COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS State of Health Preparedness Report 2023
Date: 2023-12-15
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: coronavirus disease, crisis management, disease prevention, epidemic, innovation, medical device, medical research, public health, therapeutics, vaccine

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 15.12.2023  COM(2023) 792 final  COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS State of Health Preparedness Report 2023  
 
 
1. INTRODUCTION 

The European Union (EU) has made important strides in strengthening its preparedness capacity to 
withstand serious cross-border health threats. December 2023 marks four years since SARS-CoV-2 
was detected for the first time, eventually unleashing a full-blown pandemic and an unprecedented 
global health crisis.  Since then, many initiatives  and lessons learned have crystallised in  new EU 
legislation  to  strengthen  our  collective  defences  and  preparedness  against  pandemics  and  other 
major threats to health, such as those brought by climate change. 

December 2023 also sees the first anniversary of the entry into force of a key legislative act in the 
EU  health  security  framework:  Regulation (EU) 2022/2371  on  serious  cross-border  threats  to 
health.1  The  Commission  proposed  the  Regulation  back  in  2020  as  part  of  the  first  pillar  of  the 
European Health Union, together with proposals for the expanded mandates for two key EU health 
agencies:  the  European  Centre  for  Disease  Prevention  and  Control  (ECDC)  and  the  European 
Medicines  Agency  (EMA).  The  Regulation  has  upgraded  the  existing  EU-level  mechanisms  for 
public health prevention, preparedness, surveillance, early warning and response, and has become 
the  backbone  of  the  EU’s  health  security  architecture.  The  European  Health  Union  –  whose 
foundations were laid while we were still undergoing the unprecedented COVID-19 crisis – is now 
operational and delivering results, including the Commission’s Health Emergency Preparedness and 
Response  Authority  (HERA),  created  in  September  20212.  This  report  outlines  those  major 
developments to date. 

The political commitment to draft an annual state of health preparedness report to reflect the overall 
changing risk landscape in the EU and the state of health preparedness was announced in the 2021 
Commission Communication ‘Drawing the early lessons from the COVID-19 pandemic’3. The first 
edition  of  the  State  of  Health  Preparedness  Report 4  was  published  in  2022  and  focused  on 
preparedness capabilities related to medical countermeasures. The primary objective of this year’s 
report is to map the EU actions that have been put in place to address serious cross-border health 
threats, with a focus on those actions implementing Regulation (EU) 2022/2371 (such reporting is, 
in  fact,  a  requirement  according  to  Article  95).  As  a  second  objective,  the  2023  report  outlines 
relevant ongoing initiatives and work that are closely related but that are, for example, coordinated 
by Commission services outside the public health policy area. By showing these interlinkages, the 
report takes stock of EU efforts in the area of stronger health security, emphasising the importance 
of taking a ‘One Health’ approach6. The value of the ‘One Health’ approach is recognised by the 
EU  and  by  many  governments,  organisations  and  global  industries  due  to  its  critical  impact  on 
overall prevention, preparedness and risk assessment processes. 

1 Regulation (EU) 2022/2371 of the European Parliament and of the  Council of 23 November 2022 on serious cross-
border  threats  to  health  and  repealing  Decision  No  1082/2013/EU,  OJ  L  314,  6.12.2022,  p.  26  (https://eur-
lex.europa.eu/eli/reg/2022/2371/oj). 
2 Commission Decision establishing the Health Emergency and Response Authority, COM(2021) 6712 final. 
3 COM(2021) 380 final. 
4 COM(2022) 669 final. 
5 Article  9  of  Regulation  2022/2371  provides  that  the  Commission  shall,  by  27  December  2023  and  every  3  years 
thereafter,  transmit  to  the  European  Parliament  and  to  the  Council  a  report  on  the  state  of  play  and  progress  on 
prevention, preparedness and response planning at EU level. 
6 As defined in Article 3(7) of Regulation (EU) 2022/2371:  
‘One Health’ means a multi-sectoral approach which recognises that human health is connected to animal health and to 
the environment, and that actions to tackle threats to health must take into account those three dimensions. 

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2. PREVENTION  

Prevention is one of the essential steps in the crisis management cycle, comprising all activities that 
aim  to  minimise  the  burden  of  health  threats  and  mitigate  their  associated  risk  factors. 
Regulation (EU) 2022/2371 firmly codified the notion of prevention in addition to preparedness and 
response, 
this  area. 
Regulation (EU) 2022/2371 covers a wide scope of serious cross-border public health threats: from 
communicable diseases to chemical  and environmental threats and threats of an unknown origin7, 
thus creating an overarching and flexible framework for preparedness and response.   

thus  providing  a  strong 

for  strengthening  work 

legal  basis 

in 

Vaccination as a key prevention measure 

Vaccination is key to preventing the spread of infectious diseases. As shown during the COVID-19 
pandemic,  the  EU  Vaccines  Strategy8  ensuring  support  to  the  development  of  vaccines  and  their 
availability to all Member States and the national vaccination campaigns were able to substantially 
alter the  course of  events, saving  tens of millions  of lives  globally  (an estimated 20 million  lives 
were saved in the first year alone 9). COVID-19 is no longer considered a public health emergency 
of international concern10, but the ECDC stresses that the continued roll-out of COVID-19 vaccines 
by  countries  (particularly  targeting  older  adults  and  other  medically  vulnerable  groups)  remains 
essential  in  order  to  reduce  severe  disease,  hospitalisations  and  deaths  from  the  virus11.  The 
Commission  is  supporting  Member  States  in  ensuring  continued  access  to  adapted  COVID-19 
vaccines. 

The Commission also continues to be active in the field of vaccination policy beyond COVID-19, 
by  supporting  the  Member  States  in  increasing  their  vaccination  coverage.  The  Commission’s 
Communication  and  the  Council  Recommendation  of  2018  on  strengthened  cooperation  on 
vaccine-preventable  diseases12  referred  to  a  number  of  priorities  in  this  field,  which  have  been 
implemented  by  the  Commission  on the  basis  of  a  publicly  available  roadmap13.  For  example,  to 
counteract  vaccine  hesitancy  in  the  population,  which  is  a  growing  risk  to  public  health,  the 
Commission has launched initiatives such as behavioural studies14,15; the Coalition for Vaccination, 
bringing together EU health professionals’ and students’ associations to advocate for vaccination; 
as  well  as  the  European  Vaccination  Information  Portal16,  which  is  an  accurate  source  of 
information  on  vaccination  for  the  general  public.  To  continue  those  efforts,  a  subgroup  of  the 
Commission’s  Public  Health  Expert  Group  (PHEG)17  is  dedicated  to  vaccination.  Moreover,  the 
ECDC  now  offers  online  training  to  the  public  on  vaccine  hesitancy  and  misinformation  via  its 
Virtual  Academy18  and  continues  to  host  the  National  Immunisation  Technical  Advisory  Group 
(NITAG)  Collaboration  of  countries  in  European  Economic  Area  (EEA),  which  assesses 
vaccination needs and advises national governments on vaccination strategies. 

7 See Article 2(1) of Regulation 2022/2371. 
8 https://commission.europa.eu/strategy-and-policy/coronavirus-response/public-health/eu-vaccines-strategy_en  
9 https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(22)00320-6/fulltext  
10 https://www.who.int/publications/i/item/9789241580496  
11 https://www.ecdc.europa.eu/en/publications-data/interim-public-health-considerations-covid-19-vaccination-roll-out-
during-2023  
12 Council Recommendation of 7 December 2018 on strengthened cooperation against vaccine-preventable diseases, OJ 
C 466, 28.12.2018, p. 1–7 (https://eur-lex.europa.eu/legal-content/GA/TXT/?uri=OJ%3AJOC_2018_466_R_0001). 
13 https://health.ec.europa.eu/system/files/2022-12/2019-2022_roadmap_en.pdf  
14 https://op.europa.eu/en/publication-detail/-/publication/8ba3bd75-7c38-11ed-9887-01aa75ed71a1/language-en  
15 https://knowledge4policy.ec.europa.eu/projects-activities/behavioural-insights-eu-bi4eu_en  
16 https://vaccination-info.eu/en  
17 https://health.ec.europa.eu/non-communicable-diseases/expert-group-public-health_en  
18 https://eva.ecdc.europa.eu/  

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Moving  forward,  the  Commission  is  developing  a  vaccine  strategy  targeting  priority  threats  for 
which  the  development  of  new  vaccines  or  improvement  of  existing  ones  would  be  needed.  In 
addition,  the  Commission’s  work  on  vaccination  also  has  strong  ties  to  Europe’s  Beating  Cancer 
Plan19,  which  is  illustrated  by  an  upcoming  proposal  for  a  Council  Recommendation  on  vaccine-
preventable cancers.  

Cross-border sharing of vaccination data with healthcare professionals in their language 

The  MyHealth@EU  infrastructure  was  launched  to  allow  health  professionals  to  access,  in  their 
language,  electronic  health  data,  including  vaccination  records,  of  patients  travelling  or  moving 
from  their  home  country  to  another  Member  State.  The  objective  is  to  ensure  continuity  of  care. 
Participation  is  voluntary  (based  on  Directive 2011/24/EU  on  patients’  rights  in  cross-border 
healthcare).  As  of  July  2023,  11  Member  States  were  already  connected  to  MyHealth@EU  and 
more  are  planning  to  join  in  the  future.  Under  the  Commission  proposal  for  a  regulation  on  a 
European  Health  Data  Space,  which  is  currently  under  negotiation  by  the  co-legislators,  the 
participation  of  Member  States  in  the  MyHealth@EU  infrastructure  would  become  mandatory. 
Under  the  EU4Health  work  programme  2023,  direct  grants  to  Member  States’  authorities  are 
planned  for  the  development  and  enhancement  of  MyHealth@EU  services,  including  vaccination 
card services. 

Monitoring vaccines on the EU market 

Experience  with  COVID-19  has  reiterated  the  importance  of  post-marketing  monitoring  of 
vaccines.  The  Vaccine  Monitoring  Platform  was  therefore  launched  as  a  collaborative  space 
between  the  ECDC  and  the  EMA  to  address  research  questions  through  large-scale  EU-wide 
independent studies on vaccine effectiveness and safety monitoring. It is necessary to build capacity 
in  the  Member  States  and  create  the  infrastructures,  at  both  national  and  subnational  levels,  to 
enable  the  sustainable  and  long-term  monitoring  that  is  required  to  inform  public  health  and 
regulatory decisions regarding vaccines on the EU market and their use in real-life settings. 

Addressing antimicrobial resistance 

Antimicrobial  resistance  (AMR)  is  the  ability  of  microbes  like  bacteria,  viruses  and  fungi  to 
develop resistance and to overpower the medicines designed to kill them. AMR threatens to unravel 
modern medicine as we know it. The coming years will be crucial to ensure prudent use, access and 
development  of  effective  antimicrobials  and  thus  require  greater  awareness  of  the  fight  against 
AMR.  It  is  estimated  that  at  least  35 000  people  die  each  year  in  the  EU/EEA  as  a  direct 
consequence of resistant infections. This is more than the combined total of deaths due to influenza, 
tuberculosis and HIV/AIDS, and this number is growing20. AMR is not as acutely in the public eye 
as  COVID-19  was,  but  it  is  no  longer  a  silent  pandemic  and  needs  urgent  action  to  prevent  the 
currently projected catastrophic outcomes.  

Building on the 2017 EU action plan on antimicrobial resistance21, in April 2023 the Commission 
proposed a Council Recommendation, adopted in June 202322. It recommends measures to combat 

19 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2021:44:FIN  
20 https://www.ecdc.europa.eu/sites/default/files/documents/Health-burden-infections-antibiotic-resistant-bacteria.pdf 
21 https://health.ec.europa.eu/system/files/2020-01/amr_2017_action-plan_0.pdf  
22 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. 1–20. 

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AMR in the fields of human health, animal health and the environment through the  ‘One Health’ 
approach. For the first time in the EU, the Recommendation sets EU and national targets to reduce 
the  consumption  of  antimicrobial  medicine  and  control  the  spread  of  critical  pathogens  in  human 
health. Devised with the support of the ECDC, these recommended targets should serve as a driver 
of national action and monitoring of progress in the coming years. 

