This is an HTML version of an attachment to the Freedom of Information request 'Working Party on Public Health'.


 
  
 
 
 

Council of the 
 
 

 European Union 
   
 
Brussels, 27 October 2020 
(OR. en) 
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SAN 344 

 
 
PHARM 43 
MI 404 
IPCR 31 
 
NOTE 
From: 
General Secretariat of the Council 
To: 
Working Party on Public Health 
Subject: 
Draft Council conclusions on COVID-19 lessons learned in health 
 
 
Delegations will find draft Council Conclusions on COVID-19 lessons learned in health developed 
by the Presidency in the Annex to this Note. These draft Conclusions will be the subject of the 
elaborations at the informal videoconference of the members of the Working Party on Public Health 
on 29 October 2020. 
 
 
 
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Draft Council conclusions 
on COVID-19 lessons learned in health 
 
Square brackets are used when the Council Conclusions refer to forthcoming Commission 
proposals or meetings that have not yet taken place. 
 
Introduction 
The year 2020 has been a year of unprecedented challenges for Member States, the European Union 
and the entire world. The COVID-19 pandemic is the worst health crisis in living memory, causing 
human tragedy and socio-economic upheaval. It still remains a Public Health Emergency of 
International Concern, declared by the World Health Organisation (WHO) on 30 January 20201
 
Being aware that the epidemiological situation is still evolving and will so be, until a high 
percentage of the world population is vaccinated, the European Union, its Member States and its 
citizens need to be prepared for the future. The challenges which we currently confront can only be 
effectively tackled together. This requires close collaboration and coordination between Member 
States, the institutions of the European Union, the civil society and the entire global community. 
                                                 
1 
https://www.who.int/news-room/detail/30-01-2020-statement-on-the-second-meeting-of-the-
international-health-regulations-(2005)-emergency-committee-regarding-the-outbreak-of-
novel-coronavirus-(2019-ncov) 

 
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Learning the lessons from the crisis and jointly drawing the right consequences is and will be an 
important step towards a stronger and more resilient European Union. It is a fundamental finding 
that the outbreak of the COVID-19 pandemic has revealed and exacerbated vulnerabilities in a great 
variety of issues and areas. In the area of health, the focus must be on the pandemic preparedness 
and response of the European Union and its Member States to tackle the ongoing COVID-19 
pandemic and future health threats, on ensuring the supply of medicinal products, the use of health 
data, and on strengthening the role of the European Union in global health – issues that are partly 
inseparable. The pandemic also affects the health care services and treatments of patients, in 
particular those with cancer and other non-communicable diseases. It is our responsibility in the 
European Union to draw the lessons learned and to emerge stronger and more resilient from this 
crisis. In full respect of their respective competencies, the European Union, its Member States and 
European Institutions need to jointly enhance their capabilities to ensure the capacity to act 
effectively in the event of health emergencies and to work towards achieving the European 
autonomy in strategic areas: Acting together. Towards European Health Sovereignty. 
 
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Lessons learned: Improving EU crisis management 
 
THE COUNCIL OF THE EUROPEAN UNION 
1. 
RECALLS its Conclusions adopted on 13 February 2020 on COVID-19 that call for 
continued and increased cooperation at Union and international level2 and WELCOMES 
solidarity and enhanced cooperation among Member States during the COVID-19 crises, 
including joint efforts to address remaining bottlenecks in deliveries of medical supplies and 
provide mutual support in treating patients. 
 
2. 
WELCOMES the proposal by the Commission for a stand-alone health programme 
EU4Health within the Multiannual Financial Framework 2021-2027 as an instrument to 
support projects with a clear added value in both crisis management and health and taking into 
account the results of the European Council of 21 July 2020. 
 
3. 
RECALLS the need to enhance the Union crisis management and preparedness by 
strengthening the EU health security framework and the European Centre for Disease 
Prevention and Control (ECDC) as well as the European Medicines Agency (EMA), and the 
need to ensure the supply of medicinal products in the EU, as well as the need for 
improvements regarding the exchange of health data for the purposes of research, diagnostics 
and development of new treatments. 
 
4. 
STRESSES the importance of the work carried out by the ECDC and TAKES NOTE of the 
measures outlined in the Communication on Short-term EU health preparedness for COVID-
19 outbreaks3
                                                 
2 
https://www.consilium.europa.eu/de/meetings/epsco/2020/02/13/  
3 
https://ec.europa.eu/info/sites/info/files/communication_-_short-
term_eu_health_preparedness.pdf 

 
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5. 
TAKES NOTE of the discussions on contact tracing for cross-border travel held at the virtual 
meeting of Chief Medical Officers on 29 September 2020, in particular on the need for an 
integrated approach in gathering data for contact tracing in accordance with data security, data 
protection and privacy rules, and for the establishment of a digital single point of entry 
platform in the long term perspective. 
 
6. 
STRESSES that the development and deployment of an effective and safe vaccine is key to 
achieve a permanent solution to the pandemic. