Proposal for a COUNCIL REGULATION 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
Date: 2021-09-16
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: coronavirus disease, crisis management, cross-border cooperation, disease prevention, emergency aid, emergency medical treatment, epidemic, health care, public health, security of supply

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   EUROPEAN COMMISSION  Brussels, 16.9.2021  COM(2021) 577 final 2021/0294 (NLE)  Proposal for a COUNCIL REGULATION 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  
 
 
EXPLANATORY MEMORANDUM 

1. 

• 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

This proposal for a Regulation aims to put in place a framework of measures to be 
activated in case of a public health emergency by enabling the Union to take the 
necessary  measures  for  a  sufficient  and  timely  availability  and  supply  of  crisis-
relevant medical countermeasures.  

On 15 June 2021, the Commission presented a Communication on the early lessons 
from  the  COVID-19  pandemic1  setting  out  the  need  for  the  Union  to  have  special 
arrangements in place to better react in times of health crisis. In November 2020, the 
Commission had put forward proposals for a stronger European Health Union, and is 
now  creating  a  new  Union  Health  Emergency  preparedness  and  Response 
Authority  (HERA)  within  its  services.  This  will  provide  an  agile,  robust  and 
sustainable  health  security  structure  to  improve  the  availability  of  medical 
countermeasures. It would operate during both preparedness and crisis situations.  

The COVID-19 pandemic revealed significant vulnerabilities in the European health 
preparedness for and response to public health emergencies. The measures set out in 
this  Regulation  relate  to  the  crisis  response  mode.  They  will  complement  the 
development  of  HERA  as  a  new  driver  for  Union  action  to  address  cross-border 
threats.  

EU  structures,  Member  States  and  the  industrial  sector  involved  in  medical 
countermeasures were not sufficiently prepared to ensure the efficient development, 
manufacturing,  procurement,  and  equitable  distribution  of  key  medical 
countermeasures2 in response to the pandemic. The pandemic also revealed too many 
fragmented  research  activities  across  the  Union,  often  rather  limited  in  scope  and 
limited  manufacturing  capacities  for  medical  countermeasures,  as  well  as 
vulnerability in related global supply chains. These limitations ultimately resulted in 
delays and inefficiencies in the response, which cost lives and harmed the economy. 

In  particular, 
countermeasures were identified. 

the 

following  problems 

related 

to  crisis-relevant  medical 

● 

● 

Insufficient  and  scattered  intelligence  gathering  and  analysis,  which  is 
crucial  for  underpinning  preparedness  and  response  plans  for  crisis-relevant 
medical  countermeasures  as  well  as  for  ensuring  that  response  interventions 
adequately  ensure  availability  and  accessibility  of  crisis-relevant  medical 
countermeasures. 

Sub-optimal intervention tools and the absence of fully functional public-
private  ecosystems,  which  did  not  allow  the  Union  to  take  a  proactive 
approach with strategic and well-informed interventions, which are required to 
mobilise  resources  and  accelerate  the  short  timeframes  for  the  process  of 
research to final market product. 

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2 

COM(2021)380  
These are medicinal products for human use as defined in Directive 2001/83/EC and medical devices as 
defined  in  Regulation  (EU)  2017/745  or  other  goods  or  services  for  the  purpose  of  preparedness  and 
response to a serious cross-border threat to health. 

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● 

● 

to 

Impediments 
swift  manufacturing  of  crisis-relevant  medical 
countermeasures,  which  can  be  linked  to  vulnerabilities  and  difficulties 
experienced  in  manufacturing  and  supply  chains,  emergency  funding  and 
regulatory  frameworks,  research  and  data  sharing  as  well  as  insufficient 
manufacturing capacities in particular at the beginning  of the COVID-19 
pandemic. 

Fragmented  and  dispersed  efforts  at  the  Union  and  national  levels, 
aggravated by inadequate coordination and information sharing, which resulted 
the  availability  of  crisis-relevant  medical 
in  an 
countermeasures and to provide timely access to them. 

to  secure 

inability 

Some  steps  to  address  these  shortcomings  come  through  better  preparedness.  But 
others  require  powers,  instruments  and  actions  which  are  only  appropriate  to  cross 
border emergency situations. The Union did not have a specific emergency mandate 
for  the  coordination  of  Union  activities  able  to  ensure  rapid  availability  and 
accessibility  of  crisis-relevant  medical  countermeasures  for  all  Member  States. 
Member  States  each  had  different  capacities  to  prepare,  respond  with  and  manage 
crisis-relevant  medical  countermeasures.  Neither  national  nor  EU  level  had  the 
capacity to respond as required already in place: the response had to be created from 
imperfect  foundations.  This  situation  is  likely  to  be  replicated:  probably  no  single 
country  can  adequately  address  all  the  challenges  associated  with  public  health 
emergencies  that  have  the  ability  to  affect  one  or  more  Member  States,  such  as 
COVID-19.  Rapidly  changing  technological  and  competitive  environments  make 
country-specific responses still more difficult. Uncoordinated efforts may also lead to 
fragmentation of an already complex market and duplication of public funding. 

Moreover,  due  to  globalisation,  climate  change,  natural  and  man-made  disasters, 
biodiversity loss, habitat encroachment as well as armed conflicts and terrorism, the 
continuation,  emergence  and  threat  of  public  health  emergencies  remains  a  serious 
likelihood  globally,  requiring  swift  availability  and  accessibility  of  crisis-relevant 
medical countermeasures. 

• 

Consistency with existing policy provisions in the policy area 

This proposal for a Regulation forms one of the main pillars of the European Health 
Union  by  solidifying  the  Union’s  capacity  to  support  timely  availability  and 
accessibility  for  crisis-relevant  medical  countermeasures  during  a  public  health 
emergency.  It  is  proposed  in  conjunction  with  the  proposals  put  forward  by  the 
Commission  in  November  2020:  the  proposal  for  a  Regulation  on  serious  cross-
border  threats  to  health3  and  the  extended  mandates  of  the  European  Centre  for 
Disease  Prevention  and  Control  (ECDC)4  and  the  European  Medicines  Agency 
(EMA).5  Overall,  it  reinforces  the  Union’s  crisis  management  framework.  With 
regard  to  the  proposal  for  an  extended  EMA  mandate,  there  will  be  a  close  link 
between  the  Commission  and  the  EMA  in  order  to  ensure  consistency  and  inform 
crisis-relevant  medical 
Commission 

decision  making  with 

regard 

to 

3 

4 

5 

Proposal for a Regulation of the European Parliament and of the Council on serious cross-border threats 
to health and repealing Decision No 1082/2013/EU (COM(2020) 727 final). 
Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 
851/2004 establishing a European Centre for disease prevention and control (COM/2020/726 final). 
Proposal for a Regulation 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 (COM/2020/725 final). 

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countermeasures.  This  close  link  specifically  pertains  to  the  information  and  the 
recommendations  of  the  Medicines  Steering  Group  and  the  Commission’s  role  to 
take action to ensure mitigation of potential or actual shortages of medicinal products 
on the critical medicines list and the need for medical countermeasures, in line with 
Articles 12 and 26 of the proposal for a Regulation 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.6. 

The  proposed  measures  complement  the  following  current  Union  measures  in  the 
fields of crisis response and health: 

– 

– 

– 

– 

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 282/20147;  

the  medical  response  envisaged  under  Decision  No  1313/2013/EU  of  the 
European  Parliament  and  of  the  Council on  a  Union  Civil  Protection 
Mechanism8; 

the  Union’s  Emergency  Support  Instrument  (Council  Regulation  (EU) 
2016/369 on the provision of emergency support within the Union9); and 
the proposed Pharmaceutical Strategy for Europe10.  

The  proposed  measures  also  complement  other  policies  and  actions  under  the 
European  Green  Deal11  in  the  field  of  climate  and  environment  that  will  support 
enhanced environmental health, disease prevention and increased resilience. 

These  measures  will  support  Member  States,  ensuring  cooperation  towards  the 
availability and supply of crisis-relevant medical countermeasures and raw materials. 
The  Commission,  the  European  Parliament  and  the  Council  have  strongly  affirmed 
the Union’s commitment to scaling up global health emergency preparedness.  

• 

Consistency with other Union policies 

The  proposed  measures  are  in  line  with  the  overarching  objectives  of  the  Union. 
These  include  a  stronger  European  Health  Union,  the  smooth  functioning  of  the 
internal market, fostering sustainable health systems including through the cohesion 
policy that supports regional authorities’ investments in public health and supporting 
cross-border  cooperation  notably  in  neighbouring  regions,  global  health  security 
preparedness, improved preparedness to protect workers12, and an ambitious research 
and  innovation  agenda.  The  proposal  will  also  provide  synergies  with  the  Union’s 
Digital Single Market agenda and in the context of the future European Health Data 
Space,  by  encouraging  innovation  and  research,  facilitating  the  sharing  of 
information  and  data  (including  of  real  world  evidence),  and  supporting  the 

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COM/2020/725 final. 
OJ L 107, 26.3.2021, p. 1. 
OJ L 347, 20.12.2013, p. 924. 
OJ L 70, 16.3.2016, p. 1. 
COM(2020) 761 
COM(2019) 640 final. 
COM(2021) 323 final, EU strategic framework on health and safety at work 2021-2027.   
Occupational safety and health in a changing world of work. 

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development  of  a  Union-level 
countermeasures. 

IT 

infrastructure 

for  monitoring  medical 

The  measures  will  also  further  strengthen  the  framework  of  preparedness  and 
response to threats of biological, chemical, or unknown origin threats at Union level, 
as  well  as  human,  animal  and  environmental  health  in  a  coordinated  One  Health 
approach. This framework also includes the Union’s One Health Action Plan against 
antimicrobial  resistance  (AMR)13  as  well  as  the  EU’s  Action  Plan  to  enhance 
preparedness against chemical, biological, radiological and nuclear security risks14.  

Many EU policy areas are currently drawing the lessons from the crisis and the need 
for dedicated measures to be ready to be put in place in the event of a crisis. 

2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

Given that the proposal for this Regulation aims to ensure the supply and the timely 
availability  and  accessibility  of  crisis-relevant  medical  countermeasures  addressing 
the  economic  impacts  caused  by  public  health  emergencies,  it  is  based  on  Article 
122(1) of the Treaty on the Functioning of the European Union (TFEU). The Council 
may act pursuant to Article 122(1) TFEU to adopt measures that are appropriate to 
address the economic situation, in particular if severe difficulties arise in the supply 
of certain products. 

• 

Subsidiarity (for non-exclusive competence)  

Public  health  emergencies  of  the  magnitude  of  the  COVID-19  pandemic  have  an 
impact  on  all  Member  States.  Actions  by  individual  Member  States  could  neither 
address the challenges resulting from such an emergency nor are they able to provide 
a sufficient response on their own. Unilateral action through Member State initiatives 
aiming  to  ensure  the  sufficient  and  timely  availability  and  supply  of  crisis-relevant 
medical  countermeasures  runs  the  risk  of  increasing  internal  competition  and  sub-
optimal  Union  level  response.  Such  unilateral  action  can  ultimately  result  in 
significant economic consequences and affect the health of Union citizens. 

