COMMISSION STAFF WORKING DOCUMENT Accompanying the document COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Introducing the Union prevention, preparedness and response plan for health crises
Date: 2025-11-28
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, EU action, European Health Union, crisis management, cross-border cooperation, disease prevention, disease surveillance, emergency aid, public health

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  EN 

   EUROPEAN COMMISSION  Brussels, 28.11.2025  SWD(2025) 393 final  COMMISSION STAFF WORKING DOCUMENT    Accompanying the document COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Introducing the Union prevention, preparedness and response plan for health crises {COM(2025) 745 final}  
 
 
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Manuscript completed in November 2025. 

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doi:10.2875/8766164     EW-01-25-125-EN-N 

 
 
 
 
Contents 

Abbreviations ................................................................................................... 6 

1. 

Introduction .............................................................................................. 8 

1.1.  Why do we need a Union prevention, preparedness and response plan 
for health crises? ................................................................................... 8 

1.2.  What types of health crises are covered? ............................................ 10 

1.3.  How to use the Union plan? ................................................................. 12 

1.4.  How will the Union plan be kept up to date? ........................................ 13 

2.  Key  EU  health  crisis  governance  structures,  mechanisms  and 
instruments ............................................................................................ 15 

3.  Health crisis management cycle ........................................................... 21 

4.  PHASE 1: Preventing and preparing for health crises ....................... 24 

4.1.  Prevention, preparedness and response planning............................... 24 

4.1.1.  Development of prevention, preparedness and response plans .............. 26 
4.1.2.  Reporting on prevention, preparedness and response planning ............. 27 
4.1.3.  Assessment of national prevention, preparedness and response planning

 28 

4.2.  Ensuring healthcare system preparedness and resilience ................... 29 

4.2.1.  Health system capacities ........................................................................ 30 
4.2.2.  Health workforce ..................................................................................... 31 
4.2.3.  Vaccination ............................................................................................. 33 

4.3.  Medical countermeasures .................................................................... 35 

4.3.1.  Development and innovation ................................................................... 35 
4.3.2.  Authorisation and certification ................................................................. 36 
4.3.3.  Manufacturing ......................................................................................... 37 
4.3.4.  Stockpiling .............................................................................................. 37 
4.3.5.  Procurement of MCMs ............................................................................ 38 

5.  PHASE 2: Detecting and assessing health threats ............................. 40 

5.1.  Public health intelligence ..................................................................... 40 

5.1.1.  Epidemiological surveillance ................................................................... 42 
5.1.2.  Laboratory-based surveillance and diagnostics....................................... 44 
5.1.3.  Wastewater surveillance ......................................................................... 45 

3 

 
5.1.4.  Vector surveillance and control ............................................................... 46 
5.1.5.  Serious drug-related risks ....................................................................... 47 
5.1.6.  Anticipation and forecasting .................................................................... 47 

5.2.  Threat assessment and early warning ................................................. 48 

5.3.  Risk assessments ................................................................................ 49 

5.3.1.  National risk assessments ...................................................................... 50 
5.3.2.  Public health risk assessment at EU level ............................................... 51 
5.3.3.  Other EU risk assessments ..................................................................... 52 
5.3.4.  Threat  assessment  and  prioritisation 
the  area  of  medical 
countermeasures .................................................................................... 53 

in 

6.  PHASE 3: Responding in an EU coordinated manner ........................ 55 

6.1.  Coordination of response ..................................................................... 55 

6.1.1.  Coordination of response within the HSC ................................................ 56 
6.1.2.  Coordination of MCM response .............................................................. 58 
6.1.3.  Coordination of response within the IPCR ............................................... 58 
6.1.4.  Response coordination under the Union Civil Protection Mechanism ...... 59 

6.2.  Situational awareness .......................................................................... 62 

6.3.  Risk and crisis communication............................................................. 63 

6.4.  Emergency research and innovation ................................................... 65 

6.5.  Emergency funding .............................................................................. 67 

6.6.  Continuity of care across borders ........................................................ 68 

6.6.1.  Cross-border healthcare ......................................................................... 68 
6.6.2.  Cross-border contact tracing ................................................................... 70 
6.6.3.  Medical evacuation of patients ................................................................ 71 
6.6.4.  Health documents ................................................................................... 72 

6.7.  Recognising a public health emergency at Union level ........................ 72 

6.7.1.  Medicinal products and medical devices ................................................. 75 
6.7.2.  Activation  of  the  emergency  framework  for  ensuring  the  supply  of  crisis-
relevant medical countermeasures ......................................................... 75 
6.7.3.  Global and EU support for national healthcare systems .......................... 78 

7.  PHASE 4: Recovering and learning lessons ....................................... 80 

ANNEXES ........................................................................................................ 82 

ANNEX 1: Glossary ...................................................................................... 82 

ANNEX 2: Relevant international agreements and legislation ...................... 87 

ANNEX 3. EU Governance structures .......................................................... 92 

EU governance structures, support mechanisms and capacities ....................... 92 
Commission Expert Groups ............................................................................... 96 

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ANNEX 4. Relevant EU agencies and bodies ............................................. 102 

ANNEX 5. Global governance framework ................................................... 109 

ANNEX  6:  Overview  of  EU-funded  actions,  grants,  and  projects  related  to 
health crises....................................................................................... 113 

ANNEX 7: Digital platforms for public health intelligence in the EU/EEA .... 123 

ANNEX 8. Alert information systems in the EU for managing health crises 124 

5 

 
 
 
Abbreviations  

Abbreviation 

Meaning 

ACPHE 

Advisory Committee on Public Health Emergencies 

AMR 

CECIS 

CBRN 

CVO 

ECDC  

ECHA 

ECPP 

EEA 

EEA 

EFSA 

EGE 

EMA 

EMT 

EPSCO 

EUDA  

ERCC 

ERVISS 

ESI 

ETF 

EU 

EU FAB 

EUHTF 

EUdPLF 

EURL 

EWRS 

FPI 

GDHCN 

GHSI 

GOARN 

HAI(s) 

HCB 

HSC  

IAEA 

IHR 

IPCR  

ISAA  

JRC 

Antimicrobial Resistance 

Common Emergency Communication and Information System 

Chemical, biological, radiological and nuclear threats 

Chief Veterinary Officer 

European Centre for Disease Prevention and Control 

European Chemicals Agency 

European Civil Protection Pool 

European Economic Area 

European Environment Agency 

European Food Safety Authority 

European Group on Ethics in Science and New Technologies 

European Medicines Agency 

Emergency Medical Team 

Employment, Social Policy, Health and Consumer Affairs Council 

European Union Drugs Agency 

Emergency Response Coordination Centre 

European Respiratory Virus Surveillance Summary 

Emergency Support Instrument 

Emergency Task Force 

European Union 

Network of ever-warm production capacities for vaccines and therapeutics manufacturing 

EU Health Task Force 

EU digital Passenger Locator Form 

European Reference Laboratories 

Early Warning and Response System 

Foreign Policy Instrument 

Global Digital Health Certification Network 

Global Health Security Initiative  

Global Outbreak Alert and Response Network 

Healthcare associated infection(s)  

Health Crisis Board 

Health Security Committee 

International Atomic Energy Agency 

International Health Regulations  

Integrated Political Crisis Response 

Integrated Situational Awareness and Analysis Reports 

Joint Research Centre  

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JPA 

LSCO 

MCMs 

MFF 

MDSSG  

Medevac 

MSSG  

NITAG 

OECD 

PHEPA 

PIWG+ 

RRF 

SCBTH 

SAM 

SIMEX 

SoHO 

Joint Procurement Agreement 

Large-Scale Combat Operation 

Medical Countermeasures 

Multiannual Financial Framework 

Medical Device Shortages Steering Group 

Medical Evacuation 

Medicine Shortages Steering Group 

National Immunisation Technical Advisory Groups  

Organisation for Economic Co-operation and Development 

Public Health Emergency Preparedness Assessment 

Pandemic Influenza and other respiratory diseases working group 

Recovery and Resilience Facility 

Serious cross-border threats to health 

Scientific Advice Mechanism 

Simulation exercise(s)  

Substances of Human Origin  

SoHO-Net 

Network for the Microbial Safety of Substances of Human Origin  

TATFAR 

TFEU 

UCPM  

UNHRD 

WHA 

WHO  

WOAH 

Transatlantic Taskforce on Antimicrobial Resistance  

Treaty on Functioning of the European Union 

Union Civil Protection Mechanism 

United Nations Humanitarian Response Depot 

World Health Assembly 

World Health Organization 

World Organisation for Animal Health Organisation  

7 

 
 
 
 
1.  Introduction 

1.1.  Why do we need a Union prevention, preparedness and 

response plan for health crises?  

The  Union  prevention,  preparedness  and  response  plan  for  health  crises  (‘Union 
plan’) is established by the European Commission in accordance with Article 5 of the 
EU Regulation on serious cross-border threats to health (1). It is published at a 
time when multiple threats endanger the lives, health and well-being of people living in 
the EU/EEA and when crisis preparedness and resilience are high on the EU’s political 
agenda.  It  is  among  the  actions  listed  in  the  action  plan  accompanying  he  EU 
Preparedness Union Strategy (2), adopted in March 2025, which aims to strengthen 
Europe’s capability to prevent, prepare for and respond to emerging threats and risks, 
regardless of their nature or origin. The  Union plan, which focuses on health crises, 
promotes an effective and coordinated response and synergies at EU level. Together 
with the national prevention, preparedness and response plans,  it will form a robust 
planning framework for the EU. 

In recent years, the EU has significantly strengthened its health security architecture 
in  order  to  improve  its  readiness  and  response  to  future  health  crises.  The 
Commission, Member States and EU agencies took decisive steps toward a stronger, 
more  resilient  European  Health  Union,  aiming  to  strengthen  the  EU’s  ability  to 
prepare for and respond to health crises. The building blocks of the EU Health Union 
included the revision of the EU health security legislation in the form of  the new EU 
Regulation  on  serious  cross-border threats  to  health and  strengthened  mandates  of 
the European Centre for Disease Prevention and Control (ECDC) (3) and the European 
Medicines  Agency  (EMA) (4).  Moreover,  the  Health  Emergency  Preparedness  and 
Response Authority (HERA) (5) was created to strengthen Europe’s ability to prepare 
for and respond to a health crisis by, among other things, ensuring the swift availability 
and accessibility of medical countermeasures (MCMs) (6). Prevention, preparedness 

(1)  Article 5(1) of 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 (OJ L 314, 6.12.2022, p. 26, ELI: 
http://data.europa.eu/eli/reg/2022/2371/oj). 

(2)  European Commission, ‘Joint Communication to the European Parliament, the European Council, the Council, the 
European Economic and Social Committee and the Committee of the Regions’, JOIN(2025)130, 26 March 2025, 
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52025JC0130.  

(3)  Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a 

European centre for disease prevention and control (OJ L 142, 30.4.2004, p. 1, ELI: 
http://data.europa.eu/eli/reg/2004/851/oj).  

(4)  Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role 

for the European Medicines Agency in crisis preparedness and management for medicinal products and medical 
devices. (OJ L 20, 31.1.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/123/oj).  

(5)  Commission Decision of 16.9.2021 establishing a Health Emergency Preparedness and Response Authority (HERA), 

C(2021)6712, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=intcom:C(2021)6712. 

(6)  Also supported by the adoption of Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of 

measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health 
emergency at Union level (OJ L 314, 6.12.2022, p. 64, ELI: http://data.europa.eu/eli/reg/2022/2372/oj).  

8 

 
 
and response planning for health crises is an essential starting point for an effective 
and coordinated response. The Regulation on serious cross-border threats to health 
therefore creates a robust planning framework for the EU where national plans and the 
Union  plan  complement  each  other  and  operate  in  coherence (7).  The  Union  plan 
includes provisions on joint arrangements for governance, capacities and resources 
in place at EU level that can be relied upon to effectively prevent, prepare for, respond 
to  and  recover  from  health  crises.  It  is  an  operational  document  that  navigates  the 
reader through the overall EU health crisis infrastructure and serves as a toolbox for 
crisis managers to identify and use relevant resources as required.  

The Union plan was developed by the Commission in cooperation with Member States 
(through  the  Health Security  Committee)  and  the  relevant EU agencies and  bodies. 
The public was also consulted during webinars and via a call for evidence. The Union 
plan therefore brings together a vast amount of current knowledge, best practices and 
information from different sectors on prevention, preparedness and response planning 
in  the  EU.  By  presenting  this  information  in  one  practical  resource,  the  Union  plan 
contributes to promoting effective synergies between different governance structures 
and  levels.  This  approach  helps  prevent  the  emergence  of  health  crises  and/or 
facilitate a more effective and coordinated response across the EU if a crisis occurs. 

While the Union plan focuses on the joint arrangements within the EU, it is aligned with 
EU global health priorities (8) (9) and contributes to the implementation of the recently 
reinforced  global  health  security  framework,  as  set  out  in  the  International  Health 
Regulations  (IHR)  amended  in  2024  (10) (11).  These  amendments  aim  to  increase 
global readiness, surveillance and response to public health emergencies (12). 

The current document is the first version of the first ever Union plan to prevent, prepare 
for and respond to serious cross-border threats to health. As such, it will be important 
to test that the Union plan is ‘fit for purpose’ through simulation exercises, the first of 
which  is  planned  for  2026.  These  exercises  will  test  whether  the  plan  promotes  an 
effective  and  coordinated  response  in  the  EU/EEA  to  a  specific  threat  scenario 

(7)   Articles 5–9 of Regulation (EU) 2022/2371. 
(8)  Communication from the Commission to the European Parliament, the Council, the European economic and Social 
Committee and the Committee of the Regions: EU Global Health Strategy, COM/2022/675 final, 30.11.2022, 
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2022:0675:FIN.  

(9)  Efforts are also under way under the auspices of the WHO to conclude the negotiations of the WHO Pandemic 

Agreement, including its Annex on a Pathogen Access and Benefit Sharing (PABS) System. The objective is to submit 
the outcome of the negotiations to the World Health Assembly in May 2026. The Pandemic Agreement will be open 
for signature and ratification only once the negotiations on the PABS Annex are concluded. Once implemented, the 
Agreement is expected to improve global pandemic prevention, preparedness and response. 

(10)  World Health Organization, International Health Regulations (‘IHR’), 2005 (as amended in 2014, 2022 and 2024), 

https://apps.who.int/gb/bd/pdf_files/IHR_2014-2022-2024-en.pdf.  

(11)  Council Decision (EU) 2025/1129 of 26 May 2025 inviting Member States to accept, in the interest of the European 
Union, the amendments to the International Health Regulations (2005) contained in the Annex to Resolution WHA77.17 
and adopted on 1 June 2024. (OJ L, 4.6.2025, ELI: http://data.europa.eu/eli/dec/2025/1129/oj). 

(12)  Efforts are also under way under the auspices of the World Health Organization to conclude the negotiations on the 
WHO Pandemic Agreement, including its Annex on a Pathogen Access and Benefit Sharing (PABS) System. The 
objective is to submit the outcome of the negotiations to the World Health Assembly in May 2026. The Pandemic 
Agreement will be open for signature and ratification only once the negotiations on the PABS Annex are concluded. 
Once implemented, the Agreement is expected to improve global pandemic prevention, preparedness and response. 

9 

 
 
focusing  on  the  joint arrangements  for governance,  capacities and  resources. It  will 
also  be  important  to  adapt  it  in  accordance  with  EU-level  developments  in  relevant 
policy areas, in particular following the implementation of relevant actions announced 
to  support  medical 
in 
countermeasures (13)  against  public  health  threats  and  the  EU  Stockpiling  Strategy 
(14).  

the  Preparedness  Union  Strategy, 

the  EU  Strategy 

1.2.  What types of health crises are covered?  

The current threat and risk landscape in the EU is complex and continuously evolving 
due  to  megatrends  such  as  climate  change,  demographic  transition,  globalisation, 
urbanisation,  migration,  habitat  destruction  and  geopolitical  power  relations (15) (16). 
These megatrends, often interlinked, not only increase the likelihood of health threats 
occurring,  but  might  also  make  the  population  more  vulnerable  to  adverse  health 
crises. For example, extreme weather conditions can disrupt ecosystems, increasing 
the  likelihood  of  infectious  diseases  emerging,  but  can  contribute  to  the  population 
being more vulnerable to such diseases by negatively impacting food security. 

Considering the current operating environment, the Union plan takes an all-hazards 
approach  when  it  comes  to  health  crises  that  the  EU  could  face.  It  addresses  life-
threatening  or  otherwise  serious  threats  to  public  health  that  spread  or  entail  a 
significant  risk  of  spreading  across  Member  States’  national  borders  and  may 
necessitate coordination at EU level to ensure a high level of human health protection 
(17).  Such  events  involving  serious  cross-border  threats  to  health  can  be  natural, 
accidental or intentional, and can be of biological, chemical, environmental, unknown 
or  other  origin  (see  Table  1).  Events  of  ‘other’  origin  can  include  any  exceptional 
emergency situation impacting public health that requires a coordinated cross-border 
response, particularly in situations where the national public health measures prove to 
be  insufficient.  In  these  situations,  which  can  cover  also  armed  conflicts,  the 
coordinated response between the EU institutions and the Member States is needed 
if it is considered that public health measures taken previously have proven insufficient 
to ensure a high level of protection of human health (18). Serious cross-border threats 
to  health  can  endanger  health  either  directly  –  by  causing  disease  or  trauma  –  or 

(13)  European Commission, ‘Medical Countermeasures Strategy’, European Commission website, accessed 3 November 
2025, https://health.ec.europa.eu/health-emergency-preparedness-and-response-hera/preparedness/medical-
countermeasures-strategy_en. 

(14)  European Commission, ‘Communication from the Commission to the European Parliament, the Council, the European 

Economic and Social Committee and the Committee of Regions: EU stockpiling strategy: Boosting the EU’s material 
preparedness for crises’, COM(2025) 528 final, 9 July 2025, https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=celex:52025DC0528.  

(15)  Lentini, A., Eklund, G., Corbane, C., Asikainem, T., Ronco, M. et al., Analysis of Risks Europe is facing - An analysis of 

current and emerging risks, Publications Office of the European Union, Luxembourg, 2025, 
https://data.europa.eu/doi/10.2760/0176850, JRC141673. 

(16)  European Commission: Secretariat-General, Strategic Foresight Report 2025. Resilience 2.0: Empowering the EU to 

thrive amid turbulence and uncertainty, Publications Office of the European Union, Luxembourg, 2025, 
https://commission.europa.eu/strategy-and-policy/strategic-foresight/2025-strategic-foresight-report_en. 

(17)  Articles 3(1) and 19 of Regulation (EU) 2022/2371. 
(18)  Articles 2(1) and (4) of Regulation (EU) 2022/2371. 

10 

 
 
indirectly by impacting the health systems’ capacities to provide services, as it is the 
case in armed conflicts. 

Table 1. Examples of serious cross-border threats to health covered by the Union plan  

Human outbreak 
of zoonotic 
influenza 

Explosion in a 
chemical 
production 
facility 

Scenario: A highly pathogenic Avian influenza virus jumps from animals 
to humans with sustained transmission between people is observed. 

Scenario:  A  chemical  production  facility  bordering  several  countries 
experiences an explosion in its storage tanks, releasing a large volume 
of toxic chlorine gas and other volatile chemicals into the atmosphere. 

Extreme weather 
event 

Scenario: Extreme temperatures lead to excess morbidity and mortality 
in multiple countries, resulting in overburdened healthcare systems. 

Armed conflict 
involving the use 
of an unknown 
toxin 

Scenario:  A  regional  armed  conflict  erupts  involving  the  use  of  an 
unknown  toxin  that  spills  into  rural  zones  rich  in  agriculture  and 
freshwater  sources,  creating  an  exceptional  emergency  situation  to 
public health that requires cross-border coordination. 

Cyber incidents 
in healthcare 

Scenario:  A  cyberattack  results  in  service  disruptions  and  outages  in 
hospitals  in  several  countries,  disrupting  the  provision  of  essential 
services. 

Disclaimer: The scenarios are hypothetical situations for illustrative purposes only. They are not presented in 
any order of priority. 

The  Union  plan  also  covers  events  that  are  of  such  a  serious  nature  that  they  are 
recognised as a public health emergency at Union level by the Commission or as a 
Public  Health  Emergency  of  International  Concern  (PHEIC)  by  the  World  Health 
Organization (WHO) (19). 

While  EU  external  action  in  health  contributes  to  health  security  in  both  partner 
countries  and  EU  Member  States,  the  Union  plan  describes  joint  arrangements  for 
governance, capacities and resources to prevent, prepare for and respond to events 
in the EU/EEA regardless of whether these threats have originated within the EU or 
outside Europe. The Union plan therefore does not cover EU actions taken to address 
health crises that occur outside the EU/EEA area and that are unlikely to pose a health 
threat to people living in the EU/EEA. 

(19)   Provided that they fall under one of the categories of threats set out in points (a) to (d) of Article 2(1) of Regulation 

(EU) 2022/2371. 

11 

 
 
 
 
 
 
 
 
1.3.  How to use the Union plan?  

The Union plan shows how governance for prevention, preparedness and response to 
health  crises  across  the  EU  is  implemented  and  includes  provisions  for  joint 
arrangements  for  capacities  and  resources  that  can  be  mobilised  to  prevent  the 
emergence of a health threat and/or to mitigate its impact. Moreover, the Union plan 
provides details on the procedure for recognising a public health emergency at Union 
level  and  related  additional  measures.  Finally,  the  Union  plan  describes  joint 
arrangements in place for learning and continuous improvement. These are important 
for updating national prevention, preparedness and response plans as well as ensuring 
swift recovery. 

The development of the Union plan is founded on four guiding approaches: all-hazards, 
One Health, whole-of-government and whole-of-society: 

Table 2. Approaches considered by the Union plan 

• 

• 

• 

• 

The all-hazards approach to preparedness ensures that organisational capabilities, and controls are 
designed  and  applied  in  such  a  way  as  to  be  able  to  respond  to  all  types  of  disruptive  events, 
irrespective of their nature or cause.  
The One Health approach is an integrated, unifying approach that aims to sustainably balance and 
optimise the health  of people, animals, and ecosystems. It  recognises that the health  of humans, 
domestic  and  wild  animals,  plants,  and  the  wider  environment  (including  ecosystems)  are  closely 
linked and interdependent, as well as the need for coordination and collaboration between relevant 
sectors (20). 
The  whole-of-government  approach  brings  together  all  levels  of  administration  (from  local  and 
regional  to  national  and  EU  level  as  well  as  international  level)  and  promotes  multisectoral  and 
multidisciplinary collaboration, policy coherence and the sharing of resources.  
The whole-of-society approach supports an inclusive culture of preparedness and resilience and is 
essential  for  achieving  national  unity  and  solidarity  for  managing  the  risks  and  impacts  of  health 
crises, as well as the resilience of communities and countries. 

The Union plan is relevant to all EU Member States and EEA countries, including 
the  outermost  regions (21).  Its  main  audience  is  relevant  authorities  in  the  Member 
States  responsible 
for  prevention, 
preparedness and response planning and for crisis management. Other key audiences 
include  EU  agencies  and  bodies,  international  organisations  such  as  the  WHO  and 
neighbouring countries. The general population, private sector, civil society, academia 
and the media can also benefit from the Union plan.  

implementing  policies 

for  developing  and 

The  Union  plan  complements  national  prevention,  preparedness  and  response 
plans. When preparing or developing their national plans, Member States must seek 
coherence  with  the  Union  plan  to  the  largest  extent  possible,  in  accordance  with 
national responsibility for prevention, preparedness and response to health crises and 

(20)  One Health High-Level Expert Panel (OHHLEP), Adisasmito W.B., Almuhairi S., Behravesh C.B., et al., ‘One Health: A 

new definition for a sustainable and healthy future’. PLoS Pathogens, Vol. 18, Issue 6, 2022, 
https://doi.org/10.1371/journal.ppat.1010537. 

(21)  Article 349 of the Treaty on the Functioning of the European Union (TFEU). 

12 

 
 
considering  national  circumstances  (22).  For  example,  national  plans  can  include 
references  to  the  joint  arrangements  for  governance,  capacities  and  resources 
described  in  the  Union  plan.  Documenting  such  linkages  can  facilitate  coordinated 
action from local, regional and national to EU level and, as appropriate, international 
level and across sectors. 

Throughout  the  Union  plan,  special  focus  is  given  to  cross-border  interregional 
preparedness elements for prevention, preparedness and response to health crises 
(see  Table  3).  The  Union  plan  illustrates  examples  of  existing  cross-border 
arrangements to ensure seamless, coordinated action and efficient use of resources. 

Table 3. Types of cross-border interregional collaboration considered in the Union plan 

• 
• 
• 

• 

Collaboration between regions sharing an EU/EEA internal border 
Collaboration at national level between countries sharing an EU/EEA internal border 
Collaboration  at  regional  or  national  level  between  regions  or  countries  not  sharing  an  EU/EEA 
internal border 
Collaboration across EU external borders, in particular with the countries and regional organisations 
that border the EU’s outermost regions. 

Regions refer to any sub-national territorial units as per NUTS classification (23). 

The  Union  plan  should  not  be  considered  an  exhaustive  blueprint  of  step-by-step 
procedures to follow if a certain event arises. Each health crisis would require different 
types of expertise and response adapted to the type of threat, the socio-demographic 
characteristics of the population, and the environment in which it occurs. However, the 
Union  plan  represents  an  asset  providing  an  overview of  the  joint arrangements  for 
governance, capacities and resources currently in place to effectively respond to health 
crises in the EU/EEA. For this reason, it does not contain references to relevant new 
actions announced in a number of cross-cutting and sectoral EU strategies, as these 
activities and arrangements are yet to be implemented. 

Furthermore, the Union plan does not refer to time-limited EU-funded projects that are 
relevant for the prevention of, preparedness for or response to health crises. However, 
Annex  6  provides  an  overview  of  EU  funding  instruments  relevant  to  strengthening 
health security, including activities funded under the EU4Health and Horizon Europe 
programmes. 

1.4.  How will the Union plan be kept up to date?  

The current version of the Union plan is its first edition. It should be considered a living 
document that the Commission in coordination with Member States and relevant EU 
agencies  and  bodies will  regularly  review and,  as necessary,  revise  to  address any 
changes  that  can  occur  in  its  legal  basis  or  in  the  overall  operating  environment  or 
based  on  lessons  learned  from  simulation  exercises  or  from  real-life  events.  To 

(22)  Article 6 of Regulation (EU) 2022/2371. 
(23)  European Commission: Eurostat, ‘NUTS - Nomenclature of territorial units for statistics’, European Commission 

website, accessed 31 October 2025, https://ec.europa.eu/eurostat/web/nuts.  

13 

 
 
measure the plan's performance, the Commission plans to develop a set of indicators 
that will enable the assessment of its performance. Moreover, as the Union plan is to 
complement the national plans and promote synergies between the Member States, 
the  Commission  and  the  relevant  EU  agencies,  the  findings  and  recommendations 
from the regular reporting and assessment of national prevention, preparedness and 
response  plans  can  identify  needs  for  further  development  of  the  Union  plan. 
Implementation of the Union plan will be monitored and discussed in the HSC. 

To ensure that the Union plan continues to meet its aim of promoting an effective and 
coordinated  response  to  serious  cross-border  threats  to  health  in  the  EU,  the 
Commission  will  regularly  organise  simulation  exercises  testing  the  content  of  the 
Union  plan  against  a  range  of  hazards.  Based  on  the  lessons  identified  from  these 
exercises,  the  Commission  will  revise  the  Union  plan.  Moreover,  should  a  real-life 
event  occur,  the  Commission  will  carry  out  in-action  or  after-action  reviews  with 
Member States to ensure that the Union plan is updated, functional and operational. 

Based on the findings of the first simulation exercise planned for 2026, as well as the 
implementation  of  the  relevant  actions  of  the  EU  Preparedness  Union  Strategy,  the 
Commission will assess whether an update is required.  

14 

 
 
 
2.  Key  EU  health  crisis  governance  structures, 

mechanisms and instruments 

Effective governance and coordination mechanisms within the EU, its agencies, bodies 
and Member States, as well as with international organisations such as WHO and other 
international  partners,  are  crucial  for  ensuring  effective  readiness  and  response  to 
serious  cross-border  threats  to  health.  Coordinated  action  enables  timely  early 
detection,  information  sharing,  joint  risk  assessments,  prevention  and  response 
measures, efficient resource mobilisation, and effective risk and crisis communication. 
These governance arrangements not only strengthen the EU’s collective preparedness 
and response capacity, but also uphold the principles of solidarity, resilience, equity 
and trust in times of crisis.  

The  EU  governance  structures  and  support  mechanisms  for  health  crises  are 
presented in Annexes 3 and 4. The key joint arrangements to ensure health security 
in  the  EU are  active  in  different  phases of the  health  crisis management  cycle  (see 
Figure  1).  These  governance  structures,  mechanisms  and  instruments  act  in 
coordination, cooperation and complementarity in the prevention of, preparedness for 
and response to health crises, avoiding any overlaps or duplication of efforts. 

Figure 1. Main EU health crisis governance structures, mechanisms and instruments 
that can be operational during different phases of the health crisis management cycle. 
HSC=Health  Security  Committee;  HCB=Health  Crisis  Board;  ERCC=  Emergency 
Response  Coordination  Centre;  UCPM=Union  Civil  Protection  Mechanism; 
IPCR=Integrated  Political  Crisis  Response;  ACPHE=Advisory  Committee  on  Public 
Health Emergencies; EUHTF=EU Health Task Force. 

15 

 
 
The Health Security Committee (HSC), composed of nominated representatives of EU 
Member States and EEA countries, plays an important role in coordinating activities 
related  to  the  prevention,  preparedness  and  response  to  health  crises  with  cross-
border  potential  at  EU  level  (24).  The  HSC  operates  throughout  the  entire  crisis 
management  cycle  and  provides  a  platform  where  EU  Member  States  and  EEA 
countries  and  the  Commission  meet  to  discuss  and  ensure  coordination  on  health 
security matters. It meets at regular intervals and whenever the situation requires, at 
the request of the Commission or an EU Member State or an EEA country. The HSC 
invites  relevant  EU  agencies  and  bodies,  the  European  Parliament  as  well  as 
international organisations  –  such  as  the  WHO  –  to  participate  as  observers  where 
relevant to the topic.  

The HSC is chaired by the Commission and operates at two working levels: the senior 
level group and technical working groups dedicated to specific subjects. It allows 
for  rapid  information  exchange,  the  sharing  of  best  practices  and  experiences, 
discussion  on  EU  support  needs  and  actions  required  to  strengthen  prevention, 
preparedness and response planning, as well as the development and adoption of EU-
level guidance and opinions to support the coordination of national measures ensuring 
a  coherent  EU-wide  response  to  a  health  crisis (25).  By  maintaining  a  strong 
communication  channel  and  encouraging  collaboration,  the  HSC  supports  Member 
States in their preparedness planning (see Section 4.1.1) for emerging health threats 
and for continuously improving their readiness to mitigate future health crises. 

In  the  area  of  MCMs,  the  HERA  Board  is  composed  of  the  representatives  of  the 
Member States and chaired by the  Commission, while EU institutions and agencies 
may participate as observers (26). The task of the HERA Board is to assist and advise 
the  Commission  in  the  formulation  of  strategic  decisions  concerning  Commission’s 
activities  on  MCMs,  contributing  to  leveraging  Member  States’  resources  and 
capacities.  This  entails  work  on  the  assessment  of  health  threats  and  intelligence 
gathering;  promoting  advanced  research  and  development;  addressing  market 
challenges  and  boosting  the  Union’s  open  strategic  autonomy  in  production;  swift 
procurement  and  distribution;  increasing  stockpiling  capacity;  and  strengthening 
knowledge and skills in preparedness and response related to MCMs. In view of the 
information that is exchanged during meetings of the HERA Board, its work can help 
decision-making on measures at national level to improve the availability of and access 
to MCMs. 

The HERA Board is supported by the HERA Advisory Forum consisting of Member 
State  experts  in  the  area  of  health  security,  research  and  industrial  policy  (27).  The 
Advisory Forum exchanges technical information and pools knowledge on  MCMs to 

(24)   Articles 4, 10 and 21 of Regulation (EU) 2022/2371. 
(25)  European Commission, ‘Health security and infectious diseases – Publications. Opinions of the Health Security 

Committee’, European Commission website, accessed 31 October 2025, https://health.ec.europa.eu/health-security-
and-infectious-diseases/publications_en?f%5B0%5D=topic_topic%3A224. 

(26)   Commission Decision of 16.9.2021 establishing a Health Emergency Preparedness and Response Authority (HERA), 

C(2021)6712, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=intcom:C(2021)6712. 

(27)   European Commission, ‘HERA Advisory Forum’, European Commission website, accessed 31 October 2025, 

https://health.ec.europa.eu/health-emergency-preparedness-and-response-hera/overview/hera-advisory-forum_en.  

16 

 
 
provide  scientific  knowledge  and  advice  to  the  HERA  Board.  As  a  subgroup  of  this 
Forum, a Joint Industrial Cooperation Forum has been set up to link Member States 
and  industry  representatives  in  the  whole-of-society  approach.  It  complements  the 
Commission’s  broader  intelligence  tools  and  bodies  by  focusing  specifically  on  the 
industrial aspects of preparedness. It aims to identify market failures and supply chain 
dependencies that could limit the production capabilities of relevant  MCMs and their 
raw materials. The Civil Society Forum ensures exchanges with academia and civil 
society  and  provides  recommendations  to  the  Advisory  Forum  on  specific  matters 
related  to  health  crisis  preparedness  and  response,  with  a  focus  on  MCMCs,  and 
monitors relevant research, industrial and policy developments.  

The Health Crisis Board is established when the emergency framework for MCMs is 
activated following the recognition of a public health emergency at Union level (28). The 
Health Crisis Board ensures the coordination of action by the Council, the Commission 
and relevant Union agencies and bodies and Member States to ensure the supply of 
and access to crisis-relevant MCMs. It is composed of the Commission and one high-
level representative from each Member State. It meets whenever the situation requires, 
upon  request  from  the  Commission  or  a  Member  State  and  is  co-chaired  by  the 
Commission  and  the  Member  State  holding  the  rotating  Presidency  of  the  Council. 
Relevant  EU  institutions,  agencies  and  bodies  as  well  as  a  representative  of  the 
European Parliament, the HSC and, where relevant, international organisations – such 
as  WHO, Food  and  Agriculture  Organization  of  the  United  Nations  (FAO)  and  the 
World  Organisation  for  Animal  Health  (WOAH)  –  to  participate  as  observers  where 
relevant to the topic.  

The  Health  Crisis  Board  and  the  HERA  Board  coordinate  on  the  MCMs  response 
based on their distinct roles. Moreover, they coordinate with the HSC and exchange 
information to effectively respond  to  the  threat. Given their mutually  complementary 
roles  and  responsibilities,  close  coordination,  including  the  exchange  of  information 
and the facilitation of discussions, is ensured (29). 

In terms of EU support mechanisms that are in place in case of natural and human-
induced disasters, including health crises, the EU Civil Protection Mechanism (UCPM) 
plays a crucial role. It aims to strengthen civil protection cooperation between the EU 
Member States and 10 additional UCPM Participating States to improve prevention, 
preparedness,  and  response  to  disasters  in  Europe  and  beyond.  The  Emergency 
Response Coordination Centre (ERCC) of the Commission is at the heart of the UCPM, 
ensuring 24/7 operational capacity to facilitate rapid coordination and support (30). 

The  Integrated  Political  Crisis  Response  (IPCR)  arrangements  of  the  European 
Council are the central EU mechanism that support rapid and coordinated decision-
making at EU political level for major and complex crises. Chaired by the Presidency 

(28)  Article 5 of Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the 

suppy of crisis-relevant medical countermeasures in the event of a public health emergency at Union level (OJ L 314, 
6.12.2022, p. 64, ELI: http://data.europa.eu/eli/reg/2022/2372/oj).  

(29)  Article 5(5) of Regulation (EU) 2022/2372. 
(30)  Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil 

Protection Mechanism (OJ L 347, 20.12.2013, p. 924, ELI: http://data.europa.eu/eli/dec/2013/1313/oj).  

17 

 
 
of the Council, the IPCR is scalable according to the gravity of the crises (31). It can be 
triggered either by the Presidency of the Council or by a request from a Member State 
(32). During a health crisis, the HSC, and the Health Crisis Board, if established, work 
closely with the IPCR mechanism to ensure that political coordination at EU level is 
supported  by  public  health  expertise  and  operational  input  from  Member  States, 
including  through  information  exchange,  situational  awareness  in  the  form  of 
Integrated Situational Awareness and Analysis (ISAA) reports and sharing opinions or 
guidance. The Emergency response Coordination Centre (ERCC) supports both the 
EU institutions and the Member States when IPCR arrangements are activated, or the 
solidarity  clause  is  invoked.  Annex  3  contains  further  examples  of  important 
governance structures and instruments for EU health security in the European Council, 
as well as the Council of the EU and the European Parliament.  

The Advisory Committee on Public Health Emergencies (ACPHE) is a multidisciplinary 
expert group whose mission is to provide advice, at the request of the Commission or 
the  HSC,  on  whether  an  emerging  threat  constitutes  a  public  health  emergency  at 
Union  level.  It  also  provides  advice  on  appropriate  response  measures for  an 
emergency and the need for termination of a public health emergency at Union level 
(33). 

Throughout  all  phases  of  the  health  crisis  management  cycle,  the  EU  Health  Task 
Force  (EUHTF),  established  and  operated  by  the  ECDC (34),  is  ready  to  provide 
support  to  Member  States  where  needed.  The  EUHTF  can  be  mobilised  on  field 
missions or for remote support in an EU Member State or an EEA country or outside 
the EU based on a request for support. Once a public health emergency at Union level 
has been recognised and following the request of at least two Member States and the 
Commission, the ECDC must mobilise the EUHTF enhanced emergency capacity and 
its pools, in coordination with the Commission and the HSC (35) (36). 

The  European  Centre  for  Disease  Prevention  and  Control  (ECDC);  European 
Medicines  Agency  (EMA);  European  Food  Safety  Authority  (EFSA);  European 
Environment  Agency  (EEA);  and  the  European  Chemicals  Agency  (ECHA)  have 
established the Cross-agency task force on One Health (37). This is a collaborative 
framework that brings together these five EU agencies to address health threats at the 
interface.  The  network  promotes  a  holistic, 
human-animal-environment 

(31)  Council Decision 2014/415/EU of 24 June 2014 on the arrangements for the implementation by the Union of the 

solidarity clause (OJ L 192, 1.7.2014, p. 53, ELI: http://data.europa.eu/eli/dec/2014/415/oj). 

(32)  European Council, ‘How the Council coordinates the EU response to crises’, European Council/Council of the European 
Union website, accessed 31 October 2025, https://www.consilium.europa.eu/en/policies/ipcr-response-to-crises/.  

(33)  Article 24 of Regulation (EU) 2022/2371.  
(34)  European Centre for Disease Prevention and Control (ECDC), EU Health Task Force (EUHTF), ECDC website, accessed 
31 October 2025, https://www.ecdc.europa.eu/en/about-ecdc/what-we-do/partners-and-networks/support-and-
services-eueea-countries/health-task-force.  
(35)  Article 11a of Regulation (EC) No 851/2004. 
(36)  Commission Implementing Regulation (EU) 2025/1536 of 29 July 2025 setting out the procedure concerning the 
mobilisation of the enhanced emergency capacity of the EU Health Task Force (OJ L, 2025/1536, 30.7.2025, ELI: 
http://data.europa.eu/eli/reg_impl/2025/1536/oj).  

(37)   One Health cross-agency task force: Strengthening EU agencies’ scientific advice on One Health, EFSA website, 

accessed 31 October 2025, https://www.efsa.europa.eu/sites/default/files/documents/news/one-health-cross-agency-
task-force.pdf. 

18 

 
 
interdisciplinary  approach  to  preventing  and  managing  risks  such  as  zoonotic 
diseases,  antimicrobial  resistance  (AMR), 
food  safety  threats  and  emerging 
pandemics.  

Additionally, several EU agencies and bodies can be tasked with carrying out joint 
risk assessments of the potential severity of a threat to public health, including possible 
health measures (see Figure 2) (38). Each EU agency and body has a specific mandate 
and role in the prevention, preparedness and response to health crises (see Annex 4). 

Figure 2: EU agencies and bodies tasked with carrying out joint risk assessments on 
threats to public health  

To strengthen evidence-informed crisis prevention, preparedness and response, the 
Commission’s  Scientific  Advice  Mechanism  (SAM)  plays  a  pivotal  role  in  delivering 
independent,  evidence-based  scientific  advice  and  opinions  with  policy 
recommendations  upon  request  from  the  College  of  Commissioners (39).  The 
mechanism  collaborates  with  the  European  Group  on  Ethics  in  Science  and  New 
Technologies (EGE), which is an independent, multi-disciplinary body advising on all 
policies  where  ethical,  societal  and  fundamental  rights  issues  intersect  with  the 
development of science and new technologies. 

