  on  inspection,  surveillance,  and  sanitary  control.  By  focusing  on  risk  management  of  the 
products under its jurisdiction, INVIMA aims to protect and promote public health. 

Regarding HERA’s tasks, INVIMA supports the Ministry of Health and Social Protection in gathering 
and  analysing  intelligence  regarding  medicines  and  medical  supplies.  In  preparedness,  the  entity 
assists the Ministry in identifying medications and medical supplies at risk of shortages in cooperation 
with the Ministry. 

Furthermore, INVIMA supports the efforts to strengthen local manufacturing capacities. 
Since  March  2024,  INVIMA  collaborates  with  the  University  of  Antioquia  in  Medellín  to  initiate 
preparations for the public manufacturing of medicines in Colombia. Although no specific molecule or 
medicines were specified, the aim of the initiative is to unite experts from both institutions to deliberate 
on "the standardization, validation, verification, and implementation of testing methods" necessary for 
establishing Colombia's public medicine production facility237. 

Finally, INVIMA is the National Reference Laboratory. Consequently, it advises and technically supports 
the Ministry of Health and Social Protection in the formulation of policies, standards, and guidelines 
related to the National Laboratory Network. Therefore, it plays a role in health security coordination by 
coordinating and ensuring the capacity of the Laboratory Network238. 

237 Latin America Roundup: Brazil and Colombia advance public drug-making initiatives, LATAM Regulatory Roundup, March 2024 
238 INVIMA - Red Nacional de Laboratorios, INVIMA official website 

363 

 
 
 
 
 
 
 
 
 
 
d. Ecuador 

Key contextual elements 

Population: 
18 million 

Current health expenditure (% of GDP): 
8% 

Socio-demographic and public health situation 
Ecuador is a middle-income country, with a high poverty incidence (5.2%)239. 
In terms of public health, like many other Latin American countries, Ecuador is subject to infectious and 
neglected tropical diseases outbreaks. For instance, Ecuador frequently faces dengue fever, typhoid, 
hepatis A. 
Additionally, malnutrition and access to safe remain challenges in the country240. 

Key information regarding medical countermeasures 
Ecuador frequently faces medical supplies shortages. 
A new agreement between UNOPS and Ecuador’s Ministry of Public Health (MSP) will help strengthen 
the public health system in the country. Under the agreement, UNOPS will support the government to 
enhance health infrastructure and support the sustainable procurement of essential medical supplies 
and equipment241. 

Comprehensive mapping of identifies entities 

The Ministry of Public Health 
The Ministry of Health assumes responsibility for leadership, regulation, planning, coordination, control, 
and  management  of  public  health  in  Ecuador.  This  encompasses  governance,  public  health 
surveillance,  provision  of  comprehensive  care  services,  disease  prevention,  health  promotion  and 
equality,  R&D  of  science  and  technology,  and  coordination  among  various  stakeholders  within  the 
healthcare system. 

In  terms  of  preparedness  and  response,  the  Ministry  conducts  monitoring  and  analysis  of  MCMs, 
providing technical support for the development of the national drug policy. It also plays a crucial role 

239 Poverty & Equity Brief: Ecuador, World Bank, April 2023 
240 Challenges  to  Water  Management  in  Ecuador:  Legal  Authorization,  Quality  Parameters,  and  Socio-Political  Responses,  Water  2021,  13(8), 
1017; https://doi.org/10.3390/w13081017 
241 UNOPS and Ecuador sign new agreement to strengthen public healthcare, UNOPS Press release, June 2023 

364 

 
 
 
 
 
 
 
 
 
 
in health security coordination, elaborating strategies to ensure the availability and access to quality, 
safe, and effective essential drugs and medicines. 
Furthermore, in emergency situations, the Ministry is empowered to directly contract necessary works, 
goods, or services essential for overcoming the crisis, and ensures their distribution accordingly. 

The Ecuadorian Ministry of Health is part of the Immunization Capacity Scaling Project in the countries 
of PROSUR, with the Ministries of Health of Brazil, Peru, Paraguay and Chile. This initiative aims to 
foster  regional  capacities  for  vaccine  research,  development,  production,  and  distribution,  thereby 
enhancing preparedness and response capabilities across PROSUR member countries. 
Moreover, it is part of the Andean Regional Health Agency (ORAS) and contributes in this framework 
to  a  set  of  initiatives  and  policies,  including  projects  aimed  at  improving  access  to  medications  and 
promoting  R&D  for  MCMs  in  the  region.  Still  within  this  framework,  the  Ministry  has  contributed  to 
strengthening decision-making in the control of the Covid-19 pandemic through genomic surveillance 
in collaboration with its neighbours (Bolivia, Peru, Colombia). 

365 

 
 
 
 
 
 
e. Paraguay 

Key contextual elements 

Population: 
6.8 million 

Current health expenditure (% of GDP): 
7% 

Socio-demographic and public health situation 
Paraguay is an upper-middle income country with significant inequalities, as indicated by a Gini index 
of 0.45. Like other countries in the region, the country is prone to droughts, floods, and storms that can 
have a big impact on the economy, like in 2022.  

Paraguay  has  a  significant  burden  from  infectious  diseases,  including  chikungunya,  Chagas,  and 
tuberculosis, waterborne-related diseases, and zoonotic diseases such as avian influenza. Paraguay 
was certified malaria-free by the WHO in 2018242. 
Recently, the country experienced a large chikungunya outbreak, with more than 81 000 suspected, 
probable, or confirmed cases recorded between October 2022 and March 2023243. 
In the first months of 2024, Brazil, Argentina, and Paraguay have been the worst hit, in what PAHO 
officials  have  described  as  potentially  the  worse  outbreak  in  the  Americas  to  date.  Paraguay  had 
recorded 271,000 confirmed or suspected cases in the year as of mid-May 2024244.  

Key information regarding medical countermeasures 
In terms of pandemic preparedness and response, Paraguay prioritizes the One Health approach. 
This  strategic  emphasis  is  underscored  by  the  country's  unique  geographical  characteristics:  it  is 
landlocked, with porous and extensive borders, experiencing significant rural-to-urban migration, and a 
unique ecosystem that faces threats from climate change and deforestation. In this context, the country 
notably receives support from the World Bank to strengthen disease surveillance, enhance laboratory 
systems,  build  capacity,  and  foster  cross-sectoral  collaboration  for  the  country's  pandemic 
preparedness and response efforts245. 

Comprehensive mapping of identifies entities 

242 World Malaria Report – 2023  
243 Amid Paraguay Chikungunya Outbreak, Vaccine Candidate Safe, Immunogenic, Medical News in brief, June 2023 
244 Reported Cases of Dengue Fever in The Americas – PAHO  
245 The Pandemic Fund: Strengthening Pandemic PPR in Paraguay, The World Bank, September 2023 

366 

 
 
 
 
 
 
 
 
 
 
The Ministry of Public Health and Social Welfare 
The Paraguayan Ministry of Public Health and Social Welfare aims to guarantee the fulfilment of the 
functions  of  rectory,  conduction,  financing,  and  provision  of  health  services,  to  achieve  universal 
coverage, under the social protection approach, within the framework of the National Health System. 

It is at the forefront of preparing for and responding to health crises as it coordinates with various sectors 
and  programs,  addressing  not  only  the  health  crisis  but  also  the  economic  and  social  crises.  For 
instance, amid the COVID-19 pandemic, it forged partnerships with private enterprises to ensure the 
accessibility of essential biosafety and hospital infrastructure equipment. 
Additionally, it conducts thorough analyses of health threats and evaluates their potential implications 
for public health. 

In Paraguay, public sector procurement within the healthcare domain is currently centralized, overseen 
by the General Operational Directorate of Procurement and the General Directorate of Strategic Health 
Supplies Management within the Ministry. 
The General Directorate of Strategic Supplies Management also holds responsibility for the stockpiling 
and  distribution  system  of  medications  and  supplies  nationwide.  This  includes  the  management  of 
central-level public medication warehouses246. 

Regarding  the  manufacturing  of  MCMs,  in  emergency  situations,  the  Ministry  of  Public  Health  and 
Social Welfare can collaborate with the Ministry of Industry and Commerce to stimulate local production. 
For  example,  during  the  COVID-19  pandemic,  a  National  Agreement  was  established  to  produce 
medical supplies for healthcare. This agreement involved coordination between the Ministry of Health, 
Ministry of Industry and Commerce, and textile and metallurgical industries to facilitate the production 
of PPE247. 

In  addition,  the  Paraguayan  Ministry  of  Public  Health  and  Social  Welfare  seeks  to  contribute  to 
reinforcing  the  global  health  emergency  preparedness  and  response.    For  example,  Paraguay 
collaborates  with  ORAS  on  a  project  aimed  at  enhancing  and  improving  the  quality  of  tuberculosis 
diagnosis in laboratory networks across the Americas by bolstering the region's installed capacity248. 
The  Ministry  of  Health  of  Paraguay  is also  part  of  the  Immunization  Capacity  Scaling  Project  in  the 
countries of PROSUR, with the Ministries of Health of Ecuador, Peru, Brazil, and Chile. This initiative 
aims  to  foster  regional  capacities  for  vaccine  research,  development,  production,  and  distribution, 
thereby enhancing preparedness and response capabilities across PROSUR member countries. 

The Ministry of Industry and Commerce 
The Paraguayan Ministry of Industry and Commerce aims to promote the development and growth of 
private sector enterprises through policymaking. 
As mentioned earlier, it can intervene in the event of a health crisis to collaborate with the Ministry of 
Public Health and Social Welfare to enhance local production of MCMs. This was exemplified during 
the COVID-19 pandemic when a National Agreement was initiated to provide medical supplies for the 
healthcare  sector.  This  agreement  entailed  coordination  among  the  Ministry  of  Health,  Ministry  of 
Industry and Commerce, and textile and metallurgical industries to facilitate the production of PPE249. 

The National Council for Science and Technology - CONACYT 
The National Council for Science and Technology, also known as “CONACYT”, is a public institution 
under the Presidency of Paraguay. Established in 1997 it is responsible for formulating, coordinating, 

246 The General Directorate of Strategic Supplies Management, Ministry of Public Health and Social Welfare website 
247 Response to the COVID-19 Pandemic by the Paraguayan Government, Paraguayan Government and PAHO/WHO, November 2020 
248 Strengthening Tuberculosis Laboratory Diagnosis in the Americas Region, ORAS – Current projects  
249 Response to the COVID-19 Pandemic by the Paraguayan Government, Paraguayan Government and PAHO/WHO, November 2020 

367 

 
 
 
 
 
 
 
 
 
articulating,  promoting,  evaluating,  and  implementing  public  policies  for  scientific  and  technological 
development, innovation, and quality, to contribute to the sustainable development of Paraguay. 

In terms of preparing for and responding to health crises, CONACYT advises the National Government 
on national science, technology, and innovation policies. This entity plays a significant role in promoting 
and  coordinating  R&D  efforts  aimed  at  developing  safe  and  effective  MCMs  by  encouraging  and 
fostering related initiatives. 
At the peak of the Covid-19 pandemic, CONACYT issued a call for competitive funding of R&D projects 
to  support  scientific  research  within  the  context  of  the  coronavirus  pandemic.  The  funded  projects 
encompass a wide range of areas, including epidemiological studies, research on social behaviour, the 
development  of  medical  devices,  and  preclinical  trials  of  treatments  designed  to  prevent  and  treat 
infectious diseases250. 

250 The role of science, technology, and innovation in accelerating the recovery from the coronavirus disease (COVID-19) and the full implementation 
of the 2030 Agenda for Sustainable Development at all levels, UN Commission on science and technology for development (CSTD), 26th session, 
Statement by Paraguay, Geneva, 27-31 March 2023 

368 

 
 
 
 
 
f.  Peru 

Key contextual elements 

Population: 
34 million 

Current health expenditure (% of GDP): 
5% 

Socio-demographic and public health situation 
Peru is an upper-middle income country with a Gini index of 0.40, one of the lowest indexes in South 
America. Covid led to a significant economic recession in 2020 but bounced back the following year.  

Peru  was  one  of  the  countries  most  affected  by  the  COVID-19  pandemic  in  terms  of  health  and 
economic impacts. By July 2022, Peru had recorded over 6,000 COVID-19 deaths per million population, 
placing it among the nations with the highest per capita COVID-related mortality rates251.  
Regarding other infectious diseases, Malaria cases decreased over the last decade, but the disease is 
still prevalent252. Yellow fever outbreaks have also been common in Peru, such as the 2021 outbreak. 
Chikungunya, dengue, and Zika are also present in Peru, with prevalence varying depending on the 
period. The country is currently under a health alert due to a dengue fever outbreak.  

To enhance its preparedness and response capacities to health crises, Peru has implemented various 
initiatives. It collaborates notably with the World Bank on a project from 2021 to 2026 to strengthen 
epidemiological surveillance and public health emergency preparedness253.  
Health and development indicators increased in the last decade and an Integrated Health Networks 
was approved in 2019254. One of the country’s challenges is to increase health expenditure as it is today 
one of the lowest in South America.  

Key information regarding medical countermeasures 
Peru  regularly  faces  shortages  of  critical  supplies.  While  the  country's  pharmaceutical  production 
capacities  are  expected  to  expand,  they  remain  relatively  small  compared  to  other  countries  in  the 
region255. 
However,  the  country  is  involved  in  strengthening  skills  in  the  management  of  MCMs,  both  at  the 
national level through the implementation of new decrees and at the regional level within the Andean 
Regional Health Agency (ORAS). 

251 Rising strong: Peru Poverty and Equity Assessment, The World Bank, April 2023 
252 World Malaria Report – 2023 
253 Peru: Strengthening of the Public Health Emergency Preparedness and Response, The World Bank, June 2021 
254 Peru profile - Pan American Health Organisation 
255 Medical devices – Peru, International Trade Administration, December 2023 

369 

 
 
 
 
 
 
 
 
Comprehensive mapping of identifies entities 

The Ministry of Health (MINSA) 
The Peruvian Ministry of Health is mandated to protect personal dignity by promoting health, preventing 
diseases, and ensuring comprehensive healthcare for all inhabitants of the country. It is the central body 
for the preparation and response to health crises in the country, particularly for MCMs. 

Firstly, it ensures health security coordination, in collaboration with relevant stakeholders. It establishes 
the  guidelines  and  protocols  for  managing  MCMs  for  the  preparation  and  response  to  health 
emergencies. 
The Ministry also ensures the monitoring, supervision, and dissemination of the availability of MCMs for 
the prevention, diagnosis, and treatment of diseases in the event of health crises256. 
It also ensures the procurement of medical supplies on a national scale (including vaccines, PPE, and 
medical  devices  related  to  Covid-19).  It  can  collaborate  with  the  Public  Procurement  Centre  "Perú 
Compras" in the context of this activity. 

Furthermore,  to  enhance  preparedness  capacities  for  health  crises,  the  MINSA  issued  a  decree  in 
March 2024 regarding the establishment of a stockpiling of essential medications. This decree sets forth 
the requirement that pharmacies, drugstores, and private health establishments maintain a minimum 
stock of 30% of essential generic medications. Failure to comply with this rule will result in financial 
penalties  for  the  establishments.  The  ministry  is  responsible  for  establishing  the  list  of  products 
involved257. 
Regarding the distribution of MCMs, the MINSA defines the policy and strategy to ensure effective and 
equitable distribution during emergencies. 