In particular, in a highly interconnected and interdependent world, people and goods 
move across borders and pathogens and contaminated products can circulate rapidly 
across  the  globe.  Public  health  measures  at  national  level  therefore  need  to  be 
coordinated  across  borders  and 
the  area  of  crisis-relevant  medical 
countermeasures, in  order to  contain further spread and minimise the consequences 
of such threats. Where appropriate to the economic situation, a coordinated response 
at  Union-level  to  ensure  the  availability  and  accessibility  of  crisis-relevant  medical 
countermeasures  can  help  avoiding  uncoordinated  investments  across  Member 
States.  

in 

• 

Proportionality 

The  proposal  constitutes  a  proportionate  response  to  addressing  the  problems 
described in point 1, in particular by putting in place a framework in place that will 
enable the Union to take the necessary measures to ensure the sufficient and timely 

13 
14 

https://ec.europa.eu/health/sites/health/files/antimicrobial_resistance/docs/amr_2017_action-plan.pdf.  
COM(2017) 610 final. 

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availability and supply of crisis-relevant medical countermeasures in case of a public 
health emergency at Union level where that is appropriate to the economic situation.  

In  accordance  with  the  principle  of  proportionality,  as  set  out  in  Article  5  of  the 
Treaty  on  European  Union,  this  proposal  and  the  measures  proposed  do  not  go 
beyond what is necessary in order to achieve those objectives. 

• 

Choice of the instrument 

The  proposal  takes  the  form  of  a  Council  Regulation.  This  is  considered  to  be  the 
most suitable instrument as a key element of the proposal is to establish procedures 
and  structures  for  cooperation  on  joint,  Union-level  work  focussing  on  response  to 
cross-border health emergencies. The measures do not require the implementation of 
national measures and can be directly applicable. 

3. 

• 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

Stakeholder consultations 

The framework of measures to be activated to strengthen the response in the event of 
a  public  health  emergency  was  not,  as  such,  subject  to  consultation,  but  there  has 
been a thorough consultation with relevant stakeholder groups about the setting up of 
HERA to ensure that their views were presented and considered in the policymaking 
process.  That  feedback  gave insight  in  the emergency measures that are considered 
necessary for an effective response and informed the proposal for this Regulation. 

More specifically, the following consultation activities were carried out:  

● 

● 

● 

a 4-week feedback period on the Inception Impact Assessment (27 January to 
24 February 2021); 

a 6-week internet-based public consultation (31 March to 12 May 2021), which 
received contributions from 135 stakeholders15; and 

targeted  consultations  with  stakeholders,  via  the  creation  of  a  High  Level 
Group  with  Member  States,  a  ‘Sherpa’  group  with  the  industry,  as  well  as 
bilateral meetings with Member States, international actors, and the European 
Parliament. 

Overall,  the  Commission  has  received  support  for  the  creation  of  HERA,  with 
stakeholders noting the clear added value of this initiative as well as the need for the 
Union to increase its activities related to crisis-relevant medical countermeasures for 
preparedness  and  crisis  management.  Given the  broadly  shared view that there is  a 
need for swift and effective response at Union level, the Commission proposes a set 
of  emergency  measures  that  can  be  activated  in  the  event  of  health  emergencies  to 
ensure such a swift and effective response. 

• 

Collection and use of expertise 

N/A 

15 

Factual  summary  report  on  the  public  consultation  on  the  European  Health  Emergency  Preparedness 
and  Response  Authority 
https://ec.europa.eu/info/law/better-regulation/have-your-
say/initiatives/12870-European-Health-Emergency-Preparedness-and-Response-Authority-HERA-
/public-consultation_en.  

(HERA): 

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• 

Impact assessment 

Due  to  the  urgency  of  the  matter  to  strengthen  the  emergency  framework  in 
preparation of a future public health emergency, this proposal is not accompanied by 
a formal impact assessment, as this could not have been delivered in the timeframe 
available  prior  to  the  adoption  of  the  proposal.  As  regards  medical  devices  and  in 
vitro diagnostic medical devices, the proposal however takes into account the impact 
assessment carried out in preparation for the adoption of Regulation (EU) 2017/745 
of  the  European  Parliament  and  of  the  Council16  and  Regulation  (EU)  2017/746  of 
the  European  Parliament  and  of  the  Council17.  The  proposal  also  draws  on  the 
recommendations contained in the joint opinion ‘Improving pandemic preparedness 
and management’ by the Group of Chief Scientific Advisors (GCSA)18, the European 
Group on Ethics in Science and New Technologies (EGE), and the Special Advisor 
to the President of the European Commission on the response to COVID-19. 

• 

Fundamental rights 

The proposal contributes to achieving a high level of human health protection as well  
as    to  upholding  the  highest  standards  in  the  protection  of  human  rights  and  civil 
liberties,  as  enshrined in the Charter of Fundamental Rights of the European Union 
(‘the  Charter’).  The  measures  under  this  Regulation  may  limit  the  freedom  to 
conduct business and the freedom of contract, which are protected by Article 16 of 
the  Charter  and  the  right  to  property,  protected  by  Article  17  of  the  Charter.  Any 
limitation  of  those  rights  will,  in  accordance  with  Article  52(1)  of  the  Charter,  be 
provided  for  by  law,  respect  the  essence  of  those  rights  and  freedom,  and  comply 
with the principle of proportionality. 

Where  the  activities  to  be  carried  out  pursuant  to  this  Regulation  involve  the 
processing  of  personal  data,  the  lawfulness  of  that  processing  will  be  based  on  the 
acts  assigning  their  tasks  to  the  different  actors  involved,  not  this  Regulation.  Any 
such  processing  must  comply  with  the  relevant  Union  legislation  on  personal  data 
protection,  namely  Regulation  (EU)  2018/1725  of  the  European  Parliament  and  of 
the Council19 and Regulation (EU) 2016/679 of the European Parliament and of the 
Council20. 

4. 

BUDGETARY IMPLICATIONS 

In  the  event  of  a  public  health  emergency  at  Union  level,  in  order  to  ensure  the 
necessary  flexibility  and  rapidity  in  implementation,  the  Council  could  also  trigger 

16 

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18 
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Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 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 (OJ L 295, 21.11.2018, p. 39). 
Regulation (EU) 2017/746 of the European Parliament  and of the Council of 5 April 2017 on  in 
vitro  diagnostic  medical  devices  and  repealing  Directive  98/79/EC  and  Commission  Decision 
2010/227/EU (OJ L 119, 4.5.2016, p. 1). 
https://op.europa.eu/en/publication-detail/-/publication/a1016d77-2562-11eb-9d7e-01aa75ed71a1 
Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the 
protection of natural persons with regard to the  processing of personal data by the Union institutions, 
bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 
45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). 
Regulation  (EU)  2016/769  of  the  European  Parliament  and  of  the  Council  of  27  April  2016  on  the 
protection of natural persons with regard to the processing of personal data and on the free movement of 
such data, and repealing Directive 95/46/EC (OJ L 119, 4.5.2016, p. 1). 

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financing through the Emergency Support Instrument (ESI).21 As ESI does not have 
an  annual  dedicated  budget,  when  it  is  activated,  the  Commission  will  analyse  the 
necessity  of  transferring  funding  from  existing  programmes  or  resort  to  Special 
Instruments.  As  foreseen  under  Article  4  of  Council  Regulation  (EU)  2016/369, 
contributions could also be made by Member States (and by other public or private 
donors as external assigned revenue) in accordance with Article 21(5) of Regulation 
(EU, Euratom) 2018/1046 of the European Parliament and of the Council.22 

5. 

• 

OTHER ELEMENTS 

Implementation plans and monitoring, evaluation and reporting arrangements 

The  Commission  plans  to  conduct  a  review  in  2025,  or  at  the  latest  after  the  first 
activation  of  the  emergency  measures,  on  the  framework  of  measures  related  to 
medical countermeasures in event of a public health emergency. The main findings 
of  the  evaluation  will  be  presented  in  a  report  to  the  European  Parliament  and  the 
Council. 

• 

Detailed explanation of the specific provisions of the proposal 

The proposal for a framework for ensuring the supply of medical countermeasures in 
the event of a public health emergency puts forward the following key measures: 

● 

● 

● 

● 

the  establishment  of  a  Health  Crisis  Board  to  ensure  coordination  and 
integration  of  approaches  to  crisis-relevant  medical  countermeasures  at  a 
Union level in the event of a public health emergency; 

the establishment of mechanisms for the monitoring,  activation of emergency 
funding, procurement and purchase of crisis-relevant medical countermeasures 
and  raw  materials,  including  swift  and  solid  assessment  of  supply  chains  and 
production capacity of manufacturers, possibly  also  by on-site visits  ahead of 
the conclusion of advanced purchase agreement or innovation partnership; 

the  activation  of  EU  FAB  facilities  to  make  available  reserved  surge 
manufacturing  capacities  to  ensure  the  delivery  of  the  crisis-relevant  medical 
countermeasures and raw materials; 

the  activation  of  emergency  research  and  innovation  plans  in  dialogue  with 
Member  States,  and  the  use  of  Union-wide  clinical  trial  networks  and 
provisions and platforms for the rapid sharing of data; and 

●  measures 

the 

concerning 

crisis-relevant  medical 
production 
countermeasures, including the establishment of an inventory of crisis-relevant 
medical  countermeasures  production  and  production  facilities,  raw  materials, 
consumables,  devices,  equipment  and  infrastructure  and  including  measures 
aiming at increasing their production in the EU. 

of 

21 

22 

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). 
Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on 
the  financial  rules  applicable  to  the  general  budget  of  the  Union,  amending  Regulations  (EU)  No 
1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) 
No  1316/2013,  (EU)  No  223/2014,  (EU)  No  283/2014,  and  Decision  No  541/2014/EU  and  repealing 
Regulation (EU, Euratom) No 966/2012 PE/13/2018/REV/1 (OJ L 193, 30.7.2018, p. 1. 

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2021/0294 (NLE) 

Proposal for a 

COUNCIL REGULATION 

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 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 122(1) thereof, 

Having regard to the proposal from the European Commission, 

Whereas:  

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

The  ad-hoc  measures  taken  by  the  Commission  in  order  to  restrict  the  spread  of  the 
COVID-19  pandemic  were  reactive  and  the  Union  was  not  sufficiently  prepared  to 
ensure  efficient  development,  manufacturing,  procurement  and  distribution  of  crisis-
relevant  medical  countermeasures,  especially  in  the  early  phase  of  the  COVID-19 
pandemic. The pandemic also revealed insufficient oversight of research activities and 
manufacturing capacities as well as vulnerabilities related to the global supply chains.  

However,  the  experience  gained  showed  the  need  for  a  framework  for  ensuring  the 
supply of crisis-relevant medical countermeasures of measures in the event of a public 
health emergency, in order to enable the Union to take measures that are necessary to 
ensure  the  sufficient  and  timely  availability  and  supply  of  crisis-relevant  medical 
countermeasures in the event of a public health emergency where that is appropriate to 
the economic situation. 

In the event  of recognition  of a public health emergency at  Union level,  the Council 
may,  upon  the  proposal  of  the  Commission,  decide  to  activate  the  framework  of 
measures to the extent that those measures are appropriate to the economic situation. 
The  use  of  measures  within  this  framework  should  be  limited  in  time  to  6  months, 
after which they can be prolonged in view of the situation.  

The framework of measures should include the establishment of a Health Crisis Board 
on  crisis-relevant  medical  countermeasures  to  ensure  coordination  and  integration  of 
approaches  at  Union  level.  This  is  of  particular  importance  given  the  spread  of 
responsibilities between national and Union level. To support the Health Crisis Board, 
the  Commission  should  be  entitled  to  set  up  sub-groups,  including  if  needed  for 
industrial aspects.  

