REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Review of the implementation of the operations of the Health Emergency Preparedness and Response Authority (HERA)
Date: 2025-03-26
Institutions: European Commission, Secretariat-General
Subjects: European Health Union, Health Emergency Preparedness and Response Authority, crisis management, disease prevention, disease surveillance, emergency aid, medical device, medicinal product, operation of the Institutions, public health

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 26.3.2025  COM(2025) 147 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Review of the implementation of the operations of the Health Emergency Preparedness and Response Authority (HERA)  
 
 
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL 

Review of the implementation of the operations of the Health Emergency Preparedness 
and Response Authority (HERA) 

1. 

INTRODUCTION  

The COVID-19 pandemic brought huge challenges for the EU. It soon became clear that the 
scale of the EU could make a major contribution to tackling the pandemic, and common action 
could also ensure better mitigation of the threat. From the first lessons drawn from the COVID-
19  pandemic1,  it  became  clear  that  more  structural  solutions  were  needed,  to  address  the 
COVID-19 pandemic itself but also to prepare for future health crises. Recent crises reinforce 
the conclusions of Special Advisor Niinistö’s report,2 underlining the need for a strong health 
crisis preparedness and response framework. 

The Health Emergency Preparedness and Response Authority (HERA) was set up in a time of 
urgency, in the midst of the COVID-19 pandemic, and with an acute awareness of the EU’s 
vulnerabilities in preparedness and response to health emergencies. It was recognised from the 
start that it would be important to review the situation at an early stage3. This report presents a 
review of the work and functioning of HERA since its establishment and draws first lessons on 
its achievements.  

2.  HERA’S SET UP AND ROLE  

In the 2020 State of the Union address, President von der Leyen called to build a European 
Health Union where Member States prepare for, prevent and protect their population against 
health crises, by acting together where joint European action is necessary. A year later, the State 
of  the  Union  address  set  out  the  establishment  of  HERA,  citing  global  examples  where  a 
dedicated health security structure was in place. HERA was swiftly set up by a Commission 
Decision4 and was able to start its work in 2021. 

HERA  was  tasked  with  anticipating  health  threats  and  potential  health  crises  through 
intelligence gathering, and with putting in place the necessary response capacities. To allow for 
a swift operationalisation and to give access to the Commission’s existing powers, tools and 
programmes, HERA was established within the Commission. Given the national competences 
in the area of health, strong cooperation with Member States was established.  HERA is assisted 
and  advised  by  the  HERA  Board,  with  high-level  representation  from  each  Member  State5. 

1  Communication 'Drawing the early lessons from the COVID-19 pandemic', COM(2021) 380, 15.6.2021. 
2  Report by Sauli Niinistö, former President of the Republic of Finland, in his capacity as Special Adviser to the 
President  of  the  European  Commission:  Safer  Together:  Strengthening  Europe’s  Civilian  and  Military 
Preparedness and Readiness (26 November 2024). 

3  This  was  recognised  in  the  Commission  Decision  establishing  the  Health  Emergency  Preparedness  and 

Response Authority, C(2021) 6712, 16.9.2021 (hereafter “HERA Decision”). 

4   HERA Decision, C(2021) 6712, 16.9.2021. See also Communication introducing HERA, COM(2021) 576, 
16.9.2021. Preparatory work had started earlier in 2021 following the Communication on HERA Incubator: 
Anticipating together the threat of COVID-19 variants, COM(2021) 78, 17.02.2021. 

5   The HERA Board was set up under the HERA Decision. Its role was defined as assisting and advising the 
Commission  in  the  formulation  of  strategic  decisions  concerning  HERA,  given  the  need  to  develop  close 

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When an emergency hits – and to the extent possible, already before – HERA helps to ensure 
the development, production and distribution of medical countermeasures. Its core mission is 
set out in the HERA Decision: to improve preparedness and response to serious cross-border 
threats in the area of medical countermeasures, in particular by: 

•  strengthening  health  security  coordination  during  preparedness  and  crisis  response 
times, and bringing together the Member States, industry and stakeholders in a common 
effort; 

•  addressing  vulnerabilities  and  strategic  dependencies  related  to  the  development, 
production, procurement, stockpiling and distribution of medical countermeasures; 

•  contributing  to  the  reinforcement  of  the  global  health  emergency  preparedness  and 

response architecture. 

Medical  countermeasures6  include  vaccines,  therapeutics  (medicines),  medical  equipment, 
chemical antidotes, diagnostic tests, and personal protective equipment such as surgical gloves 
and masks. They can also include services required to prepare and respond to serious cross-
border threats to health. 

Within this initial mission, HERA is responsible for working on medical countermeasures in 
terms of assessment of health threats and intelligence gathering; promoting advanced research 
and  development;  addressing  market  challenges  and  boosting  the  Union’s  open  strategic 
autonomy in production;  swift procurement and distribution; increasing stockpiling capacity; 
and strengthening knowledge and skills in preparedness and response. 

The creation of HERA was one of a number of steps taken by the Commission to enable the 
EU and Member States to be better prepared for and better manage health crises, based on the 
lessons learned from the COVID-19 pandemic. In November 2020, the Commission proposed 
a “Health union package”. Its adoption led to Regulation 2022/23717 (“Regulation on serious 
cross-border  health  threats”),  providing  a  mandate  to  the  Commission  for  coordination  and 
cooperation  for  a  more  effective  response  to  serious  cross-border  health  threats;  and  to 
strengthened mandates for both the European Centre for Disease Control (ECDC) and of the 
European Medicines Agency (EMA). All these steps play a part in helping the EU to anticipate, 
prepare  for,  and  respond  to  major  health  threats  –  not  only  infectious  diseases  but  also,  for 
instance,  environmental,  climate-related  and  chemical  threats,  reflecting  the  evolving  threat 
landscape. This  new  landscape  already  put  an  onus  on  the  importance  of  coordination  and 

cooperation between HERA and Member States, ensuring that Member States’ resources and capacities are 
leveraged  as  much  as  possible  towards  HERA’s  joint  goals.  Key  areas  identified  for  the  HERA  Board’s 
assistance  and  advice  were:  the  functions  of  HERA  within  the  Union’s  crisis  preparedness  and  response 
management, research and innovation as well as industrial strategy in the area of medical countermeasures; 
the scientific/technical management of HERA; and the performance of the tasks entrusted to HERA.  

6   Medical countermeasures are defined in the Regulation on serious cross-border health threats and include (i) 
medicinal products for human use, (ii) medical, and (iii) other goods or services necessary for the purpose of 
preparedness for and response to serious cross-border threats to health.  

7   Regulation (EU) 2022/2371 on serious cross-border threats to health, OJ L 314, 6.12.2022, p. 26; Regulation 
(EU) 2022/2370 establishing a European Centre for disease prevention and control, OJ L 314, 6.12.2022, p. 
1;  and  Regulation  (EU)  2022/123  on  a  reinforced  role  for  the  European  Medicines  Agency  in  crisis 
preparedness and management for medicinal products and medical devices, OJ L 20, 31.1.2022, p. 1. 

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cooperation between HERA and the ECDC and EMA, as well as between structures such as 
the Health Security Committee (HSC)8 and the HERA Board. 

In 2023, persistent shortages of critical medicines resulted in calls to step up action at EU level9. 
The Commission responded with a coordinated strategy, building on existing work10. HERA 
had already developed experience in addressing market challenges and boosting coordinated 
EU action in respect of medical countermeasures. HERA therefore was well placed to start to 
take forward several actions in the area of critical medicines, including helping to launch the 
Critical Medicines Alliance and a preparatory study on a potential Critical Medicines Act.  

3.  THE HERA REVIEW  

HERA  was  designed  to  be  a  flexible  structure  that  would  be  adapted  as  required,  and  the 
Commission already committed to a review. The HERA Decision provides for, by 2025, “an 
in-depth review of the implementation of the operations of HERA, including its structure and 
governance. The review shall address in particular any need to modify the mandate of HERA 
and the financial implications of any such modification”. This report contains the findings of 
the Commission’s in-depth review in accordance with that requirement. 

Elements relevant to the review were also included in other legal acts. The regulation on serious 
cross-border health threats11 and Regulation (EU) 2022/2372 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  “Emergency  Framework  Regulation”)12  both  provide  for  an 
evaluation of their implementation by HERA, as well as an assessment of the need to establish 
HERA as a distinct entity (i.e. separate from the Commission).  The Emergency Framework 
Regulation covers response actions only and it has not so far been activated, so there is formally 
no action to assess. This report follows the logic of the HERA Decision, also addressing the 
issue of assessing HERA as a distinct entity in accordance with the different review provisions.  