The  Peruvian  Ministry  of  Health  seeks  to  contribute  to  reinforcing  the  global  health  emergency 
preparedness and response. For this purpose, it establishes bilateral agreements with neighbouring 
countries. This is the case of its bilateral agreement with Chile, which includes a focus on exchanging 
information on communicable diseases258. 
Moreover, it is part of the Andean Regional Health Agency (ORAS) and contributes in this framework 
to  a  set  of  initiatives  and  policies,  including  projects  aimed  at  improving  access  to  medications  and 
promoting  R&D  for  MCMs  in  the  region.  Still  within  this  framework,  the  MINSA  has  contributed  to 

256 Preparation and Response plan for a possible second wave of the covid-19 pandemic in Peru, MINSA, R.M. n°928-2020 
257 Urgent  Decree  That  Dictates  Extraordinary  Measures  in  Economic  and  Financial  Matters  to  ensure  access  to  generic  medications  for  the 
population, Ministry of Health, March 2024 
258 Chile and Peru define a cooperation program for 2023 - 2025 with a focus on the health sector, AGCID Chile, December 2022 

370 

 
 
 
 
 
 
 
 
strengthening decision-making in the control of the Covid-19 pandemic through genomic surveillance 
in collaboration with its neighbours (Bolivia, Colombia, Ecuador). 
The  Peruvian  Ministry  of  Health  is  also  part  of  the  Immunization  Capacity  Scaling  Project  in  the 
countries  of  PROSUR,  with  the  Ministries  of  Health  of  Ecuador,  Brazil,  Paraguay,  and  Chile.  This 
initiative  aims  to  foster  regional  capacities  for  vaccine  research,  development,  production,  and 
distribution,  thereby  enhancing  preparedness  and  response  capabilities  across  PROSUR  member 
countries. 

Perú Compras 
Public procurement centre, Perú Compras aims to develop efficient, transparent, agile, and innovative 
procurement mechanisms and strategies for the State, to contribute to the country's competitiveness. 
As part of preparing for or responding to health crises, this entity can intervene in support of the Ministry 
of Health for the procurement of MCMs259. 

National Institute of Health 
Public health institute under the Ministry of Health, the National Institute of Health conducts scientific 
research to understand the health situation in Peru. 
Specifically  regarding  HERA’s  task,  the  National  Institute  of  Health  promotes  R&I  of  technological 
interventions that effectively and timely address the public health needs and demands. 

259 Peru Compras official website 

371 

 
 
 
 
 
 
 
 
6) Oceania 

Monitoring, Intelligence Gathering and Analysis 

Entity 

The Australia Department of Health and Aged Care 

The Defence Science and Technology (DST) Group, under 
the Department of Defence 

ESR – the Institute of Environmental Science and Research 

The Public Health Agency - Te Pou Hauora Tūmatanui 

Advanced Research and Development Capacities  

Entity 

The Australia Department of Health and Aged Care 

The interim Australian Centre for Disease Control (CDC) 

The Health Security Systems Australia (HSSA), division of 
DMTC Limited 

The Defence Science and Technology (DST) Group, under 
the Department of Defence 

Australian Institute for Infectious Disease (AIID) 

Country 

Australia 

Australia 

New Zealand 

New Zealand 

Country 

Australia 

Australia 

Australia 

Australia 

Australia 

The Ministry of Business, Innovation and Employment 

New Zealand 

Production / Manufacturing Capacities 

Entity 

The Australia Department of Health and Aged Care 

The interim Australian Centre for Disease Control (CDC) 

The Health Security Systems Australia (HSSA), division of 
DMTC Limited 

Country 

Australia 

Australia 

Australia 

PHARMAC - Te Pātaka Whaioranga 

New Zealand 

372 

 
 
 
 
 
 
 
 
 
 
Procurement of MCMs  

Entity 

The Australia Department of Health and Aged Care 

Health New Zealand - Te Whatu Ora 

PHARMAC - Te Pātaka Whaioranga 

Stockpiling and Distribution Capacities 

Entity 

The Australia Department of Health and Aged Care 

The Ministry of Health (Manatu Hauora) 

Health New Zealand - Te Whatu Ora 

PHARMAC - Te Pātaka Whaioranga 

International Cooperation  

Entity 

The Australia Department of Health and Aged Care 

The interim Australian Centre for Disease Control (CDC) 

The Defence Science and Technology (DST) Group, under 
the Department of Defence 

The Ministry of Health (Manatu Hauora) 

The Ministry of Business, Innovation and Employment 

Country 

Australia 

New Zealand 

New Zealand 

Country 

Australia 

New Zealand 

New Zealand 

New Zealand 

Country 

Australia 

Australia 

Australia 

New Zealand 

New Zealand 

ESR – the Institute of Environmental Science and Research 

New Zealand 

373 

 
 
 
 
 
 
 
 
 
 
 
 
Health Security Coordination 

Entity 

The Australia Department of Health and Aged Care 

The interim Australian Centre for Disease Control (CDC) 

The Ministry of Health (Manatu Hauora) 

PHARMAC - Te Pātaka Whaioranga 

Country 

Australia 

Australia 

New Zealand 

New Zealand 

ESR – the Institute of Environmental Science and Research 

New Zealand 

The Public Health Agency - Te Pou Hauora Tūmatanui 

New Zealand 

374 

 
 
 
 
 
 
a. Australia 

Key contextual elements 

Population: 
25.7 million 

Current health expenditure (% of GDP): 
10% 

Socio-demographic and public health situation 
With the 9th highest GDP per capita in the world, Australia is a highly developed country with the lowest 
Gini coefficient of the OCDE countries in 2022 (0.318). 
In terms of public health, Australia has a world-leading health system. Nevertheless, some inequalities 
remain in health outcomes across socio-economic groups as well between Australia’s Indigenous and 
non-Indigenous population260. 
Regarding health crisis preparedness and response, Australia notably is part of the countries where the 
impacts of the COVID-19 pandemic, in terms of mortality and excess deaths, were minimal compared 
with much of the rest of the world261.  
Exposure to infectious diseases is relatively low in Australia, and it is non-communicable diseases that 
represent the major cause of mortality262. 

Key information regarding medical countermeasures 
Australia has a robust domestic pharmaceutical manufacturing sector. However, it relies significantly 
on imports for certain medications and active pharmaceutical ingredients, primarily from countries like 
the United States, Germany, and China. 

Recognizing  the  impact  of  the  Covid-19  crisis,  Australia  seeks  to  enhance  its  preparedness  and 
response to health crises by establishing a Centre for Disease Control and developing initiatives related 
to  advanced  R&D  for  medical  countermeasures  through  its  MCM  program,  led  by  Health  Security 
Systems Australia (HSSA). 

Moreover, the country is involved in reinforcing the global health emergency preparedness & response 
architecture  through  bilateral  agreements  and  international  initiatives.  For  instance,  regarding  the 
establishment of the new Australia CDC, the bilateral cooperation established between Singapore and 
Australia led to exchanges of experiences and ideas between the two new agencies created in response 
to the Covid-19 crisis: the new Communicable Disease Agency of Singapore and the interim Australian 
Centre for Disease Control. 

260 Australia’s public health achievements and population health gains, The Lancet, published in 2023. 
261 The WHO estimates of excess mortality associated with the COVID-19 pandemic, Nature 613, 130-137, published in 2023. 
262 The burden and trend of diseases and their risk factors in Australia, 1990–2019: a systematic analysis for the Global Burden of Disease Study 
2019, Lancet Public Health. 2023 Aug; 8(8): e585–e599. 

375 

 
 
 
 
 
 
 
 
Comprehensive mapping of identifies entities 

The Australian Department of Health and Aged Care 
The Australian Department of Health and Aged Care is a government body responsible for overseeing 
health-related matters. Within this department, the Health Emergency Management branch coordinates 
preparedness and response efforts during health crises. 

With  regards  to  HERA’s  tasks,  the  Department  conducts  resource  mapping  to  promptly  address 
identified gaps at national, state, and territory levels. This task is under the Communicable Diseases 
Network  Australia  (CDNA),  which  aims  to  provide  high-quality  surveillance  of  communicable  and 
notifiable  diseases,  including  HIV/AIDS,  vaccine-preventable  diseases,  arboviruses,  and  zoonotic 
diseases. 

The Department,  through  the  Australian  Health  Protection Committee  (AHPPC),  ensures  that  public 
health emergency response plans across various sectors and levels are effectively linked to facilitate a 
coordinated  response  nationwide.  The  AHPC  is  the  key  decision-making  committee  for  health 
emergencies. 

The National Medical Stockpile serves as a strategic reserve of drugs, vaccines, antidotes, and PPE 
for  use  in  national  health  emergencies.  Managed  by  the  Department  of  Health,  it  is  responsible  for 
procurement, stockpiling and distribution activities. 

The Australian Department of Health and Aged Care oversees production and manufacturing capacities 
related  to  health  crisis  preparedness  and  response.  This  includes  collaborating  with  relevant 
departments  and  stakeholders  to  establish  liability  protection  concerning  the  manufacture,  testing, 
development, distribution, administration, and use of medical countermeasures during response efforts. 

Regarding international cooperation, the Department develops policies to engage alternative sources 
for medical countermeasures from overseas manufacturers and supports local development initiatives 
for such countermeasures in foreign countries. 
The cooperation for health emergency preparedness and response is well established between 
Australia and New Zealand. For instance, representatives and experts from New Zealand are part of 
the  AHPC  and  part  of  the  Communicable  Diseases  Network  Australia.  This  collaboration  was 
particularly  evident  during  the  COVID-19  pandemic,  where  the  two  countries  worked  together  to 
optimize their vaccination schedules and share resources. 
These two countries are also key players in the regional health emergency preparedness and response 
architecture, as they collaborate with each other and with other countries in the Pacific to strengthen 
capacities.  During  the  COVID-19  crisis,  Australia  and  New  Zealand  supported  the  Autonomous 

376 

 
 
 
 
 
 
 
 
 
Bougainville Government’s response to the COVID-19 pandemic. They provided technical assistance 
and helped distribute information to local communities on how to prevent the spread of COVID-19263. 
Another example is their collaboration with the Pacific Public Health Surveillance Network. Australia 
and  New  Zealand  actively  support  the  PPHSN,  which  aims  to  improve  the  ability  of  Pacific  Island 
countries to detect and respond to public health threats. They provide training, technical assistance, 
and resources to enhance epidemiological surveillance and laboratory capabilities. 

In addition, the Department has developed bilateral agreements with other countries. For instance, its 
bilateral cooperation with  the  Singaporean  Ministry of  Health  has notably  led  to  an  agreement  for  a 
dose-sharing arrangement of COVID-19 vaccines, to support each other in optimizing their respective 
schedules for vaccinating their populations against COVID-19. 
It  also  cooperates  with  ASEAN.  During  the  COVID-19  crisis,  ASEAN  and  Australia  committed  to 
strengthening  their  strategic  partnership  by  refocusing  cooperation  on  a  number  of  priority  areas  to 
address the challenges brought about by the COVID-19 pandemic, including enhancing cooperation on 
health security. 

The interim Australian Centre for Disease Control (CDC) 
The  interim  CDC  aims  to  enhance  the  national  health  emergency  planning  and  preparedness  by 
strengthening partnerships with stakeholders and providing transparent and consistent public health 
advice. 
The CDC is a very new agency. Launched on January 1st, 2024, it seeks to build Australia's One Health 
and health security capabilities. It will continue to grow in a phased approach, pending a decision from 
Government on the final scope and functions. The CDC will lead the Australian Government’s response 
to public health emergencies of national significance. 

Once fully implemented, the missions and tasks of the Australian CDC will be: 

-  To increase independence and strengthen evidence-based and transparent decision-making, 
-  To improve national coordination of effort and efficiencies by building stronger partnerships, 
including  across  Commonwealth  agencies  and  between  the  Commonwealth  and  state  and 
territory governments, 

-  To support the Australian efforts to enhance national capabilities, 
-  To develop international connections, 
-  To  increase  and  support  preparedness  and  response  across  all  Commonwealth,  state,  and 

territory governments, including nationally264. 

In addition, the interim Australia CDC seeks to expand Australia’s ability to implement a One Health 
approach. Its activities will include:  

- 

- 
- 

identifying  steps  to  improve  One  Health  capabilities  and  activities,  including  enhanced 
surveillance and greater availability and sharing of data. 
supporting horizon scanning for new and emerging human health threats. 
establishing and maintaining clear, practical partnerships with the relevant stakeholders in New 
Zealand. 

In the context of international cooperation, the activities of the CDC are limited as it is a new entity. 
However, the bilateral cooperation established between Singapore and Australia has notably led 
to  exchanges  of  experiences  and  ideas  between  the  two  new  agencies  created  in  response  to  the 
Covid-19 crisis: the new Communicable Disease Agency of Singapore and the interim Australian Centre 
for Disease Control. 

263 Australia and New Zealand step up to support Bougainville’s response to the COVID-19 pandemic, Australia High Commission – Papua New 
Guinea 
264 Australian CDC website, About us – What we do, consulted in March 2024 

377 

 
 
 
 
 
 
 
 
The Health Security Systems Australia (HSSA), division of DMTC 
DMTC, the Defence Materials Technology Centre is a Federal initiative of the Australian Department of 
Defence. The Health Security Systems Australia Division (HSSA) was established in 2021 as a division 
of the DMTC, with the mandate of ‘building sovereign industrial and research capabilities for Australia’. 
To  achieve  this  objective,  the  division  encompasses  seven  sectors,  in  line  with  the  national  health 
security  priorities:  MCMs,  Medical  devices  (medical  monitors,  treatment  equipment),  Hazard 
management,  CBR  modelling  and  simulation,  CBR  sensing  systems,  PPE,  strategic  advisory.  The 
HSSA  division  leads  programs  and  projects  within  these  six  sectors  to  develop  products  for  the 
protection  of  military  and  civilian  against  CBRN  threats  and  emerging  infectious  diseases  and 
pandemics. 

In  comparison  to  HERA's  tasks,  the  HSSA  division  primarily  focuses  on  advanced  R&D  and 
manufacturing capacities through its MedCM program. This program aims to foster industry-research 
collaborations in the development of medical countermeasures, advancing technologies and directing 
skilled  resources  toward  activities  that  bolster  Australian  defense,  health,  and  national  security 
objectives. 
The program is currently engaged in ten active projects, including 2 therapeutic initiatives, 2 vaccine 
candidates, 4 rapid diagnostics projects, and 2 manufacturing scale-up projects265. 

The DST Group, under the Department of Defence 
The Defence Science and Technology (DST) Group is an Australian government’s agency under the 
Australian  department  of  Defence,  responsible  for  applying  science  and  technology  to  safeguard 
Australia and its national interest. 

With regards to MCMs, the DST Group seeks to grow Australia's medical countermeasures capability, 
ensuring  that  the  country  is  well-placed  to  combat  health-related  risks  to  the  military  and public.  To 
achieve  this,  the  DST  has  established  a  national  initiative  to  develop  Australia's  medical 
countermeasures capabilities and regularly conducts audit on the national capability regarding MCMs. 

Additionally, the DST group conducts CBRN research aimed at effectively preventing, responding to, 
and defending against CBRN attacks. The research addresses capability requirements in various areas, 
including PPE against unavoidable CBRN hazards. 

Regarding  international  cooperation,  the  DST  Group  has  multilateral  relationships  through  The 
Technical Cooperation Program (TTCP) with the United States, Canada, United Kingdom, and New 
Zealand.  It  is  also  involved  in  the  Medical  Countermeasures  Consortium  with  the  UK,  the  USA  and 
Canada. 

The Australian Institute for Infectious Disease (AIID) 
The  AIID  is  a  new  initiative  supported  by  the  Victorian  Government  to  enhance  Australia  research, 
public health, educational and translational capabilities in infectious diseases, including COVID-19 and 
other  major  global  health  issues.  The  AIID  is  still  a  project,  it  will  aim  to  be  a  centre  of  expertise 
dedicated to research against future diseases and pandemics.  

