COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Building a European Health Union: Reinforcing the EU’s resilience for cross-border health threats
Date: 2020-11-11
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: European Centre for Disease Prevention and Control, disease prevention, disease surveillance, epidemiology, health control, health risk, health technology, infectious disease, international cooperation, medical device

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 11.11.2020  COM(2020) 724 final  COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Building a European Health Union: Reinforcing the EU’s resilience for cross-border health threats   
 
 
1. 

THE NEED FOR A STRONGER EU HEALTH SECURITY FRAMEWORK  

Health is a precondition for our society and economy to function. The COVID-19 pandemic is 
causing  immense  human  suffering,  pushing  health  systems  and  healthcare  workers  to  their 
limits. As of early-November 2020, over 50 million people worldwide had been infected with 
the coronavirus. More than 12 million, or  25% of those, were people living in Europe. In the 
EU/EEA  and  UK,  nearly  250  000  people  had  lost  their  lives  to  COVID-191.  The  measures 
needed to  contain the pandemic and save lives have  a huge impact  on people’s livelihoods, 
their jobs and their freedoms.  

During  the  early  days  of  the  COVID-19  outbreak  in  Europe,  Member  States  took  unilateral 
measures2 to protect their own populations. However, these uncoordinated measures were not 
effective  in  overcoming  the  virus.  Reintroduction  of  internal  border  controls,  for  example, 
disrupted  mobility  and  the  daily  life  of  millions  of  people  living  and  working  in  border 
regions.  They  disrupted  vital  supply  chains  and  prevented  the  flow  of  essential  goods  and 
services across the internal market.  

European citizens have been increasingly clear that they expect the EU to have a more active 
role  in  protecting  their  health,  particularly  in  protecting  them  from  health  threats  that 
transcend  national  borders3.  Coordinating  and  where  necessary  pooling  efforts  at  European 
level will deliver more effective responses to the expectations of European citizens in an area 
which  is  consistently  among  their  top  concerns.  We  need  to  heed  this  call  now  and  in  our 
discussions on the future of Europe.   Attention needs to be given also to the risk of popular 
scepticism  on  health  measures,  that  is  partly  triggered  by  an  increase  of  mis-  and 
disinformation on health issues. Health is a prerequisite for a dynamic economy stimulating 
growth, innovation and investment. 

From the beginning of the pandemic, solidarity has been real and tangible. Healthcare workers 
were at the forefront, working day and night to  care for COVID-19 patients, social workers 
continued  to  perform  indispensable  tasks  to  support  the  most  vulnerable,  including  older 
persons  and  persons  with  disabilities.  Often,  these  essential  workers  were  operating  while 
being  confronted  with  staff  shortages,  limited  information  on  preparedness  and  insufficient 
protective equipment, resulting in an overexposure to the virus. 

Solidarity  has  also  inspired  the  EU’s  response:  as  the  pandemic  progressed,  EU  Member 
States  turned  from  unilateral  measures,  such  as  export  restrictions  or  the  reintroduction  of 
internal  border  controls,  to  support  each other,  either by  receiving COVID-19 patients  from 
neighbouring countries or by sending healthcare professionals and key medical equipment to 
other  regions  in  need4.  Through  the  Coronavirus  Response  Investment  Initiative  (CRII), 
which enabled the mobilisation of unspent EU funds under Cohesion policy, so far EUR 5.9 

1 https://www.ecdc.europa.eu/en/covid-19/situation-updates  

2 Such as export restrictions on personal protective equipment and the reintroduction of internal border controls.  

3 https://europarl.europa.eu/at-your-service/en/be-heard/eurobarometer/public-opinion-in-the-eu-in-time-of-coronavirus-crisis-2 

4  Many 

border 

regions 

already 

have 

a 

history 

of 

and 

structures 

for 

cross-border 

cooperation, 

including 

in 

health. 

https://ec.europa.eu/info/sites/info/files/guidelines_on_eu_emergency_assistance_in_cross-bordercooperationin_heathcare_related_to_the_covid-19_crisis.pdf 

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billion  euros  have  been  reallocated  since  1st  February  2020  to  support  health  systems  and 
actions in EU Member States and regions5. In addition, the European Solidarity Fund’s scope 
was extended to encompass major public health emergencies. Cooperation and coordination at 
EU level has increased  and efforts across all sectors have been made. This is the only way to 
effectively  address  the  different  interlocking  damage  caused  by  the  pandemic  in  the  health, 
economic and social sectors. 

The collective effort to fight the ongoing COVID-19 pandemic, as well as other future health 
emergencies, calls for strengthened coordination at EU level. Public health measures need to 
be consistent, coherent and coordinated to maximise their effect and minimise the damage for 
people and business alike. The health situation in one Member State is contingent on that of 
others.  Fragmentation  of  effort  in  tackling  cross-border  health  threats  makes  all  Member 
States collectively more vulnerable. 

In her 2020 State of the Union address, the President of the Commission called on Europe to 
draw lessons from the current crisis and build a European Health Union. As the experience 
of  the  current  pandemic  is  showing,  gathering  the  EU  Member  States’  strengths  helps 
overcome individual weaknesses. By working with the European Parliament and the Council 
towards a stronger Health Union, the EU can be equipped to prevent, prepare for and manage 
health crises both at the EU and global level, with all the societal and economic benefits that it 
would bring.  

A strong European Health Union will protect our way of living, our economies and societies. 
If public health is in danger, the economy inevitably suffers. The close relationship between 
saving  lives  and  saving  livelihoods  has  never  been  so  apparent.  The  proposals  put  forward 
today  will  also  contribute  to  a  more  resilient  EU  internal  market  and  a  sustained  economic 
recovery.  

This  agenda  for  a  Health  Union  is  presented  in  the  midst  of  a  widespread  resurgence  in 
COVID-19 cases across Europe and the world.  The EU and its Member States will need to 
continue to take the necessary measures to contain and manage the pandemic on a day-to-day 
basis, for which coordinated EU-level action remain essential. At the same time, planning for 
future  outbreak  and  increasing  our  capacity  for  preparedness  and  response  becomes  more 
pressing  as  recurrent  outbreaks  of  communicable  diseases  are  becoming  more  likely.6 
Moreover, long-term trends such as  antimicrobial resistance7, pressures on biodiversity8 and 
climate change, all associated with increasing communicable disease threats worldwide and in 
Europe,  keep  rising9.  In  addition,  changing  demographic  structures  in  our  population,  in 
particular ageing, lead to changing health vulnerabilities and disease patterns. This require a 
systemic,  foresight-based  approach  recognising  the  interaction  between  human  and  animal 

5 https://ec.europa.eu/commission/presscorner/detail/en/IP_20_1864 
6 https://www.weforum.org/agenda/2020/03/coronavirus-global-epidemics-health-pandemic-covid-19/  

7 https://atlas.ecdc.europa.eu/public/index.aspx?Dataset=27&HealthTopic=4 
8 https://ipbes.net/pandemics  
9 https://easac.eu/projects/details/climate-change-and-health/ 

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health and the environment to develop structural, future-proof solutions, coherent with a One-
Health approach.  

The European Health Union builds on the EU’s joint effort to reconcile our relationship with 
the natural environment by engaging in different and more sustainable patterns of economic 
growth, as put forward the by the European Green Deal. Fighting climate change and finding 
ways  to  adapt  to  it,  preserving  and  restoring  biodiversity,  improving  diets  and  lifestyles, 
reducing and removing pollution from the environment improves will have positive effects on 
citizens’ health and the European Health Union will be able to better protect.       

This  Communication  proposes  first  building  blocks  for  a  European  Health  Union.  It 
implements  the obligation to  ensure high level  of human health protection as defined in  the 
Charter of Fundamental Rights of the European Union. It outlines the lessons learnt from the 
first  stage  of  the  pandemic,  and  advocates  the  strengthening  of  existing  structures  and 
mechanisms  for  better  EU  level  protection,  prevention,  preparedness  and  response  against 
human  health  hazards.  It  recommends  a  reinforced  framework  for  cross-border  cooperation 
against all health threats in order to better protect lives and the internal market as well as to 
maintain  the  highest  standards  in  the  protection  of  human  rights  and  civil  liberties.  It  also 
strengthens the EU role in international coordination and cooperation to prevent and control 
cross-border health threats and improve global health security. 