HERA was set up in a landscape of existing legal and funding tools. It benefited from being 
established under a dedicated Commission Decision, reflecting HERA’s particular nature and 
the  circumstances  in  which  it  was  established.  Setting  up  a  service  inside  the  Commission 

8   The role and composition of the Health Security Committee is set out in the Regulation on serious cross-border 
health threats. It is composed of representatives of Member States, with EU agencies as observers. Its tasks 
are to: (a) support coordinated action by the Commission and the Member States; (b) liaison with the work of 
the  Commission  on  prevention,  preparedness  and  response  planning;  (c)  coordinate,  in  liaison  with  the 
Commission, the risk and crisis communication and responses of the Member States; (d) adopt opinions and 
guidance for Member States, including on specific response measures; and (e) an annual work programme.  
9   The  June  2023  European  Council  conclusions  invited  the Commission  to  “propose  an  initiative  for  urgent 
measures to ensure sufficient production and availability of the most critical medicines and components in 
Europe and to diversify international supply chains”. 

10   See Communication Addressing Medicine Shortages in the EU, COM(2023) 672, 24.10.2023. 
11   Article 33, second subparagraph, of the regulation on serious cross-border health threats : “The evaluation 
…shall also include an evaluation of the Commission's work in preparedness and response activities provided 
for in this Regulation including, where relevant, a review of the implementation of this Regulation by [HERA], 
as well as an assessment of the need to establish HERA as a distinct entity, considering relevant agencies or 
authorities active in the field of health preparedness and response”. 

12   Article 16 of the Emergency Framework Regulation: “That review shall include an evaluation of the work of 
[HERA] under the emergency framework established by this Regulation, and its relation to the preparedness 
activities of HERA. That review shall also include an assessment as regards the need to establish HERA as a 
distinct entity considering relevant agencies or authorities active in the field of health crisis.” 

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through  an  establishing  Decision  is  not  common,  but  was  not  unprecedented13. The  HERA 
Decision does not impinge on the prerogative of the President to assign additional tasks14 – as 
illustrated when HERA was tasked with launching work on critical medicines.  

The Commission has organised the review in separate workstreams. An external study15 drew 
on stakeholder consultation, including public consultation, a call for evidence, targeted surveys 
and interviews, as well as an extensive literature review. A separate workstream looked into the 
internal dimension within the Commission and the interaction with the ECDC and EMA.  

The consultation exercise encompassed a public consultation16, call for evidence feedback17, 
targeted surveys18 and interviews19. The consultation covered the general public, Member State 
national  authorities  (covering  health,  civil  protection,  industry  and  research),  the  European 
Parliament,  EU  agencies,  international  organisations  and  partners,  as  well  as  concerned 
stakeholders (civil society, healthcare professionals, patients, industry, researchers etc.). It also 
drew on the reports of internal and external audit services.  

The review has also drawn on positions from both the European Parliament and the Council. 
The European Parliament’s July 2023 resolution on lessons to be learned from COVID-1920 
saw HERA as a “much-needed body to improve the EU’s preparedness for health emergencies”. 
It also argued for HERA as an “independent EU agency with sufficient funding” and called for 
a greater degree of parliamentary scrutiny. This was echoed in April 2024 when the European 
Parliament  agreed  its  position  on  the  pharmaceutical  reform,  proposing  to  make  HERA  a 
separate entity under the ECDC. As for the Council, the most recent conclusions came in June 
2024,  with  the  Council  Conclusions  on  the  Future  of  the  European  Health  Union21.   These 
included  a  call  for  a  thorough  evaluation  of  the  post-pandemic  EU  health  emergency 
governance framework, and to clarify the relations between relevant entities involved in crisis 
preparedness and management. This debate has continued: On 4 February 2025, 12 Member 
States submitted a non-paper to the Commission on HERA’s missions and governance, calling 
on the Commission to preserve HERA’s structure. This argued that HERA’s “missions are an 

13   The European Anti-Fraud Office OLAF was also set up by a Commission Decision of 28 April 1999. 
14   Article 17(6) (b) TEU provides that the President of the Commission shall “decide on the internal organisation 

of the Commission”. 

15   https://data.europa.eu/doi/10.2929/322979 (Study) and https://data.europa.eu/doi/10.2929/939775 (Executive 

summary). 

16   The Public Consultation questionnaire published on the Commission’s central webpage  Have your say was 
launched  on  27th  November  2023  and  ran  until  19th  February  2024.  A  total  of  44  submissions  to  the 
questionnaire were received, and 19 documents were uploaded by respondents.  

17   The  Call  for  Evidence  was  launched  on  28th  November  2023  and  closed  on  19th  February  2024.  The  total 
number of replies received was 47, including 15 attached documents. The feedback to the call for evidence is 
available on the Have your say portal. 

18   Three sets of targeted surveys were sent to identified stakeholders on 28th November 2023. The surveys yielded 
a total of 210 responses. Six duplicated responses (same author, same reply) were deleted. Out of the remaining 
204 responses, only those that replied to at least 30% of the questions were considered in the analysis. Overall, 
117 valid responses across the three stakeholder groups were considered. 

19   Nine targeted interviews were conducted, comprised of six MEPs, two representatives of ECDC and EMA 

and one advisor to the Commission. 

20   Texts adopted - COVID-19 pandemic: lessons learned and recommendations for the future - Wednesday, 12 

July 2023 (europa.eu) 

21  Council conclusions on the Future of the European Health Union: A Europe that cares, prepares and protects, 

see https://data.consilium.europa.eu/doc/document/ST-9900-2024-INIT/en/pdf 

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essential  element  of  the  EU’s  sovereignty  and  strategic  autonomy  that  must  be  dealt  with 
centrally and specifically without losing the health perspective.”  

Although this review of HERA is a sui generis exercise, the process has sought to follow the 
principles  of  the  Better  Regulation  Guidelines  to  the  extent  possible.  It  assesses  the 
implementation  of  HERA’s  operations,  including  its  structure,  governance  and  mandate, 
compared with the situation before its establishment22.  

4.  HERA’S  WORK  AND  INTERACTIONS  WITH  OTHER  SERVICES  AND 

STAKEHOLDERS 

The  ecosystem  for  health  crisis  preparedness  or  crisis  response  is  complex:  an  effective 
response  needs  to  engage  a  wide  variety  of  stakeholders,  at  national,  EU  and  global  level. 
HERA’s goal to reinforce the existing health security framework implies close cooperation and 
coordination with other services of the Commission, EU agencies, and other structures. Key 
areas  of  cooperation  include  Commission  services  responsible  for  health23,  research  and 
innovation, civil protection and international partnerships; the EU agencies EMA and ECDC, 
as well as the European Health and Digital Executive Agency (HaDEA)24 on implementation; 
and  with  Member  States,  industry  and  civil  society.  In  addition,  there  has  been  significant 
cooperation with international organisations and third countries.  

This interconnection of different dimensions of health preparedness and response requires a 
constant  flow  of  information,  common  prioritisation,  and  operational  cooperation  and 
coordination.  

4.1.  Work with Member States and other stakeholders 

One of the defining features of HERA is cooperation and coordination with national efforts. 
The HERA Board brings together senior Member States representatives to assist and advise the 
Commission on strategic decisions concerning HERA activities. The work of the HERA Board 
can also help decision-making at the national level, because it informs Member States of the 
broader  European  context.  Representatives  of  the  ECDC  and  the  EMA,  the  Emergency 
Response Coordination Centre, as well as a representative of the European Parliament, may 
participate as observers in the meetings of the HERA Board, and other Commission services 
have also been regularly invited to attend. To strengthen information exchange and knowledge 
generation more broadly, the HERA Board is also supported by the HERA Advisory Forum, 
consisting of Member State experts from the area of health, research and industrial policy. As 
a subgroup of this Forum, a Joint Industrial Cooperation Forum has been set up to link Member 
States and industry representatives. The Civil Society Forum ensures exchanges with academia 
and civil society.  

In  the  area  of  critical  medicines,  the  Commission  set  up  the  Critical  Medicines  Alliance 
(involving Member States, industry and civil society), with HERA as secretariat, and EMA and 

22  This review assesses the operations of HERA until the end of November 2024. 
23   In addition to the usual processes to align within the Commission, the HERA Decision points explicitly to a 

close collaboration with the Directorate-General for Health and Food Safety.  

24   As an executive agency, the  European Health and Digital Executive Agency supports EU policies through 

operational support to the work of the Commission. 

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its  Medicines  Shortages  Steering  Group  (MSSG25).  Other  Commission  services  with 
responsibilities linked to critical medicines are involved in the work of the Alliance and able to 
link into their own stakeholder networks.   

To improve the coordination of clinical research in response to public health emergencies, a 
dedicated  sub-group  of  the  HERA  Board  was  established  in  June  2024  to  advise  on  the 
prioritisation  of  clinical  trials  and  their  funding  for  public  health  emergencies  (the  Clinical 
Trials Coordination Mechanism) and involves several Commission services, Member States, 
and the EMA.  

4.2.  HERA’s contribution to health security preparedness and response 

Actors and tools in delivery on medical countermeasures (MCMs) and critical medicines (CMs) 

Assessment of health threats to ensure the availability of medical countermeasures 

Several  actors  have  responsibilities  for  the  assessment  of  health  threats.  ECDC26  monitors 
communicable diseases, including identification and assessment of the threats to human health 
from communicable diseases. It also provides science-based recommendations and support to 
the coordination of the EU response. The Health Security Committee (HSC)27 brings together 
Member States representatives with the Commission services dealing with prevention of cross-
border  health  threats,  health  security  preparedness  and  response,  as  well  as  health  crisis 

25  The role of the MSSG, is to ensure a robust response to medicine supply issues caused by major events or 
public-health emergencies. It coordinates urgent actions within the EU to manage medicine supply issues and 
issues related to the quality, safety and efficacy of medicines. 

26   Article 3 of Regulation (EU) 2022/2370. 
27   Article 4 of Regulation (EU) 2022/2371. 

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response  and  coordination. A  key  role  of  the  HSC  is  to  ensure  coordinated  action  by  the 
Commission  and  Member  States,  including  on  prevention,  preparedness  and  response 
planning.  It  provides  opinions  and  guidance  on  preparedness,  planning,  risk  and  crisis 
communication and response – drawing on the expertise of EU agencies (for example, EMA's 
input  on  the  effectiveness  of  different  medicines,  ECDC’s  rapid  risk  assessments,  or  the 
European Chemicals Agency’s risk assessment of a threat of chemical origin).  

In  addition  to  advice  received  from  the  HERA  Board,  HERA  draws  on  the  work  and  on 
expertise from across the Commission and EU agencies. Delivering results action in the area 
of  medical  countermeasures  involves  different  actors  at  different  stages.  Early  analysis,  the 
definition of gaps and the prioritisation of needs feeds action, to target the problems identified 
by deploying steps such as fostering research and development, boosting production capacity 
or joint procurement. This requires close cooperation – between Member States, ECDC, EMA 
and the Commission, as well as inside the Commission. 

After broad consultation28, in June 2022, HERA put forward the first list of high-impact health 
threats to ensure preparedness and response, in particular by addressing possible gaps in the 
availability and accessibility of medical countermeasures. This list guides EU-level medical 
preparedness interventions, also tied into global alignment and close collaboration on global 
health security. The list of priority threats identified by HERA, as updated in 2024, includes 
anti-microbial resistance (AMR), pathogens with pandemic potential and CBRN (Chemical, 
Biological, Radiological and Nuclear) threats originating from accidental or deliberate release, 
and threats associated with emerging technologies. Climate change is increasingly seen as a 
growing  threat29.  HERA,  in  consultation  with  Member  States  and  its  Joint  Industrial 
Cooperation and Civil Society Forum, also established a catalogue of medical countermeasures 
relevant for preparedness and response to these threats. This prioritisation then informs actions 
in  terms  of  research  and  development,  industrial  policy  measures  such  as  manufacturing 
capacity, and procurement or stockpiling actions.  

Research and innovation 

Research and innovation are critical to the delivery of medical countermeasures now and into 
the future. This is carried out by the public or private sector, using private or public, national 
or EU funds. When HERA was established, it was recognised that this work should draw on 
two main sources of funding: Horizon Europe, the EU Framework Programme for Research 
and Innovation, in particular its cluster on Health, and the EU4Health programme.    

HERA, taking into account the advice of the HERA Board and together with other Commission 
services  responsible  for  research  and  innovation,  assesses  the  need  and  priority  for  novel 
medical  countermeasures  with  a  view  to  providing  effective,  safe  and  affordable  products. 
Depending on the assessment, EU funds can be directed either to the earlier stages of research 

28   HERA consulted Member States, Union and national agencies, Chief Medical Officers, international actors 
and experts on the threat prioritisation exercise. At the international level, HERA has notably exchanged with 
specific departments of government in the United States, CEPI, and the WHO Hub for Pandemic and Epidemic 
intelligence. The first ever list of top-3 health threats was presented in July 2022. HERA's work on threat 
assessment and prioritisation will continue to be regularly updated. 

29   Climate  change impacts health in many different ways, including death and illness caused by increasingly 
frequent extreme weather events; the disruption of food systems; increases in zoonoses and food-, water- and 
vector-borne diseases; and mental health issues. It also undermines many of the social determinants for good 
health, such as livelihoods, equality and access to health care and social support structures. 

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(for example, to innovative anti-microbials), or to boost development of products that are closer 
to approval. The EMA also has a key role in terms of expertise on the effectiveness and efficacy 
of different products, as well as when these products reach the approval stage. 

This work has supported research and innovation within the Horizon  Europe programme to 
develop medical countermeasures for pathogens with high pandemic potential. This includes 
the  development  of  next-generation  vaccines,  in  vitro  diagnostics,  and  broad-spectrum 
antivirals. A  notable  achievement  was  the  Commission’s  support  for  the  first-ever  vaccine 
protecting against Chikungunya virus, a mosquito-borne virus that poses a growing threat to 
the EU due to climate change30. The vaccine was authorised by the Commission in June 2024.   

The ability of the EU to respond to patients’ future needs for medical countermeasures will 
depend heavily not only on research results, but on ensuring the development and scaling up 
of  successful  research  projects.  HERA  supports  this  effort,  including  through  innovative 
financing tools to help offset potential underinvestment by the private sector. In 2023, EUR 
100  million  from  EU4Health  were  directed  to  Invest  EU  programme31,  to  facilitate  the 
development  and  production  of  innovative  medical  countermeasures.  “HERA  INVEST” 
provides financial support to innovative European small and medium-sized enterprises working 
on medical countermeasures against high-impact health threats. The first transactions support 
measures on CBRN countermeasures and new antimicrobials.  

EU  research  funding  has  well-established  ways  of  working  determined  by  its  legislative 
framework, often with a focus on basic research and the pre-clinical phase, whereas HERA’s 
work tends more naturally towards research closer to market deployment.  

Critical medicines, vulnerability analysis, management of shortages 

For critical medicines, HERA has started to build up a monitoring capacity through interaction 
with the EMA32 and the MSSG, which fed the discussions in the Critical Medicines Alliance.  

Following  the  Commission  Communication  on  medicines  shortages33,  HERA  and  the 
Commission service dealing with the Internal Market jointly led a pilot project on vulnerability 
analysis, in order to help develop a methodology for critical medicines in the Union list34. 11 
critical medicines were selected, to cover a broad set of supply chain specificities. This analysis 
has been the basis of the work of Critical Medicines Alliance and contributed to reinforcing 
expertise  in  market  and  supply  chain  intelligence.  While  the  responsibilities  for  Critical 
Medicines Act have now been entrusted to the Commission service dealing with health, HERA 
will continue to provide support on collaborative procurements, given its experience in  this 
area and the overlaps between critical medicines and medical countermeasures.  

30   An  EU  Horizon  partnership  with  the  Coalition  for  Epidemic  Preparedness  Innovations  (CEPI)  has  been 

ongoing already since 2019. 