The AIID will endorse a cooperative alliance comprising experts in infectious diseases and public health 
that will define a unified strategic vision and research priorities. 
The  AIID  will  facilitate  the  development  of  medical  countermeasures  that  save  lives,  such  as  the 
advancement  of  therapeutics,  diagnostics,  and  vaccines,  providing  opportunities  for  research 
collaboration, platforms, and knowledge-sharing. 

265  HSSA  official  website,  Medical  countermeasures,  consulted 
countermeasures/ 

in  March  2024:  https://dmtc.com.au/health-security-systems/medical-

378 

 
 
 
 
 
 
 
 
 
 
b. New Zealand 

Key contextual elements 

Population: 
5.1 million 

Current health expenditure (% of GDP): 
10% 

Socio-demographic and public health situation 
New Zealand is a high-income country, with a high performing health system, which provides universal 
coverage and publicly funded access to a large set of core health services.  
Like other high-income countries, New Zealand faces the challenges posed by an ageing population, 
health inequities, as well as the growing burden of non-communicable and chronic diseases. 
Health inequalities is a subject in New Zealand given that Pacific communities in the country face a 
higher burden of health challenges compared to other groups. These challenges include obesity, high 
blood  pressure,  diabetes,  mental  health  disorders,  respiratory  issues,  smoking,  excessive  alcohol 
consumption, disabilities, and chronic conditions266. 
Additionally, New Zealand is prone to a range of natural hazards, including earthquakes, volcanoes, 
erosion, landslides, and extreme weather events due to its geography and location. Flooding is the most 
common natural hazard in New Zealand. 

Key information regarding medical countermeasures 
New  Zealand's  pharmaceutical  industry  relies  heavily  on  imports  for  many  of  its  medicines  (from 
Australia, China, US…), making it vulnerable to global supply chain disruptions. The last two years have 
stress-tested New Zealand's medical supply chain with events like the COVID-19 pandemic, the Russia-
Ukraine war, Red Sea conflict, shipping delays, and product discontinuations which led to shortages of 
some pharmaceuticals. 

New  Zealand  is  progressively  investing  to  strengthen  its  capacities  in  terms  of  preparedness  and 
response  to  health  crisis.  In  response  to  the  Covid-19  crisis,  it  established  a  new  entity,  the  Public 
Health  Agency,  aiming  to  reinforce  its  capacities  in  health  threats  monitoring  and  health  security 
coordination. 
New Zealand has a strong cooperation with Australia in this field,  

Comprehensive mapping of identifies entities 

The Ministry of Health - Manatū Hauora 

266 Priority Health Needs and Challenges in New Zealand Pacific Communities: A Qualitative Analysis of Healthcare Delivery during the COVID-19 
Pandemic, Healthcare (Basel), published in August 2023, doi: 10.3390/healthcare11162239 

379 

 
 
 
 
 
 
 
 
 
 
The main mandate of the MoH (Manatū Hauora) is to advise the Government on policy, set direction, 
and  regulate  and  monitor  the  health  system  to  ensure  it  performs  well  and  delivers  better  health 
outcomes for everyone.  

In terms of health crisis preparedness and response, the MoH oversees health security coordination 
with relevant stakeholders and develops emergency-related plans. 
Additionally, the Ministry collaborates with Health New Zealand (Te Whatu Ora) to manage the national 
reserve of medical supplies, encompassing PPE, antivirals, medicines, vaccines, clinical equipment, 
and  vaccination  supplies.  The  role  of  the  MoH  is  to  establish  the  national  reserve  policy  direction, 
including its composition. 

The cooperation for health emergency preparedness and response is well established between 
Australia and New Zealand. For instance, representatives and experts from New Zealand are part of 
the  AHPC  and  part  of  the  Communicable  Diseases  Network  Australia.  This  collaboration  was 
particularly  evident  during  the  COVID-19  pandemic,  where  the  two  countries  worked  together  to 
optimize their vaccination schedules and share resources. 
These two countries are also key players in the regional health emergency preparedness and response 
architecture, as they collaborate with each other and with other countries in the Pacific to strengthen 
capacities.  During  the  COVID-19  crisis,  Australia  and  New  Zealand  supported  the  Autonomous 
Bougainville Government’s response to the COVID-19 pandemic. They provided technical assistance 
and helped distribute information to local communities on how to prevent the spread of COVID-19267. 
Another example is their collaboration with the Pacific Public Health Surveillance Network. Australia 
and  New  Zealand  actively  support  the  PPHSN,  which  aims  to  improve  the  ability  of  Pacific  Island 
countries to detect and respond to public health threats. They provide training, technical assistance, 
and resources to enhance epidemiological surveillance and laboratory capabilities. 

The Ministry also participates in reinforcing the global health emergency preparedness and response 
architecture. For instance, it is currently involved in a process at the WHO to draft and negotiate a treaty 
on  pandemic  prevention,  preparedness,  and  response  (also  referred  to  as  a  ‘pandemic  treaty’)  with 
other WHO Member States268. 
Furthermore,  through  its  Ministry  of  Health,  New  Zealand  is  heavily  involved  in  strengthening  the 
preparedness  and  response  of  ASEAN  Member  States.  For  example,  in  2022,  during  the  45th 
Anniversary of ASEAN-New Zealand Dialogue Relations, ASEAN and New Zealand reaffirmed their 
commitment to sharing information on infectious diseases to enhance surveillance in the region and to 
cooperate on initiatives to ensure fair and equitable global access to and distribution of MCMs. It is 
noteworthy that New Zealand participated in the Covid-19 ASEAN Response Fund. 
The cooperation with ASEAN also includes joint simulation exercises. Both Australia and New Zealand 
regularly participate in and support joint simulation exercises with Pacific Island countries and ASEAN 
members.  These  exercises  test  and  improve  the  effectiveness  of  national  and  regional  health 
emergency plans, ensuring that countries are better prepared for real health crises. 

Health New Zealand – Te Whatu Ora 
Established in 2022, Te Whatu Ora is the New Zealand public health agency. Its mandate is to lead the 
‘day-to-day running of the health system across New Zealand’, with functions delivered at local, district, 
regional and national levels. 
Regarding HERA’s tasks, Te Whatu Ora cooperates with the Ministry of Health in the supply functions 
(storage  and  distribution)  related  to  the  national  reserve  of  medical  supplies.  Te  Whatu  Ora  is  also 
responsible for the procurement of MCMs. 

267 Australia and New Zealand step up to support Bougainville’s response to the COVID-19 pandemic, Australia High Commission – Papua New 
Guinea 
268 Governments are working towards an outcome by the 77th World Health Assembly in May 2024. 

380 

 
 
 
 
 
 
 
The Ministry of Business, Innovation and Employment 
The  Ministry  of  Business,  Innovation  and  Employment  is  considered  the  central  agency  in  New 
Zealand’s business and employment fields. It is a government body which works to develop and deliver 
on policy, services, and regulation to promote and support business growth. 
In the context of its activities, the MBIE promotes and encourages advanced research and innovation. 
Notably, during the Covid-19 crisis, it created the "Covid-19 Innovation Acceleration Fund" aiming: 

- 

- 

to accelerate the operational deployment of innovative solutions in order to support responses 
to COVID-19 and alleviate the direct impacts of the virus threat,  
to provide rapid short-term support to NZ based entities to develop and more quickly deploy a 
range of new products, processes, or services. 

The MBIE is involved in international cooperation for R&D, for instance the joint initiative between the 
New Zealand MBIE and the European Commission to enhance the engagement of the New Zealand 
research,  science  and  innovation  community  with  the  European  Union’s  Framework  Programme  for 
Research and Innovation. It includes health research and innovation. 

PHARMAC – Te Pātaka Whaioranga 
Te  Pātaka  Whaioranga  –  PHARMAC  mandate  is  “to  secure  the  best  health  outcomes  that  are 
reasonably achievable from pharmaceutical treatment and from within the amount of funding provided”. 
When a health crisis occurs, the agency plays a crucial role in the field of production, procurement, and 
distribution of MCMs. In fact, during the Covid-19 crisis, the agency:  

-  was part of the team that brokered deals for covid-19 vaccines and implementing vaccine rollout, 
- 
ensured  that  hospitals  had  access  to  the  critical  care  medicines  they  need  through  efficient 
distribution. 

The Agency also seeks to enhance the production capacities. At the same period, it supported suppliers 
with guidelines and protocols, to ensure access to medicines. 

ESR – the Institute of Environmental Science and Research 
ESR, the Institute of Environmental Science and Research, is the New Zealand government research 
agency. It is mandated to provide scientific support to prevent, detect and investigate infectious disease 
outbreaks, biological threats, and emerging threats to public and environmental health.  

ESR provides intelligence on notifiable diseases and other serious health threats, such as influenza 
and  antimicrobial  resistance.  It  undertakes  surveillance  of  notifiable  diseases  in  New  Zealand  and 
manages the national notifiable disease database (EpiSurv) on behalf of the Ministry of Health - Manatū 
Hauora. 
ESR  is  responsible  for  the  surveillance  of  notifiable  diseases,  outbreak  surveillance,  sexually 
transmitted infections, influenza viruses, and respiratory, enteric, and herpes viruses. 

Furthermore,  ESR  supports  health  security  coordination  as  a  central  entity  for  communication  and 
information sharing. 
Indeed, ESR maintains a number of key relationships and rapid information sharing mechanisms with 
international technical counterparts through regional and international surveillance networks, including 
the Pacific Public Health Surveillance Network and World Health Organisation initiatives. 

The Public Health Agency - Te Pou Hauora Tūmatanui 
New agency established in 2022, the Public Health Agency aims to lead all public health and population 
health  strategy,  policy,  regulatory,  intelligence,  surveillance,  knowledge  and  monitoring  functions  in 
New Zealand to support the Ministry of Health. 
The Agency conducts health threats analysis and intelligence gathering in collaboration with the ESR. 

381 

 
 
 
 
 
 
 
 
The core mission of the Agency is to support the Ministry of Health in the health security coordination. 
It provides guidelines and is responsible for the Strategic Approach to Health at the Border for Aotearoa 
New Zealand. This strategy suggests that the Agency is in charge of: 

- 

- 

supporting the Ministry as representative for health on the Border Executive Board, an inter-
departmental board established in 2020 to deliver an integrated and effective border system, 
coordinating with Te Whatu Ora, the operational lead for health at the border and to support 
the implementation of a single vision for health at the border, 

-  monitoring  and  reporting  on  how  New  Zealand  is  fulfilling  its  international  obligations  at  the 

border, including the IHR. 

382 

 
 
 
 
III.  Supranational organisations 

1) Africa 

Monitoring, Intelligence Gathering and Analysis 

Name 

Africa CDC 

African Pharmaceutical Technology Foundation 

Indian Ocean Commission (IOC) 

Advanced Research and Development Capacities  

Name 

Africa CDC 

African Pharmaceutical Technology Foundation 

Production / Manufacturing Capacities 

Name 

Africa CDC 

African Pharmaceutical Technology Foundation 

Indian Ocean Commission (IOC) 

Procurement of MCMs  

Name 

Africa CDC 

Indian Ocean Commission (IOC) 

383 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Stockpiling and Distribution Capacities 

Name 

Africa CDC 

Indian Ocean Commission (IOC) 

International Cooperation  

Name 

Africa CDC 

African Pharmaceutical Technology Foundation 

Indian Ocean Commission (IOC) 

Health Security Coordination 

Name 

Africa CDC 

Indian Ocean Commission (IOC) 

384 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
a. Africa CDC 

Key contextual elements 

Date of creation: 
2016 

Member States: African Union Member States, 55 Member States 
which represent all the countries on the African continent. 

Main mission 
Africa  Centres  for  Disease  Control  and  Prevention  (Africa  CDC)  was  established  in  2016,  as  the 
specialized technical institution of the African Union dedicated to support public health initiatives 
of Member States. 
As a continental autonomous health agency of the African Union, Africa CDC aims to strengthen the 
capacity and capability of Africa’s public health institutions as well as partnerships to detect and respond 
quickly  and  effectively  to  disease  threats  and  outbreaks,  based  on  data-driven  interventions  and 
programmes. 
It  supports  African  Union  Member  States  in  providing  coordinated  and  integrated  solutions  to  the 
inadequacies  in  their  public  health  infrastructure,  human  resource  capacity,  disease  surveillance, 
laboratory diagnostics, and preparedness and response to health emergencies and disasters. 

Regarding its organisation, Africa CDC is organized with five regional coordination centres (RCC): 

RCC 

Host Country  Member States 

Central Africa RCC  Gabon 

Eastern Africa RCC  Kenya 

Northern Africa 
RCC 
Southern Africa 
RCC 

Western Africa 
RCC 

Egypt 

Zambia 

Nigeria 

Burundi, Cameroon, Central African Republic, Chad, Congo, 
Democratic Republic of Congo, Equatorial Guinea, Gabon, São Tomé 
and Príncipe 
Union of the Comoros, Djibouti, Eritrea, Ethiopia, Kenya, Madagascar, 
Mauritius, Rwanda, Seychelles, Somalia, Sudan, South Sudan, 
Tanzania, Uganda 
Algeria, Egypt, Libya, Mauritania, Morocco, Sahrawi Arab Democratic 
Republic, Tunisia 
Angola, Botswana, Eswatini, Lesotho, Malawi, Mozambique, Namibia, 
South Africa, Zambia, Zimbabwe 
Benin, Burkina Faso, Cabo Verde, Côte d’Ivoire, Gambia, Ghana, 
Guinea, Guinea-Bissau, Liberia, Mali, Niger, Nigeria, Senegal, Sierra 
Leone, Togolese Republic 

Contextual elements regarding the global situation 
The  African  continent  is  frequently  affected  by  emerging  and  re-emerging  diseases  with  pandemic 
potential such as Ebola, Marburg, Mpox, Measles, Dengue Fever, Cholera, COVID-19, and others269. 
The  2014–2016  Ebola  Virus  Disease  outbreak  in  West  Africa  was  the  catalyst  that  accelerated  the 
commitments  that  led  to  the  establishment  of  Africa  CDC  as  it  highlighted  the  difficulties  of  health 
systems  in  affected  countries  and  the  challenges  of  organizing  well-coordinated  regional  and 
continental responses. African Heads of State and Government launched the Africa CDC in January 
2017, to strengthen public health institutions’ capacity to prevent, detect, control, and respond quickly 
and effectively to disease threats. 
Africa played a crucial role in the Covid-19 response in the continent, coordinating health programs and 
policies, and supporting local production of vaccines, therapeutics, and diagnostics. 
More recently, in 2021, the African Union through Africa CDC launched a framework for action, “A New 
Public Health Order for Africa” aiming to “strengthen the self-sufficiency of African public health systems 
and to address the current global imbalances by augmenting Africa’s collective voice on global health 

269 Spatial and temporal distribution of infectious disease epidemics, disasters and other potential public health emergencies in the World Health 
Organisation Africa region, 2016-2018, Global Health, Jan 2020, doi: 10.1186/s12992-019-0540-4 

385 

 
 
 
 
 
 
 
matters  and  further  enhancing  the  continent’s  efficiency  in  preparedness  and  response  to  disease 
threats”270. 

Activities and tasks 

Monitoring, Intelligence gathering and analysis 
Africa CDC supports the development and testing of multi-hazard and multi-sectoral preparedness and 
response plans for public health emergencies at national, regional, and continental levels. 
Africa CDC supported the preparedness of Member States early when the COVID-19 outbreak started, 
through  surveillance  and  capacity-assessment.  For  instance,  when  early  assessments  revealed  the 
weaknesses in laboratory systems, with only two countries capable of diagnosing the disease (South 
Africa and Senegal), Africa CDC coordinated efforts to train laboratory staff in other Member States and 
provided test kits to enhance the diagnostic capacities. 