Finally, although the Union plan does not focus on the international level in terms of 
health crises emerging in and affecting regions outside of the  EU, the Union plan is 
aligned with EU global health priorities, enshrined in the EU Global Health Strategy (40). 
Furthermore,  health  is  a  key  area  of  partnership  under  the  EU  Global  Gateway 
strategy and the EU collaborates extensively with its international partners by pooling 
resources  and  expertise  for  effectiveness  and  greater  impact  through  the  Team 
Europe approach (41) (42). For example, at global level the EU supports global health 
initiatives such as the Pandemic Fund, the Vaccine Alliance Gavi and the Global Fund. 

(38)  Article 20 of Regulation (EU) 2022/2371. 
(39)  Scientific Advice Mechanism to the European Commission, accessed 3 November 2025, https://scientificadvice.eu/. 
(40)  European Commission, ‘Report from the Commission to the European Parliament, the Council, the European 

Economic and Social Committee and the Committee of the Regions on the implementation of the EU Global Health 
Strategy’, COM(2025) 392 final, 10 July 2025, https://health.ec.europa.eu/latest-updates/report-implementation-eu-
global-health-strategy-2025-07-10_en. 

(41)  European Commission, ‘Team Europe Initiatives’, European Commission website, accessed 31 October 2025, 

https://international-partnerships.ec.europa.eu/policies/team-europe-initiatives_en.  

(42)  European Commission, ‘Global Gateway’, European Commission website, accessed 19 November 2025, 

https://commission.europa.eu/topics/international-partnerships/global-gateway_en.  

19 

 
 
 
At  regional  level,  the  EU  engages  with  African  regional  partners  in  a  Team  Europe 
approach, while EU Delegations manage bilateral health programmes at country level. 
Annex 5 contains more information on global health security governance. 

20 

 
3.  Health crisis management cycle 

The  Union  plan  is  structured  around  the  different  phases  of  the  health  crisis 
management  cycle,  a  comprehensive  framework  that  guides  preparation  for, 
management of and recovery from health crises in the EU (see Figure 3). The cycle 
consists  of  four  interconnected  phases:  Prevention  &  Preparedness;  Detection  & 
Assessment;  Response;  and  Recovery.  Each  phase  builds  on  the  previous  one, 
creating a continuous process that strengthens the EU’s ability to protect public health 
and respond effectively to emerging threats. 

Establishing  capacities  and  resources,  preparedness  planning,  training,  testing  the 
plans, implementing lessons learned and building resilience take place every day for 
continuous  improvement  (inner  circle).  An  effective  and  coordinated  response  to  a 
serious cross-border threat to health relies on early threat detection and assessment 
of  risks,  taking  the  necessary  steps  to  manage  the  situation  and  to  learn  from  the 
response through in-action and after-action reviews (middle circle). The recognition of 
a public health emergency at Union level releases additional capacities and resources 
(outer circle). 

The Prevention & Preparedness phase focuses on reducing the risk of health crises 
before  they  occur.  This  involves  building  response  capacities  and  resources  to 
strengthen the resilience of the health systems by ensuring a skilled health workforce, 
investing  in  health  infrastructure,  ensuring  continuous  access  and  availability  of 
medicines and other MCMs, and in developing national prevention, preparedness, and 
response  plans.  The  Commission  and  EU  agencies  and  bodies  work  closely  with 
Member States to assess their readiness, identify gaps, and support improvements in 
their  capacity  to  manage  cross-border  health  threats.  Moreover,  the  EU  joint 
arrangements provide additional support for the prevention of health threats such as 
EUHTF support for planning and EU training for the health workforce. 

The  Detection  &  Assessment  phase  involves  identifying  potential  health  threats 
early,  assessing  their  risks  and  determining  the  appropriate  level  of  response.  This 
phase relies on public health intelligence on health threats performed by the Member 
States, the Commission and the EU agencies and bodies according to their mandates. 
Member States and the Commission are responsible for alerting events through early 
warning systems to trigger a response. Risk assessments and intelligence gathering 
conducted at national or EU level help us understand the type, likelihood and severity 
of the threat. This allows the EU and Member States to take informed, necessary and 
proportionate action. 

21 

 
Figure 3. Health crisis management cycle. Adapted from ECDC, 2025 (43).  

The Response phase is vital to prevent an escalation of an event and to mitigate the 
impacts of a health crisis by coordinating actions across the EU, mobilising capacities 
and  resources,  and  supporting  affected  countries.  The  Member States,  relevant EU 
agencies and bodies and the Commission coordinate their actions, among others, in 
the  Health  Security  Committee,  in  the  HERA  Board  and  under  the  Union  Civil 
Protection  Mechanism,  if  activated.  In  major  or  complex  crises,  the  Council  is 
responsible for the overall cross-sectoral coordination of responses with the activation 
of  the  Integrated Political Crisis  Response  arrangements.  These  joint  arrangements 
for governance enable information exchange, consultation, coordination and adoption 
of  advice,  guidance  and  recommendations  based  on  which  the  stakeholders 
implement response measures in accordance with their respective mandates. EU joint 
arrangements  for  capacities  and  resources  ensure  situational  awareness,  risk  and 
crisis communication, emergency research and innovation, availability and supply of 
related MCMs and emergency funding. Moreover, these joint arrangements facilitate 
continuity of care across borders, including contact tracing and medical evacuation. If 
a situation becomes serious enough, the Commission can formally recognise a public 
health emergency at Union level. This allows the Council to decide on the activation of 
measures for ensuring the supply of crisis-relevant MCMs and establishing the Health 
Crisis Board. 

(43)  ECDC, Recommendations for preparedness planning for public health threats, Stockholm, 2025, 

https://www.ecdc.europa.eu/sites/default/files/documents/Recommendations-for-preparedness-planning-for-public-
health-threats.pdf. 

22 

 
 
 
The Recovery phase focuses on restoring people’s health and well-being, rebuilding 
the health systems’ resilience and supporting broader social and economic recovery. 
As the immediate emergency subsides, efforts turn to helping affected communities 
recover  and  restoring  essential  services.  This  phase  also  involves  strengthening 
systems  to  better  withstand  future  crises,  by  reviewing  the  response,  identifying 
lessons  learned  during  and  after  the  health  crisis,  and  using  these  insights  to  drive 
concrete  improvements  that  enhance  the  health  and  stability  of  all.  Simulation 
exercises  help  to  identify  areas  of  improvement  in  the  joint  arrangements  for 
governance, capacities and resources outside real-life events.  

By following the health crisis management cycle, the EU and its Member States can 
ensure they are better prepared to prevent, prepare for, respond to and recover from 
health  crises,  ultimately  protecting  the  health  and  well-being  of  people  living  in  the 
EU/EEA.  

23 

 
 
 
4.  PHASE 1: Preventing and preparing for health crises 

Ensuring robust prevention and preparedness for potential cross-border health crises 
is essential for the EU’s  ability  to  protect  its  population and  safeguard  public  health 
security. In an interconnected Europe, health crises do not respect borders, meaning 
that  an  event  in  one  Member  State  can  rapidly  escalate  into  a  continent-wide 
emergency  if  it  is  not  addressed  swiftly  and  collectively.  Building  population 
preparedness for health crises requires involvement of a broad range of stakeholders 
in a ‘whole-of-society’ approach. 

Prevention,  including  the  resilience  of  healthcare  systems  and  strong  occupational 
safety and health measures, as well as good working conditions to protect workers on 
the frontlines of health systems as well as critical infrastructures and services, is the 
first and most effective line of defence. This is complemented by communicating clear 
and science-based preventive messages to the public and other actions to build health 
literacy especially among vulnerable groups. Training of healthcare and public health 
staff and the presence of coordinated research capabilities enable the EU to identify 
emerging health threats swiftly and prevent them from spiralling into full-blown crises. 
Preparedness complements prevention by ensuring that, when crises do occur, the EU 
can respond rapidly and efficiently. This involves robust coordination between national 
health authorities, the development of national and EU plans, the development of joint 
response  capacities  including  strategic  stockpiling  of  MCMs,  and  clear  lines  of 
communication and decision-making between EU institutions, its agencies and bodies 
and EU Member States as well as social partners and international stakeholders.  

Health crises can have a significant impact on the mental health and well-being. This 
is especially the case for vulnerable populations (elderly, children and young people) 
and  socioeconomic  disadvantaged  population  groups,  who  are  disproportionately 
affected,  deepening  health  inequalities.  Ensuring  that  prevention, preparedness and 
response  measures  are  designed  and  implemented  in  a  way  that  is  inclusive  and 
accessible to all people is essential for strengthening trust, equity and resilience of the 
Union’s public health systems.  

Ultimately, preventing cross-border health crises reflects core EU values of solidarity 
and cooperation. By embracing an all-hazards, whole-of-society, whole-of-government 
and  One  Health  approach,  the  EU  can  more  effectively  anticipate,  mitigate,  and 
respond to complex crises that transcend borders and sectors. 

4.1.  Prevention, preparedness and response planning 

Prevention, preparedness  and  response  plans  are  the  starting point  for an  effective 
and  coordinated  action.  The  development of  these  plans  provides  an  opportunity to 
engage individuals from across relevant sectors and neighbouring regions, promoting 
learning  and  building  connections  that  will  support  the  implementation  of  the  plan. 

24 

 
Ensuring  political  commitment  and  sufficient  financial  and  human  resources  for  the 
planning process is essential. The Health Security Committee (HSC) plays a crucial 
role in the coordination of prevention, preparedness and response planning, and in the 
discussions on the overall state of preparedness in the EU/EEA (44). 

In the EU/EEA, national prevention, preparedness and response planning for health 
crises is enhanced through interlocking reporting and assessment cycles taking place 
every three years and starting in 2023 and 2024 respectively (see Figure 4). Based on 
the information submitted by the Member States while reporting on national prevention, 
preparedness  and  response  planning,  the  Commission  prepares  a  report  to  initiate 
discussions  in  the  HSC.  In  parallel,  the  ECDC  assesses  national  planning  through 
Public Health Emergency Preparedness Assessments (PHEPA), while also providing 
recommendations  for  improvement.  Afterwards,  the  Commission  summarises  the 
findings from the reporting and assessment cycles in a report on the state of play and 
progress on prevention, preparedness and response planning at Union level. This is 
then submitted to the European Parliament and the Council, to ensure transparency 
and accountability in the EU’s health security efforts (45). 

Figure  4.  The  interlocking  reporting  and  assessment  cycles  of  Member  States’ 
prevention, preparedness and response planning taking place every three years under 
Regulation 
response. 
(EU)  2022/2371.  PPR=prevention,  preparedness  and 
COM=Commission.  ECDC=European  Centre  for  Disease  Prevention  and  Control. 
HSC=Health  Security  Committee.  MS=Member  State.  PHEPA=Public  Health 
Emergency Preparedness Assessment. 

(44)  Article 10 of Regulation (EU) 2022/2371. 
(45)  Articles 6-9 of Regulation (EU) 2022/2371.  

25 

 
 
 
4.1.1.  Development  of  prevention,  preparedness  and  response 

plans 

Member States develop their national prevention, preparedness and response plans 
for health crises, which are tailored to their respective health systems, preparedness 
and response structures, protocols, capacities, resources and circumstances. National 
prevention,  preparedness  and  response  plans  can  include  elements  relating  to 
governance,  capacities  and  resources,  as  well  as  cross-border  interregional 
preparedness  elements  laid  down  in  this  plan.  When  preparing  their  national plans, 
Member States are to liaise with each other within the HSC and  coordinate with the 
Commission  in  order  to  seek  coherence  with  the  Union  plan  to  the  largest  extent 
possible. Moreover, they must inform the Commission and the HSC of any substantial 
revisions  of  their  plans  (46).  Through  the  Early  Warning  and  Response  System 
(EWRS),  the  Member  States  can  share  information  on  their  national  prevention, 
preparedness and response plans securely. 

The  template  for  the  provision  of  information  on  prevention,  preparedness  and 
response  planning  in  relation  to  serious  cross-border  threats  to  health  provides 
benchmarks  to  support  Member  States  in  preparing  their  national  prevention, 
preparedness  and  response  plans  for  health  crises  (47).  The  WHO  has  developed 
guidance and tools for the development and implementation of national plans (48) (49). 
The EUHTF can support countries in the preparation of their national plans following a 
country’s request. 

At EU level, the general plan for crisis management in the field of food and feed safety 
established by the Commission specifies the procedures necessary to manage a crisis, 
including the principles of transparency to be applied and a communication strategy. 
The scope of the plan covers emergency situations that involve risks to human health 
arising from food and feed, which are not likely to be prevented, eliminated or reduced 
to  an acceptable  level  by  legal provisions  already  in  place  or cannot  adequately be 
managed solely by way of the application of usual protective measures (suspension of 
placing  on 
interim 
measures) (50) (51). 

the  market,  special  conditions  or  any  other  appropriate 

(46)  Article 6 of Regulation (EU) 2022/2371. 
(47)  Commission Implementing Regulation (EU) 2023/1808 of 21 September 2023 setting out the template for the 
provision of information on prevention, preparedness and response planning in relation to serious cross-border 
threats to health in accordance with Regulation (EU) 2022/2371 of the European Parliament and of the Council (OJ L 
234, 22.9.2023, p. 105, ELI: http://data.europa.eu/eli/reg_impl/2023/1808/oj). 

(48)  WHO, WHO benchmarks for strengthening health emergency capacities, Geneva, 2023, Licence: CC BY-NC-SA 3.0 

IGO, https://iris.who.int/server/api/core/bitstreams/8883ae92-ecbe-4cc6-8ad4-500297ef1df9/content.  

(49)  WHO, WHO guidance on preparing for national response to health emergencies and disasters, Geneva, 2021, Licence: 

CC BY-NC-SA 3.0 IGO, https://www.who.int/publications/i/item/9789240037182.  

(50)  Article 55 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down the general principles and requirements of food law, establishing the European Food Safety Authority and 
laying down procedures in matters of food safety (OJ L 031, 1.2.2002, p. 1, ELI: 
http://data.europa.eu/eli/reg/2002/178/2024-07-01). 

(51)  Commission Implementing Decision (EU) 2019/300 of 19 February 2019 establishing a general plan for crisis 

management in the field of the safety of food and feed (OJ L 50, 21.2.2019, p. 55, 
http://data.europa.eu/eli/dec_impl/2019/300/oj). 

26 

 
 
On medicines, the EMA has established plans for dealing with incident and crisis-level 
issues  related  to  the  quality,  efficacy,  or  safety  of  medicines  (European  medicines 
regulatory network incident management plan for medicines for human use) (52) and 
for addressing the medicine-related aspects of the response to health threats (EMA 
Health Threats Plan) (53). 

4.1.2.  Reporting  on  prevention,  preparedness  and  response 

planning 

By  December  2023,  and  every  three  years  after  that,  Member  States  report  to  the 
Commission  and  relevant  EU  agencies  and  bodies  on  national  prevention, 
preparedness  and  response  planning.  They  provide  an  overview  of  the  national 
arrangements  for  governance,  capacities  and  resources  in  place  to  ensure  their 
countries’  readiness  and  response  to  cross-border  health  crises  (54).  This  self-
assessment is structured based on a template built around 16 capacities and aligned 
with the reporting requirements for Members to WHO under the International Health 
Regulations (IHR) (55) (56).  

Based on the information on national planning submitted by the Member States, the 
Commission prepares an  overview  report  in  cooperation  with the ECDC  and  other 
relevant EU agencies and bodies, which is discussed within the HSC. The overview 
report  allows  for  the  monitoring  of  progress  and  the  identification  of  gaps  in 
preparedness  at  national  and  EU  levels (57).  Recommendations  stemming  from  the 
findings of the report are published online by the Commission and the ECDC (58). 

In addition, the Commission prepares a report every three years on the state of play 
and  progress  on  prevention,  preparedness  and  response  planning  at  Union 
level, which is submitted to the European Parliament and Council (59). The first report 
outlining  the  EU’s  comprehensive  efforts  to  improve  health  preparedness,  disease 
surveillance, and antimicrobial resistance management through integrated One Health 

(52)  European Medicines Agency (EMA), The European Medicines Regulatory Network Incident Management Plan for 

Medicines for Human Use, 2009 (revised in 2017 and 2025), https://www.ema.europa.eu/en/documents/other/eu-
regulatory-system-incident-management-plan-medicines-human-use_en.pdf.  

(53)  EMA, ‘EMA’s work on public health emergencies’, EMA website, accessed 31 October 2025, 

https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/emas-work-public-health-
emergencies#:~:text=The%20European%20Medicines%20Agency%20%28EMA%29%20has%20developed%20a,thr
eat.%20This%20enables%20a%20rapid%20and%20efficient%20response.  

(54)  Article 7 of Regulation (EU) 2022/2371. 
(55)  Commission Implementing Regulation (EU) 2023/1808. 
(56)  11 of the 16 capacities are also IHR core capacities reported annually in February to the WHO as part of the IHR 
States Parties Self-Assessment Annual Report (SPAR). For more information, see International Health Regulations 
(2005) GUIDANCE DOCUMENT FOR STATE PARTY SELF-ASSESSMENT ANNUAL REPORTING TOOL. Geneva: World 
Health Organization; 2018. Licence: CC BY-NC-SA 3.0 IGO, https://www.who.int/publications/i/item/WHO-WHE-CPI-
2018.17. 

(57)  This report is not publicly available.  
(58)  European Commission, ‘Recommendations for health security preparedness’, European Commission website, 
accessed 3 November 2025, https://health.ec.europa.eu/publications/recommendations-health-security-
preparedness_en. 

(59)  Article 9 of Regulation (EU) 2022/2371. 

27 

 
 
strategies, legislation and funding initiatives across human, animal and environmental 
health sectors was published in December 2023 (60). 

4.1.3.  Assessment  of  national  prevention,  preparedness  and 

response planning  

Every three years, the ECDC assesses the state of implementation each EU Member 
State’s  or  EEA  country’s  national  prevention,  preparedness  and  response  plans  as 
part of the Public Health Emergency Preparedness Assessments (PHEPA) (61) (62). 
Based  on  the  findings  and  taking  into  consideration  the  context  and  national 
circumstances,  the  ECDC  provides  country-specific  recommendations  on  how to 
improve prevention, preparedness and response planning as well as implementation. 
Member  States  can  opt  to  have  their  country  reports  published  on  the  ECDC 
website (63).  

Within  nine  months  of  receiving  the  recommendations,  each  country  develops  an 
Action  plan  addressing  the  ECDC’s  recommendations.  Action  plans  provide  a 
detailed  breakdown  of  steps  to  be  taken  within  a  specific  timeline  to  achieve  the 
strategic priorities. Furthermore, the National Action Plans for Health Security involve 
a country owned, multi-year planning process developed by the WHO that can be used 
by the Member States as a guide in preparing their action plans after the PHEPAs (64). 
The  One  Health  national  action  plans  on  antimicrobial  resistance  also  include  key 
components on prevention and surveillance actions (65). 

In  addition  to  the  PHEPAs,  Member  States  may  also  request  to  be  evaluated  by  a 
WHO  team  of  experts.  The  Joint  External  Evaluation  is  a  voluntary,  collaborative, 
multisectoral  process  to  assess  country  capacities  to  prevent,  detect  and  rapidly 
respond to public health threats, whether they occur naturally or due to deliberate or 
accidental  events (66).  Based  on  a  Member  State’s  preference,  a  PHEPA  can  be 
conducted  jointly  with  a  Joint  External  Action  and/or  a  One  Health  fact-finding 
mission using a modified methodology that enables both assessments to fulfil their 
objectives.  In  addition,  WHO’s  Universal  Health  and  Preparedness  Review  is a 

(60)  European Commission, ‘State of Health Preparedness Report’, 15 December 2023, 

https://health.ec.europa.eu/publications/state-health-preparedness-report-2023_en.  

(61)  Article 8 of Regulation (EU) 2022/2371. 
(62)  Delegated Regulation (EU) 2024/1232 of 5 March 2024 supplementing Regulation (EU) 2022/2371 of the European 
Parliament and of the Council as regards assessments of the state of implementation of national prevention, 
preparedness and response plans and their relation with the Union prevention, preparedness and response plan (OJ L 
2024/1232, 8.5.2024, ELI: http://data.europa.eu/eli/reg_del/2024/1232/oj).  

(63)  ECDC, ‘Public Health Emergency Preparedness Assessments’, ECDC website, accessed 31 October 2025, 

https://www.ecdc.europa.eu/en/about-ecdc/what-we-do/public-health-emergency-preparedness-assessments.  

(64)  WHO, ‘National Action Plan for Health Security (NAPHS)’, WHO website, accessed 31 October 2025, 
https://www.who.int/emergencies/operations/international-health-regulations-monitoring-evaluation-
framework/national-action-plan-for-health-security.  

(65)  WHO, ‘Country-specific template for a national One Health action plan’, WHO website, 26 September 2023, accessed 
31 October 2025, https://www.who.int/publications/m/item/country-specific-template-for-a-national-one-health-
action-plan.  

(66)  WHO, ‘Joint External Evaluation (JEE)’, WHO website, accessed 31 October 2025, 

https://www.who.int/emergencies/operations/international-health-regulations-monitoring-evaluation-framework/joint-
external-evaluations. 

28 

 
 
voluntary,  transparent,  Member  State-led  peer  review mechanism,  that  aims  to 
establish  regular  intergovernmental  dialogue  between  Member  States  on  their 
respective national capacities for health emergency preparedness (67). 

4.2.  Ensuring  healthcare  system  preparedness  and 

resilience 

Ensuring  healthcare  system  preparedness  and  resilience  is  a  cornerstone  of  health 
security.  A  strong  and  adaptable  healthcare  system  with  well-equipped  and  trained 
workers, with good working conditions, enables the early detection, rapid response and 
sustained  delivery  of  essential  services.  By  investing  in  system-wide  readiness  and 
infrastructure resilience as well as health workforce capacity, working conditions and 
skills, governments and institutions can mitigate risks, protect  persons in vulnerable 
situations and maintain trust in health services. 

Cross-cutting EU legislation that addresses the cyber and physical resilience of critical 
sectors applies to the healthcare sector. The NIS2 Directive (68) sets out requirements 
on  the  cybersecurity  of  essential  and  important  entities  in  sectors  including  health, 
while the Critical Entities Resilience Directive (69) lays down rules for critical entities on 
their physical resilience. Furthermore, the European action plan on the cybersecurity 
of  hospitals  and  healthcare  providers (70)  is  a  non-legislative  initiative  that  sets  out 
actions to improve prevention, detection, response, recovery and deterrence against 
cybersecurity  threats.  The  action  plan  indicates  activities  for  the  Commission,  the 
European  Union  Agency  for  Cybersecurity  and  Member  States.  Furthermore,  the 
Cyber  Solidarity  Act (71)  as  one  of  the  initiatives  provides  for  the  coordinated 
preparedness testing of entities operating in sectors of high criticality. The health sector 
has been chosen as one of the first sectors where this exercise will be conducted. 

Moreover, Council Recommendation of 6 June 2025 on an EU blueprint for cyber crisis 
management (72) recalls that, in a large-scale cybersecurity incident with cross-sectoral 

(67)  WHO, ‘Universal Health and Preparedness Review’, WHO website, accessed 3 November 2025, 

https://www.who.int/emergencies/operations/universal-health---preparedness-review.  

(68)  Directive (EU) 2022/2555 of the European Parliament and of the Council of 14 December 2022 on measures for a 

high common level of cybersecurity across the Union, amending Regulation (EU) No 910/2014 and Directive (EU) 
2018/1972, and repealing Directive (EU) 2016/1148 (‘NIS 2 Directive’) (OJ L 333, 27.12.2022, p. 80, ELI: https://eur-
lex.europa.eu/eli/dir/2022/2555/oj/eng). 

(69)  Directive (EU) 2022/2557 of the European Parliament and of the Council of 14 December 2022 on the resilience of 

critical entities and repealing Council Directive 2008/114/EC (OJ L 333, 27.12.2022, p. 164, ELI: https://eur-
lex.europa.eu/eli/dir/2022/2557/oj/eng). 

(70)  Communication from the Commission to the European Parliament, the Council, the European Economic and Social 

Committee and the Committee of the Regions: European action plan on the cybersecurity of hospitals and healthcare 
providers, COM/2025/10 final, 15.1.2025, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52025DC0010. 

(71)  Regulation (EU) 2025/38 of the European Parliament and of the Council of 19 December 2024 laying down 

measures to strengthen solidarity and capacities in the Union to detect, prepare for and respond to cyber threats and 
incidents and amending Regulation (EU) 2021/694 (Cyber Solidarity Act) (OJ L, 2025/38, 15.1.2025, ELI: 
http://data.europa.eu/eli/reg/2025/38/2025-01-15). 

(72)   Council Recommendation of 6 June 2025 on an EU blueprint for cyber crisis management (OJ C, C/2025/3445, 

20.6.2025, ELI: http://data.europa.eu/eli/C/2025/3445/oj). 

29 

 
 
impact  requiring  an  EU-level  response,  the  Commission  should  facilitate  the 
information flow between points of contact of relevant EU-level crisis mechanisms. 

4.2.1.  Health system capacities  

An  essential  element  of  improving  the  resilience  of  health  systems  is  targeted 
investment in health infrastructure and equipment, for example  in hospitals, primary 
healthcare  centres and  laboratories.  IT  technology  and  the  secondary use  of  health 
data contribute to the efficiency and resilience of health systems. The Recovery and 
Resilience  Facility  (RRF),  within  its  lifetime  of  2021–2026,  is  offering  significant 
financing  to  Member  States  for  investments  that  strengthen  the  resilience  of  their 
health  systems,  in  response  to  the  COVID-19  pandemic  and  for  enhancing  their 
preparedness  for  future  health  crises (73)  (see  Annex  6).  Cohesion  policy  funding 
and the InvestEU programme offer additional financing possibilities for Member States 
to invest in health  infrastructure, to strengthen the resilience of their health systems 
and promote interregional cross-border healthcare both along internal and external EU 
borders (see Annex 6). Member States participating in the European Partnership on 
Pandemic  Preparedness  seek  to  establish  a  European  research  and  innovation 
ecosystem to avoid uncoordinated research efforts during future health crises. 

Each year, country-specific analysis in the European Semester points to the need for 
reforms and investments, where macroeconomically relevant, in the health systems of 
several  Member  States.  These  Member  States  then  receive  country-specific 
recommendations (CSRs) to strengthen their health systems. In 2020, at the onset 
of the COVID-19 pandemic, all 27 Members States received CSRs related to health 
and some Member States have received additional health CSRs since 2020 (74). The 
national  recovery  and  resilience  plans  under  the  RRF  help  address  these  CSRs 
effectively.  The  Commission  monitors  the  progress  that  Member  States  make  in 
addressing the CSRs on an annual basis. 

The recent 2025 European Semester Spring Package communication advocated 
that several Member States need to build resilient health systems, including by shifting 
towards  a  preventive  and  primary  healthcare  model.  Investments  to  strengthen 
primary  healthcare  are  essential,  given  that  a  strong  primary healthcare  forms  the 
foundation  of  emergency  responses  and  is  central  to  addressing  public  health 
crises (75). The EU4Health Programme (see Annex 6), among others, is supporting the 

(73)  For example, the Slovenian Recovery and Resilience Plan includes investments to tackle emerging health threats 

such as new communicable diseases and to increase the efficiency of the management and functioning of the 
health system in crisis situations. Similarly, the Latvian Recovery and Resilience Plan includes investments in the 
infrastructure of health institutions to adapt to crisis situations and to improve the preparedness of the health 
system to deliver services during epidemiological crises. 

(74)  European Commission, ‘The European Semester’, European Commission website, accessed 4 November 2025. 

https://commission.europa.eu/business-economy-euro/european-semester_en.  

(75)  European Commission, ‘Organisation of resilient health and social care following the COVID-19 pandemic’, European 

Commission website, 7 December 2020, accessed 31 October 2025, 
https://health.ec.europa.eu/publications/organisation-resilient-health-and-social-care-following-covid-19-
pandemic_en. 

30 

 
 
transfer of good practices in primary healthcare among Member States  and building 
an improved coordination of e.g. laboratory capacities (76). 

Complementary  to  investments,  regular  testing  of  the  resilience  of  health  systems 
under  various  shock  scenarios  is  required  to  identify  weaknesses  and  areas  for 
remedial action. With funding from EU4Health, a handbook for resilience testing of 
health systems has been developed and made available to health authorities (77).  

4.2.2.  Health workforce 

Healthcare and public health workers are critical as they are in strong demand at every 
level of the health system. Health professionals – from doctors, nurses, to pharmacists 
and other health professions and workers – are the backbone of crisis preparedness, 
ensuring timely care, safe access to care and medicines, and the resilience of health 
systems  when  it  matters  most.  However,  in  2022,  EU  countries  were  facing  an 
estimated shortage of 1.2 million doctors, nurses and midwives (78). The military sector 
faces the same shortage of medical professionals as the civilian one. Only half of EU 
Member States and EEA countries have a strategy for workforce planning in the field 
of  prevention  and  control  of  infectious  diseases,  and  many  countries  experience 
difficulties  in  recruiting  and  retention  of  staff  (79). Addressing  health  crises  in  One 
Health approach requires human resources also outside the health sector.  

Attractiveness  and  staff  retention as  well as good  working  conditions  are  crucial  for 
improving  the  resilience  of  the  health  workforce.  For  that  reason,  the  Commission 
supports Member States in addressing systematic challenges. For example, the Expert 
Group on Health Systems Performance Assessment, collects practices on minimum 
staffing  levels.  It  provides  an  opportunity  to  exchange  knowledge  between  Member 
States.  The  Commission  also  supports  Member  States  through  various  actions  and 
projects (see Annex 6) which aim at addressing structural challenges with shortages 
of  health  professionals  and  the  development  of  relevant  skills.  Member  States  also 
benefit from financial support provided by the RRF within its 2021–2026 lifetime and 
cohesion policy funding to address their country-specific needs. 

The development of staffing plans for health emergencies is crucial to ensure Member 
States are  prepared  to  manage  any  serious  health threat (80).  These  should  include 
defining  essential  public  health  functions,  recruitment,  good  working  conditions, 

(76)  See for example CIRCE-JA, ‘JA Transfer of best practices in primary care’, CIRCE-JA website, accessed 21 November 

2025 https://circeja.nfz.gov.pl/. 

(77)  Zimmerman J, McKee C., Karanikolos M., Cylus J. and members of the OCD Health Division, Strengthening Health 

Systems: A Practical Handbook for Resilience Testing, WHO Regional Office for Europe and OECD Publishing, Paris, 
2024, https://iris.who.int/server/api/core/bitstreams/7d611fde-18cc-46dd-9740-1afb50489802/content. 
(78)  OECD and the European Commission, Health at a Glance: Europe 2024: State of Health in the EU Cycle, OECD 

Publishing, Paris, 2024, https://doi.org/10.1787/b3704e14-en. 

(79)  ECDC, ECDC assessment of public health workforce capacity in prevention and control of infectious diseases in the 
EU/EEA, Stockholm, 2025, https://www.ecdc.europa.eu/en/publications-data/ecdc-assessment-public-health-
workforce-capacity-prevention-and-control. 

(80)  As per Article 5(6) of Regulation (EU) 2022/2371 and at the Member States’ request, the Commission can provide 
technical assistance to countries for the development of their staffing plans to address specific healthcare needs 
and facilitate the exchange of staff between Member States in the event of a serious cross-border threat to health. 

31 

 
 
retention, repositioning, and capacity building. Information on the availability, skills, and 
location of staff is necessary for the management of human resources (81). The EUHTF 
can  provide  support  to  Member  States  in  strengthening  the  preparedness  of  their 
health workforce. 

Training and exercises strengthen the knowledge, skills and collaboration of staff in 
relation  to  health  crisis  management. The  Commission  can  organise  training  for 
healthcare  staff,  social  service  staff  and  public  health  staff  together  with  Member 
States and the ECDC and in particular the EUHTF (82). To this end, the Commission 
has already organised in-person training courses, national workshops and exchange 
visits under the EU Health Preparedness Training Programme on the development 
and  implementation  of  the  national  prevention,  preparedness  and  response  plans, 
together with activities to strengthen crisis preparedness and surveillance capacities 
(83). 

Joint civil-military trainings and exercises on health crises can significantly contribute 
to  enhance  civil-military  cooperation  in  health  security  preparedness.  They  are 
important in both cases of military support provided to the civil health sector in case of 
e.g.  natural  disasters  and  for  support  provided  by  the  civilian  health  sector  to  the 
military in case of an armed conflict. 

Furthermore,  the ECDC  provides  a  wide  range of  training activities for public health 
professionals in the areas of epidemiology, communicable diseases and public health 
(84).  For  example,  mid-career  professionals,  who  have  roles  in  preparing  for  and 
responding to public health emergencies, are offered a four-month Preparedness and 
Response  Executive  Training  Programme  in  coordination  with  neighbouring 
countries. Moreover, the ECDC Learning Portal offers free online courses on various 
(85).  The  ECDC  Fellowship 
disease-specific  and  public  health 
Programme hosts  a  learning-by-doing  programme  –  the  European  Programme  for 
Intervention  Epidemiology  Training  –  and  the  European  Public  Health  Microbiology 
Training Programme path – to strengthen the prevention, preparedness, surveillance 
and control of infectious diseases and other cross-border health threats in the Member 
States and at EU level (86). 

topics 

The  Commission  also  organises  training  courses  related  to  the  management  of 
MCMs 
to  manufacturing,  procurement,  stockpiling,  and 
distribution as  part  of  of  crisis  management (87).  Under  the  Union  Civil  Protection 

from  development 

(81)  WHO, National workforce capacity for essential public health functions: operational handbook for country-led 

contextualization and implementation, Geneva, 2024, Licence: CC BY-NC-S, 
https://www.who.int/publications/i/item/9789240091412.  

(82)  Article 11 of Regulation (EU) 2022/2371.  
(83)  Service contract ‘EU preparedness: analysis, planning, reporting and training programmes for health specialists’ 

(HaDEA/2022/OP/0017). 

(84)  ECDC, ‘Training programmes’, ECDC website, accessed 31 October 2025, https://www.ecdc.europa.eu/en/training. 
(85)  ECDC, Learning Portal, accessed 31 October 2025, https://learning.ecdc.europa.eu/.  
(86)  ECDC, ‘Fellowship programme: EPIET/EUPHEM’, ECDC website, accessed 31 October 

2025, https://www.ecdc.europa.eu/en/epiet-euphem. 

(87)  Article 2(2)(f) of the Commission Decision of 16.9.2021 establishing the Health Emergency Preparedness and 

Response Authority. 

32 

 
 
Mechanism, the Commission also supports training (88) and simulation exercises (89), 
that  often  involve  emergency  health  professionals  due  to  the  health  impacts  of 
disasters and crises. 

Example of cross-border interregional collaboration: Emergency medicine training on the Polish-Ukrainian 
border 

The  EMERGENCY  project  under  the  Interreg  Poland-Ukraine  programme  organises  joint  training  courses, 
workshops  and  exchanges  of  experience  in  cardiology,  vascular  surgery  and  emergency  medical  care  for 
medical staff from Poland and Ukraine. The project aims to develop and introduce modern clinical procedures, 
tailored to the realities of both countries. 

4.2.3.  Vaccination  

Vaccination  is  one  of  the  most  effective  public  health  measures  for  preventing 
communicable diseases and also often the most effective tool to respond to outbreaks 
limiting  the  spread  of  infectious  agents  avoiding  overwhelming  health  systems' 
capacity. While the design and implementation of national vaccination programmes is 
a Member State competence, the EU has an important role to play in the provision of 
guidance.  Furthermore,  EU-level  coordination  helps  Member  States  align  their 
strategies  and  allows for faster information  sharing.  Through  funding  and  initiatives, 
the  EU  supports  national  efforts  to  increase  vaccination  coverage,  to  promote 
sustainable vaccination programmes, and to secure vaccine supply. In times of crises, 
the  role  of  the  EU  may  become  more  prominent  in  ensuring  the  supply  of  certain 
vaccines  for  example  through  central  purchases,  or  in  providing  guidance  to  the 
Member States. 

The  Commission,  together with  the  ECDC  and  the  EMA,  in  helping  Member States 
develop  national  vaccination  programmes  and  strategies  (see  Table  4).  Strategic 
discussions on purchasing, monitoring and stockpiling vaccines are also coordinated 
at EU level together with other MCMs (see section 4.3).  

Evidence-based vaccination policies are a key pillar of public health systems in the EU. 
The ECDC provides the Member States with technical knowledge to strengthen and 
support  vaccination  policies.  EU  Member  States  and  EEA  countries  base  their 
decisions on vaccines and their use on evidence-based recommendations from their 
National 
Immunisation  Technical  Advisory  Groups  (NITAGs).  These  are 
independent expert committees that help shape national immunisation strategies by 
evaluating scientific evidence and assessing data on vaccine safety and effectiveness. 
The  ECDC  manages  the  EU/EEA  NITAG  collaboration  –  a  network  for  sharing 
information,  best  practices  and  scientific  evidence  as  well  as  facilitating  the  joint 
collection  of  evidence.  It  provides  a  structured  forum  for  regular  dialogue  among 

(88)  UCP Knowledge Network, ‘Union Civil Protection Mechanism training’, accessed 31 October 2025, https://civil-

protection-knowledge-network.europa.eu/UCPM-training-programme. 

(89)  UCP Knowledge Network, ‘Civil protection exercises’, accessed 31 October 2025, https://civil-protection-knowledge-

network.europa.eu/civil-protection-exercises.  

33 

 
 
NITAGs and the ECDC, to assess vaccination needs and provide advice to national 
governments on vaccination strategies supporting their continuous updates. 

Table 4. Roles played by the Commission, the ECDC and the EMA in relation to authorisation and 
vaccination programme monitoring and implementation 

Commission 

-  Grants marketing authorisations for new centrally authorised vaccines 
- 
- 

Ensures exchanges on vaccination strategies in the HSC 
Supports  EU  Member  States  in  coordinating  vaccination  policies  and  programmes 
and in maintaining or increasing vaccination rates 

- 
- 
- 
- 

- 

- 

- 

- 

- 
- 
- 
- 

- 

ECDC 

EMA 

-  Helps raise awareness of the importance of immunisation 
- 

Runs communication campaigns designed to support informed vaccination decision-
making 
Collects intelligence on vaccine development and manufacturing 
Analyses supply chain vulnerabilities 
Funds the development of novel vaccines  
Supports  the  procurement  of  vaccines  at  EU  level,  including  through  advance 
purchase agreements and reservation contracts 
Supports the reservation of vaccine manufacturing capacities to allow swift scale-up 
in times of crisis 
Coordinates the work of the HERA Board and  ensures the secretariat of the Health 
Crisis Board in case of activation of the  emergency  framework for  MCMs during a 
public health emergency at Union level 

Responsible for EU surveillance and data collection that allows for the monitoring of 
vaccination coverage, the impact of vaccination programmes and gaps  
Assesses  and  monitors  vaccine  effectiveness  (i.e.  from  the  point  vaccines  are 
deployed to the population) 
Provides scientific advice and guidance on vaccination strategies and target groups 
Supports the coordination of vaccination strategies devised by the Member States 
Supports the strengthening of national immunisation systems  
Addresses vaccine hesitancy and carries out communication campaigns  

Assesses the safety, efficacy, quality and benefit-risk balance of centrally authorised 
vaccines 

-  Develops guidelines and sets standards on the non-clinical and clinical development 

- 
- 

of vaccines  
Facilitates the development and access to vaccines 
Provides information to healthcare professionals and patients, e.g. in the European 
public assessment reports that also include the summary of product characteristics 

The EMA and the ECDC jointly coordinate independent vaccine studies through the 
Vaccine  Monitoring  Platform.  It  generates  real-word  evidence  on  the  safety, 
effectiveness and use of  vaccines in the EU Member States and EEA countries. Its 
principal aim is to enable and coordinate large vaccine post-authorisation studies at 
the European level, following the identification and prioritisation of evidence gaps. The 
studies  are  independent  and  use  the  EMA  and  the  ECDC  scientific/operational 
infrastructures and procurement (90). 

(90)  ECDC, ‘Vaccine Monitoring Platform’, ECDC website, accessed 31 October 2025, https://www.ecdc.europa.eu/en/about-

ecdc/partners-and-networks/eu-institutions-and-agencies/vaccine-monitoring-platform.  

34 

 
 
The ECDC developed the Vaccine Scheduler – an interactive tool that shows up-to-
date information on national vaccination schedules across EU Member States and EEA 
countries. This enables comparisons to be made between countries and by disease 
(91). The ECDC also helps monitor the impact of vaccination programmes through the 
regular surveillance of vaccine-preventable diseases.  

Vaccine hesitancy and vaccine fatigue can result in an upsurge in vaccine-preventable 
diseases such as measles. Vaccine hesitancy remains a significant challenge, driven 
by  mis-  and  dis-information,  which  the  EU  is  fighting  via  the  promotion  of  science-
based  information  through  platforms  like  the  European  Vaccination  Information 
Portal  and  campaigns  like  #UnitedInProtection,  and ECDC tools available  in all  EU 
languages based on social and behavioural science (92). It is also promoting increased 
transparency over the authorisation of vaccines and post-marketing monitoring. 

4.3.  Medical countermeasures 

4.3.1.  Development and innovation 

Advanced  research,  innovation  and  development  of  MCMs  are  promoted  by  the 
Horizon  Europe  and  EU4Health  programmes  as  well  as  innovative  technologies  for 
existing and emerging threats, including those related to climate change and chemical, 
biological,  radiological,  and  nuclear  threats  (CBRN) (93).  The  scope  of  EU  support 
extends  from  vaccines  to  therapeutics, diagnostics,  medical  devices,  and  protective 
equipment. Building on the work done during the preparedness phase, the objective 
during  the  response  phase  is  to  swiftly  identify  the  most  relevant  and  promising 
technologies and products in the pipeline and support their development from proof-
of-concept to market in a timely manner.  