31  The Research, Innovation, and Digitalisation Policy Window Thematic Innovation financial product.  
32   In crisis times, EMA, under its renewed mandate, monitors the shortages of medicines and medical devices. 
See Regulation (EU) 2022/123 of 25 January 2022 on a reinforced role for the European Medicines Agency 
in crisis preparedness and management for medicinal products and medical devices, OJ L 20, 31.1.2022, p.1 

33  “Addressing medicine shortages in the EU” COM(2023)672, 27.10.2023. 
34   Article 131 of the proposed revision of the  pharmaceuticals legislation COM(2023) 193, 26.4.2023. A first 
version of the Union Critical Medicines (First Union Critical Medicines list (europa.eu)) list was published on 
12 December 2023 by the Commission, the EMA and Member States' Heads of Medicines Agencies.  

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Encouraging supply and production  

The COVID-19 pandemic demonstrated that industrial readiness and security of supply chains 
are key for emergency preparedness and response. Monitoring of supplies, addressing market 
failures  and  a  targeted  industrial  policy  are  necessary  to  ensure  access  to  medical 
countermeasures and critical medicines, to meet the needs of patients and citizens and promote 
the EU’s open strategic autonomy. 

Recognising  that  crises  can  bring  surges  in  demand,  ever-warm  production  capacities  and 
support  given  to  develop  innovative  medicine  production  technologies  and  processes  were 
recognised as  a key element  of preparedness.  In 2022, the Commission set  up the EU FAB 
programme35,  the  EU’s  first  ever-warm  network  of  manufacturing  facilities  for  vaccines. 
Annually, EUR 160 million is devoted to ensuring sufficient and agile manufacturing capacities 
for three different vaccine platforms in six production facilities located across Europe. This 
network is ready to be activated swiftly in the event of a public health emergency and to deliver 
up to 325 million doses annually. 

Tackling  the  risks  of  anti-microbial  resistance  is  an  EU  priority36.  HERA  is  working  to 
coordinate measures  at  EU level  to  ensure access to  the relevant  antimicrobials,  but  also  to 
diagnostics, other treatments and vaccines preventing the unnecessary use of antimicrobials. In 
addition, to improve access to antimicrobials that are by their nature very rarely used and not 
widely available across the EU, HERA is working with 23 Member States to develop a financial 
pull incentive, in the form of a revenue guarantee. This revenue guarantee scheme would offer 
an annual revenue guarantee to producers, in return for launching and maintaining production 
on  the  market  and  deliver  the  ordered  products  in  participating  countries  within  24  hours. 
Unfortunately, so far none of the pilots have led to an agreement with a producer. 

Collaborative procurement, in its various forms, can be a powerful tool, giving assurances of 
scale to manufacturers and suppliers and assurances of delivery to Member States. Based on 
contracts initially negotiated by the Commission service dealing with health, joint procurement 
has been used by HERA to secure the products needed to address COVID-19. HERA secured 
medical countermeasures to address mpox, or zoonotic avian flu37. This included vaccines, but 
has  also  been  used  for  other  key  products  such  as  personal  protective  equipment.  Lessons 
learned include the need to ensure that purchase agreements promote post-authorisation and 
comparative research. This makes an important contribution to the securing reliable supply of 
medical countermeasures. 

This industrial action experience on medical countermeasures was the basis for HERA taking 
responsibility for supporting similar activities in the area of critical medicines. The work on 

35   Framework contract signed under EU4Health to guarantee a fast response to future health crises  - European 

Commission (europa.eu). 

36   Antimicrobial resistance is considered a serious cross-border health threat under the Regulation on serious 
cross-border threats to health. It is estimated that more than 35 000 people die each year in the EU/EEA as a 
direct consequence of an infection due to bacteria resistant to antibiotics, with the situation deteriorating. For 
more details on state of play and EU measures, see Council Recommendation on stepping up EU actions to 
combat antimicrobial resistance in a One Health approach (2023/C 220/01), OJ C 220, 22.6.2023, p. 1. 

37   Making  use  of  ‘Purchase  Agreements,’  Joint  Procurement,  Emergency  procurement  under  EU4Health  and 

through stockpiling under rescEU. 

9 

 
 
 
 
critical medicines has been crystallised in the Critical Medicine Alliance, and led to a first set 
of recommendations in a strategic report in February 202538, identifying priority challenges 
and recommending possible steps at EU level to tackle the vulnerability of supply chains for 
critical  medicines.  The  Commission  has  followed  up  with  a  proposal  to  enable  structural 
cooperation and industrial measures in the form of a Critical Medicines Act39. The task-force 
approach with the Commission service dealing with health will continue on critical medicines, 
with HERA focusing on collaborative procurements. 

HERA’s work necessarily involved coordination at EU level, between Member States and with 
a  wide  variety  of  EU  policies,  in  the  broader  setting  of  EU  public  health,  industrial  policy, 
strategic autonomy and economic security, with major efforts under way to ensure EU supply 
in areas such as critical raw materials. It also needs to work with broader policy goals in health, 
the global dimension, competition, and trade. The expertise of other Commission services, the 
EMA and Member States is essential to ensure effective targeting and delivery. It is increasingly 
important that information is available on existing capacity to meet future needs. HERA brings 
together industry, Member States and other stakeholders, fostering collaboration to identifying 
actions and instruments to address vulnerabilities in the supply chains of critical medicines and 
of medical  countermeasures at  large. The working relations developed by HERA with  third 
country equivalent organisations also help in addressing these issues with like-minded partners. 

Stockpiling and distribution  

The Commission has a well-developed crisis response policy and coordination mechanism in 
civil  protection40. Medical  needs are at  the forefront  of EU response capabilities, and when 
HERA  was  established,  the  provision  of  medical  countermeasures  at  times  of  crisis  was 
recognised  as  a  key  part  of  this  work.  In  the  EU,  stockpiling  and  distribution  of  medical 
countermeasures  remain  a  primary  competence  of  Member  States,  supported  by  EU-level 
initiatives such as rescEU. Nevertheless, the added value of coordination and complementary 
action at EU level is recognised as an essential element of preparedness, so HERA works to 
this end.  

The legal framework of the rescEU programme governs how this work is taken forward. Since 
its  creation  in  2022,  HERA  has  stepped  up,  in  coordination  with  the  Commission  service 
responsible for civil protection, the work with Member States to identify where stockpiles are 
required to be ready in case of needs which can follow pandemics, but also security threats 
such as CBRN attacks. By the end of 2024, a total of thirteen grant agreements were put in 
place, with stockpiles so far focused on CBRN, containing antidotes, antibiotics, and vaccines, 
as well as specific CBRN response equipment such as detection, decontamination, and personal 
protective equipment.  

38  https://health.ec.europa.eu/document/download/3da9dfc0-c5e0-4583-a0f1-

1652c7c18c3c_en?filename=hera_cma_strat-report_en.pdf  

39  COM(2025) 102, 11.03.2025. 
40   Civil protection assistance consists of governmental aid delivered in preparation for or immediately after a 
disaster strikes in Europe and worldwide. When an emergency strikes, the EU Civil Protection Mechanism can 
be activated by national authorities to enable a coordinated assistance. The Emergency Response Coordination 
Centre (ERCC) is the heart of the EU Civil Protection Mechanism. It coordinates the delivery of assistance to 
disaster-stricken countries, such as relief items, expertise, civil protection teams and specialised equipment. 
The ERCC operates 24/7. It can help any country inside or outside the EU affected by a major disaster upon 
request from the national authorities or a UN body.  

10 

 
 
 
These  rescEU  stockpiles  are  designed  to  be  used  as  a  last  resort,  complementing  national 
stockpiles and only activated when national capacity is exhausted. They provide an extra layer 
of preparedness and can be accessed by Member States and rescEU partner countries. However, 
stockpiling is a complex exercise, with many different factors to consider (including shelf-life, 
regulatory  requirements,  environment  and  security  requirements,  and  transport),  requiring 
strong coordination with EU and national authorities and experts. Under the mandate of the 
new Commission, HERA is developing a Strategy on medical countermeasures, alongside a 
wider reflection on stockpiling, as part of the Preparedness Union Strategy. 

Contribution to coordination and response to public health emergencies 

Health crisis coordination and crisis response in the EU is governed by different legislation. 
The Regulation on serious cross-border threats to health is the main legal act, setting out the 
EU health security architecture, including mechanisms such as for EU agencies to provide risk 
assessments,  for  the  coordination  of  response  within  the  Health  Security  Committee,  for 
ensuring  public  health  preparedness,  including  of  relevant  national  capacities  of  Member 
States,  and  also  the  procedure  for  recognising  a  public  health  emergency  at  Union  level41. 
HERA contributes to its implementation, notably on the provisions of joint procurement.  