Advanced Research and Development capacities 
Africa CDC aims to strengthen public health science and improved public health decision-making and 
practice to achieve positive health outcomes. 

Production / Manufacturing capacities 
One  of  the  pillars  of  the  “New  Public  Health  Order  for  Africa”  framework  seeks  to  expand  local 
manufacturing  of  vaccines,  diagnostics,  and  therapeutics.  Currently,  less  than  1%  of  vaccines 
administered on the continent are manufactured locally. Africa CDC is developing actions to support 
and  enhance  local  production,  with  the  objective  of  having  60%  of  the  continent's  vaccine  needs 
manufactured locally by 2040271. 
More precisely, Africa CDC strategy to achieve this objective is based on: 

-  Encouraging Member States to collaborate with Africa CDC and the African Union Commission 
as they enhance manufacturing capacity and opportunities for all health products in Africa, 
-  Supporting  the  Member  States,  the  Secretariat  of  the  African  Continental  Free  Trade  Area 
(AfCFTA), and the African Union Commission, to manage the rising demand for health products 
manufactured on the continent, 

-  Negotiating  and  collaborating  with  vaccine  procurement  mechanisms,  such  as  GAVI, 
multilateral  institutions,  philanthropic  organisations,  and  other  stakeholders,  to  ensure  their 

270 The New Public Health Order: Africa’s health security Agenda, Press release, Africa CDC, April 2023 
271 Partnerships for African Vaccine Manufacturing (PAVM) Framework for Action, Africa CDC, March 2022 

386 

 
 
 
 
 
 
 
 
commitment  to  purchasing  a  minimum  of  30  percent  of  their  vaccines  from  African 
manufacturers, 

-  Encouraging  governments,  multilateral  organisations,  philanthropic  foundations,  and  other 
stakeholders to remove trade and intellectual property barriers hindering the promotion of local 
production of health products in Africa272. 

Additionally, in February 2024, the African Union voted to broaden the Africa CDC’s mandate to include 
the manufacturing of medicines and diagnostics, in addition to the current remit of vaccines. 

Procurement of MCMs 
Regarding procurement of MCMs, the role of Africa is to ensure quality and efficiency. 
In February 2024, Africa CDC announced leading a pooled procurement initiative in collaboration with 
continental and global partners. This initiative seeks to ensure that African Union member states can 
get better deals on price273. 

Stockpiling and distribution capacities 
One  of  the  strategic  objectives  of  Africa  CDC  is  to  establish  and  manage  national  and  regional 
stockpiles for public health emergency response. 

International cooperation 
Africa  CDC  collaborates  with  international  actors  to  reinforce  the  global  health  emergency 
preparedness and response. For instance, Africa CDC has partnerships with the European Commission, 
UNICEF, CEPI… 

Health security coordination 
Africa CDC plays a crucial part in health security coordination by overseeing the African preparedness 
and response to health crisis, bringing together Member States and relevant stakeholders. 
During  the  Covid-19,  Africa  CDC  played  a  central  role  in  coordinating  the  continent’s  response  by 
supporting informed decision-making and the development of common efforts. 

272 Call To Action: Africa’s New Public Health Order, Africa CDC News, September 2022 
273 Africa CDC Spearheads Bold Move to Secure Africa’s Health Future by Creating a 50 billion Dollar Medical Market, Africa CDC News, February 
2024 

387 

 
 
 
 
 
 
 
 
 
 
 
b. Indian  Ocean  Commission  (IOC),  and  the  SEGA 

One-Health Network 

Key contextual elements 

Date of 
creation: 
1984 

Member  States:  5  South-western  Indian  Ocean  islands: 
Union  of 
the  Comoros,  Réunion/France,  Madagascar, 
Mauritius, and the Seychelles 

Main mission 
The  mission  of  the  Indian  Ocean  Commission  is  ‘to  strengthen  the  links  between  the  islands  of  the 
Indian Ocean region and to support its member states in the path towards sustainable development. 
The  Indian  Ocean  Commission  thus  intervenes  in  areas  where  regional  action  has  a  strong  added 
value’. 

Regarding  public  health,  the  mission  of the  IOC  is  to  improve  health  of  member  states’  populations 
through  better  and  more  intense  cooperation,  collaboration,  integration,  capacity  building  and 
coordination in public health at regional level, by following a comprehensive approach that integrates 
health in all policies. In terms of preparedness and response to health crisis, the IOC efforts mainly 
consists  in  the  RSIE  3  project  and  the  development  of  the  SEGA  One-health network.  The  SEGA 
One-Health network aims to improve Member States’ prevention and response capacities in the face 
of pandemic and epidemic risks. 

Contextual elements regarding the global situation 
The  Union  of  the  Comoros,  Réunion,  Madagascar,  Mauritius  and  the  Seychelles,  all  islands  in  the 
western  Indian  Ocean  and  members  of  the  Indian  Ocean  Commission  (COI),  see  high  volumes  of 
economic, social, and familial exchanges. They also share a common space within which infectious 
diseases circulate, both human- and animal-borne, and are interdependent when it comes to the risk of 
an epidemic. In fact, the Indian Ocean islands are particularly vulnerable to infectious diseases with 
epidemic risks (Zika, Ebola, Chikungunya…) and have faced several disease outbreaks: 

-  Chikungunya epidemic (2006), 
-  Rift Valley fever in Madagascar and Comoros (2007-2008), 
-  Pandemic influenza - A(H1N1) pdm09 (2009), 
-  Dengue fever in Seychelles (2016), 
-  Plague in Madagascar (2017), 
-  Dengue and Measles (2018-2020), 
-  Covid-19, (2020), 
-  Recurring outbreaks of plague, malaria, diseases transmitted by ticks, etc. 

In 2006, the Indian ocean countries have been hardly hit by the major outbreak of chikungunya diseases. 
This  crisis  highlighted  the  difficulties  in  communication  between  the  Ministries  of  Health  of  the  five 
countries.  After  the  outbreak,  it  was  agreed  by  the  country  representatives  within  the  Indian  Ocean 
Commission  to  develop  a  disease  surveillance  network  within  the  region:  the  SEGA  “One  Health” 
regional surveillance and monitoring network, which seeks to promote better anticipation and 
management by Member States in response to health risks. 

388 

 
 
 
 
 
 
 
Activities and tasks 

Monitoring, Intelligence gathering and analysis 
Regional  surveillance  involves  sharing  health  information  among  countries.  This  is  coupled  with 
international health monitoring, conducted by the Indian Ocean Commission. In practice, every month, 
surveillance officials from countries participate in a teleconference hosted by the COI. Each participant 
presents  the  health  situation  in  their  respective  country.  These  teleconferences  also  provide  an 
opportunity to ask questions and exchange experiences. 

Advanced Research and Development capacities 
- 

Production / Manufacturing capacities – only for diagnostic capacities 
The SEGA One-Health network seeks to reinforce to diagnostic capacities. 
In fact, one of the objectives of the network is to "improve diagnostic capabilities for priority diseases". 
This mainly concerns the strengthening of technical platforms at the level of the Member States. Several 
acquisitions  of  laboratory  equipment  and  reagents  have  started  since  2020,  for  the  benefit  of  the 
Comoros, Madagascar, Mauritius, and the Seychelles. These acquisitions will continue, including PCR 
platforms, sequencing devices, training courses, and various reagents. 

Procurement of MCMs 
The Indian Ocean Commission oversees the procurement of MCMs in case of an outbreak. 
For instance, following the emergence of Covid-19 cases in the region, a comprehensive response plan 
was developed in April 2020 by IOC to provide significant support to national response efforts, reflecting 
the  expressed  needs  of  beneficiary  member  states.  It  involved  additional  funding  from  the  AFD, 
primarily allocated to the purchase of medical equipment, protective gear, and medicines for Comoros, 
Madagascar, Mauritius, and Seychelles. 

Stockpiling and distribution capacities 
The  IOC  coordinates  the  distribution  of  MCMs,  by  ensuring,  for  example,  the  delivery  of  batches  of 
equipment via special flights to the Seychelles, Madagascar, and Comoros to support the response to 
Covid-19 in 2020. 
However, there is no evidence of stockpiling of MCMs. 

389 

 
 
 
 
 
 
 
 
 
International cooperation 
The  SEGA  network  collaborates  with  global  partners  (WHO,  FAO…)  mainly  to  reinforce  global 
surveillance and facilitate cooperation and support. 

Health security coordination 
The  SEGA  One-health  Network  seeks  to  promote  regional  cooperation  in  efforts  to  prevent  and 
response to health crisis. 

390 

 
 
 
 
 
 
 
c. African Pharmaceutical Technology Foundation 

Key contextual elements 

Date of creation: 
2022 

Foundation by the African Development Bank   

Main mission 
Established by the African Development Bank as an independent agency, the African Pharmaceutical 
Technology Foundation is dedicated to enhancing the capabilities of African businesses, research 
institutions, and governments to ensure a robust and competitive pharmaceutical industry in 
the region. 
It works with relevant stakeholders (governments, global agencies, industry associations, the private 
sector…) to improve Africa’s access to the technologies needed to discover, develop, and manufacture 
medicines, vaccines, and diagnostics. 

Contextual elements regarding the global situation 
Africa  accounts  for  2%  of  global  research  on  new  infections  and  hosts  just  375  pharmaceutical 
manufacturers, with 15% of these being locally owned. 
Access to basic diagnostics remains limited, with 19% of the African population able to access them, 
and few African manufacturers produce new testing technologies. 

Activities and tasks 

Monitoring, Intelligence gathering and analysis 
The APTF plays a crucial role in technology monitoring and analysis, as part of its mission to assess 
technology alternatives and engage in the search and negotiation for technological advancements. This 
aims  to  strengthen  Africa's  capabilities  in  research  and  development,  as  well  as  manufacturing  of 
pharmaceutical products. 

Advanced Research and Development capacities 
The APTF is committed to advancing R&D capacities across Africa through various strategic initiatives. 
One of its key focuses is on supporting and promoting innovation within the pharmaceutical sector. This 
involves investing in critical regional pharmaceutical infrastructure to create an enabling environment 

391 

 
 
 
 
 
 
 
 
 
for  R&D  activities.  The  APTF  also  provides  resources  and  supports  research  institutions  and 
universities across the continent. 
Furthermore, the foundation actively promotes collaborative linkages among existing R&D initiatives to 
foster  knowledge  sharing  and  synergy.  By  building  stronger  centres  of  excellence  and  networks  for 
basic and translational research, the APTF seeks to accelerate progress in pharmaceutical innovation 
and ultimately improve healthcare outcomes for the people of Africa. 

Production / Manufacturing capacities 
The APTF is dedicated to enhancing pharmaceutical manufacturing capacities across Africa through 
comprehensive support and strategic investments. One of its primary objectives is to provide scale-up 
support  and  capacity  development  initiatives.  This  involves  co-financing  investments  in  both  private 
companies  and  public  sector  institutions  to  facilitate  expansion  and  modernization  of  manufacturing 
facilities. 
Additionally, the APTF collaborates with countries to develop conducive industrial policies that foster 
growth  in  the  pharmaceutical  sector.  Through  targeted  investments  in  critical  pharmaceutical 
infrastructure  and  the  promotion  of  impact-driven  models  of  technology  engagement  at  the  regional 
level, the foundation aims to catalyse sustainable manufacturing practices. 
Lastly, the APTF supports local African companies, facilitating technology acquisition and technological 
upgrading to ensure competitiveness in the global market. 

Procurement of MCMs 
- 

Stockpiling and distribution capacities 
- 

International cooperation 
The APTF seeks to develop partnerships between local and international pharmaceutical companies 
and research institutions to fulfil its goal of enhancing Africa’s pharmaceutical sector. 

Health security coordination 
- 

392 

 
 
 
 
 
 
 
 
 
 
2) Americas 

Monitoring, Intelligence Gathering and Analysis 

Name 

ORAS: the Andean Regional Health Agency 

PAHO: The Pan American Health Organisation 

Advanced Research and Development Capacities  

Name 

ORAS: the Andean Regional Health Agency 

PAHO: The Pan American Health Organisation 

Production / Manufacturing Capacities 

Name 

ORAS: the Andean Regional Health Agency 

PAHO: The Pan American Health Organisation 

Procurement of MCMs  

Name 

CARPHA: Caribbean Public Health Agency 

ORAS: the Andean Regional Health Agency 

PAHO: The Pan American Health Organisation 

Stockpiling and Distribution Capacities 

Name 

CARPHA: Caribbean Public Health Agency 

PAHO: The Pan American Health Organisation 

393 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
International Cooperation  

Name 

ORAS: the Andean Regional Health Agency 

PAHO: The Pan American Health Organisation 

Health Security Coordination 

Name 

ORAS: the Andean Regional Health Agency 

PAHO: The Pan American Health Organisation 

394 

 
 
 
 
 
 
 
 
 
 
 
 
 
a. CARPHA: Caribbean Public Health Agency 

Key contextual elements 

Date of creation: 
2013 

Member States: 
Caribbean Countries (26 member states) 

Main mission 
CARPHA's mandate is to strengthen and reoriente the health system approach so that the Caribbean 
countries are equipped to address the changing nature of public health challenges. The approach is 
people-centred and evidence-based. 
The objectives of CARPHA are: 

- 
- 

- 
- 

- 

- 

to promote the physical and mental health and wellness of people within the Caribbean, 
to provide strategic direction, in analysing, defining, and responding to public health priorities 
of the Caribbean Community, 
to promote and develop measures for the prevention of disease in the Caribbean, 
to  support  the  Caribbean  Community  in  preparing  for  and  responding  to  public  health 
emergencies and threats, 
to  support  solidarity  in  health,  as  one  of  the  principal  pillars  of  functional  cooperation  in  the 
Caribbean Community, 
to support the relevant objectives of the Caribbean Cooperation in Health (CCH). 

Contextual elements regarding the global situation 
The Caribbean region, with the small island developing states, is highly vulnerable to natural hazards 
like  severe  storms,  droughts,  and  floods,  which  are  expected  to  become  more  frequent  with  global 
warming. 
In addition, the population of the Region is undergoing a demographic shift, with the population over 60 
years old expanding rapidly. On a social perspective, The Caribbean is one of the poorest regions of 
the world. Currently, about 32% of people in the Caribbean live below the poverty line. Because of the 
lack  of  economic  growth,  poverty  in  the  Caribbean  is  worsening,  and  the  Caribbean  is  on  track  to 
become the poorest region in the world as soon as 2050.274 

Regarding public health, the region has made progress over the last years, including the elimination of 
indigenous  measles,  scaling  up  the  prevention  and  control  of  HIV…  Nevertheless,  significant 
challenges remain and represent important health threats. Infectious diseases, such as dengue fever, 
are an important burden in the region275. 

Recognizing that many cost-effective public health solutions require multiple sectors to take joint action, 
the  member  states  decided  to  establish  CARPHA.  CARPHA  was  created  from  the  merger  of  five 
Caribbean Regional Health Institutes into a single agency with the aim of forming "one single strong 
force" to address issues needing a regional response276. 

274 5 facts about poverty in the Caribbean, The Borgen Project, Aug. 2023 
275 Strategic Plan 2018-2020, CARPHA 
276 CARPHA booklet 

395 

 
 
 
 
 
 
 
 
Activities and tasks 

Monitoring, Intelligence gathering and analysis 
- 

Advanced Research and Development capacities 
- 

Production / Manufacturing capacities 
- 

Procurement of MCMs 
During the Covid-19 crisis, one of the goals of the Caribbean Cooperation in health was to facilitate 
centralized  procurement  of  medical  devices  and  supplies  specifically  for  addressing  the  challenges 
posed by the pandemic. 
Another project of the CARPHA, titled "Health Systems Strengthening for CARICOM Member States to 
Respond  to  the  COVID-19  Pandemic  and  Other  Emerging  and  Re-emerging  Threats,"  included 
activities  aimed  at  procuring  and  distributing  PPE  and  related  supplies  to  prevent  and  respond  to 
COVID-19, as well as activities which aim to strengthen regional capacity for laboratory diagnostic and 
genome  sequencing  for  COVID-19  and  other  emerging  and  re-emerging  threats  within  CARICOM 
Member States. 

Stockpiling and distribution capacities 
Regarding the distribution of MCMs during the Covid-19 crisis, The Caribbean Public Health Agency 
(CARPHA) provided vaccine allocation guidelines, based on a formula for the equitable distribution of 
three vaccine types. 
No evidence of a stockpiling strategy. 

International cooperation 
- 

Health security coordination 
- 

396 

 
 
 
 
 
 
 
 
 
 
 
 
b. ORAS: the Andean Regional Health Agency 

Key contextual elements 

Date of creation: 
1971 

Member States:  
6 Andean countries: Bolivia, Chile, Colombia, 
Ecuador, Peru, Venezuela 

Main mission 
ORAS  is  a  subregional  integration  body  within  the  Andean  Integration  System.  Its  objective  is  to 
coordinate and support the efforts made by member countries, individually or collectively, to improve 
the health of their populations. 
It aims to establish the right to health as the central axis of human development, strengthening regional 
integration  and  cooperation,  promoting  social  and  environmental  justice,  reducing  inequalities  and 
inequities, strengthening national health systems, building health sovereignty, and promoting research 
with gender, intercultural, territorial, generational, and life course perspectives. 

Contextual elements regarding the global situation 
The countries of the Andes Mountains regularly face disease outbreaks. Dengue is present in the overall 
context  of  the  Americas,  and  the  Andean  subregion  reported  a  203%  increase  in  EW  15  in  2024 
compared to the average of the last 5 years277.  
The Andean subregion is also exposed to natural disasters that have significant impacts on public health, 
such as earthquakes, floods, and droughts, whose frequency tends to increase with global warming278. 

The Andean region has established cooperation for health crisis preparedness and response for several 
years.  A  relevant  example  is  the  Andean  Initiative  for  Chagas  Disease,  created  in  1997  by  the 
association of four countries: Peru, Ecuador, Colombia, and Venezuela. This initiative aimed to interrupt 
vector-borne  and  transfusion  transmission  of  the  Chagas  Disease  through  technical  cooperation  on 
diverse subjects: vector-control activities, dissemination of reports and methodologies on prevention, 
control,  surveillance,  sharing  information  of  blood  blank  risk-management,  strategies  to  provide 
accessible, timely and effective care to infected patient…279 

Activities and tasks 

277 Report on the epidemiological situation of dengue in the Americas, PAHO, May 2024 
278 Andean strategy for disaster management, Andean Community, 2017 
279 Andean subregional Chagas disease area and the Andean Initiative of Chagas Disease, Archives of the Oswaldo Cruz Institute, October 2007 

397 

 
 
 
 
 
 
 
 
 
 
Monitoring, Intelligence gathering and analysis 
ORAS supports its member states in analysing health threats and evaluating potential consequences 
and impacts on public health. 
To assist its member states in decision-making during health crises, ORAS has established a platform 
called  the  "Regional  Genomic  Surveillance  Observatory"  which  utilizes  genomic  surveillance  for 
monitoring and serves in the analysis and dissemination of findings. It provides comparable data among 
member states through standardized processes and aims to assist in decision-making at both political 
and technical levels. 

Furthermore,  ORAS  has  facilitated  the  implementation  of  the  Andean  Medicines  Observatory,  a 
platform  containing  information  on  medication  access,  quality,  effectiveness,  and  safety,  rational 
medication use, and research and development. This platform was established as a "measure for the 
public and transparent management of medication information in the countries"280. 

Advanced Research and Development capacities 
ORAS  promotes  and  encourage  R&D  for  the  develop  of  effective,  safe,  and  affordable  MCMs  and 
related technologies in the region. 
In its Andean Medicines Policy, ORAS mentions the following objectives: 

-  Prioritize  and  incentivize  the  development  and  production  of  medicines  that  address  public 

health needs in the subregion. 

-  Develop and strengthen information, monitoring, and evaluation systems in the pharmaceutical 

sector. 

-  Promote  R&D  of  pharmaceutical  technologies,  particularly  new  pharmaceutical  forms  to 

improve treatment adherence. 

-  Facilitate  the  progression  from  basic  research  to  applied  research  for  traditional  natural 

products, with an emphasis on medicinal plants in the countries of the subregion281. 

Production / Manufacturing capacities 
Since its establishment in 1971, ORAS has recognized that the high cost of medicines posed a serious 
challenge both in the development of health programs and in managing health crises. Therefore, as 
early as 1971, ORAS and its member states signed a resolution with the objective of increasing the 
production capacity of the pharmaceutical industry to achieve self-sufficiency in the Andean Area and 
thus  guarantee  the  protection  of  the  population's  health.  Until  this  goal  is  achieved,  ORAS  aims  to 
facilitate  collaboration  channels  between  member  countries  for  the  exchange  of  technology  and  the 
supply of biological products. More recently, the Andean Medicines Policy of ORAS incorporated the 
promotion and incentivization of medicine production. 

ORAS  worked  on  strengthening  laboratory  diagnostics  capacities  in  the  Andean  region.  The 
"Strengthening Tuberculosis Laboratory Diagnostics in the Americas Region" program, funded by the 
Global Fund, aimed to improve the quality of TB diagnosis in laboratory networks across the Americas 
by  enhancing  the  installed  capacity  in  the  region.  This  program,  executed  by  the  ORAS,  began  in 
November  2020  and  concluded  in  October  2023,  involving  17  countries  in  the  Andean  and  Central 
American regions.282. 

280 ORAS official information 
281 Andean Medicines Policy, ORAS, 2017 
282 3  countries  with  Supranational  TB  Reference  Laboratories  :  Argentina,  Chile,  and  Mexico;  and  14  countries  with  National  TB  Reference 
Laboratories : Bolivia, Colombia, Ecuador, El Salvador, Guyana, Guatemala, Haiti, Honduras, Nicaragua, Paraguay, Peru, the Dominican Republic, 
Suriname, and Venezuela 

398 

 
 
 
 
 
 
 
 
Procurement of MCMs 
ORAS supports its member countries for the negotiation and procurements of medicines and supplies 
at the Andean regional level. During the period 2005-2010, ORAS facilitated joint procurement of MCMs 
(medicines, diagnostics, etc.) to combat malaria in the region and negotiated affordable prices. 

Stockpiling and distribution capacities 
- 

International cooperation 
ORAS is committed to enhancing the global health emergency preparedness and response framework, 
with a particular focus on the Americas region. The "Strengthening Tuberculosis Laboratory Diagnostics 
in the Americas Region" program is being carried out in collaboration with Argentina, Mexico, Nicaragua, 
and other countries. 

Health security coordination 
ORAS supports its member states in health security coordination by providing guidelines to national 
and local governments to prepare for and respond to health crises.  

399 

 
 
 
 
 
 
 
 
c. PAHO: The Pan American Health Organisation 

Key contextual elements 

Date of creation: 
1902 

Member States:  
35  Member  States  in  the  Americas  and  4  Associate 
Members (Aruba, Curaçao, Puerto Rico, Sint Marteens). 

Main mission  
The Pan American Health Organisation (PAHO) is the specialized international health agency for the 
Americas. It works with countries throughout the region to improve and protect people's health. PAHO 
also serves as the Regional Office for the Americas of the WHO. 
PAHO  engages  in  technical  cooperation  with  its  member  countries  to  fight  communicable  and 
noncommunicable  diseases  and  their  causes,  to  strengthen  health  systems,  and  to  respond  to 
emergencies and disasters. 
PAHO is dedicated to guaranteeing universal access to timely, quality healthcare without the fear of 
failing into poverty, ensuring that individuals receive the care they require when needed. Through its 
work, PAHO advocates for and reinforces the fundamental right of every individual to enjoy good health. 

Contextual elements regarding the global situation 
The  necessity  to  control  epidemics  to  safeguard  public  health  and  national  economies  led  to  the 
establishment of PAHO in 1902, following a severe yellow fever epidemic. Indeed, in 1870, a yellow 
fever epidemic hit Brazil, Paraguay, Uruguay, and Argentina, and within eight years, it had reached the 
United States, killing over 20,000 people due primarily to the rapid expansion of maritime transport and 
international trade at the end of the 19th century283. 

In more recent history, the Region of the Americas frequently experience infectious diseases epidemic. 
For instance, in the first months of 2024, Brazil, Argentina, and Paraguay have been hit in what PAHO 
officials have described as potentially the worse outbreak in the Americas to date284.  
PAHO aims to ensure that each Member State builds its own preparedness and response capabilities. 

Activities and tasks 

283 History of PAHO, PAHO 
284 PAHO calls for collective action in response to record increase in dengue cases in the Americas, PAHO news, March 2024 

400 

 
 
 
 
 
 
 
 
 
 
 
Monitoring, Intelligence gathering and analysis 
PAHO collects data and provides guidelines (including on MCMs) to ensure that Member States receive 
evidence-based guidance, tools, and equipment to adequately manage cases and protect healthcare 
workers from the infection. 

Advanced Research and Development capacities 
PAHO aims to promote R&D and facilitate research on critical knowledge gaps.  

Production / Manufacturing capacities 
Through its Special Program, Innovation and Regional Production Platform (RP) in the Department of 
Innovation,  Access  to  Medicines  and  Health  Technologies  (IMT),  PAHO  aims  to  enhance  the 
communication  and  knowledge  exchange  to  identify  opportunities  for  regional  cooperation  with  the 
objective of increasing the production capacities of medicines and other essential health technologies, 
including vaccines, to contribute to equitable access to these products. 
The platform will foster research and incentivize the development and manufacturing of essential and 
strategic health technologies in the Americas, expanding manufacturing capacities to ensure access to 
safe, effective, and quality products, facilitating information exchange and foster cooperation between 
partners and countries. 

Procurement of MCMs 
In case of health emergency, PAHO can procure laboratory materials, including extraction DNA kits, 
primers and probes, enzymes, and other essential materials to ensure secured access to supplies to 
Member States. 

Stockpiling and distribution capacities 
PAHO provides guidelines to Member States about stockpiling of MCMs and distribution. 

International cooperation 
PAHO  establishes  international  partnerships  to  reinforce  the  global  emergency  preparedness  and 
response architecture. Examples of its partners are USAID, Health Canada, AECID (Spanish Agency 
for International Development Cooperation). 

Health security coordination 
PAHO provides leadership, coordination, and logistical support for the emergency response phase of 
the epidemics in the Region. 
For instance, the Preparedness and Resilience against Emerging Threats (PRET) initiative, organized 
by PAHO, which brings together Bolivia, Colombia, Guatemala, Mexico, and Saint Lucia. This initiative 
aims to provide comprehensive guidance to countries to strengthen health emergency preparedness, 
response coordination, sustainable financing, and core capacities for responding to future public health 
events. 

401 

 
 
 
 
 
 
 
 
 
 
 
 
 
3) Asia 

Monitoring, Intelligence Gathering and Analysis 

Name 

ASEAN: The Association of Southeast Asian Nations 

Gulf-Centre for Disease Prevention and Control 

Advanced Research and Development Capacities  

Name 

ASEAN: The Association of Southeast Asian Nations 

Gulf-Centre for Disease Prevention and Control 

Production / Manufacturing Capacities 

Name 

ASEAN: The Association of Southeast Asian Nations 

Gulf-Centre for Disease Prevention and Control 

Procurement of MCMs  

Name 

ASEAN: The Association of Southeast Asian Nations 

Gulf-Centre for Disease Prevention and Control 

Stockpiling and Distribution Capacities 

Name 

ASEAN: The Association of Southeast Asian Nations 

Gulf-Centre for Disease Prevention and Control 

402 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
International Cooperation  

Name 

ASEAN: The Association of Southeast Asian Nations 

Gulf-Centre for Disease Prevention and Control 

Health Security Coordination 

Name 

ASEAN: The Association of Southeast Asian Nations 

Gulf-Centre for Disease Prevention and Control 

403 

 
 
 
 
 
 
 
 
 
 
 
 
a. ASEAN:  The  Association  of  Southeast  Asian 

Nations 

Key contextual elements 

Date of creation: 
1967 

Member States: 
10  Southeast  Asian  countries:  Thailand,  Vietnam,  Singapore, 
Philippines,  Malaysia,  Lao  PDR,  Myanmar,  Indonesia,  Cambogia, 
Brunei 

Main mission 
ASEAN was established in 1967, with the aims and purposes of:  

-  Accelerating the economic growth, social progress, and cultural development in the region, 
-  Promoting regional peace and stability, as well as active collaboration and mutual assistance 

on matters of common interest, 

-  Facilitating the collaboration, to encourage further growth in the agriculture, industry, and trade 

sector, and promote Southeast Asian studies, 

-  Maintaining  close  and  beneficial  cooperation  with  existing  international  and  regional 
organisations  with  similar  aims  and  purposes  and  explore  all  avenues  for  even  closer 
cooperation among themselves. 

The ASEAN Health Sector seeks to "achieve a healthy and caring ASEAN Community, wherein the 
people achieve maximal health potential through the promotion of healthy lifestyles; responding to all 
hazards and emerging threats; strengthening health systems and access to care; and ensuring food 
safety in the region. Other priorities for the ASEAN Health Sector also include universal access to quality 
care and financial risk protections, as well as ensuring sustainable inclusive development where health 
is incorporated in all policies." 

Contextual elements regarding the global situation 
The  ASEAN  region  is  recognized  as  a  global  hotspot  for  viral  outbreaks,  due  to  various  such  as 
population  growth,  deforestation,  pollution,  industrialization,  water  and  sanitation  issues,  poverty  in 
some  regions  and  communities…  Some  countries  also  struggle  with  the  dual  burden  of  non-
communicable  and  communicable  diseases,  as  well  as  emerging  infectious  diseases 285 .  These 
challenges are compounded by the region's vulnerability to natural disasters, which disproportionately 
affect disadvantaged communities, exacerbating the impacts of climate change. 
Moreover, inequitable access to affordable, appropriate, and quality healthcare also remains an issue 
between and within AMS in the region. 

In  terms  of  medical  countermeasures,  the  region  consistently  faces  several  difficulties  to  ensure 
continuous access to medicines for the population. This includes disruptions in the availability of some 
essential medicines, particularly those required to treat infectious diseases, which are often deemed 
economically  unviable  to  produce  due  to  low  demand.  Consequently,  these  essential  medicines 
become inaccessible. As these medicines are essential for treatments, when supply is disrupted, the 
Member States seek alternative solutions, often resulting in higher costs and potential compromises in 
product quality. 

285 Strengthening  Virology Research  in the  Association  of Southeast  Asian Nations: Preparing  for  Future Pandemics,  The  American Journal  of 
tropical medicine and hygiene 105(5), September 2021, doi :10.4269/ajtmh.21-0589 

404 

 
 
 
 
 
 
 
 
The  ASEAN  projects  in  public  health  include  the  ‘ASEAN  Drug  Security  and  Self-Reliance’  project 
(ADSSR), which seeks to enhance to collaboration between the AMS to improve the drug security and 
self-reliance in the region286. 