The  Clinical  Trial  Coordination  Mechanism  is  an  expert  group  under  the  HERA 
Board that advises the Commission on the prioritisation and funding of clinical studies 
for public health emergencies. If the emergency framework for MCMs is activated, the 
Health Crisis Board ensures coordination of action by the Council, the Commission, 
the  relevant  Union  bodies,  offices  and  agencies  and  Member  States  in  the  area  of 
research to ensure the supply and access to crisis-relevant MCMs. One of the specific 
emergency  measures  that  the  Council  can  activate  is  the  emergency  research 
measure (see 6.4) (94). 

(91)  ECDC, ‘ECDC Vaccine Scheduler’, ECDC website, 26 August 2024, accessed 31 October 2025, 

https://www.ecdc.europa.eu/en/publications-data/ecdc-vaccine-scheduler. 

(92)  ECDC, Tools and methods for promoting vaccination acceptance and uptake: a social and behavioural science 

approach, Stockholm, April 2025, https://www.ecdc.europa.eu/en/publications-data/tools-and-methods-promoting-
vaccination-acceptance-and-uptake.  

(93)  Articles 2(2)b and 6(4)a of the Commission Decision of 16.9.2021 establishing the Health Emergency Preparedness 

and Response Authority. 

(94)  Article 9 of the Regulation (EU) 2022/2372. 

35 

 
 
To  ensure  access  to  MCMs  for  priority  health  threats,  the  Commission  mobilises 
financing  and  other  actions  for  the  procurement,  stockpiling,  and  research  and 
development of novel MCMs. 

4.3.2.  Authorisation and certification 

In  the  EU,  the  Commission  is  responsible  for  granting  marketing  authorisations  of 
medicinal products under the centralised procedure, which are valid in all EU Member 
States  and  EEA  countries.  Under  this  procedure,  a  single  marketing  authorisation 
application for a human medicinal product is submitted to EMA, where it is assessed 
by the Committee for Medicinal Products for Human Use. 

For  medicinal  products  addressing  a  public  health  emergency,  this  assessment  is 
supported  by  EMA’s  Emergency  Task  Force.  It  provides  scientific  advice  to  the 
developers  on  the  development  of  medicinal  products  with  the  potential  to  treat, 
prevent, or diagnose and that can be used in a public health emergency.  It involves 
representatives of Member States with clinical trial expertise in the preparation of the 
scientific  advice,  in  particular  in  cases  where  an  application  for  authorisation  of  a 
clinical  trial  is  submitted  or  is  intended  to  be  submitted  to  harmonise  requirements 
between clinical trials and medicine authorisations. 

The  pharmaceutical  legislation  provides  for  several  regulatory  mechanisms  for 
facilitating the development and access to medicines. These include issuing regulatory 
guidance  for  developers,  providing  scientific  support  to  facilitate  larger  multinational 
clinical trials and encouraging new approaches by organising scientific workshops and 
publishing reflection papers. 

During  public  health  emergencies,  faster  timelines  and  exceptional  accelerated 
procedures  for  the  rapid  assessment  and  approval  of  medicines  targeting  the 
emergency  can  be  implemented  where  warranted  –  while  fully  respecting  the 
standards of quality, safety and efficacy of medicines. 

For medical devices and in vitro diagnostic medical devices, while self-certification is 
allowed for low-risk devices, for medium- and high-risk devices their placing on the EU 
market  requires  an  EU certificate  to be  issued  by a  notified  body  –  an  independent 
third party – after the relevant conformity assessment procedure against the relevant 
requirements  of  the  Medical  Device  Regulation  and  the  In  Vitro  Diagnostic  Medical 
Device  Regulation,  and  for  auditing  manufacturers.  Member  States  competent 
authorities  are  responsible  for  designating  notified  bodies  and  for  monitoring  their 
activities, as well as for carrying out appropriate market surveillance. 

The  Medical  Device  Regulation  and  in  vitro  Diagnostic  Medical  Device  Regulation 
allow authorities to make exceptions to the usual approval process for certain medical 
devices  when  this  is  necessary  to  protect  public  health  or  patient  safety.  The 
Commission, in exceptional cases relating to public health or patient safety or health, 
may extend the validity of an authorisation granted by a Member State to the territory 

36 

 
of the EU for a limited period and set the conditions under which the device may be 
placed on the market or put into service. 

Other  MCMs  such  as personal protective  equipment  or  substances  of  human  origin 
follow  their  specific  regulation  and  procedures  including  accelerated  processes  that 
can be used in emergency situations. 

4.3.3.  Manufacturing 

During crises, the demand for MCMs can increase substantially in a very short period. 
While the use of existing stockpiles and emergency procurement often serves as the 
first option to ensure the availability of MCMs, in prolonged crises the manufacturing 
capacity needs to be scaled up. 

To strengthen MCM manufacturing preparedness, it is essential to monitor the access 
and  availability  of  MCMs  and  identify  vulnerabilities  across  the  supply  chain.  The 
Commission  is  implementing  targeted  actions  to  improve  supply  chain  resilience. 
These actions complement the Critical Medicines Act by extending mapping efforts to 
broader  categories  of  MCMs  and  preparedness-related  products,  beyond  critical 
medicines and active pharmaceutical ingredients.  

technologies.  The  Commission 

As a risk mitigation measure in the event of future health emergencies, the Commission 
has put in place the EU Factory for EU-based Vaccines framework contract (EU FAB) 
to  reserve  vaccine  manufacturing  capacity  for  up  to  325  million  vaccines  in  three 
different  vaccine 
innovative 
manufacturing to stimulate innovation and support improved manufacturing process of 
MCMs that are more efficient, greener, easier to scale up, and support EU production 
of MCMs. The European Vaccines Hub for Pandemic Readiness is a consortium of 
leading  European  organisations  in  charge  of  advancing  vaccine  development  and 
manufacturing for public health threats (see Annex 6). Additionally, the  Commission 
and  Member  States  can  gather  information  on  strategic  production  sites  for  crisis-
relevant MCMs to enable scaling up at the EU level during health crises. 

is  also 

funding 

4.3.4.  Stockpiling 

Member States have the primary responsibility of ensuring the availability of MCMs for 
the needs of their population during crises. Several Member States maintain strategic 
national  stockpiles  and/or  have  provisions  in  national  legislation  that  mandate  the 
different operators in the supply chain to maintain a contingency stock in order to have 
a buffer when short-term shortages occur. Stocks in Member States can therefore exist 
at  national,  subnational  and  service  provider  levels.  MCMs  serve  both  civilian  and 
military settings. 

At EU level, stockpiles of MCMs are an additional preparedness measure to support 
the Member States and act as insurance to gain time in the event of a crisis affecting 

37 

 
the health of the population. They aim to complement Member States’ efforts and focus 
on  critical  gaps  where  national  response  capabilities  are  insufficient,  inadequate,  or 
unavailable.  This  requires  a  strategic  approach  as  stockpiling  may  impact  market 
availability, be costly and potentially wasteful (95). 

The Commission has built stockpiles of MCMs as part of the rescEU strategic reserves 
within the Union Civil Protection Mechanism (UCPM). These stockpiles are meant for 
the EU but can be deployed outside the Union if there is an EU interest at stake. The 
rescEU stockpiles are procured, hosted and managed by several Member States in 
strategic  locations.  The  stocks  encompass  MCMs  with  a  significant  risk  of  rapid 
depletion  or  increased  demand  during  crises.  Items  in  rescEU  stockpiles  include 
medicines (e.g. intensive care medicines, antibiotics, vaccines, and antidotes), medical 
devices, personal protective  equipment and equipment  to  respond  to  CBRN  threats 
(96).  Under  the  UCPM  framework,  the  Commission  can  in  duly  justified  cases  of 
urgency also directly purchase necessary materials and enable support services for 
emergency response, including MCMs (97). Strategically located across the EU, these 
stockpiles ensure immediate access to life-saving treatments also in case of security-
related events. 

4.3.5.  Procurement of MCMs 

The  Commission  has  different  procurement  mechanisms  at  its  disposal  to  secure 
MCMs  for  Member  States  and  beyond,  including  central  purchasing  (98).  The 
Commission  can  also  purchase  directly.  The  third  procurement  tool  is  the  joint 
procurement  at  EU  level,  which  can  be  used  both  in  times  of  crisis  but  also  during 
preparedness phase (99).  

In joint procurement, as contracting parties, Member States and the Commission can 
engage  in  a  voluntary  joint  procurement  procedure  with  a  view  to  purchase  MCMs 
against  serious  cross-border threats  to  health  (100).  This mechanism aims  to  ensure 
equitable access to and increase the availability of MCMs in participating countries, as 
well as improve the security of supply, together with fair prices and better purchasing 

(95)  Communication from the Commission to the European Parliament, the Council, the European Economic and Social 
Committee and the Committee of the Regions addressing medicine shortages in the EU, COM/2023/672 final, 
24.10.2023, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52023DC0672. 

(96)   Commission Implementing Decision (EU) 2019/570 of 8 April 2019 laying down rules for the implementation of 
Decision No 1313/2013/EU of the European Parliament and of the Council as regards rescEU capacities and 
amending Commission Implementing Decision 2014/762/EU (OJ L 99, 10.4.2019, p. 41, ELI: 
http://data.europa.eu/eli/dec_impl/2019/570/oj). 

(97)  Article 12(3b) of Decision No 1313/2013/EU. 
(98)  As per: Financial Regulation (Regulation 2024/2509, article 168), Regulation (EU) 2021/522 of the European 

Parliament and of the Council of 24 March 2021 establishing a Programme for the Union’s action in the field of 
health (‘EU4Health Programme’) for the period 2021-2027, Council Regulation (EU) 2022/2372 of 24 October 2022 
on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a 
public health emergency at Union level, Regulation (EU) 2022/2371 of the European Parliament and of the Council of 
23 November 2022 on serious cross-border threats to health 

(99)  Article 12 of Regulation (EU) 2022/2371. 
(100)  European Commission, ‘Public procurement of medical and protective equipment’, European Commission website, 
accessed 31 October 2025, https://commission.europa.eu/strategy-and-policy/coronavirus-response/public-
health/ensuring-availability-supplies-and-equipment_en#public-procurement-of-medical-and-protective-equipment.  

38 

 
 
conditions. As example, the reservation contracts for pandemic influenza vaccines (101) 
and  zoonotic  influenza  vaccines  (102)  have  been  used  to  prepare  for  a  potential 
influenza pandemic.  

Practical arrangements governing the procedure and the decision-making process for 
joint  procurement  are  set  out  in  the  Joint  Procurement  Agreement  involving  EU 
(104). 
Member  States  and  EEA  countries  and  EU  candidate  countries 
Representatives  of  the  participating  countries  in  the  Joint  Procurement  Agreement 
Steering  Committee  decide  which  MCMs  should  be  purchased.  The  Commission 
involves the participating countries in the procurement processes of individual MCMs 
through the  respective  Specific Procurement  Procedure  Steering  Committees. Such 
procurement  procedures  result  in  the  signature  of  contracts  that  set  the  terms  and 
conditions applicable to all contracting authorities. Countries use their national budgets 
to purchase the products contracted. The Commission is also a contracting party and 
can  benefit  from  the  joint  procurement  contracts  for  its  own  needs  or  for  further 
donations. 

(103) 

(101)  European Commission, ‘Commission offers 17 countries the possibility to purchase over 27 million influenza vaccine 

doses’, European Commission website, 29 April 2025, accessed 31 October 2025, 
https://ec.europa.eu/commission/presscorner/detail/en/ip_25_1096. 

(102)  European Commission “Commission secures access for Member States to 665,000 doses of zoonotic influenza 

vaccines”, European Commission website, 11 June 2024, accessed 12 November 2025, 
https://ec.europa.eu/commission/presscorner/detail/en/ip_24_3168 

(103)  European Commission, Joint procurement agreement to procure medical countermeasures, 

https://health.ec.europa.eu/document/download/1926f539-98d3-44ef-b16d-373be1202623_en. 

(104)  European Commission, ‘Signing ceremonies for Joint Procurement Agreement’, European Commission website, 

accessed 20 November 2025, https://health.ec.europa.eu/health-security-and-infectious-diseases/preparedness-and-
response-planning/signing-ceremonies-joint-procurement-agreement_en. 

39 

 
 
 
 
5.  PHASE 2: Detecting and assessing health threats 

5.1.  Public health intelligence 

Public health intelligence, which is the integration, interpretation, and communication 
of health data collected through  surveillance and monitoring, forms the backbone of 
the EU’s approach to health security, underpinning both preparedness and response. 
Member States play a key role in this as EU surveillance and public health intelligence 
rely on the data gathered and shared by countries. In addition to joint arrangements 
for  the  surveillance  and  monitoring  of  communicable  diseases,  public  health 
intelligence also collects information on other threats (Table 5). 

Table 5. Different surveillance approaches  

Description  

Focus 

Integrated  surveillance  is a  strategy  that  brings  together  different 
streams  of  data  and  surveillance  activities  within  the  human  health 
system. This holistic approach streamlines processes like data collection, 
reporting, analysis and interpretation to more effectively monitor health 
threats, from individual patient symptoms to widespread outbreaks.  

Cross-disease, 
cross-data or 
cross-level 
integration 

Type of 
integration 

Cross-system 

The concept of One Health surveillance is cross-sectoral and therefore 
broader  than  integrated  surveillance  as  it  aims  to  link  data  and 
surveillance  systems  across  humans,  animals  and  the  environment  in 
order to capture and monitor the full ecosystem range of health risks (e.g. 
zoonotic influenza).  

Cross-domain 

Cross-sectoral 
(human, animal, 
environmental) 

Collaborative  surveillance,  a  concept  used  by  the  WHO,  is a  multi-
sectoral approach to public health that strengthens information systems 
by coordinating collaboration between diverse stakeholders to improve 
decision-making for public health emergencies and routine health needs. 

Cross-
institutional and 
cross-border 
cooperation 

Cross-actor 

In  the  preparedness  phase,  public  health  intelligence  provides  an  early  warning  of 
emerging  threats  and  disease  severity  from  different  data  sources,  informs  risk 
assessments  and  guides  planning  and  capacity  building.  During  a  response,  public 
health intelligence delivers real-time situational awareness, monitors the effectiveness 
of  interventions,  analyses  of  MCM  needs  and  enables  the  rapid  adaptation  of 
strategies. It also supports cross-border coordination by ensuring a shared evidence 
base across countries. In essence, surveillance ensures preparedness is proactive and 
the response is targeted.  

The  integration  and  interoperability  of  digital  technologies  and  surveillance  data 
reporting  platforms  enable  authorities  to  track  health  threats  faster  and  more 
accurately. They can, therefore, also respond more efficiently. Surveillance systems 
ensure  that  policymakers,  healthcare  providers,  and  laboratories  can  coordinate 
responses  and  mobilise  resources  where  they  are  most  needed.  Strong,  integrated 
surveillance and monitoring systems supported by rapid digital data sharing platforms, 

40 

 
 
 
 
are  essential  not  only  for  crisis  response  but  also  for  building  preparedness  and 
resilience  against  future  health  emergencies.  A  number  of  tools  and  platforms 
contribute to surveillance at EU level (see Annex 7). 

Surveillance  systems  have  evolved 
into  several  distinct  but  complementary 
approaches  as  no  single  method  can  fully  capture  the  complexity  of  today’s 
interconnected  health  threats.  As  outbreaks  require  rapid,  coordinated  responses 
across different sectors and governance levels, health security relies on frameworks 
that address different aspects of detection and preparedness. Together, these different 
approaches build a comprehensive, resilient understanding of health risks. 

Example of integrated surveillance in action 

The ECDC is taking an integrated surveillance approach when it comes to monitoring communicable diseases in 
the EU. Through the implementation of its new mandate, it defines surveillance standards starting from intended 
public  health  objectives.  For  diseases  that  are  prone  to  developing  into  pandemics,  vector-  and  food-borne 
diseases  as  well  as  zoonoses  and  antimicrobial  resistance,  this  entails  integrated  surveillance  systems  across 
sectors, with timely joint analyses and the sharing of actionable data.  

For example, the ECDC, together with the WHO, has published operational considerations for the surveillance of 
respiratory  viruses  in  the  EU,  integrating  information  on  relevant  diseases  such  as  COVID-19,  influenza  and 
respiratory  syncytial  virus  (RSV) (105).  The  ECDC  is  now  developing  updated  guidance  with  action-oriented 
surveillance objectives that will support national systems for respiratory virus surveillance in the EU.  

Example of One Health action 

The ECDC has adopted a One Health Framework (106), set up a One Health working group, and joined the cross-
agency task force on One Health to strengthen transdisciplinary cooperation among five EU agencies in order to 
better  address  challenges  to  human,  animal,  plant  and  environmental  health  and  contribute  to  the 
implementation of the One Health approach in Europe (107).  

The Commission has conducted One Health fact-finding visits to Member States to identify both good practices 
and  critical  gaps  in  multisectoral  coordination,  guidance  and  policy  actions  aimed  at  reducing,  for  example, 
zoonotic risks that pose a serious threat to public health. These visits facilitate the exchange of knowledge and 
practices across EU, national, and local levels, while identifying policy gaps to be overcome for strengthening 
multidisciplinary  prevention,  preparedness  and  response  mechanisms  in  order  to  prevent  and  prepare  for 
spillover events. The outcomes of the visits are documented in reports that are made publicly available subject 
to the agreement of the Member State concerned (108) (109). While the reports do not issue recommendations, 
they present factual observations on practices, gaps, and risks, including on joint surveillance efforts (110).   

(105)  ECDC and WHO, Operational considerations for respiratory virus surveillance in Europe, Copenhagen: WHO Regional 

Office for Europe and Stockholm: European Centre for Disease Prevention and Control, 2022, 
https://www.ecdc.europa.eu/en/publications-data/operational-considerations-respiratory-virus-surveillance-europe.  

(106)  ECDC, 

‘ECDC  One  Health  Framework’,  ECDC  website,  7  May  2024,  accessed  3  November  2025, 

https://www.ecdc.europa.eu/en/publications-data/ecdc-one-health-framework.  

(107)  ECDC, ‘Cross-agency One Healthtask force framework for action’, ECDC website, 7 May 2024, accessed 3 November 
2025, https://www.ecdc.europa.eu/en/publications-data/cross-agency-one-health-task-force-framework-action.  
(108)  European  Commission,  ‘Finland  2024-7983’,  European  Commission  website,  accessed  3  November  2025, 

https://ec.europa.eu/food/audits-analysis/audit-report/details/4813.  

(109)  European  Commission,  ‘Belgium  2024-7986’,  European  Commission  website,  accessed  3  November  2025, 

https://ec.europa.eu/food/audits-analysis/audit-report/details/4884. 

(110)  Article 116 of Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official 
controls and other official activities performed to ensure the application of food and feed law, rules on animal health 
and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, 
(EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 

41 

 
 
 
 
 
5.1.1.  Epidemiological surveillance 

The ECDC serves as the EU’s central hub for global epidemic intelligence from open 
sources and EU-level epidemiological surveillance. It aims to monitor communicable 
diseases, detect outbreaks and inform relevant public health interventions and policies 
in the EU. Within this scope, the ECDC collects, validates, analyses and disseminates 
routine  surveillance  data  on  notifiable  infectious  diseases  (111)  from  30  EU  Member 
States and EEA countries.  

Table 6. Examples of routine EU/EEA integrated surveillance outputs 

Surveillance Atlas of Infectious Diseases (112) 
Annual Epidemiological Reports (113) 

- 
- 
-  Daily and weekly communicable disease threat reports (114) 
- 
-  Weekly bulletins focusing on specific diseases (116) 
-  Online surveillance maps for certain diseases or indicators (117) 

Enhanced surveillance reports produced jointly with other EU agencies or the WHO (115) 

The ECDC works closely with the Member States and coordinates disease or health-
issue-specific  networks  for  infectious  disease  surveillance  in  the  EU/EEA (118). 
These  networks  involve  nominated  national  disease  experts  and  experts  in  public 
health  functions  with  cross-cutting  roles  in  different  areas.  The  ECDC’s  network  of 
National  Focal  Points  (NFPs)  for  Surveillance (119)  is  a  structured  system  of 
designated  experts  in  each  EU  Member  State  and  EEA  country.  They  ensure 
continuous  dialogue  between  the  Commission,  the  ECDC  and  the  relevant  national 
competent  authorities  on  matters  of  epidemiological  surveillance.  The  NFPs  are 
officially  nominated  by  their  countries  and  play  a  crucial  role  in  providing  expertise, 
ensuring  smooth  communication,  sharing  data  sharing,  and  coordinating  relevant 
activities  across  the  EU.  NFPs  in  other  areas  exist  as  well.  These  also  make  a 

of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council 
Directives  98/58/EC,  1999/74/EC,  2007/43/EC,  2008/119/EC  and  2008/120/EC,  and  repealing  Regulations  (EC)  No 
854/2004  and  (EC)  No  882/2004  of  the  European  Parliament  and  of  the  Council,  Council  Directives  89/608/EEC, 
89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (‘Official 
Controls Regulation’) (OJ L 95, 7.4.2017, p. 1, ELI: http://data.europa.eu/eli/reg/2017/625/oj). 

(111)  Commission Implementing Decision (EU) 2018/945 of 22 June 2018 on the communicable diseases and related special 
health issues to be covered by epidemiological surveillance as well as relevant case definitions (OJ L 170, 6.7.2018, 
p. 1, ELI: http://data.europa.eu/eli/dec_impl/2018/945/oj). 

(112)  ECDC, ‘Surveillance Atlas of Infectious Diseases’, ECDC website, 23 April 2023, accessed 3 November 2025, 

https://www.ecdc.europa.eu/en/surveillance-atlas-infectious-diseases.  

(113)  ECDC, ‘Annual Epidemiological Reports (AERs)’, ECDC website, accessed 3 November 2025, 

https://www.ecdc.europa.eu/en/annual-epidemiological-reports.  

(114)  ECDC, ‘Weekly threats reports (CDTR): Communicable disease threats reports’, ECDC website, accessed 3 November 

2025, https://www.ecdc.europa.eu/en/publications-and-data/monitoring/weekly-threats-reports.  

(115)  See for example WHO, ‘Epidemic Intelligence from Open Sources (EIOS)’, WHO website, accessed 3 November 2025, 

https://www.who.int/initiatives/eios.  

(116)  For example, weekly surveillance bulletins on West Nile virus infections in humans in Europe, see ECDC, ‘Surveillance 
of West Nile virus infections in humans in Europe, weekly report’, ECDC website, accessed 3 November 2025, 
https://www.ecdc.europa.eu/en/west-nile-fever/surveillance-and-disease-data/disease-data-ecdc.  

(117)  For example, map on polio cases worldwide, updated on a monthly basis, see ECDC, ‘Polio dashboard’, ECDC website, 
26 May 2025, accessed 3 November 2025,  https://www.ecdc.europa.eu/en/publications-data/polio-dashboard.  

(118)  ECDC, ‘Disease and laboratory networks’, ECDC website, accessed 3 November 2025, 

https://www.ecdc.europa.eu/en/about-ecdc/partners-and-networks/disease-and-laboratory-networks.  

(119)  Article 13 of Regulation (EU) 2022/2371. 

42 

 
 
significant contribution to overall EU surveillance, including the NFPs for microbiology, 
NFPs for Threat Detection, EWRS and IHR. 

As  epidemiological  surveillance  in the EU  therefore depends  on  data  collection and 
transmission by Member States, it is crucial to ensure that harmonised case definitions 
are  developed  for  accurate  and  comparable  EU  surveillance.  This,  together  with 
agreed  standards  for  data  transmission  for  relevant  diseases  and  events,  will  be 
agreed in the future as part of the implementation of Articles 13 and 14 of Regulation 
(EU) 2022/2371.  

The ECDC works closely with the WHO Regional Office for Europe (WHO/Europe) to 
produce the Joint European region surveillance reports for specific communicable 
diseases, such as HIV/AIDS and tuberculosis (120). 

The  Network  for  Substances  of  Human  Origin  (SoHo-Net)  (121)  is  a  cooperative 
network established by the ECDC. It aims to ensure the microbial safety of human-
derived  substances  like  blood,  tissues  and  cells,  and  including  transfusion  and 
transplantation.  SoHo-Net  facilitates  strategic  and  operational  collaboration,  data 
collection, and surveillance among EU Member States and EEA countries to monitor, 
assess and help address disease outbreaks that are relevant to substances of human 
origin.  The  existence  of  the  network  is  critical  for  maintaining  the  high  standards  of 
quality and safety for substances of human origin, which are vital for various medical 
treatments. 

Furthermore,  through  the  EU4Health  Programme  funds  several  actions  to  improve 
surveillance systems at EUand national level (see Annex 6).  

Finally,  WHO  also  plays  a  key  role  in  epidemiological  surveillance  in  the  European 
region. One key example is the Epidemic Intelligence from Open Sources tool (EIOS) 
(122), which is an initiative led by the WHO that uses open-source information to detect 
and assess public health threats in near real time. It uses cutting-edge technology to 
gather and analyse data from sources like websites and social media to provide public 
health officials with evidence for quick decision-making. The initiative is built on a global 
community  of  practice  and  collaboration  with  various  organisations,  including  the 
Commission (123).  

(120)  For example, ECDC and WHO, ‘HIV/AIDS Surveillance in Europe 2024 – 2023 data’, ECDC website, 28 November 

2024, accessed 21 November 2025, https://www.ecdc.europa.eu/en/publications-data/hiv-aids-surveillance-europe-
2024-2023-data; and ECDC and WHO, ‘Tuberculosis surveillance and monitoring in Europe 2025 – 2023 data’, ECDC 
website, 24 March 2025, accessed 21 November 2025, https://www.ecdc.europa.eu/en/publications-
data/tuberculosis-surveillance-and-monitoring-europe-2025-2023-data and  

(121)  Article 16 of Regulation (EU) 2022/2371. 
(122)  WHO, ‘Epidemic Intelligence from Open Sources’, Who website, accessed 3 November 2025, 

https://www.who.int/initiatives/eios. 

(123)  WHO, ‘Epidemic Intelligence from Open Sources’, both portal and processing chain have been developed by the 

European Commission. 

43 

 
 
5.1.2.  Laboratory-based surveillance and diagnostics 

Laboratories  serve  as  the  backbone  of  EU  surveillance  systems  because  of  their 
crucial  role  in  monitoring,  detecting  and  confirming  health  threats.  Their  diagnostic 
capacities  allow  for  the  timely  identification  of  pathogens,  support  outbreak 
investigations and provide the scientific evidence necessary for risk assessments and 
decision-making  at  both  national  and  EU  level.  Beyond  diagnostics,  laboratories 
contribute  to  enabling  early  warning,  strengthening  situational  awareness  and 
supporting  coordinated  response  measures.  Investments  in  laboratory  capacity, 
biosafety  and  biosecurity  standards,  and  cross-border  collaboration  are  therefore 
critical for sustaining resilient EU-wide surveillance. 

5.1.2.1. 

Laboratory networks and capacities  

The  ECDC  does  not  operate  its  own  laboratories  but  relies  instead  on  laboratory 
information  provided  at  national  level.  Since  2010,  ithas  coordinated  12  EU-wide 
networks of public health microbiology laboratories embedded in disease-specific 
networks(124).  Within  these  networks,  the  ECDC  supports  microbiology  activities  via 
EU-wide  laboratory  network  coordination,  capability  building  and  external  quality 
assessments,  laboratory  staff  training,  outbreak  investigations,  risk  assessments, 
method  harmonisation  and  the  development  of  standard  procedures,  and  the 
integration of molecular typing into surveillance programmes. 

The  ECDC  also  operates  the  EU  laboratory  capability  (EULabCap)  system  for 
monitoring the capacities and capabilities of microbiology laboratories in EU Member 
States.  National  laboratory  capacities  are  also  among  the  elements  that  are  being 
assessed  as  part  of  the  prevention,  preparedness  and  response  reporting  and 
PHEPAs. In the future, such capacities and capabilities will be assessed through the 
compliance monitoring of surveillance standards.  

The Commission is developing detection tools – such as novel assays and reference 
materials  –  to  contribute  to  the  standardisation  and  harmonisation  of  data  across 
laboratories (125) (126). 

The  European  Civil  Protection  Pool  currently  includes  two  quality-assured  rapid 
response mobile laboratories, ready for deployment under the Union Civil Protection 
Mechanism.  

(124)  For more information about the ECDC microbiology networks and their activities, see Albiger, B., Revez, R., Leitmeyer, 
K. C., Struelens, M. J., ‘Networking of Public Health Microbiology Laboratories Bolsters Europe’s Defenses against 
Infectious Diseases’, Frontiers in Public Health, Vol. 6, 2018, p. 46, https://doi.org/10.3389/fpubh.2018.00046. 
(125)  Buttinger, G., Petrillo, M., Valastro, V., et al., ‘Novel (d)PCR assays for influenza A(H5Nx) viruses clade 2.3.4.4b 

surveillance’, Eurosurveillance, Vol. 30, Issue 33, 2025, https://doi.org/10.2807/1560-7917.ES.2025.30.33.2500183. 
(126)  Marchini, A., Toth, K., Buttinger, G., et al., Certification of the identity and the copy number concentration of synthetic 
single-stranded RNA including fragments of the SARS-CoV-2 genome and part of the human RNAse P gene: EURM®-
014k, Publications Office of the European Union, Luxembourg, 2024, https://op.europa.eu/en/publication-detail/-
/publication/d5857267-b12a-11ef-acb1-01aa75ed71a1/language-en.   

44 

 
 
Recently, with the adoption of the new mandate of the European Union Drugs Agency 
(EUDA) in 2024, an EU-wide network of forensic and toxicological laboratories active 
in investigations into drugs and drug-related harm was set up, as required by Article 
15 of Regulation No 2023/1322. 

5.1.2.2. 

EU reference laboratories  

EU reference  laboratories  (EURLs) for  public  health have been designated  by  the 
Commission,  bringing  together  consortia  of  specialised  laboratories,  based  in  EU 
Member  States  and  EEA  countries,  to  provide  scientific  and  technical  expertise  in 
specific fields (see Table 7). They play a crucial role in strengthening laboratory-based 
surveillance by guaranteeing the reliability and comparability of data generated across 
the EU; strengthening capacities and capabilities of laboratories throughout the EU; 
and  by  enabling  the  timely  detection  of  cross-border  health  threats.  The  ECDC  is 
responsible  for  running  the  network  of  EURLs  for  public  health.  These  EURLs  are 
supporting national reference laboratories and coordinate the networks managed by 
the ECDC that are relevant to the scope of their work.  

Table 7. EU reference laboratories relevant for prevention, preparedness and response to cross-border health 
threats 

EURLs  for  public  health  aim  to  support  national  reference  laboratories  to 
promote good practice and alignment by Member States on a voluntary basis 
regarding  diagnostics,  testing  methods  and  use  of  certain  tests  for  the 
uniform surveillance, notification and reporting of serious cross-border health 
threats.  

EURLs  for  in  vitro  diagnostic  medical  devices  (IVDs)  provide  scientific  and 
technical expertise for high-risk (class D) IVDs. Their tasks include verifying the 
performance and compliance of class D devices, performing batch testing on 
behalf of notified bodies, and assisting the Commission and other authorities. 
They also contribute to developing common specifications and harmonising 
testing methods across the EU. 

EURLs  for  animal  health,  food  and  feed,  and  plant  health  support  the 
Commission  and  Member  States  by  harmonising  diagnostic  methods, 
ensuring  laboratory  quality,  providing  expert  advice,  and  coordinating  the 
network of National Reference Laboratories. They also offer technical support 
during outbreaks. 

5.1.3.  Wastewater surveillance 

Article 15 of Regulation (EU) 
2022/2371 

Article 100 of Regulation (EU) 
2017/746 

Regulation (EU) No 2017/625 

Wastewater-based  surveillance  has  emerged  as  a  potential  complement  to 
traditional public health surveillance within the EU’s health security framework. It 
can  provide  a  community-wide  overview  of  circulating  pathogens  as  it  captures 
information  independent  of  clinical  testing  or  healthcare  seeking  behaviour.  Since 
pathogens  such  as  SARS-CoV-2,  poliovirus  and  influenza  viruses  are  excreted  in 
human waste, analysing sewage wastewater  can provide insights into the presence 
and  trends  of  infections  across  populations  as  well  as  the  sequencing  of  pathogen 

45 

 
genomes.  In  addition,  wastewater-based  surveillance  could  serve  as  an  additional 
cost-effective tool as a single wastewater sample can represent thousands of people 
and is scalable, making it useful for both urban centres and smaller communities. On 
the other hand, methodologies used to detect and analyse wastewater samples vary, 
and  site-specific  factors  can  influence  the  measured  results.  This  makes  direct 
comparison of absolute values between locations challenging.  

The  new  Urban  Wastewater  Treatment  Directive(127)  requires  Member  States  to 
coordinate between public health and wastewater treatment authorities and to identify 
health parameters for monitoring, for example SARS-CoV-2, poliovirus, influenza and 
emerging  pathogens.  In  a  public  health  emergency,  relevant  parameters  must  be 
monitored.  Additionally,  Member  States  must  establish  antimicrobial  resistance 
surveillance in urban wastewater for areas with populations of 100,000 or more. The 
Commission will set a minimum sampling frequencies and a harmonised methodology 
for monitoring antimicrobial resistance in urban wastewater by July 2026 and ensure 
results  are  communicated  to  the  relevant  authorities  and  reported  annually  to  the 
European  Environment  Agency.  The  Commission  will  define  the  reporting  format 
through implementing acts. 

The Joint Research Centre has built and maintains the EU Wastewater Observatory 
for Public Health(128). 

Since the COVID-19 pandemic, the Commission has significantly invested in scaling 
up capacities for wastewater surveillance at national and global levels, including via 
the  creation  of  the  Global  Consortium  for  Wastewater  and  Environmental 
Surveillance  for  Public  Health.  Annex  6  contains  more  examples  of  EU  initiatives 
that promote wastewater-based surveillance. 

The ECDC concept paper to guide the integration of wastewater-based surveillance 
into EU-level infectious disease surveillance provides insights on its potential uses for 
public  health  decision  making (129).  The  document  describes  the  status  of  EU/EEA 
support  to  wastewater-based  surveillance  implementation  for  infectious  disease 
surveillance.  It  also  highlights  the  role  of  wastewater-based  surveillance  in  public 
health  as  well  as  the  challenges  and  considerations  for  implementation  to  support 
Member States in developing national wastewater-based surveillance systems.  

5.1.4.  Vector surveillance and control 

Vector  surveillance  and  control  are  key  in  the  prevention  of  vector-borne  disease 
transmission,  and  their  organisation  can  be  complex  due  to  the  many  stakeholders 

(127)  Directive (EU) 2024/3019 of the European Parliament and of the Council of 27 November 2024 concerning urban 
wastewater treatment (recast) (OJ L 2024/3019, 12.12.2024, ELI: http://data.europa.eu/eli/dir/2024/3019/oj). 
(128)  European Commission, ‘EU Wastewater Observatory for Public Health’, European Commission website, accessed 3 

November 2025, https://wastewater-observatory.jrc.ec.europa.eu/.   

(129)  ECDC,  ECDC  concept  for  integration  of  wastewater  data  in  surveillance  of  infectious  diseases  at  EU/EEA  level, 
Stockholm,  2025,  https://www.ecdc.europa.eu/en/publications-data/ecdc-concept-paper-guide-integration-wastewater-
data-infectious-disease. 

46 

 
 
involved. EU-level  collaboration  and  coordination  on  vectors  and  vector-borne 
diseases enable the pooling of expertise, developing joint guidance and strategies and 
advocating for research and innovation (130). The European network for medical and 
veterinary  entomology  (VectorNet)  started  in  2014  and  coordinated  jointly  by  the 
ECDC and  the  EFSA.  It  supports  the  collection  of  data  on  vectors  related  to  both 
animal and human health (131).  

The  Commission  is  supporting  Member  States  to  strengthen  national  vector 
surveillance and control capacities (see Annex 6). This includes assessing the ability 
of vectors to transmit and spread  emerging diseases across Europe and strengthen 
laboratory capabilities for monitoring insecticide resistance and One Health fact-finding 
missions.  

5.1.5.  Serious drug-related risks  

Serious  risks  related  to  illegal  drugs  are  captured  via  event-based  surveillance, 
aggregated routine reporting and other complementary methods implemented by the 
EUDA.  Where  relevant,  signals  and  alerts  are  shared  with  the  Commission  and 
Member States and, when cross-border criteria are met, an alert can be pushed by the 
Commission  to  the  Early  Wardning  and  Response  System  to  enable  coordinated 
assessment and response. 

5.1.6.  Anticipation and forecasting 

Strategic  foresight  and  anticipation  are  structural  forward-looking  approaches  for 
identifying emerging risks early and preparing effectively for alternative futures. The 
Commission  provides  systematic  risk  analysis  and  develops  tools  and  techniques, 
such as epidemiological modelling and other outbreak analytics, for public health risk 
assessment and forecasting of emerging infectious disease threats (132) (133) (134). The 
Commission also works on threat assessment modelling and forecasts of MCMs (135). 

The  ECDC  is  tasked  to  provide  analyses  and  advice  on  prevention  and  control  of 
communicable  diseases  and  related  special  health  issues  through  epidemiological 

(130)  ECDC, Organisation of vector surveillance and control in Europe, Stockholm, 2021, 

https://www.ecdc.europa.eu/sites/default/files/documents/Organisation-vector-surveillance-control-Europe_0.pdf.  
(131)  ECDC, ‘European network for medical and veterinary entomology (VectorNet)’, ECDC website, accessed 11 November 

2025, https://www.ecdc.europa.eu/en/about-us/partnerships-and-networks/disease-and-laboratory-networks/vector-
net. 

(132)  Lentini, A., Eklund, G., Corbane, C., Asikainen, T., Ronco, M. et al., Analysis of Risks Europe is facing - An analysis of 

current and emerging risks, Publications Office of the European Union, Luxembourg, 2025, 
https://data.europa.eu/doi/10.2760/0176850.  

(133)  Corbane, C., Eklund, G., Gyenes, Z., et al., Cross-border and emerging risks in Europe, Publications Office of the 

European Union, Luxembourg, 2024, https://op.europa.eu/en/publication-detail/-/publication/e7ccf960-1ef7-11ef-
a251-01aa75ed71a1/language-en. 

(134)  Angelou, A., Pappa, A., Markov, P.V. et al., ‘Early warning system of the seasonal West Nile virus infection risk in 

humans in Northern Greece, 2020–2024’, Scientific Reports, Vol. 15, Issue 1, 2025, https://doi.org/10.1038/s41598-
025-91996-9. 

(135)  Article 6 of the Commission Decision of 16.9.2021 establishing the Health Emergency Preparedness and Response 

Authority. 

47 

 
 
modelling, anticipation and forecasting, and to coordinate such effort across the EU 
and with international partners (136). The ECDC Foresight Programme aims to inform 
strategic  decisions  and  policy  in  the  area  of  infectious  disease  prevention  and 
control (137). 

5.2.  Threat assessment and early warning 

Once a signal of a potential serious cross-border threat to health is detected through 
public  health  intelligence,  it  will  be  assessed  to  determine  whether  specific  actions 
should be taken (see Figure 5). 

The threat will first be evaluated by Member States and/or the Commission against the 
following three criteria to determine whether it constitutes a serious cross-border threat 
to health: 

a)  it is unusual or unexpected for the given place and time, or it causes significant 
morbidity or mortality in humans, or it grows rapidly or may grow rapidly in scale, 
or it exceeds or may exceed national response capacity; and  

b)  it affects or may affect more than one Member State; and  
c)  it requires or may require a coordinated response at EU level (138). 

If  a  threat  of  biological,  chemical,  environmental  or  unknown  origin  meets  all  of  the 
above criteria or is notifiable in accordance with the International Health Regulations, 
it  must  be  notified,  without  delay,  in  the  Early  Warning  and  Response  System 
(EWRS).  If  a  threat  does  not  (yet)  fulfil  all  the  criteria  but  is  deemed  to  be  of 
significance,  national  competent  bodies  and/or  the  Commission  can  submit  a 
notification in EWRS. Information on the alert notification must be updated as soon as 
new information becomes available (139). 

When a Member State notifies a serious cross-border threat  to health that can also 
constitute a Public Health Emergency of International Concern (PHEIC), the national 
authority can fulfil their notification obligation to WHO through a push-notification from 
EWRS (140). 

Apart from an alert being notified directly in EWRS, a threat can also initially be notified 
though and picked up from another alert information system (AIS) or platform for public 
health intelligence of the Commission or EU agencies (see Annexes 7 and 8). This can 
occur when the event does not meet all the criteria of a serious cross-border threat to 
health or does not seem to cause health impacts in the first instance. However, as the 
threat evolves, it may become relevant to also submit a notification in EWRS. 

(136)  Articles 3 and 5 of Regulation (EC) No 851/2004. 
(137)  ECDC, ‘ECDC Foresight Programme’, ECDC website, accessed 20 November 2025, 

https://www.ecdc.europa.eu/en/about-ecdc/what-we-do/ecdc-foresight-programme.  