The Commission should ensure that a list of crisis-relevant medical countermeasures 
and raw materials is established and that their supply and demand is monitored. This 
should  provide  a  comprehensive  overview  of  the  needed  crisis-relevant  medical 
countermeasures  as  well  as  of  the  Union’s  capacity  to  meet  this  need  and  to  guide 
relevant decision-making during public health emergencies.  

In  view  of  the  mandate  of  the  European  Medicines  Agency  (EMA)  and  its  role  as 
regards  monitoring  and  mitigating  potential  and  actual  shortages  of  medicinal 
products,  medical  devices  and  in  vitro  diagnostic  medical  devices  including 

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(7) 

(8) 

establishing  lists  of  critical  medical  products  and  critical  medical  devices,  under 
Regulation  (EU)  …/…  of  the  European  Parliament  and  of  the  Council  [EMA 
Regulation  (COM/2020/725)]23,  close  cooperation  and  coordination  between  the 
Commission and EMA should be ensured to implement the measures provided for in 
this  Regulation.  If  use  is  made  of  the  possibility  to  establish  a  Health  Crisis  Board 
during a public health emergency, a representative of the Executive Steering Group on 
Shortages of Medical Devices, a representative from the Emergency Task Force and a 
representative  from  the  Executive  Steering  Group  on  Shortages  and  Safety  of 
Medicinal  Products  should  be  invited  as  observers  to  the  Health  Crisis  Board,  as 
established  under  Regulation  (EU)  No…/…[the  EMA  Regulation].  This  should 
complement  the  smooth  transition  of  data  and  information  during  public  health 
emergencies at Union level, including via integrated IT systems. 

The measures should also take into consideration the structures and mechanisms set up 
by the Union acts on serious cross-border threats to health, Regulation (EU) …/… of 
the European Parliament and of the Council [SCBTH Regulation (COM/2020/727)]24, 
and on the extended mandate of the ECDC laid down by Regulation (EU) …/… of the 
European  Parliament  and  of  the  Council  [ECDC  Regulation  (COM/2020/726)]25,  to 
ensure response coordination within the Health Security Committee and the Advisory 
Committee  on  public  health  emergencies,  taking  into  account  input  by  ECDC  on 
epidemiological surveillance and monitoring. The Director of the European Centre for 
Disease  Prevention  and  Control,  and  a  representative  of  the  Advisory  Committee  on 
public  health  emergencies  established  under  Regulation  (EU)  No…/…[the  SCBTH 
Regulation]  should  be  invited  to  attend  the  meetings  of  the  Health  Crisis  Board.  A 
member of the Health Security Committee should be invited as observer to the Health 
Crisis Board.  

The activation of emergency research and innovation plans, as well as the repurposing 
and  activation  of  clinical  trial  networks,  and  conduct  of  clinical  trials,  should  be 
ensured  to  reduce  any  delays  in  the  development  phase  of  crisis-relevant  medical 
countermeasures.  Research  and  innovation  activities  may  use  the  European  Health 
Data  Space  digital  Infrastructure  and  platforms  operating  under  the  European  Open 
Science Cloud and other accessible EU digital platforms, to get access to (real-world) 
data for quick analysis. Close coordination of the Commission with ECDC and EMA, 
as the Agency  responsible for scientific  advice  and scientific assessment  of new and 
repurposed  medicinal  products,  should  be  ensured  for  these  matters,  as  well  as  for 
those related to regulatory aspects concerning the authorisation of medicinal products 
including  for  the  establishment  of  new  manufacturing  sites  for  authorised  medicinal 
products and to guarantee the acceptability of the clinical trials and the evidence they 
generate for the authorisation of new or repurposed medicines. This should allow key 
actors  and  relevant  infrastructure  to  be  immediately  ready  for  operation  in  times  of 
public health emergencies, thereby reducing any delays.  

23 

24 

25 

Regulation (EU) No …/… of the European Parliament and of the Council of … on a reinforced role for 
the  European  Medicines  Agency  in  crisis  preparedness  and  management  for  medicinal  products  and 
medical devices [OJ: please insert number, date and publication reference]. 
Regulation (EU) No …/… of the European Parliament and of the Council of … on serious cross-border 
threats  to  health  and  repealing  Decision  No  1082/2013/EU  [OJ:  please  insert  number,  date  and 
publication reference]. 
Regulation (EU) No …/… of the European Parliament and of the Council of … amending Regulation 
(EC) No 851/2004 establishing a European Centre for disease prevention and control [OJ: please 
insert number, date and publication reference]. 

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(9) 

Efficient procurement procedures for crisis-relevant medical countermeasures and raw 
materials  should  be  ensured,  and  the  Commission  should  be  entrusted  with  a 
negotiating  mandate  to  act  as  a  central  procurement  body  for  Member  States,  using 
rules  and  procedures  under  Regulation  (EU,  Euratom)  2018/1046  of  the  European 
Parliament and of the Council26 as well as Council Regulation (EU) 2016/36927.  

(10)  These  rules  and  procedures  may  be  supported  by  any  necessary  preparatory  steps, 
including  on-site  visits  at  the  location  of  the  production  facilities  of  crisis-relevant 
medical  countermeasures.  This  should  allow  for  the  rapid  procurement  and  purchase 
of crisis-relevant medical countermeasures across the Union and promote accessibility 
across  the  Member  States,  with  the  primary  objective  of  securing  the  speediest 
possible  provision  of  the  countermeasures  in  the  required  quantity  and  with  all 
necessary guarantees.   

(11)  During  a  public  health  emergency  at  Union  level  demand  for  crisis-relevant  medical 
countermeasures may be greater than supply. In such a situation, surge production and 
manufacturing  of  crisis-relevant  medical  countermeasures  is  essential  and  the 
Commission should be entrusted to activate the surge Union manufacturing capacities 
for crisis-relevant medical countermeasures, including ensuring resilient supply chains 
for the needed raw materials and ancillary supplies, under the ‘EU-FAB’. As outlined 
in the Communication ‘HERA Incubator: Anticipating together the threat of COVID-
19 variants’28 , an “EU FAB” project is a network of ‘ever-warm’, single and/or multi 
user,  single  and/or  multi-technology  production  capacities  for  vaccine  and  medicine 
manufacturing at European level. 

(12)  Appropriate intellectual property tools are needed to mitigate the risks of abandonment 
of  development  efforts  or  supply  issues  of  crisis-relevant  medical  countermeasures 
during  a  public  health  emergency,  especially  where  public  authorities  provided 
financial  support  for  the  development  and  production  of  such  countermeasures.  The 
Commission  should  therefore  be  able  to  require  the  licensing,  under  fair  and 
reasonable  terms,  of  intellectual  property  rights  and  know-how  pertaining  to  crisis-
relevant  medical  countermeasures,  the  development  and  production  of  which  the 
Commission  has  financed,  in  justified  exceptional  cases,  as  a  safety  net  and  an 
incentivising element. 

(13)  Council Regulation (EU) 2016/36929 provides for a flexible framework for emergency 
financial support. It allows to provide support that cannot be implemented through the 
existing  spending  programmes.  Such  a  tool  should  become  available  if  there  is  a 
recognition  of  a  public  health  emergency  at  Union  level  to  the  extent  that  that  is 
appropriate to the economic situation.  

(14)  During  a  public  health  emergency,  detailed  overviews  of  the  Union’s  current  and 
short-term future production capacities of crisis-relevant medical countermeasures are 

26 

27 

28 
29 

Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on 
the  financial  rules  applicable  to  the  general  budget  of  the  Union,  amending  Regulations  (EU)  No 
1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) 
No  1316/2013,  (EU)  No  223/2014,  (EU)  No  283/2014,  and  Decision  No  541/2014/EU  and  repealing 
Regulation (EU, Euratom) No 966/2012 PE/13/2018/REV/1 (OJ L 193, 30.7.2018, p. 1). 
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). 
COM/2021/78 final. 
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). 

EN 

10 

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an  integral  element  of  demand  and  supply  management.  Therefore,  an  inventory  of 
crisis-relevant  medical  countermeasure  production  facilities  should  be  created  and 
regularly updated on the basis of the compulsory transmission of information by the 
relevant economic operators.  

(15)  Supply shortages of raw materials, consumables, devices, equipment or infrastructure 
may  impact  the  production  of  crisis-relevant  medical  countermeasures.  Upon 
identification of a supply shortage or the risk thereof, the inventory should also cover 
these  elements.  This  complements  the  detailed  overview  of  the  Union’s  current  and 
near-future  production  capacities,  in  order  to  allow  for  the  factoring  in  of  supply 
elements  that  may  impact  production  capacities  and  to  improve  demand  and  supply 
management of crisis-relevant medical countermeasures at Union level. 

(16) 

Informed  by  the  detailed  overviews  of  production  capacities,  raw  materials, 
consumables, equipment and infrastructure, further measures to bolster supply chains 
and  production  capacities  may  be  needed.  Where  the  market  does  not,  or  cannot, 
ensure  adequate  supply  of  needed  crisis-relevant  medical  countermeasures,  the 
Commission should therefore be able to implement measures in these areas that serve 
to increase the availability and accessibility of crisis-relevant medical countermeasures 
and raw materials,  

HAS ADOPTED THIS REGULATION: 

Article 1 

Subject matter and scope 

1. 

This  Regulation  establishes  a  framework  for  ensuring  supply  of  crisis-relevant 
medical countermeasures in the event of a public health emergency (‘the emergency 
framework’).  

2. 

The measures referred to in paragraph 1 include: 

(a) 

establishment of a Health Crisis Board; 

(b)  monitoring,  procurement 

and  purchase  of 
countermeasures and crisis-relevant raw materials; 

crisis-relevant  medical 

(c) 

the activation of emergency research and innovation plans, including the use of 
Union-wide clinical trial networks and data sharing platforms; 

(d) 

emergency funding and financing; 

(e)  measures  concerning the production, availability  and supply  of  crisis-relevant 
medical countermeasures, including the establishment of an inventory of crisis-
relevant  production  and  production  facilities,  raw  materials,  consumables, 
equipment  and  infrastructure,  and  including  measures  aiming  at  increasing 
their production in the Union.   

3. 

The measures referred to in paragraph 1 may be activated only to the extent that they 
are appropriate to the economic situation. 

For the purposes of this Regulation, the following definitions shall apply: 

Article 2 

Definitions 

EN 

11 

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(1) 

(2) 

(3) 

(4) 

(5) 

1. 

2. 

3. 

4. 

1. 

2. 

30 

‘monitoring’ means monitoring as defined in Article 3, point (5), of Regulation (EU) 
No…/…[the SCBTH Regulation]; 

‘public  health  emergency’  means  a  public  health  emergency  at  Union  level 
recognised  by  the  Commission  in  accordance  with  Article  23  of  Regulation  (EU) 
No…/…[the SCBTH Regulation]; 

‘medical  countermeasures’  means  medical  countermeasures  within  the  meaning  of 
Article 3, point (8), of Regulation (EU) …/… [the SCBTH Regulation], in addition 
to personal protective equipment and substances of human origin; 

‘raw  materials’  means  the  materials  required  in  order  to  produce  the  required 
quantities of crisis -relevant medical countermeasures;  

‘real-world  data’  means  data  relating  to  patient  health  status  or  the  delivery  of 
healthcare from sources other than clinical trials.  

Article 3 

Activation of the emergency framework  

In  the  event  of  recognition  of  a  public  health  emergency  the  Council,  upon  the 
proposal  of  the  Commission,  may  adopt  a  regulation  activating  the  emergency 
framework where that is appropriate to the economic situation.  