These  first  proposals  are  envisaged  within  the  current  Treaty  provisions,  particularly  in 
respect  of  Article  168  (5)  of  the  TFEU.  By  upgrading  the  EU  framework  for  cross-border 
health  threats,  these  first  building  blocks  of  the  European  Health  Union  will  bring  greater 
overall impact while fully respecting the Member States’ competence in the area of health. 

Concretely, this Communication is accompanied by three legislative proposals: an upgrading 
of  Decision  1082/2013/EU  on  serious  cross-border  health  threats,  a  strengthening  of  the 
mandate  of  the  European  Centre  for  Disease  Prevention  and  Control  (ECDC),  and  an 
extension of the mandate of the European Medicines Agency (EMA)10. It links to the proposal 
for enhancing the Union Civil Protection Mechanism11, proposed by the Commission in June 
202012. Together, these proposals will put in place a robust and cost-effective framework to 
enable EU Member States to respond to future health crises as a Union. 

Where the legislative proposals entail the processing of personal data, this will happen in full 
compliance  with  the  applicable  EU  data  protection  rules.  The  principles  and  specific 
safeguards  laid  down  by  the  EU  data  protection  framework13  allow  for  an  effective  and 
comprehensive protection of personal data, including data concerning health.  

10 To be added once available 

11 The Union Civil Protection Mechanism (UCPM) allows the Commission to support Member States in coordination of efforts to prevent and prepare for disasters as well as 

through its Emergency Response Coordination Centre (ERCC) in responding when their national capacities are overwhelmed by any kind of disaster, including ones such as 

COVID-19. Indeed, amidst the pandemic, EU Member States, UCPM Participating States as well as third countries resorted to the UCPM for support requesting for in-kind 

assistance in form of PPE, sanitation, but also for requesting for support of medical teams.  
12 COM(2020)220 
13 Regulation (EU) 2016/679 (the General Data Protection Regulation (GDPR) and Regulation (EU) 2018/1725 

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2. 

EARLY  LESSONS  LEARNT  FROM  THE  COVID-19  PANDEMIC  AND 
PROPOSALS FOR THE WAY FORWARD  

In 2013, the EU put  in  place  a health security  framework to  protect  its citizens, to  promote 
coordination between Member States and with neighbouring countries, and to respond to the 
increasing  threat  of  communicable  diseases.  The  Decision  on  serious  cross-border  health 
threats14  was  adopted,  aiming  to  improve  preparedness  across  Europe  and  to  strengthen  its 
capacity to rapidly detect, monitor and coordinate responses to health emergencies caused by 
communicable diseases, biological or chemical agents, or environmental and climate events, 
and threats of unknown origin.  

The 2020 Annual Strategic Foresight Report showed that there is a need to better anticipate 
health  risks  and  prevent  the  spread  of  new  infectious  diseases  and  associated  disorders. 
Embedding  foresight  in  health  policies  will  therefore  contribute  to  better  preparedness  and 
resilience. 

The COVID-19 public health crisis has highlighted that the EU and Member States must do 
more  regarding  preparedness  and  response  planning  for  epidemics  and  other  serious  cross-
border  health  threats.  While  structures  and  mechanisms  set  up  at  EU  level  as  part  of  the 
Decision on serious cross-border health threats facilitated the exchange of information on the 
evolution of the pandemic and supported specific national measures taken, they could do little 
to trigger a timely common EU level response and ensure coherent risk communication. This 
lack of coherence and coordination continues to be an obstacle to tackling the pandemic.  

The  crisis  response  from  the  European  Centre  for  Disease  Prevention  and  Control 
(ECDC) and the European Medicines Agency (EMA) 

ECDC’s  role  in  the  EU’s  health  security  framework  is  crucial.  However,  there  is  a  need  to 
strengthen  the  Agency’s  capabilities  to  better  protect  citizens.  For  example,  its  surveillance 
system  has  to  be  reinforced  so  as  to  deliver  its  full  potential  as  at  present  the  ECDC  has  a 
limited mandate/capacity to provide analysed data that support early evidence-based decision 
making  and  real-time  situational  awareness.  In  a  context  such  as  the  COVID-19  pandemic, 
ECDC  needs  to  be  able  to  provide  hands-on  support  to  Member  States,  and  the  Agency’s 
scientific  recommendations  for  appropriate  health  measures  need  to  address  Member  State-
specific elements. The ECDC needs to become a real EU Health Agency that Member States 
can entrust to deal with crisis preparedness and response as appropriate.  

EMA  also  plays  an  essential  role  in  the  EU’s  health  security  framework,  particularly 
regarding  the  assessment  of  safe  and  effective  treatments  and  vaccines.  However,  the 
COVID-19  pandemic  has  shown  that  EMA  lacks  a  strong  system  to  monitor  and  mitigate 
shortages of critical medicines, as well as a solid framework for crisis response. As a result, 

14Decision No 1082/2013/EU https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32013D1082 

4 

 
 
 
 
 
 
 
                                                           
the  Agency’s  ability  to  fast  track  scientific  advice,  procedures  and  obligations  on  Member 
States and developers has been hampered.  

The  COVID-19  pandemic  has  thus  clearly  shown  that  there  are  opportunities  to  further 
strengthen and improve  the EU health security framework  to  be ready for all health  threats. 
Significant  gaps  and  an  evident  need  for  more  EU  coordination  have  become  apparent  in 
public health preparedness and response. Inconsistencies in the application of health measures 
–  such  as  the  use  of  masks,  social  distancing  requirements,  testing  strategies  and 
isolation/quarantine requirements – have led citizens to question the scientific basis for these 
policies.  Capacity  shortages,  shortfalls  in  equipment,  shortcomings  in  testing  and  contact 
tracing,  and  a  failure  to  protect  the  most  vulnerable  groups  have  all  pointed  to  a  lack  of 
readiness  and  preparation,  as  well  as  to  structural  weaknesses  and  lack  of  resources.  EU 
solidarity mechanisms offered ways to offset these problems, but were not extensively used. 
For  example,  the  EU  Civil  Protection  Mechanism  could  have  been  drawn  on  far  more 
effectively15. Such disparities when dealing with an identical threat, which threatens all of us, 
cannot be maintained.  

While the pandemic is still ongoing, early lessons learnt have identified these challenges and 
are being addressed herewith. It is evident that further investments and reforms are necessary 
in health systems to ensure that they have the required means and resources to come out of the 
current crisis, as well as to strengthen their longer-term resilience in order to manage public 
health crises in the future. 

3. 

ENFORCING COORDINATED RESPONSE AT THE EU LEVEL 

Coordination of health measures is central not only to an effective practical response by the 
authorities  but  also  to  ensure  that  citizens  understand  that  action  is  evidence-based  and 
grounded  in  consensus.  The  EU’s  health  security  framework  sets  out  the  work  of  the 
Commission through the EU Health Security Committee and the Early Warning and Response 
System  (EWRS).  At  Council  level,  the  EU  Integrated  Political  Crisis  Response  (IPCR) 
arrangements  have  been  used  to  carry  out  coordination  and  to  support  the  EU’s  political 
response. 

The Health Security Committee16 is a key body where EU Member States consult each other 
in  liaison  with  the  Commission  with  a  view  to  coordinating  preparedness  and  response 
planning,  national  responses,  and  risk  and  crisis  communication  related  to  serious  cross-
border threats to health.  

15 For example, the response capacity of the Union Civil Protection Mechanism (UCPM) was initially hindered due to the scale of the outbreak, which hit simultaneously all 

the Member States at a time when markets for personal protective equipment were saturated.  As a result, several requests for assistance went unfulfilled for some weeks in 

the  early  stages  of  the  outbreak  in  Europe.  This  experience  demonstrated  that  the  need  to  further  enhance  the  UCPM  and  prompted  the  Commission  to  propose  targeted 
amendments to the legal framework in June 2020. 
16 The HSC is composed of public health representatives of Member States, and observers from European Economic Area (EEA) countries, EU agencies, most importantly 

the European Centre for Disease Prevention and Control (ECDC), as well as international partners such as the World Health Organization. 