(138)  Article 19(1) of Regulation (EU) 2022/2371. 
(139)  Article 19(5) of Regulation (EU) 2022/2371. 
(140)  Article 6 and Annex 2 of WHO IHR 2005 (amended in 2014, 2022 and 2024). 

48 

 
 
Figure 5. Process of threat assessment and early warning in the EU/EEA 

5.3.  Risk assessments 

Risk assessment and vulnerability analyses are crucial for evidence-based decision-
making for health crises. The objectives of a risk assessment depend on the phase of 
the health crisis management cycle in which it is conducted. During the prevention and 
preparedness phase, risk assessments help identify, analyse and evaluate the risks 
and  can  be  used  for  decision-making  on  preventive  measures  and  to  prioritise 
resources. During the response phase, they support evidence-based decision-making, 
including on what measures to take. To ensure transparency of governance, the risk 

49 

 
 
assessment should be conducted independently of the decision-making process even 
though it includes options or recommendations for measures. 

Risk  assessments  improve  awareness  and  understanding  of  the  risks  among 
stakeholders, foster inclusive debate and decision-making about the relative priority of 
areas of work and the use of resources, and helps engage relevant groups in society. 
Whereas  single-risk  assessments  determine  a  singular  risk  from  a  particular  threat, 
multi-risk  assessments  determine  the  overall  risk  from  several  threats  occurring 
simultaneously  or  threatening  the  same  at-risk  entities.  Geographical  risk  maps 
provide information on risks for a specific geographical area (141). 

5.3.1.  National risk assessments 

In  the  prevention  and  preparedness  phase,  risk  assessment  and  prioritisation 
exercises conducted at national or regional level make it possible to pan and prioritise 
health emergency preparedness and disaster risk management activities. The WHO 
has developed a toolkit for this (142). 

Member States carry out all-hazards risk and vulnerability assessments in the critical 
sectors  and  subsectors.  On  the  basis  of  the  outcome  of  those  risk  assessments, 
Member States identify critical entities and inform the Commission of the types of risks 
identified (143) (144). 

Every  three  years,  Member  States  report  to  the  Commission  on  their  national  all-
hazards  risk  assessments  (145).  The  Commission  has  developed  specific  reporting 
guidelines for this (146) (147). Member States identify key risks that could have significant 
adverse human, economic, environmental and political/social impacts and assess their 
probability and impact. From among these risks, Member States are asked to identify 
high-impact  low  probability  risks,  emerging  risks  and  climate-related  risks  and  risks 
that  could  have  a  cross-border  impact.  The  Commission  summarises  the  Member 
States’ reports for the European Parliament and the Council to give an indication of the 

(141)  Commission staff working paper, Risk Assessment and Mapping Guidelines for Disaster Management, 

SEC(2010) 1626 final of 21 December 2010, 
https://ec.europa.eu/echo/files/about/COMM_PDF_SEC_2010_1626_F_staff_working_document_en.pdf. 

(142)  WHO, Strategic Toolkit for Assessing Risks – A comprehensive toolkit for all-hazards emergency risk assessment, 

Geneva, 2021, Licence: CC BY-NC-SA 3.0 IGO, https://www.who.int/publications/i/item/9789240036086.  

(143)  Directive (EU) 2022/2557 of the European Parliament and of the Council of 14 December 2022 on the resilience of 

critical entities and repealing Council Directive 2008/114/EC (OJ L 333, 27.12.2022, p. 164, ELI: 
http://data.europa.eu/eli/dir/2022/2557/oj).  

(144)  Communication from the Commission, Commission Guidelines and reporting template developed pursuant to Articles 

5(5), 6(6) and 7(3) of Directive (EU) 2022/2557 on the resilience of critical entities (OJ C, C/2025/4990, 12.9.2025, 
ELI: http://data.europa.eu/eli/C/2025/4990/oj).  

(145)  Article 6 of Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a 
Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924, ELI: http://data.europa.eu/eli/dec/2013/1313/oj). 
(146)  Commission Notice, Reporting Guidelines on Disaster Risk Management, Art. 6(1)d of Decision No 1313/2013/EU, 

C/2019/8929 (OJ C 428, 20.12.2019, p. 8, ELI: https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=uriserv:OJ.C_.2019.428.01.0008.01.ENG).  

(147)  Commission staff working paper, Risk Assessment and Mapping Guidelines for Disaster Management, 

SEC(2010) 1626 final of 21 December 2010, 
https://ec.europa.eu/echo/files/about/COMM_PDF_SEC_2010_1626_F_staff_working_document_en.pdf. 

50 

 
 
progress made towards implementing risk assessments at EU level. In 2025, risks to 
human health were among the most frequently reported risks (148). 

Similarly, every three years, when reporting on national prevention, preparedness and 
response planning, Member States report to the Commission on their plans to assess 
serious  cross-border  threats  to  health.  The  ECDC  then  assesses  Member  States’ 
capacities  for  health  emergency  risk  assessment  as  part  of  the  PHEPAs (149).  The 
ECDC  can  support  Member  States  improve  both  their  risk  assessment  and  risk 
prioritisation capacities for infectious diseases (150). 

Starting  in  2025,  Member  States  in  the  Network  and  Information  Systems  (NIS) 
Cooperation  Group,  in  cooperation  with  the  Commission  and  the  European  Union 
Agency  for  Cybersecurity  (ENISA),  can  conduct  cybersecurity  risk  assessments  on 
medical devices starting in 2025 (151).  

 Member States also conduct climate change and vulnerability analyses to provide a 
basis for their national climate adaptation strategies and plans. These strategies and 
plans  are  guided  by  the  best  available  scientific  evidence  and  take  account  of  the 
particular  vulnerabilities  of  the  sectors  concerned  including  the  health  sector. (152) 
Moreover,  every  six  years,  Member  States  assess  and  manage  the  risks  to  human 
health  posed  by  the  drinking  water  supply  chain  including  risks  related  to  urban 
wastewater discharges (153) (154). 

5.3.2.  Public health risk assessment at EU level 

After receiving an alert about a serious cross-border threat to health, the Commission 
or  the  HSC  can  request  a  public  health  risk  assessment.  These  assessments  are 
conducted  by  the  relevant  EU  agencies  and  bodies  and/or  by  the  Commission  to 
ensure that the EU’s response to serious cross-border threats to health is data-driven, 
evidence-based and supported by expert advice (155). In urgent situations, the first rapid 
risk assessment should be delivered within 48 hours and can be updated later as more 

(148)  ‘Report from the Commission to the European Parliament and the Council, Advancing risk management and 

resilience-building in Europe: First report on the implementation of the union disaster resilience goals and Second 
update on preventing and managing disaster risk in Europe’, COM(2025) 561 final of 25 September 2025, 
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52025DC0561. 

(149)  Articles 7 and 8 of Regulation (EU) 2022/2371. 
(150)  Article 8a of Regulation (EC) No 851/2004. 
(151)  Article 22 of the NIS 2 Directive. In line with this Article, the Cooperation Group, in cooperation with the Commission 

and ENISA, may carry out coordinated security risk assessments of specific critical ICT services, ICT systems or ICT 
products supply chains. 

(152)  Article 5 of Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing 

the framework for achieving climate neutrality and amending Regulations (EC) No 401/2009 and (EU) 2018/1999 
(‘European Climate Law’) (OJ L 243, 9.7.2021, p. 1, ELI: http://data.europa.eu/eli/reg/2021/1119/oj).  

(153)  Article 18 of Directive (EU) 2024/3019 of the European Parliament and of the Council of 27 November 2024 

concerning urban wastewater treatment (recast) (OJ L 2024/3019, 12.12.2024, ELI: 
http://data.europa.eu/eli/dir/2024/3019/oj).  

(154)  Articles 7, 8, 9 and 10 of Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 
2020 on the quality of water intended for human consumption (recast) (OJ L 435, 23.12.2020, p. 1, ELI: https://eur-
lex.europa.eu/eli/dir/2020/2184/oj). 
(155)  Article 20 of Regulation (EU) 2022/2371. 

51 

 
 
information  becomes  available.  Public  health  risk  assessments  are  shared  through 
EWRS and, if relevant, through other Alert Information Systems (AIS).  

ECDC, EMA, EFSA, ECHA, EEA, EUDA, and Europol each contribute to public health 
risk assessments on the basis of their respective mandates and expertise. If an event 
of a serious cross-border threat to health is caused by communicable diseases or of 
unknown  origin,  the  ECDC  is  responsible  for  carrying  out  the  risk  assessment (156). 
When the event, its impact or its management requires expertise from several sectors, 
the agencies conduct the risk assessment jointly. If the risk assessment falls outside 
the  mandates  of  the  EU  agencies  and  is  considered  necessary  for  coordinating  a 
response at EU level, it is carried out by the Commission, either at the request of the 
HSC or on its own initiative. 

The EU agencies assess the potential severity of the threat to public health, its impact 
on  public  health  and  the  effectiveness  of  possible  social  measures.  They  take  into 
account the information provided by other entities, such as the Member States and the 
WHO.  Public  health  risk  assessments  can:  provide  information  on  risk  factors  for 
disease  and  the  associated  disease  burden,  including  social,  economic  and 
environmental  determinants;  include  forecasts  of  the  evolution  of  the  event  and  the 
pressure  on  the  capacity  of  the  health  system  as  well  as  other  types  of  modelling; 
assess the risk for different population groups; and recommend general and targeted 
science-based  response  options,  including  public  health  and  social  measures  (157). 
These  recommendations  and  response  options  are  comprehensively  discussed and 
considered  in  the  relevant  governance  structures  where  Member  States,  the 
Commission and EU agencies convene to manage the response as well as present it 
to the ACPHE if called to formulate advice and response measures. 

However,  given  its  mandate,  the  ECDC  is  tasked  with  providing  (rapid)  risk 
assessments on disease threats and related special health issues, on its own initiative 
or  at  the  request  of  a  Member  State  or  the  Commission  (158)  (159).  These  risk 
assessments are based on a standardised approach and contain clear and actionable 
recommendations for mitigating the risks at EU and Member States level. The ECDC 
prepares these risk assessments independently, although there is an internal quality 
control  process  in  place.  These  risk  assessments  are  published  on  the  ECDC’s 
website. 

5.3.3.  Other EU risk assessments 

Using information provided by Member States in their national risk assessments, the 
Commission  updates  the  cross-sectoral  overview  and  the  map  of  natural  and  man-
made  disaster  risks  that  can  have  multi-country  transboundary  effects  (160).  An 

(156)  Article 8a of Regulation (EC) No 851/2004. 
(157)  Article 8a of Regulation (EC) No 851/2004. 
(158)  Articles 3 and 8a of Regulation (EC) No 851/2004. 
(159)  ECDC, Operational tool on rapid risk assessment methodology, Stockholm, 2019, 

https://www.ecdc.europa.eu/en/publications-data/operational-tool-rapid-risk-assessment-methodology-ecdc-2019.  

(160)  Article 5(1)(c) of Decision No 1313/2013/EU. 

52 

 
 
overview of 16 key hazards and transboundary cross-sectoral scenarios shapes the 
subsequent  prevention,  preparedness,  disaster  anticipation  and  risk  management 
planning and the response activities, including disaster risk reduction strategies, at EU 
and Member State level (161). 

Risk  assessments  on  climate-related  risks  are  performed  by  the  EEA  and  the 
European Climate and Health Observatory (162) (163). Based on risk assessments, the 
EEA  also  develops  guidance  on  various  topics,  including  on  mobile  measuring 
technology regarding air quality and air pollution. 

5.3.4.  Threat assessment and prioritisation in the area of medical 

countermeasures 

The Commission assesses health threats and gathers intelligence relevant to MCMs. 
It  does  this  using  the  Advanced  Technology  for  Health  Intelligence  and  Action  IT 
System (ATHINA) (164).  

takes 

Firstly, this anticipatory threat assessment involves identifying and prioritising health 
threats in relation to the availability of relevant MCMs. When prioritising health threats, 
into  account  existing  scientific  and  epidemiological 
the  Commission 
assessments and refers to global and EU-level frameworks, including from the WHO 
and the ECDC. The Commission aims to assess the pandemic potential, the likelihood 
of a public health emergency at Union level, the availability of MCMs, and the impact 
of climate change on the spread and severity of viral threats. Threat prioritisation is a 
dynamic,  consultative,  and  iterative  process  that  is  continuously  evolving.  This 
assessment serves as a basis for outreach and engaging with stakeholders, including 
Member  States,  other  EU  institutions  and  the  professional  and  scientific  MCM 
community.  It  will  make  it  easier  to  mount  a  coordinated  and  effective  response  to 
emerging threats (165). 

On the basis of the threat assessment and prioritisation, the Commission works closely 
with EU agencies to maintain a list of priority threats against which the EU needs to 
improve its MCM preparedness and response.  

(161)  Communication from the Commission to the European Parliament, the Council, the European Economic and Social 
Committee and the Committee of the Regions, European Union Disaster Resilience Goals: Acting together to deal 
with future emergencies, COM(2023) 61 final of 8 February 2023, https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=CELEX:52023DC0061. 

(162)  European Environment Agency, European climate risk assessment., Publications Office of the European Union, 2024, 

https://op.europa.eu/publication-detail/-/publication/8e234e44-7bb5-11ef-bbbe-01aa75ed71a1.  

(163)  European Climate and Health Observatory, ‘Climate risk exposure of vulnerable groups - map viewer’, European 
Climate and Health Observatory website, 22 October 2025, accessed 3 November 2025, https://climate-
adapt.eea.europa.eu/en/observatory/publications-data/analysis-data/copy_of_exposure-of-vulnerable-groups-to-
climate-risks.  

(164)  Commission Decision of 16.9.2021 establishing a Health Emergency Preparedness and Response Authority (HERA), 

C(2021) 6712 final, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=intcom:C(2021)6712.   

(165)  European Commission, ‘Medical Countermeasures Strategy’, European Commission website, accessed 3 November 
2025, https://health.ec.europa.eu/health-emergency-preparedness-and-response-hera/preparedness/medical-
countermeasures-strategy_en.  

53 

 
 
The current priority health threats for MCM preparedness are listed below: 

i.  Respiratory or contact-based viruses with pandemic potential. These are highly 
transmissible  viruses  that  have  a  history  or  likelihood  of  causing  large-scale 
outbreaks and are influenced by environmental factors such as biodiversity loss. 

ii.  Vector-borne  or  animal-reservoir  viruses  with  epidemic  potential.  These  are 
is  accelerated  by  climate  change  and  other 
viruses  whose  spread 
environmental  factors,  and  which  are  categorised  as  a  specific  threat  due  to 
their  growing  relevance  for  the  EU,  given  that  Europe  is  the  fastest-warming 
continent. 

iii.  Antimicrobial resistance (AMR). This is a  rising global concern that threatens 
the  efficacy  of  existing  treatments  and  increases  the  burden  of  infectious 
diseases. 

iv.  Armed conflict-related threats and chemical, biological, radiological and nuclear 

(CBRN) threats. 

Secondly,  the  Commission  has  put  in  place  processes  for  systematic  threat 
assessment  to  review  signals  and  events  that  might  call  for  action  to  be  taken  as 
regards  MCM  preparedness  or  response.  This  builds  on  the  public  health  risk 
assessment  delivered  by  EU  agencies  to  assess:  the  relevance  of  events  for  MCM 
preparedness,  including  whether  a  MCM  response  is  considered  effective  and 
desirable; and the potential gaps identified in terms of innovation, availability or access 
to the required MCMs. 

54 

 
 
 
6.  PHASE 3: Responding in an EU coordinated manner 

6.1.  Coordination of response 

Coordination is crucial to respond effectively to a health crisis. EU coordination entails 
exchanging  information  and  coordinating  measures  between  national  and  EU-level 
governance structures. Joint arrangements for governance – including the HSC, the 
Health Crisis Board, if the emergency framework for MCMs is activated, and the UCPM 
–  all  have  the  primary  objective  of  coordinating  action  within  their  respective 
mandates (166). When activated, the Integrated Political Crisis Response (IPCR) has 
an important coordination role as well. Moreover, the Council of the European Union, 
through its Employment, Social Policy, Health and Consumer Affairs Council (EPSCO), 
and the European Parliament, specifically through its SANT and ENVI committees, 
can provide further leadership and strategic guidance on health crisis management in 
the EU/EEA (167) (168). 

Coordination  takes  place  within  and  between  these  governance  structures,  and 
involves  the  Commission,  EU  agencies  and  Member  States.  The  EU  agencies  and 
bodies  have  an  important  role  in  providing  the  evidence  base  for  coordination, 
including through their public health risk assessments. 

To ensure consistent and timely crisis management, it is essential that there is a clear 
division of powers and responsibilities across the EU’s crisis coordination structures. 
While  the  EU  governance  structures  each  operate  within  distinct  mandates,  health 
crises often have a multidimensional impact that requires them to act simultaneously, 
coordinate  closely  and  exchange  information,  with  a  view  to  maximising  synergies, 
efficiency and effectiveness and avoiding overlaps. Joint meetings between different 
governance structures are an asset in bringing a wide range of expertise to the same 
table and ensuring a joint situational awareness. The EU’s matrixed approach to health 
crisis governance improves consistency, speeds up decision-making and ensures that 
all stakeholders work within a shared situational picture during complex emergencies. 

Coordination is escalated to EU level only where EU-level coordination brings added 
value. Most early responses to serious cross-border threats to health are managed at 
national level or in collaboration with neighbouring regions. 

(166)  The HERA Board provides support to the work of the Commission in the area of MCM as per C(2021) 6712 final. 
(167)  European Council / Council of the European Union, ‘Employment, Social Policy, Health and Consumer Affairs Council 
configuration (EPSCO)’, European Council/Council of the European Union website, accessed 3 November 2025, 
https://www.consilium.europa.eu/en/council-eu/configurations/epsco/. 

(168)  European Parliament, ‘Committee on Public Health’, European Parliament website, accessed 3 November 2025, 

https://www.europarl.europa.eu/committees/en/sant/home/highlights. 

55 

 
 
6.1.1.  Coordination of response within the HSC 

After  notification  of  a  serious  cross-border  threat  to  health  in  EWRS,  the  Member 
States and the Commission will assess whether there is a need for consultation and 
coordination of response within the HSC. If a need is identified, a Member State or the 
Commission  will  make  a  request  for  coordination  of  response  within  the  HSC 
(Figure  6)  (169). A  request  for  coordination  can  also  be  made  in  an  exceptional 
emergency situation caused by a threat that is not biological, chemical, environmental 
or unknown origin (170). 

Following a request for consultation for the purposes of coordination of response within 
the  HSC,  the  Commission  must  in  principle  organise  such  a  consultation  within  48 
hours of the request depending on the urgency. During the consultation, and on the 
basis of the available information, the HSC can: (i) consult the Member States affected; 
(ii) draw on the expertise of the Commission, EU agencies and bodies, international 
partners,  and  subject-matter  experts,  (iii)  exchange  information;  (iv)  coordinate 
national response measures, research needs, and risk and crisis communication; (v) 
adopt  opinions  and  guidance;  and  (vi)  support 
if 
activated (171)  (172). 

IPCR  arrangements 

the 

Upon  adoption  of  public  health  measures  in  response  to  a  serious  cross-border 
threat to health, Member States must promptly inform the other Member States and 
the  Commission  of  the  nature,  purpose and  scope of  those measures, especially  in 
cross-border  regions.  Similarly,  they  must  coordinate  within  the  HSC  before 
terminating measures.  Only in  urgent  situations,  can  this be done  immediately after 
adopting or terminating the measures  (173). 

To  coordinate  the  response,  the  HSC  collaborates  with  other  structures  and 
coordinates  with  the  UCPM  and,  where  activated,  the  Health  Crisis  Board.  When  it 
comes  to  requesting,  offering  and  delivering  cross-border  medical  assistance, 
including  medical  evacuation,  the  HSC  coordinates  with  the  UCPM.  On  matters 
relating to MCMs, the HERA Board collaborates with the HSC. In case of a recognition 
of  a  public  health  emergency  at  Union  level  and  an  activation  of  the  emergency 
framework for MCMs, the Health Crisis Board acts in close coordination with the HSC 
and ensures timely and efficient exchange of information. 

(169)  Article 21 of Regulation (EU) 2022/2371. 
(170)  Article 2(4) of Regulation (EU) 2022/2371. 
(171)  Article 4 of Commission Implementing Decision (EU) 2017/253 of 13 February 2017 laying down procedures for the 
notification of alerts as part of the early warning and response system established in relation to serious cross-border 
threats to health and for the information exchange, consultation and coordination of responses to such threats 
pursuant to Decision No 1082/2013/EU of the European Parliament and of the Council (OJ L 37, 14.2.2017, p. 23, 
ELI: http://data.europa.eu/eli/dec_impl/2017/253/oj). 

(172)  Article 21 of Regulation (EU) 2022/2371. 
(173)  Article 21 of Regulation (EU) 2022/2371. 

56 

 
 
Figure 6. Process for the initial coordination of response within the HSC. 

57 

 
 
 
6.1.2.  Coordination of MCM response 

When  an event  constituting  a  serious  cross-border threat  to  health  is notified  in  the 
EWRS, the Commission will assess the need to coordinate the MCM response at EU 
level.  If  EU-level  action  on  MCMs  is  needed,  the  Commission  will  open  a  response 
case and seek advice of the HERA Board, where relevant. Depending on the event 
and availability of MCMs, an ad hoc meeting of the HERA Board can be convened to 
assess  the  demand  for  and  availability  of  crisis-relevant  MCMs  and  to  discuss  the 
actions  (e.g.  joint  procurement)  that  the  Commission  could  take  to  support  the 
availability  of  and  equitable  access  to  MCMs.  This  could  include  possible  support 
through the UCPM (joint or centralised procurement) and the deployment of rescEU 
capacities. Where appropriate, the results of the set of options identified by the HERA 
Board will be shared with the HSC. 

An  event  or  likely  imminent  event  may  also  lead  to  a  notification  in  the  Common 
Emergency Communication and Information System (CECIS) of a possible upcoming 
or actual request for assistance to the UCPM. In such cases, the ERCC is responsible 
for coordinating the response including the deployment of rescEU stocks.  

6.1.3.  Coordination of response within the IPCR 

In  the  event  of  activation  of  the  Integrated  Political  Crisis  Response  (IPCR) 
arrangements,  the  HSC  coordinates  support  for  the  IPCR  to  ensure  that  political 
coordination at EU level is supported by public health expertise and operational input 
from  Member  States.  This  may  also  include  exchanging  information  or  sharing  of 
opinions or guidance (174). The IPCR is the EU mechanism designed to support a rapid 
and coordinated political response for major and complex crises (175). It is under the 
leadership of the Presidency of the Council, which can activate it, has political control 
over  it  and  determines  its  strategic  direction  (176).  The  IPCR  provides  a  flexible 
framework  that  can  be  scaled  depending  on  the  severity  and  characteristics  of  the 
crisis. Once activated, the IPCR has three  operational modes, namely: a monitoring 
mode  (for  situational  awareness);  an  information  sharing  mode  (for  collecting  and 
analysing data); and a full activation mode (for active coordination of the preparation 
of response measures).  

The Commission’s Emergency Response Coordination Centre (ERCC) operates on a 
24/7 basis and supports both the EU institutions and the Member States in its capacity 
of single point of contact for IPCR. It provides assistance to Member States and the 
EU when IPCR arrangements are activated, or the solidarity clause is invoked. 

(174)  Article 21 of Regulation (EU) 2022/2371. 
(175)  Council Implementing Decision (EU) 2018/1993 of 11 December 2018 on the EU Integrated Political Crisis Response 

Arrangements (OJ L 320, 17.12.2018, p. 28, ELI: https://eur-lex.europa.eu/eli/dec_impl/2018/1993/oj). 

(176)  Article 222 of the TFEU. 

58 

 
 
The  Committee  of  Permanent  Representatives  of  the  Governments  of  the  Member 
States  to  the  European  Union  (Coreper)  oversees  the  implementation  of  the  IPCR 
arrangements. 

6.1.4.  Response  coordination  under  the  Union  Civil  Protection 

Mechanism 

When  any  country  in  the  world  is  hit  by  a  disaster  or  faces  an  imminent  threat  of 
disaster – such as a health crisis – it can request emergency assistance from the Union 
Civil Protection Mechanism (UCPM) (see Figure 7). Requests for assistance can also 
be  made  by  the  United  Nations  and  its  agencies  (e.g.  the  WHO)  and  certain  other 
relevant international organisations in coordination with and on behalf of the affected 
country(177). 

The request for assistance is sent via the Common Emergency Communication and 
Information  System  (CECIS  2.0) (178)  to  the  Commission’s  Emergency  Response 
Coordination  Centre  (ERCC).  The  ERCC  operates  on  a  24/7  basis  to  be  ready  to 
coordinate and deploy emergency support. 

After the ERCC has validated a request for assistance, EU Member States and states 
participating in the UCPM may offer assistance via CECIS 2.0. 

In addition to experts, capacities may be mobilised under the UCPM from  national 
response capacities (‘ad hoc’ offers of assistance by Member States or participating 
states), the European Civil Protection Pool (ECPP, pre-committed national capacities 
that meet certain UCPM requirements) and/or  rescEU (the ‘last resort’ EU strategic 
reserve of capacities) (179). The UCPM can also involve the EUHTF. Where an effective 
response  cannot  be  ensured  through  national  ‘ad  hoc’  offers  of  assistance  and/or 
capacities  available  as  part  of  the  ECPP,  the  Commission  may  decide,  through  the 
ERCC, to deploy rescEU capacities, in consultation with the requesting Member State 
or participating state and the state hosting the rescEU capacity.  

The ERCC coordinates the operational response between all 27 EU Member States, 
the  10  additional  participating  states,  the  affected  country,  and  civil  protection  and 
humanitarian aid experts. It can help with the transport and effective deployment of the 
assistance once it has been accepted by the requesting country. It can also help 

(177)  Including the International Federation of Red Cross and Red Crescent Societies (IFRC). 
(178)  Non-EU countries have no access to CECIS; their requests are sent to the ERCC, which enters them in CECIS.  
(179)  Report from the Commission to the European Parliament and the Council, Capacity Progress Report on the Response 

Capacities of the Union Civil Protection Mechanism, COM(2025) 286 final of 6 June 2025, https://eur-
lex.europa.eu/legal-content/EN/TXT/?uri=celex:52025DC0286; and the accompanying Union Civil Protection 
Mechanism Capacity Development and Gaps Overview, SWD(2025) 146 final of 6 June 2025, https://eur-
lex.europa.eu/legal-
content/EN/TXT/?uri=celex:52025SC0146#:~:text=This%20Staff%20Working%20Document%20represents%20the%
20descriptive%20portion,foreseen%20under%20Article%2034.2%20of%20Decision%20No%201313%2F2013%2F
EU. 

59 

 
 
with the production of satellite maps (180), and scientific emergency reports (181) (e.g. 
in the event of major natural disasters, or chemical, radiological or nuclear incidents). 

Figure  7.  Process  for  responding  to  a  request  for  assistance  under  the  Union  Civil 
Protection  Mechanism  as  per  Decision  No  1313/2013/EU.  CECIS  =  Common 
Emergency Communication and Information System. ERCC = Emergency Response 
Coordination Centre. 

(180)  Produced by the Copernicus Emergency Management Service in support of civil protection operations; see ‘Copernicus 

Emergency Management Service – Mapping’, Copernicus website, accessed 3 November 2025, 
https://mapping.emergency.copernicus.eu/#zoom=4&lat=41.92304&lon=17.89688&layers=0BT00.   

(181)  Prepared under the Scientific and Technical Advisory Facility (‘STAF’) of the UCPM. 

60 

 
 
 
During health crises, where health systems are overwhelmed, damaged or unable to 
provide adequate care, the UCPM can provide support by offering, for example: 

1.  MCMs  and  in-kind  assistance:  addressing  shortages  of  essential  medicines, 

personal protective equipment, and medical equipment; 

2.  reinforcement  of  medical  staff  and  services:  deploying  health  experts  and 

emergency medical teams (EMTs) (see also Section 6.7.3); 

3.  medical evacuation (Medevac): facilitating patient evacuation and transport to 
hospitals across EU Member States and UCPM  participating states (see also 
Section 6.6.3);  

4.  help with the transport and/or operational costs of deployments.  

When to end of a UCPM operational response depends on the evolving needs of the 
emergency  and  the  situation.  The  requesting  country  informs  the  ERCC  when 
assistance  is  no  longer  required.  Disengagement  is  coordinated  by  the  requesting 
country together with the assisting EU Member State(s) or UCPM participating state(s), 
in close consultation with the ERCC. Decisions to withdraw the rescEU capacity are 
taken by the Commission, through the ERCC, in close coordination with both the host 
state of the rescEU capacity and the requesting country. 

In  parallel  to  the  UCPM’s  response  to  requests  for  assistance  and  coordination  for 
individual  requests,  the  ERCC  and  national civil  protection  focal points  hold  regular 
coordination  meetings  on  the  ongoing  emergencies  and  related  general  UCPM 
response  coordination  matters.  For  health  emergencies  to  which  response    is 
coordinated  in  the  HSC,  the  ERCC  participates  in  the  relevant  meetings  to  ensure 
appropriate  information  exchange  and  coordination  with  the  UCPM  operational 
response.  Similarly,  if  the  framework  of  measures  for  ensuring  the  supply  of  crisis-
relevant MCMs is activated in the event of a public health emergency at Union level, 
coordination is ensured with the Health Crisis Board.  

Finally,  the  ERCC  uses  ReliefEU (182),  to  extend  EU  assistance  to  humanitarian 
settings worldwide. It coordinates the provision of ReliefEU assistance to disaster- and 
crisis-stricken  areas  outside  the  EU,  either  in  addition  to  or  as  a  humanitarian 
alternative to UCPM support. ReliefEU capacities (183) and funding help bridge the gap 
between the urgent needs of the affected population in those areas and the resources 
available from European humanitarian partners. 

(182)  European Civil Protection and Humanitarian Aid Operations, ‘ReliefEU’, European Commission website, accessed 3 
November 2025, https://civil-protection-humanitarian-aid.ec.europa.eu/what/humanitarian-aid/reliefeu_en. 

(183)  Logistic services, warehousing, stockpiling and deployment of expertise. 

61 

 
 
 
6.2.  Situational awareness 

Situational awareness builds on the information exchanged between Member States, 
the relevant EU agencies and the Commission, and is crucial for an effective response. 
Following a request for consultation and coordination of a response within the HSC, 
the Member States and the Commission exchange the available relevant information 
in the Early Warning and Response System (EWRS) to build a situational picture and 
awareness  (184).  Information  on  MCMs  is  primarily  communicated  through  ATHINA, 
while requests and offers for cross-border emergency assistance are communicated 
via CECIS. The Commission coordinates the information exchange to avoid duplication 
of  efforts  and  ensures  the  transfer  of  relevant  information  between  different 
Commission alert information systems (Annex 8).  

To consult on and coordinate national public health measures, Member States must 
inform the HSC of their intention to adopt or terminate such measures. In urgent cases, 
the HSC must be informed and consulted promptly after the adoption or termination of 
the public health measures concerned (185). 

Integrated  situational  awareness  and  analysis  (ISAA)  reports,  part  of  IPCR 
arrangements, facilitate a common understanding of the crisis and make it possible to 
identify  urgent  needs  and  gaps  and  promote  solidarity  measures  in  the  IPCR.  The 
ERCC as well as EU agencies such as ECDC and EMA assist with the production of 
ISAA  reports,  which  are  developed  by  the  Commission  or  EEAS  depending  on  the 
centre of gravity of the crisis.  

Secure  exchange  of  information  within  the  EU  is  facilitated  by  the  various  digital 
platforms for public health intelligence and alert notification (Annexes 7 and 8) and for 
communication (186).  EU  classified  information  means  any  information  or  material 
designated by an EU security classification, the unauthorised disclosure of which could 
cause varying degrees of prejudice to the interests of the European Union or one or 
more  Member  States.  Where  Member  States  enter  classified  information  bearing  a 
national security classification marking into the Commission’s structures or networks, 
the  Commission  must  protect  that  information  in  accordance  with  the  requirements 
applicable  to  EU  classified  information  of  the  equivalent  level  (187).  Sensitive  non-
classified  information,  on  the  other  hand,  is  information  or  material  that  the 
Commission  must  protect  because  of  legal  obligations  and/or  because  of  its 
sensitivity (188). 

(184)  Article 19(3) to (5) of Regulation (EU) 2022/2371. 
(185)  Article 21 of Regulation (EU) 2022/2371.  
(186)  Secure Union Environment (SUE) system for the Member States, EU agencies and the Commission, and the HCI 

system for the Council. 

(187)  Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU classified 

information (OJ L 72, 17.3.2015, p. 53, ELI: http://data.europa.eu/eli/dec/2015/444/oj).  

(188)  Commission Decision (EU, Euratom) 2015/443 of 13 March 2015 on Security in the Commission (OJ L 72, 17.3.2015, 

p. 41 ELI: http://data.europa.eu/eli/dec/2015/443/oj).  

62 

 
 
Example of cross-border interregional collaboration: Nordic mechanism for sharing situational awareness 

The Nordic public health agreement between the governments of Denmark, Finland,  Iceland, Norway, and 
Sweden has been in place since 2002 and serves as a basis for cooperation between the Nordic countries in 
the  development  of  public  health  preparedness  to  address  crises  and  disasters.  This  group,  which  is  also 
known as the ‘Svalbard Group’, has established a common framework and common situational awareness 
data  for  preparedness  for  and  management  of  crisis  situations  in  health  and  social services  in  the  Nordic 
countries (189). 

6.3.  Risk and crisis communication 

Risk  and  crisis  communication  is  one  of  the  core  capacities  for  the  successful 
management of a health crisis (190). Communicating science-based, accurate and clear 
information adapted to the target audience, early and often, and through the channels 
used  by  the  target  audience,  improves  health  literacy  and  enables  people  to  make 
informed  choices  to  protect  themselves  and  others  from  hazards.  Communicating 
science-based, accurate and clear information adapted to the target audience, early 
and  often,  and  through  the  channels  used  by  the  target  audience,  improves  health 
literacy  and  enables  people  to  make  informed  choices  to  protect  themselves  and 
others from hazards. Open, timely and consistent communication can increase public 
trust  and  prevent  misinformation  and  disinformation  from  taking  root.  From  a 
preparedness perspective, efforts to build trust in science, MCMs and institutions more 
broadly, lay the foundations for a successful crisis response.  

Risk and crisis communication is comprised of several interconnected areas. These 
include: the timely flow of accurate and relevant information; intelligence gathering and 
monitoring  perceptions; 
including  countering  harmful 
misinformation  and  disinformation (191);  and  coordination  of  messages.  Managing 
public perception and addressing false or misleading narratives during a health crisis 
is  pivotal,  as  panic  or  distrust  can  undermine  the  effectiveness  of  public  health 
responses. 

infodemic  management, 

Member  States  provide  the  public  with  information  on  the  prevention  of  and 
preparedness  for  cross-border  threats  to  their  health.  Given  the  increasingly  global 
nature of information and the need to strive for consistency of messaging across the 
EU, the Commission works together with EU agencies and bodies to ensure: EU-wide 
public  recommendations,  warnings  and  risk  communication,  and  accessible  and 
inclusive  crisis  communication,  which  reaches  all  those  concerned  regardless  of 
possible social and cultural barriers (192).  

(189)  Nordic Group for Public Health Preparedness (‘Svalbard Group’), ‘Nordic Public Health Preparedness Agreement’, 
Nordic Health Preparedness website, accessed 3 November 2025, https://nordichealthpreparedness.org/. 

(190)  Capacity 8 in Commission Implementing Regulation (EU) 2023/1808.  
(191)  WHO, ‘Infodemic’, WHO website, accessed 3 November 2025, https://www.who.int/health-topics/infodemic. 
(192)  Joint Communication to the European Parliament, the European Council, the Council, the European Economic and 

Social Committee and the Committee of the Regions, on the European Preparedness Union Strategy, JOIN(2025) 130 
final of 26 March 2025, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52025JC0130. 

63 

 
 
The Commission and EU agencies support Member States in ensuring that timely and 
accurate information on a health crisis reaches the public and the media. Both digital 
and  more  traditional  communication  channels  are  used.  Media  representatives  pay 
close attention to EU-level announcements and approach EU bodies for reactions to 
or  comments  on  the  latest  developments.  This  requires  a  rapid  and  coordinated 
response at all levels. Close collaboration with the relevant EU agencies ensures that 
messaging  is  rooted  in  the  latest  scientific  evidence.  Moreover,  local  healthcare 
professionals and members of the community often enjoy high levels of trust. They can 
play  a  pivotal  role  during  a  crisis  by  communicating  risk,  providing  insights  and 
supporting the roll-out of response measures. These partners, however, rely on expert 
public health advice from national and EU bodies during public health emergencies.  

The ECDC is tasked with communicating information on current and emerging threats 
to public health in the EU/EEA and has provided guidance on the best way to involve 
members of the community in crisis preparedness and response (193) (194). The ECDC 
operates a public health network for communicating with representatives from Member 
States (195). 

Information  manipulation,  including  foreign  interference,  is  a  major  challenge  for 
coherent  health  emergency  response.  With  the  Digital  Services  Act,  the  Code  of 
Conduct on Disinformation and the European Democracy Shield, the Commission has 
policies in place that make it more difficult for threat actors to misuse online platforms, 
while  simultaneously  protecting  freedom  of  speech  and  media  pluralism.  The 
Commission also has the capability to support situational awareness across the Union 
through monitoring, detection and analysis of open-source information. There is close 
cooperation with other EU institutions, national authorities, fact-checkers, civil society 
organisations, media, academia and other organisations.  

Awareness-raising programmes provide tools for the Commission to support risk and 
crisis  communication  in  the  Member  States.  Such  programmes  include  citizens’ 
panels, the EUvsDisinfo portal for detecting, analysing, and raising awareness about 
disinformation (196),  online  campaigns,  and  toolkits  for  strategic  communication  and 
countering information manipulation.  

In the event of a serious cross-border threat to health or a public health emergency at 
Union  level,  EU  information,  communication  and  coordination  structures  enable 
systematic and consistent crisis communication. The HSC is the forum where Member 
States coordinate risk and crisis communication messages (197). The Commission can 
provide suggested messaging, templates or communication assets; but each Member 

(193)  ECDC, Community engagement for public health events caused by communicable disease threats in the EU/EEA, 

Stockholm, 2020, https://www.ecdc.europa.eu/en/publications-data/guidance-community-engagement-public-health-
events-caused-communicable-disease. 

(194)  Article 2c of Regulation (EU) 2022/2370 of the European Parliament and of the Council of 23 November 2022 

amending Regulation (EC) No 851/2004 establishing a European centre for disease prevention and control (OJ L 314, 
6.12.2022, p. 1, ELI : http://data.europa.eu/eli/reg/2022/2370/oj). 

(195)  ECDC, ‘Public Health Networks’, ECDC website, accessed 3 November 2025, https://www.ecdc.europa.eu/en/about-

us/what-we-do/partners-and-networks/public-health-networks.  

(196)  EUvsDisinfo, accessed 3 November 2025, https://euvsdisinfo.eu/.   
(197)  Article 21 of Regulation (EU) 2022/2371. 

64 

 
 
State develops its own communication strategy, in line with its national, regional and 
cross-border  context (198).  The  Commission  works  with  EU  representations  in  the 
Member States and fact-checking networks to respond to false narratives before they 
take hold. Public health risk assessments can also be used for crisis communication 
at national, EU and international level.  

The Presidency of the Council takes the lead on public communication from the IPCR. 
It is supported in this by the informal Crisis Communicators’ Network which is made 
up of communication experts from Members States and relevant EU bodies. 

6.4.  Emergency research and innovation 

Scientific  evidence  is  crucial  for  taking  decisions  on  preventing,  preparing,  and 
responding to serious cross-border threats to health (199). When an event is unusual or 
unknown  and  growing  rapidly  in  scale,  emergency  research  is  needed  to  better 
understand the threat and to guide the development and implementation of response 
measures and the use of resources. 

Emergency research in the EU/EEA covers a broad range of study settings, grounded 
in  continuous  research  preparedness  efforts.  Examples  include  basic  biomedical 
research, pre-clinical and clinical research, behavioural science, observational studies, 
implementation,  and  public  health  research.  Such  research  and  innovation  may  be 
publicly  funded  at  national  level  or  at  European  level,  the  latter  mainly  through  the 
European research and innovation framework programmes. 

Coordinating  emergency  research  priorities  and  resources  at  EU  level  ensures 
efficiency and underpins evidence-based policymaking. Key players include the HSC, 
the HERA Board and the Health Crisis Board (when activated), along with the Horizon 
Europe and EU4Health Programme committees. Each body plays an important role, 
within  their  respective remits,  in facilitating  research and  innovation  and  its  funding, 
ultimately strengthening the EU’s resilience in preparing for and responding to serious 
cross-border threats to health. The Clinical Trial Coordination Mechanism advises 
the Commission on prioritising clinical studies and their funding. 