The  Council  shall  set  out  in  the  Regulation  activating  the  emergency  framework 
which  of  the  measures  as  set  out  in  Articles  5  to  11  and  13  are  appropriate  to  the 
economic situation and which measures are therefore to be activated. 

The  duration  of  the  activation  is  6  months,  renewable  in  accordance  with  the 
procedure set out in Article 4.  

The  regulation  on  the  activation  of  the  emergency  framework  shall  be without 
prejudice  to  Decision  No.  1313/2013/EU  of  the  European  Parliament  and  of  the 
Council30 and the overall coordination role of the Emergency Response Coordination 
Centre under the Union Civil Protection Mechanism. 

Article 4 

Prolongation and expiry of the activation of the emergency framework  

No  later  than  1  week  before  the  expiry  of  the  duration  for  which  the  emergency 
framework  was  activated,  the  Commission  shall  submit  to  the  Council  a  report 
assessing whether the activation of the emergency framework should be prolonged. 
The  report  shall  in  particular  analyse  the  public  health  situation  and  the  economic 
consequences  of  the  public  health  crisis  in  the  Union  as  a  whole  and  in  Member 
States.  

Where  that  assessment  concludes  that  it  is  appropriate  that  the  activation  of  the 
emergency framework is prolonged, the Commission may propose the prolongation 
to  the  Council.  The  prolongation  shall  not  exceed  6  months.  The  Council  may 

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. 

EN 

12 

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3. 

4. 

1. 

2. 

repeatedly decide to prolong the activation of the emergency framework where that 
is appropriate to the economic situation.  

The  Commission  may  propose  to  the  Council  to  adopt  a  regulation  activating 
additional measures set out in Articles 5 to 11 and 13 in addition to those measures 
that it had already activated, where that is appropriate to the economic situation.  

Upon  expiry  of  the  duration  for  which  the  emergency  framework  is  activated,  the 
measures taken in accordance with Articles 5 to 11 and 13 shall cease to apply in so 
far as they had been activated by the Council. 

Article 5  

Establishment of the Health Crisis Board  

Where  this  measure  is  activated,  the  Health  Crisis  Board  shall  be  set  up.  It  shall 
ensure  coordination  of  action  by  the  Council,  the  Commission,  the  relevant  Union 
agencies  and  bodies,  and  Member  States  to  ensure  the  supply  of  and  access  to 
medical countermeasures. 

The coordination shall, in particular, be aimed at supporting the Commission in the 
preparation of measures to be taken pursuant to Articles 6 to 11 and 13.  

The  Health  Crisis  Board  shall  be  composed  of  the  Commission  and  one 
representative from each Member State. The Commission shall be represented by its 
President, the Member of the Commission in charge  of Health and other Members of 
the Commission as appropriate.  

The Commission shall ensure the participation of all relevant Union institutions and 
bodies, including the European Medicines Agency, the European Centre for Disease 
Prevention and Control,  and the Advisory Committee on public health emergencies 
established  under  Regulation  (EU)  …/…  [the  SCBTH  Regulation]  as  observers  to 
the  Health  Crisis  Board.  The  Commission  shall  invite  a  representative  from  the 
European Parliament and a member of the Health Security Committee as observers 
to the Health Crisis Board.  

Each  Member  State  shall  nominate  one  senior  representative  and  one  alternate 
representative to the Health Crisis Board.  

3. 

The Health Crisis Board shall ensure coordination and information exchange with the 
structures established under: 

(a)  Regulation  (EU) …/…  [the EMA Regulation] during the period of the public 

health emergency, related to medicinal products and medical devices;  

(b)  Regulation (EU) …/… [the SCBTH Regulation];  

(c)  Decision  No  1313/2013/EU  and  in  particular  the  Emergency  Response 
Coordination Centre for the purpose of bridging operational gaps in accessing 
medical  countermeasures  and  raw  materials  and  ensuring,  where  necessary, 
corresponding on-site monitoring and coordination tasks. 

4. 

invite  experts  with 

including 
The  Commission  may 
representatives  of  Union  agencies  and  bodies,  national  authorities  including  central 
purchasing  bodies  and  health  care  organisations  or  associations,  international 
organisations,  experts  from  the  private  sector  as  well  as  other  stakeholders,  with 
respect to a subject matter on the agenda, to take part in the work of the Health Crisis 
Board or sub-groups on an ad hoc basis.  

specific  expertise, 

EN 

13 

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5. 

6. 

7. 

8. 

1. 

2. 

3. 

4. 

5. 

6. 

The  Health  Crisis  Board  shall  meet  whenever  the  situation  requires,  upon  request 
from the Commission or a Member State. 

The Health Crisis Board shall be chaired by the Commission.  

The Secretariat of the Health Crisis Board shall be provided by the Commission. 

The Commission may set up working groups to support the Health Crisis Board in its 
work  for  the  purpose  of  examining  specific  questions  on  the  basis  of  the  tasks 
defined in paragraph 1. 

Article 6 

Mechanism for monitoring crisis-relevant medical countermeasures 

Where  this  measure  is  activated,  the  Commission  shall,  after  seeking  the  advice  of 
the Health Crisis Board, draw up and regularly update a list of crisis-relevant medical 
countermeasures and raw materials, as well as a template for monitoring their supply 
and  demand,  including  production  capacity,  stockpiles,  possible  critical  aspects  or 
the risk of disruption in the supply chains and purchasing agreements.  

The list referred to in paragraph 1 shall include a shortlist of specific crisis-relevant 
medical  countermeasures  and  raw  materials  for  the  preparation  of  measures  to  be 
taken in accordance with this article and Articles 7 to 11 and 13, taking into account 
the information obtained pursuant to:  

(a)  Regulation  (EU)  …/…  [the  EMA  Regulation]  and  in  particular  Articles  XX 
[Article  numbers  to  be  confirmed  after  adoption]  thereof,  concerning  the 
monitoring  and  mitigating  shortages  of  critical  medicinal  products,  medical 
devices and in vitro diagnostic medical devices;  

(b)  Regulation  (EU)  …/…  [the  ECDC  Regulation],  and  in  particular  Article  3, 
point (e), thereof,  concerning available indicators of Member States’ capacity 
regarding  health  services  necessary  to  the  management  and  response  to 
communicable disease threats. 

Member  States  shall  provide  the  Commission  with  information  based  on  the 
monitoring template referred to in paragraph 1.  

Where a Member State intends to adopt measures for the procurement, purchase or 
manufacturing  of  crisis-relevant  medical  countermeasures  or  raw  materials,  it  shall 
inform and consult the Health Crisis Board. 

Upon request of the Commission, EMA shall provide it with information with regard 
to monitoring of medicinal products, medical devices and in vitro diagnostic medical 
devices, including their demand and supply, in accordance with Articles XX [Article 
numbers  to  be  confirmed  after  adoption]  of  Regulation  (EU)  …/…  [the  EMA 
Regulation]. 

The Commission shall gather information through a secured IT system and monitor 
all relevant information concerning the supply and demand of crisis-relevant medical 
the  Union.  The 
countermeasures  and 
interoperability  of  the  IT  system  with  the  electronic  monitoring  and  reporting 
systems developed by EMA pursuant to Article 9, point (c), [Article numbers to be 
confirmed after adoption], of Regulation (EU) …/… [the EMA Regulation] shall be 
ensured by the Commission when necessary.  

raw  materials  within  and  outside 

EN 

14 

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7. 

The Commission shall provide information on the results of the monitoring of crisis-
relevant medical countermeasures and raw materials to the European Parliament and 
the Council through the Integrated Political Crisis Response provided for in Council 
Implementing Decision (EU) 2018/199331. 

The  Commission  shall  make  available  to  the  European  Parliament  and  the  Council 
through  the  Integrated  Political  Crisis  Response,  modelling  and  forecasts  regarding 
the  needs  for  crisis-relevant  medical  countermeasures  and  raw  materials  with  the 
support of relevant Union agencies, where appropriate.  

Procurement, purchase and manufacturing of crisis-relevant medical countermeasures 
and raw materials  

Article 7 

1. 

2. 

Where  this  measure  is  activated,  a  negotiating  mandate  shall  be  established  by  the 
Commission  on  behalf  of  Member  States  that  wish  to  be  represented  by  the 
Commission (‘participating Member States’) to act as a central purchasing body for 
crisis-relevant  medical  countermeasures through  the activation of existing  contracts 
or the negotiation of new contracts using all available instruments, such as Article 4 
of Regulation (EU) 2016/369; the joint procurement procedure referred to in Article 
12  of  Regulation  (EU)  …/…  [the  SCBTH  Regulation],  or  European  Innovation 
Partnerships. 

Without prejudice to paragraph 1 above, procurement under this Regulation shall be 
carried  out  by  the  Commission  in  accordance  with  the  rules  set  out  in  Regulation 
(EU,  Euratom)  2018/1046  of  the  European  Parliament  and  of  the  Council32  for  its 
own procurement. The following simplifications of procurement procedures may be 
used: 

(a)  By  way  of  derogation  from  Article  137  of  Regulation  (EU,  Euratom) 
2018/1046, possibility to provide proof or evidence on exclusion and selection 
criteria  after  signature  of  contract  provided  that  a  declaration  on  honour  has 
been submitted in this regard before the award;  

(b)  By  way  of  derogation  from  Article  172(2)  of  the  Regulation  (EU,  Euratom) 
2018/1046, the Commission may modify the contract, as necessary to adapt to 
the evolution of the public health emergency; 

(c)  By  way  of  derogation  from  Article  165  of  Regulation  (EU,  Euratom) 
2018/1046,  possibility  to  add  contracting  authorities,  not  identified  in 
procurement documents, after the signature of the contract; 

(d)  By  way  of  derogation  from  Article  172(1)  of  Regulation  (EU,  Euratom) 
2018/1046, the contracting authorities shall be entitled to request the delivery 
of  goods  or  services  as  from  the  date  of  sending  the  draft  contracts  resulting 

31 

32 

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). 
Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on 
the  financial  rules  applicable  to  the  general  budget  of  the  Union,  amending  Regulations  (EU)  No 
1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) 
No  1316/2013,  (EU)  No  223/2014,  (EU)  No  283/2014,  and  Decision  No  541/2014/EU  and  repealing 
Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). 

EN 

15 

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3. 

4. 

5. 

6. 

1. 

2. 

from the procurement carried out for the purposes of this Regulation, no later 
than 24 hours as from the award. 

In line with the negotiating mandate given to it, the Commission may have the ability 
and  responsibility,  on  behalf  of  all  participating  Member  States,  to  enter  into 
purchase  agreements  with  economic  operators,  including  individual  producers  of 
crisis-relevant  medical  countermeasures,  concerning 
the  purchase  of  such 
countermeasures  or  concerning  the  advance  financing  of  the  production  or  the 
development of such countermeasures in exchange for a right to the result.  

In order to prepare the fulfilment of such tasks, representatives of the Commission or 
experts nominated by the Commission may carry out on-site visits at the locations of 
production facilities of crisis-relevant medical countermeasures. 

The  Commission  shall  have  the  ability  and  responsibility  to  activate  the  EU-FAB 
facilities  in  order  to  make  available  reserved  surge  manufacturing  capacities  to 
ensure  the  delivery  of  crisis-relevant  medical  countermeasures  and  raw  materials, 
corresponding to the agreed quantities and in accordance with the timing of the EU-
FAB contracts. Specific procurement procedures for these agreed quantities of crisis-
relevant medical countermeasures shall be conducted.  