In the event of a public health emergency, the Emergency Framework Regulation allows the 
Commission  to  propose to  Council to  activate emergency measures to  ensure the supply of 
crisis-relevant  medical  countermeasures,  as  well  as  setting  up  a  Health  Crisis  Board  42.  If 
emergency measures are activated (“crisis response mode”), the state of play for crisis-relevant 
medical countermeasures and raw materials is to be monitored, including production capacity, 
stockpiles, and the risk of disruption in supply chains – this would be a key role for HERA and 
preparation for this eventuality is an important part of HERA’s work.  

This preparedness for crises ensures that it can effectively and efficiently operate in the EU 
crisis  response  architecture,  requiring  strong  coordination  and  collaboration  with  other 
Commission services,  Member States  and stakeholders. HERA organises regular simulation 
exercises to assess coordination and interoperability between all EU institutions involved in 
the current health crisis architecture and to ensure better preparedness of all actors. Procedures 
to  optimise  HERA’s  response,  by  developing  an  emergency  protocol,  and  threat-specific 
response blueprints, have also been developed.  

Capacity building for Member States 

HERA’s  role  includes  work  with  Member  States  which  have  identified  gaps,  sharing  best 
practices learnt from previous health crises and strengthening skills and knowledge on the full 
cycle  of  management  of  medical  countermeasures  through  tailored  trainings  and  exercise 
programmes. Since 2023, training offered by HERA has included four dedicated workshops, 
on the scope and operational management of stockpiles of medical countermeasures, and on 
public procurement. This work complements ECDC training to build capacity in areas such as 

41   By the Commission, after considering any expert opinion issued by the ECDC, with provision for independent 
advice to the provided to the Commission and the Health Security Committee by an Advisory Committee, 
amongst  others  on  whether  a  threat  constitutes  a  public  health  emergency  at  Union  level  and  on  response 
measures (see Article 23 of Regulation 2022/2371). 

42   EMA, ECDC, the Advisory Committee under Regulation (EU) 2022/2371 on serious cross-border threats to 

health, and the Health Security Committee, as well as the European Parliament. 

11 

 
 
 
epidemic intelligence and risk assessment.  A Pact for Skills in the pharmaceutical sector also 
supports the development of skills to help production in this area. 

HERA also  organises tabletop  exercises to  assess  coordination and interoperability between 
HERA and Member States. This work requires a strong coordination with Member States and 
other Commission services. It also requires strong coordination within the EU in relation to 
global outreach to link into the work of the World Health Organization Academy.  

International coordination  

HERA’s work has an important international dimension. Supporting the availability of medical 
countermeasures  depends  on  global  supply  chains,  while  new  medical  countermeasures  are 
developed  in  the  context  of  a  global  research  community.  With  the  aim  to  provide  early 
information regarding possible needs for medical countermeasures, HERA also supports work 
to reinforce global surveillance and intelligence gathering, in coordination with ECDC. 

HERA collaborates at global level with the World Health Organization Hub for pandemic and 
epidemic  intelligence  and  the African  Centre  for  Disease  and  Control,  and  bilaterally  with 
similar organisations in countries such as the United States, Japan, South Korea and Canada. 
Working  arrangements  have  been  put  in  place  or  are  being  developed  to  frame  these 
collaborations.  On  more  sectoral  issues,  HERA  is  also  supporting  the  Global  Antibiotic 
Research and Development Partnership, the Coalition for Epidemics Preparedness Initiative 
and  the  work  of  the  European  and  Developing  Countries  Clinical Trials  Partnership43. This 
work needs to be taken forward in close synergy with the wide range of ties developed in other 
areas  of  health  and  international  partnerships  policy  and  programmes  by  the  Commission 
services and the EEAS, EU agencies, and Member States. HERA’s work on the production and 
supply of medical countermeasures also feeds into the Commission’s work to deepen the global 
framework for health, including negotiations on a potential new WHO Pandemic Agreement.  

4.3. 

Funding 

The EU budget allocated to health, and to protecting citizens from cross-border health threats 
in particular, saw a steep rise with the COVID-19 crisis. In the period 2014-2020, only EUR 
5.4 million was allocated for crisis preparedness, out of a total of around EUR 500 million for 
health policies in total. This amount has risen significantly under the EU4Health Programme 
for the 2021-2027 period, which had an overall budget of EUR 5.4 billion.  

When HERA was created, it was recognised that substantial funding would be required at EU 
level, to complement the investment by Member States in their own preparedness. With the 
2020-2027 Multiannual Financial Framework already under way, funds were identified to be 
devoted  to  HERA’s  activities  from  existing  programmes:  EU4Health,  Horizon  Europe  and 
rescEU.  This  amounted  to  some  EUR  6  billion.44  However,  a  targeted  revision  of  the 
Multiannual  Financial  Framework45  led  to  a  reduction  of  several  programmes,  including 

43  https://www.global-health-edctp3.europa.eu/  
44   Other EU programmes also make an important contribution to the resilience of health systems (and therefore 
to  preparedness  for  crisis),  such  as  the  Recovery  and  Resilience  Facility,  REACT-EU,  STEP44,  Cohesion 
Funds  and  the  InvestEU  Programme,  as  well  as  the  Neighbourhood,  Development  and  International 
Cooperation Instrument (NDICI) outside the EU. During the COVID-19 pandemic, the EU also drew on the 
possibilities offered by the Emergency Support Instrument (ESI), demonstrated to be both flexible and fast. 
45  This aimed at providing urgent financial support to Ukraine, supporting EU action on migration, investing in 

strategic industries and covering higher NextGenerationEU funding costs. 

12 

 
 
 
EU4Health and Horizon Europe. To mitigate the reduction, the largest part of this cut would be 
in 2027, when the budget will be at its peak. 

HERA  manages  funds  mainly  devoted  to  promoting  advanced  research  and  innovation  of 
medical countermeasures, production capacity, and joint procurement, as well as stockpiling 
and health crisis coordination, in cooperation with other Commission services. It also supports 
threat assessment capacities and surveillance systems. Private funding has also been mobilised 
under InvestEU through HERA Invest leveraging cooperation with the European Investment 
Bank  Group  and  other  financial  actors.  Both  national  support  for  actions  related  to 
preparedness and response to health threats, and multi-country projects, can also contribute to 
the mission of HERA46. This diversity of funding sources allows HERA to use different types 
of award procedures and financial instruments under direct and indirect management, varying 
from grants, procurements, and financial instruments/loans under the Financial Regulation47.  

The fact that HERA’s activities draw on existing funding programmes also means that these 
activities are governed by the legal frameworks already in place, implying different governance 
structures, and different stakeholders, with a broader range of concerns than the specific goals 
of HERA. This means not only that the different services responsible inside the Commission 
need to be well coordinated, but it also calls for close cooperation at national level between the 
HERA  stakeholders  and  the  Member  States  representatives  in  the  governance  bodies/ 
programme committees of the respective funding programmes. 

HERA’s  activities,  whether  innovative  steps  such  as  maintaining  ever-warm  production 
facilities, or pull incentives for antibiotics, meet very targeted needs. For example, it is often 
only late in the product development cycle that the specific medical countermeasures required 
can be defined. This is not always easy to reconcile with the existing programmes on which it 
draws for funding. 

5.  FINDINGS OF THE REVIEW 

The review has sought to assess HERA’s relevance, effectiveness, efficiency, coherence and 
EU added value.  

The relatively recent establishment of HERA means that any assessment of its delivery must 
recognise that much of its work is still being developed and consolidated. The fact that HERA 
took on new tasks related to critical medicines also underlines that its tasks as set out in the 
HERA Decision are evolving with changing needs. Nevertheless, all its key work strands are 
being implemented, and a wide variety of stakeholders have been able to comment on how they 
see the effectiveness of its work so far. 

The quantitative evidence base of this review is necessarily limited, given its timeframe, so the 
emphasis has been on qualitative evidence and analysis.  

As HERA’s “crisis response mode” has never been activated by the Commission, there are no 
points of comparison against which HERA’s performance during a recognised public health 
emergency can be assessed. Nevertheless, HERA’s role in the response to the mpox outbreaks 

46   For example, Important Project of Common European Interest (IPCEI) define actions to promote the execution 

of an important project of common European interest. 

47   Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council of 23 September 2024 

and the financial rules applicable to the general budget of the Union (recast). 