5 

 
 
 
                                                           
In  response  to  COVID-19,  the  Health  Security  Committee  convened,  from  January  to 
November  2020,  more  than  40  times,  to  discuss  risk  assessments,  guidance  from  ECDC, 
preparedness and response measures implemented, as well as capacities and needs in Member 
States17.  The  Committee  proved  to  be  a  key  forum  for  exchange  of  information  and 
developing  common  positions  in  certain  areas,  such  as  the  Health  Security  Committee 
agreement on recommendations for COVID-19 testing strategies. This was a prerequisite for 
effectively communicating to citizens, at EU but also at national level. On the  other hand, it 
became  apparent  that  the  Health  Security  Committee  has  a  limited  ability  to  enforce  or 
coordinate  the  national  responses  around  control  measures  or  to  implement  the  agreed 
common approaches. This is exemplified by the wide variety of national control measures that 
exist  and  that  were  implemented  across  the  EU,  such  as  social  distancing,  mask  wearing  or 
measures  at  points  of  entry.  The  imposition  of  export  restrictions  on  personal  protective 
equipment,  the  implementation  of  border  restrictions  without  mechanisms  to  ensure  the 
necessary flow  and exchange of  goods and people, or the use of therapeutics outside of the 
context of clinical trials, further showed the plethora of measures identified.  

Moreover, the coordination of communication aspects, under the remit of the Health Security 
Committee Communicators’ Network, proved to have limited EU efficacy. This was partly a 
consequence of different national approaches taken. However, it may also be a result of the 
minimal  engagement of  Member States,  exemplified by low  rates of attendance in  Network 
meetings.  

In  addition,  experience  has  shown  that  the  interplay  between  technical  discussions  in 
European structures, such as the Health Security Committee, and the Ministries of Health in 
Member States, is not always straightforward and this has a clear impact on decisions taken at 
national level. Moreover, given that health crises like COVID-19 are multi-sectoral in nature, 
a key priority will be to enhance cross-sectoral linkages and coordination with other relevant 
structures and constituencies beyond the Health Security Committee, for instance in the area 
of civil protection, which has a cross-cutting emergency and disaster preparedness as well as 
response function. 

In  light  of  this,  it  has  become  apparent  that  the  Health  Security  Committee  must  be 
strengthened  to  allow  the  triggering  of  a  common  EU-level  response  and  enhanced 
coordination  of  risk  communication18.  Based  on  this,  the  proposals  present  a  strengthened 
mandate to enforce coordinated response at EU level in the Health Security Committee. This 
will  be  enabled  by  targeted  recommendations  on  response  measures  by  the  ECDC  and 
relevant  EU  decentralised  Agencies,  incorporated  in  the  risk  assessments  provided  to  the 
Health  Security  Committee.  In  turn,  the  Health  Security  Committee  can  formally  adopt 
guidance  and  opinions  complemented  by  Commission  recommendations.  Crucially,  the 
adoption  of  these  recommendations  would  translate  into  actual  implementable  measures 

17  Practically  speaking,  this  has  provided  an  additional  means  to  keep  Member  States  informed  of  joint  procurements  and  their  practicalities,  as  well  as  supporting  the 

practical implementation of Emergency Support Instrument funded activities, such as the distribution of the masks for healthcare workers and treatment courses of Veklury 

(remdesivir).  
18 This also relates to  the research aspect of the response. 

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within  countries.  It  is  essential  that  Member  States  commit  to  implement  the  work  of  the 
Health  Security  Committee.  In  order  to  underline  the  increased  role  of  the  Health  Security 
Committee and in analogy to the Economic and Financial Committee (EFC), Deputy Health 
Ministers will meet in the high-level working group of the HSC, in particular when politically 
sensitive issues are on its agenda. 

The  legal  framework  for  the  recognition  of  an  emergency  at  the  EU  level  will  also  be 
amended. The new rules will enable the activation of EU emergency response mechanisms, in 
close coordination with the World Health Organization (WHO), without making it contingent 
upon  the  WHO’s  own  declaration  of  a  Public  Health  Emergency  of  International  Concern 
(PHEIC). This will give further flexibility to the EU when tackling health crises. For example, 
the  recognition  of  an  emergency  situation  at  EU  level  would  allow  for  the  flexible 
development, manufacturing, stockpiling and procurement of critical products during a crisis, 
as  well  as  the  adoption  of  immediately  applicable  implementing  acts  by  the  Commission 
concerning  the  protection  of  human  health  and  to  ensure  the  smooth  functioning  of  the 
internal  market.  This  should  be  done  ensuring  full  complementarity  with  the  Union  Civil 
Protection Mechanism, including its Emergency Medical Teams. 

The Commission will not act unilaterally in such a recognition, with the process supported by 
an independent Advisory Committee to provide advice on the recognition and termination 
of a public health emergency as well as on response measures. The Advisory Committee will 
be  essential  in  ensuring  evidence-based  health  policy,  covering  diverse  scientific  areas  and 
policies,  composed  of  a  multidisciplinary  group  of  members  as  well  as  representatives  of 
Union bodies or agencies relevant  to the specific threat, which will participate as observers. 
The identification of the pool of experts will be in place prior to any future emergencies, so 
that  they  are  immediately  available  and  are  ready  to  collaborate  across  their  sectorial 
expertise.  

PROPOSED ACTIONS  

Proposal 
  Recommendations on response measures by ECDC as part of rapid 

Responsibility 
ECDC 

risk assessments  

  Commission Recommendation on response measures  

  EU recognition of an emergency situation and advice on response 
measures, supported by an independent Advisory Committee 

Commission 

Commission; 
EU Agencies 

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4. 

MEDICAL COUNTERMEASURES19 

The COVID-19 pandemic has revealed the lack of medical countermeasure stockpiles at EU 
and  Member  State  level  and  the  vulnerability  of  EU  supply  chains  for  critical  medical 
countermeasures.  It  has  also  highlighted  the  lack  of  a  coordinated  and  systematic  EU-level 
approach  to  support  the  development,  production,  procurement  and  purchase  of  necessary 
vaccines,  therapeutics,  diagnostics  as  well  as  personal  protective  equipment  (PPE)  and 
medical devices. Given the of lack of up-to-date, reliable and comparable information on the 
level of demand per Member State, it has been challenging to predict and meet the demand 
across the EU for certain products that are key in fighting the disease, but also essential raw 
materials,  components  and  accessories  used  during  production.    The  EU  lacked  effective 
mechanisms  and  structures  to  have  an  overview  of  demand  and  supply  of  critical  medical 
countermeasures and to monitor and support Member States in addressing shortages.  

Moreover, in the context of an outbreak or pandemic caused by a novel pathogen, the pressure 
is  high for research to  deliver results that can be acted upon rapidly, to  be integrated in  the 
emergency response. Further support and coordination are needed at EU level to facilitate the 
conduct of large scale, multi-centric clinical trials, to allow for their rapid implementation in 
times  of  crisis  and  save  precious  time  towards  making  the  necessary  countermeasures 
available20. Rules on the conduct of clinical trials need to allow for their rapid implementation 
in  times  of  crisis  and  save  precious  time  towards  making  the  necessary  countermeasures 
available. 

Despite these shortcomings, several measures were introduced to facilitate access to medical 
countermeasures.  In  order  to  facilitate  this  access  the  Commission  introduced  the  strategic 
rescEU  stockpile  of  emergency  medical  equipment  as  part  of  the  UCPM  in  March  202021. 
This  tool  acts  as  an  emergency  mechanism  to  provide  countries  with  needed  medical 
countermeasures,  such  as  PPE,  laboratory  supplies  and  intensive  care  unit  medical  devices 
when national capacities are overwhelmed, and complementing the capacities available in the 
EU  Civil  Protection  Pool.  A  number  of  actions  were  introduced  to  better  monitor  and 
maintain  the  supply  of  critical  medicines  or  medical  devices,  by  providing  regulatory 
flexibility,  while  maintaining  safety  standards.  Specific  guidance  has  been  published  and 
continuously  updated  to  inform  stakeholders  about  expectations  and  flexibilities22.  The 

19  Medical  countermeasures  relevant  for  public  health  response  include  pharmaceutical  products,  as  well  as  non-  pharmaceutical  products,  such  as,  but  not  limited  to, 

medical devices, personal protective equipment, vaccination supplies, testing material and kits, and laboratory equipment. 