Highlight: joint Action on AMR 

The EU is also mobilising its financial resources to support effective AMR policies and measures. 
Over EUR 57 million was invested under the EU4Health programme in its first 3 years (2021-2023) 
in  tackling  AMR  –  most  notably  a  new  joint  action  on  AMR  to  be  launched  in  2024  to  bring 
together  all  EU  Member  States,  Iceland,  Norway  and  Ukraine  in  common  activities  to  combat 
AMR. across the One Health approach. 

To address increasing AMR, it is essential to ensure both access to existing antimicrobials and the 
development  of  novel  effective  ones.  On  26 April 2023,  the  Commission  adopted  proposals  for  a 
new  directive  and  regulation  to  revise  and  replace  existing  Union  general  pharmaceutical 
legislation23. These proposals  contain measures to  improve innovation  and access  to  medicines in 
the  EU,  including  antimicrobials.  Some  measures  specifically  address  AMR,  in  conjunction  with 
the  above-mentioned  Council  Recommendation,  which  aim  to  strengthen  the  prudent  use  of 
antimicrobials and include ‘transferable data-protection vouchers’24 to incentivise the development 
of novel antibiotics. Eligibility for the voucher scheme would be restricted to novel antimicrobials 
that address AMR and the priority pathogens recognised by the World Health Organization (WHO). 
The  Council  Recommendation  on  stepping  up  EU  actions  to  combat  AMR  also  welcomed  the 
Commission’s  intention  to  design  an  EU  multi-country  ‘pull’  incentive  scheme  to  improve 
innovation, the development of new antimicrobials and access to existing and new antimicrobials, 
with financial support from the EU4Health programme25.  

As regards the availability of existing antibiotics and prevention of their shortages during the 2023 
autumn and winter season, the Commission together with the EMA monitor the supply and demand 
of  key  antibiotics  used  in  the  treatment  of  respiratory  infections.26  Based  on  the  results  of  this 
monitoring,  the  EMA  Executive  Steering  Group  on  Shortages  and  Safety  of  Medicinal  Products 
issued  recommendations  to  ensure  the  availability  of  antibiotics  at  potential  risk  of  shortages.  As 
announced in the Communication on addressing medicine shortages in the EU27, the Commission 
and EMA will continue to closely monitor the situation. 

The Commission is further supporting the development of and access to preventive, diagnostic and 
therapeutic medical countermeasures against AMR through its work. This support includes funding 
international  bodies  such  as  the  WHO,  the  Global  Antibiotic  Research  &  Development 
Partnership28  and  their  joint  initiative  SECURE29,  which  is  working  to  develop  new  antibiotics30 

 (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023H0622%2801%29).  
23 https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/promoting-our-european-way-life/european-
health-union/reform-eu-pharmaceutical-legislation_en 
24 The voucher will offer to the developer an additional year of data protection from competition for the medicine that 
the voucher is used for. 
25 https://health.ec.europa.eu/funding/eu4health-programme-2021-2027-vision-healthier-european-union_en 
26 See also below section on safe and effective medicinal products and medical devices. 
27 Communication from the Commission to the European Parliament, the Council, the European Economic and Social 
Committee and the Committee of the Regions: Addressing medicine shortages in the EU, COM(2023) 672 final 
(https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2023:672:FIN).  
28 https://gardp.org/  

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and vaccines against AMR infections31. HERA Invest, an EUR 100 million top-up to the InvestEU 
programme,  which  is  geared  towards  small  and  medium-sized  companies  that  develop  medical 
countermeasures, will also address AMR. 

At the same time, the EU’s framework programme for research and innovation, Horizon Europe, is 
delivering on the objectives of the 2017 EU action plan and the 2023 Council Recommendation on 
AMR. In the past year it has provided support through a coordination and support action, DESIGN 
OH AMR (DESIGN One Health AntiMicrobial  Resistance)32, for  the  development  of a European 
co-fund partnership on OH AMR research and innovation, to be launched in 2025, to which the EU 
is expected to contribute EUR 100 million.33 It has also continued to provide funding resources for 
research  and  innovation  actions  on  OH  AMR  of  nearly  EUR 200 million  since  the  start  of  the 
Horizon Europe programme.34 

Besides  its  efforts  in  human  and  animal  health,  the  Commission  continues  to  recognise  the 
environment as  a reservoir of resistance that needs further understanding as recognised in the EU 
Strategic Approach to Pharmaceutical in the Environment35. Through initiatives under the European 
Green  Deal 36  and  in  particular  the  Zero  Pollution  Action  Plan37,  the  Commission  has  acted  in 
several  environmental  domains.  Regarding  water,  the  Commission  proposes  to  revise  the  list  of 
pollutants in groundwater and surface water38, including a number of AMR substances and AMR 
genes. The Commission proposal for a recast of the Urban Wastewater Treatment Directive39 also 
establishes,  among  other  measures,  the  monitoring  of  health  parameters  in  urban  wastewater, 
including the mandatory surveillance of AMR to enhance the EU's preparedness against pandemics 
or other major public health threats, as is currently being done for COVID-19.  

Regarding soil, the Commission is looking into AMR genes in microorganisms in agricultural soils 
through survey LUCAS Soil 201840, with reports expected by the end of 2023. Preliminary results 
show that over 600 samples contained detectable levels of AMR genes41. The Commission, through 
its proposal on the Nature Restoration Law,  also aims to act on increasing resilience against such 
genes  by  restoring  the  health  of  ecosystems  that  can  act  as  a  barrier  to  the  spread  of  AMR.  In 
addition,  through LUCAS Soil 2018, the Commission is  looking  into antibiotics synthesis (ABG) 
genes  in  soils  which  can  contribute  to  new  medicines.  The  results  of  both  AMR  and  ABG  genes 
will be hosted in the EU Soil Observatory (EUSO)42. 

29 https://www.who.int/groups/secure-expanding-sustainable-access-to-antibiotics 
30 A  total  of  EUR 8 million  was  provided  under  the  action  CP-g-06.7:  ‘Strengthening  preparedness  and  response  to 
cross-border health threats at global level’ (EU4Health Work Programme 2021). 
31 The  Commission  has  issued  an  EUR 82 million  call  for  tenders:  ‘Speed  up  the  Development  of  and  Access  to 
Innovative Medical Countermeasures’. 
32 https://www.jpiamr.eu/activities/one-health-amr/design-oh-amr/  
33https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/horizon-hlth-2024-
disease-09-01  
34 Horizon Europe (europa.eu) 
35 eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52019DC0128 
36 https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/european-green-deal_en 
37 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52021DC0400   
38 https://environment.ec.europa.eu/publications/proposal-amending-water-directives_en 
39 https://environment.ec.europa.eu/publications/proposal-revised-urban-wastewater-treatment-directive_en 
40 The Land Use and Coverage Area frame Survey (LUCAS) is a regular harmonised survey organised by the European 
Statistical Office (EUROSTAT) in cooperation with other Commission services, to gather information on land use and 
land coverage across all Member States. 
41 https://esdac.jrc.ec.europa.eu/projects/lucas 
42 https://esdac.jrc.ec.europa.eu/ 

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Preventing zoonotic diseases such as avian influenza 

Over  60%  of  emerging  infectious  disease  threats  are  of  zoonotic  origin43,  so  we  must  remain 
vigilant about the possibility of a next pandemic coming from an animal source. 

The EU has relied on two main pieces of legislation to address infectious disease risks coming from 
animals. These are Directive 2003/99/EC44, ensuring proper monitoring and evaluation of zoonoses, 
zoonotic  agents  and  food-borne  outbreaks,  and  Regulation (EU) 2016/42945  (the  ‘Animal  Health 
Law’)  which  lays  down  rules  for  the  prevention  and  control  of  zoonoses,  including  their  early 
detection, notification and reporting.  

The One Health approach has already been considered in EU actions for decades, but the COVID-
19  pandemic  underlined  once  again  the  importance  of  this  approach  for  prevention,  preparedness 
and response and the need for optimal coordination across sectors. Regulation (EU) 2022/2371 now 
explicitly calls for the One Health approach in addressing current and emerging crises.  

Within months of the adoption of Regulation (EU) 2022/2371, the Health Security Committee46 – 
the  key  EU  body  dealing  with  public  health  threats  –  held  several  joint  meetings  with  the  EU’s 
Chief Veterinary Officers to discuss the threat of Highly Pathogenic avian influenza (HPAI) and the 
animal  and  human  health  measures  needed  to  prevent  the  risk  of  zoonotic  spillover  to  humans. 
HPAI is a major health threat and requires vigilance, early detection and a rapid and early response 
to any spillovers early on. The 2022/23 season saw one of the largest HPAI epidemics in wild birds 
and poultry in the EU to date and large outbreaks among mammals. The relevant EU legislation47 
provides  that  all  Member  States  must  carry  out  surveillance,  to  allow  early  detection  of  HPAI  in 
birds  and  mammals.  Animal  health  law  ensures  harmonisation  of  the  measures  that  all  Member 
States  have  to  implement  once  the  HPAI  virus  is  detected  in  kept  birds  in  order  to  prevent  and 
control its spread; and provides the legal basis for the competent authorities to take the necessary 
measures when the virus is detected in mammals. 

Since  September  2017,  the  European  Food  Safety  Authority  (EFSA)  and  the  ECDC  have  been 
mandated  by  the  Commission  to  regularly  assess,  jointly  with  the  EU  Reference  Laboratory  for 
avian  influenza  in  animal  health48,  the  HPAI  epidemiological  situation  and  the  evolution  of  the 
genetic  characteristics  of  HPAI  viruses  detected  in  animals.  Scientific  reports  with  the  results  of 
these  assessments  are  published  every  2  to  3  months49  and  present  options  for  responding  to  the 
identified risks for animal and public health.  

43 https://www.nature.com/articles/nature06536  
44 Directive  2003/99/EC  of  the  European  Parliament  and  of  the  Council  of  17  November  2003  on  the  monitoring  of 
zoonoses and zoonotic agents, amending Council Decision 90/424EEC and repealing Council Directive 92/117/EC, OJ 
L 325, 12.12.2003, p. 31–40 (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32003L0099). 
45 Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2006 on transmissible animal 
diseases  and  amending  and  repealing  certain  acts  in  the  area  of  animal  health  (‘Animal  Health  Law’),  OJ  L  84, 
31.3.2016, p. 1–208. 
(https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32016R0429&qid=1699617422821). 
46 See also below section on Health Security Committee. 
47 https://eur-lex.europa.eu/eli/reg_del/2020/689/oj  
48 https://www.izsvenezie.com/reference-laboratories/avian-influenza-newcastle-disease/  
49 Commission Delegated Regulation (EU) 2020/689 of 17 December 2019 supplementing Regulation (EU) 2016/429 
of the European Parliament and of the Council as regards rules for surveillance, eradication  programmes, and disease-
free  status  for  certain  listed  and  emerging  diseases,  OJ  L  174,  3.6.2020,  p.  211–340  (https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=CELEX%3A32020R0689&qid=1699963567960).  

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Together  with  some  Member  States,  the  Commission  is  working  on  the  possibility  of  securing 
vaccines  against  zoonotic  influenza  in  humans  via  the  Joint  Procurement  mechanism.  First 
shipments  of  such  a  vaccine  to  the  Member  States  are  planned  for  early  2024.  The  common 
purchase of zoonotic vaccines would strengthen the preparedness of the Member States in face of 
an  (Avian)  Influenza  pandemic  by  adding  up  to  the  two  existing  framework  contracts  –  also 
concluded  under  the  Joint  Procurement  mechanism  –  for  the  reservation  of  over  110  million 
pandemic vaccine doses. The pandemic vaccine doses would be distributed to the Member States 
participating  in  the  reservation  contracts  after  the  declaration  of  an  influenza  pandemic  by  the 
WHO.  