Activities and tasks 

Monitoring, Intelligence gathering and analysis 
The ASEAN Health Sector seeks to facilitate the sharing of information for preparedness and response 
to health emergencies.  
For instance, during the Covid-19 crisis, the ASEAN Health Sector aimed to facilitate the sharing of 
preparedness  and  response  strategies,  best  practices,  lessons  learned,  as  well  as  operational 
challenges, gaps, and needs through video conferences and webinars among ASEAN Member States 
and international partners (such as the US, Italy, France, etc.). 

Advanced Research and Development capacities 
The  ASEAN  Health  Sector  promotes  R&I  initiatives  to  enhance  the  preparedness  and  response  to 
health  emergencies.  For  instance,  during  the  Covid-19  pandemic,  R&I  projects  with  the  European 
Commission have been conducted among research and academic institutions of the ASEAN and EU 
regions. 

Production / Manufacturing capacities 
During the Covid-19 crisis, the ‘Hanoi Plan of Action on Strengthening ASEAN Economic Cooperation 
and Supply Chain Connectivity in Response to the COVID-19 Pandemic’ (June 2020) included support 
and cooperation in the production of COVID-19 medicines and vaccines. 
Moreover, the ADSSR framework (previously mentioned) will include manufacturing to enhance drug-
security and self-reliance in the region. At this stage of the study, publicly available information has not 
provided further details. 

Procurement of MCMs 
During the Covid-19 crisis, the ‘Hanoi Plan of Action on Strengthening ASEAN Economic Cooperation 
and Supply Chain Connectivity in Response to the COVID-19 Pandemic’ (June 2020) also included 
cooperation on enabling the trade of important goods (food, medicines, medical equipment, and other 
related products). 

286 Situational  Analysis  and  Feasibility  of  Regional  Collaboration  to  Improve  ASEAN  Drug  Security  and  Self-Reliance  (ADSSR),  The  ASEAN 
Secretariat, Jakarta, December 2022 

405 

 
 
 
 
 
 
 
 
 
 
Furthermore,  the  ADSSR  project  includes  medicines  procurement  and  pricing.  The  strategy  in  this 
domain of the ADSSR is to ensure the uninterrupted and timely supply of medicines. The goals are to 
enhance  collaboration  among  the  Member  States  and  strengthen  the  procurement  capability  are 
needed  to  ensure  that  medicines  are  available  and  in  continuous  supply  in  both  normal  times  and 
emergencies. 
The  ADSSR  also  encourages  price  transparency  among  the  Member  States  and  to  strengthen 
procurement management. 

Stockpiling and distribution capacities 
During the COVID-19 crisis, the ASEAN ensured the provision of medical supplies and equipment at 
bilateral and regional levels, cooperating with China, Canada, and South Korea. 
The  ‘Hanoi  Plan  of  Action  on  Strengthening  ASEAN  Economic  Cooperation  and  Supply  Chain 
Connectivity in Response to the COVID-19 Pandemic’ also included cooperation on improving access 
to COVID-19 medicines and vaccines through the strengthening of supply chain connectivity. 

International cooperation 
The ASEAN seeks to reinforce the global health emergency preparedness and response architecture, 
participating in several initiatives with international partners: 

-  Technical  assistance  and  exchanges,  and  provision  of  medical  supplies  and  equipment  at 
bilateral and regional levels with China, South Korea, Canada, and Germany during the Covid-
19 crisis, 

-  Working  relationship  with  the  WHO  WRPO  and  WHO  SEARO,  which  support  the  ASEAN 

efforts to improve the regional coordination, 

-  Discussions with multilateral key actors (ex: Gavi, the Vaccine Alliance on the Global COVID-
19 Vaccine Access Facility to ensure COVID-19 vaccine supplies and distribution for the region). 

For instance, ASEAN launched in 2023 the ASEAN One Health Joint Plan of Action (2023-2030) 
with the objectives of: 

-  Guiding the ASEAN One Health Network in facilitating and streamlining the implementation and 

resource mobilisation for identified OH priorities, 

-  Serving  as  reference  for  the  ASEAN  Member  States  in  developing  and  implementing  their 

respective national One Health plans of actions or equivalent, 

-  Strengthening the health of humans, animals, plants, and environment, as well as food safety, 
and  AMR,  through  cross-sectoral  collaboration  between  the  relevant  sectors,  (including 
bilateral and multilateral cooperation). 

- 

In addition, ASEAN and the EU have a 45 years-partnership, with includes health matters. 
The plan of action to implement the 2023-2027 ASEAN-EU partnership includes the following actions: 
the enhancement of the cooperation in addressing the challenges of communicable diseases 
and emerging infectious and zoonotic diseases, including pandemics, 
the improvement of the effectiveness of regional surveillance and response towards emerging 
infectious diseases, including tropical diseases, 
the strengthening of both regions ‘preparedness for and capacity to respond effectively to public 
health emergencies. 

- 

- 

Health security coordination 
The ASEAN Health Sector aims to enhance the health security coordination in the region. 
The ‘ASEAN Strategic Framework for public health emergencies’ (2020) seeks to enhance ASEAN’s 
preparedness, detection, response, and resilience to public health emergencies. It aims to strengthen 
ASEAN’s cooperation in enhancing regional health security287. 

287 The ASEAN Strategic Framework for public health emergencies, 2020 

406 

 
 
 
 
 
 
 
 
b. Gulf-Centre for Disease Prevention and Control 

Key contextual elements 

Date of 
creation: 
2021 

Member States: 
Member states of the Gulf Cooperation Council (The Kingdom of 
Bahrain,  Kuwait,  the  Sultanate  of  Oman,  Qatar,  Saudi  Arabia,  the 
United Arab Emirates) 

Main mission 
The Gulf-Centre for Disease Prevention and Control (Gulf CDC) is the semi-autonomous technical body 
of the Gulf Health Council, established in 2021. 
It  aims  to  promote  coordination,  build  knowledge,  and  generate  evidence  to  enable  prevention  of 
communicable  and  non-communicable  diseases,  mitigate  public  health  emergencies,  and  promote 
healthy communities across the Gulf. 

Contextual elements regarding the global situation 
The  establishment  of  the  Gulf  CDC  reflects  the  Gulf  countries'  recognition  of  the  importance  of 
enhancing their capacities regarding MCMs to effectively respond to health crises. Gulf countries have 
been investing in R&D initiatives to develop their own MCMs, particularly vaccines, therapeutics, and 
diagnostic tools, to address regional health challenges. 
These countries have also been actively engaging in international partnerships and collaborations to 
leverage expertise and resources for MCM development. Additionally, Gulf nations have been working 
to strengthen their regulatory frameworks to ensure the safety, efficacy, and quality of MCMs produced 
and used within their borders. 

Activities and tasks288 

Monitoring, Intelligence gathering and analysis 
Gulf CDC aims to promote regional training, support the development of practices and collaborative 
programs.  Gulf  CDC  is  tasked  with  providing  global,  all-health  hazards  situational  awareness,  risk 
assessment and surveillance for the 6 Member States.  
In addition, the entity provides scientific advice on medical countermeasures to prepare for and respond 
to a specific health emergency. 

288 Gulf CDC official web site: https://gulfcdc.org/en 

407 

 
 
 
 
 
 
 
 
 
Advanced Research and Development capacities 
One of the goals of Gulf CDC is to "promote the principle of cooperation in conducting research studies 
related to public health of priority and coordination among its members". 
More specifically on MCMs, Gulf CDC ensures research prioritization and advocacy for regional public 
health research. The organisation also shares information across the Member States on R&D. 

Production / Manufacturing capacities – advocacy only 
As part of Gulf CDCs role in regional health hazards preparedness, Gulf CDC has a role in advocating 
for local manufacturing and production capacities. 
For this task, the role of Gulf CDC is limited to advocacy, and the organisation does not handle the 
coordination or implementation of projects. 

Procurement of MCMs 
Gulf CDC does not directly intervene in the procurement of MCMs. However, the Gulf CDC is part of 
the Gulf Health Council, which operates one of the oldest regional joint procurement programs. Gulf 
CDC plays a role in providing scientific advice for the joint procurement. The Gulf CDC has a role in 
scientific advice for the joint procurement. 

Stockpiling and distribution capacities 
Gulf CDC supports the Gulf Health Council to coordinate and monitor national stockpiling efforts in the 
Member States. 

International cooperation 
Gulf CDC aims to establish collaboration agreements to reinforce the global health preparedness and 
response  architecture.  The  organisation  has  already  established  cooperation  agreements  with 
international partners. 
For  instance,  in  February  2024,  it  signed  a  cooperation  agreement  with  the  United  Kingdom  Health 
Security Agency (UKHSA), with ‘the aim of exchanging experiences and best practices in the field of 
public health289. Gulf CDC is also linked with WHO EMRO and HQ preparedness activities and aims to 
enhance  common  positions  of  Gulf  CDC  Member  States  in  international  negotiations  related  to 
pandemic preparedness. 

Furthermore,  Gulf  CDC  is  willing  to  develop  other  collaborations,  and  is  interested  in  exploring 
possibilities for EU-Gulf CDC collaboration in these fields.  

Health security coordination 
The  Gulf  CDC  seeks  to  enhance  the  health  security  coordination  among  the  gulf  countries,  mainly 
through knowledge sharing and science-based advice. 
During preparedness phase, the organisation coordinates the Member States preparedness efforts and 
supports them in building their own preparedness and response capacities. In case of health crisis, Gulf 
CDC coordinates and supports its member states response and emergency management efforts. 

289 GCDC Prevention signs a cooperation agreement with the United Kingdom Health Security Agency to promote public health, Press release, Gulf 
CDC, February 2024 

408 

 
 
 
 
 
 
 
 
 
 
 
4) Europe 

a. Nordic Pharmaceutical Forum 

Key contextual elements 

Date of 
creation: 
2015  

Member States: 
5 Nordic countries: Finland, Iceland, Norway, 
Sweden, Denmark 

Main mission 
The mission of Nordic Pharmaceutical Forum is to “ensure timely access to the right pharmaceuticals 
to the right price for patients in the five Nordic countries”. Its ambition is to become a “recognized Nordic 
collaboration, developing and delivering sustainable solutions to supply medicines to the public sector.” 

The  Nordic  Pharmaceutical  Forum  is  a  voluntary  cooperation  between,  primarily,  procurement 
organisations in the five Nordic Countries. The organisations in the Nordic Pharmaceutical Forum 
are: 

  Amgros I/S, Denmark, the centralized procurement organisation for hospital medicines, 
  Sykehusinnkjøp  HF,  Norway,  the  centralized  procurement  organisation  for  e.g.  hospital 

medicines 

  Norwegian Medical Products Agency, 
  Swedish Association of Local Authorities and Regions (SALAR), 
 
  Landspítali, Iceland, 
  HUS Pharmacy, HUS Group, the joint authority for Helsinki and Uusimaa, Finland. 

Icelandic Medicines Agency, 

The cooperation ensures knowledge sharing and facilitates joint initiatives across countries, like 
joint procurement and joint price negotiations. 

Contextual elements regarding the global situation 
The rationale behind the establishment the Nordic Pharmaceutical Forum stemmed from several shared 
challenges across the Nordic countries: 

-  Escalating  medication  expenses  due  to  demographics,  the  emergence  of  new  treatment 

modalities, and the introduction of innovative yet costly drugs, 

-  Growing supply difficulties, 
-  Limited market size, as the Nordic nations face less leverage in pricing negotiations compared 

to larger markets, 

-  Greater efforts required to maintain attractiveness for industry investments due to the relatively 

small market size. 

409 

 
 
 
 
 
 
 
Activities and tasks 

Monitoring, Intelligence gathering and analysis 
While each member of the NPF conducts its own horizon scanning activities, the Nordic Pharmaceutical 
Forum ensures knowledge sharing and collaboration in this area in the objective of providing for a better 
understanding of the products that are forthcoming. 

Additionally,  the  Forum  aims  to  facilitate  knowledge-sharing  among  Member  States  concerning 
strategic initiatives aimed at enhancing supply security in each country. Subsequently, member states 
and  organisations  within  the  Nordic  Pharmaceutical  Forum  engage  in  knowledge-sharing  regarding 
strategic and practical initiatives aimed at enhancing supply security in each respective country. 

Advanced Research and Development capacities 
- 

Production / Manufacturing capacities 
As  part  of  the  "security  of  supply"  objective,  the  Nordic  Pharmaceutical  Forum  aims  to  strengthen 
cooperation  between  Nordic  countries  to  produce  safe  and  effective  medicines.  Specifically,  the 
manufacturing conducted by hospital pharmacies in the Nordic countries is crucial for ensuring patient 
access to treatments. It plays a vital role in maintaining the region's preparedness for a future crisis 
given that hospital pharmacies produce unlicensed pharmaceutical preparations and pharmaceuticals 
tailored for individual patients or small patient groups with specific needs that cannot be addressed by 
commercially available products. 
Thus, the Nordic Pharmaceutical Forum seeks to look at opportunities for collaboration within the Nordic 
countries for the development and production of unlicensed pharmaceutical preparations, especially in 
case of medical shortages. 

Moreover,  the  Nordic  Pharmaceutical  Forum  has  discussed  the  potential  for  sharing/selling  locally 
produced pharmaceuticals to each other in crisis situations. However, this would require new legislation 
and involvement from the authorities. 
The  Nordic  Pharmaceutical  Forum  has  also  attempted  to  create  an  overview  of  product  types, 
illustrating schematically which production facilities are available in the Nordic countries. However, the 
overview has not been completed yet.  

410 

 
 
 
 
 
 
 
 
 
Finally, the Nordic Pharmaceutical Forum is sharing knowledge and information on how to handle day 
to  day  backorders  and  supply  failures.  Also,  the  Nordic  Pharmaceutical  Forum  discusses  potential 
strategic initiative that could be taken to ensure better security of supply in the Nordics. 

Procurement of MCMs 
The Nordic Pharmaceutical Forum supports efforts of its member organisations to collaborate on joint 
Nordic procurement of medicines to ensure that patients in the Nordic countries have access to primarily 
older medications. It is believed that joint procurement can create a larger and more attractive market 
for suppliers, resulting in better security of supply and possibly better prices. These joint procurements 
have mainly focused on older pharmaceuticals. 
Additionally, the organisations within the Nordic Pharmaceutical Forum collaborate on procuring 'new, 
often  promising,  and  expensive  medicines'.  It  consists  of  sharing  knowledge  and  engage  in  joint 
negotiations  on  new  pharmaceuticals  (e.g.,  Zynteglo,  a  gene  therapy  for  the  treatment  of  beta 
thalassemia, 2020). The purchasing organisations behind the Nordic Pharmaceutical Forum recently 
approved common guidelines and criteria for joint price negotiations on new medicines. 

Amgros in Denmark, Sykehusinnkjøp in Norway and Landspítali in Iceland have carried out four joint 
Nordic procurements. The cooperation has dialogue with suppliers and follews EU-rules for tendering. 

However, there is no specific process for joint procurement during a public health crisis. 

Stockpiling and distribution capacities 
Supply security is of utmost importance to the Nordic Pharmaceutical Forum, as it guarantees timely 
access to medications for patients across the five Nordic countries. 
To address supply chain difficulties, the Forum shares knowledge on how to handle, operationally, day-
to-day supply problems. The focus has mostly been on back orders and short-term initiatives. 
In its strategy for 2023-2025, the Nordic Pharmaceutical Forum estimates that the Member States would 
benefit from knowledge-sharing on more strategic subjects to improve the security of supply.  

Regarding  stockpiling,  the  Forum  mentions  in  its  strategy:  “it  may  be  relevant  for  the  Nordic 
Pharmaceutical Forum to discuss whether there is a possible need to establish a common Nordic stock 
of pharmaceuticals in order to improve security of supply across the Nordics”. 
Regarding this subject, the Nordic Pharmaceutical Forum informed the study team that at the time of 
conducting this study, the project has not progressed and is still under consideration. However, if this 
idea were to materialize, there would likely be a requirement for legal adoption. 