20 COVID-19 illustrated suboptimal coordination and decision making as regards multinational clinical trials. The process has been slow and inefficient, causing delays in 

the  adoption  of  research  outcomes  and  eventually  delays  and  unequal  patient  access  to  new  or  repurposed  medicines.  A  very  high  number  of  trials  were  submitted  for 

medicines on Covid-19, both therapeutic and vaccines (454 distinct clinical trial applications submitted in at least one EU MS or the UK from March to end of September 

2020);  the  high  proportion  of  trials  (88%)  takes  place  in  only  one  Member  State  and  is  performed  by  non-commercial  researchers  (75%);  even  well-known  international 

clinical  trial  protocols  are  submitted  to  individual  Member  States  as  a  separate  project  –  leading  to  differences  in  approach  and  potentially  a  lesser  comparability  of  the 

results. Lastly, the experience to date has shown a need for clear, fast and streamlined positioning and communication on therapeutic and prophylactic “candidate” medicines 

21 The system of civil protection relies on solidarity among Member States, in the sense that it depends on their voluntary requests and offers of assistance. This voluntary 

system works very well in emergencies of limited scope, which affects one or a few Member States. But, as we have come to learn, it is ineffective in cases where a large 

number or all Member  States are affected at the same time. That is why reinforced rescEU to create strategic stockpiles of medical and personal protective equipment has 

been created. The rescEU strategic stockpile of emergency medical equipment is a last resort capacity under the Union Civil Protection Mechanism. 
22 https://ec.europa.eu/health/sites/health/files/human-use/docs/guidance_regulatory_covid19_en.pdf 

8 

 
 
                                                           
Commission  Clearing  house  for  COVID-19  medical  equipment  was  established  on  1  April 
2020  to  facilitate  matching  the  supply  and  demand  of  PPE,  medical  devices  and  medicines 
and  address  regulatory  and  other  supply  chain  issues.  The  activation  of  the  Emergency 
Support  Instrument,  research  funding  and  advanced  purchase  agreements  with  vaccine 
developers under the EU's vaccine strategy  are other concrete examples of decisive  actions. 
Through the Emergency Support Instrument, the Commission helped in responding to needs 
that can be best addressed in a strategic, coordinated manner at European level. Over €2 000 
million  from  the  instrument  has  thus  been  made  available  for  the  advanced  purchase 
agreements  for  vaccines,  €70  million  for  the  purchase  and  distribution  to  Member  States  of 
Veklury (the therapeutic remdesivir), and €100 million will be used for rapid antigen tests. 

All together, these measures have helped in building the response to the on-going crisis, to fill 
in  the  gaps  of  the  existing  framework.  However,  they  do  not  address  the  EU’s  long-term 
structural challenges with regards to medical countermeasures.  

Joint Procurement  

The  EU’s  Joint  Procurement  Agreement  for  medical  countermeasures,  enabled  by  Decision 
1082/2013/EU, was used throughout 2020 in response to the COVID-19 crisis. However, the 
Joint  Procurement  Agreement  is  predominately  a  preparedness  tool  and,  as  such,  is  not 
designed to deal with an on-going crisis. It aims at improving Member States' preparedness to 
mitigating  serious  cross-border  threats  to  health,  allowing  for  a  more  equitable  access  to 
specific  medical  countermeasures  and  an  improved  security  of  supply,  together  with  more 
balanced prices for participating Member States.  

However,  in  the  proposed  Regulation  for  serious  cross-border  threats  to  health,  elements  of 
the legal framework of the joint procurement agreement will be enhanced, as it remains a key 
tool  for  preparedness.  Specifically,  the  participation  to  European  Free  Trade  Association 
(EFTA)  States  and  Union  candidate  countries  is  formally  envisaged.  Moreover,  it  will  be 
strengthened  as  a  key  EU  procurement  process,  whilst  mitigating  the  risk  of  internal 
competition for limited resources or parallel national tracks, through an “exclusivity clause”. 
This exclusivity approach, implemented in the EU vaccines strategy, has proven successful23. 
Complementarity  should  be  ensured  with  the  strategic  rescEU  stockpiling  of  emergency 
medical equipment under the Union Civil Protection Mechanism. 

Addressing shortages through the European Medicines Agency  

The pandemic has also demonstrated that the Union’s ability to coordinate work to ensure the 
availability of medicinal products and medical devices and facilitate the development of new 
treatment  is  currently  limited.  EMA  has  played  a  crucial  role  by  setting  up  temporary 
mechanisms to monitor shortages of medicines and offer scientific advice to developers. Ad 
hoc  solutions,  including  contingent  arrangements  between  the  Commission,  the  European 

23  A  similar  clause  was  successfully  included  in  the  Agreement  between  the  Commission  and  the  Member  States  as  regards  the  Advanced  Purchase  Agreements  on  the 
purchase of vaccines against COVID-19. 

9 

 
 
 
                                                           
Medicines Agency, marketing authorisation holders, manufacturers and Member States have 
been  used.  In  addition,  a  scientific  task  force  facilitated  the  development  of  potential 
treatments and vaccines for COVID-19. Such temporary solutions need to be formalised, as a 
key  element  of  an  improved  EU  health  security  framework.  For  medical  devices  it  became 
apparent  that  there  is  no  mechanism  at  the  EU  level  providing  for  the  monitoring  of  their 
availability in times of crisis. 

On medicinal products, during the COVID-19 pandemic, the EU Executive Steering Group on 
Shortages  of  Medicines  Caused  by  Major  Events24  was  set  up  to  urgently  ensure  a  better 
overview of real needs. The group has provided strategic direction for the process in case of 
potential  supply  shortages.  This  includes  dealing  with  emerging  issues,  agreeing  remedial 
action  where  necessary,  addressing  shortages  in  a  coordinated  way,  including  crisis 
communication  and  overseeing  the  implementation  of  agreed  actions.  The  proposed 
Regulation  will  therefore  formalise  and  reinforce  the  current  structure  of  the  Steering 
Group on medicines, as well as its two-way fast-track communication channel between the 
European medicines regulatory network and marketing authorisation holders. Specifically, the 
proposed  changes  will  result  in  a  permanent  structure  within  the  EMA  to  monitor  events 
related to the pharmaceutical area, which could lead to future crises, as well as monitoring and 
mitigating  the  risk  of  shortages  of  key  medicines  once  a  crisis  is  declared.  To  support  such 
work  obligations  will  be  placed  on  marketing  authorisation  holders  and  Member  States  to 
provide  the  necessary  data  through  streamlined  IT  tools  and  fast-track  procedures  already 
established in view for future crises.  

In April 2020, the EMA also established an ad hoc COVID-19 EMA pandemic Task Force as 
part of its health threat plan. The Task Force contributes to direct scientific advice on clinical 
trials design and product development and provides a rolling review25 of incoming evidence to 
allow a more efficient  assessment approach of promising therapies or vaccines for COVID-
1926.  These  measures  are  crucial  to  ensure  timely  authorisation  of  products  and  the 
compilation  of  robust  data.  The  Task  Force  also  offers  scientific  support  to  COVID-19 
products’  clinical  trials  and  contributes  to  activities  on  emerging  safety  issues  related  to 
COVID-19 products. In the medium-term, strengthened access of EMA to health data, in the 
context of the upcoming European Health Data Space, should support its regulatory capacity. 
To reinforce the work of EMA, the legal proposal builds on the above and intends to replace 
the  current  ad  hoc  arrangements,  by  introducing  permanent  structures  within  the  EMA 
with a clear and unambiguous mandate. For clinical trials, the legal proposal includes a role 
for the Task Force in providing advice on clinical trial protocols, but also a broader role in 
the  coordination  and  facilitation  of  clinical  trials  in  the  European  Union.  It  also  implies  a 

24  The  group  is  chaired  by  the  European  Commission,  with  representatives  from  the  Heads  of  Medicines  Agencies,  European  Medicines  Agency,  the  chairs  of  the 

Coordination groups for Mutual-recognition and Decentralised Procedures (human and veterinary), as well as risk communication specialists. 