The ECDC is mandated to collect data and provide concrete analyses and independent 
science-based recommendations to prevent and control communicable diseases and 
other  serious  cross-border  threats  to  health  and  multinational  outbreaks  to  rapidly 
generate evidence on epidemiological parameters such as transmissibility, routes of 
transmission and risk factors for disease. The ECDC develops its scientific studies and 
opinions on its own initiative or at the request of the Commission or the HSC (200). The 
HSC is also consulted on the planning and priority setting of the ECDC’s research and 

(198)  Article 21 of Regulation (EU) 2022/2371. 
(199)  European Commission, ‘EU preparedness union strategy’, European Commission website, accessed 3 November 

2025, https://commission.europa.eu/topics/preparedness_en. 

(200)  Articles 6 and 11 of Regulation (EC) No 851/2004. 

65 

 
 
public  health  studies (201).  The  EMA  collaborates  with  ECDC  to  conduct  vaccine 
effectiveness and safety studies through  the agencies’ Vaccine Monitoring Platform. 
The EMA also gives scientific advice on data generation for medicines.  

Research  during  health  crises  can  benefit  from  existing  research  and  innovation 
networks and infrastructure and build on the investments made during prevention and 
preparedness stages. The European partnership on pandemic preparedness helps 
create  the  required  research  and  innovation  ecosystem  to  respond  to  health  crises 
quickly  and  effectively (202).  The  partnership’s  strategic  research  and  innovation 
agenda  provides  a  solid  foundation  for  rapidly  responding  to  serious  cross-border 
threats to health. The ever-warm clinical research networks under the partnership 
have the built-in ability to adapt quickly in emergency situations and are an essential 
component of this preparedness ecosystem. Other networks in the partnership cover 
basic  fundamental  and  pre-clinical  research,  as  well  as  clinical  and  public  health 
research (203).  

When  a  public  health  emergency  at  Union  level  is  recognised  and  the  emergency 
research  measure  of  the  emergency  framework  for  MCMs  is  activated,  the 
Commission  and  Member  States  must,  after  consulting  the  Health  Crisis  Board, 
activate the Union plan’s emergency research and innovation mechanisms (204). This 
is  to  be  done  in  coordination  with  the  ECDC  and  with  the  involvement  of  the  EMA 
Emergency Task Force (Annex 4) and the European Clinical Research Infrastructure 
Network.  

The  Commission  and  the  Member  States  can  activate  several  emergency  research 
and innovation mechanisms (Table 8). 

(201)  Article 6 of Regulation (EC) No 851/2004. 
(202)  European partnership on pandemic preparedness (BE READY 4 PANDEMICS), accessed 3 November 2025, 

https://beready4pandemics.eu/. 

(203)  The Horizon 2020 funded project EU RESPONSE provides an example for ever-warm clinical trials networks. Similar 

networks are envisaged by the Horizon Europe partnership on pandemic preparedness; see EU Response website, 
accessed 3 November 2025, https://eu-response.eu/. 

(204)  Articles 5 and 9 of Regulation (EU) 2022/2372. 

66 

 
 
Table 8. Emergency research and innovation mechanisms in the EU/EEA. 

• 
• 
• 

EU research and innovation funding; 
European partnership for pandemic preparedness; 
The Commission’s Scientific Advice Mechanism (SAM); 

o 
o 

o 

o 

identifying emerging risks and providing anticipatory advice to inform proactive measures; 
rapid evidence synthesis: mobilising expert networks to deliver timely scientific input in an 
emergency; 
strategic  policy  guidance:  making  recommendations  to  ensure  EU  action  is  grounded  in 
robust scientific evidence; 
stakeholder  engagement  and  communication:  facilitating  dialogue  between  the  scientific 
community, policymakers and the public to build trust and increase transparency; 

• 
• 

• 

European Group on Ethics in Science and New Technologies; 
Information exchange on national emergency research and coordination of national research needs 
within the HSC in response to a cross-border threat to health; 
Coordination of clinical studies related to the cross-border threat to health as part of the Clinical Trial 
Coordination Mechanism under the HERA Board. 

6.5.  Emergency funding 

The  EU’s  long-term  budget  (the  multiannual  financial  framework  or  ‘MFF’)  sets  out 
rules with which the EU’s annual budget must comply. The MFF can include funding 
instruments  for  preventing,  preparing  for  and  responding  to  health  crises  (205)  (206). 
Member States also benefit from financial support from the Recovery and Resilience 
Facility  for the  period 2021–2026  and  cohesion  policy  funding to meet  their  specific 
needs (207) (208) (209). 

The  Emergency  Support  Instrument  (ESI) enables  the  EU  to  provide  financial 
assistance,  logistical  support,  technical  expertise  and  resources  to  Member  States 
facing  crises  in  exceptional  circumstances  where  other  available  resources  are 
insufficient. It is a flexible tool designed to respond rapidly to different types of evolving 
needs. Member States can use it when they require immediate support in managing a 
crisis, preventing a crisis, and during recovery. The ESI can be activated by the Council 
based on a proposal by the Commission where such assistance is appropriate to the 
economic situation and the exceptional scale and impact of the disaster is such that it 
gives rise to severe wide-ranging humanitarian consequences in one or more Member 

(205)  European Commission, ‘EU4Health programme 2021–2027 – a vision for a healthier European Union’, European 

Commission website, accessed 3 November 2025, https://health.ec.europa.eu/funding/eu4health-programme-2021-
2027-vision-healthier-european-union_en.   

(206)  European Commission, ‘Horizon Europe’, European Commission website, accessed 3 November 2025, 

https://research-and-innovation.ec.europa.eu/funding/funding-opportunities/funding-programmes-and-open-
calls/horizon-europe_en.  

(207)  European Commission, ‘New Cohesion Policy’, European Commission website, accessed 3 November 2025, 

https://ec.europa.eu/regional_policy/2021-2027_en.  

(208)  European Commission, ‘Recovery and Resilience Facility (RRF)’, European Commission website, accessed 3 November 
2025, https://commission.europa.eu/business-economy-euro/economic-recovery/recovery-and-resilience-facility_en.   

(209)  European Commission, ‘Technical Support Instrument (TSI)’, European Commission website, accessed 3 November 
2025, https://commission.europa.eu/funding-tenders/find-funding/eu-funding-programmes/technical-support-
instrument/technical-support-instrument-tsi_en.  

67 

 
 
States including in a public health emergency at Union level (210) (211). The ESI aims 
to create synergies and consistency with existing EU programmes and instruments, 
such as the Union Civil Protection Mechanism (UCPM). The support provided under 
ESI is intended to complement ongoing efforts of the affected Member State(s). 

6.6.  Continuity of care across borders 

The design and organisation of national health systems and health services fall within 
the  competence  of  Member  States.  The  EU  plays  a  complementary  role  to  ensure 
continuity of care when patients or healthcare personnel cross borders and move freely 
in  the  EU.  Many  Member  States  have  put  in  place  cross-border  interregional 
arrangements for surge capacity and specialised services. These arrangements can 
include agreements, service procurement, projects or other initiatives. Guidance from 
the WHO ensure continuity of operations and services (212) (213). 

The Commission can deploy coordinated crisis response measures by the customs 
authorities of the Member States at the external borders facilitated by the Customs 
Risk  Management  System  (CRMS2) (214).  These  measures  can  include  export 
control mechanisms in which customs authorities help secure the supply of critical 
MCMs by facilitating their import and, where necessary, restricting their export during 
a  crisis.  The  Commission  can  issue  crisis  alerts,  provide  guidance  and  to  prioritise 
customs controls for critical goods (vaccines, medical equipment, personal protective 
euipment, disinfectants) while maintaining trade flow facilitation. Customs role is also 
important in curbing illicit and dangerous imports of medicines and medical equipment. 

6.6.1.  Cross-border healthcare 

Cross-border interregional cooperation in healthcare can optimise resources and give 
access to care during health emergencies when there is available healthcare capacity 
across  the  border (215).  Operating  arrangements  in  border  regions  can  help  tackle 
emergency situations while preserving the continuity of care for the many people living 
in these regions (about 30% of the EU population).  

(210)  Council Regulation (EU) 2016/369 of 15 March 2016 on the provision of emergency support within the Union (OJ L 

70, 16.3.2016, p. 1, ELI: http://data.europa.eu/eli/reg/2016/369/oj). 

(211)  Article 13 of Regulation (EU) 2022/2372. 
(212)  WHO, WHO Guidance for Contingency Planning,  Geneva, 2018. Licence: CC BY-NC-SA 3.0 IGO., 

https://www.who.int/publications/i/item/WHO-WHE-CPI-2018.13.  

(213)  WHO, Hospital safety index: guide for evaluators, 2nd edition, 2017, Licence: CC BY-NC-SA 3.0 IGO, 

https://www.who.int/publications/i/item/9789241548984. 

(214)  European Commission, ‘Customs risk management’, European Commission website, accessed 21 November 2025, 

https://taxation-customs.ec.europa.eu/customs/customs-risk-management_en. 

(215)  European Commission: Directorate-General for Health and Food Safety, Asterisk Research and Analysis, Empirica, 

Tetra Tech International Development Sp. z o.o, Dates, M. et al., Study supporting the evaluation of the Directive 
2011/24/EU to ensure patients’ rights in the EU in cross-border healthcare : Final report, Publications Office of the 
European Union, 2022, https://data.europa.eu/doi/10.2875/88566. 

68 

 
 
Interregional  cooperation  under  the  Interreg  programme  (a  cohesion  policy  pillar) 
covers multiple types of projects, initiatives and strategies. These aim to promote the 
development  of  cross-border  public  healthcare  services;  share  resources,  staff  and 
knowledge;  build  up  administrative  capacities;  upgrade  technologies;  and  support 
innovation. Long-term cooperation helps structure local networks of professionals and 
institutions  who  know  one  another  and  regularly  work  together.  As  a  result,  these 
networks  can  be  mobilised  more  effectively  to  implement  coordinated  prevention, 
preparedness and response measures in a health crisis (216). 

EU citizens and nationals of EEA countries have the right to access medical treatment 
with the same terms as local patients in any other EU Member State or EEA country 
subject  to  certain  conditions.  The  citizen’s  country  of  affiliation  (country  where  the 
patient is insured) will cover part or all the medical costs, up to the amount their home 
system  would  have  paid  for  the  same  treatment  locally  (or  the  actual  cost  of  the 
treatment, whichever is lower). However, patients usually pay all costs upfront and then 
apply  for  reimbursement,  based  on  their  home  country’s  fee  and  reimbursement 
schedule. For unplanned treatment while temporarily abroad, EU citizens and nationals 
of  EEA  countries must  have a  European  Health  Insurance  Card. There  are  national 
contact points in each EU Member State and EEA country that can advise the public 
on cross-border healthcare procedures (217) (218) (219).  

MyHealth@EU is a cross-border digital infrastructure connecting EU Member States 
and  EEA  countries’  contact  points  for digital  health,  enabling  patients  to  share  their 
health data in a standardised European format (220). MyHealth@EU can facilitate and 
support  the  interoperable  exchange  of  electronic  health  data  with  public  health 
applications.  This  can be of  help  in  a  health crisis,  for example,  to issue and  check 
health certificates or to support contact tracing (221). 

The  European  Reference  Networks  can  support  the  care  of  patients  with  rare,  low 
prevalence  and  complex  diseases  also  during  health  crises.  These  cross-border 
networks bring together European hospital centres of expertise and reference to tackle 
rare,  low-prevalence  and  complex  diseases  and  conditions.  The  collaboration  is 
facilitated by the Clinical Patient Management System.  

(216)  Interreg, accessed 3 November 2025, https://interreg.eu/. 
(217)  Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of 

social security systems (OJ L 166, 30.4.2004, p. 1, ELI: http://data.europa.eu/eli/reg/2004/883/oj). 

(218)  Regulation (EC) No 987/2009 of the European Parliament and of the Council of 16 September 2009 laying down the 

procedure for implementing Regulation (EC) No 883/2004 on the coordination of social security systems (OJ L 284, 
30.10.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/987/oj). 

(219)  Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ 

rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45, ELI: http://data.europa.eu/eli/dir/2011/24/oj).  
(220)  European Commission, ‘Electronic cross-border health services’, European Commission website, accessed 3 

November 2025, https://health.ec.europa.eu/ehealth-digital-health-and-care/digital-health-and-care/electronic-cross-
border-health-services_en.  

(221)  Article 24 of Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the 
European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 
5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj).  

69 

 
 
Example  of  cross-border  interregional  collaboration:  emergency  medical  services  at  the  French–Spanish 
border 

The Catalan Health Service (SCS) and the French Agence Régionale de Santé Occitanie have an administrative 
agreement in place to coordinate emergency medical services. This serves to foster cooperation across the 
entire border region, especially in Cerdanya, where both services already share facilities at the cross-border 
hospital in Puigcerdà. The agreement sets out communication protocols, leadership roles in emergencies and 
shared tools such as for transmitting coordinates instead of map names. 

Example  of  cross-border  interregional  collaboration:  cross-border  ambulance  services  at  the  Austrian-
Hungarian border 

Austria and Hungary signed an agreement in 2024 on joint ambulance operations across the border. Rescue 
dispatchers in Burgenland (Austria) and western Hungary can request assistance from one another so that 
patients  can  reach  the  closest  emergency  site  faster.  The  cooperation  also  extends  to  air  rescue  services, 
ensuring that severe cases, including accidents and critical illnesses, receive timely and effective treatment. 
The collaboration improves safety and healthcare access for patients in border regions. 

6.6.2.  Cross-border contact tracing 

Health authorities need to collaborate across borders when trying to limit the spread of 
diseases from cross-border movement. This can include contact tracing between an 
EU  Member  State  and  a  non-EU  country.  Cross-border  contact  tracing  is  a 
responsibility of national, subnational or local authorities, depending on the Member 
States. 

Cross-border contact tracing involves the secure exchange of personal data, including 
personal health data, between Member State competent authorities to identify contacts 
at risk of infection or contamination. The EWRS contact tracing module provides for 
the  secure  exchange  of  information  between  the  competent  authorities  in  Member 
States and participating countries.  

Digital contact tracing can complement conventional contact tracing especially when 
the demand for contact tracing threatens to exceed the health system’s capacity. By 
measuring  signal  strength  between  personal  mobile  devices,  these  digital tools  can 
determine proximity between users, identify contacts at risk and then send alerts. The 
effectiveness  of  these  digital  tools  in  limiting  the  spread  of  disease  depends  on  the 
specific  situation  and  on  their  users.  The  interoperability  of  tools  between  countries 
enables  individuals to use  a  single  application  when  travelling  in  different  countries. 
When  implemented  effectively,  digital  contact  tracing  tools  can  free  up  healthcare 
resources for other purposes (222). 

Member  States  can  request  information  from  incoming  travellers,  carry  out  non-
invasive medical examinations and inspect physical items for public health purposes 

(222)  European Commission, Digital Contact Tracing Study: Study on lessons learned, best practices and epidemiological 
impact of the common European approach on digital contact tracing to combat and exit the COVID-19 pandemic, 
Publications Office of the European Union, Luxembourg, 2022, https://commission.europa.eu/system/files/2023-
02/DigitalContactTracingStudy.pdf. 

70 

 
 
 
(223).  Public  health  measures  for  travellers  are  free  of  charge (224).  The  EU  Digital 
Passenger Locator Form (EUdPLF) is a digital tool and platform that the Commission 
developed  to  help  collect  essential  travel  information  from  passengers  entering  or 
travelling within the EU (225). Passengers can use the online EUdPLF tool to fill in their 
travel history, contact details and seat assignments. On submission, the data is stored 
temporarily and is only made available to the national public health authorities of the 
relevant Member States involved in the journey. Public health authorities can use the 
tool  to  share  information  across  borders  for  contact  tracing.  The  EUdPLF  code  is 
publicly  available  under  the  European  Union  Public  Licence,  allowing  for  reuse, 
modification and distribution, provided that any derivative use remains under the same 
licence (226) (227). 

6.6.3.  Medical evacuation of patients 

The  EU’s  medical  evacuation  programme  (Medevac)  is  funded  and  run  under  the 
Union Civil Protection Mechanism (UCPM). Medevac involves the organised transfer 
of  patients,  who  require  treatment,  that  cannot  be  given  in  the  affected  country,  to 
healthcare facilities in EU Member States and UCPM participating states where such 
treatment is available. For patient safety and logistical reasons, it may be sometimes 
beneficial  to  set  up  Medevac  Hubs  as  stopover  points  along  the  treatment  route. 
Medevac is coordinated by the ERCC using the CECIS and the EWRS. 

Example:support to Ukraine and medical evacuation of patients 

In  response  to  the  deteriorating  humanitarian  situation  in  Ukraine,  all  27  EU  Member  States  and  6 
participating  states  (Iceland,  North  Macedonia,  Norway,  Serbia,  Moldova  and  Türkiye)  have  made  help 
available to Ukraine via the UCPM. The assistance includes millions of items such as first aid kits, medical and 
shelter equipment, water pumps, power generators and firefighting equipment. The EU is also coordinating 
the medical evacuation of Ukrainian patients in need of urgent care to hospitals across Europe through the 
UCPM  and  the  medical  evacuation  hub  set  up  in  Poland.  As  of  November  2025,  over  4600  patients  had 
received treatment in 22 EU Member States and EEA countries, as part of the medical evacuations  

(223)  Article 23 ‘Health measures on arrival and departure’ of IHR 2005 (amended in 2014, 2022 and 2024). As far as 

persons enjoying the right of free movement under EU law are concerned, such requirements must comply with 
Article 29 of Directive 2004/38/EC of the European Parliament and of the Council of 29 April 2004 on the right of 
citizens of the Union and their family members to move and reside freely within the territory of the Member States 
amending Regulation (EEC) No 1612/68 and repealing Directives 64/221/EEC, 68/360/EEC, 72/194/EEC, 73/148/EEC, 
75/34/EEC, 75/35/EEC, 90/364/EEC, 90/365/EEC and 93/96/EEC (OJ L 158, 30.4.2004, p. 77, ELI: 
http://data.europa.eu/eli/dir/2004/38/oj).   

(224)  Article 40 ‘Charges for health measures regarding travellers’ of IHR 2005 (amended in 2014, 2022 and 2024).  
(225)  Commission Implementing Decision (EU) 2017/253 of 13 February 2017 laying down procedures for the notification 
of alerts as part of the early warning and response system established in relation to serious cross-border threats to 
health and for the information exchange, consultation and coordination of responses to such threats pursuant to 
Decision No 1082/2013/EU of the European Parliament and of the Council (OJ L 37, 14.2.2017, p. 23, ELI: 
http://data.europa.eu/eli/dec_impl/2017/253/oj). 

(226)  Commission Decision of 8 December 2021 on the open source licencing and reuse of Commission software 2021/C 

495 I/01 (OJ C 495I, 9.12.2021, p. 1, ELI: https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=CELEX%3A32021D1209%2801%29). 

(227)  Code development platform for open source projects from the European Institutions, ‘European Digital Passenger 

Locator Form’, accessed 3 November 2025, https://code.europa.eu/sante/eudplf. 

71 

 
 
6.6.4.  Health documents 

EU  Member  States  and  EEA  countries  may  require  specific  health  documents  for 
international travel in digital or non-digital formats (228). The WHO oversees developing 
and updating, in consultation with IHR States Parties, technical guidance on issuing 
and  verifying  the  authenticity  of  these  documents in  both  formats  (229)  (230).  It  has 
developed the Global Digital Health Certification Network (GDHCN), which is an open-
source platform that provides standards for a range of digital products (231) building on 
the EU Digital COVID Certificate framework for issuing and verifying vaccination, test 
and recovery certificates, while preserving privacy (232) (233). 

6.7.  Recognising a public health emergency at Union level 

A public health emergency at Union level can be recognised by the Commission where 
the serious cross-border threat to health endangers public health at EU level (234). This 
recognition extends the legal mandates of some authorities, enhances coordination at 
EU level and releases resources (Table 9). 

To  recognise  a  public  health  emergency  at  Union  level,  the  Commission  needs  to 
assess whether the event endangers public health at EU level and whether the legal 
effects  of  recognising  it  are  necessary  and  proportionate.  For  this  assessment,  the 
Commission must consider any expert opinions from relevant EU agencies or bodies 
or the ACPHE (Figure 8) (235). The public health risk assessment conducted by one or 
more of the agencies or bodies at the request of the HSC, or the Commission, can be 
considered as an expert opinion of the EU agencies and bodies involved (236). ACPHE 
gives its advice in response to requests of the HSC or the Commission (237). Moreover, 
information  shared  by  Member  States  in  the  EWRS,  as  well  as  in  consultation  and 
coordination with the HSC, and any possible opinions or guidance adopted by the HSC 
or the HERA Board can contribute to decision-making in the Commission. 

(228)  Article 35 of the IHR 2005 (amended in 2014, 2022 and 2024). As far as persons enjoying the right of free 

movement under EU law are concerned, such requirements must comply with Article 29 of Directive 2004/38/EC. 

(229)  Part VI ‘Health documents’ of the IHR 2005 (amended in 2014, 2022 and 2024). 
(230)  WHO, Digital Documentation of COVID-19 Certificates: Vaccination Status – Technical Specifications and 

Implementation Guidance, 27 August 2021, Geneva, 2021, Licence: CC BY-NC-SA 3.0 IGO, 
https://www.who.int/publications/i/item/WHO-2019-nCoV-Digital_certificates-vaccination-2021.1.  

(231)  WHO, ‘Global Digital Health Certification Network’, WHO website, accessed 3 November 2025, 

https://www.who.int/initiatives/global-digital-health-certification-network.  

(232)  European Commission, ‘Administrative arrangement between the WHO and the European Commission on technical 

cooperation related to the global digital health certification network’, 17 May 2023, 
https://commission.europa.eu/document/d1fb7b2e-0966-4496-a56a-5ab4a35ab15f_en. 

(233)  European Commission, ‘Report from the Commission to the European Parliament and the Council pursuant to Article 
16(3) of Regulation (EU) 2021/953 of the European Parliament and of the Council on a framework for the issuance, 
verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID 
Certificate) to facilitate free movement during the COVID-19 pandemic’, COM(2022)753 final, 22 December 2022, 
https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX:52022DC0753.  

(234)  Article 23 of Regulation (EU) 2022/2371. 
(235)  Article 23 of Regulation (EU) 2022/2371. 
(236)  Article 20 of Regulation (EU) 2022/2371. 
(237)  Article 24 of Regulation (EU) 2022/2371. 

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Table 9. Legal effects of recognising a public health emergency at Union level. 

Measures 

Legal effects 

Measures related to medicinal 
products and medical devices in 
Regulation (EU) 2022/123 

Measures to ensure the availability 
of MCMs in Regulations (EU) 
2022/123, 2022/2371 and 
2022/2372 

Activation of the EU Health Task 
Force Enhanced Emergency 
Capacity in Regulation (EC) 
851/2004 

Activation of the IPCR 
arrangements 

Mobilisation of research funds 
under Horizon Europe  

Temporary restrictions on travel to 
the EU in line with Article 21a of 
Regulation (EU) 2016/399 

EMA activities are expanded by:  

• 
adopting the lists of critical medicines and critical medical devices; 
•  monitoring  demand  and  supply  of  critical  medicines  and  critical 

• 

• 

• 

medical devices; 
reporting on actual or potential shortages of critical medicines and 
critical  medical  devices;  recommending  measures  to  prevent  or 
mitigate  these shortages;Fully activatingof  the EMA’s Emergency 
Task  Force  (ETF)  activities,  including  free  scientific  advice  with 
shorter timelines and the possibility to use a dedicated procedure 
to 
issue  formal  opinions  on  the  use  and  distribution  of 
unauthorised medicinal products. 

Possibility for the Council to activate the emergency framework for 
ensuring  the  supply  of  crisis-relevant  MCMs  under  Regulation 
2022/2372. 
If the emergency framework is activated, the Health Crisis Board is 
established. 

facilitate 

•  Depending  on  the  emergency  framework  measures  activated, 
there is the possibility to: monitor the supply and demand of crisis-
relevant  MCMs; 
the  procurement,  purchase  or 
manufacturing  of  MCMs  and  raw  materials;  activate  emergency 
research and innovation on MCMs; monitor a production inventory 
of  relevant  MCMs,  materials,  equipment  and  infrastructure; 
ensure the availability and supply of crisis-relevant MCMs; activate 
the EU FAB facilities; and release emergency funding for MCMs 

• 

• 

Possibility  to  activate  ECDC  support  to  mobilise  and  deploy  the 
EUHTF Enhanced Emergency Capacity. 
The EUHTF can help with prevention, preparedness and response 
planning,  training,  and  responses  to  outbreaks, 
including 
operational research and after-action reviews. 

•  Activation of all EUHTF Expert Pools. 

•  Activation  of  the  IPCR  arrangements  to  ensure  political  level 
coordination  the  EU’sresponse  to  the  solidarity  clause  being 
invoked. 

•  Option  to  mobilise  Horizon  Europe  research  funds  allowing  for 

procedures tailored to a particular emergency. 

• 

Possibility for the Council to impose temporary travel restrictions, 
including measures such as testing, quarantine and self-isolation. 

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Figure 8. Process to recognise a public health emergency at Union level. 

A public health emergency at Union level is formally recognised through the adoption 
of a Commission implementing act. In urgent and severe situations, the Commission 
can  decide  that  the  implementing  act  applies  immediately  and  proceed  with  a 
Comitology Committee procedure only after the act’s adoption. 

Recognising a public health emergency at Union level is independent of the decision 
of WHO’s Director-General to determine, based on the views of the IHR Emergency 
Committee,  that  an  event  constitutes  a  Public  Health  Emergency  of  International 
Concern  (PHEIC) (238).  However,  before  recognising  a  public  health  emergency  at 

(238)  Article 12 of the IHR 2005 (amended in 2014, 2022 and 2024). 

74 

 
 
 
Union  level,  the  Commission  must  liaise  with  the  WHO  to  share  the  Commission’s 
analysis of the situation and to inform it that it intends to adopt such a decision (239). 

6.7.1.  Medicinal products and medical devices 

Once a public health emergency is recognised in the EU, the EMA Emergency Task 
Force (ETF) reviews all available data on medicines that could help tackle the situation. 
The EFT provides scientific advice to developers (including free clinical studies) and 
supports the organisation of clinical trials in the EU for the most promising medicines, 
including via discussions on protocols and interactions with the clinital trial coordination 
mechanism.  

Additionally, the ETF supports the authorisation procedures for relevant medicines and 
can  provide  scientific  recommendations  on  the  use  of  medicines  before  they  are 
authorised.  This  is  done  in  liaison  with  EMA’s  scientific  committees,  working 
parties and scientific advisory groups. The EFT also considers the best use of real-
world evidence and cooperates closely with various stakeholders and partners. The 
EMA may apply accelerated regulatory procedures to approve manufacturing changes 
that could increase the supply of critical medicines in a crisis.  

In  a  public  health  emergency  at  Union  level,  EMA’s  Executive  Steering  Group  on 
Shortages  and  Safety  of  Medicinal  Products  (MSSG)  draws  up  a  list  of  critical 
medicines  that  need  to  be  monitored  for  supply  issues.  This  monitoring  involves 
collecting demand and supply forecasts to identify any potential or actual shortages. 
The  group  also  coordinates activities  to  prevent  shortages  or mitigate  the  effects of 
such shortages. It also makes recommendations on actions to be taken at EU level to 
tackle shortages and vulnerabilities in the critical medicines supply chain and issues 
related to the quality, safety and effectiveness of critical medicines.  

To deal with shortages of medical devices, similar activities are carried out by EMA’s 
Executive Steering Group on Shortages of Medical Devices (MDSSG).  

6.7.2.  Activation  of  the  emergency  framework  for  ensuring  the 
supply of crisis-relevant medical countermeasures 

When  a  public  health  emergency  at  Union  level  is  recognised  and  if  it  is  deemed 
appropriate  given  the  economic  situation,  the  Commission  may  propose  a  draft 
proposal for a Council regulation activating the Regulation to ensure the supply of 
crisis-relevant  MCMs  (240)  (Figure  9).  The  Commission’s  proposal  can  take  into 
account advice from the relevant EU governance structures, including EU agencies. 

(239)  Article 23(3) of Regulation (EU) 2022/2371. 
(240)  Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the supply of 
crisis-relevant medical countermeasures in the event of a public health emergency at Union level (OJ L 314, 
6.12.2022, p. 64, ELI: http://data.europa.eu/eli/reg/2022/2372/oj). 

75 

 
 
Figure  9.  Process  to  activate  the  emergency  framework  for  ensuring  the  supply  of 
crisis-relevant MCMs. 

The adoption of a Council regulation activating the emergency framework requires an 
assessment of the economic situation and the economic implications of the measures 
to be adopted. This assessment outlines how the public health emergency at  Union 
level  is  likely  to  affect  the  economy,  and  how  the  proposed  measures  can  alleviate 
those effects.  

76 

 
 
 
If the emergency framework is activated, the Health Crisis Board will be established 
(Figure 9). The Health Crisis Board coordinates efforts by the Council, the Commission, 
the relevant EU bodies, offices and agencies and Member States to ensure the supply 
of and access to crisis-relevant MCMs.  

The  Health  Crisis  Board  is  co-chaired  by  the  Commission  and  the  Member  State 
holding the rotating presidency of the Council. It is composed of the Commission and 
one  representative  from  each  Member  State.  The  Health  Crisis  Board  will  invite  an 
HSC  Member  State  representative,  the  European  Parliament,  the  relevant  EU 
institutions,  bodies  or agencies  (e.g.  the  EMA  and  the  ECDC)  and  a  representative 
from  the  ACPHE  as  observers.  To  improve  coordination  and  information  exchange, 
the Health Crisis Board co-chairs may invite experts with specific expertise to take part 
as  observers  in meetings  of  the  Health  Crisis Board  or its  subgroups  on an  ad  hoc 
basis,  based  on  the  agenda.  The  Health  Crisis  Board  ensures  coordination  and 
information  exchange  with  the  IPCR,  the  HSC  and  the  Emergency  Response 
Coordination Centre (ERCC). 

Additional measures under the emergency framework for MCMs can be activated at 
any time through the same procedure as the framework’s activation. The activation of 
the emergency framework for MCMs can be extended for up to six months. To do so, 
the Commission must submit a report to the Council, analysing, in particular, the public 
health situation, the economic consequences of the emergency in the EU as a whole 
and in Member States, and the impact of the measures already put in place. The report 
must be submitted no later at least three weeks before the date on which the activation 
of  the  framework  is  set  to  expire.  The  Council  can,  upon  a  proposal  from  the 
Commission, decide to prolong the activation of the emergency framework if deemed 
necessary  given  the  economic  situation  and  the  need  to  ensure  a  high  level  of 
protection of human health. 

The  emergency  framework  for  MCMs  is  deactivated  either  when  the  Council 
Regulation activating the framework expires or when the recognition of a public health 
emergency at Union level is ended. 

Depending  on  which  measures  of  the  emergency  framework  are  activated,  various 
outcomes are possible. These include strengthening coordination of MCMs, improving 
monitoring of MCMs and potentially increasing reporting requirements for those in the 
supply chain (Table 10). 

77 

 
Table 10. Measures of the  emergency framework for ensuring the supply of crisis-relevant MCMs in line 
with Regulation (EU) 2022/2372 

Emergency framework measure 

Legal effects 

Monitoring 
MCMs (Article 7) 

crisis-relevant 

• 

Procurement, 
and 
manufacturing of crisis-relevant MCMs 
and raw materials (Article 8) 

purchase 

innovation 
Emergency  research  and 
aspects  of 
the  preparedness  and 
response  plans  and  the  use  of  clinical 
trial 
data-sharing 
platforms (Article 9) 

networks 

and 

Inventory  of 
crisis-relevant  MCM 
production  and  production  facilities 
(Article 10) 

Inventory of crisis-relevant raw 
materials, consumables, medical 
devices, equipment, and infrastructure 
(Article 11) 

Measures to ensure the availability and 
supply of crisis-relevant MCMs (Article 
12) 

Emergency funding (Article 13) 

• 

• 

• 
• 

• 

• 

• 

• 
• 

• 

• 

• 

• 

The Commission adops an implementing act setting out a list of 
crisis-relevant  MCMs  and  raw  materials  and  a  template  for 
monitoring their supply and demand.  
The Commission gathers additional information on the supply 
and demand of crisis-relevant MCMs and raw materials. 

The  Commission,  with  advice  from  the  Health  Crisis  Board, 
proposes  an  appropriate  mechanism  to  purchase  crisis-
relevant MCMs and raw materials. 
The Commission leads the procurement process. 
Participating  Member  States  negotiate 
the  purchasing 
agreements  (opt-out  mechanism,  simplified  procedures,  EU-
FAB activation). 

The  Commission  and  Member  States  activate  the  emergency 
research and innovation aspects of the Union plan related  to 
MCMs. 
To set up clinical trials, the Commission involves the Emergency 
Task  Force,  the  Clinical  Trial  Coordination  Mechanism,  the 
European  partnership  on  pandemic  preparedness  and  its 
research networks and the ECDC. 

The  Commission  adopts  an  implementing  act  drawing  up  an 
inventory and template for monitoring the production capacity 
and stocks of MCMs. 
Producers inform the Commission about production capacity. 
The  Commission  informs  Parliament  and  the  Council  about 
production capacity in EU and in non-EU countries. 

 The  Commission  adopts  an  implementing  act  to  extend  the 
inventory  and  template  provided  for  in  Article  10  to  crisis-
relevant  raw  materials,  consumables,  medical  devices, 
equipment and infrastructure. 

The Commission decides on the reorganisation of supply chains 
and production lines and the use of existing stocks. 
financial 
The  Commission  provides 
mechanisms, if feasible. 

incentive 

timely 

The ESI is activated to finance the required spending to manage 
the public health emergency. 

EU-FAB=Network of ever-warm production capacities for vaccines and therapeutics manufacturing facilities. 

6.7.3.  Global and EU support for national healthcare systems  

In response to local outbreaks of communicable diseases, the  EUHTF, managed by 
the ECDC, supports Member States and non-EU countries. Support can include field 
epidemiology,  data  management,  operational  research  support,  infection  prevention 

78 

 
 
and control and logistics expertise (241). In a public health emergency at Union level, 
the  Commission,  along  with  at  least  two  Member  States,  can  mobilise  the  EUHTF 
Enhanced Emergency Capacity. This brings the coordination of the EUHTF under 
the  ECDC  and  the  Commission’s  control  in  order  to  assist  the  HSC(242).  The 
mobilisation of the EUHTF can be funded by the EU depending on the situation. 

The emergency medical teams (EMTs) are a reserve of response teams provided by 
Member States as part of the European Civil Protection Pool (ECPP), which enable 
mutual assistance under the UCPM. The EMTs include modules classified on the basis 
of WHO standards such as specialised care teams. 

In  addition  to  the EMTs under the  ECPP,  the  rescEU EMT  serves  as  the  first pan-
European field hospital under the UCPM. It consists of three emergency medical team 
type 2 (EMT2-type) units and 18 specialised care teams. These teams cover a wide 
range of services, including intensive care, burn treatment, patient transport, advanced 
diagnostics,  mother  and  child  support,  rehabilitation,  mental  health  support, 
orthopaedic  treatment,  laboratory  services,  oxygen  supply,  telecommunications 
support, and dialysis. The modular structure of the rescEU EMT makes it flexibile in 
response to the different needs of local healthcare facilities.  

The Global Health Emergency Corps (GHEC) coordinated by the WHO is a framework 
for increasing health emergency workforce capacity in health emergency prevention, 
preparedness, response and resilience work and a collaborative platform for countries 
and  health  emergency  networks.  The  GHEC  framework  includes  several  initiatives 
such as the Global Outbreak Alert and Response Network (GOARN) (243). On request, 
the GOARN can deploy staff and resources to support affected countries in preventing 
and controlling infectious disease outbreaks and public health emergencies. Several 
universities, research institutes and public health agencies in Member States and the 
ECDC are partners of the GOARN (244). 

(241)  Article 11a of Regulation (EC) No 851/2004. 
(242)  Commission Implementing Regulation (EU) 2025/1536 of 29 July 2025 setting out the procedure concerning the 
mobilisation of the enhanced emergency capacity of the EU Health Task Force (OJ L 2025/1536, 30.7.2025, ELI: 
http://data.europa.eu/eli/reg_impl/2025/1536/oj).  

(243)  WHO, ‘Global Health Emergency Corps’, WHO website, accessed 3 November 2025, 

https://www.who.int/emergencies/partners/global-health-emergency-corps.  

(244)  Global outbreak alert and response network (GOARN), accessed 3 November 2025, https://goarn.who.int/. 

79 

 
 
7.  PHASE 4: Recovering and learning lessons 

Recovering  from  health  crises  is  essential  for  restoring  health,  livelihoods,  the 
economy,  the  physical,  social  and  cultural  environments  and  assets  of  disaster-
affected communities. Effective recovery helps avoid or minimise the impact of future 
crises and it is an integral part of health system resilience.  

De-escalation  of  the  EU  health  crisis  response  occurs  when  crisis  mechanisms  or 
structures  are  no  longer  considered  necessary  and  proportionate  for  effective 
management  and  protection  of  public  health.  If  a  public  health  emergency  at  Union 
level was recognised, the de-escalation process would begin as soon as the serious 
cross-border threat  to health no longer endangers public health at  EU level and the 
activated measures are no longer required. After considering any expert opinion from 
EU agencies or bodies or the ACPHE, the Commission can adopt an implementing act 
that ends the recognition of the public health emergency.  

The  Council  decision  on  activating  the  emergency  framework  regulation  on  MCMs 
expires  after  the  defined  timeframe  for  its  activation  unless  it  is  prolonged.  If  the 
Commission  ends  the  public  health  emergency  at  Union  level,  the  emergency 
framework  is  also  deactivated.  The  Council  can  decide  to  de-escalate  the  IPCR 
arrangements to monitoring mode or deactivate them, if they are no longer deemed 
necessary.  

The UCPM is deactivated when there is no longer need for assistance regarding the 
specific event. The UCPM is deactivated when there is no longer a need for assistance 
related  to  the  specific  event.  To  follow-up,  the  Commission  draws,  manages  and 
disseminates lessons and best practices from UCPM activations through the Lessons 
Learnt Programme within the Union Civil Protection Knowledge Network (245). 

In-action and after-action reviews or evaluations can be conducted to capture lessons 
learned from real-life response to health crises. At EU level, the Commission conducts 
in-action and after-action reviews to revise the current Union plan based on the lessons 
learned (246). Findings from in-action and after-action reviews can also lead to changes 
in  response  strategies  and  legal  frameworks.  Moreover,  the  Commission  regularly 
evaluates  Regulation  (EU)  2022/2371  on  serious  cross-border  threats  and,  on  the 
basis of the findings, can adopt proposals to improve the EU legal framework. 

After-action reviews or evaluations also play a crucial rule in informing the public on 
the  effectiveness  and  impact  of  the  crisis  response.  This  process  improves 
accountability and transparency and results in increased trust. To evaluate the EU’s 
crisis response and recovery policy, the Commission can ask for the scientific advice 
of the Scientific Advise Mechanism (SAM) during or after a crisis (247). Moreover, the 

(245)  Article 13(1)(b) of Decision No 1313/2013/EU. 
(246)  Article 5(5) of Regulation (EU) 2022/2371. 
(247)  Scientific Advice Mechanism to the European Commission, ‘Strategic crisis management in the EU’, SAM website, 

accessed 3 November 2025, https://scientificadvice.eu/advice/strategic-crisis-management-in-the-eu/. 

80 

 
 
 
European  Court  of  Auditors is responsible  for evaluating  how the EU uses  its  funds 
and implements its policies, including in a crisis (248). 

Example of cross-border interregional collaboration: after-action study to assess cross-border cooperation 
at the Belgian-Dutch-German border 

Since its creation in 1976, the Meuse-Rhine Euroregion has built on long-term cross-border cooperation to 
develop integrated public healthcare schemes, including hospitals and ambulance services (EMRIC: Euregio 
Meuse-Rhine Incident control and Crisis management). After the COVID-19 pandemic, the region supported 
the  PANDEMRIC  study  to  examine  the  benefits  of  regional  cooperation  in  a  pandemic  or  the  large-scale 
outbreak of an infectious disease. Detailed analysis of obstacles to cross-border cooperation on ambulance 
and intensive care transport was provided and concrete recommendations to tackle the main challenges were 
made. 

Simulation exercises test joint arrangements for governance, capacities and resources 
using  hypothetical  scenarios.  The  Commission  is  responsible  for  facilitating  these 
exercises, most notably, to ensure the implementation of the current Union plan with 
the  first  exercise  scheduled  for  2026  (249).  These  exercises  aim  to  assess  how 
effectively the Union plan helps to coordinate responses to cross-border health threats 
in the EU/EEA. In addition to testing the joint arrangements, the exercises will test and 
assess  the  implementation  of  the  One  Health,  whole-of-government  and  whole-of-
society approaches, along with the cross-border interregional preparedness elements 
of the Union plan. Based on the lessons learned from these exercises, the Commission 
reviews the Union plan and amend it as required. 

(248)  European Court of Auditors, The EU’s response to the COVID-19 pandemic – The EU medical agencies generally 
managed well in unprecedented circumstances, Special report 12/24, Publications Office of the European Union, 
Luxembourg, 2024, https://www.eca.europa.eu/en/publications/SR-2024-12.  

(249)  Article 5(5) of Regulation (EU) 2022/2371. 