Where the Commission provides financing for the production and/or development of 
crisis-relevant  medical  countermeasures,  the  Commission  shall  have  the  right  to 
require  the  licensing,  under  fair  and  reasonable  conditions,  of  intellectual  property 
and  know-how  pertaining  to  such  countermeasures,  if  an  economic  operator 
abandons their development effort or is unable to ensure their sufficient and timely 
delivery  under  the  terms  of  the  agreement  concluded.  Further  conditions  and 
procedures  relating  to  the  exercise  of  this  right  may  be  set  out  in  the  specific 
agreements with economic operators. 

The  Commission  shall  carry  out  the  procurement  procedures  and  conclude  the 
resulting agreements with economic operators on behalf of the participating Member 
States. The Commission shall invite Member States participating in the Health Crisis 
Board  set  up  under  Article  5  to  nominate  representatives  to  take  part  in  the 
preparation  of  the  procurement  procedures  as  well  as  the  negotiation  of  the 
purchasing  agreements.  The  deployment  and  use  of  the  crisis-relevant  medical 
countermeasures shall remain the responsibility of the participating Member States.  

Article 8 

Activation of emergency research and innovation plans and the use of Union-wide 
clinical trial networks and data-sharing platforms 

Where  this  measure  is  activated,  the  Commission  and  the  Member  States  shall 
activate  the  emergency  research  and  innovation  aspects  of  the  Union  Preparedness 
and Response Plan referred to in Regulation (EU) …/… [the SCBTH Regulation]. 

The Commission shall support access to relevant data from clinical trials, but also to 
real-world data. If possible, the Commission shall build upon existing preparedness 
research initiatives such as Union-wide networks for clinical trials and observational 
studies, or strategic cohorts, supported by digital platforms and infrastructures, such 
as  high  performance  computing,  enabling  the  open  sharing  of  findable,  accessible, 
interoperable  and  reusable  (FAIR)  data,  as  well  as  the  activities  of  the  national 
competent bodies supporting availability and access to data, including health data.  

EN 

16 

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3. 

4. 

1. 

2. 

3. 

In  setting  up  actions  on  clinical  trials,  the  Commission  shall  involve  the  EMA 
Emergency Task force established by Regulation (EU) …/… [the EMA Regulation] 
as well as ensure coordination with ECDC. 

The  participation  and  contribution  of  the  Union  in  the  emergency  research  and 
innovation  aspects  of the Union Preparedness  and Response Plan with  the Member 
States  shall  be  in  accordance  with  the  rules  and  procedures  of  the  various 
Multiannual Financial Framework programmes.  

Inventory of crisis-relevant medical countermeasures production and production 
facilities  

Article 9 

Where  this  measure  is  activated,  the  Commission  may,  after  consulting  the  Health 
Crisis  Board,  establish  an  inventory,  and  for  this  purpose  request  the  producers  of 
crisis-relevant  medical  countermeasures  to  inform  the  Commission  within  5  days 
about the actual total production capacity and possible existing stocks of the crisis-
relevant  medical  countermeasures  and  components  thereof  in  its  Union  production 
facilities  and  third  country  facilities  which  it  operates  or  contracts  or  purchases 
supply  from,  and  to  transmit  to  the  Commission  a  schedule  of  the  expected 
production output for the following 3 months for each Union production facility.  

Upon  request  of  the  Commission,  each  producer  of  crisis-relevant  medical 
countermeasures  shall  inform  the  Commission  within  a  maximum  of  5  days  about 
any  Union  crisis-relevant  medical  countermeasures  production  facility  it  operates, 
including  information  on  its  production  capacity  as  regards  crisis-relevant  medical 
countermeasures via regular updates. For medicinal products, this information shall 
comprise facilities related to both finished products as well as active pharmaceutical 
ingredients.  

The  Commission  shall  regularly  inform  the  European  Parliament  and  the  Council 
about  the  production  of  crisis-relevant  medical  countermeasures  and  the  expected 
production  rate  within  the  Union  and  for  supplies  from  third  country  facilities 
whether finished product, intermediates or other components, as well as the capacity 
of  Union  and  third  county  crisis-relevant  medical  countermeasures  production 
facilities,  while  adequately  protecting  commercially  sensitive  information  of  the 
producers.  

Article 10 

Inventory of crisis-relevant raw materials, consumables, devices, equipment and 
infrastructure  

Where this measure is activated, the Commission shall extend the inventory provided for in 
Article  9  to  crisis-relevant  relevant  raw  materials,  consumables,  devices,  equipment  and 
infrastructure, if it considers that there is a risk of a shortage in supply of crisis-relevant raw 
materials, consumables, devices, equipment or any problems with infrastructure. 

Article 11 

Measures to ensure the availability and supply of crisis-relevant medical 
countermeasures 

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1. 

Where this measure is activated, the Commission shall, when it considers that there 
is  a  risk  of  a  shortage  of  crisis-relevant  raw  materials,  consumables,  devices, 
equipment  and  infrastructure,  implement  together  with  the  relevant  Member  States 
specific  measures  to  ensure  the  efficient  re-organisation  of  supply  chains  and 
production lines and utilise existing stocks to increase the availability and supply of 
crisis-relevant medical countermeasures, as quickly as possible.  

2. 

In particular, the measures referred to in paragraph 1 shall include: 

(a) 

(b) 

(c) 

(d) 

facilitating  the  expansion  or  repurposing  of  existing  or  the  establishment  of 
new production capacities for crisis-relevant medical countermeasures; 

facilitating  the  expansion  of  existing  or  the  establishment  of  new  capacities 
related  to  activities,  the  introduction  of  measures  ensuring  regulatory 
flexibility,  aimed  at  supporting  the  production  and  placing  on  the  market  of 
crisis-relevant medical countermeasures; 

implementing  procurement  initiatives,  reserving  stockpiles  and  production 
capacities to coordinate approaches, and providing critical supply, services and 
resources for the production of crisis-relevant medical countermeasures; 

facilitating the collaboration of relevant companies in a joint industry effort to 
ensure the  availability and supply of  crisis-relevant  medical  countermeasures; 
and 

(e) 

facilitating  the  licensing  of  intellectual  property  and  know-how  pertaining  to 
the crisis-relevant medical countermeasures. 

3. 

The  Commission  may  provide  financial  incentives  necessary  to  ensure  the  rapid 
implementation of the measures referred to in paragraph 2.  

Article 12 

Review  

By 2025 at the latest, the Commission shall carry out a review of this Regulation and present 
a report on the main findings of that review to the European Parliament and the Council.  

Article 13 

Activation of emergency funding  

Where  this  measure  is  activated,  emergency  support  under  Regulation  (EU)  2016/369  is 
activated  to  finance  expenditure  necessary  to  address  the  public  health  emergency  in 
accordance with this Regulation.  

Article 14 

Entry into force  

This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

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This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels, 

For the Council 
The President 

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LEGISLATIVE FINANCIAL STATEMENT 

1. 

1.1. 

1.2. 

1.3. 

1.4. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE ................................................. 3 

Title of the proposal/initiative ...................................................................................... 3 

Policy area(s) concerned .............................................................................................. 3 

The proposal/initiative relates to: ................................................................................. 3 

Objective(s) .................................................................................................................. 3 

1.4.1.  General objective(s) ..................................................................................................... 3 

1.4.2.  Specific objective(s) ..................................................................................................... 3 

1.4.3.  Expected result(s) and impact ...................................................................................... 3 

1.4.4. 

Indicators of performance ............................................................................................ 3 

1.5. 

Grounds for the proposal/initiative .............................................................................. 4 

1.5.1.  Requirement(s) to be met in the short or long term including a detailed timeline for 

roll-out of the implementation of the initiative ............................................................ 5 

1.5.2.  Added value of Union involvement (it may result from different factors, e.g. 

coordination gains, legal certainty, greater effectiveness or complementarities). For 
the purposes of this point 'added value of Union involvement' is the value resulting 
from Union intervention which is additional to the value that would have been 
otherwise created by Member States alone. ................................................................. 5 

1.5.3.  Lessons learned from similar experiences in the past .................................................. 5 

1.5.4.  Compatibility with the Multiannual Financial Framework and possible synergies 

with other appropriate instruments............................................................................... 5 

1.5.5.  Assessment of the different available financing options, including scope for 

redeployment ................................................................................................................ 5 

1.6. 

1.7. 

2. 

2.1. 

2.2. 

2.2.1. 

2.2.2. 

Duration and financial impact of the proposal/initiative ............................................. 7 

Management mode(s) planned ..................................................................................... 7 

MANAGEMENT MEASURES................................................................................... 8 

Monitoring and reporting rules .................................................................................... 8 

Management and control system(s) ............................................................................. 8 

Justification of the management mode(s), the funding implementation mechanism(s), 
the payment modalities and the control strategy proposed .......................................... 8 

Information concerning the risks identified and the internal control system(s) set up 
to mitigate them............................................................................................................ 8 

2.2.3.  Estimation and justification of the cost-effectiveness of the controls (ratio of "control 

costs ÷ value of the related funds managed"), and assessment of the expected levels 
of risk of error (at payment & at closure) .................................................................... 8 

2.3. 

3. 

3.1. 

Measures to prevent fraud and irregularities .............................................................. 10 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE ............ 11 

Heading(s) of the multiannual financial framework and expenditure budget line(s) 
affected ....................................................................................................................... 11 

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3.2. 

Estimated financial impact of the proposal on appropriations ................................... 12 

3.2.1.  Summary of estimated impact on operational appropriations.................................... 12 

3.2.2.  Estimated output funded with operational appropriations ......................................... 18 

3.2.3.  Summary of estimated impact on administrative appropriations ............................... 19 

3.2.4.  Compatibility with the current multiannual financial framework.............................. 22 

3.2.5.  Third-party contributions ........................................................................................... 22 

3.3. 

Estimated impact on revenue ..................................................................................... 23 

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LEGISLATIVE FINANCIAL STATEMENT 

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1. 

Title of the proposal/initiative 

European Health Emergency Preparedness and Response Authority (HERA) 

1.2. 

Policy area(s) concerned  

Heading 1: Single market, innovation and digital   

Heading 2b: Resilience and values 

1.3. 

The proposal/initiative relates to:  

X a new action  

 a new action following a pilot project/preparatory action33  

 the extension of an existing action  

 a merger or redirection of one or more actions towards another/a new action  

1.4. 

Objective(s) 

1.4.1.  General objective(s) 

The  HERA  would  seek  to  improve  public  health  by  strengthening  the  EU’s 
preparedness and response for serious cross-border threats to health, both of natural 
and intentional origin. 

1.4.2. 

Specific objective(s) 

Specific objective No 

1. 

2. 

3. 

4. 

Ensure  timely  availability  and  equitable  access  to  medical  countermeasures 
during a cross-border threat to health  

Improve  intelligence  gathering,  analysis  and  sharing  on  serious  cross-border 
health  threats,  identify  and  address  raw  material  dependencies  as  well  as 
market and regulatory challenges/failures 

Improve  medical  countermeasures  development  and  production,  setting  up 
structures to integrate research and technological development projects 

Coordinate  action  on  medical  countermeasures  between  national  competent 
authorities,  public  buyers,  industrial  and  research  stakeholders,  as  well  as 
global actors 

1.4.3.  Expected result(s) and impact 

Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted. 

Specific objective No 1: 

Ensure  timely  availability  and  equitable  access  to  medical  countermeasures  during  a 
cross-border threat to health  

Expected result(s) and impact:  

33 

As referred to in Article 58(2)(a) or (b) of the Financial Regulation. 

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3 

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Better  preparedness  in  terms  of  availability  and  supply  (procurement,  stockpiling, 
reservation) of critical medical countermeasures.  