International cooperation 
The  Nordic  Pharmaceutical  Forum  aims  to  contribute  to  reinforcing  the  global  health  emergency 
preparedness and response architecture. 
The Nordic Pharmaceutical Forum is, through some of the member organisations, engaged in various 
EU  initiatives  like  the  Critical  Medicines  Alliance.  Also,  the  Nordic  Pharmaceutical  Forum  shares 
knowledge and experiences in EU, like the NCAPR, for a when asked. 

Additionally, the organisation seeks to cooperates with the EU and its Member States on MCMs. For 
example,  the  Forum  ambitions  to  “draw  attention  to  the  need  for  legislation  at  EU  level  to  enable 
stockpiling of unlicensed pharmaceutical preparations” (as mentioned in its strategy). 

Health security coordination 
- 

411 

 
 
 
 
 
 
 
 
 
 
 
Other relevant information 

Relations / actions with HERA and other organisations 
HERA has visited the Nordic Pharmaceutical Forum in January 2024 to learn about how the Nordic 
countries  organise  tendering  procedures  and  about  their close collaboration  to secure  the supply  of 
medicines in Nordic countries290. 

290 Press article published on January 26, 2024, on the NPF official website. 

412 

 
 
 
 
 
5) Supraregional organisations 

a. The Medical Countermeasures Consortium 

Key contextual elements 

Date of creation: 
2012 

Status: 
4-nation partnership between Australia, Canada, the UK and the USA 

Main mission 
The  Medical  Countermeasures  Consortium  is  a  four-nation  partnership  involving  the  Defence  and 
Health Departments of Australia, Canada, the United Kingdom and the United States. 

The Consortium seeks to develop medical countermeasures to assist with all-hazard preparedness and 
response for the participant countries. 
Initially,  the  emphasis  of  the  Consortium  is  on  chemical,  biological  and  radiological  (CBR)  threats 
affecting civilian and military populations. It has been expanded to include emerging infectious diseases 
and pandemics. 

Contextual elements regarding the global situation 
The strategic drivers of the Medical Countermeasures Consortium have been defined by the traditional 
issues  associated  with  medical  countermeasure  development  and 
include  burden  sharing, 
nontraditional development methods and overcoming the strategy gap. 

Activities and tasks 

Monitoring, Intelligence gathering and analysis 
- 

Advanced Research and Development capacities 
The Medical Countermeasures Consortium focuses on sharing information and cooperation regarding 
the advanced development of MCMs (drugs, vaccines, and diagnostics) that are already at Technology 
Readiness Levels 5-8. 
Its goal is to enable participating countries to stay abreast of diagnostic and therapeutic developments, 
to act swiftly in deploying appropriate treatments, and to achieve significant cost savings by accessing 
the results of joint research and development with other countries. 

413 

 
 
 
 
 
 
 
 
 
 
 
 
This Consortium leads to enhanced cooperation between entities of member countries to share information and 
identify innovations for MCMs. 
For instance, ASPR has integrated the defence and health departments of the four member nations of the MCMC 
into the Portfolio Tracking and Coordination Initiative (PTCI), enabling portfolio data interoperability and providing 
appropriate access to data and information. 
Additionally, the MCMC is part of the Subject Matter Experts consulted by The Public Health Agency of Canada as 
it manages the National Emergency Strategic Stockpile, for the identification of gaps by comparing MCMs needs 
with the National Emergency Strategic Stockpile holdings and prioritization of MCM requirements in consultation 
with Subject Matter Experts. 

Production / Manufacturing capacities 
- 
Procurement 
- 
Stockpiling and distribution capacities 
- 
International cooperation 
- 
Health security coordination 
- 

414 

 
 
 
 
 
 
b. HeDPAC 

Key contextual elements 

Date of creation: 
2023 

Status: 
International not-for-profit organisation 

Main mission 
The primary objective of HeDPAC, the Health Development Partnership for Africa and the Caribbean, 
aims to bolster South-South cooperation and enhance institutional capacity both within and between 
the  two  regions  and  beyond,  to  maximize  health  development  impact  and  achieve  Universal  Health 
Coverage. HeDPAC will align its catalytic role with existing national and regional development plans to 
ensure efficiency, synergy, and coherence. 

Its member states are the CARICOM countries (20) and the African Union countries (55). 

The HeDPAC focuses on three main priorities: 

-  Human health workforce, to address the challenges faced by the workforce of the Africa and 

Caribbean region including education, employment, retention, and performance, 

-  Resilient Health Systems, to build health systems capable of withstanding the climate crisis and 

other emerging threats with a particular emphasis on robust primary health care, 

-  Local manufacturing of medical products. 

Activities and tasks 

Monitoring, Intelligence gathering and analysis 
- 
Advanced Research and Development capacities 
- 

Production / Manufacturing capacities 
HeDPAC promotes advances in technology transfer to enhance self-reliance, improved access to 
quality  and  affordable  medical  products  with  increased  regulatory  capacity  in  the  Africa  and  the 
Caribbean regions. It leverages on the Pharmaceutical Equity for Global Health Initiative, particularly in 
the local manufacturing of medical products. 

415 

 
 
 
 
 
 
 
 
 
 
 
Procurement 
- 
Stockpiling and distribution capacities 
- 
International cooperation 
- 
Health security coordination 
- 

416 

 
 
 
 
 
 
 
IV. 

International organisations 

1) DNDi: Drugs for Neglected Diseases initiative 
Key contextual elements 

Date of creation: 
2003  

Status: 
Not-for-profit research organisation 

Main mission 
As a not-for-profit research organisation, DNDi aims to research, develop, and deliver safe, effective, 
and affordable treatments for people living with neglected diseases. 
DNDi addresses existing R&D gaps in essential drugs for these diseases by initiating and coordinating 
drug  R&D  projects  in  collaboration  with  the  international  research  community,  the  public  sector,  the 
pharmaceutical industry, and other relevant partners. 
DNDi  promotes  innovation,  open  science,  partnerships,  and  advocacy  to  foster  a  more  inclusive, 
sustainable, and equitable global system for biomedical innovation and treatment access. 

Regarding pandemic preparedness and response, DNDi's goal is to use its experience in non-profit 
drug  development  and  its  partnerships  with  medical  research  institutions  worldwide  to  prepare  for 
future viral pandemics in low- and middle-income countries. 

Contextual elements regarding the global situation 
DNDi’s research focuses on the least researched diseases, including neglected tropical diseases: 

-  Chagas Disease, 
-  Cryptococcal meningitis, 
-  Dengue,  
-  Mycetoma, 
-  Sleeping sickness. 

In terms of pandemic preparedness, DNDi supports and develops several initiatives to reinforce the 
capacities of low- and middle-income countries. For instance, DNDi is a co-founder of PANTHER: the 
PANdemic preparedness plaTform for Health and Emerging infectious Response. Launched in 2022, 
this platform aims to contribute to the control of future epidemics or pandemics on the African continent 
through a flexible ‘ready-to-use’ clinical research platform, supporting preparedness and rapid response 
through the development and assessment of adapted tools, starting with therapeutics and vaccines in 
Africa. 

417 

 
 
 
 
 
 
Activities and tasks 

Monitoring, Intelligence gathering and analysis 
Since  2003,  DNDi  has  supported  the  creation  and  maintenance  of  five  regional  clinical  research 
platforms (Chagas platform, Dengue Alliance, HAT Platform, LEAP Platform, redeLEISH Network). 
These networks aim to help to identify and evaluate patients’ needs and R&D gaps, strengthen and 
sustain clinical research capacity, facilitate access to new treatments, advocate for an enabling policy 
and regulatory environment for needs-driven R&D. 

Advanced Research and Development capacities 
DNDi works to promote and to foster collaborations among key actors in endemic countries, including 
health ministries, national disease control programmes, regulatory authorities, WHO, academia, and 
civil society groups, aiming: 

- 
- 
- 

to consolidate and strengthen existing R&D capacity,  
to promote scientific exchange, 
to facilitate access to new tools. 

More specifically, in terms of pandemic preparedness, DNDi leverages its experience in public-interest 
R&D  and  its  alliances  with  research  partners,  notably  in  Africa  and  Latin  America,  to  contribute  to 
prepare for and response to future pandemics. DNDi's missions are: 

- 

- 

- 
- 

to coordinate clinical trials by leveraging its assets, expertise, and network of partners to design 
and conduct urgently needed clinical research, 
to  facilitate  and  accelerate  research  through  cooperation  and  coordination  of  partners,  to 
guarantee  that  clinical  research  ensures  the  participation  and  meets  the  specific  needs  of 
resource-constrained settings, 
to identify drug candidates for the treatment of future viruses of pandemic potential, 
to advocate for accountability from governments, industry, and the research community to make 
sure  that  pandemic  R&D  is  driven  by  the  public  interest  and  that  new  health  tools  reach 
everyone who needs them. 

Production / Manufacturing capacities 
- 

Procurement of MCMs 
- 

418 

 
 
 
 
 
 
 
 
Stockpiling and distribution capacities 
- 

International cooperation 
DNDi  works  in  consortiums  of  research  institutes,  universities,  not-for-profit  organisations,  and 
pharmaceutical companies to develop new drugs and improve access to treatment. 
DNDi also has partners in different regions of the world (USA, UK, India, France, Italy, Mali, Sudan, 
South Africa), including NGOs, Networks, Universities, Ministries of Health, industries.291 

Health security coordination 
- 

291 Source for this profile sheet: DNDi official website : https://dndi.org/ 

419 

 
 
 
 
 
 
 
 
 
2) FIND, Diagnosis for all 
Key contextual elements 

Date of creation: 
2003  

Status: 
Global health non-profit organisation 

Main mission 
FIND’s mission is to ensure equitable access to reliable diagnosis around the world. 
As  a  non-profit  organisation,  FIND  aims  to  link  nations  and  communities,  financiers,  policymakers, 
healthcare  providers,  and  innovators  to  promote  diagnostic  innovation  and  integrate  testing  into 
sustainable, resilient health systems. 

Contextual elements regarding the global situation 
FIND  works  through  different  health  programmes  to  deliver  its  goals  in  support  of  universal  health 
coverage and global health security. Its programmes include: 

-  AMR testing and surveillance, 
-  Hepatitis and HIV, 
-  Malaria and fever, 
-  Neglected tropical diseases, 
-  Pandemic threats, 
-  Non-communicable diseases, 
-  Tuberculosis, 
-  Women’s health. 

Activities and tasks 

Monitoring, Intelligence gathering and analysis 
FIND works with partners to tailor testing strategies and delivery models that can help meet national 
and regional health delivery goals, including supporting the development and implementation of national 
essential diagnostics lists. 

Advanced Research and Development capacities 
FIND's pandemic threats strategy is focused on expediting the development of diagnostic tools that can 
support  acute  outbreak  management  and  strengthen  in-country  capacity  for  outbreak  detection  and 

420 

 
 
 
 
 
 
 
 
 
rapid response. FIND's work includes new rapid diagnostic tests for outbreak diseases (Marburg, yellow 
fever), development of a point-of-care molecular testing platform (for Lassa fever), test evaluations for 
priority outbreak diseases, strengthening of outbreak preparedness and response, and optimization of 
diagnostic networks. 

Production / Manufacturing capacities 
- 

Procurement 
FIND works in partnership with the industry, global health procurement agencies, and private sector 
buyers to provide tools that fill gaps where no global procurement mechanism currently exists. FIND 
also  provides  market  information  and  works  with  manufacturers  to  make  diagnostic  prices  more 
affordable. 

Stockpiling and distribution capacities 
- 

International cooperation 
FIND’s work includes direct cooperation with countries to support their diagnostic capacity-building. 
For instance, FIND cooperated to development of a point-of-care molecular testing platform (for Lassa 
fever),  test  evaluations  for  priority  outbreak  diseases,  strengthening  of  outbreak  preparedness  and 
response in West Africa, as well as the optimization of diagnostic networks in Nigeria using diagnostic 
network optimization analysis and community-based surveillance initiatives292. 

Health security coordination 
- 

292 Source for this profile sheet: FIND official website: https://www.finddx.org 

421 

 
 
 
 
 
 
 
 
 
 
3) CEPI: 

the  Coalition 

for  Epidemic  Preparedness 

Innovations 
Key contextual elements 

Date of creation: 
2017 

Status: 
International non-profit association 

Main mission 
The Coalition for Epidemic Preparedness Innovations (CEPI) was launched during the World Economic 
Forum in Davos, in 2017, in reaction to the 2014-2015 Ebola outbreak in west Africa. Its objective is to 
finance  and  coordinate  the  development  of  vaccines  and  other  biological  countermeasures  against 
epidemic and pandemic. 
CEPI seeks to outsmart epidemics by developing safe and effective vaccines against known infectious 
disease threats that could be swiftly deployed to mitigate outbreaks, pre-empting them from becoming 
global health emergencies. 
Additionally, CEPI aims to shorten the delays to develop new vaccines against viruses that emerge 
suddenly. To achieve this, CEPI aims to capitalise on adaptable vaccines technology and investing in 
facilities capable of promptly respond to previously unknown pathogens293 294. 

The ambition set by CEPI regarding the vaccine development and manufacturing capacities is the “100 
days mission”: a safe and effective vaccine in 100 days from the moment that a pathogen is sequenced 
and/ or the need for a vaccine is recognised to initial availability for use. 

Contextual elements regarding the global situation 
CEPI’s  priority  pathogens  include  Chikungunya,  COVID-19,  Ebola,  Lassa  Fever,  MERS,  Nipah,  Rift 
Valley Fever, and novel viral threats with epidemic or pandemic potential (also known as “Disease X”). 
Between  2017  and  2021,  CEPI  has  invested  a  total  of  US$2.310  billion  -  US$1.950  billion  into  35 
candidate  vaccines  and  US$360  million  in  other  enabling  science  projects  against  known  threats. 
Through these programs, CEPI has simultaneously advanced the development of 11 rapid response 
platforms to deploy against unknown threats, or Disease X295. 

293 CEPI officially launched, Press release, January 2017 
294  CEPI:  Driving  progress 
10.1093/epirev/mxz012 
295 CEPI 2022-2026 Strategy, Objectives and ambitions for the second 5-year cycle, published in November 2021 

toward  Epidemic  preparedness  and  response,  Epidemiol  Rev.,  November  2019,  41(1) :  28-33,  doi : 

422 

 
 
 
 
 
 
 
Activities and tasks296 

Monitoring, Intelligence gathering and analysis 
CEPI develops several initiatives in this category: 

-  CEPI’s  Centralised  Laboratory  Network:  the  world’s  largest  network  of  vaccine  testing 
laboratories which aims to support CEPI-supported developers and others to evaluate CEPI 
priority-pathogen  vaccines  against  common  protocols  to  ensure  alignment  and  information 
sharing  when  identifying  the  most  promising  candidates.  In  the  event  of  an  outbreak  of 
infectious disease, having an established global clinical laboratory network in place will facilitate 
faster data readouts by harmonising analyses and reducing sample shipping times due to its 
worldwide footprint, 

-  CEPI’s Laboratory Research and Innovations Team works with WHO to develop international 
standards, and with PATH297 to identify gaps in the creation or validation of diagnostics for its 
priority pathogens. 

Advanced Research and Development capacities 
CEPI  supports  enabling  science  activities  to  accelerate  development  of  safe  and  effective 
epidemic  or  pandemic  vaccines  and  other  biological  countermeasures  and  supports  the 
development of vaccines candidates against its priority pathogens. 
CEPI  also  promotes  and  invests  in  the  development  of  platforms  technologies  to  develop  vaccines 
against Disease X, to facilitate rapid responses to emerging threats. 