81 

 
 
 
ANNEXES 

ANNEX 1: Glossary 

Term 

Definition 

All-hazards approach 

Biosafety 

Biosecurity 

Civil protection 

Collaborative 
surveillance 

Contact tracing 

A  comprehensive  approach  to  preparedness  and  response  planning  that 
addresses a wide range of potential emergencies and disasters, where different 
hazards  (outbreaks,  cyberattacks,  extreme  weather  events,  etc.)  could  be 
managed by similar responses from the health system (250). 

The  principles,  practices,  and  containment  measures  implemented  to  prevent 
unintentional  exposure  to,  or  release  of,  biological  agents  and  toxins  that  may 
pose risks to human health, agriculture, animals, or the environment (251). 

The  policies,  practices  and  measures  implemented  to  prevent  the  loss,  theft, 
misuse,  diversion,  release  or  even  weaponisation  of  biological  materials, 
technology  or  equipment,  as  well  as  methods,  skills  and  data  related  to  their 
handling  that  may  pose  risks  to  human  health,  agriculture,  animals,  or  the 
environment (252). 

Protection of people, the environment and property against all kinds of natural 
and  human-induced  disasters.  Along  with  the  deployment  of  forces  and 
equipment  in  response  to  an  emergency,  it  also  involves  the  planning  and 
preparation  for  such  events.  This  includes  carrying  out  risk  assessments  and 
developing protection and rescue plans and procedures (253). 

The  systematic  strengthening  of  capacity  and  collaboration  among  diverse 
stakeholders, both within and beyond the health sector, with the ultimate goal of 
enhancing  public  health  intelligence  and  improving  the  evidence  base  for 
decision-making (254). 

Measures  to  identify  persons  who  have  been  exposed  to a  source  of  a  serious 
cross-border health threat, who are at risk of infection, being infectious, or having 
developed  a  communicable  disease.  This  identification  is  carried  out  through 
manual  or  technological  means,  with  the  sole  objective  of  rapidly  identifying 
potentially newly infected persons, who may have come into contact with existing 
cases, in order to reduce further onward transmission (255). 

(250)  ECDC, Recommendations for preparedness planning for public health threats, Stockholm, 2025, 

https://www.ecdc.europa.eu/sites/default/files/documents/recommendations-preparedness-planning-public-health-
threats.pdf. 

(251)  WHO, Laboratory biosecurity guidance, Geneva, 2024, Licence: CC BY-NC-SA 3.0 IGO, 

https://iris.who.int/bitstream/handle/10665/377754/9789240095113-eng.pdf?sequence=1.   

(252)  WHO, Laboratory biosecurity guidance, Geneva, 2024, Licence: CC BY-NC-SA 3.0 IGO, 

https://iris.who.int/bitstream/handle/10665/377754/9789240095113-eng.pdf?sequence=1.   

(253)  Access to European Union Law; see EUR-Lex, ‘Civil Protection’, accessed 3 November 2025, https://eur-

lex.europa.eu/EN/legal-content/glossary/civil-protection.html  

(254)  WHO, Defining collaborative surveillance: a core concept for strengthening the global architecture for health 
emergency preparedness, response, and resilience (HEPR), Geneva, 2023, Licence: CC BY-NC-SA 3.0 IGO, 
https://www.who.int/publications/i/item/9789240074064. .  

(255)  Article 3(4) of Regulation (EU) 2022/2371. 

82 

 
 
Crisis 

Early warning 

A serious, unexpected and often dangerous situation having such a wide-ranging 
impact  or  political  significance,  that  it  requires  timely  policy  coordination  and 
response  at  Union  level.  The situation  may  affect  or  threaten  human  lives,  the 
environment,  critical  infrastructure  or  core  societal  functions  and  it  may  be 
caused by natural or man-made disasters (256).  

The timely and effective provision of information that allows action to be taken to 
avoid  or  reduce  risks  and  the  adverse  impacts  of  a  crisis,  and  to  facilitate 
preparedness for an effective response (257). 

Early warning system 

A  system  for  the  identification  of  potential  threats  and  crises,  mainly  through 
notifications, forecasts and alerts (258). 

Event-based surveillance 

The  organised  collection,  monitoring,  assessment  and  interpretation  of  mainly 
unstructured  ad  hoc  information  regarding  health  events  or  risks,  which  may 
represent an acute risk to human health. (259). 

Food-borne outbreak 

An incidence of two or more human cases of the same disease and/or infection, 
where the cases are linked, or are probably linked, to the same food source (260). 

Hazard 

Health crisis 

Health system 

Anything  that  has  the  potential  to  cause  harm  to  humans,  animals,  the 
environment or property. The existence of a hazard does not necessarily mean it 
poses a threat (for example, a zoonotic pathogen is a hazard because it has the 
potential  to  cause  disease  in  humans,  but  it  is  not  necessarily  a  threat  unless 
people are exposed to it and transmission occurs) (261). 

A crisis or serious incident resulting from threats of various origins, including those 
related to humans, animals, plants, food, biological, chemical, environmental or 
unknown sources, which impacts public health and requires urgent action by the 
authorities (262). 

Consists of all the organisations, institutions, resources and people whose primary 
purpose is to improve health (263). The Union plan does not differentiate between 
a health system, a public health system or a system for healthcare services. 

(256)  ECDC, HEPSA – health emergency preparedness self-assessment too: User guide, Stockholm, 2018, 

https://www.ecdc.europa.eu/sites/default/files/documents/Technical-Doc-HEPSA-tool-update-dec-18.pdf. 

(257)  Article 4(5) of Decision No 1313/2013/EU. 
(258)  ECDC, HEPSA – health emergency preparedness self-assessment too: User guide, Stockholm, 2018, 

https://www.ecdc.europa.eu/sites/default/files/documents/Technical-Doc-HEPSA-tool-update-dec-18.pdf. 

(259)  WHO, Early detection, assessment and response to acute public health events: Implementation of early warning and 
response with a focus on event-based surveillance, Geneva, 2014, https://www.who.int/publications/i/item/WHO-HSE-
GCR-LYO-2014.4.   

(260)  Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of 

zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC 
(OJ L 325, 12.12.2003, p. 31, ELI: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32003L0099).  

(261)  ECDC, Recommendations for preparedness planning for public health threats, Stockholm, 2025, 

https://www.ecdc.europa.eu/sites/default/files/documents/recommendations-preparedness-planning-public-health-
threats.pdf. 

(262)  Article 2(3) of Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 

establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021-
2027, and repealing Regulation (EU) No 282/2014 (OJ L 107, 26.3.2021, p. 1, ELI: 
http://data.europa.eu/eli/reg/2021/522/oj). 

(263)  WHO, Monitoring the building blocks of health systems: a handbook of indicators and their measurement strategies, 

WHO Document Production Services, Geneva, 2010, ISBN 978 92 4 156405 2, 
https://iris.who.int/handle/10665/258734. 

83 

 
 
Incident 

Indicator-based 
surveillance 

Integrated surveillance 

Medical 
countermeasures 
(MCMs) 

One Health 

An event which has the potential to significantly disrupt, or actually disrupts, the 
provision of essential services, including national systems safeguarding the rule of 
law (264). Additionally, the detection of biological, chemical or physical hazards in 
food, feed or humans which might result in or indicate a possible public health 
risk. This occurs when more than one person is exposed to the same hazard, or 
when the number of human cases or hazard detections exceeds expectations, and 
where cases are (probably) linked to the same food or feed source (265). 

The  objective-driven,  regular,  and  systematic  reporting,  collection,  monitoring, 
analysis and interpretation of structured data on communicable disease cases and 
pathogen isolates (266). 

A  strategy  that  combines  and  coordinates  different  surveillance  activities  to 
improve disease detection, prevention, and response, often by linking data and 
systems across various sources and levels of a health system.  

Medicinal  products  and  devices  for  human  use,  and  other  essential  goods  and 
services, that are necessary for preparing and responding to serious cross-border 
health threat (267). 

A multi-sectoral approach which recognises the interconnected nature of human 
health, animal health, and the environment, and that effective actions to tackle 
threats to health must consider all three dimensions (268). 

Passenger Locator Form 
(PLF) 

A secure form, completed at the request of public health authorities, that collects 
passengers’ data to assist these authorities in managing a public health events by 
facilitating the tracing of passengers crossing borders (269). 

Public health measure 

A decision or action aimed at preventing, monitoring or controlling the spread of 
diseases  or  contamination  in  order  to  combat  severe  risks  to  public  health  or 
mitigate their impacts (270). 

Public health risk  

The occurrence of a hazard that can pose a risk to human health (271). 

Recovery 

The  medium-  and  long-term  rebuilding  and  sustainable  restoration  of  critical 
infrastructure,  services,  housing,  facilities  and  livelihoods,  required  for  the  full 
functioning of a community or society affected by a disaster. These efforts should 
align with the principles of sustainable development and the “build back better” 
approach to make these more resilient and reduce future disaster risks (272). 

(264)  Article 2(3) of Directive (EU) 2022/2557 of the European Parliament and of the Council of 14 December 2022 on the 

resilience of critical entities and repealing Council Directive 2008/114/EC (OJ L 333, 27.12.2022, p. 164, ELI: 
http://data.europa.eu/eli/dir/2022/2557/oj). 

(265)  Commission Implementing Decision (EU) 2019/300 of 19 February 2019 establishing a general plan for crisis 

management in the field of the safety of food and feed (OJ L 50, 21.2.2019, p. 55, ELI: https://eur-
lex.europa.eu/eli/dec_impl/2019/300/oj). 

(266)   ECDC, Recommendations for preparedness planning for public health threats, Stockholm, 2025, 

https://www.ecdc.europa.eu/sites/default/files/documents/recommendations-preparedness-planning-public-health-
threats.pdf. 

(267)  Article 3(10) of Regulation (EU) 2022/2371. 
(268)  Article 3(7) of Regulation (EU) 2022/2371. 
(269)  Article 1a “Definitions” of Commission Implementing Decision (EU) 2021/858 of 27 May 2021 amending 

Implementing Decision (EU) 2017/253 as regards alerts triggered by serious cross-border threats to health and for 
the contact tracing of passengers identified through Passenger Locator Forms (OJ L 188, 28.5.2021, p. 106, ELI: 
http://data.europa.eu/eli/dec_impl/2021/858/oj). 

(270)  Article 3(9) of Regulation (EU) 2022/2371. 
(271)  ECDC, Recommendations for preparedness planning for public health threats, Stockholm, 2025, 

https://www.ecdc.europa.eu/sites/default/files/documents/recommendations-preparedness-planning-public-health-
threats.pdf. 

(272)  UN General Assembly, ‘Report of the open-ended intergovernmental expert working group on indicators and 

terminology relating to disaster risk reduction’, 1 December 2016,  
https://www.preventionweb.net/files/50683_oiewgreportenglish.pdf?startDownload=true.  

84 

 
 
Resilience 

Risk 

The ability of a system to absorb, adapt and recover from disruptions. It involves 
the capacity to withstand shocks, maintain essential functions during crises and 
recover to a state of normal functioning in an efficient manner (273). 

The  likelihood  of  an  adverse  event  occurring  and  the  associated  negative 
consequences  (274).  It  encompasses  the  potential  for  loss  or  disruption  and  is 
evaluated as a combination of the magnitude of such loss or disruption and the 
likelihood of the incident taking place (275). 

Risk assessment 

The overall process of identifying, analysing and evaluating risks (276). 

Risk analysis 

The process of understanding the nature, and determining the level, of risks (277). 

Risk identification 

The process of finding, recognising and describing risks (278). 

Serious cross-border 
threat to health  

Simulation exercise 

Situational awareness 

Solidarity 

Surveillance 

A  life-threatening  or  otherwise  serious  health  hazard  of  biological,  chemical, 
environmental  or  unknown  origin,  that  spreads  or  poses  a  significant  risk  of 
spreading  across  the  national  borders  of  Member  States,  and  which  may 
necessitate coordination at Union level to ensure a  high  level of human health 
protection (279). 

A training activity that recreates real-life scenarios to help develop, assess, and 
test  the  functional  capabilities  of  emergency  systems,  procedures  and 
mechanisms to respond to outbreaks and public health emergencies (280).  

The continuous process of collecting, analysing, and sharing reliable information 
to  provide  decision-makers  with  a  clear  and  unified  common  picture  of  the 
situation (281). 

The principle enshrined in the Treaty on the Functioning of the European Union 
which  requires  Member  States  to  offer  help  when  another  Member  State  is 
affected by a crisis and requests assistance (282). When a crisis has cross-border 
impacts, the EU’s role is to ensure efficient coordination of measures and facilitate 
collaboration to foster an effective crisis response. 

The systematic ongoing collection, collation and analysis of data for public health 
purposes,  along  with  the  timely  dissemination  of  public  health  information  to 
facilitate  the  assessment  of  needs  and  to  guide  effective  public  health 
responses (283). 

(273)  ECDC, Recommendations for preparedness planning for public health threats, Stockholm, 2025, 

https://www.ecdc.europa.eu/sites/default/files/documents/recommendations-preparedness-planning-public-health-
threats.pdf. 

(274)  ECDC, Recommendations for preparedness planning for public health threats, Stockholm, 2025, 

https://www.ecdc.europa.eu/sites/default/files/documents/recommendations-preparedness-planning-public-health-
threats.pdf. 

(275)  Article 2(6) of the Directive (EU) 2022/2557 of the European Parliament and of the Council of 14 December 2022 on 
the resilience of critical entities and repealing Council Directive 2008/114/EC (OJ L 333, 27.12.2022, p. 164, ELI: 
http://data.europa.eu/eli/dir/2022/2557/oj). 

(276)  ECDC, Recommendations for preparedness planning for public health threats, Stockholm, 2025, 

https://www.ecdc.europa.eu/sites/default/files/documents/recommendations-preparedness-planning-public-health-
threats.pdf. 

(277)  ISO 31073:2022(en) Risk management — Vocabulary. 
(278)  ISO 31073:2022(en) Risk management — Vocabulary. 
(279)  Article 2 and 3 of Regulation (EU) 2022/2371. 
(280)  WHO, WHO Simulation Exercise Manual, Geneva, 2017, License: CC BY-NC-SA 3.0 IGO, 

https://iris.who.int/server/api/core/bitstreams/b7f2aa99-15c1-4e95-a0d6-c1006db0493f/content.   

(281)  Access to European Union Law; see EUR-Lex, ‘Integrated political crisis response (IPCR)’, EUR-Lex website, accessed 3 
November 2025, https://eur-lex.europa.eu/EN/legal-content/glossary/integrated-political-crisis-response-ipcr.html.  

(282)  Article 222 of the TFEU. 
(283)  Article 1 of the IHR 2005 (amended in 2014, 2022 and 2024). 

85 

 
 
Syndromic surveillance 

Threat assessment 

Vulnerability 

Whole-of-government 
approach 

Whole-of-society 
approach 

The  public  health  monitoring  method  that  collects  and  analyses  health-related 
data in real-time relying on clinical observations rather than laboratory-confirmed 
diagnoses (284). 

The  overall  cross-sectoral  process  of  identifying,  analysing  and  evaluating  the 
origin and magnitude of an emerging threat and its associated risks (285). 

The characteristics and circumstances of a community, system or asset that make 
it susceptible to the damaging effects of a crisis (286). 

The  whole-of-government  approach  that  brings  together  all  relevant  sectors 
across  all  levels  of  administration  spanning  local,  regional,  national,  EU  and 
international levels to ensure effective prevention, preparedness and response to 
health crises. While it promotes multisectoral and multidisciplinary collaboration, 
policy  coherence  and  sharing  of  resources,  it  also  aims  to  comprehensively 
address  the  interactions  and  cascading  effects  of  risks  and  threats  (287).  In  this 
vein, civil-military cooperation is vital for strengthening prevention, preparedness 
and response to health crises, and it is therefore included among the key sectors 
considered in the Union plan (288). 

The whole-of-society approach fosters an inclusive culture of preparedness and 
resilience (289). It acknowledges and promotes the full and effective contributions 
of  all  relevant  stakeholders  to  risk  prevention  and  the  management  of 
emergencies.  Such  stakeholders  include  individuals,  families  and  communities, 
governments, intergovernmental organisations, the private sector and industry, 
faith  groups,  civil  society,  the  media,  academia,  research  organisations  and 
voluntary associations. Whole-of-society action is essential for achieving national 
unity  and  global  solidarity  in  managing  the  risks  and  impacts  of  all  types  of 
emergencies,  overall  health  security,  and  the  resilience  of  communities  and 
countries (290).  

Zoonoses / Zoonotic 
diseases 

Diseases and/or infections that can be transmitted directly or indirectly between 
animals and humans (291).  

(284)  WHO, WHO guidance on research methods for health emergency and disaster risk management, Geneva, revised 
2022, Licence: CC BY-NC-SA 3.0 IGO, https://wkc.who.int/our-work/health-emergencies/research-methods/sections-
and-chapters. 

(285)  European Commission, ‘Risk assessment’, European Commission website, accessed 3 November 2025, 

https://health.ec.europa.eu/health-security-and-infectious-diseases/risk-assessment_en.  

(286)  ECDC, HEPSA – health emergency preparedness self-assessment too: User guide, Stockholm, 2018, 

https://www.ecdc.europa.eu/sites/default/files/documents/Technical-Doc-HEPSA-tool-update-dec-18.pdf. 
(287)  European Commission, ‘EU preparedness union strategy’, European Commission website, accessed 3 November 

2025, https://commission.europa.eu/topics/preparedness_en. 

(288)  WHO, National civil-military health collaboration framework for strengthening health emergency preparedness: WHO 
guidance document, Geneva, 2021, License: CC BY-NC-SA 3.0 IGO, https://iris.who.int/handle/10665/343571.  

(289)  European Commission, ‘EU preparedness union strategy’, European Commission website, accessed 3 November 

2025, https://commission.europa.eu/topics/preparedness_en. 

(290)  WHO, Everyone’s business: Whole-of-society action to manage health risks and reduce socioeconomic impacts of 

emergencies and disasters, Geneva, 2020, ISBN 978-92-4-001508-1, 
https://www.who.int/publications/i/item/9789240015081. 

(291)  Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of 

zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC 
(OJ L 325, 12.12.2003, p. 31, ELI: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32003L0099).   

86 

 
 
ANNEX 2: Relevant international agreements and legislation 

The  following  table  provides  an  overview  of  relevant  agreements  and  legislation  in 
place  at  international  and  EU  levels  to  prevent,  prepare  for  and  respond  to  serious 
cross-border threats to health. The list should not be viewed as exhaustive, and the 
overviews  are  not  meant  to  be  comprehensive.  Neither do  they  provide  a  complete 
overview of the contents of the legislations included in the table. Instead, they offer a 
summary of the elements of the listed agreements and legislation that are relevant to 
the Union plan. 

Table  11.  Key  legislation  in  place  at  EU  and  international  levels  to  prevent,  prepare  for  and  respond  to 
serious cross-border threats to health. 

Name of the legal act/treaty 

Description 

Regulation (EU) 2022/2371 of the  European 
Parliament  and  of  the  Council  on  serious 
cross-border threats to health 

Regulation  (EU)  2022/123  of  the  European 
Parliament and of the Council on a reinforced 
role  for  the  European  Medicines  Agency  in 
crisis  preparedness  and  management  for 
medicinal products and medical devices 

Regulation  (EC)  No  851/2004  establishing  a 
European centre for disease prevention and 
control  (as  amended  by  Regulation  (EU) 
2022/2370) 

Council  Regulation  (EU)  2022/2372  on  a 
framework  of  measures  for  ensuring  the 
medical 
supply 
countermeasures  in  the  event  of  a  public 
health emergency at Union level 

crisis-relevant 

of 

Regulation  (EU)  2016/425  of  the  European 
Parliament  and  of  the  Council  on  personal 
protective equipment and repealing Council 
Directive 89/686/EEC 

The  Regulation  reinforces  prevention,  preparedness  and 
response  planning  and  capacities  for  serious  cross-border 
health  threats  of  biological,  chemical,  environmental  or 
unknown  origin.  It  establishes  the  HSC  and  defines  its  role 
across the entire health crisis management cycle. It contains 
provisions  on  joint  procurement  of  MCMs,  lays  down  a 
framework  for  advanced  integrated  surveillance  in  the  EU, 
and  defines  the  EU  procedure  for  early  warning  of  events, 
public health risk assessments and the declaration of a public 
health emergency. 

The  Regulation  defines  the  European  Medicines  Agency’s 
(EMA)  role in  preparing for and responding to  public health 
threats.  It  includes  provisions  for  the  EMA  to  monitor  and 
report  on  the  availability  of  medicines  and  medical  devices, 
and offer guidelines and expert support related to the use of 
medicines. 

The Regulation lays down the responsibilities of the European 
Centre  for  Disease  Prevention  and  Control  (ECDC),  covering 
communicable  disease  prevention  and  preparedness 
planning,  and  risk  assessment  and  support  during  crisis 
response.  The  Regulation  also  specifies  Member  States’ 
reporting and notification obligations to the ECDC. 

The Regulation lays down provisions on the activation of the 
emergency  framework,  the  establishment  of  a  Health  Crisis 
Board,  monitoring  and  safeguarding  the  supply  of  crisis-
relevant  MCMs  as  well  as  emergency  financial  support 
provided by the Union in the event of a public health threat. 

The  Regulation  lays  down  requirements  for  the  design  and 
manufacture of personal protective equipment placed on the 
Union market. 

87 

 
Regulation (EU) 2023/1322 of the European 
Parliament  and  of  the  Council  on  the 
European  Union  Drugs  Agency  (EUDA)  and 
repealing Regulation (EC) No 1920/2006 

and  of 

Regulation  (EU)  2016/429  of  the  European 
Parliament 
the  Council  on 
transmissible animal diseases and amending 
and  repealing  certain  acts  in  the  area  of 
animal health (‘Animal Health Law’) 

Regulation  (EU)  2017/745  of  the  European 
Parliament  and  of  the  Council  on  medical 
devices,  amending  Directive  2001/83/EC, 
Regulation (EC) No 178/2002 and Regulation 
(EC)  No  1223/2009  and  repealing  Council 
Directives 90/385/EEC and 93/42/EEC 

Regulation  (EU)  2017/746  of  the  European 
Parliament  and  of  the  Council  on  in-vitro 
diagnostic  medical  devices  and  repealing 
Directive 98/79/EC and Commission Decision 
2010/227/EU 

Regulation  (EU)  2016/399  of  the  European 
Parliament  and  of  the  Council  on  the  rules 
governing  the  movement  of  persons  across 
borders (Schengen Borders Code). 

(EU)  No  528/2012  of 

Regulation 
the 
European  Parliament  and  of  the  Council 
concerning  the  making  available  on  the 
market and use of biocidal products 

Directive  (EU)  2022/2557  of  the  European 
Parliament  and  of  the  Council  of  14 
December  2022  on  the  resilience  of  critical 
entities  and  repealing  Council  Directive 
2008/114/EC (CER Directive) 

The Regulation establishes the European Union Drugs Agency 
and lays down its general tasks in relation to drugs, drug use, 
drug  use  disorders  and  addictions,  prevention,  treatment, 
care, 
rehabilitation,  social 
reduction, 
reintegration,  recovery,  drug  markets  and  supply,  including 
illicit  production  and  trafficking,  and  other  relevant  drug-
related issues.  

risk  and  harm 

The  Regulation  lays  down  rules  and  measures  for  the 
prevention  and  control  of  animal  diseases  transmitted 
between  animals  or  between  animals  and  humans  in  the 
Member States. 

The Regulation lays down rules for the placing on the market, 
making available on the market or putting into service in the 
European Union of medical devices for human use and their 
accessories.  The  Regulation  also  applies  to  clinical  trials  of 
such medical devices and their accessories. 

The Regulation lays down rules for the placing on the market, 
making available on the market or putting into service in the 
European Union of medical devices for human use intended 
for in-vitro diagnostics and their accessories. It also applies to 
performance  studies  on  in-vitro  diagnostic  medical  devices 
and their accessories. 

Under  this  Regulation,  persons  crossing  internal  borders 
between  Member  States  are,  in  principle,  not  subject  to 
border controls. Among other things, it contains provisions on 
border  control  of  persons  crossing  the  external  borders  of 
Member  States,  entry  conditions  and  the  temporary 
reintroduction of border control at internal borders. 

The  Regulation  improves  the  functioning  of  the  internal 
market  through  the  harmonisation  of  rules  on  the  making 
available  on  the  market  and  use  of  biocidal  products,  while 
ensuring a high level of protection of both human and animal 
health and the environment. 

The CER Directive lays down obligations for Member States to 
take specific measures to ensure the provision of vital services 
for maintaining critical societal and economic activities in the 
internal  market.  The  Member  States  must  adopt  national 
resilience strategies, carry out risk assessments, identify their 
critical  entities  in  11  sectors  and  enable  them  to  fulfil  their 
obligations under the Directive. The Directive also lays down 
rules on the supervision of critical entities.  

88 

 
Directive  (EU)  2022/2555  of  the  European 
Parliament  and  of  the  Council  of  14 
December  2022  on  measures  for  a  high 
common  level  of  cybersecurity  across  the 
(EU)  No 
Union,  amending  Regulation 
910/2014 and Directive (EU) 2018/1972, and 
repealing  Directive  (EU)  2016/1148  (NIS  2 
Directive) 

Decision No 1313/2013/EU of the European 
Parliament  and  of  the  Council  of  17 
December  2013  on  a  Union  Civil  Protection 
Mechanism 

Regulation (EU) 2024/2747 of the European 
Parliament  and  of  the  Council  of  9  October 
2024  establishing  a  framework  of  measures 
related to an internal market emergency and 
to  the  resilience  of  the  internal  market  and 
amending  Council  Regulation 
(EC)  No 
2679/98  (Internal  Market  Emergency  and 
Resilience Act) 

Regulation  (EU)  2025/327  of  the  European 
Parliament and of the Council of 11 February 
2025 on the European Health Data Space and 
amending  Directive 
and 
Regulation (EU) 2024/2847 

2011/24/EU 

The  NIS2  Directive  sets  out  requirements  as  regards 
cybersecurity  risk-management  measures  and 
incident 
reporting  for  essential  and  important  entities  in  18  critical 
sectors.  The  Directive  also  sets  out  measures  as  regards 
cooperation  at  national  level  and  at  European  level,  with  a 
view  to  promoting  a  high  common  level  of  cybersecurity 
across the Union. 

The  Decision  defines  the  UCPM’s  aim  to  strengthen  EU  and 
Member  State  cooperation  and  coordination  on  disaster 
prevention,  preparedness,  and  response.  The  Mechanism 
promotes  Member  State  solidarity  while  ensuring  national 
responsibility for disaster management. It outlines rules with 
general  and  specific  objectives  to  improve  protection  and 
preparedness  at  Member  State  and  Union  levels,  facilitate 
rapid and efficient  response and public awareness, enhance 
scientific  knowledge  on  disasters  and  step  up  cross-border 
cooperation and coordination. 

The  Internal  Market  Emergency  and  Resilience  Act  (IMERA) 
instrument aims to strengthen the resilience of the EU's single 
market  during  emergencies.  It  establishes  a  framework  for 
crisis  management  ensuring  the  free  movement  of  goods, 
services, and people, and addresses supply chain disruptions. 
The IMERA includes measures for transparency, coordination, 
and 
response  during  emergencies,  enhancing 
cooperation among EU member states to maintain economic 
stability and consumer protection. 

swift 

The  European  Health  Data  Space 
(EHDS)  Regulation 
establishes a common framework for the use and exchange of 
personal  electronic  health  data  across  the  EU.  It  enhances 
individuals’  access  to  and  control  over  their  personal 
electronic health data, while also enabling certain data to be 
reused  for  public  interest,  policy  support,  and  scientific 
research  purposes. 
fosters  a  health-specific  data 
environment that supports a single market for digital health 
services and products. Additionally, the regulation establishes 
a  harmonised  legal  and  technical  framework  for  electronic 
health record systems, fostering interoperability, innovation, 
and  the  smooth  functioning  of  the  internal  market.  This 
regulation will become applicable in stages by 2031.  

It 

89 

 
Directive  (EU)  2024/3019  of  the  European 
Parliament  and  of  the  Council  of  27 
November 
urban 
wastewater  treatment  (recast)  (Text  with 
EEA relevance) 

concerning 

2024 

Directive  2012/18/EU  of 
the  European 
Parliament and of the Council of 4 July 2012 
on  the  control  of  major-accident  hazards 
involving  dangerous  substances,  amending 
and subsequently repealing Council Directive 
96/82/EC (Text with EEA relevance) 

Regulation (EU) 2021/2282 of the European 
Parliament  and  of  the  Council  of  15 
technology 
December  2021  on  health 
assessment 
amending  Directive 
2011/24/EU (Text with EEA relevance) 

and 

Regulation  (EU)  2017/625  of  the  European 
Parliament  and  of  the  Council  of  15  March 
2017  on  official  controls  and  other  official 
activities 
the 
application  of  food  and  feed  law,  rules  on 
animal health and welfare, plant health and 
plant protection products 

performed 

ensure 

to 

The recast Urban Wastewater Treatment Directive objectives 
include  the  protection  the  environment  and  human  health 
from  urban  wastewater  discharges.  The  Directive  requires 
Member  States  set  up  urban  wastewater  surveillance, 
establishing national systems between competent authorities 
responsible  for  public  health  and  for  urban  wastewater 
management.  Member  States  must  develop  a 
list  of 
parameters  relevant  for  public  health  to  be  monitored  in 
urban  wastewater,  and  consider  the  following  health 
parameters  for  inclusion  in  such  a  list:  SARS-CoV-2  and  its 
variants, poliovirus, influenza virus and emerging pathogens. 
Member  States  are  required  to  monitor  relevant  health 
parameters  in  urban  wastewater  in  the  event  of  a  public 
health  emergency.  In  addition,  the  Directive  requires  a 
monitoring  obligation  for  the  presence  of  antimicrobial 
resistance (AMR) in urban wastewater. 

The Seveso III Directive lays down rules for the prevention of 
major accidents which involve dangerous substances, and the 
limitation  of  their  consequences  for  human  health  and  the 
environment,  with  a  view  to  ensuring  a  high  level  of 
protection throughout the Union in a consistent and effective 
manner.  It  applies  to  over  12  000  industrial  establishments 
across the EU.  

The  Regulation  establishes  a  support  framework  and 
procedures  for  cooperation  of  Member  States  on  health 
technologies at Union level. It lays down that any information, 
data, analysis and other evidence required for the joint clinical 
assessment of health technologies is submitted by the health 
technology developer only once at Union level. Moreover, it 
outlines  the  common  rules  and  methodologies  for  the  joint 
clinical assessment of health technologies. 

Regulation 
(EU)  2017/625  establishes  a  harmonised 
framework for official controls across the agri-food chain to 
ensure  compliance  with  EU  rules  on  food  and  feed  safety, 
animal health, plant health, and animal welfare. It strengthens 
cooperation  and  coordination  between  Member  States  and 
EU  institutions  to  guarantee  a  high  level  of  protection  for 
human,  animal  and  plant  health.  The  Regulation  sets  out 
general  and  specific  objectives  to  improve  the  efficiency, 
uniformity and transparency of controls, enhance risk-based 
approaches, support rapid and appropriate corrective actions, 
and  reinforce  EU  capacities  through  reference  laboratories, 
coordinated audits, and cross-border collaboration. 

90 

 
the  European 
Directive  2003/99/EC  of 
Parliament  and  of  the  Council  of  17 
November  2003  on  the  monitoring  of 
zoonoses  and  zoonotic  agents,  amending 
Council  Decision  90/424/EEC  and  repealing 
Council Directive 92/117/EEC 

Food  Hygiene  Package  -  Regulation  (EC)  No 
852/2004  —  General  food  hygiene  and 
Regulation  (EC)  No  853/2004  —  Hygiene 
rules for food of animal origin 

WHO’s International Health Regulations, (IHR 
2005 amended) 

Directive  2003/99/EC  establishes  the  EU  framework  for  the 
surveillance, monitoring and reporting of zoonoses, zoonotic 
agents,  and  related  antimicrobial  resistance.  It  aims  to 
strengthen  cooperation  between  Member  States  and  EU 
bodies  to  ensure  early  detection,  consistent  data  collection 
and coordinated responses to zoonotic threats. The Directive 
outlines  key  duties  to  improve  public  health  protection, 
ensure  harmonised  monitoring  across  the  Union,  facilitate 
rapid information exchange, deepen scientific understanding 
of zoonotic risks, and enhance preparedness and cross-sector 
coordination under the One Health approach. 

The Food Hygiene Package lays down comprehensive EU rules 
governing food hygiene, official controls and responsibilities 
of  food  business  operators  to  ensure  a  high  level  of  food 
safety throughout the supply chain. It strengthens consistency 
and  cooperation  between  Member  States  and  the  EU  by 
harmonising  hygiene  requirements,  establishing  clear  risk-
based  control  systems  and  promoting  shared  responsibility 
for  safe  food  production.  The  framework  sets  general  and 
specific  objectives  to  protect  consumer  health,  guarantee 
traceability  and  transparency,  reinforce  scientific  and  risk-
based  standards,  and  support  effective  cross-border 
coordination  and  rapid  response  in  case  of  food  safety 
incidents. 

IHR  contains  provisions 

The 
for  collaboration,  and 
coordination among States Parties and the WHO to enhance 
prevention, detection, preparedness, and response efforts to 
public  health  events  of 
international  concern  (PHEIC) 
including pandemic emergencies, while avoiding unnecessary 
interference with international traffic and travel. IHR is legally 
binding  on  196  countries,  including  the  194  WHO  Member 
States, as well as the Holy See and Liechtenstein. All the EU 
Member  States  are  States  Parties  to  the  IHR.  Many  IHR 
provisions  concern  issues  that  are  regulated  at  EU  level 
requiring coordinated implementation of the IHR across the 
EU.  IHR  amendments  of  2024  aim  to  enhance  global 
readiness,  surveillance  and  response  to  public  health 
emergencies,  taking  into  account  COVID-19  lessons,  in  line 
with key EU global health priorities. 

91 

 
ANNEX 3. EU Governance structures 

EU governance structures, support mechanisms and capacities 

Health Security Committee 

in  2001, 

the  HSC  serves  as 

The  Health  Security  Committee  (HSC) (292)  plays  an  important  role  in  the 
coordination of prevention, preparedness, and response to cross-border health crises. 
Established 
the  EU  platform  where  national 
representatives  from  Member  States  convene  to  exchange  information,  discuss 
prevention, preparedness and response to health security matters, consult each other 
and  coordinate  on  national  response  measures,  including  research  needs  and  risk 
communication messages. The HSC can also adopt joint opinions as well as guidance 
on prevention, control and response measures during health crises.  

The HSC is chaired by the Commission and operates at two working levels: the senior 
level group and technical working groups dedicated to specific subjects (293). The 
senior level group meets at least twice a year and engages in strategic and political 
discussions on cross-border health threats and adopts HSC opinions by consensus. 
Technical  working  groups,  including  a  General  Working  Group,  which  is  the  only 
permanent technical working group of the HSC, meet more regularly to discuss general 
coordination as well as technical and operational matters. The HSC liaison officers 
are  Member  State  representatives  for  day-to-day  contact  with  the  secretariat  of  the 
HSC,  which  is  run  by  the  Commission.  Representatives  of  relevant  Union  agencies 
and  bodies,  as  well  as  the  European  Parliament  and  WHO  may  participate  in  HSC 
meetings as observers (294). The HSC should ensure regular consultation with public 
health  experts,  international  organisations  such  as  the  North  Atlantic  Treaty 
Organization (NATO) and other national and regional centres for disease prevention 
and control. Where relevant, the HSC also coordinates the response to public health 
emergencies with the Health Crisis Board, where it is established in accordance with 
Regulation (EU) 2022/2372. 

EU Health Task Force  

The EU Health Task Force (EUHTF), established by the ECDC, is composed by pools 
of experts ready to provide rapid, on-demand assistance on prevention, preparedness 

(292)  Articles 4, 10 and 21 of Regulation (EU) 2022/2371. 
(293)  European  Commission,  ‘List  of  authorities  represented  in  the  Health  Security  Committee’,  European  Commission 
website,  accessed  3  November  2025,  https://health.ec.europa.eu/health-security-and-infectious-diseases/crisis-
management/list-authorities-represented-health-security-committee_en. 

(294)  European Commission, ‘Health Security Committee: Rules of procedure for the Health Security Committee’, European 

Commission website, accessed 3 November 2025, https://health.ec.europa.eu/health-security-and-infectious-
diseases/crisis-management_en#:~:text=Health%20Security%20Committee-,Rules%20of%20procedure,-
List%20of%20authorities.  

92 

 
 
and response to communicable diseases or unknown diseases. The EUHTF can be 
deployed on field missions or for remote support in an EU Member State or an EEA 
country or outside the EU based on a request for support (295). The EUHTF is managed 
by the ECDC with guidance from the EUHTF Advisory Group. It collaborates and can 
complement  other  assistance  mechanisms  under  the  UCPM  as  well  as  the  Global 
Outbreak and Response Network (GOARN) mechanism. 

The EUHTF is composed of a permanent capacity of ECDC staff members and three 
pools of experts. ECDC is in charge of the daily operations of the Task Force.  One 
such pool is the ECDC pool involving experts from ECDC. Another pool is the ECDC 
Fellowship  Pool  involving  experts  from  the  ECDC  Fellowship  Programme  including 
The  European  Programme  for  Intervention  Epidemiology  Training  (EPIET),  The 
European Public Health Microbiology Training Programme (EUPHEM), and affiliated 
national field epidemiology programmes. While the External Expert Pool is composed 
of  external  experts.  The  Commission,  along  with  at  least  two  Member  States,  can 
mobilise the EUHTF Enhanced Emergency Capacity during a public health emergency 
at Union level with its pools being fully mobilised to assist the HSC during health crises. 

Health Crisis Board  

Should  the  Council  decide  to  activate  the  emergency  framework  for  MCMs  in 
accordance with Regulation (EU) 2022/2372, the Health Crisis Board is established 
to ensure coordination of action by the Council, the Commission, the relevant Union 
bodies, offices, agencies, and Member States to ensure the supply of and access to 
crisis-relevant  MCMs.  The  Health  Crisis  Board  supports  high-level  coordination  and 
decision-making  by  bringing  together  representatives  from  Member  States,  the 
Council, the Commission, and relevant Union bodies and agencies  (296). The Health 
Crisis  Board  also  coordinates  with  the  Emergency  Response  Coordination  Centre 
(ERCC)  to  close  operational  gaps  in  accessing  crisis-relevant  MCMs  and  their  raw 
materials, and to ensure, where necessary, the corresponding on-site monitoring and 
coordination  tasks.  The  Health  Crisis  Board  assists  and  provides  guidance  to  the 
Commission  in  the  preparation  and  implementation  of  measures  under  Regulation 
(EU) 2022/2372. The Health Crisis Board may issue opinions. 

The Health Crisis Board brings together high-level Member State representatives to 
expedite  the  supply  of  and  access  to  crisis-relevant  MCMs  and  raw  materials,  and 
ensure the coordination of the relevant tasks (297). It coordinates with the HSC (298) and 
with the HERA Board where appropriate (299), to effectively respond to the threat. 

The  Health  Crisis  Board  is  co-chaired  by  the  Commission  and  the  Member  State 
holding  the  rotating  presidency  of  the  Council.  A  representative  from  the  European 
Parliament and a Member State representative of the HSC are invited to Health Crisis 

(295)  Article 11 of Regulation (EC) No 851/2004. 
(296)  Article 5 of Regulation (EU) 2022/2372.  
(297)  Article 5 of Regulation (EU) 2022/2372.  
(298)  Article 10(3) of Regulation (EU) 2022/2371. 
(299)  See also recital 4 of Regulation (EU) 2022/2372. 

93 

 
 
Board meetings as observers. Relevant Union institutions, bodies and agencies, and 
the  ACPHE,  may  participate  as  observers.  International  organisations  such  as  the 
WHO  or  NATO,  and  national  authorities,  including  central  purchasing  bodies,  and 
healthcare  organisations  and  associations,  can  also  be  invited  as  observers.  The 
Health Crisis Board may establish subgroups or working groups on an ad-hoc basis to 
support its activities.  

EU Civil Protection Mechanism  

The  EU  Civil  Protection  Mechanism  (UCPM)  (300)  is  the  EU’s  framework  for 
facilitating and strengthening civil protection cooperation between EU Member States 
and Participating States in preventing, preparing for, and responding to various types 
of disasters, including non-health crises that are outside the scope of the Union plan. 
The  UCPM  is  designed  to  respond  to  emergencies,  accidents,  human-induced 
disasters  and  natural  hazards,  such  as  forest  fires,  earthquakes  and  disease 
outbreaks, that occur either inside or outside the European Union.  

Any  country  hit  by  a  disaster,  in  Europe  and  beyond,  can  request  emergency 
assistance, such as medical teams, equipment and relief supplies, through the UCPM. 
The  Commission  plays  a  key  role  in  coordinating  the  disaster  response  and 
contributing  to  the  transport  and/or  operational  costs  of  deployments.  The  UCPM 
coordinates these efforts via the European Emergency Response Coordination Centre 
(ERCC),  which  manages  assistance  requests  and  deployments.  Under  the  UCPM 
framework,  the  Commission  and  Member  States  work  together  to  enhance  risk 
assessments, disaster risk management, and knowledge building and sharing (301).  