Specific objective No 2: 

Improve  intelligence  gathering,  analysis  and  sharing  on  serious  cross-border  health 
threats,  identify  and  address  raw  material  dependencies  as  well  as  market  and 
regulatory challenges/failures  

Expected result(s) and impact:  

Anticipatory  threat  assessment,  horizon  scanning,  market  intelligence,  foresight  of 
serious cross-border threats to health at EU level 

Specific objective No 3: 

Improve  medical  countermeasures development  and production, setting  up structures 
to integrate research and technological development projects. 

Expected result(s) and impact:  

Better integration of advanced research, innovation and development of corresponding 
technologies  and  countermeasures  (including  end  stage  R&D,  clinical  trials  and 
regulatory pathways). 

Ensuring  production,  establishing  EU  flexible  and  scalable  manufacturing  capacities 
for  the  production  of  crisis-relevant  countermeasures  (including  crisis  relevant  raw 
materials) adequate to respond to health emergencies. 

Specific objective No 4: 

Coordinate  action  on  medical  countermeasures  between  national  competent 
authorities,  public  buyers,  industrial  and  research  stakeholders,  as  well  as  global 
actors. 

Expected result(s) and impact:  

Capacity building in Member States e.g. through trainings, expert exchanges  

International  engagement  and reinforcement  for  medical  countermeasures access  and 
development, as well as threat assessments, surveillance and capacity building 

1.4.4. 

Indicators of performance 

Specify the indicators for monitoring progress and achievements. 

General objectives: 

I. 

Strengthening  the  EU’s  preparedness  and  response  for  serious  cross-border 
threats to health, both of natural and intentional origin. 

Indicator 1: Sufficient and timely availability of critical medical countermeasures in 
case of a crisis.  

Indicator  2:  Scaled  up  production/stockpiling/reservation  of  critical  medical 
countermeasures to ensure an equitable access to them. 

Indicator  3:  Improved preparedness and  response planning  for serious  cross-border 
threats to health in the area of medical countermeasures at the national and EU level. 

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1.5. 

Grounds for the proposal/initiative  

1.5.1.  Requirement(s) to be met in the short or long term including a detailed timeline for 

roll-out of the implementation of the initiative 

The current COVID-19 crisis has shown that emergency preparedness and response 
must  be  given  higher  priority.  It  demonstrated  the  need  for  coordinated  EU  level 
action  to  respond  to  health  emergencies.  It  revealed  gaps  in  foresight,  including 
demand/supply  dimensions,  and  preparedness  and  response  tools.  The  European 
Health  Emergency  Preparedness  and  Response  Authority  (HERA)  is  a  central 
element  for  strengthening  the  European  Health  Union  with  better  EU  preparedness 
and  response  to  serious  cross-border  health  threats,  by  enabling  rapid  availability, 
access and distribution of needed countermeasures 

1.5.2.  Added  value  of  Union  involvement  (it  may  result  from  different  factors,  e.g. 
coordination gains, legal certainty, greater effectiveness or complementarities). For 
the purposes of this point 'added value of Union involvement' is the value resulting 
from  Union  intervention  which  is  additional  to  the  value  that  would  have  been 
otherwise created by Member States alone. 

Reasons for action at European level (ex-ante):  

The  current  COVID  pandemic  has  revealed  the  importance  of  preparedness  and 
response  capacities  of  the  Member  States  to  swiftly  react  to  health  emergencies 
which require an engagement across borders.  

Expected generated Union added value (ex-post): 

A strong, legally sound and financially well equipped framework for EU health crisis 
preparedness  and  response,  able  to  cope  with  cross-border  health  threats,  including 
those from outside the EU, where EU intervention can add tangible value. The social 
and  economic  activity  in  the  EU  should  be  secured  in  all  times.  From  a  post-crisis 
recovery perspective, the HERA will make an important contribution to ensuring that 
the  EU  will  be  better  prepared  to  face  future  health    threats  affecting  the  whole  or 
large parts of its territory.  

1.5.3.  Lessons learned from similar experiences in the past 

No similar experience in the past. 

1.5.4.  Compatibility  with  the  Multiannual  Financial  Framework  and  possible  synergies 

with other appropriate instruments 

The  HERA  will  be  using  funds  within  existing  programmes  under  the  MFF  2021-
2027  such  as  the  EU4Health  programme,  Horizon  Europe  Health  Cluster, 
UCPM/RescEU.  It  will  work  in  synergy  and  complementarity  with  existing  EU 
policies  and  funds  such  as  actions  implemented  under  the  Digital  Europe 
Programme,  the  InvestEU  fund,  Single  Market  Programme,  European  Regional 
Development Fund or the Recovery and Resilience Facility. 

1.5.5.  Assessment  of  the  different  available  financing  options,  including  scope  for 

redeployment 

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1.6. 

Duration and financial impact of the proposal/initiative 

 Proposal/initiative of limited duration  

 unlimited duration 

–  Implementation  with  an  estimated  start-up  period  from  September  2021  till 

middle of 2023, 

–  followed by full-scale operation. 

1.7.  Management mode(s) planned34  

 Direct management by the Commission 

–   by its departments, including by its staff in the Union delegations;  

–    by the executive agencies  

 Shared management with the Member States  

 Indirect management by entrusting budget implementation tasks to: 

–   third countries or the bodies they have designated; 

–   international organisations and their agencies (to be specified); 

–   the EIB and the European Investment Fund; 

–   bodies referred to in Articles 70 and 71 of the Financial Regulation; 

–   public law bodies; 

–   bodies governed by private law with a public service mission to the extent that 

they provide adequate financial guarantees; 

–   bodies governed by the private law of a Member State that are entrusted with 
the  implementation  of  a  public-private  partnership  and  that  provide  adequate 
financial guarantees; 

–    persons  entrusted  with  the  implementation  of  specific  actions  in  the  CFSP 

pursuant to Title V of the TEU, and identified in the relevant basic act. 

– 

If more than one management mode is indicated, please provide details in the ‘Comments’ section. 

Comments  

Part of the activities envisaged to be managed by HERA and currently foreseen under specific 
EU programme (EU4Health / Horizon) are delegated to executive agencies. The HERA may 
decide  to  further  delegate  part  of  the  implementation  of  its  programmes  to  an  executive 
agency. 

Moreover  it  may  entrust  decentralised  Agencies  (ECDC,  EMA,  EFSA,  ECHA,  Europol, 
EMCDDA,    European  Climate  and  Health  Observatory)  with  tasks  aiming  to  achieve  the 
objectives of the HERA. 

Indirect management with international organisations: 

34 

Details of management modes and references to the Financial Regulation may be found on the 
BudgWeb site: 
https://myintracomm.ec.europa.eu/budgweb/EN/man/budgmanag/Pages/budgmanag.aspx  

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For the implementation of its mandate, cooperation with international organisations like UN 
agencies,  notably  the  WHO,  Council  of  Europe,  OECD,  or  any  other  relevant  international 
organisations will be ensured, extended or pursued. 

2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

Specify frequency and conditions. 

the  programmes  being 
Performance  frameworks  will  be  developed  within 
implemented by HERA, building on the relevant practices of the programmes 2021-
2027 to ensure that data is collected efficiently, effectively and timely. 

2.2.  Management and control system(s)  

2.2.1. 

Justification of the management mode(s), the funding implementation mechanism(s), 
the payment modalities and the control strategy proposed 

The HERA will be implemented through direct and indirect management, using the 
implementation modes offered by the Financial Regulation, mainly being grants and 
procurement. Direct management allows to establish grant agreements/contracts with 
beneficiaries/contractors directly engaged in activities that serve Union policies. The 
Commission ensures direct monitoring over the outcome of the actions financed. The 
payment  modalities  of  the  actions  funded  will  be  adapted  to  the  risks  pertaining  to 
the financial transactions.  

In  order  to  ensure  the  effectiveness,  efficiency  and  economy  of  the  Commission 
controls,  the  control  strategy  will  be  oriented  towards  a  balance  of  ex-ante  and  ex-
post  checks  and  focus  on  three  key  stages  of  grant/contract  implementation,  in 
accordance with the Financial Regulation: 

– 

– 

Selection of proposals/tenders that fit the policy objectives of the programme; 

Operational,  monitoring 
implementation,  public  procurement,  pre-financing, 
payments, management of guarantees;  

controls 

ex-ante 

and 

that 

cover  project 
final 

interim  and 

Ex-post controls at the beneficiaries/contractors’ sites will also be carried out  on a 
sample  of  transactions.  The  selection  of  these  transactions  will  combine  a  risk 
assessment and a random selection. 

2.2.2. 

Information concerning the risks identified and the internal control system(s) set up 
to mitigate them 

The implementation  of the HERA focuses on the attribution of public procurement 
contracts as well as a number of grants for specific activities and organisations. 

The  public  procurement  contracts  will  mainly  be  concluded  in  areas  such  as 
procurement  of  medicines,  vaccines,  potential  new  treatments,  surveys,  studies, 
collection  of  data,  benchmark  exercises,  monitoring  and  assessment  activities, 
information  campaigns,  IT  and  communication  services,  etc.  The  contractors  are 
mainly  consultancy  firms  and  other  private  companies;  institutes  and  laboratories 
might also be main contractors.    

Grants will mainly be awarded for support activities to competent authorities of the 
Member States, health organisations, national agencies, etc. The period of execution 
of the subsidised projects and activities varies from one to three years mostly. 

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The main risks are the following: 

•    Risk  of  not  fully  achieving  the  objectives  of  the  programme  due  to  insufficient 
uptake or quality/delays in the implementation of the selected projects or contracts; 

•  Risk  of  inefficient  or  non-economic  use  of  funds  awarded,  both  for  grants 
(complexity  of  funding  rules)  and  for  procurement  (limited  number  of  economic 
providers with the required specialist knowledge entailing insufficient possibilities to 
compare price offers in some sectors); 

• Reputational risk for the Commission, if fraud or criminal activities are discovered; 
only partial  assurance  can be drawn from  the third parties' internal control  systems 
due to the rather large number of heterogeneous contractors and beneficiaries, each 
operating their own control system. 

The  Commission  puts  in  place  internal  procedures  that  aim  at  covering  the  risks 
identified  above.  The  internal  procedures  are  in  full  compliance  with  the  Financial 
Regulation  and  include  anti-fraud  measures  and  cost-benefit  considerations.  Within 
this  framework,  the  Commission  continues  to  explore  possibilities  to  enhance  the 
management and to realise efficiency gains. Main features of the control framework 
are the following:  

Controls before and during the implementation of the projects:  

•  An  appropriate  project  management  system  will  be  put  in  place  focussing  on  the 
contributions of projects and contracts to the policy objectives, ensuring a systematic 
involvement  of  all  actors,  establishing  a  regular  project  management  reporting 
complemented  by  on-site-visits  on  a  case  by  case  basis,  including  risk  reports  to 
senior management, as well as maintaining appropriate budgetary flexibility. 

•  Model  grant  agreements  and  service  contracts  used  are  developed  within  the 
Commission.  They  provide  for  a  number  of  control  provisions  such  as  audit 
certificates, financial guarantees, on-site audits as well as inspections by OLAF. The 
rules  governing  the  eligibility  of  costs  are  being  simplified,  for  example,  by  using 
unit costs, lump sums, contributions not linked to costs and other possibilities offered 
by the Financial Regulation. This will reduce the cost of controls and put the focus 
on checks and controls in high risk areas. 