25  In  general,  all  data  on  a  medicine’s  effectiveness,  safety  and  quality  and  all  required  documents  must  be  submitted  in  the  initial  formal  application  for  marketing 

authorisation.  In  the  case  of  a  “rolling  review”  data  is  reviewed  as  they  become  available  from  ongoing  studies,  before  a  formal  application  is  submitted.  Once  the  data 

package  is  complete,  the  developer  submits  a  formal  marketing  authorisation  application  to  be  assessed  under  a  shortened  timetable.  That  significantly  shortens  the  time 

needed to make the medicine available, while maintaining the principles of quality, safety and efficacy. 

26 By October 2020, EMA had finalised 39 scientific advice procedures to provide developers with direction on the most appropriate methods and study designs for potential 

COVID-19 medicines. A further 14 such procedures are ongoing: The European Medicines Agency continuously updates on the activities of the Task Force on its website: 

www.ema.europa.eu 

10 

 
 
                                                           
stronger  role  in  providing  recommendations  with  regard  to  the  use  of  both  centrally  and 
nationally  authorised  medicinal  products,  which  may  have  the  potential  to  address  public 
health  emergencies.  The  proposal  will  also  include  tools  to  ensure  that  companies  and 
Member  States  submit  the  necessary  data  to  facilitate  the  assessment,  given  the  crucial 
importance of robust and comprehensive evidence for sound scientific advice and regulatory 
decision-making. Moreover, after the authorisation of vaccines, it is necessary to have safety 
and  effectiveness  data  to  complement  the  set  of  data  generated  by  industry  to  support  the 
authorisation. The proposals therefore provide for an IT platform to allow EMA and ECDC 
to  coordinate  vaccines  safety  and  effectiveness  studies  –  a  major  element  in  the  current 
landscape of pandemic management. 

In  the  area  of  medical  devices,  the  legal  proposal  builds  on  lessons  learnt  from  the  ad  hoc 
work undertaken during the COVID-19 pandemic by the Commission Clearing House given 
the  EMA  currently  has  no  competence  in  the  area  of  medical  devices.  The  purpose  is  to 
improve the Union’s crisis preparedness and facilitate a coordinated Union-level response by 
setting  a  permanent  structure  to  monitor  and  mitigate  shortages  of  medical  devices  (a 
Steering Group for Medical Devices) and to ensure that industry and Member States submit 
the necessary data to facilitate the monitoring and possible mitigation measures. 

Additionally, the EMA will host on a permanent basis the medical device Expert Panels, 
which could play an essential role in crisis preparedness and crisis management, in particular 
by  providing  scientific,  technical  and  clinical  assistance  to  the  Commission,  the  Medical 
Device  Coordination  Group  (MDCG),  Member  States,  notified  bodies  and  manufacturers.27 
At  the  beginning  of  the  COVID-19  crisis,  when  availability  of  medical  devices  such  as 
ventilators and protective devices was essential for saving lives and containing the pandemic, 
such  advice  would  have  been  invaluable,  for  example,  in  the  context  of  repurposing 
production lines for fast production of ventilators with the associated minimal technical and 
safety specifications.   

This approach will benefit from the long-founded expertise of the Agency in the management 
of various scientific committees and working groups.  

In order for the EMA to carry out these further tasks in addition to its current mandate, a swift 
increase in the number of permanent staff in this agency is required. 

PROPOSED ACTIONS  

Proposal 
  A reinforced joint procurement agreement beyond the EU  

Responsibility 
Commission 

  A permanent EU Executive Steering Group on shortages of 

EMA 

27 In addition, the panels are entrusted with other functions, including providing  various types of scientific advice to Commission, Medical Devices Coordination  Group, 

Member  States,  Notified  Bodies  and  manufacturers.  Such  advice  may  cover  safety  and  performance  aspects,  Common  Specifications,  clinical  strategies,  conformity 
assessment in relation to the state of the art for biocompatibility, mechanical, electrical, electronic and toxicological testing. 

11 

 
 
 
                                                           
medicines 

  A new EU Executive Steering Group on medical devices 

  A permanent EMA emergency Task Force 

  New EMA Expert Panels on high risk medical devices  

  A stronger EU clinical trials infrastructure 

  Creation of a vaccine monitoring platform 

EMA 

EMA 

EMA 

EMA;  
ECDC 
EMA; ECDC 

5. 

PREPAREDNESS & RESPONSE PLANNING AND REPORTING 

Under the current Decision on cross-border threats to health, the Commission’s monitoring of 
Member  States  preparedness  and  response  planning  is  primarily  based  on  Member  States 
reporting,  every  three  years,  on  their  respective  plans.  This  includes  the  intersectoral 
dimensions at the EU level and supporting the implementation of core capacity requirements 
under the World Health Organization’s International Health Regulations.  

COVID-19  has  revealed  that  national-level  preparedness  and  response  capacities  were  sub-
optimal.  This  was  illustrated,  for  example,  when  many  EU  Member  States  were  confronted 
with inadequate stockpiling (e.g. PPE), the lack of immediately available surge capacities for 
healthcare  systems,  testing,  contact  tracing  and  surveillance  and  the  lack  of  implementable 
business  continuity  plans  for  healthcare  provision  (to  avoid  postponement  of  inpatient 
scheduled treatments) as well as shortages of qualified medical staff.  

COVID-19  has  also  shown  that  there  was  a  clear  lack  of  an  overall  vision  on  the 
operationalisation  of  Member  State  preparedness  and  response  plans,  as  well  as  an 
incoherence with regards to their compatibility. This was greatly a result of the EU’s inability 
to compare plans in a uniform manner across the EU due to a lack of EU baseline standards 
and indicators28, a lack of EU knowledge on national level capacities to implement plans and 
incoherent feedback from Member States on respective preparedness and response plans. The 
situation  was  further  exacerbated  by  the  absence  of  an  overarching  EU  pandemic 
preparedness plan.  

It  is  therefore  proposed  to  strengthen  coordination  mechanisms  for  preparedness,  via  the 
development  of  a  binding  EU  health  crisis/pandemic  preparedness  and  response  plan. 
This  plan  will  include  clear  provisions  for  the  EU  and  Member  States  to  adopt  similar  and 
interoperable plans at national and local levels. To ensure these plans are actually operable in 
times  of  crisis,  regular  full-scale  exercises  and  carry-out  after-action  reviews  to 
implement corrective measures will be organised.  

28 With regards to assessing preparedness and response plans and corresponding capacities.  

12 

 
 
 
                                                           
To further strengthen the operationalisation of these plans, an EU audit process on national 
level  capacities  will  be  launched.  The  audit  process  will  be  led  and  coordinated  by  the 
Commission with the technical implementation primarily undertaken by the ECDC to further 
ensure,  preparedness,  transparency  and  adequate  operationalisation.  The  Commission  will 
report on these findings to the European Parliament and the Council.  

The conclusions will be  drawn upon  to address  the gaps  identified  during this reporting 
and  auditing  process  and  to  ensure  optimal  use  of  financial  support  through  the  future 
EU4Health  programme,  as  well  as  the  Structural  Funds  and  support  to  research  and 
innovation under Horizon Europe. 

Another  area  of  actions  concerns  support  to  Member  States  to  improve  the  resilience, 
accessibility  and  effectiveness  of  their  health  systems.  This  may  include  knowledge 
brokering, best  practice  exchange, hands-on technical  support  as well as financing from  EU 
programmes  to  initiate  and  implement  relevant  health  system  reforms  in  order  to  overcome 
structural weaknesses and address challenges identified in the European Semester. The Social 
Scoreboard that monitors Member States' performance in relation to the  European Pillar of 
Social Rights29, will further help to detect key problems, including in healthcare and skills and 
deliver  on  implementation  of  the  EPSR.  The  Recovery  and  Resilience  Facility30  offers  an 
unprecedented  opportunity  for  Member  States  to  carry  out  structural  reforms  supported  by 
investments,  aiming  at,  amongst  others,  enhancing  the  preparedness  and  resilience  of  their 
national health systems and ensuring equal access to affordable and quality health care31.  

Targeted  actions  may  concern,  for  instance,  reorganising  hospital  networks  with  flexible 
capacity  for  surge  in  demand,  the  cross-border  transport  and  treatment  of  patients  during 
health emergencies, sufficient availability  of primary care structures,  good  integration of all 
levels of health and social care, availability of sufficient and up-skilled healthcare staff who 
can be redeployed to new roles in case of emergency, deployment and financial coverage of 
eHealth tools (including telemedicine).  