To tackle the challenges of emergency medical response, the EU has developed the 
European  Civil  Protection  Pool  (ECPP) (302)  to  improve  the  operational  readiness 
and  quality  of  the  UCPM  response  to  disasters.  Member  States  and  UCPM 
Participating States can commit response capacities on a voluntary basis to the ECPP, 
making them available for UCPM response operations. Through the ECPP, the UCPM 
can  mobilise  different  types  of  emergency  medical  support,  including  emergency 
medical teams (EMTs).  

Additionally, as an integral part of the UCPM, rescEU (303) was established as a ‘last 
resort’  strategic  reserve  of  European  disaster  response  capabilities  and  stockpiles, 
fully funded by the EU. rescEU provides a safety net via EU-funded disaster response 
capabilities to fill resource gaps when national or ECPP assets are insufficient. rescEU 

(300)  Council Decision 2001/792 (Euroatom) of 21 October 2001 establishing a Community mechanism to facilitate 

reinforced cooperation in civil protection assistance interventions (OJ L 297, p. 7, ELI: https://eur-lex.europa.eu/legal-
content/en/TXT/?uri=CELEX:32001D0792). 

(301)  Union Civil Protection Knowledge Network, accessed 3 November 2025, https://civil-protection-knowledge-

network.europa.eu/. 

(302)  European Civil Protection and Humanitarian Aid Operations, ‘European Civil Protection Pool’, European Commission 

website, accessed 3 November 2025, https://civil-protection-humanitarian-aid.ec.europa.eu/what/civil-
protection/european-civil-protection-pool_en. 

(303)  European Civil Protection and Humanitarian Aid Operations, ‘RescEU’, European Commission website, accessed 3 

November 2025, https://civil-protection-humanitarian-aid.ec.europa.eu/what/civil-protection/resceu_en. 

94 

 
 
strengthens  Europe’s  disaster  preparedness  by  establishing  strategic  reserves  of 
emergency response capacities, including medical capabilities, such as field hospitals, 
therapeutics, critical medical supplies, personal protective equipment, and equipment 
to respond to chemical, biological, radiological, and nuclear emergencies.  

Emergency Response Coordination Centre  

At the core of the UCPM is the Emergency Response Coordination Centre (ERCC) 
(304),  the  Commission’s  operations  centre  that  ensures  24/7  operational  capacity  to 
facilitate  rapid  coordination  and  support during  natural hazards  and  human-induced 
disasters, delivering assistance such as relief items, expertise, civil protection teams 
and specialised equipment. The ERCC monitors risks and events as part of its early 
warning  capability,  develops  situational  awareness,  supports  the  development  of 
response  capacities  and  coordinates  the  provision  of  aid  to  affected  countries  that 
request  assistance.  It  acts  as  the  main  coordination  centre  by  connecting  national 
authorities, EU agencies, and international partners to share information and manage 
resources in real time. The ERCC can, in the context of the UCPM, respond to health 
and non-health related emergencies.  

In the case of health crises, the ERCC supports joint operations such as deployment 
of experts, transporting medical equipment, organising patient transfers, and handling 
logistics  and  practical  arrangements  to  ensure  the  smooth  delivery  of  medical  aid, 
including emergency medical teams to support efforts on the ground. The ERCC also 
coordinates  citizens’  repatriations  as  part  of  EU  consular  support  (e.g.  during  the 
COVID-19 pandemic). Finally, the ERCC serves Member States and the EU when the 
Integrated  Political  Crisis  Response  (IPCR)  arrangements  are  activated,  or  the 
solidarity clause is invoked. 

Scientific Advice Mechanism  

The Scientific Advice Mechanism (SAM) (305) aims to deliver independent, evidence-
based scientific advice upon request from the College of Commissioners. Its three-part 
structure is designed to ensure that EU policies are informed by the latest scientific 
knowledge (306). It comprises:  

•  The Group of Chief Scientific Advisors: A panel of eminent scientists providing 

high-level policy recommendations to the Commissioners.  

•  Science  Advice  for  Policy  by  European  Academies  (SAPEA):  A  consortium  that 
synthesises  evidence  from  over  100  academic  institutions  and  learned  societies 
across Europe. 

•  The SAM Secretariat: A Commission unit that coordinates SAM’s activities.  

(304)  Article 7 of Decision (EU) No 1313/2013. 
(305)  Scientific Advice Mechanism to the European Commission, accessed 3 November 2025, https://scientificadvice.eu/.   
(306)  European Commission, ‘The Scientific Advice Mechanism – Outputs and impacts’, European Commission website, 2 
April 2025, accessed 3 November 2025, https://research-and-innovation.ec.europa.eu/news/all-research-and-
innovation-news/scientific-advice-mechanism-outputs-and-impacts-2025-04-02_en. 

95 

 
 
SAM’s  role  includes  synthesising  evidence  by  mobilising  expert  networks  during 
emergencies, and offering strategic policy guidance to ensure EU actions are based 
on  solid  scientific  evidence.  It  also  engages  with  stakeholders,  fostering  dialogue 
between the scientific community, policymakers, and the public to promote trust and 
transparency. 

Commission Expert Groups  

Commission expert groups are consultative bodies established by the Commission to 
provide  advice  and  expertise  on  policy  initiatives  and  legislative  proposals.  These 
groups, composed of experts from various sectors, play a crucial role in, for example, 
shaping EU policy and offering input on delegated acts of EU legislative proposals. 

HERA Board  

In  the  area  of  MCMs,  the  HERA  Board  is  composed  of  the  representatives  of  the 
Member States and chaired by the Commission, while EU institutions  and agencies 
may participate as observers (307). The task of the HERA Board is to assist and advise 
the  Commission  in  the  formulation  of  strategic  decisions  concerning  Commission’s 
activities  on  MCMs,  contributing  to  leveraging  Member  States’  resources  and 
capacities.  This  entails  work  on  the  assessment  of  health  threats  and  intelligence 
gathering;  promoting  advanced  research  and  development;  addressing  market 
challenges  and  boosting  the  Union’s  open  strategic  autonomy  in  production;  swift 
procurement  and  distribution;  increasing  stockpiling  capacity;  and  strengthening 
knowledge and skills in preparedness and response related to MCMs. In view of the 
information that is exchanged during meetings of the HERA Board, its work can help 
decision-making on measures at national level to improve the availability of and access 
to MCMs. The HERA Board meets 3-4 times a year. 

The HERA Board is supported by the HERA Advisory Forum consisting of Member 
State experts in the area of health security, research and industrial policy (308). The 
Advisory Forum exchanges technical information and pools knowledge on  MCMs to 
provide  scientific  knowledge  and  advice  to  the  HERA  Board.  As  a  subgroup  of  this 
Forum, a Joint Industrial Cooperation Forum has been set up to link Member States 
and  industry  representatives  in  the  whole-of-society  approach.  It  complements  the 
Commission’s  broader  intelligence  tools  and  bodies  by  focusing  specifically  on  the 
industrial aspects of preparedness. It aims to identify market failures and supply chain 
dependencies that could limit the production capabilities of relevant MCMs and their 
raw materials. The Civil Society Forum ensures exchanges with academia and civil 
society  and  provides  recommendations  to  the  Advisory  Forum  on  specific  matters 

(307)  Commission Decision of 16.9.2021 establishing a Health Emergency Preparedness and Response Authority (HERA), 

C(2021)6712, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=intcom:C(2021)6712. 

(308)  European Commission, ‘HERA Advisory Forum’, European Commission website, accessed 31 October 2025, 

https://health.ec.europa.eu/health-emergency-preparedness-and-response-hera/overview/hera-advisory-forum_en.  

96 

 
 
related  to  health  crisis  preparedness  and  response,  with  a  focus  on  MCMCs,  and 
monitors relevant research, industrial and policy developments. 

Advisory Committee on Public Health Emergencies 

While  the  main  role  of  the  Advisory  Committee  on  Public  Health  Emergencies 
(ACPHE) (309) is to support the Commission in decision making related to the formal 
recognition and termination of public health emergencies at Union level, and to advise 
on response measures. While on stand-by, the ACPHE is actively engaging in activities 
to maintain full readiness.  

ACPHE  brings  together  experts  from  16  different  economic  sectors  and  disciplines 
including  human  health,  media,  transportation,  business,  veterinary  services  and 
academia (310). It convenes in person annually for a general assembly, with additional 
online  meetings.  These  meetings,  chaired  by  the  Commission,  aim  to  facilitate 
collaboration, refine working methods and enhance operational readiness. The ECDC 
and EMA participate as permanent observers, and the WHO may also participate as 
an observer.  

When requested by the Commission or the HSC, ACPHE advises on whether a threat 
constitutes a public emergency at Union level and on response measures building on 
the scientific advice and risk assessments produced by EU agencies, WHO and other 
relevant agencies or bodies, as appropriate (311).  

Expert Group on Public Health 

The  Expert Group  on  Public  Health  (312),  advises  and  guides  the  Commission  on 
public health matters, related to both communicable and non-communicable diseases 
– as well as health systems. The Commission chairs the expert group, which comprises 
representatives of Member States’ health ministries.  

In  June  2025  (313)  a  temporary  sub-group  on  serious  cross-border  threats  to  health 
was  established,  which  has  been  tasked  to  review  draft  delegated  acts  that  are 
prepared  by  the  Commission  under  the  serious  cross-border  threats  to  health 
Regulation. 

(309)  Register of Commission Expert Groups and Other Similar Entities, ‘Advisory Committee on Public Health Emergencies’ 
(ACPHE), European Commission website, accessed 3 November 2025, https://ec.europa.eu/transparency/expert-
groups-register/screen/expert-groups/consult?lang=en&groupID=3914. 

(310)  Register of Commission Expert Groups and Other Similar Entities, European Commission website, accessed 3 

November 2025, https://ec.europa.eu/transparency/expert-groups-register/screen/home?lang=en. 

(311)  Article 24 of Regulation (EU) 2022/2371. 
(312)  Register of Commission Expert Groups and Other Similar Entities, ‘Expert group on public health’, European 

Commission website, accessed 3 November 2025, https://ec.europa.eu/transparency/expert-groups-
register/screen/expert-groups/consult?lang=en&groupID=3884. 

(313)  Register of Commission Expert Groups and Other Similar Entities, ‘Sub-group on serious cross-border threats to 

health’,  European Commission website, accessed 3 November 2025, https://ec.europa.eu/transparency/expert-
groups-register/screen/expert-groups/consult?lang=en&fromMainGroup=true&groupID=105492. 

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Expert Group on Health Systems Performance Assessment 

The Expert Group on Health Systems Performance Assessment (314) was set up 
to provide  EU  countries  with  a  forum  to  exchange experiences  in  the field  of  health 
system  performance  assessment.  It  aims  to  support  national  policymakers  by 
identifying 
to  develop  health  system  performance 
assessments.  International  organisations  such  as  WHO  and  the  OECD  proactively 
contribute to the work of the Expert Group. Each year, it focuses on a specific priority 
area (315),  such  as  quality  of  care,  integrated  care,  and  primary  care,  for  which  it 
develops evidence, frameworks and good practice examples. 

tools  and  methodologies 

Clinical Trials Coordination Mechanism  

The  Clinical  Trials  Coordination  Mechanism  advises  on  clinical  trials  and  their 
funding,  with  a  focus  on  identifying  and  prioritising  the  most  promising  medicinal 
products and clinical studies relevant to EU public health objectives, particularly those 
that  enhance  preparedness  for  and  response  to  public  health  emergencies.  The 
Clinical Trials Coordination Mechanism is established as a dedicated sub-group of the 
HERA Board. The group is composed of Member State representatives with technical 
expertise in clinical research and funding mechanisms. 

AMR One Health Network  

The AMR One Health Network (OHN) brings together government experts from the 
human  health,  animal  health,  and  environmental  sectors,  EU  scientific  agencies 
working in One Health domains (ECDC, EMA, ECHA, EEA, and EFSA), international 
organisations, independent experts, as well as EU-level professional and civil society 
organisations. The network is coordinated by the Commission. Within the AMR OHN, 
members collaborate to facilitate mutual learning, share best practices and innovative 
ideas, build consensus, compare progress made in key areas, and, where necessary, 
accelerate  national efforts  to  tackle  antimicrobial  resistance  (AMR).  It  thus  plays  an 
important  role  in  the  prevention  of  further  spread  of  AMR  and  other  health  crises 
including those caused by infections with antimicrobial resistant microorganisms. 

European Group on Ethics in Science and New Technologies  

An independent, multi-disciplinary body appointed by the President of the Commission, 
the European Group on Ethics in Science and New Technologies (EGE) provides 
the Commission with high quality, independent advice on all aspects of EU legislation 
and policies, where ethical, societal and fundamental rights issues intersect with the 

(314)  European Commission, ‘Health systems performance assessment’, European Commission website, accessed 3 

November 2025, https://health.ec.europa.eu/health-systems-performance-assessment/overview_en.  

(315)  European Commission, ‘Priority areas for HSPA’, European Commission website, accessed 3 November 2025, 

https://health.ec.europa.eu/health-systems-performance-assessment/priority-areas-hspa_en.   

98 

 
 
development of science and new technologies. The group's legal mandate is enshrined 
in Commission Decision 2021/156 and its amending Commission Decision 2024/1997, 
and it reports to the President of the Commission and to the College of Commissioners 
as a whole. The EGE has been working on the topics of planetary ethics, democracy, 
values in policy making, pandemics and crisis management, genome editing, artificial 
intelligence and the future of work. 

The  EGE  is  tasked  with  integrating  ethical  considerations  into  scientific  and 
technological  policies  at  international  level,  at  inter-institutional  level  in  cooperation 
with the European Parliament and the Council, and within the Commission itself. EGE 
members  are  appointed  for  their  expertise  in  the  fields  of  law,  natural  and  social 
sciences,  philosophy  and  ethics.  This  ensures  an  independent,  interdisciplinary 
perspective on the ethical questions arising from scientific and technological innovation 
and cross-border crises. The EGE acts as a key reference point for the 27 National 
Ethics Councils in the EU and further afield within the international ethics framework. 

Informal  Commission  Expert  Group  on  Global  Health  in  Development 
Cooperation  

In  the  Informal  Commission  Expert  Group  on  Global  Health  in  Development 
Cooperation,  Member  States’  experts  provide  the  Commission  with  advice  and 
expertise  on  the  development,  implementation,  and  assessment  of  its  global  health 
policies. This collaboration aims to stimulate and improve joint EU efforts in the field of 
global health, with a focus on development cooperation and international partnerships. 

Further EU coordination mechanisms and structures 

Critical Medicines Alliance  

The Critical Medicines Alliance (CMA) (316), set up in January 2024, is a consultative 
mechanism that brings together relevant stakeholders from EU Member States, key 
industries, civil society, and the scientific community. The CMA discusses the industrial 
challenges  contributing 
formulate 
recommendations  for  action  areas  and  priorities  by  and  propose  solutions  to 
strengthen the supply of critical medicines in the EU.  

to  shortages  of  critical  medicines 

to 

European Climate and Health Observatory  

The European Climate and Health Observatory (317), a joint initiative between the 
Commission  and  the  European  Environment  Agency,  aims  to  support  Europe  in 

(316)  European Commission, ‘Critical Medicines Alliance’, European Commission website, accessed 3 November 2025, 
https://health.ec.europa.eu/health-emergency-preparedness-and-response-hera/overview/critical-medicines-
alliance_en.   

(317)  European Climate and Health Observatory, accessed 3 November 2025, https://climate-

adapt.eea.europa.eu/en/observatory.  

99 

 
 
 
preparing  for  and  adapting  to  the  impacts  of  climate  change  on  human  health  by 
providing access to relevant information and tools. It fosters information exchange and 
cooperation between relevant international, European, national, sub-national and non-
governmental entities. Some of the Observatory’s partners include the ECDC, EFSA 
and WHO.  

Team Europe approach 

The Team Europe approach brings together the EU, Member States, and financial 
institutions to pool resources, expertise, and efforts for more effective and impactful 
support  for  a  coordinated  global  response  to  crises  and  development  challenges. 
Team Europe  was  initially  put  in place  to  ensure  a  coordinated and  comprehensive 
response between the EU and its Member States to the COVID-19 pandemic and its 
consequences. The new approach became the backbone of Global Europe (the EU’s 
main financial instrument for international cooperation during the 2021–2027 period) 
and its programming. 

European Council 

The Integrated Political Crisis Response (IPCR) (318) of the European Council is the 
central EU mechanism for rapid and coordinated decision-making at EU political level 
for major and complex crises. The activation, political control and strategic direction of 
the  IPCR  is  under  the  leadership  of  the  Presidency  of  the  Council  (319).  The  IPCR 
provides  a  flexible  framework  that  can  be  scaled  depending  on  the  severity  and 
characteristics  of  the  crisis.  Once  activated,  the  IPCR  has  three  operational  modes 
including a monitoring mode (for situational awareness); an information sharing mode 
(for collecting and analysing data); and a full activation mode (for active coordination 
for the preparation of response measures).  

The IPCR arrangements consist of supporting elements that are essential to ensure 
informed decision-making within the Council and an effective political coordination and 
collaboration at Union level. It facilitates a common understanding of the crisis through 
regular integrated situational awareness and analysis (ISAA) reports, enables the 
identification of urgent needs and gaps, and promotes solidarity measures. 

The  Committee  of  Permanent  Representatives  of  the  Governments  of  the  Member 
States to the European Union (Coreper) has oversight of the implementation of the 
IPCR  arrangements.  The  Presidency  of  the  Council  leads  on  communication  to  the 
public from the IPCR with the support of the informal Crisis Communicators’ Network 
composed of communication experts from Members States. 

During a public health emergency at Union level, the Health Crisis Board and the HSC 
work closely with the IPCR mechanism to ensure that political coordination at EU level 
is  supported  by  public  health  expertise  and  operational  input  from  Member  States, 
including by exchanging information and sharing the opinions and guidance of the HSC 

(318)  Council Implementing Decision (EU) 2018/1993. 
(319)  Article 222 of the TFEU.  

100 

 
 
and the Health Crisis Board (320). The ERCC serves the Member States and the EU as 
central  24/7  contact  point  when  IPCR  arrangements  are  activated,  or  the  solidarity 
clause is invoked.  

Council of the EU 

The Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) 
(321)  is  one  of  the  configurations  of  the  Council  of  the  European  Union,  where 
government  ministers  from  all  EU  Member  States  meet  to  discuss,  negotiate,  and 
adopt  policies  and  legislation.  EPSCO  brings  together  health  ministers  from  EU 
Member  States  to  coordinate  and  adopt  policies  that  strengthen  public  health 
preparedness  and  response.  EPSCO  shapes  legislation  and  strategies  to  improve 
health systems resilience, cross-border cooperation, and crisis management, ensuring 
effective  EU-wide  action  during  health  emergencies.  While  it  does  not  execute 
measures directly, EPSCO’s decisions guide member states and the Commission in 
protecting the health of the population and enhancing EU health security frameworks. 

European Parliament  

The  European  Parliament  has  several  committees, 
the  SANT 
Committee (322).  The  SANT  Committee  –  formally  known  as  the  Subcommittee  on 
Public Health within the European Parliament's Committee on the Environment, Public 
Health and Food Safety (ENVI) – was voted by Members of the European Parliament 
to  become  a  fully-fledged  committee  in  December  2024,  thereby  assuming 
responsibility for health policy previously overseen by the broader ENVI committee. 

including 

The  SANT  Committee  is  responsible  for  files  related  to  health  policy  including 
preparedness  and  response  to  health  crises,  pharmaceuticals and  medical devices, 
mental  health  and  patients'  rights,  as  well  as  health  aspects  of  bioterrorism,  and 
supervises inter-institutional relations with other health authorities at EU or global level, 
such as the ECDC and the WHO. 

(320)  Article 20(1) of Regulation (EU) 2022/2371.  
(321)  European Council / Council of the European Union, ‘Employment, Social Policy, health and Consumer Affairs Council 
configuration (EPSCO)’, European Council/Council of the European Union website, accessed 3 November 2025, 
https://www.consilium.europa.eu/en/council-eu/configurations/epsco/. 

(322)  European Parliament, ‘Committee on Public Health’, EP website, accessed 3 November 2025, 

https://www.europarl.europa.eu/committees/en/sant/home/highlights.   

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ANNEX 4. Relevant EU agencies and bodies 

Cross-agency task force on One Health 

The  Cross-agency  task  force  on  One  Health  (323)  is  a  collaborative  framework 
established  by  five  EU  agencies  (ECDC,  EMA,  EFSA,  EEA  and  ECHA)  to  address 
health threats at the human-animal-environment interface. The coordination of the task 
force will rotate among the agencies with each term will lasting 18 months. 

The  network  promotes  a  holistic,  interdisciplinary  approach  to  preventing  and 
managing risks such as zoonotic diseases, antimicrobial resistance (AMR), food safety 
threats,  and  emerging  pandemics.  The  objectives  of  the  cross-agency  task  force 
include 

•  Facilitating strategic coordination of the work of the agencies on implementing 

One Health; 

•  Promoting research coordination and One Health-driven agenda setting; 
•  Providing a forum for the coordination of activities to update, inform and support 
EU policymakers and other relevant stakeholders in their goal to prioritise One 
Health, providing scientific advice in key areas such as food safety, global public 
health, biodiversity, and chemical pollution; and  

•  Strengthening  joint  activities  and  the  sharing  of  information  on  One  Health 
interlinkages, 
aspects  among 
interdependencies  and  fields  of  cooperation  and  providing  a  platform  for  the 
exchange of good practices within individual agencies.  

the  agencies, 

including  by 

identifying 

The role of Agencies under Regulation (EU) 2022/2371 

Under  Regulation  (EU)  2022/2371,  one  or  more  relevant  EU  agencies  is  tasked  to 
carry  out  joint  risk  assessments  of  the  potential  severity  of  threats  to  public  health, 
including possible health measures. These agencies include the European Centre for 
Disease Prevention and Control (ECDC), the European Food Safety Authority (EFSA), 
the European Chemicals Agency (ECHA), Europol, the European Medicines Agency 
(EMA), the European Union Drugs Agency (EUDA), and the European Environment 
Agency (EEA) and Europol. Each EU agency and body has a specific mandate and 
role  in  the  prevention,  preparedness,  and  response  to  health  crises  which  are 
described below. 

(323)  One Health cross-agency task force, ‘Strengthening EU agencies’ scientific advice on One Health’, EFSA website, 

accessed 31 October 2025, https://www.efsa.europa.eu/sites/default/files/documents/news/one-health-cross-agency-
task-force.pdf. 

102 

 
 
European Centre for Disease Prevention and Control 

The  European  Centre  for  Disease  Prevention  and  Control  (ECDC)  (324)  is 
responsible  for  identifying,  assessing  and  reporting  on  current  and  emerging 
communicable  disease  threats  to  human  health,  ensuring  accessible  information 
dissemination. The mandate of the ECDC was strengthened as part of the European 
Health Union initiative. The ECDC supports the EU’s and Member States’ prevention, 
preparedness and response to serious cross-border health threats through collecting 
and  analysing  data  on  infectious  diseases,  issuing  early  warnings,  providing  risk 
assessments, monitoring epidemiological data, coordinating disease surveillance, and 
offering  scientific  advice  on  communicable  diseases.  The  ECDC  also  provides 
transparent and reliable information on health risks to the public, along with scientific 
and technical advice, opinions, guidelines, and science-based recommendations. 

The  ECDC  is  supported  by  three  interrelated  structures  that  together  ensure  the 
effective governance, scientific integrity and coordination between the Centre and EU 
Member States and EEA countries.  

•  The  Management  Board,  composed  of  representatives  from  all  Member 
States,  the  Commission,  and  independent  experts,  oversees  the  Centre’s 
operational  and  strategic  direction,  budget,  and  work  programme.  Together, 
these bodies ensure that the ECDC functions with transparency, accountability, 
and  scientific  integrity  in  its  mission  to  strengthen  Europe’s defences  against 
infectious disease threats.  

•  The Advisory Forum consists of representatives from the Member States, the 
Commission, and other stakeholders, providing scientific and strategic advice 
to  ensure  that  the  ECDC's  work  reflects  the  needs  and  priorities  of  national 
public health authorities. It fosters cooperation, exchange of best practices, and 
alignment of prevention efforts across Europe.  

•  The ECDC Coordinating Competent Bodies (CCBs) are national authorities or 
institutions formally designated by each Member State. A system has been put 
in place that allows for the interaction between the ECDC and the CCBs in three 
different levels:  

▪  High-level  relational  and  coordination  interactions  between  ECDC  and 

the CCBs take place at the level of a National Coordinator. 

▪  Strategic and overarching interactions related to a specific disease group 
or public health function take place at the level of National Focal Points. 
▪  Technical and operational interactions related to specific areas within the 
domains of a disease group or public health function  take place at the 
level of the Operational Contact Points. 

(324)  European Centre for Disease Prevention and Control (ECDC), accessed 3 November 2025, 

https://www.ecdc.europa.eu/en. 

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European Medicines Agency  

The European Medicines Agency (EMA) (325) is responsible for scientific evaluation, 
supervision,  and  safety  monitoring  of  medicines,  and  its  tasks  include  facilitating 
development  and  access,  monitoring  safety,  and  providing  information  regarding 
medicines. The mandate of the EMA was strengthened as part of the European Health 
Union initiative. The EMA monitors events that could lead to emergencies and, in the 
event  of  a  crisis,  manages  supply  and  demand  issues  for  medicines  and  medical 
devices while also providing scientific support to the development of high-quality, safe 
and effective medicines.  

The coordination between Member States and the EMA is supported by a governance 
structure  that  ensures  scientific  consistency,  regulatory  alignment,  and  efficient 
decision-making in the area of medicines regulation and safety. 

•  The  EMA  Management  Board  is  the  Agency’s  primary  governing  body.  It 
oversees the EMA’s strategic direction, budget, and performance, and ensures 
that the Agency serves the public interest across all Member States. 

•  The Network of National Competent Authorities: Each Member State has a 
National  Competent  Authority  responsible  for  regulating  medicines  at  the 
national level. These authorities work closely with the EMA through committees, 
working parties, and task forces by sharing data, expertise, and resources as 
part of a coordinated European medicines regulatory network. 

•  Several  Scientific  Committees,  comprising  representatives  from  Member 
States'  national  authorities,  are 
for  assessing  marketing 
authorisation applications, safety issues, and other regulatory matters using the 
pooled expertise from across the EU. Key committees include: 

responsible 

▪  Committee for Medicinal Products for Human Use (CHMP) 
▪  Pharmacovigilance Risk Assessment Committee (PRAC) 
▪  Committee for Advanced Therapies (CAT) 
▪  Committee for Orphan Medicinal Products (COMP) 

EMA and national regulators also take any necessary action to protect patients in the 
event  of  safety-related  issues.  The  EMA  and  ECDC  jointly  coordinate  independent 
vaccine effectiveness and safety studies through their Vaccine Monitoring Platform 
(326). 

A collaborative network of the Heads of Medicines Agencies from EU Member States 
and EEA countries works closely with the EMA to harmonise regulatory practices and 
coordinate  responses to  EU-wide  challenges,  such as medicine  shortages  or public 
health emergencies. 

The  EMA  Emergency  Task  Force  (ETF)  was  established  under  the  revised 
pharmaceutical legislation and reinforced during the COVID-19 pandemic. The ETF is 
an advisory and support body comprising experts from the EMA and Member States. 

(325)  European Medicines Agency (EMA), accessed 3 November 2025, https://www.ema.europa.eu/en/homepage. 
(326)  EMA, ‘Vaccine Monitoring Platform’, EMA website, accessed 3 November 2025, https://www.ema.europa.eu/en/about-

us/what-we-do/crisis-preparedness-management/vaccine-monitoring-platform.   

104 

 
 
It is activated during health emergencies to coordinate countries, healthcare providers, 
and industry stakeholders to address supply chain disruptions and ensure equitable 
resource  distribution.  The  ETF  supports  accelerated  scientific  advice,  clinical  trial 
coordination, and rapid evaluation of medicinal products during crises. 

While not part of the EMA’s formal governance structure, Steering Committees are 
essential  operational  and  planning  bodies  that  help  align  regulatory  actions,  share 
expertise,  and  support  EU-wide  coordination  across  the  European  medicines 
regulatory network. Examples of Steering Committees are:  

-  The  Executive  Steering  Group  on  Shortages  and  Safety  of Medicinal 
Products (the ‘Medicine Shortages Steering Group’ - MSSG) addresses issues 
related to shortages and safety of medicinal products (327). When a public health 
emergency or major event is recognised, the MSSG establishes lists of critical 
medicines and monitors its supply and demand to identify any potential or actual 
shortages of these medicines. 

-  The  Executive  Steering  Group  on  Shortages  of  Medical  Devices  (also 
known as the Medical Device Shortages Steering Group or MDSSG) manages 
the availability of medical devices during public health emergencies within the 
EU. It monitors the supply situation, identifies potential or actual shortages, and 
assesses their impact on healthcare systems and public health. 

European Food Safety Authority  

The European Food Safety Authority (EFSA) (328) provides independent scientific 
advice on risks related to food and feed safety, nutrition, animal health and welfare, 
plant health, and the environment, while ensuring a high level of consumer protection. 
In the event of a health crisis, the EFSA supports the response by providing scientific 
advice, assessing food and feed-related risks, advising on measures to protect public 
health,  and  liaising  with  Member  States  to  ensure  coordinated  communication 
messages. 

Coordination between EU Member States and the European Food Safety Authority 
(EFSA)  is  supported  by  a  multi-level  governance  framework  that  ensures  scientific 
cooperation, information exchange, and alignment on food safety and related public 
health issues.  

-  The  Management  Board  is  EFSA’s  main  governing  body,  comprising  of 
representatives appointed by the Commission, the European Parliament, and 
the Council of the EU, including individuals with expertise in risk assessment, 
public  health,  food  safety,  and  of  representatives  from  civil  society  and  food 
chain interests. It provides overall strategic oversight,  approves budgets, and 
ensures accountability for EFSA’s activities. 

(327)  Article 3 of Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a 

reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products 
and medical devices (OJ L 20, 31.1.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/123/oj). 
(328)  European Food Safety Authority (EFSA), accessed 3 November 2025, https://www.efsa.europa.eu/en.  

105 

 
 
-  The  Advisory  Forum  plays  a  central  role  in  Member  State  coordination.  It 
comprises  of  representatives  from  the  national  food  safety  authorities  or 
competent  bodies  of  all  EU  Member  States,  along  with  observers  from 
EEA/EFTA countries and the Commission. 

-  Each Member State designates a national EFSA Focal Point - typically a food 
safety  or  public  health  authority  –  to  act  as  a  liaisons  between  EFSA  and 
national institutions, helping coordinate communication, data sharing, research 
collaboration, and capacity building. 

-  EFSA operates a range of scientific networks involving experts from national 
authorities  across  Member  States.  These  networks  and  temporary  working 
groups address specific issues such as zoonotic diseases, pesticides, GMOs, 
foodborne  outbreaks,  and  risk/crisis  communication,  enabling  shared  risk 
assessments and harmonised methodologies. 

While  the  Chief  Veterinary  Officers  (CVOs)  of  EU  Member  States  are  not  part  of 
EFSA’s internal governance, they play a key role in interfacing with EFSA on matters 
related to animal health and welfare, zoonoses, and other issues at the human-animal-
environment interface, which are particularly relevant under the One Health approach. 

European Environmental Agency 

The  European  Environmental  Agency  (EEA)  (329)  supports  the  EU’s  health  crisis 
governance by providing high-quality, evidence-based data on environmental factors 
that  influence  public  health.  The  EEA  is  responsible  for  collecting  a  broad  range  of 
environmental data that is then used to develop knowledge to support and inform policy 
development and implementation. In the event of a health crisis, the EEA contributes 
by identifying environmental risk factors that can impact public health.  

The  EEA  is  supported  by  three  interrelated  structures  that  ensure  effective 
governance, scientific integrity, and strong coordination between the Agency and EU 
Member States and EEA countries.  

-  The  Management  Board,  composed  of  representatives  from  EU  Member 
States  and  EEA  countries  the  Commission,  the  European  Parliament,  and 
independent experts, plays a key role in overseeing the effective and efficient 
functioning of the EEA as well as its strategic direction.  

-  The Bureau provides recommendations to the Management Board and takes 

executive decisions to ensure its effective operation.  

-  Composed  of  up  to  20  independent  scientists,  the  Scientific  Committee 
provided  independent  scientific  advice  and  expertise  in  areas  key  to  the 
agency’s work.  

The  EEA  works  in  close  collaboration  with  38  member  and  cooperating  countries 
through the European Environment Information and Observation Network (Eionet). 

(329)  European Environment Agency (EEA), accessed 3 November 2025, https://www.eea.europa.eu/en. 

106 

 
 
European Chemicals Agency 

The European Chemicals Agency (ECHA) (330) is responsible for the implementation 
of the EU’s chemical legislation and policy to ensure the safe use of chemicals, and it 
plays a vital role in protecting human health and the environment from the risks posed 
by  chemicals.  The  ECHA  supports  preparedness  and  response  to  health  crises  by 
identifying and assessing hazardous substances, providing independent, high-quality 
scientific opinions and facilitating access to information on chemical safety. 

ECHA is supported by the following key structures that ensure effective governance, 
scientific integrity, and coordination within EU Member States and EEAcountries:  

-  The  Management  Board,  composed  of  representatives  from  EU  Member 
States and EEA countries, the Commission, the European Parliament, and key 
stakeholders, oversees ECHA’s strategic and financial planning.  

-  The Member State Committee works to resolve differences of opinion on draft 
decisions proposed by the Agency and makes proposals for the identification of 
substances of very high concern.  

-  Several scientific committees – such as the Risk Assessment Committee and 
the  Committee  for  Socio-economic  Analysis  –  work  to  provide  expert 
opinions  on  the  risks,  classification,  restriction,  and  safe  use  of  chemical 
substances. These committees ensure the scientific quality and independence 
of ECHA’s regulatory decisions and recommendations. The Biocidal Products 
Committee (BPC) – ensures the safe and effective use of biocidal products in 
the EU, by providing scientific opinions and guidance on the approval of active 
substances and the authorisation of biocidal products.  

-  The Forum for Exchange of Information on Enforcement, that coordinates 
a network of Member State competent authorities responsible for enforcement. 
One  of  the  Forum’s  Subgroups  is  the  Biocidal  Products  Regulation  (BPR) 
Subgroup which is a network of the enforcement authorities responsible for the 
BPR. 

European Union Drugs Agency  

The  European  Union  Drugs  Agency  (EUDA)  (331)  is  responsible  for  providing 
independent, evidence-based information on drugs, drug use, and their consequences, 
supporting EU policymaking and contributing to the protection of public health. In the 
event  of  a  health  crisis,  the  EUDA  supports  the  response  by  monitoring,  providing 
expertise, assessing drug-related risks, issuing drug alerts, conducting risk and treat 
assessments, and communicating and advising on response measures.  

The work of the EUDA is supported by two statutory bodies that advise and assist in 
the decision-making process of the EUDA:  

(330)  European Chemicals Agency (ECHA), accessed 3 November 2025, https://echa.europa.eu/. 
(331)  European Union Drugs Agency (EUDA), accessed 3 November 2025, https://www.euda.europa.eu/index_en. 

107 

 
 
-  The Management Board, composed of representatives from EU Member State 
and  EEA  countries,  the  Commission,  the  European  Parliament,  and  other 
stakeholders, oversees the Agency’s strategic direction and financial planning.  
-  The Scientific Committee, composed of independent experts in fields related 
to drug use, delivers opinions on scientific matters concerning the activities of 
the EUDA.  

European Union Agency for Law Enforcement Cooperation 

The  European  Union  Agency  for  Law  Enforcement  Cooperation  (Europol)  (332) 
supports  EU  Member  States  in  preventing  and  combating  forms  of  serious  cross-
border  crime  and  terrorism,  including  organised  crime  and  forms  of  crime  affecting 
public health such as the trafficking of counterfeit medicines or the disruption of critical 
health  infrastructure.  During  health  crises,  Europol  supports  Member  States,  EU 
institutions  and  EU  agencies  and  bodies  by  preventing,  detecting,  identifying  and 
disrupting threats that would exploit these crises.  

Europol  is  supported  by  key  structures  that  ensure  effective  governance,  scientific 
integrity, and coordination within EU Member States and EEA countries:  

-  The Management Board, composed of one representative from each Member 
State and one representative of the Commission, provides strategic guidance, 
and oversees the implementation of Europol’s tasks.  

-  The Member States’ Liaison Officers serve as direct links between Europol 
and their national law enforcement authorities. They play a key role in real-time 
information exchange, operational coordination, and joint investigations.  

-  Europol also works with Advisory and Oversight Bodies.  

Europol also has in place strategic partnerships and collaborates with the Commission, 
national Law Enforcement Authorities, and other relevant EU agencies and bodies. 

(332) European Union Agency for Law Enforcement Cooperation (Europol), accessed 3 November 2025, 

https://www.europol.europa.eu/. 

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ANNEX 5. Global governance framework 

Table  12.  Summary  of  roles  and  responsibilities  of  key  global  stakeholders  involved  in  the  prevention, 
preparedness and response to serious cross-border threats to health. 

Name  

Role and tasks in prevention, preparedness and response to health crises 

World Health Organization 
(WHO) 

The World Health Organization (WHO) serves as the leading and coordinating 
authority on international health initiatives, acting as a fundamental pillar of the 
multilateral health system, and maintaining a close partnership with the EU. In 
the area of global health security, the WHO supports the implementation of the 
WHO emergency preparedness and response framework, established in the IHR 
(2005 amended) and the WHO Pandemic Agreement, by regular exchanges of 
information and alerts, consultation, coordination and joint activities. The WHO 
has access to the Early Waring and Response System (EWRS) and participates 
regularly as an observer in the HSC meetings.  

The WHO also works with the Food and Agriculture Organization of the United 
Nations  (FAO),  the  United  Nations  Environment  Programme  (UNEP),  and  the 
World  Organisation  for  Animal  Health  (WOAH),  all  together  known  as  the 
“Quadripartite organisations”. Together, the Quadripartite developed the One 
Health Joint Plan of Action (2022-2026) (333), designed to create sustainable and 
holistic  solutions  to  better  manage  threats  to  human,  animal,  plant,  and 
environmental  health,  and  to  prevent  potential  future  pandemics.  The 
Quadripartite are also working on practical guidance on how to implement the 
One Health Joint Plan of Action at National Level.  

The WHO has several networks to respond to public health events, including the 
Global Outbreak Alert  and Response Network (GOARN) (334) aiming to rapidly 
detect,  verify,  and  respond  to  acute  health  events  with  the  deployment  of 
experts, specialists and resources to the affected countries to support outbreak 
investigation and strengthen local response capacity.  

WHO/Europe (officially titled the WHO Regional Office for Europe), is one of the 
six WHO regional offices, serving the 53 Member States of the WHO European 
Region. Preparedness 2.0 is the strategy and action plan on health emergency 
preparedness,  response  and  resilience  of  the  WHO/Europe (335).  The 
Commission  collaborates  closely  with  WHO/Europe  to  ensure  readiness  and 
response to health crises affecting the EU (336). 

(333)  WHO, ‘One Health Joint Plan of Action’, WHO website, accessed 3 November 2025, https://www.who.int/teams/one-

health-initiative/quadripartite-secretariat-for-one-health/one-health-joint-plan-of-action.   

(334)  Global outbreak alert and response network (GOARN), accessed 3 November 2025, https://goarn.who.int/. 
(335)  WHO, ‘Strategy and action plan on health emergency preparedness, response and resilience in the WHO European 
Region (Preparedness 2.0)’, WHO website, accessed 3 November 2025, https://www.who.int/europe/teams/who-
health-emergencies-programme-(whe)/preparedness-2.0.  

(336)  EU is also involved via EIOS, Epidemic Intelligence from Open Sources; see WHO, ‘Epidemic Intelligence from Open 

Sources’, WHO website, accessed 3 November 2025, https://www.who.int/initiatives/eios. 

109 

 
 
Centres for Disease 
Control (CDCs) 

United Nations (UN) 

The  ECDC  works  closely  with  Centres  for  Disease  Control  (CDCs)  in  non-EU 
countries at bilateral and multilateral levels to address cross-border threats to 
health  and  improve  global  health  security.  The  ECDC  has  formal  agreements 
with  several  national  CDCs  (337)  (338),  as  well  as  with  continental  and  regional 
CDCs in Africa (339) and the Caribbean. In 2019, on the initiative of the ECDC, the 
Network  of  ECDC  focal  points  in  CDCs  in  third  countries  was  established  to 
exchange information and expertise to respond effectively to threats posed by 
infectious diseases.  

The  United  Nations  (UN)  (340)  plays  a  crucial  role  in  global health  security  by 
coordinating  international  efforts  to  prevent,  detect,  and  respond  to  health 
crises.  Through  its  specialised  agencies,  such  as  the  WHO,  the  UN  supports 
countries in strengthening health systems, improving disease surveillance, and 
managing  disease  outbreaks.  The  UN  facilitates  collaboration  between 
governments,  humanitarian  organisations,  and  other  stakeholders  to  ensure 
rapid  and  effective  response  to  health  crises.  The  UN  has  several  bodies  and 
agencies  involved  in  the  prevention,  preparedness,  and  response  to  health 
crises, including:  

-  The Food and Agriculture Organization of the UN (FAO) addresses zoonotic 

disease risks linked to food security and animal health. 