13 

 
 
 
in  Europe in  2022 and in Africa in  2024 help  to assess HERA’s performance in  emergency 
response48. As HERA works at EU level, and that combined efforts are central to its way of 
working, it cannot be compared quantitatively with institutions performing similar functions at 
the national level.  

In reviewing HERA’s actions, it is important to note that it is closely integrated and builds on 
the work of other entities, in particular of other services inside the Commission, EU agencies, 
or Member States. The ability of HERA to help galvanise a collective impact within the EU, as 
well as cooperating with partners globally, should be seen as an important part of the work to 
be analysed.  

5.1.  Key points from the review exercise 

The different workstreams of the review, and including the study carried out by the external 
contractor,  have  resulted  in  a  comprehensive  picture  of  HERA’s  work.  The  study  sets  out 
findings  relating  to  effectiveness,  efficiency,  relevance,  coherence  and  EU  added  value. A 
summary of the consultation exercise undertaken as part of the external study has also been 
published49.  

The  consultation  exercise  reported  a  consensus  among  the  general  public,  stakeholders  and 
experts  that  HERA’s  mission  remains  relevant  and  in  line  with  the  EU  policy  goals  and 
priorities50. As new threats emerge or gain in importance – whether climate change, accidental 
or deliberate health threats – actions to reinforce preparedness and response at EU level will 
continue  to  be  required.  The  role  of  the  EU  in  working  to  reduce  the  risks  of  not  being 
sufficiently prepared, and to help in response, now seems well established.  

Member  States  as  well  as  international  stakeholders  recognised  the  importance  that  the 
Commission could play in that field, and the additional role played by HERA since its creation 
has been welcomed by several stakeholders from Member States, industry and civil society. In 
less than three years, and in the wake of an unprecedented health crisis, HERA is seen to have 
brought concrete and new deliverables. The added value of EU action also helped to contribute 
to the visibility of EU leadership in health security. The role demonstrated by HERA was also 
reflected when it was called upon to stimulate the active participation of key stakeholders in 
the Critical Medicines Alliance and the role it will continue to play in supporting collaborative 
procurements of critical medicines and of other medicinal products of common interest.  

48  WHO Director-General Dr Tedros Adhanom Ghebreyesus determined on 14 August 2024 that the upsurge of 
mpox in the Democratic Republic of the Congo and a growing number of countries in Africa constituted a 
public health emergency of international concern (PHEIC) under the International Health Regulations (2005).  
49   Factual Summary Report of the Contributions to the Public Consultation and Stakeholders Consultation on 
HERA  Review  -  Synopsis  Report,  available  at  https://ec.europa.eu/info/law/better-regulation/have-your-
say/initiatives/14035-Review-of-the-Health-Emergency-Preparedness-and-Response-Authority-HERA-
/public-consultation_en 

50   In both the Public Consultation and in the targeted surveys there is above 80% agreement that HERA’s mission 
and activities are still relevant, that the needs addressed require action at EU level, and that HERA’s activities 
correspond to wide EU policy goals and priorities. This clearly converges with opinions expressed in scientific 
articles  and  policy  reports,  as  well  as  with  the  views  stakeholders  expressed  in  free-text  replies  to  open 
questions,  in  documents  attached  to  the  Public  Consultation  and  to  the  Call  for  Evidence,  and  in  targeted 
interviews. Https://data.europa.eu/doi/10.2929/322979, pages 20-23. 

14 

 
 
 
From the perspective of effectiveness of its actions, the consultation and the analysis51 of the 
77 activities launched and implemented by HERA in its first three years of activity52 show the 
different  ways in  which  HERA has worked on its  specific objectives. HERA has positively 
contributed to strengthening the health security architecture in the EU, through coordination 
and  centralisation  of  activities,  strengthening  threat  assessment  capabilities,  improving 
intelligence on market and supply chain intelligence, and contributing to research on, as well 
as production and deployment of, new medical  countermeasures to be deployed in times of 
crisis. When Europe was faced with the mpox outbreak in 2022, HERA responded immediately 
by purchasing and donating medical countermeasures to affected countries, drawing on the EU 
budget for the first time for this purpose.  

The joint procurement instrument in particular has proven very valuable, with medical counter 
measures being secured for better preparedness against zoonotic avian influenza, COVID-19 
or diphtheria. HERA’s  work contributed to  the overall stockpiling  already under way under 
rescEU.  The  stockpile  of  medical  and  CBRN  countermeasures  are  seen  to  have  offered  an 
effective  contingency  for  preparedness:  the  experience  will  help  to  inform  the  stockpiling 
strategy foreseen to be adopted soon.  

HERA  cooperated  effectively  with  other  Commission  services,  including  the  Emergency 
Response Cooperation Centre, to manage rescEU grants and ensure the distribution of vaccine 
donations via ReliefEU. 

As regards the international dimension, HERA has developed into a credible and recognised 
player valued by international partners, as for example illustrated by the rapid response to the 
mpox  outbreak  in  Africa  during  the  summer  of  2024,  where  the  Commission  purchased, 
donated and coordinated Team Europe donations of vaccines. Synergies were developed with 
the  EU’s  humanitarian  response  capacity  (ReliefEU)  managed  by  the  ERCC  to  ensure  the 
effective delivery of the donations of Member States to the different affected countries, as well 
as with research projects on global health. 

The ability of HERA to respond to challenges beyond the tasks set out in the HERA Decision, 
by mobilising resources and offering innovative solutions to new emerging issues, such as the 
shortages of critical medicines, also demonstrates its effectiveness, as well as its flexibility and 
readiness to respond intrinsic to its mission.  

This effectiveness also needs to be seen in the broader context of the Commission’s approach 
to build a European Health Union with a strong health security pillar in response to COVID-
19 pandemic, that will continue to be developed as part of a wider EU Preparedness Union 
Strategy. The broader efforts of the Commission and EU agencies, as well as the impulse given 
to cooperation with Member States in the wake of the pandemic, have all been key to the ability 
of HERA to deliver.  

In terms of resource efficiency, the external study53 showed that, based on the budget spent so 
far, HERA produced most of the planned outputs within the costs initially foreseen. HERA has 

51   Detailed 

analysis 

per 

specific 

objectives 

on 

pages 

25-40 

of 

the 

final 

study, 

https://data.europa.eu/doi/10.2929/322979 

52   The  study  sets  out  HERA’s  activities  under  the  2022,  2023  and  2024  Work  Programmes.  See 

https://data.europa.eu/doi/10.2929/322979, study table 3 (p. 32). 

53   Https://data.europa.eu/doi/10.2929/322979, pages 51-59. 

15 

 
 
 
a very important role in the design of the work programmes and of different calls, but this can 
vary between funding programmes. As HERA relies on different funding programmes, strong 
coordination and cooperation between services is needed to avoid overlaps and inefficiencies 
in the management of funds. For the implementation of its tasks, HERA also uses innovative 
funding mechanisms.  

A majority of consulted stakeholders consider that the potential benefits from HERA's activities 
largely outweigh its cost. This seems to be in line with analysis concluding that investment in 
preparedness is generally cost-effective, given the risk of much higher costs in the event of a 
crisis and given the evidence that EU-level action can provide real added value.  

HERA contributed to coherence by giving a new focus to pandemic preparedness in the work 
of  the  EU.  Coordination  during  preparedness  and  crisis  response  times  is  a  key  mission  of 
HERA, with the establishing decision specifying that HERA should bring together Member 
States, industry and stakeholders. The HERA Board has played a key role in this regard. HERA 
coordinates  and  collaborates  with  other  entities  at  five  levels:  first,  with  other  Commission 
services, and with agencies; second, with Member States54, both bilaterally and collectively; 
third, with countries included in the WHO’s European Regions that are not part of EU27 or 
EEA30; fourth, at global level with the WHO and with other key groupings such as the G20 and 
G7, to promote collective agreements on sustainability and resilience; and finally, in bilateral 
collaborations, both on an intergovernmental basis and with private companies, especially in 
countries with strong research infrastructure.  

This  complex  environment  requires  HERA  and  its  partners  to  pay  particular  attention  to 
collaboration and coordination. The Commission has well-established procedures for internal 
coordination, and a dedicated Coordination Committee was set up at political level to provide 
strategic oversight55. Strategic coherence entails that HERA draws on the work of EU agencies, 
including in terms of threat intelligence (primarily from ECDC) and medical countermeasures 
intelligence (with a strong role by EMA), as well as on the guidance and advice provided by 
the HERA Board and the Health Security Committee.   