Preventing climate-change- and environment-related health threats and preparing for them 

The  effects  of  climate  change  and  environmental  degradation  were  felt  heavily  in  the  summer  of 
2023,  as  extreme  weather  events  caused  devastating  floods  in  Bulgaria,  Croatia,  Greece,  Spain, 
Italy,  Romania  and  Slovenia  and  a  heatwave  brought  some  of  the  hottest  temperatures  ever 
recorded in the EU. Public health action is needed to protect the most vulnerable in particular, and 
to prevent as many heat-related deaths as possible. The EU’s fast-warming climate is also becoming 
increasingly  suitable  for  certain  climate-sensitive  infectious  diseases,  notably  vector-borne  ones. 
Furthermore, climate change is accelerating permafrost thawing, which may release long-dormant 
microorganisms of concern. 

Pandemic-prone  pathogens  that  are  also  vector-borne,  such  as  yellow  fever,  dengue,  zika, 
chikungunya  and  West  Nile  fever,  have  been  identified  by  HERA  as  priority  threats  and  work  is 
ongoing  to  expand  the  medical  countermeasures  arsenal  by  investing  in  the  research  and 
development  of  innovative  medical  tools  for  pandemic  preparedness  through  the  Horizon  Europe 
and EU4Health programmes. For instance, the Commission is funding the Coalition for Epidemic 
Preparedness Innovations (CEPI) through the Horizon Europe Programme to carry out effectiveness 
and  further  scientific  studies  to  expand  the  potential  use  of  licensed  chikungunya  vaccines  to 
children,  immunocompromised  people  and  pregnant  women.  The  Commission  is  also  exploring 
ways to support different vector-control measures (e.g. sterile insect techniques).  

Other recent work to support health preparedness in relation to climate change and environmental 
risks includes inter alia: 

• 

•  new  products  of  the  European  Climate  and  Health  Observatory50,  operated  by  the 
European  Environment  Agency  and  the  European  Commission,  released  in  2023  (notably 
indicators, fact sheets and forecasts on heat health, infectious diseases, occupational health 
and air pollution); 
the  Declaration  of  the  Seventh  Ministerial  Conference  on  Environment  and  Health 
(Budapest  Declaration)51  of  July  2023,  which  formulates  political  commitments  and 
actions to address the health risks posed by climate change, pollution and biodiversity loss; 
the COP28 Declaration on Climate and Health, signed on the occasion of the first Health 
Day at the 28th session of the Conference of the Parties to the United Nations Framework 
Convention on Climate Change (COP28) on 2 December 202352; 
the launch of a major update of the guidance on heat health action plans for the WHO 
European Region53, which the EU supports under its LIFE programme54; 

• 

• 

50 https://climate-adapt.eea.europa.eu/en/observatory  
51 https://www.who.int/europe/publications/i/item/EURO-Budapest2023-6  
52 https://www.cop28.com/en/cop28-uae-declaration-on-climate-and-health  
53 https://www.who.int/publications/i/item/9789289071918  

7 

 
 
• 

the  development  of  the  first-ever  EU  Climate  Risk  Assessment55,  which  would  include 
dedicated chapters on health and is scheduled to be published by the European Environment 
Agency in spring 2024; 

•  publication  of  an  integrated  zero  pollution  monitoring  and  outlook  report  in  December 
2022, whose bi-yearly updated data will regularly feed the Cancer Inequalities Registry and 
the Atlas of Demography, to better identify trends in relation also to other pollution-related 
diseases,  enable  people  to  compare  how  much  pollution  affects  their  health  across  EU 
regions  and  help  targeting  interventions  at  EU,  national  and  local  level  to  enhance  cost-
effectiveness and preparedness. 

In  the  framework  of  the  zero-pollution  action  plan,  the  Commission  has  taken  further  action  to 
tackle air, water and soil pollution. Despite significant improvements in air quality during the past 
few  decades,  air  pollution  continues  to  be  the  largest  environment-related  health  risk,  with 
significant associated mortality (with estimated more than 230.000 premature deaths in the EU each 
year)  and  morbidity.56  The  Commission  on  26  October  2022  proposed  to  align  EU  air  quality 
standards  more  closely  with  WHO  recommendations  as  key  element  to  its  zero-pollution  policy 
package.57 

In addition to the already mentioned proposals on wastewater treatment and water pollutants58, the 
Commission has also adopted proposals on the revision of the Industrial Emissions Directive59, as 
well as a new Soil Health and Resilience Directive60 that both aim to bring tangible health benefits. 

3. PREPAREDNESS 

Preparedness – having the structures and capacities in place at national and EU level to effectively 
anticipate, respond to and recover from public health threats – is an essential element in the EU’s 
health security framework. Failing to prepare is preparing to fail.  

Preparedness, reporting and assessment: stronger requirements 

The  recent  adoption  of  Regulation  (EU)  2022/2371  has  allowed  preparedness  activities  to  be 
strengthened at EU level and both within and across Member States. Most notably, the Regulation 
requires expanded reporting on national preparedness planning and introduces the possibility of EU 
review  and  assessment  of  national  preparedness  capacities  to  ensure  that  they  are  adequately 
maintained.  A  new  reporting  cycle  has  been  introduced:  expanded  reporting  on  preparedness 
capacities of Member States to the Commission, followed by assessments carried out by the ECDC 
and a Commission report to the European Parliament and the Council. The first implementing act 
under the Regulation was adopted in September 2023, providing the specifications for the Member 
States reporting on prevention, preparedness and response planning at national level61.  

54 https://cinea.ec.europa.eu/programmes/life_en  
55 https://www.eea.europa.eu/en/about/who-we-are/projects-and-cooperation-agreements/european-climate-risk-
assessment  
56 See, for example, https://www.eea.europa.eu/publications/air-quality-in-europe-2022/health-impacts-of-air-pollution 
57 https://ec.europa.eu/commission/presscorner/detail/en/ip_22_6278 
58 See section on AMR above. 
59 https://environment.ec.europa.eu/publications/proposal-revision-industrial-emissions-directive_en 
60 https://environment.ec.europa.eu/topics/soil-and-land/soil-health_en 
61 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2023:234:TOC 

8 

 
 
 
 
 
 
 
The Regulation also introduces the Union Prevention, Preparedness and Response plan, which will 
be developed in  2024. The plan will cover work and activities related to health preparedness  and 
response,  across  all  Commission  services,  the  Council  and  EU  agencies  and  bodies,  as  well  as 
interactions and coordination with relevant international bodies.  

In  close  cooperation  with  the  Member  States,  the  Commission  is  also  strengthening  emergency 
health planning via the Union Civil Protection Mechanism (UCPM)62. This is done by developing 
specific emergency health preparedness and response plans, such as the burns preparedness plan63, 
which outlines the medical evacuation guidelines to follow in the event of a disaster involving mass 
burn patients. In addition, the Commission is developing, under the UCPM and in close cooperation 
with Member States, two EU-wide disaster scenarios focusing entirely on the scenario of a health 
emergency, such as a pandemic or nuclear disaster64.  

The  Commission  has  also,  in  its  Communication  adopted  in  the  context  of  the  2023  European 
Semester  on  the  Annual  Sustainable  Growth  Survey  202365,  underlined  the  need  for  increased 
vigilance and investment in all Member States to ensure that health systems are suitably prepared to 
deal with future health crises. 

Training and testing of preparedness capacities 

Training and capacity building 

The EU PREPAREDNESS project, which is funded by the EU4Health programme, is intended to 
develop  and  deliver  a  training  programme  in  30  countries.  It  will  help  strengthen  crisis 
preparedness and surveillance capacities and facilitate cross-country collaboration between experts 
in public health and other sectors. 

Moreover, under the UCPM, a number of medical  field  exercises have been organised to  test the 
coordination and inter-operability of Emergency Medical Teams.  

A training programme on management of medical countermeasures needed for preparedness for and 
response to serious cross-border health threats is also being developed. Initial training activities are 
focusing on stockpiling, procurement and supply-chain constraints and will be complemented with 
simulation exercises to test and improve coordination and response frameworks. 

Training and capacity-building in the Member States are aspects of preparedness where the EU can 
offer added value. Training  activities are organised by the Commission  in close  cooperation with 
the  relevant  EU  agencies  and  bodies,  as  well  as  professional  and  patient  organisations.  These 
activities  provide  healthcare  and  public  health  staff  with  the  knowledge  and  skills  necessary  to 
develop and implement the national prevention, preparedness and response plans.  

In  addition,  resilience-testing  of  health  systems  against  specific  shock  scenarios  (e.g.  pandemics, 
heat waves and shortage of health workers) can improve crisis preparedness. A project, co-led by 
the  Organisation  for  Economic  Co-operation  and  Development  (OECD)  and  the  European 
Observatory  on  Health  Systems  and  Policies  and  supported  by  the  EU4Health  programme,  is 

62 The UCPM includes both Member States and 10 non-EU participating states. 
63 SWD(2020) 3 final. 
64  Europe-wide  disaster  scenarios  are  one  of  the  flagship  initiatives  from  the  Commission’s  EU  Disaster  Resilience 
Goals 
https://civil-protection-humanitarian-aid.ec.europa.eu/what/civil-
protection/european-disaster-risk-management/european-disaster-resilience-goals_en. 
65 COM(2022) 780 final. 

introduced 

February 

2023: 

in 

9 

 
 
developing  a  resilience-testing  methodology  for  health  systems.  The  methodology  will  enable 
Member  States  to  regularly  review  health  crisis  preparedness  and  test  their  health  systems’ 
resilience against specific high-pressure scenarios and long-term structural challenges. 

Preparedness in medical countermeasures 

Preparedness  in  medical  countermeasures  entails  strategic  coordination  for  their  development.  In 
July 2022, the Commission concluded the first prioritisation exercise to identify the top three health 
threats  for  which  medical  countermeasures  should  be  available  in  case  of  need,  and  that  require 
coordination  of  measures  at  EU  level:  (1) pathogens  with  high  pandemic  potential;  (2) chemical, 
biological,  radiological,  and  nuclear  threats;  and  (3)  threats  resulting  from antimicrobial 
resistance66.  The  Commission’s  HERA  has  been  tasked  to  contribute  to  the  development, 
production  and  distribution  of  medical  countermeasures  in  case  of  emergency.  Ensuring  efficient 
procurement  and  stockpiling  of  medical  countermeasures  remain  key  elements  of  a  good 
preparedness strategy.  

The  Joint  Procurement  Agreement  for  Medical  Countermeasures  (JPA),  which  was  concluded  in 
2014  as  a  response  to  the  A/H1N1  influenza  pandemic,  has  played  an  essential  role  in  helping 
Member  States  to  obtain  critical  medical  products  and  supplies  during  the  COVID-19  pandemic 
(therapeutics  against  COVID-19,  personal  protective  equipment,  ventilators,  vaccination  supplies, 
testing  devices,  etc.) 
total  value  exceeding 
EUR 12 billion67.  The  Commission,  Member  States  and  other  JPA  signatory  countries  are  now 
building on this experience of cooperation during an emergency in order to enhance the use of the 
JPA for preparedness and response. As announced in the Communication on addressing medicines 
shortages in the EU, the Commission will also look at using joint procurement for antibiotics and 
treatments for respiratory viruses ahead of winter 2024/2025.   

than  200  contracts  with  a 

through  more 

Joint procurement for influenza vaccines 

15 JPA signatory countries are taking part in the joint procurement of highly pathogenic influenza 
vaccines. The purpose is  to  vaccinate vulnerable  target  groups, such as  farm workers, in  order to 
help  prevent  the transfer of the virus from  birds and animals  to  humans, and, thereby, a potential 
avian influenza outbreak.  

The  JPA  also  remains  an  important  instrument  for  jointly  reserving  and  securing  the  pandemic 
influenza preparedness vaccines. There are currently two standing contracts under the JPA for such 
vaccines.  The  Commission  will  by  the  end  of  2024  consult  the  Member  States  and  other  JPA 
signatory countries on their willingness to renew such contracts within the framework of the JPA.  

The JPA can be used flexibly and thereby, play an important role in health crisis preparedness by 
facilitating  access  for  the  Commission  and  the  Member  States  to  preparedness-relevant  medical 
countermeasures, including novel or rare medical countermeasures.  