-  The UN Nations Children’s Fund (UNICEF) which supports child health and 

promotes vaccination campaigns.  

-  The UN Development Programme (UNDP) works on building resilient health 

systems and supports recovery efforts following crises. 

-  The  UN  Environment  Programme  (UNEP)  tackles  environmental  factors 

affecting health, including climate-related health risks. 

The  International  Atomic  Energy  Agency  (IAEA)  (341)  is  an  autonomous 
international organisation withing the UN system and is an intergovernmental 
forum for scientific and technical cooperation in the nuclear field. It works  to 
ensure  that  nuclear  science  and  technology  is  used  safely,  securely,  and  for 
peaceful uses. 

(337)  Formal agreements exist with several national CDCs, including with Albania, Australia, Canada, China, Israel, Japan, 
Kosovo, Mexico, Moldova, Montenegro, Serbia, Singapore, Republic of North Macedonia, South Korea, Thailand, the 
United Kingdom and the United States. 

(338)  ECDC, ‘Memoranda of Understanding with CDCs’, ECDC website, accessed 3 November 2025, 
https://www.ecdc.europa.eu/en/about-us/who-we-work/international-activities#read-more. 

(339)  ECDC, ‘Africa CDC – ECDC Partnership’, ECDC website, accessed 20 November 2025, 

https://www.ecdc.europa.eu/en/about-ecdc/partners-and-networks/international-cooperation/africa-cdc-ecdc-
partnership. 

(340)  United Nations, ‘Health’, UN website, accessed 3 November 2025, https://www.un.org/en/global-issues/health. .  
(341)  International Atomic Energy Agency (IAEA), accessed 3 November 2025, http://iaea.org/about/overview. 

110 

 
 
Global Health Security 
Initiative (GHSI) 

World Organisation for 
Animal Health (WOAH) 

United Nations Office for 
Disarmament Affairs 
(UNODA) 

Organisation for the 
Prohibition of Chemical 
Weapons (OPCW) 

Group of 7 (G7) 

Group of 20 (G20) 

The  Global  Health  Security  Initiative  (GHSI)  (342)  is  an  informal,  international 
partnership established to strengthen collective preparedness and response to 
threats  posed  by  chemical,  biological,  radiological,  nuclear,  and  pandemic 
influenza hazards. Founded in 2001, GHSI brings together a network of countries 
and  organisations,  such  as  the  WHO,  to  coordinate  strategies,  share 
information,  and  improve  capabilities  for  health  emergency  management.  Its 
focus  is  to  enhance  global  health  security  by  fostering  collaboration  on  risk 
assessment, early detection, and response to health crises, thereby reducing the 
impact  of  infectious  disease  outbreaks  and  other  public  health  emergencies 
worldwide.  The  GHSI  has  several  technical  and  scientific  working  groups 
including the Chemical Events Working Group, the Biological  Threats Working 
Group,  the  Radio-Nuclear  Threats  Working  Group,  and  the  Pandemic 
Respiratory Viruses Working Group.  

The  WOAH  is  an  intergovernmental  organisation  that  has  been  working  to 
improve  animal  health  since  1924.  The  WOAH  monitors  the  emergence  and 
development  of  animal  diseases  in  terrestrial  and  aquatic  animals,  either 
domestic or wild. The WOAH also ensures its Members have the tools, capacity 
and support they need to strengthen their Veterinary Services and respond to 
the threats posed by animal diseases. 

The  Office  for  Disarmament  Affairs  supports  multilateral  efforts  to  achieve 
general  and  complete  disarmament  under  strict  and  effective  international 
control.  The  Office  also  works  to  address  the  humanitarian  impact  of  major 
technologies,  such  as 
conventional  weapons  and  emerging  weapon 
autonomous weapons. The Biological Weapons Convention under the UNODA 
prohibits the development, production, acquisition, transfer, stockpiling and use 
of biological and toxin weapons. 

As  the  implementing  body  for  the  Chemical  Weapons  Convention,  the 
Organisation  for  the  Prohibition  of  Chemical  Weapons  (OPCW),  with  its  193 
Member States, oversees the global endeavour to permanently and verifiably 
eliminate  chemical  weapons.  The  OPCW  is  not  a  United  Nations  (UN) 
organisation, however, the OPCW has a close working relationship with the UN. 
At the request of the UN Secretary-General, the OPCW has a mandate to closely 
cooperate  with  the  UN  by  placing  its  resources  at  the  Secretary-General's 
disposal for investigating alleged uses of chemical weapons. 

The G7 is an informal grouping of the world’s seven most advanced economies, 
plus the EU, to discuss global economic and geopolitical issues. Under the G7, 
the Global Partnership against the  Spread of Weapons and Materials of Mass 
Destructions  aims  to  prevent  the  proliferation  of  chemical,  biological, 
radiological, and nuclear (CBRN) weapons and related materials. 

The  G20  is  an  international  forum  for  economic  cooperation,  comprising  19 
member counties and the EU, together representing a vast majority of the global 
GDP, international trade, and world’s population. In addition to economic and 
financial matters, the G20 also discusses socio-economic issues, such as health.  

Organisation for Economic 
Co-operation and 
Development (OECD) 

The OECD is an international organisation that works to build better policies for 
better lives. The OECD serves as a forum and knowledge hub for data, analysis 
and best practices in public policy. 

(342)  Global Health Security Initiative, accessed 3 November 2025, https://ghsi.ca/. 

111 

 
 
North Atlantic Treaty 
Organization (NATO) 

NATO is a defensive alliance with its members committed to safeguarding the 
freedom  and  security  of  all  Allies,  against  all  threats.  NATO  works  through 
political and military means. The EU is a partner to NATO. 

Global research 
collaboration for 
infectious disease 
preparedness (GloPID-R) 

Global Polio Eradication 
Initiative  

Gavi, the Vaccine Alliance 

The Global Fund 

The  Global  Research  Collaboration  for  Infectious  Disease  Preparedness 
(GloPID‑R)  is  a  network  of  research  funding  organisations  in  the  area  of 
infectious  disease  preparedness  research.  The  network  coordinates  funding 
organisations  globally  to  enhance  research  preparedness  and  facilitate  an 
effective and rapid response to epidemic or pandemic infectious diseases. The 
GloPID-R secretariat is funded through the Horizon R&I framework programme. 

The Global Polio Eradication Initiative (GPEI) is a public-private partnership with 
the goal of eradicating the highly infectious viral childhood disease poliomyelitis. 
It is made up of national governments and the six GPEI core partners (the WHO, 
Rotary  International,  the  US  Centers  for  Disease  Control  and  Prevention, 
UNICEF, the Gates Foundation, and Gavi, the Vaccine Alliance).  

The Gavi is an international institution aiming to save lives and protect people’s 
health by increasing equitable and sustainable use of vaccines. Gavi works to 
introduce and scale up vaccines, strengthen health systems to increase equity 
in  immunisation,  improve  sustainability  of  immunisation  programmes  and  to 
ensure healthy markets for vaccines and related products. 

The Global Fund is a worldwide partnership to defeat AIDS, tuberculosis (TB) and 
malaria and ensure a healthier, safer and more equitable future for all. It is the 
world’s largest multilateral funder of global  health grants in low- and middle-
income countries. 

Coalition for Epidemic 
Preparedness Innovations 
(CEPI) 

The  CEPI  is  a  global  partnership  working  to  accelerate  the  development  of 
vaccines and other biological countermeasures against epidemic and pandemic 
threats. 

Pandemic Fund 

Transatlantic Taskforce on 
Antimicrobial Resistance 
(TATFAR) 

The Pandemic Fund is a multilateral financing mechanism dedicated exclusively 
to  strengthening  critical  pandemic  prevention,  preparedness,  and  response 
capacities  and  capabilities  of low-  and  middle-income  countries through 
investments and technical support at the national, regional, and global levels 

The  Transatlantic  Taskforce  on  Antimicrobial  Resistance  (TATFAR)  (343)  was 
established  in  2009  following  a  US-EU  summit  to  address  the  urgent  global 
challenge  of  AMR.  It  is  a  collaborative  effort  between  the  US,  Canada,  the 
European Union, Norway, and the United Kingdom, focusing on improving the 
appropriate  use  of  antimicrobials,  enhancing  AMR  surveillance,  preventing 
drug-resistant infections, and fostering the development of new antimicrobial 
drugs. 

(343)  Transatlantic Taskforce on Antimicrobial Resistance (TATFAR), accessed 3 November 2025, 

https://www.cdc.gov/tatfar/php/about/index.html.   

112 

 
 
 
ANNEX 6: Overview of EU-funded actions, grants, and projects 
related to health crises 

The  Commission  has  several  funding  instruments  that  contribute  to  preparedness, 
prevention  and  response  to  health  crises  by  addressing  several  key  areas  such  as 
strengthening surveillance, laboratory capacity, advancing knowledge on surveillance, 
and  research  and  development  of  MCMs.  Below  is  a  summary  of  some  of  these 
instruments.  

EU4Health  

The  EU4Health  Programme  (344)  is  a  funding  instrument  within  the  Multiannual 
Financial  Framework  (2021–2017),  is  designed  to  strengthen  health  systems  and 
preparedness,  also  addressing  the  weaknesses  in  health  systems  revealed  by  the 
COVID-19 pandemic. It is the largest EU health programme to date, with an indicative 
budget  of  EUR  4.4  billion  over  seven  years  (2021–2027).  The  programme  aims  to 
improve  and  foster  health  in  the  Union,  protect  people  from  serious  cross-border 
threats  to  health,  improve  medicinal  products,  medical  devices  and  crisis-relevant 
products, and strengthen health systems. The EU4Health Programme is implemented 
through annual Work Programmes that support a broad range of actions, including a 
strand on crisis preparedness. The Commission is responsible for the management of 
the  EU4Health  Programme  and  is  supported  by  the  European  Health  and  Digital 
Executive Agency (HaDEA) (345) to implement actions under the programme.  

Horizon Europe 

Horizon  Europe  (346)  is  the  EU’s  flagship  funding  programme  for  research  and 
innovation.  The  programme  facilitates  collaboration  and  strengthens  the  impact  of 
research and innovation in developing, supporting and implementing EU policies while 
tackling  global  challenges  and  strengthening  the  EU  industrial  competitiveness. It 
supports  the  creation  and  better  diffusion  of  scientific  knowledge  and  new 
technologies. The indicative funding amount for Horizon Europe for 2021–2027 is EUR 
93.5  billion.  Horizon  Europe's  Pillar  II  is  organised  into  clusters,  including  cluster 
focused  on  health,  which  aims  to  improve  and  protect  the  health  and  well-being  of 
citizens of all ages. This cluster seeks to generate new knowledge, develop innovative 
solutions, and incorporate a gender perspective, where relevant, to prevent, diagnose, 
monitor, treat and cure diseases. The Commission is responsible for the management 

(344)  European Commission, ‘EU4Health’, European Commission website, accessed 3 November 2025, 

https://commission.europa.eu/funding-tenders/find-funding/eu-funding-programmes/eu4health_en. 

(345)  European Health and Digital Executive Agency, ‘Funded projects: Overview of all funded projects under the Horizon 

Europe – Health programme’, European Commission website, accessed 3 November 2025, 
https://hadea.ec.europa.eu/programmes/horizon-europe/health/funded-projects_en.. 

(346)  European Commission, ‘Horizon Europe’, European Commission website, accessed 3 November 2025, 

https://research-and-innovation.ec.europa.eu/funding/funding-opportunities/funding-programmes-and-open-
calls/horizon-europe_en. 

113 

 
 
of the activities under this cluster of Horizon Europe and is supported by HaDEA in the 
implementation of those actions.  

Union Civil Protection Mechanism 

The  Union  Civil  Protection  Mechanism  funds  both  multi-country  and  single-country 
capacity-building  projects,  exercises,  and  technical  support  actions,  including  those 
related to emergency health response. Funding sources and information on selected 
projects can be found on the UCPM Knowledge Network (347).  

Recovery and Resilience Facility 

The Recovery and Resilience Facility (348) is the centrepiece of  NextGenerationEU 
(349),  a  temporary  recovery  instrument  designed  to  support  Europe’s  economic 
recovery from the COVID-19 pandemic and to build a greener, more digital and more 
resilient future. Within the 2021–2026 period, the Recovery and Resilience Facility 
(RRF) offers  grants  and  loans  to  support  reforms  and  investments  in  EU  Member 
States. RRF funds are provided to Member States in  accordance with their national 
Recovery and Resilience plans, which serve as roadmaps for reforms and investments 
aimed at making EU economies greener, more digital and more resilient. 

Cohesion Policy Funds 

Cohesion policy is the European Union's primary investment policy, aimed at reducing 
disparities and enhancing economic, social, and territorial cohesion. In this regard, EU 
Cohesion policy supports investment in health services and infrastructure as they are 
critical to regional and territorial development, social inclusion, and competitiveness. 
Its investments play a vital role in supporting Member States and regions in facilitating 
equal  access  to  health,  social  and  long-term  care  and  creating  more  effective  and 
resilient healthcare systems. This includes enhancing preparedness and adaptability 
of  the  healthcare  sector,  ensuring  that  systems  are  equipped  to  manage  emerging 
health challenges effectively. 

While the European Social Fund Plus (ESF+) supports investments in services, human 
capital  and  social  inclusion,  the  European  Regional  Development  Fund  (ERDF) 
focuses on investments in infrastructure, equipment and cooperation across borders 
in health. For the 2021–2027 programming period, Member States have allocated EUR 
7.3  billion  from  the  ERDF  and  across  national,  regional  and  Interreg  programmes. 
Examples  of  ERDF  investments  include  health  infrastructure  and  equipment  for 
community-based,  primary,  secondary,  tertiary  and  hospital  care,  digitalisation  of 
health services, mobile health units, and cross-border service provision. 

(347)  UCPM Knowledge Network, accessed 3 November 2025, https://civil-protection-knowledge-network.europa.eu. 
(348)  European Commission, ‘The Recovery and Resilience Facility’, European Commission website, accessed 3 November 
2025, https://commission.europa.eu/business-economy-euro/economic-recovery/recovery-and-resilience-facility_en. 

(349)  NextGenerationEU, accessed 3 November 2025, https://next-generation-eu.europa.eu/index_en. 

114 

 
 
 
As part of the Cohesion policy mid-term review, new specific objectives prioritising civil 
preparedness were introduced. This would allow to address investments in healthcare 
infrastructure,  such  as  (field)  hospitals  and  medical  emergency  infrastructure  and 
equipment, stockpiling and cybersecurity. 

InvestEU Programme 

The InvestEU programme provides the European Union with crucial long-term funding 
by leveraging private and public funds in support of Europe’s sustainable recovery. It 
helps  to  mobilise  private  investments  for  the  EU's  top  policy  priorities,  such  as  the 
green, and digital transition, innovation and social investments and skills. 

Under  InvestEU, the HERA  Invest,  is an  EU-backed  financing  initiative  launched  by 
the Commission and the European Investment Bank (EIB) which aims to support small 
and mid-sized companies (SMEs) developing MCMs against major health threats such 
as: 

•  Pathogens with pandemic or epidemic potential 
•  Chemical, biological, radiological, and nuclear (CBRN) threats 
•  Antimicrobial resistance 

The initiative provides venture loans covering up to 50% of project costs, helping bridge 
funding  gaps  and  stimulate  innovation  in  health  emergency  preparedness  and 
response across Europe. 

So far, three European SMEs have been provided with a loan by the EIB. These are 
Fabentech, developing broad-spectrum therapeutics against biological threats (notably 
toxins),  SNIPR  Biome  developing  CRISPR-based  antibacterial  therapies  targeting 
antimicrobial  resistance  (AMR)  and  Leyden  Labs,  developing  intranasal  antibody 
therapies for respiratory viruses.  

Examples  of  EU-funded  actions,  grants,  and  projects  under  EU4Health 

and Horizon Europe 

The following sections outline some illustrative examples of actions, grants, and 
projects specifically funded under the EU4Health and Horizon Europe programmes. 
Information presented is indicative, subject to availability of resources and adoption 
of the annual budget and work programmes. Moreover, it does not prejudge the 
outcome of the negotiations on the Multiannual Financial Framework.  

115 

 
 
EU contribution 
(EUR) 

Period 

7 000 000 

2023-2026 

10 000 000 

2024-2026 

15 000 000 

2027-2028 

83 400 000 

2025-2030 

53 800 000 

2022-2027 

Surveillance 

Action 

Description 

Direct grants to 
Member States’ 
authorities: Union 
and national 
surveillance systems 
(Joint Action 
UNITED4Surveillance) 

Setting up a 
coordinated 
surveillance under 
the One Health 
approach 
(OH4Surveillance)  

Direct Grants to 
Member States for 
improving national 
integrated 
surveillance systems 

Direct Grants to 
Member States’ 
authorities for 
enhancing Whole 
Genome Sequencing 
and/or RT-PCR 
national 
infrastructures and 
capacities to respond 
to the COVID-19 
pandemic and future 
health threats 

This joint action aims to support Member States and 
the  Union  in  the  implementation  of  digitalised, 
integrated  surveillance  systems  at  Union  and 
national  level,  to  ensure  better  detection  of  early 
signals for accurate risk assessment and response. 

the 

supports 

OH4Surveillance 
participating 
countries  to  set  up  and  scale  up  One  Health 
surveillance  to  priority  pathogens  in  an  efficient, 
coordinated  and  collaborative  manner.  The  scope 
of the project is limited to One Health surveillance 
aiming  to  protect  public  health  through  the  early 
detection  of  emerging  and  re-emerging  zoonotic 
pathogens in animals and environment. 

The  aim  of  the  direct  grant  is  to support  Member 
States to improve their surveillance  system in line 
with  and  building  on  the  outcomes  of  the  JA 
UNITED4Surveillance.  The  activities  that  could  be 
carried out towards scaling up national surveillance 
systems  aim  to  facilitate  the  required  national 
the  development  of 
capacity  building 
interoperable, 
reliable  and  modern  national 
surveillance  systems.  The  action  will  be  driven  by 
digital  transformation,  making  use  of  relevant 
available  health  data  and  public  health  research 
results.  

for 

Set  of  several  direct  grants  covering  over  20  EU 
Member  States  and  neighbouring  countries  for 
enhancing  WGS 
national 
and/or 
infrastructures  and  capacities.  Depending  on  pre-
existing  capabilities,  these  grants  are  covering  the 
creating  of  new  national  laboratory  infrastructure 
both  at  central,  regional,  and  local  level,  against 
HERA’s priority pathogens and/or AMR. 

RT-PCR 

116 

 
EU contribution 
(EUR) 

Period 

2 625 000 

2025-2031 

3 500 000 

2025-2031 

6 975 000 

2025-2031 

2 275 000 

2025-2031 

3 500 000 

2025-2031 

Laboratories 

Action 

Description 

EU Reference 
Laboratory for 
public health in 
the field of 
Antimicrobial 
Resistance (AMR) 
in bacteria  

EU Reference 
Laboratory for 
public health in 
the field of 
Antimicrobial 
Resistance (AMR) 
in bacteria  

EU Reference 
Laboratory for 
public health in 
the field of 
Antimicrobial 
Resistance (AMR) 
in bacteria  

EU Reference 
Laboratory for 
public health in 
the field of 
Antimicrobial 
Resistance (AMR) 
in bacteria  

EU Reference 
Laboratory for 
public health in 
the field of 
Antimicrobial 
Resistance (AMR) 
in bacteria  

The  purpose  of  this  application  is  to  set  up  and 
coordinate  a  network  of  national 
reference 
laboratories  for  the  two  diseases.  This  is  achieved 
through  establishment  of  a  EURL  designated  for 
pertussis  and  diphtheria,  and  by  maintaining  the 
reference laboratory functions. This project will focus 
to  enhance  protection  and  preparedness  against 
pertussis and diphtheria in Europe. 

and 

characterisation 

The EU  funded  project  on  EURL-PH-VBV  provides 
comprehensive  scientific  and  technical  support  on 
detection 
methods, 
interpretation of results in line with EU laboratory case 
definitions, 
outbreak 
preparedness, and response strategies. A key focus of 
in 
the EURL-PH-VBV 
laboratory  testing  and  activities  across  the  EU  to 
ensure the generation of standardised data. 

to  promote  uniformity 

surveillance, 

laboratory 

is 

The  support  will  be  delivered  in  the  field  of  AMR  in 
bacteria  of  public  health  relevance,  and  relate  to 
reference  diagnostics,  reference  material  resources, 
external  quality  assessments,  scientific  advice  and 
technical  assistance,  collaboration  and  research, 
monitoring, alert and support in outbreak response to 
bacteria  resistant  to  antimicrobials  and  training.  The 
capacity 
are  
the  overarching  goal  of  this  endeavour  is  to  assess, 
develop  and  improve  strategies  for  prevention  and 
control of AMR in target priority pathogens. 

activities 

building 

The main objective of the EURL-PH-LEGI is to promote 
best practices and support EU Member States and EEA 
countries in the field of diagnosing, testing, and typing 
methods  for  Legionella.  This  aims  to  ensure  reliable 
laboratory 
and 
capacities, and improve the surveillance, notification, 
and reporting of cases. 

comparable  data, 

strengthen 

health 

concern, 

The EURL-PH-ERZV consortium provides scientific and 
technical  expertise  on  high-risk  viral  pathogens  of 
public 
poxviruses, 
arenaviruses, hantaviruses, filoviruses, henipaviruses, 
lyssaviruses,  and  novel  emerging  viruses  such  as 
disease X. These pathogens pose significant challenges 
for 
outbreak 
surveillance, 
management. 

diagnostics, 

including 

and 

117 

 
EU Reference 
Laboratory for 
public health in 
the field of 
Antimicrobial 
Resistance (AMR) 
in bacteria  

Delivering a 
Unified Research 
Alliance of 
Biomedical and 
public health 
Laboratories 
against Epidemics 
(DURABLE) 

2 893 000 

2025-2031 

The  EURL  aims  to  strengthen  national  expert 
laboratories’  capacities  and  to  support  a  uniform 
surveillance, notification and reporting of diseases or 
the  causative  bacterial  agents.  By  promoting  good 
practice and alignment on diagnostics in the network 
rapid  and 
member 
coordinated 
the  ECDC 
surveillance reporting system will be enhanced.  

laboratories,  an  efficient, 
to 
response  according 

25 000 000 

2023-2027 

DURABLE  aims  to  provide  high-quality  scientific 
information  in  record  time  to  support  Commission’s 
decision-making  in  preparing  for  and  responding  to 
cross-border health threats and assessing the impact 
of countermeasures. DURABLE will coordinate a global 
collaboration, from pathogen detection, evolutionary 
analysis and threat characterisation, with One Health 
approach,  to  data  and  information  collection  and 
sharing,  for  optimal  threat  response.  DURABLE  is  a 
unique 
with 
complementary expertise to  meet  this challenge and 
build productive interactions with the Commission and 
other stakeholders. 

multidisciplinary 

consortium 

Health system preparedness and resilience 

Action 

Description 

European 
Partnership for 
pandemic 
preparedness (BE 
READY Partnership) 

Joint Action 
HEROES 

BE  READY  Partnership  aims  to  enhance  the  EU's 
preparedness  for  predicting  and  responding  to 
emerging  infectious  health  threats.  This  will  be 
achieved by improving the coordination of funding for 
research  and  innovation  at  the  EU,  national,  and 
regional levels, directed towards common objectives 
outlined  in  an  agreed-upon  Strategic  Research  and 
Innovation  Agenda,  and  by  strengthening 
the 
readiness  of  the  research  ecosystem, 
including 
research  sites  and 
networks  of  “ever-warm” 
infrastructures. 

The  objective  of  this  action  is  to  improve  health 
workforce  planning  for  long-term  forecasting  of  the 
demand  for  health  workforce  and  use  of  health 
workforce  planning  to  address  structural  challenges 
with 
shortages  of  professionals  and  support 
modernisation of healthcare delivery. 

EU contribution 
(EUR) 

Period 

120 000 000 

2026-2032 

7 000 000 

2023-2026 

118 

 
Nursing Action 

The  aim  of  this  action  is  to  increase  the  supply  of 
nurses  and  improve  retention  in  the  EU  Member 
States.  Over  36  months,  it  will  develop  evidence-
based strategies for recruitment and retention, scale 
up mentorship programmes, promote nurses’ health 
and  well-being,  support  safe  staffing  practices,  and 
enhance  the  integration  of  digital  solutions  into 
nursing workflows.  

1 300 000 

2025-2027 

Seven Actions to 
provide training for 
health workforce, 
including digital 
skills 

The  objective  is  to  support  training  initiatives  for 
clinical  and  non-clinical  staff  with  a  focus  on  digital 
skills  and  other  relevant  skills  needed  for  surge 
capacity in crises and for the transformation of health 
systems, reaching 20.000 health professionals 

16 000 000 

2023-2026 

10 000 000 

2023-2026 

EU contribution 
(EUR) 

Period 

1 400 000 

2023-2026 

Joint Action CIRCE 

Improving access 
to healthcare for 
refugees and 
people displaced 
from Ukraine 
benefitting of 
temporary 
protection in 
Member States 

The  objective  of  this  action  is  to  transfer  good 
practices  in  primary  care  among  Member  States. 
Specifically,  six  good  practices  coming  from  four 
Member  States  (Belgium,  Portugal,  Slovenia,  and 
Spain) will be transferred to 40 new implementation 
sites  in  12  Member  States.  Strong  primary  care  is  a 
cornerstone  of  accessible,  effective  and  resilient 
health systems. 

Two complementary actions were funded to address 
this  challenge.  The  first  one  supported  Bulgaria, 
Czechia, Estonia, Hungary, Latvia, Lithuania, Moldova, 
Poland,  Romania,  and  Slovakia  in  reducing  health 
inequalities, strengthening health systems, improving 
access  for  refugees  and  displaced  persons  from 
Ukraine,  and  integrating  displaced  health  workers. 
The second one used the resilience test methodology 
for migration in the health systems of Latvia, Czechia, 
Romania, Poland, and Moldova. 

Vaccination 

Action 

Description 

Vax-Action: tackling 
effectively vaccine 
hesitancy in Europe 
(VAX-Action) 

The project  aims to support EU Member States and 
relevant stakeholders to implement a combination of 
interventions  aimed  to 
tailored,  evidence-based 
reduce  vaccine  hesitancy.  It  addresses  the  need  to 
understand  what  type  of  interventions  are  now 
available,  which  are  effective,  how  to  translate 
effective  interventions  to  new  contexts,  and  to 
explain the unsuccessful ones to create opportunities 
for learning and redesign.  

119 

 
 
 
 
 
Antimicrobial resistance 

Action 

Description 

Joint Action on 
Antimicrobial 
Resistance and 
Health Associated 
Infections 2 (EU-
JAMRAI 2) 

EU One Health 
AMR Partnership 
(EUP OH AMR)  

Following the 2017 EU One Health Action Plan against 
AMR to make Europe a best practice region and the 
first  European  Joint  Action  (JA)  on  AMR  and 
Healthcare-Associated  Infections  (EU-JAMRAI),  this 
new 
JA,  EU-JAMRAI  2,  will  support  Member 
States/Associated  Countries  (MS/AC)  in  their  efforts 
to  develop  and  update  their  National  Action  Plan 
(NAP) on AMR.  

The European partnership on One Health AMR is one 
of the key partnerships that has been identified by the 
EC  within  the  framework  of  the  Horizon  Europe 
programme  to  support  R&I  to  respond  to  the 
challenges  of  AMR. EUP  OH  AMR (2025-2035) will 
contribute to the objectives of the EU Action Plan on 
antimicrobial resistance (AMR), to combat the critical 
societal challenge of AMR and reduce the burden of 
AMR by:  

Period 

EU 
contribution 
(EUR) 

50 000 000 

2024-2028 

75 000 000 

2025-2035 

European 

Enhancing 

global synergy, 
• 
collaboration 
different  One 
Health sectors and multiple disciplines, and alignment 
of strategic OH AMR R&I and policies to break silos;  

between 

and 

the 

•  Boosting  AMR  R&I  to  generate  knowledge  and 
develop solutions to prevent and tackle AMR;  

• Facilitating knowledge  valorisation  of  R&I 
products, policy and practice.  

into 

Vector-borne diseases 

Action 

Description 

The  project  aims  to  contribute  to  the  work  of  the 
Ministry  of  Health  of  Cyprus  to  train,  supervise 
laboratory  technicians  for  the  production  of  Aedes 
aegypti mosquitos to be used in Cyprus to suppress 
Aedes aegypti. 

Sterile Insect 
Technique (SIT) 
approach as tool to 
suppress yellow 
fever mosquito 
(Aedes aegypti) on 
Cyprus and to build 
capacity for the use 
of this vector 
control technique 
in the Union 

120 

EU contribution 
(EUR) 

Period 

500 000 

2024-2027 

 
Medical countermeasures  

Action 

Description 

Ever-warm facilities 
(EU FAB) for 
vaccines and 
therapeutics 
production 

Joint action on 
comprehensive and 
sustainable 
strategic stockpiles 
of medical 
countermeasures 
used in crisis 

European Vaccines 
Hub for Pandemic 
Readiness (EVH) 

The EU FAB network comprises vaccine producers in 
the EU (Belgium, Ireland, the Netherlands, Spain). The 
actions  of  the  network  will  close  the  gap  between 
manufacturing and scaling up of vaccine production, 
while ensuring the capacity of the industry to produce 
life-saving  medicines. EU 
reserve 
manufacturing  capacities  for  the  EU  to  produce 
vaccines in case of public health emergencies. 

FAB  will 

This  Joint  Action  (JA  Stockpile)  will  contribute  to 
better  preparedness  against  serious  cross-border 
threats  to  health,  more  sustainable  stockpiles  of 
MCMs, 
and 
dispensing  of  MCMs,  better  collaboration  between 
Member  States,  better  evidence-base  for  future 
thus 
proposals  on  stockpiling  of  MCMs  and 
strengthening of European independence in crisis. 

faster  distribution,  deployment 

To  ensure  Europe’s  vaccines 
readiness  and 
responsiveness to pandemics, this project will create 
the European Vaccine Hub (EVH) by aligning existing 
nationally  funded  vaccine  R&D  investments  into  a 
collaborative  network  for  the  end-to-end  vaccine 
delivery. 

EU contribution 
(EUR) 

160  000  000  (per 
year) 

Period 

2023-2027 

10 000 000 

2025-2028 

102 000 000 

2025-2029 

121 

 
Wastewater surveillance 

Action 

Description 

Joint Action EU-
Wastewater Integrated 
Surveillance for Public 
Health (EU-WISH) 

Global Consortium for 
Wastewater and 
Environmental 
Surveillance for Public 
Health (GLOWACON) 

EU Wastewater 
Observatory for Public 
Health  

The European Super-Sites 
for Wastewater 
Surveillance  

Support strategies, 
capacity and data for 
global wastewater and 
environmental 
surveillance 

EU-WISH brings together 25 EU Member States and EEA countriess and Ukraine 
to strengthen national capacities for wastewater surveillance for public health. It 
will map priority targets for wastewater-bases surveillance and define, harmonise 
and expand wastewater monitoring strategies, technical procedures and relevant 
operational  approaches  including  effective,  easily  interpretable,  and  actionable 
communication of wastewater-bases surveillance parameters. 

GLOWACON,  the  Global  Consortium  for  Wastewater  and  Environmental 
Surveillance for Public Health brings together diverse partners from across sectors 
and  countries  to  share  knowledge,  expertise,  and  resources,  with  the  goal  of 
creating a safer and healthier world for all.GLOWACON’s mission is to promote 
the  institutionalisation  of  wastewater  and  environmental  surveillance  within 
public  health  systems,  and  to  develop  a  global  sentinel  system  for  epidemic 
outbreaks. This system will enable early threat detection, prevention, and real-
time  monitoring,  supporting  public  health  decision-making  and  pandemic 
preparedness.  By  building  on  existing  local,  national,  and  regional  efforts,  and 
governed by a mechanism agreed upon by participating stakeholders, the sentinel 
system creates a voluntary network of data sharing that transcends borders and 
time zones to detect and respond to health threats more quickly and effectively, 
saving lives and protecting communities. 

The European Wastewater Surveillance Dashboard, an innovative tool designed 
to track the spread of infectious diseases by analysing wastewater across Europe. 
this platform integrates data from various sources throughout Europe, combining 
near real-time wastewater monitoring with existing national and research-based 
dashboards.  By  providing  early  warnings  for  emerging  pathogens  and  health 
crises,  the  dashboard  facilitates  rapid  responses  to  disease  outbreaks.  This 
capability  reduces  the  time  it  takes  for  health  systems  to  react,  ultimately 
protecting citizens across the EU. 

The European Super-Sites are a network of strategically located sites across the 
European Union and other areas of EU-interest, designed to enhance public health 
surveillance by monitoring wastewater for pathogens and other health indicators. 
They  are  integrated  into  the  EU  Wastewater  Observatory  for  Public  Health. 
Positioned near key transportation nodes, including airports and train stations or 
at other locations such as hospitals, these sites provide critical epidemiological 
insights  into  the  presence  and  spread  of  pathogens,  serving  as  early  warning 
systems for new threats entering through international travel. The main purpose 
of  the  European  Super-Sites  is  to  deliver  timely  and  accurate  data  to  health 
authorities,  aiding  in  public  health  decision-making.  They  collaborate  with  the 
aviation industry to include samples from aircraft and airfields, thus broadening 
the scope of surveillance. 

Collaboration with the WHO and UNEP to develop wastewater and environmental 
surveillance strategies, building capacity (especially in low-resource and strategic 
settings), and foster transparent information exchange. 

122 

 
 
ANNEX  7:  Digital  platforms  for  public  health  intelligence  in  the 
EU/EEA 

Name (abbreviation) 

Purpose 

Digital European 
Exchange Platform 
(DEEP) 

Platform of the Commission to collect and connect data from various wastewater 
surveillance  activities  and  transform  the  data  into  actionable  information  for  the 
public. 

Epidemic Intelligence 
from Open Sources 
tool (EIOS) (350) 

European surveillance 
portal for infectious 
diseases (EpiPulse) 

Monitoring open sources of information, building on a long-standing collaboration 
between the WHO and the Commission. The EIOS initiative is a WHO programme 
that supports countries and partners in early detection of public health threats by 
using open-source data, improving analytical capacities, and providing better tools 
and insights for decision-making. EIOS acts as an early detection platform, with a 
significant portion of public health events being first identified through the system 
before official notification. 

Platform owned and operated by the ECDC and used by MSs, candidate countries, 
potential candidate countries,  other non EU/EEA countries, partner organisations 
for  the  integrated  indicator-  (EpiPulse  Cases)  and  event-based  (EpiPulse  Events) 
surveillance of infectious disease origin in the EU/EEA to collect, analyse, share and 
discuss  infectious  disease  data.  Interlinked  to  the  EWRS  to  facilitate  sharing  of 
situational awareness for incident management. 

European Respiratory 
Virus Surveillance 
Summary (ERVISS) 

Weekly  integrated  epidemiological  summary  of  the  ECDC  and  the  WHO  for 
influenza, respiratory syncytial virus (RSV) and severe acute respiratory syndrome 
coronavirus 2 (SARS-CoV-2) (128).  

(350)  WHO, ‘Epidemic Intelligence from Open Sources (EIOS)’, WHO website, accessed 3 November 2025, 

https://www.who.int/initiatives/eios.  

123 

 
 
ANNEX  8.  Alert  information  systems  in  the  EU  for  managing 
health crises 

Name 
(abbreviation) 

Advanced 
Technology for 
Health Intelligence 
and Action IT 
System (ATHINA) 

Animal Disease 
Information 
System (ADIS) 

Common 
Emergency 
Communication 
and Information 
System (CECIS) 

Customs Risk 
Management 
System (CRMS2) 

Early Warning and 
Response System 
(EWRS) 

Early Warning 
System on new 
psychoactive 
substances (EWS) 

European 
Community 
Urgent 
Radiological 
Information 
Exchange (ECURIE) 

European Flood 
Awareness System 
(EFAS) 

European Public 
Warning System 
(EU-Alert) 

Purpose 

System of the Commission for identification, analysis and management of supply chain 
vulnerabilities of MCMs. 

Platform  for  gathering  information  on  demand  and  supply  of  MCMs,  analysing 
intelligence  to  detect  supply  chain  vulnerabilities  or  risks  and  supporting  threat 
assessment related to MCMs. Enables the exchange of information related to needs and 
availability of MCMs. 

System of the Commission for tracking the evolution of infectious animal diseases with 
National competent authorities in the EU/EEA and participating countries 

System of the Commission for coordination of EU-wide  emergency support, including 
medical assistance and logistics together with National competent authorities in the EU 
and UCPM Participating States 

System of the Commission for the exchange of risk related infromation between national 
customs authorities. The Crisis Management module of CRMS2 supports coordination of 
customs risk management and controls of the customs authorities. 

System  of  the  Commission,  operated  by  the  ECDC,  for  information  exchange,  alert 
notification  and  management  of  serious  cross-border  threats  to  health  with  National 
EWRS competent authorities in the EU/EEA and participating countries. It facilitates also 
cross-border  contact-tracing,  medical  evacuation,  risk  assessment  and  prevention, 
preparedness and response planning. EWRS allows for the processing of sensitive non-
confidential (SNC) information and is interlinked with the EpiPulse system. EU agencies 
associated countries and the WHO have visibility to some of its functionalities. Member 
States and the Commission are joint controllers of the personal data in the EWRS. 

First  step  in  a  three-step  legal  framework  designed  to  allow  the  European  Union  to 
rapidly  detect,  assess,  and  respond  to  health  and  social  threats  caused  by  new 
psychoactive  substances  (NPS).  EuDA’s  work  of  the  EWS aims  to  build,  maintain,  and 
strengthen situational awareness, preparedness, and response activities at national- and 
focal  points/national  EWS 
EU-level 
correspondents, the Commission and relevant EU agencies an bodies. 

in  collaboration  with  National 

to  NPS 

System  of  the  Commission  for  early  notification  and  information  exchange  on 
radiological or nuclear emergencies 

System of the Commission for probabilistic flood early warning information up to 10 days 
in advance. Part of the Copernicus Emergency Management Service. 

Framework for national systems on emergency alerts to mobile phones based on Cell 
Broadcast technology 

124 

 
HERA 
Stakeholders HUB 

Secure portal of the Commission for collaboration and information exchange with MCM 
developers, producers, and economic operators across the EU, including pharmaceutical 
manufacturers  and  suppliers.  Supports  matchmaking,  structured  communication,  and 
coordinated response to supply chain vulnerabilities. 

Rapid Alert 
System for 
Dangerous Non-
Food Products 
(Safety Gate) 

Rapid Alert 
System for Blood 
and Blood 
Components 
(RAB) 

Rapid Alert 
System for Food 
and Feed (RASFF) 

Rapid Alert 
System for Tissues 
and Cells (RATC) 

Rapid Alert for 
quality defects of 
medicinal 
products 

EU rapid alert system for dangerous non-food products (351) 

System of the Commission for communication with National vigilance contact points for 
substances  of  human  origin  regarding  serious  adverse  reactions  or  events  related  to 
blood 

System of the Commission to notify risks to human health from food or feed, including 
contaminants or infectious agents 

System of the Commission for communication with National vigilance contact points for 
substances of human origin on adverse events involving human tissues and cells 

System  of  the  EMA  for  communication  with  National  competent  authorities,  the 
Commission and international partners of urgent information related to quality defects 
and recalls of medicinal products 

Pharmacovigilance 
Rapid Alert 

System  of  the  EMA  for  rapid  exchange  of  information  with  National  competent 
authorities and the Commission on safety concerns related to medicines 

(351)  European Commission, ‘Safety Gate: EU rapid alert system for dangerous non-food products’, European Commssion 

website, accessed 20 November 2025, https://ec.europa.eu/safety-gate.  

125 

 
 
 
Getting in touch with the EU 

In person 

All over the European Union there are hundreds of Europe Direct centres. You 
the  centre  nearest  you  online  (european-
the  address  of 
can 
union.europa.eu/contact-eu/meet-us_en). 

find 

On the phone or in writing 

Europe  Direct  is  a  service  that  answers  your  questions  about  the  European 
Union. You can contact this service: 

–  by freephone: 00 800 6 7 8 9 10 11 (certain operators may charge for these 

calls), 

–  at the following standard number: +32 22999696, 
–  via the following form: european-union.europa.eu/contact-eu/write-us_en. 

Finding information about the EU 

Online 

Information about the European Union in all the official languages of the EU is 
available on the Europa website (european-union.europa.eu). 

EU publications 

You can view or order EU publications at op.europa.eu/en/publications. Multiple 
copies of free publications can be obtained by contacting Europe Direct or your 
local  documentation  centre 
(european-union.europa.eu/contact-eu/meet-
us_en). 

EU law and related documents 

For access to legal information from the EU, including all EU law since 1951 in 
all the official language versions, go to EUR-Lex (eur-lex.europa.eu). 

EU open data 

The  portal  data.europa.eu  provides  access  to  open  datasets  from  the  EU 
institutions,  bodies  and  agencies.  These  can  be  downloaded  and  reused  for 
free,  for  both  commercial  and  non-commercial  purposes.  The  portal  also 
provides access to a wealth of datasets from European countries. 

 
 
 
 
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