In  order  for  the  ECDC  to  carry  out  these  further  tasks  in  addition  to  its  current  mandate,  a 
swift increase in the number of permanent staff in this agency is required. 

PROPOSED ACTIONS  

Proposal 
  Development and implementation of an EU health crisis/pandemic 

preparedness and response plan32. 

Responsibility 
Commission; 
ECDC; Member 

29 https://ec.europa.eu/info/strategy/priorities-2019-2024/economy-works-people/deeper-and-fairer-economic-and-monetary-union/european-pillar-social-rights_en 
30 The establishment of the  Recovery and Resilience Facility is subject to  the agreement of the European Parliament and of the Council on the proposal for a Regulation 

establishing a Recovery and Resilience Facility, COM(2020) 408 final 

31  In this context, it is also important to ensure that persons with disabilities have access to essential social support services as well as access to information on 
protective measures. 
32 This plan must take into consideration the intersectoral dimensions and critical sectors at the EU level, such as those that exist for such as for transport, mobility, energy, 

communication and civil protection. These plans should include a section on research preparedness. 

13 

 
 
 
                                                           
  Development and implementation of national level preparedness and 
response  plans  following  common  structures,  standards  and 
indicators.  

  Enhanced  Member  State  reporting  of  preparedness  and  response 

plans coupled with EU auditing process 

  Strengthened  transparency  with  the  Commission  preparing  reports, 
including  results  from  the  audits  and  recommendations  to  Member 
States, transmitted to the European Parliament and the Council.  

  Regular  public  health  and  cross  sector  stress  tests  carried  out  at 

national and EU levels with corrective measures. 

  Through  the  Technical  Support  Instrument33,  targeted  training  and 
knowledge exchange activities for healthcare staff and public health 
staff to provide knowledge and skills to develop and implement the 
national preparedness plans, implement activities to strengthen crisis 
preparedness and surveillance capacities. 

  Support  to  Member States to  strengthen the resilience,  accessibility 
and  effectiveness  of  health  systems  through  co-operation,  best 
practice  exchange,  training  schemes,  technical  support,  resilience 
dashboards34 and financing from EU programmes35 

States 
Member States;  

Commission; 
Member States 
Commission; 
EU 
decentralised 
agencies  
Member States 

Commission; 
ECDC; Member 
States 

Commission; 
Member States 

6. 

EPIDEMIOLOGICAL SURVEILLANCE 

Reinforcing the European Centre for Disease Prevention and Control 

issues36  are  under  mandatory 
Several  communicable  diseases  and  special  health 
epidemiological  surveillance  at  the  EU  level.  The  network  for  this  epidemiological 
surveillance is operated and coordinated by the ECDC, including support to national reference 
laboratories. COVID-19 has demonstrated a lack of comparable data and understanding of the 
situation on which to base decision-making. Furthermore, it has prompted investigation of the 
value of monitoring infectious agents in urban waste water as a means of tracking infections, 
and as a possible early warning mechanism. 

EU surveillance systems must be bolstered with capacities for detecting, monitoring and the 
surveying  of  emerging  diseases.  The  experience  from  COVID-19  also  highlighted  the 
important  ability  to  increase  capacity  of  frontline  diagnostic  laboratory  testing,  from  which 
further  data  is  accessible  and  necessary  for  the  management  of  novel  diseases.  Up-to-date 
surveillance data enables the monitoring of trends in the incidence of communicable diseases 

33  The  establishment  of  the  Technical  Support  Instrument  is  subject  to  the  agreement  of  the  European  Parliament  and  of  the  Council  on  the  proposal  for  a  Regulation 
establishing a Technical Support Instrument, COM(2020) 409 final 
34 The JRC is developing resilience dashboards with Member States and other stakeholders, with health as an important element. These dashboards will serve as a proper 
monitoring tool for assessing the resilience. Informed by strategic foresight, they can help identify emerging challenges and propose new forward-looking indicators to assess 
vulnerabilities or capacities 
35 Such as EU4Health, Recovery and Resilience Facility, Cohesion Policy and the Technical Support Instrument. 

36 Special health issues are antimicrobial resistance and healthcare-associated infections related to communicable diseases 

14 

 
 
                                                           
over  time  and  across  Member  States,  and  allows  rapid  detection  and  monitoring  of  cross-
border outbreaks.  

The rapidly evolving technological environment and digital solutions (AI, High Performance 
Computing, computational models and simulation system) provides an opportunity to update 
surveillance  systems,  integrating  data  from  new  and  different  sources37,  and  to  create 
sensitive  systems  that  detect  early  signals38.  A  modern  approach  to  surveillance  should  be 
used, relying on linking and integrating relevant surveillance systems, using electronic health 
records and harmonised datasets, environmental data, data analytics and artificial intelligence, 
social media - linked with modelling and forecasting capacity and dedicated high-performant 
digital computing platforms39. Enhancing these technologies will increase the capacity of the 
EU  and  its  Member  States  for  accurate  risk  assessments,  rapid  response  and  informed 
decision-making.  The  ECDC’s  key  role  in  establishing  integrated  surveillance  and 
monitoring  systems  at  the  EU  level,  including  research  data40  and  data  on  health  systems 
capacity for diagnosis, prevention and treatment of specific communicable diseases as well as 
patient  safety,  should  therefore  be  reinforced,  as  should  its  interaction  with  other  relevant 
agencies  including  the  European  Food  Safety  Authority  and  the  European  Environment 
Agency.   

National  reporting  of  timely,  complete  and  comparable  data  to  ECDC,  including  health 
systems indicators, based on common EU case definitions, is an integral element in this wider 
system  of  surveillance.  To  support  Member  States,  the  upcoming  EU4Health  programme 
will provide financing to improve national surveillance systems, whilst EU decentralised 
Agencies will support Member States via tailored technical advice and guidance.  

PROPOSED ACTIONS  

Proposal 
  A new high performing epidemiological surveillance system at the 
EU level, using artificial intelligence, harmonised datasets and 
digital tools for accurate modelling, risk assessment and response for 
the surveillance of novel pathogens based on common EU case 
definitions 

Responsibility 
ECDC; 
Commission  

  Strengthen access of ECDC to health data for research and 

epidemiological aspects, in the context of the European Health Data 
Space. 

ECDC; 
Commission 

37 Such as from space, including Earth Observation data from EU Copernicus and geolocation data from Galileo applications 
38 Such as from the surveillance of infectious agents in waste wate  
39 These systems may also benefit from and use services and data enabled or generated by EU initiatives such as the EU Space Programme. The experience of COVID-19 

has shown that space enabled services, such as those enabled by EU Galileo, which could provide valuable services and data i.e. geolocation services to map contagion areas, 

warn  about  restricted  or  quarantined  areas  and  alert  authorities  in  case  of  major  gatherings.  Specifically  in  response  to  COVID-19,    Galileo,  the  EU  Satellite  Navigation 

System was used for the development of a new Galileo-enabled application “Galileo for Green Lane” to allow monitoring in real time the circulation of goods between EU 

Member States and facilitate freight traffic at borders. 
40 Integration of Research into policy recommendations, through closer and more active of EU Agencies, is  important.  

15 

 
 
 
                                                           
  Reinforced surveillance linked to other available information sources 
and data (e.g. research, environmental, trade, transport, economic 
data, health systems data, pharmaceutical supplies, contact tracing.) 

ECDC; 
Commission  

  More detailed and timely reporting requirements for Member States 
on health care data and performance (e.g. hospital beds availability, 
specialised treatment and intensive care capacity, number of 
medically trained staff, contact tracing).   

Member States  

7. 

LABORATORY FINDINGS, TESTING & CONTACT TRACING 

The Commission and ECDC support Member States to comply with existing EU legislation in 
the  area  of  surveillance,  for  which  they  are  required  to  submit  comparable  and  compatible 
data  based  inter  alia  on  laboratory  findings.  However,  whilst  there  are  extensive  national 
laboratory  systems  in  place,  there  is  currently  no  coordinated  EU-wide  system  of  reference 
laboratory  networks  for  human  pathogens.  This  has  resulted  in  a  lack  of  coordination  for 
consolidated microbiological testing standards.  