Regulation  (EU)  2022/2371  introduced  a  refined  framework  for  joint  procurement,  including  the 
possibility for the Commission to propose an exclusivity clause for a particular joint procurement 
(i.e.  once  countries  have  opted  to  participate  in  an  EU  joint  procurement,  they  must  refrain  from 
carrying  out  a  parallel  national  procurement  for  the  same  medical  countermeasure).  In  justified 

66 https://health.ec.europa.eu/publications/hera-factsheet-health-union-identifying-top-3-priority-health-threats_en 
67 https://ec.europa.eu/info/live-work-travel-eu/coronavirus-response/public-
health_en#ensuringtheavailabilityofsuppliesandequipment 

10 

 
 
cases  (and  if  all  participating  Member  States  and  other  JPA  countries  agree),  applying  the 
exclusivity  clause  should  strengthen  the  EU  negotiating  position  and  security  of  supply.  The 
Commission  will  have  to  carry  out  a  preliminary  joint  procurement  assessment  indicating  the 
general envisaged conditions of the joint procurement procedure, including as regards the possible 
need for exclusivity on a case-by-case basis.  

threats 

Anticipating  potential 
the  supply  chains  of  medical 
to,  and  vulnerabilities  of, 
countermeasures  is  an  important  factor  in  preparedness,  as  is  stockpiling  and  facilitating  the 
development  of  new  and  improved  medical  countermeasures.  In  2022,  the  Commission  launched 
EU FAB, a network of ‘ever-warm’ vaccine production capacities that can be quickly activated in 
the event of a public health emergency. On 30 June 2023, four EU FAB contracts were signed with 
pharmaceutical  manufacturers  to  reserve  the  capacity  to  produce  up  to  325  million  vaccines  of 
different types annually. The Commission also stockpiles medical countermeasures under rescEU – 
an EU-funded strategic reserve of last resort, from which Member States and associated countries 
can request assistance. To date, EUR 1.2 billion has been invested in building up stockpiles against 
serious  cross-border  health  threats,  including  chemical,  biological,  radiological  and  nuclear 
(CBRN) threats. The first call for tender in 2022 led to France, Croatia, Poland and Finland being 
chosen to host the stockpiles. The results of the second call will be announced in late 2023. 

3. SURVEILLANCE AND EARLY WARNING SYSTEMS 

Public health surveillance of communicable diseases  

Without  public  health  surveillance,  we  would  be  unable  to  monitor  trends  of  communicable 
diseases, to detect outbreaks early on or to evaluate the effectiveness of public health measures and 
policies. This was yet another key aspect of public health whose importance was emphasised during 
the COVID-19 pandemic. A recent study 68 has looked into lessons learnt from surveillance in the 
EU  during  the  COVID-19  pandemic.  There  remains  some  variation  in  the  quality  of  the  data 
reported  by  the  Member  States  across  disease  areas,  despite  the  ECDC’s  efforts  to  provide 
methodological  support  to  the  Member  States  and  reporting  protocols.  There  is  also  room  for 
improvement when it comes to technological advances, such as digital platforms for surveillance, 
notwithstanding the major efforts made during the pandemic years.  

Regulation (EU) 2022/2371 introduces a new high-performing epidemiological surveillance system 
at  EU  level.  This  incorporates  using  artificial  intelligence  and  digital  tools  for  data  validation, 
analysis  and  automated  reporting,  ensuring  accurate  modelling  and  risk  assessments.  To 
complement  epidemiological  surveillance  of  communicable  diseases,  Regulation  (EU)  2022/2371 
requires  Member  States  to  step  up  their  reporting  of  health  systems  indicators,  including  health 
system  capacity  (e.g.  hospital  bed  availability,  specialised  treatment  and  intensive  care  capacity, 
and the number of medically trained staff). The Commission is revising the list of communicable 
diseases  and  special  health  issues  (e.g.  AMR)  that  are  notifiable  at  EU  level.  The  updated  list  is 
planned  to  be  in  place  by  mid-2024.  The  Commission  is  supporting  the  upgrade  of  the  Member 
States’  national  surveillance  systems  by  providing  nearly  EUR 100 million  in  direct  grants  for 
infrastructure development, capacity-building and specific national priorities. 

68 See ‘Surveillance during the COVID-19 epidemic and other epidemics: lessons learnt’, 
https://www.nivel.nl/en/project/1920. 

11 

 
 
Strengthening 
countermeasures 

laboratory  capacities 

for  surveillance  and  development  of  medical 

EU reference laboratories in the area of public health 

Another novelty brought by Regulation (EU) 2022/2371 is the creation of EU reference laboratories 
(EURLs)  for  public  health,  to  provide  support  to  national  reference  laboratories  and  to  promote 
good practice and alignment on a voluntary basis regarding diagnostics, testing methods and the use 
of  certain  tests  for  the  uniform  surveillance,  notification  and  reporting  of  diseases  by  Member 
States. The Commission and the ECDC are working closely together in the implementation of the 
EURLs.  The  first  six  EURLs  will  be  designated  in  early  2024  and  funded  under  the  EU4Health 
programme69. 

DURABLE 

The Commission launched the DURABLE laboratory network project (2023-2027)70 composed of 
public  health  and  academic  laboratories  to  support  the  research  and  development  of  medical 
countermeasures. DURABLE, funded under the EU4Health programme, mobilises the experimental 
capacities  of  its  members  to  speed  up  the  development  of  medical  countermeasures,  including 
diagnostics, therapeutics, and vaccines. DURABLE has a global focus, thanks to the participation 
of members with laboratory capacities around the world and is complementary to the EURLs.  

Modern enhanced digital platforms for surveillance 

The  rapid  development  of  digital  tools  is  facilitating  timely  data-collection  and  sharing.  To 
strengthen  EU  surveillance  systems,  Regulation  (EU)  2022/2371  also  enhances  the  use  of  digital 
platforms. 

In  June  2021,  the  ECDC  launched  the  European  surveillance  portal  for  infectious  diseases 
(EpiPulse),  a  platform  for  enabling  real-time  surveillance  of  infectious  diseases71.  EpiPulse  is  an 
online  portal  for  EU/EEA  public  health  authorities  and  partner  organisations  to  collect,  analyse, 
share and discuss infectious disease data. It supports threat detection, monitoring, risk assessment 
and outbreak response. EpiPulse will be further developed to take into account the requirements of 
Regulation  (EU)  2022/2371  and  will  also  integrate  other  reporting  tools  such  as  the  European 
Surveillance  System  for  indicator-based  surveillance  (TESSy)72.  The  ECDC  is  working  on 
integrating Epidemic Intelligence from Open Sources (EIOS) – a key threat-detection tool that has 
been developed in collaboration with the WHO73 – with EpiPulse in order to streamline the threat-
detection, monitoring and assessment process.  

The  Commission  is  developing  the  ATHINA  (Advanced  Technology  for  Health  INtelligence  and 
Action)74 IT system to support its daily threat-assessment activities and to generate useful insights 
for  decision-making.  ATHINA  will  help  the  Commission  to  detect  relevant  signals  on  possible 

69 https://health.ec.europa.eu/health-security-and-infectious-diseases/surveillance-and-early-warning/eu-reference-
laboratories-public-health-calls-application_en 
70  https://www.pasteur.fr/en/home/institut-pasteur/institut-pasteur-throughout-world/international-research-
programs/durable-large-scale-project-emerging-diseases-within-eu4health-european-program  
71 https://www.ecdc.europa.eu/en/publications-data/epipulse-european-surveillance-portal-infectious-diseases 
72 https://www.ecdc.europa.eu/en/publications-data/european-surveillance-system-tessy  
73 https://www.who.int/initiatives/eios  
74 https://health.ec.europa.eu/latest-updates/hera-it-system-athina-collect-intelligence-and-assess-threats-call-tender-
published-2023-04-25_en  

12 

 
 
health threats that require a medical  countermeasure response based on supply chain analysis and 
identified vulnerabilities in the supply of medical countermeasures, including the risk of shortages 
and strategic dependencies. To this  end,  ATHINA  will gather intelligence by exchanging data on 
medical countermeasures and public health threats with relevant databases (e.g. those of the ECDC 
and  the  EMA);  reusing  existing  systems  (e.g.  the  WHO’s  EIOS  platform)  and  other  sources;  and 
ensuring interoperability among digital solutions.   

Unlocking the power of health data 

The proposal for a regulation on a European Health Data Space is intended to unlock the power of 
health  data  by  enabling  the  reuse  of  electronic  health  data  for  research,  innovation,  official 
statistics,  policy-making  and  regulatory  activities.  This  includes  the  reuse  of  health  data  for 
surveillance purposes in order to protect against health threats or ensure high standards of quality 
and safety of healthcare and of medicinal products and medical devices. To develop and deploy the 
EU’s infrastructure for the secondary use of health data, HealthData@EU was launched in October 
2022 as a two-year pilot project. It will test the infrastructure for the secondary use of health data on 
use  cases.  Examples  include  focusing  on  AMR  surveillance  and  test  use,  hospitalisations,  and 
vaccination adherence in vulnerable subpopulations. The ECDC will also participate in the project 
by assessing the use of the infrastructure for public health surveillance. 

Boosting integrated One Health surveillance systems  

‘Union 

and  National  Capacity  Building 

The  Commission  is  supporting  integrated  One  Health  surveillance  systems  that  cover  the  links 
between human and animal health and the environment. One of these is the EUR 7.8 million joint 
action 
Surveillance 
(UNITED4Surveillance)’75,  funded  under  the  EU4Health  programme  and  launched  in  February 
2023 with national competent authorities to promote the integration of surveillance systems at EU 
level by supporting improvements in national surveillance systems. UNITED4Surveillance focuses 
on  defining  guidelines  for  integrating  different  sources  of  electronic  health  data  and  digital 
registers/databases, surveillance capacity-building within the EU and beyond, and improving global 
health security. 

IntegraTED 

for 

In addition,  another EUR 20 million direct  grant  has  been made available to  Member States  for a 
coordinated surveillance system under the One Health approach for cross-border pathogens76. This 
grant  will  help  Member  State  authorities  to  contribute  to  the  setting-up  and  scaling-up  of  animal 
and  environmental  surveillance  system  for  zoonoses,  including  the  systematic  ongoing  collection 
and assessment of data by EFSA in collaboration with the ECDC. It will provide the animal health 
and environmental elements to complement the above action on the human side, for a One Health 
integrated surveillance. 

The  Commission  will  be  launching  a  feasibility  study  in  early  2024  on  integrated  surveillance 
systems  for  AMR  and  antimicrobial  use  from  the  human,  veterinary  and  environmental  sectors. 
This study will support Member States in developing integrated surveillance systems to efficiently 
and rapidly detect emerging resistant infections and outbreaks; and also to determine trends in, and 
the  toxicity  of,  the  presence  of  AMR  genes  and  antimicrobials  in  soils  and  waters.  This  will 
enhance  the  understanding  of  the  complex  epidemiology  of  AMR  to  guide  future  policy 
recommendations to respond to AMR risks before they become large-scale emergencies. 

75 https://united4surveillance.eu/  
76 CP-g-22-04.01. The singnature of the grants is expected towards the end of 2023. 

13 

 
 
Wastewater: a source for public health surveillance 

During  the COVID-19 pandemic, wastewater-based surveillance of SARS-CoV-2 and its  variants 
emerged as a powerful supplementary source of information on the presence of the virus and for an 
epidemiological investigation of the virus’s spread in the EU, enabled through the Digital European 
Exchange  Platform  (DEEP).  HERA  and  the  Joint  Research  Centre  (JRC)  are  supporting  a  joint 
action  to  strengthen  national  capacities  for  pathogen  prioritisation,  sampling  and  integration  of 
wastewater data into surveillance for public health decision-making and the establishment of an EU 
sentinel system to test wastewater samples when needed. Moreover, HERA is leading the process of 
setting  up  a  global  consortium  for  wastewater  surveillance  for  public  health  –  a  network  of 
stakeholders and authorities worldwide to provide comprehensive real-time monitoring in strategic 
locations that can help identify emerging risks and enable prompt action. 