HERA  also  helped  in  ensuring  coherence  and  coordination  with  national  and  international 
activities, considering the limited resources available globally for the area. It also offers a more 
coherent and strategic approach between different EU instruments. 

HERA  delivers  EU  added  value  by  filling  the  gap  at  EU  level  identified  at  the  time  of  the 
pandemic, drawing on the scale and versatility possible at EU level to effectively complement 
Member  State  efforts  on  medical  countermeasures.  For  example,  the  organisation  of  cost-
effective procurement offered an outcome that was both more certain in terms of delivery and 
more  equitable  in  terms  of  access.  Further  stockpiling  of  medical  countermeasures  under 
rescEU  was  also  cited  by  a  number  of  stakeholders  as  bringing  added  value,  drawing  on 
effective cooperation within the Commission. 

54   And, on some issues, with the 30 members of the European Economic Area. 
55   The Coordination Committee provides political steering on the planning and implementation of HERA’s tasks 
and is composed of the Vice-President of the Commission in charge of Health, the Member of the Commission 
in charge of Health and the Members of the Commission in charge of the Internal Market, Innovation and 
Research and Crisis Management. 

16 

 
 
 
The  HERA  Decision  explicitly  defines  HERA’s  activities,  and  the  focus  on  improving 
preparedness and response to cross-border threats in the area of medical countermeasures. But 
HERA’s added value has also been shown in developing skills and experience which can be 
drawn on in other areas. When HERA was called upon to act in the area of critical medicine 
shortages, it reflected an understanding that HERA was best placed to take the lead, given its 
experience on industrial measures and collaborative procurements of medicines, even if some 
stakeholders  queried  the  extension  of  HERA’s  activities  beyond  the  areas  identified  in  the 
HERA Decision. This experience will continue to be further used in this area, notably to support 
collaborative procurements.  

HERA’s  collaboration  with  global  actors  in  the  area  of  medical  countermeasures,  whether 
bilateral  or  with  bodies  such  as  the  World  Health  Organization  and  the Africa  Centre  for 
Disease Control and Prevention (AfCDC), also adds a necessary additional dimension to the 
EU’s work to build a robust global health security framework.   

The results achieved from having a structure dedicated to pandemic preparedness and response, 
with a tailor-made governance, have demonstrated the added value of working together in an 
area where the EU’s competence is otherwise limited. 

5.2.  Areas for improvement 

The risks of duplication 

HERA was created during a time of crisis and in a landscape where many actors were already 
working.  EU  health  security  policy  was  expanding  at  the  same  time,  through  the  European 
Health Union. HERA’s  need to  be up and running quickly has paid  dividends in  the results 
achieved, but has faced the challenge of finding the best ways of working hand in hand with 
the  structures  and  instruments  already  in  place.  Overlaps  in  responsibilities  or  actions  can 
create  confusion  and  dilute  the  impact  and  added  value  of  EU  policies  and  actions,  and  a 
conscious  effort  is  needed  to  resolve  the  difficulties.  These  overlaps  can  also  bring 
inefficiencies, like the parallel collection of data. Such overlaps can have a negative impact on 
the EU’s preparedness for future crisis. 

A consistent theme of the public consultation was the importance of addressing the risk that 
preparedness and emergency response can be undermined by shortcomings in coordination and 
a lack of clarity in the division of tasks, risking duplication of effort and resources. Some of 
the contributions to the consultation called for additional clarification of HERA’s mandate, also 
highlighting the difference between the tasks identified in the HERA Decision, and those which 
have subsequently emerged in the area of critical medicines. Several stakeholders consider that 
new problems have emerged, identified in the tasks covered under the HERA Decision56. 

Both  in  the  external  and  internal  consultations,    concerns  were  raised  about  the  risk  of 
duplication  and  a  lack  of  clarity  in  the  role  of  HERA  in  public  health,  civil  protection  and 

56   See p. 55 of final report: “In the Public consultation respondents were presented with the following statement 
“Industrial  policy  actions  to  support  the  availability  of  critical  medicines  should  be  taken  at  EU  level  to 
address current challenges, including those outlined in the recent Communication on addressing medicine 
shortages”. About 66% agreed with this statement. In the targeted surveys, respondents were asked to state 
their agreement with the statement “Since HERA’s establishment,  health challenges and/or problems (e.g. 
shortages of medicines) emerged or became more salient that are not (entirely) addressed by HERA’s mandate 
as currently defined”. The agreement with the statement was at 50%, and a similar proportion called for more 
flexibility in HERA’s work than implied from the HERA Decision alone. 

17 

 
 
 
research  funding,  including  in  the  interaction  with  the  ECDC,  with  the  Health  Security 
Committee and the newly established Advisory Committee on Public Health Emergencies,  as 
well as with the EMA (both on medical countermeasures and critical medicines)57 . The profile 
and branding of HERA has been seen to create some confusion amongst outside stakeholders 
as to who is speaking for the Commission. 

Tangible efforts have already been made to streamline the collaboration within the Commission 
and with agencies, for instance through working arrangements58. A good example came with 
the  Commission  proposal  for  a  Critical  Medicines  Act  where  HERA’s  expertise  in  joint 
procurement and extensive contacts with the pharmaceutical industry were drawn upon. The 
Commission  set  out  that  HERA  will  also  organise  collaborative  procurements  for  critical 
medicines  and  other  medicinal  products  of  common  interest  and  will  continue  to  provide 
secretariat services to the Critical Medicines Alliance, an essential consultative and cooperation 
mechanism aiming to reinforce the EU pharmaceutical supply chain.  

But more can be done to increase effective interaction and bring synergies. President Niinistö’s 
report  underlines  that  effective  preparedness  requires  a  comprehensive  and  integrated 
approach.  The  EU  health  security  framework  could  benefit  from  further  consolidation  to 
maximise EU preparedness and coordination for future health threats.   

Similarly,  close  cooperation  with  the  Union  Civil  Protection  Mechanism,  in  particular  the 
Emergency Response Coordination Centre, would be mutually beneficial, and would build on 
existing synergies. 

Cooperation 

An important lesson learned during the COVID-19 crisis was the need for a strong cooperation 
and coordination, between the different structures in charge of health security, all the more so 
given that implementation of health measures remains the responsibility of Member States. As 
pointed out in the Preparedness Union Strategy adopted on 26 March 202559,  the effectiveness 
of the EU response will be compromised without comprehensive, cross-sectoral cooperation. 
HERA’s work on production and supply of medical countermeasures downstream can be most 
effective when it can benefit from a strong HERA involvement upstream, in the assessment of 
health  threats  and  in  research  and  development,  as  well  as  being  coordinated  with  broader 
stockpiling and overall crisis coordination.  

57   The external study reports stakeholder concerns about overlaps between HERA and other bodies (p. 66), data 
and information gathering and are aware that HERA results cannot be achieved without a strong cooperation 
with  other  Commission  services  and  agencies  (p.  10),  as  well  as  with  Member  States  (p.  67), 
https://data.europa.eu/doi/10.2929/322979 

58   HERA  signs  agreement  with  ECDC  and  with  EMA  to  strengthen  cooperation  on  health  emergency 
preparedness and response - European Commission (europa.eu); Working arrangements between HERA and 
ECDC; Working arrangements between HERA and EMA  

59  Preparedness  Union  Strategy,  available  at  https://webgate.ec.europa.eu/circabc-ewpp/ui/group/2868c14b-

717d-4a95-93bd-57e5c4dafdae/library/b81316ab-a513-49a1-b520-b6a6e0de6986/details  

  Annex 

to 

the  Preparedness  Union  Strategy,  available  at  https://webgate.ec.europa.eu/circabc-

ewpp/ui/group/2868c14b-717d-4a95-93bd-57e5c4dafdae/library/18537b82-f73b-46ff-b1bb-
4c7e02d4404a/details 

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Funding optimisation 

HERA was created after the adoption of the current multiannual financial framework and its 
programmes. This meant that HERA had to draw on existing funds to fulfil its objectives, with 
access to funding on a substantial scale and of a nature which could reflect the diversity of 
HERA’s activities, but also the need to respect the parameters of those programmes and the 
rules governing their operations. 

These considerations lie behind stakeholder calls seen in the study60 for HERA’s activities to 
have access to more tailor-made funding. The calls for a more tailor-made or even dedicated 
funding instrument will need to be assessed as part of considerations in preparation of the next 
Multi-annual Financial Framework.  