The diversity in testing strategies and approaches put in place by Member States during the 
current  pandemic  has  been  a  consistent  challenge  and  has  significantly  hampered  the  EU’s 
coordination  efforts  to  respond  to  the  disease.  The  reasons  behind  such  diversity  in 
approaches depends on factors such as the epidemiological situation, transmission dynamics, 
resources  and  testing  capacities.  Efficient  testing  strategies,  coordinated  between  countries, 
are  a  pre-condition  to  ensuring  the  effective  implementation  of  mitigation  measures41.  This 
work can draw on the long experience in EU cooperation on research and innovation, an on 
the specific opportunities provided by the Horizon Europe programme. 

New EU networks are necessary42 to remediate these challenges and ensure these capacities 
can aptly respond to future serious cross-border threats to health: 

- 

- 

a new network of EU reference laboratories43 allowing the alignment on diagnostics, 
serological  testing,  testing  methods  and  use  and  validation  of  certain  tests  will  be 
established;  
transfusion, 
a  new  network 
transplantation  and  medically  assisted  reproduction  to  allow  for  the  continuous  and 
rapid access to sero-epidemiological data. 

including  Member  State  services  supporting 

A  key  pillar  for  mitigating  the  transmission  of  diseases  is  the  implementation  of  efficient 
contact  tracing  measures,  particularly  to  enable  the  control  of  localised  outbreaks.  In  the 
current  framework,  contact  tracing  was  solely  included  as  one  of  the  elements  for  Member 

41 To this end, the Commission, EU Agencies and Member States put forward recommendations via the Health Security Committee for a common EU testing approach for 

COVID-19 
42 To be operated by ECDC with support of the JRC Commission service. 
43  This  network  will,  amongst  other  things,  provide  a  framework  for  evaluation  and  approval  of  diagnostics  and  seek  to  ensure  mutual  EU  recognition  in  the  field  of 

diagnostics. 

16 

 
 
 
                                                           
States to coordinate via EWRS44. Based on lessons learnt from COVID-19, additional efforts 
are needed at the EU level45, to reinforce EU capacities for contact tracing across borders. To 
begin  with,  contact  tracing  will  be  a  required  element  of  the  EU  health  crisis/pandemic 
preparedness  and  response  plan.  To  complement  the  feasibility  of  contact  tracing  and  to 
support Member States in this endeavour, the ECDC will be additionally mandated to set 
up  an  automated  system46  for  contact  tracing,  building  upon  the  contact  tracing 
technologies  developed  by  the  Member  States  context  of  contact  tracing  and  warning 
applications47.  Finally,  contact  tracing  will  also  be  incorporated  into  the  epidemiological 
surveillance  network  of  the  ECDC.  Given  these  developments,  engagement  with,  and 
information sharing from Member States to the ECDC will be a prerequisite for ensuring the 
success of bolstering this capacity.   

PROPOSED ACTIONS  

Proposal 
  Creation of an EU reference laboratories’ network that would allow 
alignment on diagnostics, serological testing, testing methods, use of 
certain tests 

Responsibility 
ECDC; 
Commission 

  Creation of a network including Member State services supporting 
transfusion, transplantation and medically assisted reproduction 

  A robust system for automated contact tracing, using modern 

technologies48, building on contact tracing and warning applications 

ECDC; 
Commission; 
Member States 
ECDC; 
Commission; 
Member States 

8. 

EARLY WARNING AND RISK ASSESSMENT CAPACITY 

The  Early  Warning  and  Response  System  (EWRS)  is  a  rapid  alert  system  for  serious-cross 
border  threats  to  health,  enabling  the  Commission  and  Member  States  to  be  in  permanent 
communication for the purposes of alerting and assessing public health risks and determining 
measures that may be required to protect public health. EWRS has supported the sharing of 
notifications and information on COVID-19 cases and response measures. The platform has 
proven useful and responded to the needs required. By illustration, since 9 January, when the 
Commission formally alerted EU Member States to COVID-19 via the first alert message, the 
platform  has  processed  over  2  700  COVID-19  messages49,  from  Member  States  and  the 
Commission. Moreover, it has facilitated over 30 COVID-19 medical evacuation operations - 

44 EWRS has operationally supported the sharing of contact tracing information for COVID-19 

45  The  Emergency  Support  Instrument  has  financed  European  Federation  Gateway  Service  for  the  purpose  of  contact  tracing  and  warning  apps  and  in  July  2020,  the 

Commission also introduced an implementing Decision to enable interoperability of mobile tracing and warning apps across the EU 

46 This should allow the use of modern technologies, such as digital mobile applications, artificial intelligence models, or other applicable tools that emerge. 
47 Respect will be ensured as to GDPR 
48 Such as, but not limited to, space-enabled applications 

49 These messages, for example, relate to sharing information with regards to contact tracing, epidemiological updates, sharing of technical expertise and updates on health 

measures implemented. 

17 

 
 
 
 
 
                                                           
involving  the  Member  States,  the  Commission  and  the  World  Health  Organization  -  of 
healthcare workers50.  

At the same time, the scope of alerts will be broadened to include needs for or shortages of 
medical countermeasures, as well as requests and/or offers for cross-border emergency 
assistance.  This  responds  directly  to  the  needs  revealed  during  the  outbreak  of  COVID-19 
and to ensure coordination of EU mechanisms, notably with strategic rescEU stockpile under 
the  UCPM,  as  well  as  with  the  Mobility  Package  under  ESI  framework51.  The  EWRS  will 
further support this coordination amongst countries and the Commission, complementing the 
UCPM  and  avoiding  duplication  and  conflicting  actions,  and  it  will  be  enhanced  to  include 
functionalities  relevant  for  preparedness  planning  and  reporting,  as  well  as  interlinking  the 
platform with other EU level crisis management alert systems.  

Finally, the Commission will reinforce an all hazard approach to risk assessment in the new 
proposals. The proposed Regulation on serious cross-border threats to health will entrust all 
relevant  EU  decentralised  agencies  with 
risk  assessment,  scientific  advice  and 
recommendations  for  response  measures,  incorporating  a  mandated  responsibility  for  the 
Commission52 and Union agencies. 

PROPOSED ACTIONS  

Proposal 
  A new risk assessment framework for all hazards, including rapid 
and appropriate recommendation for response measures that 
Member States should implement 

Responsibility 
EU decentralised 
Agencies; 
Commission 

9. 

INTERNATIONAL COOPERATION AND COORDINATION 

COVID-19 has shown that serious threats to health are inherently cross-border. The EU and 
its  Member  States  provided  to,  and  also  received  assistance  from,  third  countries  in 
responding  to  the  crisis.  As  Team  Europe,  they  have  so  far  mobilised  over  EUR  36  billion 
with emergency aid and longer-term health and socio-economic support to partner countries 
in need, with a particular focus on vulnerable people. It has also set up an EU Humanitarian 
Air Bridge to maintain  vital  transport links for  humanitarian and emergency health workers 
and supplies 

50 The Commission has in place a dedicated medical evacuation system (MEDEVAC) with the World Health Organization to facilitate the medical evacuation of healthcare 

workers for viral haemorrhagic fevers. In 2020, this was extended to include COVID-19. The EWRS platform is used for the Commission to coordinate medical evacuations 

between the WHO and Member States.  

51  EWRS  has  been  integrated  into  the  EU  ‘mobility  package’  for  the  purpose  of  cross  border  transport  of  medical  teams  and  the  transfer  of  COVID-19  patients: 

https://ec.europa.eu/commission/presscorner/detail/en/ip_20_1118 

52 Where the risk assessment needed is totally or partially outside the  mandates of the agencies and it is  considered necessary  for the coordination of the  response at EU 

level, the Commission shall, upon request of the HSC or its own initiative, provide an ad hoc risk assessment. 

18 

 
 
 
 
 
                                                           
As such, the Commission and EU decentralised Agencies work, and continue to do so, with 
international  stakeholders  as  well  as  partner  countries.  This  includes,  for  example,  close 
collaboration with the WHO, non-EU centres for disease control and prevention, Participating 
States  in  the  Union  Civil  Protection  Mechanism,  as  well  as  engagement  in  coordination 
platforms  such  as  the  Global  Health  Security  Initiative  and  GloPiD-R,  the  network  of 
preparedness  research  funders.  The  Commission  also  actively  promotes  the  need  for 
continued political attention and coordination of public health preparedness and response, via 
frameworks such as the G7 and G20. 