Horizon 2020 research projects  like MOOD77  and  VEO78 have contributed to  the development of 
innovative  approaches  to  improving  disease  surveillance  through  a  One  Health  approach,  using 
multisource  big  data  and  data  on  drivers  of  disease  emergence,  including  human  movements  and 
climate  change.  PHIRI79  has  developed  a  health  information  portal  that  centralises  health  and 
healthcare data and allows researchers to link and use different data sources from across the EU.  

Early warning systems 

in  1998 
The  EU’s  Early  Warning  and  Response  System 
(Decision No 2119/98/EC)80.  It is  a  restricted access  tool used to  notify alerts and monitor public 
health  threats.  Over  the  years,  it  has  been  the  channel  for  the  rapid  notification  of  thousands  of 
alerts. The Commission posted the  first  alert  on COVID-19 back in  early January 2020. To align 
with Regulation (EU) 2022/2371, the EWRS is to be restructured according to the main categories 
of health threats, i.e. related to biological, chemical and environmental sources as well as those of 
unknown origin.  

(EWRS)  was 

set  up 

for 

to  address 

the  priorities 

further  development  of 

A preparatory action81 for the EWRS’s new development is currently being implemented. The aim 
is 
line  with 
Regulation (EU) 2022/2371:  introducing  new  governance,  architecture  and  functionalities  to 
support  the  expansion  of  structures  and  new  user-groups  and  roles;  reinforcing  security  and  data 
protection  following  a  data-protection  impact  assessment;  developing  new  modules  to  support 
preparedness  and  response  planning  and  reporting  and  crisis  management  capabilities;  and 
improving  user-support  services  (training  and  integrated  user  guidance).  Under  this  action,  the 
feasibility  assessment  for  interlinkage  with  the  EU  and  other  international  alert  and  information 
systems  is  currently being  finalised. 13 such systems were assessed and  10 will be prioritised for 
interlinkage  with  EWRS.  To  ensure  interoperability  with  other  alert  information  systems,  the 
EWRS taxonomy for biological, chemical and environmental threats is also under review. 

the  EWRS 

in 

Coordination  with  other  alert  systems  is  essential  when  faced,  for  example,  with  food-borne 
pathogens  (e.g.  the  case  of  resistant  salmonella  in  chocolate  eggs  in  2022)  or  zoonoses,  such  as 

77 https://mood-h2020.eu/  
78 https://www.veo-europe.eu/ 
79 https://www.phiri.eu/  
80 Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network 
for  the  epidemiological  surveillance  and  control  of  communicable  diseases  in  the  Community,  OJ  L  268,  3.10.1998, 
p.1–7 (https://eur-lex.europa.eu/eli/dec/1998/2119/oj).  
81 Specific contract with Alboris Consortium under the BEACON FWC DIGIT/2020/OP/0005 – BEACON Lot 2. 

14 

 
 
avian  influenza  (as  mentioned  earlier  in  this  report).  Upcoming  changes  called  for  by 
Regulation (EU) 2022/2371 include  EWRS interoperability with  other systems such as (i) the EU 
Animal Diseases Information System (ADIS) in order to monitor infectious animal diseases; (ii) the 
Rapid Alert System for Food and Feed (RASFF) for risks to public health resulting from the food 
chain; (iii) WebECURIE, the EU early notification and information exchange system in the event of 
a  radiological  emergency  including  nuclear  accidents;  (iv)  RASCHEM  for  threats  of  a  chemical 
nature; and (v) the safety-gate for threats of a biological or chemical nature in non-food consumer 
products.  The  EWRS  is  also  to  be  interoperable  with  EpiPulse  for  the  notification  of  alerts  and 
exchange  of  epidemiological  summaries  or  risk  assessments  as  part  of  the  EWRS  situation 
awareness module. 

Within  the  Commission,  ARGUS  is  the  main  crisis  management  and  coordination  mechanism.  It 
ensures that relevant information from Commission services and EU agencies, as well as from the 
Member  States,  is  collected  and  used  to  form  a  timely  and  up-to-date  situational  picture  to  help 
contingency  planning,  appropriate  coordination  and  decision-making.  During  the  COVID-19 
pandemic, ARGUS was instrumental in coordinating the Commission’s participation in meetings of 
the Council’s Integrated Political Crisis Response mechanism (IPCR), where the Commission and 
Member  States  extensively  discussed  key  issues  such  as  the  use  of  the  Emergency  Support 
Instrument, green lanes, health protocols for transport and contact-tracing, measures for travel into 
and  within  the  EU,  Re-Open  EU,  joint  procurement  for  vaccines  and  vaccines-sharing,  the  EU 
Digital  COVID  Certificate,  and  communication  and  fighting  disinformation.  ARGUS  and  EWRS 
interlinkage has been effective since 2022, ensuring the exchange of information on serious cross-
border threats to health with the EU crisis managers. ARGUS was also the channel for coordinating 
the Integrated Situational Awareness and Analysis (ISAA) reports, which were a key instrument to 
promote shared situational awareness during the COVID-19 pandemic. 

Contact-tracing: the European Federation Gateway Service and Passenger Locator Forms 

At the time of the COVID-19 pandemic, 22 public health authorities launched national tracing and 
warning apps as part of a package of measures to prevent the spread of the virus. In October 2020, 
EU  Member  States  and  the  Commission  launched  the  European  Federation  Gateway  Service 
(EFGS) to allow for the interoperability of national apps throughout the EU. By autumn 2021, 19 
Member States  were  exchanging  risk  contact  information through the  EFGS, representing tens of 
millions of active users in the EU and the rest of Europe. 

In  April  2022,  the  EFGS  was  transferred  to  the  ECDC.  This  reinforced  the  EU’s  digital  contact-
tracing capabilities, in line with the ECDC’s new mandate, by pooling the necessary expertise at the 
ECDC. The EFGS has since been withdrawn from service, but the ECDC and the Commission have 
prepared  a  reactivation  procedure  to  make  it  available  to  the  EU  Member  States  should  the  need 
arise. 

Between 1 June 2021 and 31 May 2022, a Passenger Locator Forms’ Exchange Platform (ePLF)82 
was made available to connect Member States and enable the secure exchange of passenger data for 
cross-border contact  tracing  in all transport modes  in  the EU.83 Based on feedback from  Member 
States,  the  Commission  started  to  work  with  the  ECDC  on  the  technical  integration  between  the 

82  Established  through  the  two  implementing  acts  adopted  by  the  Commission  in  May  (C/2021/3921)  and  July  2021 
(C/2021/5595). 
83 At its peak, the ePLF connected five Member State: Italy, Malta, Slovenia, Spain and – for a short period – France. 
Yet its actual use remained very limited, with only 256 messages exchanged between end 2021 and early 2022. 

15 

 
 
EWRS  selective  exchange  functionality  and  the  ePLF,  thereby  enabling  their  interoperability.84 
While the ePLF as such has been terminated, the insights gained through its development and the 
integration with the EWRS selective exchange functionality make the EU better equipped in case of 
future needs.  

4. RESPONSE  

During  the  very  early  phases  of  the  COVID-19  pandemic,  the  Crisis  Coordination  Committee 
(CCC) was convened through ARGUS on 23 January 2020 to discuss situational updates as well as 
possible courses of action. These CCC meetings were chaired by Commissioner Lenarčič and the 
Secretary-General  and attended by all relevant  Directorates-General  and  EU Agencies. Numerous 
additional  coordination  meetings  have  been  subsequently  called  in  the  framework  of  the 
Commission crisis management response mechanism at all levels, from daily calls of the President 
with  relevant  Commissioners,  to  more  operational  coordination  at  Directors-General  or  services 
level.  

In the  aftermath  of the  COVID-19 pandemic, a  number of improvements  were made to  the EU’s 
mechanisms  for  responding  to  serious  cross-border  threats  to  health.  Key  ones  are  based  on 
Regulation (EU) 2022/2371 and include a strengthened role for the EU Health Security Committee 
and a newly established EU capacity to declare a public health emergency at EU level. 

EU Health Security Committee  

The EU Health Security Committee  (HSC) is  a key forum  for exchanging information on serious 
cross-border health threats  at  EU level. It  is  made up of  representatives from the Member States’ 
health  authorities.  Created  back  in  2001  in  the  aftermath  of  the  9/11  attacks,  the  HSC  has  been 
facilitating the coordination of public health measures across the EU over the years, culminating in 
weekly  meetings  during  the  height  of  the  COVID-19  pandemic85.  The  HSC  played  a  key  role  in 
decisions  regarding  public  health  measures.  Examples  during  the  COVID-19  pandemic  include 
coordination  on  vaccination  strategies,  testing  and  surveillance  and  risk  communication. 
Subsequent health crises in which the HSC met regularly and made an important contribution to the 
coordination of response include the Ebola outbreak in Uganda and the MPOX outbreak in the EU 
in 2022, as well as close coordination on the threat of avian influenza in 2023 (often jointly with the 
HSC’s counterparts in animal health such as the EU Chief Veterinary Officers).  

A change introduced by Regulation (EU) 2022/2371 is the empowerment of the HSC to formally 
adopt  opinions  and  guidance.  During  the  pandemic,  the  HSC  issued  a  number  of  opinion  papers, 
crystallising the views of the Member States on particular topics. These opinions contributed to the 
decisions of the Council’s IPCR, such as it established coordinated measures on travel from China 
into the EU in response to a deterioration in China’s COVID-19 situation. 

84 As a result of this effort, messages sent by Member States connected to the ePLF could be technically delivered to 
Member States using the EWRS selective messaging  functionality.  Work is still ongoing within the  ECDC to enable 
messages sent through the EWRS selective exchange functionality to be received by the Member States using the ePLF 
if the system is to be activated again during a future crisis. 
85 https://health.ec.europa.eu/health-security-and-infectious-diseases/crisis-management/list-authorities-represented-
health-security-committee/health-security-committee-reports_en 

16 

 
 
 
 
First HSC opinion, only days after the entry into force of Regulation (EU) 2022/2371 

The  first  test  for  the  newly  empowered  HSC  came  with  the  record  levels  of  COVID-19  cases  in 
China  at  the  end  of  2022  that  resulted  from  relaxation  of  Chinese  domestic  measures.  The  HSC 
issued  its  first  opinion  under  the  Regulation  as  early  as  5  January  2023,  only  10  days  after  the 
Regulation’s  entry  into  force.  It  contained  several  proposed  steps  for  a  staged,  phased  and 
proportionate  common  EU  approach  to  mitigate  any  potential  risks,  which  served  to  underpin 
further political decisions in the Council’s IPCR.  

The  latest  opinion86  of  the  HSC  focuses  on  the  need  for  continued  vigilance  around  COVID-19, 
seasonal flu and other viruses that are circulating in the autumn/winter season. 

Public health emergency at Union level 

Until 2022, the EU relied entirely on the WHO’s assessment of pandemic situations and declaration 
of  a  public  health  emergency  of  international  concern.  Regulation  (EU)  2022/2371  has  now 
empowered the Commission to formally recognise a public health emergency at Union level, when 
a  serious  cross-border  threat  to  health  is  considered  to  endanger  public  health  in  the  EU.  Once  a 
public  health  emergency  at  Union  level  is  recognised,  one  or  more  measures  of  Regulation  (EU) 
2022/2372  may  be  activated  if  that  is  appropriate  to  the  economic  situation,  which  includes  the 
establishment  of  a  Health  Crisis  Board  to  ensure  coordination  and  integration  of  approaches  to 
crisis-relevant  medical  countermeasures at  EU  level, and which may include  the establishment of 
mechanisms  for  the  monitoring,  activation  of  emergency  funding,  procurement  and  purchase  of 
crisis-relevant medical countermeasures and raw materials; the activation of EU FAB facilities, the 
activation  of  emergency  research  and  innovation  plans,  and  the  use  of  Union-wide  clinical  trial 
networks and provisions and platforms for the rapid sharing of data; and measures concerning the 
production of crisis-relevant medical countermeasures. The recognition of public health emergency 
also  enables  the  introduction  of  measures  related  to  medicinal  products  and  medical  devices, 
provided  for  in  Regulation  (EU)  2022/12,  activation  of  support  from  the  ECDC  to  mobilise  and 
deploy experts to the affected areas under an EU Health Task Force, and activation of the Council’s 
IPCR.  