HERA’s  activities  often  require  an  innovative  approach,  as  they  focus  on  preparedness  for 
uncertain events that could nevertheless have dramatic consequences in terms of public health 
and even loss of lives. Therefore, the nature of the actions also means that they might need to 
be  designed  as  an  insurance,  and  assessed  not  for  their  immediate  result,  but  from  the 
perspective of the opportunity costs of having no measures in place should these events occur 
(e.g. saving lives, reducing the impact on health, on economic activity). 

HERA Board 

One  of  the  specificities  of  HERA  is  the  HERA  Board,  set  up  to  assist  and  advise  the 
Commission  on  strategic  decisions  concerning  HERA,  and  to  develop  close  cooperation 
between HERA and Member States, ensuring that Member States’ resources and capacities are 
leveraged as much as possible. The HERA Board allows EU level decision-making to take full 
account of the national context.  

However, the consultations have shown that there is concern about the coordination with other 
bodies  and  structures  such  as  the  Health  Security  Committee,  and  the  high  number  of 
(sometimes  overlapping)  activities  from  different  EU  organisations  requiring  Member  State 
participation.  Similar concerns could  emerge as  to  a certain  duplication between the HERA 
Board and the new Advisory Committee for Public Health Emergencies. All this points to the 
need for streamlining and better coordinating work and to ensure a clearer framing of the role 
of the HERA Board in its advisory role as an expert group of the Commission.  

Transparency  

One of the calls made in the European Parliament has been for more transparency on HERA’s 
activities and governance, echoed by some other stakeholders. Others considered that HERA’s 
dedicated  governance  structure  provides  such  transparency,  and  bodies  such  as  the  HERA 
Board and the Critical Medicines Alliance add variety of views to HERA’s work.  

As a service of the Commission, HERA has the established structures and rules for transparency 
and  accountability,  for  which  it  is  subject  to  the  same  mechanisms  that  apply  to  other 
Commission services (e.g. adherence to ethical standards, involvement of stakeholders, internal 
audits  and  evaluation,  access  to  documents,  reporting  obligations  etc.).  The  European 
Parliament can raise questions or ensure accountability in the same way as in other areas of the 
Commission's activities– as happened in the case of several in-camera meetings with Members 

60   https://data.europa.eu/doi/10.2929/322979  

19 

 
 
 
of Parliament on the negotiations for the COVID-19 vaccines61. The European Parliament also 
has the opportunity to participate in all meetings of the HERA Board as an observer.  

HERA  has  already  initiated  several  actions  to  strengthen  a  more  proactive  communication 
towards external stakeholders and improve transparency even further. Since February 2024, it 
has  issued  bi-monthly  newsletters  and  factsheets  explaining  its  work.  It  is  also  organising 
HERA  Info  days  across  Member  States  and  launched  the  HERA  Stakeholders  Hub.  The 
communication  activities  also  extend  to  outreach  towards  the  general  public,  through  the 
HERA website and social media. 

5.3. 

Status  

HERA  was  established  as  a  Commission  service  to  allow  it  to  start  work  fast  and  to  work 
flexibly  between  preparedness  and  crisis  mode.  Despite  its  positive  record  to  date,  some 
discussion persists regarding its institutional status (i.e. whether it should be an EU agency / 
authority). Issues raised since HERA’s establishment as a Commission service include a lack 
of independence from the Commission, the European Parliament’s position regarding specific 
scrutiny of HERA, the absence of a Scientific Advisory Committee, perception of unbalanced 
stakeholder representation, transparency issues and funding vulnerabilities.  

As  a  Commission  service,  HERA  can  work  more  effectively  with  EMA,  ECDC,  and  the 
executive  agency  HaDEA62  and  can  draw  on  the  Commission’s  resources,  and  expertise  in 
other  policy  areas  (health,  industry,  research  and  innovation,  competition,  civil  protection, 
humanitarian  aid,  external  relations,  international  partnerships,  etc).  This  helps  enhance 
synergies between policies and supports a closer involvement in the Commission’s decision 
making  process.  Having  HERA  as  part  of  the  Commission  allows  also  to  better  position 
HERA’s needs in proposals made from different policy perspectives across the Commission.  

A need for flexibility is inherent in HERA’s work in case of crisis, a Commission service can 
benefit from the fast mobilisation of human resources, by setting up ad-hoc tasks forces, while 
the  human  resources  in  an  agency  are  pre-determined  by  an  establishment  plan.  Most 
importantly, at times of crisis, swift decision-making is indispensable – it is difficult to see how 
it would be possible for a body to be engaged in this process if not inside the EU’s institutional 
core. 

There  are  a  number  of  additional  technical  advantages  in  HERA’s  position  inside  the 
Commission. For example, an agency cannot use the services of another agency for executing 
the budget, which would entail at least duplicating the HaDEA staff implementing EU4Health 
and Horizon Europe budget and diverting resources to financial management.  

Any  assessment  of  HERA’s  set-up  also  has  to  take  into  account  the  EU's  overall  policy 
objectives and budgetary context. Any change would need to establish that HERA’s ability to 
deliver would be enhanced, and not diminished, by the change.  

61  E.g. 

https://www.europarl.europa.eu/committees/en/covi-hearing-with-ecdc-hera-and-chief-ep/product-

details/20221111CHE10923  

62  The European Health and Digital Executive Agency (HaDEA) was established on 16 February 2021 with the 
purpose  of  delegating  certain  tasks  relating  to  the  management  of  Union  programmes,  including  budget 
implementation. Its tasks are linked to the implementation of Union programmes in the field of EU4Health, 
Single Market, Research and Innovation, Digital Europe, Connecting Europe Facility – Digital, and comprise 
in particular the implementation of appropriations entered in the general budget of the Union. 

20 

 
 
 
6.  CONCLUSION 

This review has explored the work of HERA so far, how it is viewed by outside stakeholders 
and  the  results  it  has  achieved.  In  almost  three  years  of  operations,  HERA  has  made  a 
significant contribution to reinforcing EU preparedness and response capabilities for medical 
countermeasures,  but  also  as  regards  threat  prioritisation  and  preparedness,  and  showed  its 
agility in adapting to new tasks. As explained in the Niinistö report, preparedness investments 
can contribute to the resilience of the EU, as well as to the competitiveness of strategic sectors, 
bringing benefits to patients in “peace times” through the strengthening of supply chains. As 
the  climate,  geopolitical  and  security  landscape  changes,  the  risk  of  health  emergencies 
increases, and the EU must further strengthen and consolidate its preparedness and response 
capabilities on health security. HERA’s work can make an important contribution to a more 
secure and better-prepared EU.  

Pandemics and other cross-border health threats can no longer be assumed to be rare events. In 
the past they were a “once-in-a-century” occurrence, but developments like globalisation and 
climate change have increased their probability and frequency. Building on the lessons from 
the  COVID-19  pandemic,  the  Commission  has  taken  major  steps  to  bolster  health  security 
preparedness and has expanded the EU’s response to health emergencies within the EU and 
globally. 

The  experience  since  the  COVID-19  crisis  has  reinforced  the  lessons  learned  during  the 
pandemic:  that  crisis  coordination  requires  agile  governance  structures.  A  high  level  of 
coordination is of critical importance, given the different responsibilities of the Commission, 
the Member States and EU agencies; and also given the many policies which need to be taken 
into account in delivering effectively, whether health, civil protection, research and innovation, 
industry,  trade,  competition,  transport,  border  management  and  overall  crisis  response 
coordination.  

This  review sets  out  how HERA has found  a place to  provide added value in  this complex 
setting, and also identifies a number of areas where further work and clarity is needed to make 
the most of the combined potential to  better protect  the health of citizens. This  review also 
highlights  areas  where  improved  coherence  between  the  Commission’s  work  on  medical 
countermeasures and broader health security could help streamline efforts and enhance overall 
coherence. 

Since HERA was established, a series of tools have been put in place by the Commission and 
EU agencies to ensure that emerging health security threats can be more rapidly detected, better 
understood, and better combatted in a one health approach. All this helps the EU to anticipate, 
prepare  for,  and  respond  to  major  health  threats  –  not  only  infectious  diseases  but  also 
environmental, climate-related, or chemical and nuclear risks, shifting the EU’s approach from 
reaction to proactive readiness. 

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