The  EU  has  a  leading  role  to  play  to  strengthen  health  systems  including  global  health 
security preparedness and response capacity. 

In  direct  response  to  COVID-19,  the  Commission  provided  the  EU’s  enlargement  countries 
and  priority  Eastern  neighbouring  countries  access  to  the  Health  Security  Committee  and 
EWRS,  access  that  was  also  given  to  Switzerland.  This  was  undertaken  to  maximise  the 
protection of citizens and support the response of the EU by clearly acknowledging that the 
virus does not  stop  at  borders, and that the strongest  response and crisis  management is  via 
regional  and  international  solidarity  and  cooperation.  The  European  Parliament  and  the 
Council  have  recently  strongly  affirmed  EU’s  commitment  to  scaling  up  global  health 
emergency  preparedness,  and  the  16  October  2020  European  Council  committed  to 
strengthening EU support to health systems  and the reinforcement of partners’ preparedness 
and response capacity in Africa. Furthermore, the Commission and EU Agencies also initiated 
regular exchanges of experience with prevention and control measures with China and other 
third countries. 

To  consolidate  and  underpin  the  benefits  of  international  cooperation  and  coordination  on 
serious cross-border threats to health, the new proposals confirm the EU’s leading role in the 
global  sphere  of  public  health  preparedness  and  response,  with  the  objective  of    addressing 
outbreaks at the source via a two-pronged approach: (1) reinforced and targeted international 
cooperation  and  coordination;  and  (2)  on  the  ground  support  to  Member  States  and  third 
countries, in times of need. On the global level, the ECDC will pursue a leading role and build 
an international network with other major Disease Control Centres, such as the US Centers for 
Disease Control and Prevention (CDC). 

This will be translated by a reinforced capacity for ECDC to mobilise and deploy the EU 
Health  Task  Force  to  assist  local  response  in  particular  in  the  Member  States  and 
greater  involvement  in  international  response  teams53,  including  ECDC  support  to  build 
more  resilient  health  systems  for  sustainable  health  security  preparedness  in  EU  partner 
countries. 

PROPOSED ACTIONS  

53  These  capacities  will  be  interlinked  with  the  UCPM  and  notably  the  work  of  the  European  Medical  Corps,  which  already  gathers  Member  States  medical  response 
capacities. 

19 

 
 
 
                                                           
Proposal 
  Establishment of the EU Health Task Force within ECDC, to 
mobilise and deploy to assist local response to outbreaks of 
communicable diseases in Member States and third countries 

  Framework for the mobilisation of the EU Health Task Force to 

provide contribution within international response teams mobilised 
by the WHO Health Emergencies Programme mechanism, the 
Global Outbreak Alert and Response Network (GOARN) and the 
Union Civil Protection Mechanism 

  Development of field response capabilities and crisis management 
expertise among ECDC’s staff and experts from EU and EEA 
countries, EU pre-accession countries, and European 
Neighbourhood Policy and EU partner countries, upon request of 
the Commission 

Responsibility 
ECDC; 
Commission 

ECDC; 
Commission; 
Member States 

ECDC; 
Commission; 
Member States; 
EEA; EU-pre-
accession 
countries; EU 
Neighbourhood 
policy and EU 
partner counters 

10. 

AN  EU  HEALTH  EMERGENCY  PREPAREDNESS  AND  RESPONSE 
AUTHORITY (HERA) 

The COVID-19 pandemic has demonstrated the need for and value of co-ordinated EU level 
action. EU-level  advanced purchase agreements for vaccines increase the likelihood that we 
will exit the crisis together, and stockpiling of medical countermeasures has already lessened 
its  impact.  At  the  same  time,  the  pandemic  has  revealed  structural  weaknesses  and  market 
failures  in  our  foresight,  preparedness  and  ability  to  respond  coherently,  rapidly  and 
appropriately to protect our citizens from health crises.  

COVID-19  is  unlikely  to  be  the  only  global  or  pan-European  health  crisis  of  our  century. 
Anticipating  this  calls  for  a  dedicated  European  authority  that  will  strengthen  the  EU’s 
preparedness  and  response  capability  for  new  and  emerging  cross-border  threats  to  human 
health.  

The authority’s mission will be to enable the EU and its Member States to rapidly deploy the 
most advanced medical and other measures in the event of a health emergency, by covering 
the whole value chain from conception to distribution and use.  

threats, 

To  that  effect,  it  will,  for  example,  undertake  horizon  scanning  and  foresight  to  anticipate 
identify  promising  potential  countermeasures  and  underpinning 
specific 
competencies,  and  generate  and  disseminate  knowledge  on  these.  It  will  monitor  and  pool 
production  capacity  and  development  facilities,  raw  material  requirements  and  availability, 
and ensure that supply chain vulnerabilities are addressed. It will support the development of 
crosscutting  technologies  and  solutions  sustaining  multiple  potential  future  threat  responses 
(e.g.  vaccine  platform  technologies,  or  the  application  of  digital  tools  and  artificial 

20 

 
 
 
intelligence)  as  well  as  the  development  of  specific  countermeasures,  including  through 
clinical trials and data infrastructure. It will ensure that sufficient production capacity will be 
available when necessary, as well as arrangements for stockpiling and distribution.  

The European authority will plan, co-ordinate and assemble ecosystems of public and private 
capabilities  that  jointly  enable  a  rapid  response  when  the  need  arises.  When  an  EU  health 
emergency  is  declared,  it  will  acquire  specific  additional  resources  required  to  adequately 
react in the interest of all Member States. 

Building  on  the  experience  with  COVID-19  vaccines  development  and  the  central  clearing 
house for medical  equipment,  the Commission  will launch a preparatory  action focusing on 
emerging  biological  threats  to  human  health,  such  as  corona-related  transmissible  diseases 
and anti-microbial resistance. In parallel, it will launch an impact assessment and consultation 
on  the  establishment  of  an  EU  authority,  with  a  view  to  proposing  in  2021  a  properly 
mandated  and  resourced  dedicated  structure  to  start  operations  in  2023.  Synergies  and 
complementarity with existing EU bodies and relevant spending programmes will be ensured.   

11.  

CONCLUSION AND NEXT STEPS 

Health is central to people’s well-being. They rightly expect it to be one of the major priorities 
of public policy. Governments must do everything they can to deliver health services and to 
protect  from  health  threats.  This  means  working  together,  and  using  the  EU’s  potential  to 
improve the health response and to support Member States to fulfil their responsibilities. This 
needs  clear  direction  at  EU  level,  close  coordination  with  the  Council  and  the  European 
Parliament, and the updating of key tools and legislation as set out in this Communication. 

The upcoming Conference on the Future of Europe, with its emphasis on outreach to citizens 
and  its  aim  to  create  a  forum  to  address  their  concerns  and  priorities,  provides  an  optimal 
platform to ignite discussions provide impetus on the evolution of the EU’s role on health in 
the  future,  in  order  to  respond  to  citizens’  expectations  towards  the  Union.  In  addition,  the 
Global Health Summit scheduled for 2021 in Italy will allow the EU to steer the worldwide 
reflection on how to strengthen global health security in the “age of pandemics". 

The  coronavirus  has  touched  every  single  aspect  of  personal,  professional,  social  and 
economic life. To effectively address the threat it poses, European health authorities need to 
work  seamlessly  together,  to  pool  their  resources  and  expertise,  and  to  operate  as  jointly  as 
possible  and  in  close  coordination  with  the  economic  authorities.  This  is  the  only  way  to 
counter the cross-border health threat of COVID-19 effectively.  

This  Communication  sets  out  the  additional  actions  that  need  to  be  taken  in  the  immediate 
future, both at the European and the national level to increase our resilience to all cross-border 
health  threats  and  provide  all  European  citizens  with  the  high  level  of  public  health  they 
expect and deserve. It is our shared and urgent responsibility to take forward these measures 
quickly  and  thoroughly,  and  to  overcome  the  fragmentation  and  gaps  in  instruments, 
information, and mind-sets, which will otherwise continue to make us collectively vulnerable 
and endanger our way of life.  

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The European Health Union will be as strong as its Member States’ commitment to it.  

22