Public health risk assessment 

The first step in responding to an emerging cross-border health threat is to assess its magnitude and 
associated risks. Regulation (EU) 2022/2371 expands the scope of EU agencies and bodies involved 
in  public  health  risk  assessments  and  defines  their  role  and  input.  The  Regulation  references  the 
European  Centre  for  Disease  Prevention  and  Control  (ECDC),  the  European  Medicines  Agency 
(EMA),  the  European  Food  Safety  Authority  (EFSA),  the  European  Chemicals  Agency  (ECHA), 
the  European  Environment  Agency  (EEA),  the  European  Monitoring  Centre  for  Drugs  and  Drug 
Addiction and the European Union Agency for Law Enforcement Cooperation (EUROPOL). 

To  support  the  Commission  in  the  decision-making  process  regarding  the  formal  recognition  of 
such an event, Article 24 of Regulation (EU) 2022/2371 envisages the establishment of an Advisory 
Committee  on  public  health  emergencies.  The  Commission  decision  setting  up  the  Advisory 
Committee was adopted in September 202387 and the final designation of the committee is planned 

86 https://health.ec.europa.eu/publications/preparing-winter-20232024-address-respiratory-infections-caused-sars-cov-
2-and-other-viruses_en  
87 Commission  Decision  of  11.9.2023  setting  up  the  group  of  experts  ʻAdvisory  Committee  on  public  health 
emergenciesʼ (C(2023) 6017) (https://ec.europa.eu/commission/presscorner/detail/en/mex_23_4442).  

17 

 
 
for spring 2024. The Advisory Committee will be a multidisciplinary expert group that can advise 
the  Commission  and  the  Health  Security  Committee  on  public  health,  biomedical,  behavioural, 
social, economic, cultural and international aspects. It will include representatives of the ECDC and 
the EMA as permanent observers. Representatives of the WHO may also participate as observers. 
The representatives of other EU agencies and bodies relevant to the specific threat may participate 
in  the  Advisory  Committee  as  non-permanent  observers.  In  addition,  and  on  an  ad  hoc  basis,  the 
Commission may invite, or Member States may propose, the appointment of experts with relevant 
expertise to take part in the committee’s work, in particular from the countries where the threat has 
arisen.  

In addition, EU emergency response capacities, not limited to public health, are maintained under 
the UCPM where the Commission, in close cooperation with the Member States, not only ensures 
emergency  response  coordination  for  products  and  medicinal  devices,  but  also  coordinates  fully 
equipped  and  self-sufficient  emergency  medical  teams  at  EU  level.  If  the  medical  capacities  of  a 
country  affected  by  an  emergency  are  insufficient,  the  UCPM  can  mobilise  different  emergency 
medical  support  from  its  European  Civil  Protection  Pool  (ECPP),  including  emergency  medical 
teams (EMTs).  

As part of rescEU, EUR 106.2 million has been allocated to eight countries to develop new rescEU 
EMTs. The objective is to boost emergency medical support to populations affected by large-scale 
natural or human-induced disasters. This rescEU EMT capability will gradually become operational 
as of 2024 and will allow a response to a wide range of disaster scenarios. The teams will be able to 
operate  autonomously  and  support  existing  national  healthcare  facilities  in  case  the  latter  are  not 
able  to  cope  with  a  given  emergency.  Furthermore,  rescEU  also  entails  medical  evacuation 
MEDEVAC)  capacities  in  case  of  emergency  needs  for  patients  affected  by  highly  infectious 
diseases, including dedicated planes. 

Safe and effective medicinal products and medical devices 

The COVID-19 pandemic reiterated the importance of ensuring the safety and the effectiveness, as 
well as the availability, of medical devices, diagnostics and medicines at times of health crisis.  

Even outside emergency situations, Regulations (EU) 2017/745 and 2017/746 on medical devices 
and  diagnostics  have  created  a  robust  regulatory  framework,  which  harmonises  and  strengthens 
requirements  for  manufacturers.  These  regulations  ensure  that  medical  devices  on  the  EU  market 
are  safe  and  effective.  During  the  COVID-19  pandemic,  the  EU  market  was  flooded  with  rapid 
antigen  tests,  which  were  not  required  to  undergo  independent  third-party  review.  With  the  new 
regulatory  framework  (applicable  since  May  2021  for  medical  devices  and  May  2022  for 
diagnostics), medical devices must undergo a more stringent conformity assessment before they can 
be placed on the EU market. At the same time, Member States may in exceptional situations grant 
derogations  from  conformity  assessment  if  this  is  in  the  interest  of  public  health  (Article  59  of 
Regulation (EU) 2017/745 and Article 54 of Regulation (EU) 2017/746). 

In addition, supply issues of medicines are an ongoing concern in the EU and affect all EU Member 
States  outside  a  declared  public  health  emergency  or  a  major  event.  A  multifaceted  system  is  in 
place  to  mitigate  shortages.  That  system  was  also  activated  when  the  EU  suffered  shortages  of 
antibiotics  in  the  winter  of  2022/2023.  To  ensure  that  a  similar  situation  does  not  recur,  the 
Commission and EMA continuously monitor the planned supply of, and estimated demand for, a set 
of key antibiotics, in order to proactively identify any gaps in supply capacities. In October 2023, 
the Commission adopted a communication on addressing medicine shortages in the EU, which aims 

18 

 
to  strengthen  security  of  supply  in  the  EU  with  complementary  actions  to  further  improve  the 
availability and security of supply of medicines. 

Since the introduction of a strengthened mandate for the EMA in 202288, the EMA has put in place 
new  bodies  and  structures  to  provide  a  quick  response  to  medicine  shortages.  The  Executive 
Steering Group on Shortages and Safety of Medicinal Products and the Executive Steering Group 
on Shortages of Medical Devices were created to coordinate EU actions  to mitigate supply issues 
with medicines and medical devices. In addition, there are now two Single Point of Contact (SPOC) 
Working  Parties  to  monitor  and  report  on  shortages,  for  both  medicine  and  medical  device 
shortages. There is also an industry single point of contact (i-SPOC) network to provide guidance to 
holders  of  marketing  authorisations.  A  European  Shortages  Monitoring  Platform  is  expected  in 
2025, to facilitate the collection of information on shortages and on the supply of and demand for 
medicinal products. 

EU stockpiles for emergency response 

Under  the  UCPM’s  rescEU  reserve,  the  Commission  has  established  since  2020  stockpiling 
capacities of medical countermeasures for preparedness and response to serious cross-border health 
threats  as  well  as  CBRN  threats.  The  medical  stockpiling  reserve  enables  the  swift  delivery  of 
medical  equipment  such  as  ventilators  and  personal  protective  equipment.  More  than  3  million 
protective  masks,  ventilators  and  other  equipment  from  the  strategic  rescEU  distribution  centres 
were  distributed  to  Member  States  that  needed  them  most.  10  Member  States  (Belgium,  Croatia, 
Denmark, Germany, Greece, Hungary, Romania, Slovenia, Sweden, and the Netherlands) currently 
host the rescEU medical stockpiles. 

In  parallel,  in  February  2023  the  Commission  awarded  EUR 545.6 million  in  grants  for  rescEU 
stockpiles  for  chemical,  biological  and  radiological  (CBRN)  emergencies.  These  will  include 
antidotes, antibiotics, vaccines, sedatives and prophylactic treatments and specific CBRN response 
equipment,  such  as  iodine  thyroid  blocking  (ITB)  tablets,  detectors  and  decontamination  supplies 
and  personal  protective  equipment.  The  stockpiles  will  be  progressively  available  from  2023 
onwards. To further bolster preparedness, there is currently an open call to develop further medical 
and  CBRN  stockpiles  with  an  indicative  budget  of  EUR 636 million,  with  9  proposals  currently 
under evaluation.  

Protecting critical infrastructure and enhancing the resilience of critical entities 

Directive  (EU)  2022/2557  on  the  resilience  of  critical  entities89  (the  CER  Directive)  entered  into 
force in January 2023 and will replace Directive 2008/114/EC on the identification and designation 
of  European  critical  infrastructures90  as  of  18  October  2024.  The  CER  Directive  applies  to  11 
sectors,  enhancing  the  resilience  of  the  entities  operating  essential  services  within  those  sectors, 
including health. 

88 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for 
the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices, 
OJ L 20, 31.1.2022, p. 1–37 (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32022R0123). 
89 Directive (EU) 2022/2557 of the European Parliament and of the Council on the resilience of critical entities and 
repealing Council Directive 2008/114/EC, OJ L 333, 27.12.2022, p. 164 (https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=CELEX%3A32022L2557&qid=1699961915719). 
90 Council Directive 2008/114/EC of 8 December 2008 on the identification and designation of European critical 
infrastructures and the assessment of the need to improve their protection, OJ L 345, 23.12.2008, p. 75 (https://eur-
lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32008L0114&qid=1699961985226). 

19 

 
 
 
In  September  2023,  the  Commission  adopted  a  proposal  for  a  Council  recommendation91  on  a 
blueprint to coordinate an EU-level response to disruptions of critical infrastructure with significant 
cross-border  relevance.  This  will  complement  the  current  framework  on  critical  infrastructure 
protection  and  resilience  of  critical  entities  by  explaining  the  interplay  between  different  existing 
EU-level arrangements and putting forward the elements of a coordinated EU-level response in the 
event of a significant critical infrastructure incident.  

Emergency task forces  

EU Health Task Force  

Under Regulation No 851/2004 establishing a European centre for disease prevention and control as 
amended  by  Regulation (EU) 2022/2370,  the  ECDC  is  to  set  up  the  EU  Health  Task  Force  to 
provide  rapid  on-demand  support  in  the  event  of  emergencies  along  with  assistance  to  Member 
States with the preparation of plans related to prevention, preparedness and response planning, local 
responses  to  outbreaks  of  communicable  diseases  and  after-action  reviews  in  EU  and  non-EU 
countries, in cooperation with the WHO. The EU Health Task Force will include experts from the 
Member  States,  ECDC  staff,  current  and  former  fellows  of  the  European  Programme  for 
Intervention  Epidemiology  Training  and  a  newly  established  list  of  experts.  The  EU  Health  Task 
Force can provide assistance to both EU and non-EU countries. 

The  ECDC  has  created  an  ad  hoc  working  group  (composed  of  Member  State  experts, 
representatives of the Commission and the WHO) to advise the ECDC on the establishment of the 
EU Health Task Force. Once operational, the ECDC will set up a permanent advisory group and a 
team to coordinate the work of the Health Task Force. 

EMA Emergency Task Force  

The  EMA  Emergency  Task  Force  (the  ETF)  is  an  advisory  and  support  body  that  carries  out 
regulatory activities in preparation for and during a public health emergency, such as a pandemic. 
Regulation (EU) 2022/123, which strengthened the mandate of the EMA92, and became applicable 
as  of  1  March  2022,  established  the  ETF  as  a  formal  advisory  and  support  body  focusing  on 
medicines  for  public  health  emergencies  and  preparedness.  In  April  2022,  the  ETF  took  over  the 
activities of the COVID-19 EMA Pandemic Task Force, which  the EMA  had convened in March 
2020  to  address  the  COVID-19  pandemic.  Regulation (EU) 2022/123  made  the  group  permanent 
and  entrusted  it  with  an  important  role  in  crisis  preparedness.  In  2023,  the  ETF  continued 
supporting  EMA  scientific  committees  with  the  authorisation  and  safety-monitoring  of  medicines 
and  with  recommendations  on  the  use  of  medicines  prior  to  authorisation.  The  ETF  looked  into 
available treatment options to combat the COVID-19 pandemic and the MPOX outbreak, such as 
facilitating clinical trials and working with EU partners. 