•  All  staff  sign  up  to  the  code  of  good  administrative  behaviour.  Staff  who  are 
involved 
the  grant 
agreements/contracts  (also)  sign  a  declaration  of  absence  of  a  conflict  of  interest. 
Staff is regularly trained and uses networks to exchange best practices.  

the  selection  procedure  or 

the  management  of 

in 

in 

• Technical implementation of a project is checked at regular intervals at the desk on 
the basis of technical progress reports of the contractors and beneficiaries; in addition 
contractors'/beneficiaries' meetings and on-site-visits are foreseen on a case by case 
basis. 

Controls  at the  end of the project:  Ex-post audits are performed on  a  sample of 
transactions  to  verify  on-the-spot  the  eligibility  of  cost  claims.  The  aim  of  these 
controls  is  to  prevent,  detect  and  correct  material  errors  related  to  the  legality  and 
regularity of financial transactions. With a view to achieving a high control impact, 
the selection of beneficiaries to be audited foresees to combine a risk based selection 
with  a  random  sampling,  and  to  pay  attention  to  operational  aspects  whenever 
possible during the on-site audit. 

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2.2.3.  Estimation and justification of the cost-effectiveness of the controls (ratio of "control 
costs ÷ value of the related funds managed"), and assessment of the expected levels 
of risk of error (at payment & at closure)  

As a reference, the  yearly  costs of the suggested  level  of controls under the Health 
programme  2014-2020  represented  approximately  4  to  7%  of  the  yearly  budget  of 
the operational expenditure. This was justified by the diversity of transactions to be 
controlled, and implementation through direct management involving the attribution 
of  numerous  contracts  and  grants  for  actions  of  very  small  to  large  sizes.  The 
Commission considers that the average costs of controls is likely to decrease in view 
of the extended scope and increased budget of the programmes. 

The  HERA  will  earmark  credits  within  several  programmes  to  ensure  its 
implementation.  The existing control system for these programmes should be able to 
prevent  and/or  to  detect  errors  and/or  irregularities,  and  in  case  of  errors  or 
irregularities, to correct them. It will ensure that residual error rates (after correction) 
remain below the threshold of 2%. 

2.3.  Measures to prevent fraud and irregularities  

Specify existing or envisaged prevention and protection measures, e.g. from the Anti-Fraud Strategy. 

As  for  its  activities  in  direct  and  indirect  management,  the  Commission  shall  take 
appropriate measures ensuring that the financial interests of the European Union are 
protected by the application of preventive measures against fraud, corruption and any 
other illegal  activities, by  effective checks and, if irregularities are detected, by the 
recovery  of  the  amounts  wrongly  paid  and,  where  appropriate,  by  effective, 
proportional and deterrent penalties. To this effect, the Commission adopted an anti-
fraud  strategy,  latest  update  of  April  2019  (COM(2019)  176),  covering  notably  the 
following preventive, detective and corrective measures: 

The  Commission  or  its  representatives  and  the  Court  of  Auditors  shall  have  the 
power  of  audit,  on  the  basis  of  documents  and  on-the-spot,  over  all  grant 
beneficiaries, contractors and subcontractors who have received Union funds. OLAF 
shall  be  authorised  to  carry  out  on-the-spot  checks  and  inspections  on  economic 
operators concerned directly or indirectly by such funding. 

The Commission also implements a series of measures such as: 

-  decisions,  agreements  and  contracts  resulting  from  the  implementation  of  the 
programme will expressly entitle the Commission, including OLAF, and the Court of 
Auditors  to  conduct  audits,  on-the-spot  checks  and  inspections  and  to  recover 
amounts unduly paid and, where appropriate, impose administrative sanctions; 

-  during  the  evaluation  phase  of  a  call  for  proposals/tender,  the  applicants  and 
tenderers are checked against the published exclusion criteria based on  declarations 
and the Early Detection and Exclusion System (EDES); 

- the rules governing the eligibility of costs will be simplified in accordance with the 
provisions of the Financial Regulation; 

-  regular  training  on  issues  related  to  fraud  and  irregularities  is  given  to  all  staff 
involved  in  contract  management  as  well  as  to  auditors  and  controllers  who  verify 
the beneficiaries' declarations on the spot. 

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3. 

3.1. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget 
line(s) affected  

  Existing budget lines  

In order of multiannual financial framework headings and budget lines. 

Budget line 

Type of 
expenditure 

Contribution  

Diff./Non-
diff. 

from 
EFTA 
countries 

from 
candidate 
countries 

from third 
countries 

within the meaning 
of Article 21(2)(b) of 
the Financial 
Regulation 

of 

Heading 
multiannual 
financial 
framework 

1  

2b 

2b 

01 02 02 10 - Horizon Europe 

06 06 01 - EU4Health Programme 

Diff. 

Diff. 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

06  05  01  -  Union  Civil  Protection 
Mechanism (rescEU) 

Diff. 

Yes 

Yes 

Yes 

No 

No 

No 

Other  programmes  as  detailed 
the 
Communication,  section  xx  (budget  lines  to 
be further detailed) 

in 

Budget lines for use in times of crisis (no budget allocation foreseen in tables below) 

2b 

06  07  01  -    Emergency  Support 
Instrument  

Diff. 

No 

No 

No 

No 

EN 

10 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2. 

Estimated financial impact of the proposal on appropriations  

3.2.1. 

Summary of estimated impact on operational appropriations  

–    The proposal/initiative does not require the use of operational appropriations  

–  X  The  proposal/initiative  requires  the  use  of  operational  appropriations,  as  explained  below  (all  appropriations  indicated  will  be 

covered by redeployement under the Horizon cluster 4 Health, UCPM,  EU4Health and other programmes) 

EUR million (to three decimal places) 

Heading of multiannual financial  
framework  

1 

Single Market, Innovation and Digital 

DG: RTD 

2021 

2022 

2023 

2024 

2025 

2026 

2027 

Post 
2027 

TOTAL 

 Operational appropriations (C1 and NGEU credits) 

01 02 02 10 – Horizon Europe 3536 

  Appropriations  of  an  administrative 
nature  financed  from  the  envelope  of 
specific programmes 

01 01 – Support expenditure 

TOTAL appropriations 
from budgetary procedures for the 
envelope of the programme 

Commitments 

Payments 

(1) 

(2) 

394.553 
157.821 

418.135 
285.620 

212.937 
328.981 

222.619 
278.369 

229.512 
222.471 

231.272 
228.148 

207.616 

1 709.027 
1 709.027 

Commitments 
= Payments 

Commitments 

Payments 

(3) 

=1+1
a +3 

=2+2

pm 

pm 

pm 

pm 

pm 

pm 

pm 

394.553 

418.135 

212.937 

222.619 

229.512 

231.272 

1 709.027 

157.821 

285.620 

328.981 

278.369 

222.471 

228.148 

207.616 

1 709.027 

35 
36 

Other budget lines under Horizon Europe programme may also be contributing 
This  amount  includes  the  potential  contribution  to  an  executive  agency  as  well  as  technical  and/or  administrative  assistance  and  expenditure  in  support  of  the 
implementation of EU programmes and/or actions (former ‘BA’ lines), indirect research, direct research which will be charged on support expenditure lines (in p.m).  

EN 

11 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
 
 
 
 
 
                                                 
a 

+3 

Heading of multiannual financial  
framework  

2b 

Resilience and Values 

EUR million (to three decimal places) 

DG: SANTE 

2021 

2022 

2023 

2024 

2025 

2026 

2027 

Post 2027 

TOTAL 

 Operational appropriations (C1 credits) 

06 06 01 – EU4Health programme37 

  Appropriations  of  an  administrative 
nature  financed  from  the  envelope  of 
specific programmes 

06 01 05 - Support 

TOTAL appropriations 
from budgetary procedures for the 
envelope of the programme 

Commitments 

Payments 

(1) 

(2) 

274.883 
82.465 

243.145 
155.409 

474.048 
325.111 

484.140 
384.714 

492.488 
482.608 

826.514 
589.357 

775.555 

2 795.218 
2 795.218 

Commitments 
= Payments 

Commitments 

Payments 

(3) 

=1+1
a +3 

=2+2
a 

+3 

pm 

pm 

pm 

pm 

pm 

pm 

pm 

274.883 

243.145 

474.048 

484.140 

492.488 

826.514 

0.000 

2 795.218 

82.465 

155.409 

325.111 

384.714 

482.608 

589.357 

775.555 

2 795.218 

37 

This  amount  includes  the  potential  contribution  to  an  executive  agency  as  well  as  technical  and/or  administrative  assistance  and  expenditure  in  support  of  the 
implementation of EU programmes and/or actions (former ‘BA’ lines), indirect research, direct research which will be charged on support expenditure line (in p.m). 

EN 

12 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
 
 
 
 
 
 
                                                 
Heading of multiannual financial  
framework  

2b 

Resilience and Values 

EUR million (to three decimal places) 

DG: ECHO 

2021 

2022 

2023 

2024 

2025 

2026 

2027 

Post 2027 

TOTAL 

 Operational appropriations (NGEU credits) 

06 05 01 – UCPM/RescEU38 

  Appropriations  of  an  administrative 
nature  financed  from  the  envelope  of 
specific programmes 

06 01 04 - support 

TOTAL appropriations 
from budgetary procedures for the 
envelope of the programme 

Commitments 

Payments 

(1) 

(2) 

630.000 
189.000 

636.000 
379.800 

pm 
442.800 

pm 
254.400 

pm 
0.000 

pm 
0.000 

1 266.000 
1 266.000 

Commitments 
= Payments 

Commitments 

Payments 

(3) 

=1+1
a +3 

=2+2
a 

+3 

pm 

pm 

pm 

pm 

pm 

pm 

pm 

630.000 

636.000 

0.000 

0.000 

0.000 

0.000 

1 266.000 

189.000 

379.800 

442.800 

254.400 

0.000 

0.000 

1 266.000 

38 
This amount includes the cost of technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former ‘BA’ 
lines), indirect research, direct research which will be charged on the support expenditure line (in p.m). 