The Global Vaccine Library initiative: CEPI is actively seeking a coalition to develop the guidelines and 
principles to enable partners to progressively build the Global Vaccine Library, a worldwide repository 
of vaccine resources, capabilities and data that would maximise epidemic and pandemic preparedness 
and accelerate vaccine development when new viral threats arise. 
It advocates for enhanced coordination among R&D funders in support of a Global Vaccine Library, and 
for the Pandemic Accord to establish a normative framework for the establishment of such a library. 

Production / Manufacturing capacities 
CEPI aims to support projects that will advance manufacturing innovations that improve vaccine 
scalability and equitable access. 

296 CEPI official web site: https://cepi.net/ 
297 the Program for Appropriate Technology in Health, global health non-profit organisation 

423 

 
 
 
 
 
 
 
 
In fact, one of CEPI’s objectives is ‘to expand and diversify the global footprint of vaccine manufacturing’. 
To achieve this: 

-  CEPI supports capability strengthening activities of selected vaccine manufactures in Global 
South countries, near areas at high risk of disease outbreaks, with a particular focus on regions 
where CEPI’s priority pathogens are endemic. 
In  the  event  of  an  outbreak,  CEPI  developers  will  promptly  transfer  their  technology  to  pre-
selected  manufacturers  with  the  necessary  expertise,  technology,  and  optimal  geographical 
position to enable rapid production and equitable distribution of vaccines to affected populations. 

- 

In its 2022-2026 strategy, CEPI indicates its objective of promoting equitable access principles as the 
foundation of any effective global response. CEPI plays a crucial role in the coordination of a scalable 
on-demand  manufacturing  network  and  to  cooperation  with  the  public  and  private  sector  to  ensure 
economically and practically viable ready manufacturing capacity across the world298. 

Procurement 
- 

Stockpiling and distribution capacities 
- 

International cooperation 
CEPI  aims  to  support  greater  agility  and  resilience  in  regional  R&D,  supply  chain  and  global  health 
architecture,  establishing  partnerships  with  vaccine  developers,  manufacturers,  governments, 
philanthropies, civil society, and global health organisations (e.g. PATH, University of Oxford, WHO, 
Gavi…). 

Health security coordination 
- 

298 CEPI 2022-2026 Strategy, Objectives and ambitions for the second 5-year cycle, published in November 2021 

424 

 
 
 
 
 
 
 
 
 
 
 
4) UNICEF Supply Division 
Key contextual elements 

Date of creation: 
1946 

Status: Agency of the United Nations responsible for 
providing humanitarian and developmental aid to children 
worldwide 

Main mission 
The UNICEF Supply Division aims to "ensure access to essential supplies and services for children and 
their families in need".  

Contextual elements regarding the global situation 
UNICEF procures and supplies products, including medical countermeasures, to address the needs of 
children. 
In 2022, the UNICEF Supply Division supported emergency preparedness by collaborating with country 
offices to strategically position supplies locally and enhance readiness and response capacities. This 
included addressing the difficulties due to the COVID-19 pandemic, as well as disease outbreaks like 
Ebola in the Democratic Republic of the Congo and neighbouring nations, Marburg virus disease in 
Ghana, and significant cholera outbreaks across 30 countries299. 

Activities and tasks300 

Monitoring, Intelligence gathering and analysis 
- 

Advanced Research and Development capacities 
- 

Production / Manufacturing capacities 
- 

299 Supply Annual Report 2022, UNICEF Supply Division, July 2023 
300 UNICEF Supply Division web site : https://www.unicef.org/supply/ 

425 

 
 
 
 
 
 
 
 
 
 
 
 
 
Procurement 
UNICEF's  Procurement  Services  Centre  can  assist  governments  in  the  procurement  of  strategic 
essential  goods,  including  vaccines,  safe  injection  materials,  essential  medicines,  medical  and 
diagnostic supplies, pharmaceuticals, equipment and supplies to ensure safe drinking water.  In addition, 
procurement  services  cover  products  required  for  children’s  education  as  well  as  other  supplies, 
equipment and services that are in line with UNICEF’s mandate. 

Stockpiling and distribution capacities 
In  terms  of  distribution  capacities:  in  case  of  a  health  emergency,  the  UNICEF  Supply  Division  is 
capable of delivering supplies from a network of global supply hubs. 
Regarding  stockpiling,  the  UNICEF  Supply  Division  is  responsible  for  establishing  emergency 
stockpiles of vaccines (meningococcal, yellow fever, oral cholera, and Ebola), and ensuring rapid supply 
of vaccines to disease outbreaks301. 

International cooperation 
UNICEF develops country programmes of cooperation on several objectives including helping countries 
to strengthen their national capacity in planning for supply needs, selection of supplies and equipment, 
effective delivery, and distribution. 

Health security coordination 
- 

301 UNICEF's dedicated web page for Emergency vaccine stockpile: www.unicef.org/supply/emergency-vaccine-stockpile 

426 

 
 
 
 
 
 
 
 
5) The Global Fund 
Key contextual elements 

Date of creation: 
2002  

Status: Non-profit foundation, under Swiss law 
and hosted by the WHO 

Main mission 
The  Global  Fund  to  Fight  AIDS,  Tuberculosis  and  Malaria  (“the  Global  Fund”)  is  an  international 
financing and partnership organisation that aims to attract, leverage and invest additional resources 
to end the epidemics of HIV/AIDS, tuberculosis and malaria to support attainment of the Sustainable 
Development Goals established by the United Nations. 

The  Global  Fund  is  the  largest  multilateral  provider  of  grants  in  global  health,  it  collaborates  with 
partners to support countries to prevent, prepare for and respond to pandemics. 
The  Global  Fund  operates  as  a  financing  mechanism  rather  than  an  implementing  agency.  It 
allocates funding for eligible countries to support HIV, TB, and malaria programs. All low and lower-
middle  income  countries  are  eligible,  regardless  of  disease  burden.  Upper-middle  income  countries 
must have at least a ‘high’ burden of disease to be eligible for Global Fund financing302. 

Activities and tasks 

Monitoring, Intelligence gathering and analysis 
- 

Advanced Research and Development capacities 
- 

Production / Manufacturing capacities 
- 

Procurement 

302 Eligibility List 2023, The Global Fund 

427 

 
 
 
 
 
 
 
 
 
 
 
 
 
The Global Fund operates as a financing mechanism rather than an implementing agency. 
Local  partners,  like  ministries  of  health,  execute  programs,  while  the  Geneva-based  Global  Fund 
secretariat  monitors  them.  Country  Coordinating  Mechanisms,  including  diverse  stakeholders 
(government,  NGOs,  faith-based  organisations,  private  sector,  and  disease-affected  individuals), 
oversee implementation. 

The  Global  Fund  uses  an  allocation  model  to  distribute  funds  to  eligible  countries.  Whether  a 
country or region is eligible for support is determined by its income classification and disease burden. 
The Global Fund policy is designed to ensure available resources are invested in countries with the 
highest disease burden, the least economic capacity, and where key and vulnerable populations are 
disproportionately affected by the diseases. 
The foundation allocates funding for eligible countries to support HIV, TB, and malaria programs. These 
programs are integrated into and help strengthen systems for health, are built around the needs and 
priorities  of  people  and  communities  and  help  protect  against  future  pandemics.  All  low  and  lower-
middle  income  countries  are  eligible,  regardless  of  disease  burden.  Upper-middle  income  countries 
must have at least a ‘high’ burden of disease to be eligible. 

Over the 2021-2023 funding cycle, the Global Fund invested US$4.9 billion, or US$1.5 billion a year, in 
formal and community health systems through core grants and its COVID-19 response – about one-
third of its total investments. 

The  financial  support  of  the  Global  Fund  contributes  to  pandemic  preparedness,  supporting 
countries to prepare for, prevent, detect, and respond to new outbreaks. 
For instance, laboratories equipped with advanced diagnostics and skilled technicians can diagnose 
diseases like HIV and TB and quickly adapt to new threats. The diagnostic machines used for TB testing 
were repurposed to test for COVID-19, allowing countries like India and Bangladesh to test for both 
diseases simultaneously. 

Stockpiling and distribution capacities 
- 

International cooperation 
- 

Health security coordination 
- 

428 

 
 
 
 
 
 
 
 
 
6) The World Health Organisation 
Key contextual elements 

Date of creation: 
1948 

Status: United Nations agency 

Main mission 
The foundation for WHO’s work in the area of emergency preparedness and response is laid down in 
Article 2 of the WHO Constitution, which charges the Organisation to “furnish appropriate technical 
assistance  and, 
in  emergencies,  necessary  aid  upon  the  request  or  acceptance  of 
Governments”. 
WHO works to strengthen emergency preparedness in Member States goes hand-in-hand with efforts 
to help countries meet their obligations under the International Health Regulations (IHR) (2005). 

The WHO's 13th general programme of work 2019−2023, regarding health emergencies includes the 
following objectives: 

  To build and sustain resilient national, regional, and global capacities required to keep the world 

safe from epidemics and other health emergencies; and 

  To ensure that populations affected by acute and protracted emergencies have rapid access to 

essential life-saving health services including health promotion and disease prevention. 

Activities and tasks 

Monitoring, Intelligence gathering and analysis 
WHO carries out this task on an international scale and produces technical documents on health threats, 
including guidelines for diagnosis, treatment, prevention, and controls (including MCMs). 
WHO  conducts  continuous  surveillance  and  monitoring  of  global  health  threats,  including  infectious 
disease  outbreaks,  natural  disasters,  and  other  health  emergencies.  This  involves  collecting  and 
analysing data from member states and other sources to detect potential health threats early. 
WHO also plays a major role at the regional level with its regional offices (such as PAHO, presented 
earlier). Regarding this task, WHO ensures surveillance and analysis of health threats and potential 
consequences at the regional level to support its member states. 

Advanced Research and Development capacities 

429 

 
 
 
 
 
 
 
 
 
WHO  organizes  meeting  to  promote  cooperation  and  capacity-building  of  R&D  regarding  health 
emergencies preparedness and response. For instance, in September 2022, WHO convened a meeting 
on respiratory pathogen pandemic preparedness in Belfast. The purpose of the meeting was to discuss 
global guidance on respiratory pathogen pandemic preparedness, drawing on lessons learned from the 
COVID-19 pandemic303. 

Additionally,  WHO  supports  initiatives  aimed  at  enhancing  R&D  capacities  for  the  development  of 
Medical Countermeasures (MCMs). During the COVID-19 pandemic, for instance, the ACT-Accelerator 
was launched as a global collaboration initiative to expedite the development, production, and equitable 
access to COVID-19 tests, treatments, and vaccines. Launched in late April 2020, the ACT Accelerator 
brought together governments, scientists, businesses, civil society, philanthropists, and global health 
organisations such as the Bill & Melinda Gates Foundation, CEPI, FIND, Gavi, The Global Fund, Unitaid, 
Wellcome, WHO, and the World Bank. 

Production / Manufacturing capacities 
WHO provides guidelines and supports initiatives which aim to ensure the production and access to 
medical countermeasures in its member states. 
Since 2018, WHO has supported more than 7000 manufacturers, regulators, and other stakeholders 
from over 70 countries worldwide to build their local manufacturing capacities. 
More recently, in 2021, WHO and partners established the mRNA Technology Transfer Hub in South 
Africa, to build sustainable manufacturing capacity in low- and middle-income countries for COVID-19 
and other global health threats including malaria and tuberculosis304. 

Procurement 
- 

Stockpiling and distribution capacities 
The  WHO  provides  guidelines  and  protocols  to  its  Member  States  regarding  the  stockpiling  and 
distribution of medical countermeasures to enhance their capacities of preparedness and response to 
health emergencies.  
For  instance,  in  2023,  WHO  published  the  “National  stockpiles  for  radiological  and  nuclear 
emergencies: policy advice”, a document describing protocols and practices for ensuring the essential 
elements of a national stockpile of medical countermeasures for radiation emergencies, particularly of 
the pharmaceuticals required to treat radiation injuries. It also addresses governance and management 
of such stockpiles. 

International cooperation 
The impact of the COVID-19 pandemic highlighted collective vulnerabilities and the need to strengthen 
the  international  community’s preparedness  to  future  pandemics.  The WHO-led  interim  coordination 
mechanism aims to enhance collaboration for timely and equitable access to medical countermeasures 
against pandemic threats, through a network-of-networks approach (i-MCM-Net) by leveraging existing 
networks in the global MCM ecosystem. 
The current focus of the i-MCM-Net is to understand how ready the world is in terms of equitable access 
to MCMs, should a new pandemic threat emerge. Including to identify gaps and potential priority actions 
to improve readiness. 

In addition, during health crises, WHO coordinates international response efforts, mobilizing resources 
and expertise from member states, other UN agencies, NGOs, and the private sector. This ensures a 
cohesive and effective response to health emergencies. 

303 Respiratory  pathogens  pandemic  preparedness:  perspectives  on  research  priorities  and  key  measures  of  success:  meeting  report,  Belfast, 
Northern Ireland, United Kingdom, WHO Meeting Report, September 2022 
304 WHO  Director-General's  opening  remarks  at  the  Second  World  Local  Production  Forum:  Enhancing  access  to  medicines  and  other  health 
technologies, WHO Speeches, Nov. 2023 

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Health security coordination 
WHO's  role  in  health  security  coordination  is  to  enhance  global  preparedness,  ensure  rapid  and 
effective  response  to  health  crises,  and  support  member  states  in  protecting  the  health  of  their 
populations. Its role is organized into several activities: 
►  Technical Guidance and Standards: WHO provides technical guidance, sets international health 
standards, and develops protocols for disease prevention, detection, and response. This includes 
guidelines for managing outbreaks, vaccination strategies, and emergency health interventions. 
►  Capacity Building: WHO supports countries in building and strengthening their health systems and 
preparedness capacities. This includes training health workers, enhancing laboratory capacities, 
and improving disease surveillance systems. 

►  Emergency  Response  Operations:  WHO  directly  engages  in  emergency  response  operations, 
deploying  teams  of  experts  to  affected  areas  to  provide  on-the-ground  support.  This  includes 
establishing field hospitals, distributing medical supplies, and providing technical assistance to local 
health authorities. 
Information  Dissemination  and  communication:  WHO  serves  as  a  central  hub  for  disseminating 
accurate  and  timely  information  about  health  threats  and  emergencies.  This  includes  issuing 
situation reports, public health advisories, and risk communication to inform and guide public health 
actions globally. 

► 

►  Policy Advocacy: WHO advocates for strong health security policies and frameworks at the national, 
regional,  and  global  levels.  This  includes  promoting  the  International  Health  Regulations  (IHR), 
which  provide  a  legal  framework  for  international  cooperation  and  response  to  public  health 
emergencies. 

Contextual information:  
Considering the impact of the COVID-19 pandemic, WHO’s Member States have agreed to a global 
process  to  draft  and  negotiate  a  new  convention,  agreement,  or  other  international  instrument  on 
pandemic  preparedness  and  response.  This  was  driven  by  the  need  to  ensure  communities, 
governments,  and  all  sectors  of  society  –  within  countries  and  globally  –  are  better  prepared  and 
protected, in order to prevent and respond to future pandemics. 
The main purpose is to ensure equity in both access to the tools needed to prevent pandemics (including 
technologies like vaccines, PPE, information, and expertise) and access to health care for all people. 

In this process, the role of the WHO Secretariat is to support its Member States as they negotiate and 
agree on the new international accord. The WHO Secretariat does not determine the contents of any 
possible international accord. 

Regarding the timeline for developing the pandemic accord, nations set themselves the deadline of May 
2024 by which they should reach agreement on what would be the world’s first ever Pandemic Accord. 

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