5. RECOVERY 

The effects of a serious health crisis  can be  profound and long-lasting. The COVID-19 pandemic 
placed health systems under severe strain, and even at risk of collapse. It is essential to support the 
recovery of Member States and their respective health systems at all levels. This can be  done not 
only through financial help, but also through direct help to those most affected by the measures put 

91 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52023DC0526  
92 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022R0123  

20 

 
 
in  place  in  times  of  crisis.  In  the  case  of  COVID-19,  it  is  known  that  the  mental  health  of  many 
people deteriorated as a result of the pandemic and that many are still suffering from long COVID. 
At the same time, recovery also entails taking stock of past events, so that we learn how to further 
improve our prevention and preparedness for, and response to, serious cross-border health threats. 

Recovery and effectiveness of public health measures  

The ECDC is continuing to assess the evidence base from the COVID-19 pandemic by carrying out 
systematic  literature  reviews  on  various  operational  and  scientific  questions  that  arose  during  the 
pandemic,  including  the  efficiency  and  cost-effectiveness  of  non-pharmaceutical  interventions, 
aircraft transmission of SARS-CoV-2, long COVID, use of masks in community settings, etc. The 
ECDC has conducted several after-action reviews on evidence-based decision-making in EU/EEA 
and  EU  Neighbourhood  countries  during  the  COVID-19  pandemic,  focusing  on  long-term  care 
facilities  and  school  closures.  It  has  also  published  relevant  guidance 93  to  help  countries  design 
their own after-action reviews. 

Health system recovery  

Under  the  Recovery  and  Resilience  Facility,  over  EUR 43 billion  has  been  earmarked  across  27 
national  Recovery and Resilience Plans (RRPs) to strengthen healthcare. This  includes  more than 
EUR 14 billion  dedicated  to  measures  for  advancing  the  digital  transition  of  health  systems.  In 
addition, health system reform challenges (such as those identified in the 2019 and 2020 European 
Semester  Country  Specific  Recommendations  (CSRs))  that  are  not  sufficiently  tackled  under  the 
Recovery  and  Resilience  Plans  can  be  addressed  via  the  European  Semester  CSRs.  These  CSRs 
also  guide  investment  priorities  for  cohesion  funds.  Under  the  most  recent  European  Semester 
(2023),  six  Member  States  received  a  healthcare  CSR,  including  on  challenges  related  to  access, 
workforce  and  primary  care.  In  addition,  Member  States  are  planning  to  invest  around 
EUR 16 billion in healthcare94, including more than EUR 2 billion in the digital transition of health 
systems.  As  mentioned  in  Health  at  a  Glance:  Europe  202295,  it  is  important  that  health  systems 
overcome the big shock and reduction in care delivery during the pandemic.  The surgery backlog 
remains significant in some countries.  

Mental Health and long COVID  

Mental health problems are known to be affecting more and more people in the EU. Even before the 
COVID-19 pandemic, mental health problems affected about 84 million people (1 in 6 individuals) 
at an estimated cost of over EUR 600 billion (more than 4% of GDP). Moreover, the consequences 
of  the  pandemic  and  other  global  crises  continue  to  increase  the  prevalence  of  anxiety  and 
depression worldwide. The devastating effects of the COVID-19 pandemic, the Russian full-scale 
invasion  of  Ukraine,  the  climate  crisis,  increased  digitalisation,  unemployment  and  rising  living 
costs  have  further  exacerbated  the  already  poor  levels  of  mental  health.  Vulnerable  groups  and 
people  in  socio-economically  disadvantaged  situations  suffer  more  than  others.  The  Health  at  a 
Glance: Europe 2022 report underlined that the pandemic had affected the mental health of young 
people particularly hard: one in two young Europeans reported unmet needs and depression among 

93 https://www.ecdc.europa.eu/en/publications-data/conducting-after-action-reviews-public-health-response-covid-19-
update-0  
94 https://cohesiondata.ec.europa.eu/2021-2027-Categorisation/2021-2027-Finances-details-categorisation-multi-
fu/hgyj-gyin  
95 https://www.oecd-ilibrary.org/social-issues-migration-health/health-at-a-glance-europe-2022_507433b0-
en;jsessionid=-ZyVma6ABAN0VaaG5paqz-epR3sPXjuLlFsJ5MXW.ip-10-240-5-108  

21 

 
 
young  people  had  more  than  doubled.  In  2022,  the  WHO  launched  a  global  wake-up  call  to  all 
countries to step up mental health services and support 96.  

The EU has set a clear recovery path by launching a comprehensive approach to mental health97 and 
supporting  research  activities  for  better  health  preparedness98.  Following  the  announcement  of 
‘a new initiative on mental health’ by President von der Leyen in her 2022 State of the  European 
Union address, the Commission adopted a communication on a comprehensive approach to mental 
health on 7 June 202399. This marks the starting point for a new approach to mental health: it looks 
beyond  health,  strongly  involving  areas  such  as  education,  digitalisation,  employment,  research, 
urban  development,  environment  and  climate.  The  Communication  has  20  flagship  initiatives, 
identifies  EUR 1.23 billion  in  funding  opportunities  and  places  a  focus  on  vulnerable  groups 
(children,  young  people,  the  elderly).  For  example,  one  key  flagship  addresses  mental  health 
support for people displaced from Ukraine, and another supports the dissemination of a minimum 
service package to deliver quality care in humanitarian emergencies. In the implementation phase, 
the Commission is continuing to work closely with the Member States (the mental health subgroup 
of  the  Public  Health  Expert  Group)  and  stakeholders  (the  network  in  the  EU  Health  Policy 
Platform). In addition, the Council’s Trio Presidency has put mental health high on its agenda and 
the  Spanish  Presidency  will  prepare  a  set  of  four  Council  conclusions  (one  setting  out  a  general 
approach and three addressing the specific policy areas of precarious work, drugs and youth). 

The Commission has created the high-level Network of Expertise on long COVID (NELC), which 
brings  together  national  institutions  that  function  as  a  reference  centre  to  other  healthcare 
institutions. The aim of the NELC is to facilitate an exchange of the most relevant information and 
best practices of long COVID management in response to the latest scientific developments relating 
to  long  COVID  as  a  growing  public  health  crisis 100.  It  will  also  contribute  to  coordinating 
initiatives  at  national,  EU  and  WHO  level.  The  NELC  met  for  the  first  time  on  2  May  2023  to 
discuss initial ideas and its priorities. The identification of research needs and gaps, together with 
the  sharing  of  guidelines  and  intelligence  on  diagnosis  and  treatment,  were  identified  as  the  two 
most urgent topics to address. Moreover, the NELC highlighted the need for guidelines and clinical 
recommendations.  

The Horizon Europe programme supports projects (including large cohort studies on COVID-19) to 
determine  the  long-term  consequences  and  symptoms  of  SARS-CoV-2  infections  for  a  better 
understanding, diagnosis and potential treatment of long COVID. 

6. RESEARCH 

The Commission funds innovation and research of relevance to health security via Horizon Europe 
and HERA Invest101 across a range of domains, such as preparedness and response. 

96 https://www.who.int/news/item/02-03-2022-covid-19-pandemic-triggers-25-increase-in-prevalence-of-anxiety-and-
depression-worldwide  
97 https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/promoting-our-european-way-life/european-
health-union/comprehensive-approach-mental-health_en  
98 https://research-and-innovation.ec.europa.eu/funding/funding-opportunities/funding-programmes-and-open-
calls/horizon-europe/european-partnerships-horizon-europe/health_en  
99 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52023DC0298  
100 https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(23)00268-0/fulltext  
101 https://health.ec.europa.eu/health-emergency-preparedness-and-response-hera/hera-invest_en  

22 

 
 
Research in preparedness  

The Horizon Europe programme is supporting projects to increase knowledge on  vaccine-induced 
immunity to viruses with a high epidemic or pandemic potential as well as to define optimal design 
of  vaccines  against  pathogens,  where  information  on  host-pathogen  interaction  and  viral  surface 
structures is known. Other research actions for medical countermeasures focus on advancing broad-
spectrum  antiviral  compounds  and  developing  novel  approaches  to  the  development  of  such 
compounds, which target viruses with high epidemic or pandemic potential for the EU.  

The Commission has also launched HERA Invest to promote advanced research and development 
of  medical  countermeasures  and  related  technologies  for  tackling  priority  cross-border  health 
threats.  Part  of  InvestEU102  -  the  EU  programme  that  supports  sustainable  investment, 
innovation  and  job  creation  in  Europe,  HERA  Invest  fills  a  vital  gap  in  the  field  with 
EUR 100 million to support innovative SMEs in the early and late phases of clinical trials. HERA 
Invest aims to reduce market failures and to enhance the EU’s strategic autonomy. 

The  Horizon  Europe  programme  is  also  supporting  the  development  of,  and  access  to,  in  vitro 
diagnostics for the detection and characterisation of pathogens with pandemic potential as well as 
supporting access to medical devices and in vitro diagnostic medical devices for cross-border health 
threats.  In  addition,  the  Commission  is,  through  the  European  Innovation  Council 103  -  Europe’s 
flagship innovation programme established under Horizon Europe, promoting the development and 
commercialisation  of  technological  solutions  for  epi/pandemic  management,  (including,  for 
example,  advanced  systems  for  aerosol  capture,  pathogen  deactivation  and  air  circulation 
optimisation, next generation face masks and rapid surface decontamination devices). 

Response and emergency research 

The Horizon Europe work programmes for  health continue to envisage the possibility to mobilise 
research funds in  case of public health emergencies. This  option was used in  2022 to  support the 
EU RESPONSE104 network for the implementation of a clinical trial to assess treatment for MPOX, 
as well as the cohorts from the VERDI105 project for a better understanding of the disease. 

The Commission, through Horizon Europe, will also build on existing adaptive platform trials and 
cohort studies to maintain and strengthen strategic coordination mechanisms in the EU and beyond. 
These  networks  make  possible  the  conduct  of  perpetual  platform  trials,  the  pivoting  of  perpetual 
strategic  cohorts  to  emerging  diseases  if  an  epidemic  strikes,  and  the  generation  of  scientific 
evidence on different possible medical countermeasures. 

The Commission,  in  cooperation with  Member States,  is  involved in  the preparatory phase of the 
EU  Partnership  on  Pandemic  Preparedness,  which  will  develop  a  consolidated  pandemic 
preparedness  research  agenda  strengthening  the  collaboration  between  Member  States  as  well  as 
prepare for the management of the research response during a crisis by establishing an EU network 
of  ever-warm  clinical  trial  sites  and  align  investments  for  pandemic  preparedness  and  response, 
from basic research, to preclinical and clinical research. 

102 https://investeu.europa.eu/index_en  
103 https://eic.ec.europa.eu/system/files/2023-08/EIC-WP2023-amended.pdf  
104 https://eu-response.eu/  
105 https://verdiproject.org/  

23 

 
 
Considering that in a pandemic ‘nobody is safe until everybody is safe everywhere’, the EU Global 
Health Strategy106 launched in November 2022 represents the external dimension of the European 
Health  Union.  The  EU  is  investing  in  improving  the  pandemic  prevention  preparedness  and 
response capacity in Lower and Middle Income Countries with  a particular focus  on sub Saharan 
Africa  through  various  instruments  as  part  of  the  Global  Gateway  strategy107.  The  European  and 
Developing  Countries  Clinical  Trials  Partnership  Joint  Undertaking108  is  funding  research  for  the 
development and testing of medical countermeasures as well as developing clinical trial networks 
and cohorts, linking the outcome of this research with the Team Europe Initiative on Manufacturing 
and  Access  to  Vaccines,  medicines  and  health  technology  in  Africa  (MAV+)  and  the  EU–LAC 
Partnership on vaccine production and health systems resilience. 

7. INTERNATIONAL DIMENSION  

International partnerships to strengthen the global health security framework  

Past  health  emergencies  have  shown  that  diseases  do  not  respect  borders.  The  EU  is  involved  in 
addressing  health  emergencies  at  international  level  in  order  to  mitigate  the  possible  spread  of 
health risks in the EU. The external dimension of the European Health Union, the EU Global Health 
Strategy,  was  adopted  on  30 November 2022  and  is  intended  to  guide  all  EU  action  for  ensuring 
better health and well-being of people across the life course through, on the one hand, strengthening 
health  systems  and  advancing  universal  health  coverage,  and  on  the  other,  preventing  and 
combating health threats, including pandemics, applying a One Health approach. 