EN 

13 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
 
 
 
 
 
 
                                                 
 
 
Heading of multiannual financial  
framework  

2b 

Resilience and Values 

DG 

2021 

2022 

2023 

2024 

2025 

2026 

2027 

Post 2027 

TOTAL 

 Operational appropriations 

06 07 01 – Emergency Support Instrument 

Commitments 

Payments 

(1) 

(2) 

pm 
pm 

pm 
pm 

pm 
pm 

pm 
pm 

pm 
pm 

pm 
pm 

Appropriations of an administrative nature 
financed from the envelope of specific 
programmes 

06 01 03 - support 

TOTAL appropriations 
from budgetary procedures for the 
envelope of the programme 

Commitments 
= Payments 

Commitments 

Payments 

(3) 

=1+1
a +3 

=2+2
a 

+3 

pm 

pm 

pm 

pm 

pm 

pm 

pm 

pm 

pm 

pm 

pm 

pm 

pm 

pm 

pm 

pm 

pm 

pm 

pm 
pm 

pm 

pm 

pm 

EN 

14 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Operational appropriations (C1 credits) 

Other  programmes  as  detailed 
the 
Communication  (budget  lines  to  be  further 
detailed) 

in 

  Appropriations  of  an  administrative 
nature  financed  from  the  envelope  of 
specific programmes39  

TOTAL appropriations 
from budgetary procedures for the 
envelope of the programme 

2021 

2022 

2023 

2024 

2025 

2026 

2027 

Post 2027 

TOTAL 

Commitments 

(1) 

41.167 

41.167 

41.167 

41.167 

41.167 

41.167 

247.000 

Payments 

(2) 

12.350 

24.700 

41.167 

41.167 

41.167 

41.167 

45.283 

247.000 

Commitments 
= Payments 

Commitments 

Payments 

(3) 

=1+1
a +3 

=2+2
a 

+3 

pm 

pm 

pm 

pm 

pm 

pm 

pm 

41.167 

41.167 

41.167 

41.167 

41.167 

41.167 

0.000 

247.000 

12.350 

24.700 

41.167 

41.167 

41.167 

41.167 

45.283 

247.000 

  TOTAL  operational  appropriations  (all 
operational headings) 

Commitments 

Payments 

(4) 

(5) 

1.340.603 

1.338.447 

728.152 

747.926 

763.167 

1.098.953 

0 

6.017.245 

441.636 

845.529 

1.138.059 

958.650 

746.246 

858.672 

1.028.454 

6.017.245 

 TOTAL  appropriations  of  an  administrative  nature 
financed from the envelope for specific programmes (all 
operational headings) 

TOTAL appropriations  
under HEADINGS 1 to 6 
of the multiannual financial framework 
(Reference amount) 

Commitments 

Payments 

(6) 

=4+ 
6 

=5+ 
6 

pm 

pm 

pm 

pm 

pm 

pm 

pm 

1.340.603 

1.338.447 

728.152 

747.926 

763.167 

1.098.953 

0 

6.017.245 

441.636 

845.529 

1.138.059 

958.650 

746.246 

858.672 

1.028.454 

6.017.245 

39 

Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former ‘BA’ lines), indirect research, 
direct research. This amount includes the potential contribution to an executive agency.  

EN 

15 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Heading of multiannual financial  
framework  

7 

‘Administrative expenditure’ 

This section should be filled in using the 'budget data of an administrative nature' to be firstly introduced in the Annex to the Legislative 
Financial Statement (Annex V to the internal rules), which is uploaded to DECIDE for interservice consultation purposes. 

HERA 
 Human resources  
 Other administrative expenditure  

TOTAL appropriations under 
HEADING 7 – HERA 

Appropriations  

TOTAL appropriations 
under HEADING 7 
of the multiannual financial 
framework  

(Total  commitments  =  Total 
payments) 

2021 

2022 

2023 

2024 

2025 

2026 

2027 

TOTAL 

EUR million (to three decimal places) 

5.776 

11.148 

14.644 

14.644 

14.644 

14.644 

14.644 

0.818 

0.864 

0.864 

0.864 

0.864 

0.864 

90.144 

5.138 

5.776 

11.966 

15.508 

15.508 

15.508 

15.508 

15.508 

95.282 

5.776 

11.966 

15.508 

15.508 

15.508 

15.508 

15.508 

95.282 

EUR million (to three decimal places) 

TOTAL appropriations  
under HEADINGS of the 
multiannual financial framework 
– from budgetary procedures 

Commitments 

Payments 

2021 

2022 

2023 

2024 

2025 

2026 

2027 

Post 2027 

TOTAL 

5.776  1.352.569  1.353.955 

743.660 

763.434 

778.675 

1.114.461 

0 

6.112.527 

5.776 

453.602 

861.037 

1.153.567 

974.158 

761.754 

874.180 

1.028.454 

6.112.527 

EN 

16 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
3.2.2.  Estimated output funded with operational appropriations  

2021 

2022 

2023 

2024 

2025 

2026 

2027 

TOTAL 

OUTPUTS 

Commitment appropriations in EUR million (to three decimal places) 

o
N

Cost 

o
N

Cost 

o
N

Cost 

o
N

Cost 

o
N

Cost  N

o

Cost 

o
N

Cost 

Total 
No 

Total 
cost 

Indicate 
objectives and 
outputs  

 

Type40 

Avera
ge 
cost 

SPECIFIC OBJECTIVE No 141… 

- Output 

- Output 

- Output 

Subtotal for specific objective No 1 

SPECIFIC OBJECTIVE No 2 ... 

- Output 

Subtotal for specific objective No 2 

TOTALS 

40 
41 

Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.). 
As described in point 1.4.2. ‘Specific objective(s)…’  

EN 

17 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.2.3. 

Summary of estimated impact on administrative appropriations  

–    The  proposal/initiative  does  not  require  the  use  of  appropriations  of  an 

administrative nature  

–  X  The proposal/initiative requires the use of appropriations of an administrative 

nature, as explained below: 

EUR million (to three decimal places) 

2021 

2022 

2023 

2024 

2025 

2026 

2027 

TOTAL 

HEADING 7 
of the multiannual 
financial framework 

Human resources  

Other administrative 
expenditure  

Subtotal HEADING 7 
of the multiannual 
financial framework  

Outside HEADING 742 
of the multiannual 
financial framework  

Human resources  

Other expenditure  
of an administrative 
nature 

Subtotal  
outside HEADING 7 
of the multiannual 
financial framework  

5.776 

11.148 

14.644 

14.644 

14.644 

14.644 

14.644 

90.144 

0.818 

0.864 

0.864 

0.864 

0.864 

0.864 

5.138 

5.776 

11.966 

15.508 

15.508 

15.508 

15.508 

15.508 

95.282 

1.240 

1.322 

1.474 

1.474 

1.474 

1.474 

1.474 

9.932 

0.022 

0.024 

0.024 

0.024 

0.024 

0.024 

0.142 

1.240 

1.344 

1.498 

1.498 

1.498 

1.498 

1.498 

10.074 

TOTAL 

7.016 

13.310 

17.006 

17.006 

17.006 

17.006 

17.006 

105.356 

The  appropriations  required  for  human  resources  and  other  expenditure  of  an  administrative  nature  will  be  met  by 
appropriations  from  the  Commission  that  are  already  assigned  to  management  of  the  action  and/or  have  been  redeployed 
within the Commission, together if necessary with any additional allocation which may be granted to the managing DG under 
the annual allocation procedure and in the light of budgetary constraints. 

42 

Technical  and/or  administrative  assistance  and  expenditure  in  support  of  the  implementation  of  EU programmes 
and/or actions (former ‘BA’ lines), indirect research, direct research. 

EN 

18 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.2.3.1.  Estimated requirements of human resources  

–    The proposal/initiative does not require the use of human resources.  

–  X  The  proposal/initiative  requires  the  use  of  human  resources,  as  explained 

below: 

Estimate to be expressed in full time equivalent units 

2021 

2022 

2023 

2024 

2025 

2026 

2027 

38 

59 

82 

82 

82 

82 

82 

6 

6 

7 

7 

7 

7 

7 

 Establishment plan posts (officials and temporary staff) 

20 01 02 01 (Headquarters and Commission’s Representation 
Offices) 

20 01 02 03 (Delegations) 

01 01 01 01  (Indirect research) 

 01 01 01 11 (Direct research) 

Other budget lines (specify) 

 External staff (in Full Time Equivalent unit: FTE)43 

20 02 01 (AC, END, INT from the ‘global envelope’) 

26 

26 

26 

26 

26 

26 

20 02 03 (AC, AL, END, INT and JPD in the delegations) 

XX 01  xx yy zz  44 

- at Headquarters 

- in Delegations  

01 01 01 02 (AC, END, INT - Indirect research) 

 01 01 01 12 (AC, END, INT - Direct research) 

Other budget lines (specify) 

TOTAL 

4 

5 

5 

5 

5 

5 

5 

48 

96 

120 

120 

120 

120 

120 

XX is the policy area or budget title concerned. 

The appropriations required for human resources and other expenditure of an administrative nature will be met by 
appropriations  from  the  Commission  that  are  already  assigned  to  management  of  the  action  and/or  have  been 
redeployed within the Commission, together if necessary with any additional allocation which may be granted to 
the managing DG under the annual allocation procedure and in the light of budgetary constraints. 

Memorandum of Understanding will be signed between  HERA and SANTE  to ensure the adminsitrative support 
tasks of  HERA. In this respect, 10 posts will be kept within DG SANTE (in addition to the 120 posts in HERA) for 
tasks that will be defined later in the domains of budget and financial management, document management, IT 
services, data protection and/or others.

43 

44 

AC=  Contract  Staff;  AL  =  Local  Staff;  END=  Seconded  National  Expert;  INT  =  agency  staff; 
JPD= Junior Professionals in Delegations.  
Sub-ceiling for external staff covered by operational appropriations (former ‘BA’ lines). 

EN 

19 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Description of tasks to be carried out: 

Officials and temporary staff 

External staff 

The HERA staffing need will be mainly consist of experts (AD level) in the following 
areas: clinical scientists, experts in infectious diseases, experts in virology, experts in 
epidemiology, data  scientists, engineers, regulatory and quality  specialists, experts in 
legal  experts  (e.g. 
manufacturing, 
procurement experts, EU legal pharmaceutical experts, etc.), project managers, experts 
in health emergencies, experts in public health, experts in global health policy, experts 
in healthcare systems, and communication experts. 

logistics  and  supply  chain  management, 

A  specialised  competition  is  ongoing  for  Health  experts  and  will  deliver  laureates  in 
2022.  In  case  an  insufficient  number  of  Officials  can  be  found  to  fill  the  posts,  a 
selection for temporary agents could be launched and/or temporary agents 2b will be 
hired on the permanent posts. 

The HERA will need to collaborate closely with the Member States. The creation of 12 
END positions will contribute to bringing to pass this collaboration and will also allow 
bringing in experts from national administrations. In addition, 20 Contract agents will 
ensure operational administrative and technical support tasks. 

EN 

20 

  EN 

 
 
 
 
 
3.2.4.  Compatibility with the current multiannual financial framework  

The proposal/initiative: 

–  X  can be fully financed through redeployment within the relevant heading of the 

Multiannual Financial Framework (MFF). 

Redeployment  of  appropriations  under  the  Horizon  Health  cluster,  UCPM  and  EU4Health 
programmes;  in  addition,  redeployments  of  a  more  limited  magnitude  in  other  programmes  (to  be 
further defined but could include the Digital Europe Programme, the Single Market Programme…). 

–  hand/or use of the special instruments as defined in the MFF Regulation. 

In time of crisis, the Emergency Support Instrument could be mobilised and financed, inter alia, by the 
margin available under the relevant heading or special instruments. 

–    requires a revision of the MFF. 

Explain what is required, specifying the headings and budget lines concerned and the corresponding 
amounts. 

3.2.5.  Third-party contributions  

The proposal/initiative: 

–    does not provide for co-financing by third parties 

–    provides for the co-financing by third parties estimated below: 

Appropriations in EUR million (to three decimal places) 

2021 

2022 

2023 

2024 

2025 

2026 

2027 

Total 

Specify  the  co-financing 
body  

TOTAL appropriations 
co-financed  

EN 

21 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.3. 

Estimated impact on revenue  

–  X  The proposal/initiative has no financial impact on revenue. 

–    The proposal/initiative has the following financial impact: 

–   

–   

on own resources  

on other revenue 

– 

please indicate, if the revenue is assigned to expenditure lines  

Appropriations 
available for 
the current 
financial year 

Budget revenue line: 

Article …………. 

     EUR million (to three decimal places) 

Impact of the proposal/initiative45 

2021 

2022 

2023 

2024 

2025 

2026 

2027 

For assigned revenue, specify the budget expenditure line(s) affected. 

Other  remarks  (e.g.  method/formula  used  for  calculating  the  impact  on  revenue  or  any  other 
information). 

45 

As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net 
amounts, i.e. gross amounts after deduction of 20 % for collection costs. 

EN 

22 

  EN