The three health-related political declarations passed during High Level Meetings at United Nations 
General  Assembly  in  New  York  during  September  2023  on  Tuberculosis,  Universal  Health 
Coverage and Pandemic Prevention, Preparedness and Response highlighted the urgency for actions 
to strengthen national health systems and improve global health security to achieve the sustainable 
development goals related to health. In this context, the EU continues to be strongly engaged in the 
ongoing  negotiations  for  the  adoption  of  a  WHO  convention,  agreement  or  other  international 
instrument on pandemic prevention, preparedness and response (“Pandemic Agreement”) and in the 
complementary  negotiations  on  the  revision  of  the  International  Health  Regulations.  The  EU  has 
made  ambitious  proposals  that  promote  equity  and  include  operative  provisions  on  the  entire 
prevention,  preparedness  and  response  cycle,  with  a  view  to  delivering  significant  and  concrete 
improvements  in  the  interest  and  for  the  benefit  of  all.  Achieving  a  successful  outcome  for  both 
processes by the May 2024 World Health Assembly is a priority for the EU.  

In  addition,  the  Commission  is  a  founding  member  of  and  contributor  to  the  Pandemic  Fund 
launched  by  the  G20  in  2022  and  hosted  by  the  World  Bank.  The  Fund  provides  long-term 
financing  to  strengthen  pandemic  prevention,  preparedness  and  response  (PPR)  capacity  and 
capabilities  in  low-  and  middle-income  countries  and  addresses  critical  gaps  through  investments 
and technical support at the national, regional, and global levels. 

Recognising  the  important  opportunity  to  strengthen  global  commitments  against  antimicrobial 
resistance, the EU has put forward a comprehensive proposal for concrete AMR provisions as part 
of the negotiations for a WHO international agreement on pandemic prevention, preparedness and 

106 https://health.ec.europa.eu/system/files/2023-03/international_ghs-report-2022_en.pdf  
107 https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/stronger-europe-world/global-gateway_en  
108 https://research-and-innovation.ec.europa.eu/research-area/health/edctp_en 

24 

 
 
 
response. The EU is committed to global cooperation on AMR and hosted an in-person meeting of 
the  Transatlantic  Task  Force  on  Antimicrobial  Resistance  on  14-15  November  2023  that  brought 
together  authorities  from  the  EU,  the  US,  Canada,  Norway  and  the  UK,  to  collaborate  and  share 
best  practices  to  strengthen  domestic  and  global  efforts.  The  EU  is  also  supporting  international 
efforts  to  combat  AMR  within  the  G7  and  G20  contexts  and  is  involved  in  preparations  for  a 
successful  United  Nations  General  Assembly  high-level  meeting  on  AMR  in  2024.  Through  its 
financial contribution  to  the AMR  Multi-Partner Trust  Fund, the EU is  supporting  efforts in  low- 
and middle-income countries to strengthen their capacities to fight AMR. 

EU Civil Protection Mechanism (UCPM) 

The UCPM is committed to providing assistance to any requesting country, inside and outside the 
EU. So far in 2023, 10 requests have been received through the UCPM from non-EU countries for 
COVID-19  related  items  (vaccines,  medical  equipment,  etc.)  and  all  were  fully  met  with  offers 
from  EU  Member  and  UCPM-participating  States.  Furthermore,  if  needed,  the  Commission  can 
also  directly  support  humanitarian  health  partners  through  the  European  Humanitarian  Response 
Capacity  with  the  provision  of  complementary  emergency  kits  (i.e.  shelter,  hygiene  and  cholera 
kits)  as  well  as  the  deployment  of  health  experts  (in  close  collaboration  with  the  ECDC)  in  the 
event of a health emergency in a humanitarian context. 

International dimension in EU-funded research and innovation 

To better coordinate research on pandemic preparedness and response, the EU has helped set up and 
is  funding  the  global  research  collaboration  for  infectious  disease  preparedness  (GloPID-R).  Its 
living  roadmap  for  clinical  trial  coordination  defines  epidemic-ready  clinical  trial  networks  and 
platforms, an agile and effective clinical trial response and an equitable research environment as the 
core  of  guidance  to  funders.  GloPID-R’s  regional  hubs  in  Africa  and  the  Asia-Pacific  support 
stronger coordination at a regional level. 

To  promote  global  collaboration  on  clinical  trials,  the  EU-funded  EDCTP  Association  brings 
together 26 countries in Africa and 15 in Europe in a clinical trial partnership that was established 
in  2003 to  promote multi-country clinical  trial  networks  in  Africa and  collaboration with  Europe. 
The  EDCTP  is  currently  in  its  third  iteration,  as  a  Joint  Undertaking,  and  has  enhanced  research 
capacity  and  accelerated  the  development  of  new  or  improved  medical  interventions  for  the 
identification, treatment  and prevention of poverty-related infectious diseases, including emerging 
and  re-emerging  diseases  in  sub-Saharan  Africa,  through  all  phases  of  clinical  trials  and  with  an 
emphasis on phase II and III trials. 

international  stakeholders  are  fundamental 

Engagement  and  close  collaboration  with 
to 
strengthening  pandemic  preparedness  and  response  efforts  globally.  Over  the  past  year, 
implementation of the 2022 administrative arrangement with the United States’ Administration for 
Strategic  Preparedness  and  Response  (ASPR)  has  continued,  including  through  an  exchange  of 
experts and a developing partnership on funding innovation in the diagnostics sector, specifically on 
technologies  for  early-outbreak  detection.  HERA  is  also  expanding  cooperation  with  partners  in 
Asia and recently signed administrative arrangements  with the Ministry of Health and Welfare of 
the Republic of Korea and the Japan Agency for Medical Research and Development.  

Close  cooperation  is  also  continuing  with  Ukraine  and  other  neighbouring  countries,  as  well  as 
partners  in  the  global  South,  particularly  in  Africa.  Key  objectives  in  the  preparedness  phase  are 
improving surveillance-sequencing  capacity, facilitating data exchange and supporting  sustainable 
production and distribution capacities for relevant medical countermeasures so that partners can in 

25 

 
times  of  crisis  rapidly  identify  and  characterise  pathogens  of  concern  and  have  broad  and  quick 
access to medical countermeasures.  

This  includes  work  through  international  partnerships  (e.g.  GH-EDCTP3JU  to  advance  the 
development of medical countermeasures for infectious diseases affecting Africa). With particular 
regard  to  global,  regional  or  national  initiatives  in  the  field  of  pandemic  preparedness,  the 
Commission has invested around EUR 25 million from the EU4Health programme. Actions include 
support for late-stage  clinical  trials  of vaccines  and treatments  against priority health threats  (e.g. 
Ebola  and  Marburg  virus);  the  enhancement  of  sequencing  capacities  in  Africa,  in  collaboration 
with the African Centre for Disease Control (CDC); and collection of data on emerging pathogens 
in Africa in collaboration with the WHO pandemic hub and WHO AFRO.  

EU Digital COVID Certificates and the WHO Global Digital Health Certification Network 

The development and use of EU Digital COVID Certificates have been key in the fight against the 
COVID-19  pandemic.  During  the  pandemic,  the  EU  Digital  COVID  Certificate  facilitated  travel 
within  the  EU  when  travel  restrictions  were  deemed  necessary.  It  also  allowed  for  a  coordinated 
lifting of these restrictions once this became possible.  

The EU Digital COVID Certificate also had an important international dimension. Based on open-
source  technologies  and  standards,  it  allowed  connection  with  non-EU  countries  that  issued 
certificates  according  to  EU  Digital  COVID  Certificate  standards  and  specifications.  With  78 
countries  and  territories  connected,  the  EU  Digital  COVID  Certificate  system  became  the  most 
widely used solution for the issuance and validation of digital COVID-19 certificates. Through this 
system, more than 1.8 billion people had access to interoperable digital certificates, and more than 
2.3 billion certificates were issued in the EU alone.  

From  the  onset  of  the  pandemic,  the  WHO  engaged  with  all  WHO  regions  to  define  overall 
guidelines for COVID-19 certificates, recognising an existing gap and continuing need for a global 
mechanism  that  would  support  bilateral  verification  of  the  provenance  and  authenticity  of  health 
documents for pandemic preparedness and continuity of care. Leveraging the experience of the EU 
Digital COVID Certificate, the WHO launched in June 2023 a Global Digital Health Certification 
Network  (GDHCN),  which  builds  on  the  solid  foundations  of  the  EU  Digital  COVID  Certificate 
framework, principles, specifications and open technologies. The WHO and the Commission have 
agreed  on  a  partnership  to  facilitate  the  uptake  of  the  EU  Digital  COVID  Certificate  and  on 
collaboration  in  the  GDHCN’s  operation  and  further  development.  The  GDHCN  will  allow  the 
world to benefit from convergence of digital certificates, while respecting and promoting common 
values  and  the  principles  of  transparency  and  openness,  inclusiveness,  accountability,  data 
protection  and  privacy,  security,  scalability  at  a  global  level  and  equity.  The  Commission/WHO 
partnership aims to work to technically develop the WHO system with a staged approach to cover 
additional  use  cases  in  the  future  (this  may  include,  for  example,  the  digitalisation  of  the 
International  Certificate  of  Vaccination  or  Prophylaxis).  Expanding  such  digital  solutions  will  be 
essential to delivering better health for citizens throughout the world. 

EU response in support of Ukraine 

Russia’s  war  against  Ukraine  has  been  a  major  humanitarian  crisis  that  has  affected  Ukraine’s 
healthcare  system  and  created  risks  for  public  health  both  within  Ukraine  and  beyond.  The  EU’s 
Member States and the Commission have sent medical countermeasures  via the UCPM to protect 
against  chemical,  biological,  radiological  and  nuclear  attacks  and  emergencies  in  Ukraine.  The 

26 

 
Commission has also set up a scheme to facilitate the logistics for donations of medical goods from 
EU companies to Ukraine via the UCPM. 

A medical  evacuation (MEDEVAC) system  established by  the UCPM  has been operational  since 
March  2022.  It  has  so  far  enabled  the  safe  evacuation  of  over  2 800  wounded  and  critically  ill 
Ukrainian  patients,  from  both  Ukraine  and  neighbouring  countries  to  hospitals  in  21  European 
countries. Such a collective MEDEVAC system is unprecedented at EU level. The Commission has 
also established a medical facility in a dedicated hub in Poland to increase the well-being of patients 
awaiting  transport  to  European  hospitals  and  to  increase  the  reliability  and  predictability  of 
MEDEVAC.  From  the  rescEU  strategic  reserve  and  since  the  beginning  of  Russia’s  full-scale 
invasion  of  Ukraine,  more  than  EUR 56 million’s  worth  of  medical  and  CBRN  items  and 
equipment  have  been  deployed  to  Ukraine,  including  masks,  potassium  iodide  tablets,  ventilators 
and other items.  

8. CONCLUSIONS 

This report has mapped the EU actions and capacities put in place to address serious cross-border 
health threats in the aftermath of the COVID-19 pandemic and building on the pre-COVID-19 EU 
health  security  architecture.  The  focus  was  on  those  actions  that  implement  Regulation  (EU) 
2022/2371, in response to the requirement of its Article 9 to report on EU prevention, preparedness 
and response planning. In addition, this report outlined ongoing initiatives and work that are closely 
related to public health in other EU policy areas, e.g. research, emergency assistance, international 
cooperation, etc. 

The COVID-19 pandemic triggered a major upheaval in our health systems and life as we know it; 
but it also brought an unexpected opportunity to improve our health security framework so that it is 
better prepared to  withstand major future health  threats.  While we may not  know what  the future 
holds – despite our best efforts to anticipate and plan – the EU has introduced upgraded structures 
for prevention, preparedness and response, which have greatly enhanced our collective capacities to 
react  to  any  future  emergency.  The  EU-level  health  security  framework  adds  an  important 
additional layer to the core functions of Member States in the field of health and the provision of 
healthcare. Health threats do not respect borders, but we are, collectively, better prepared to combat 
them, including by engaging in partnerships at global level. 

27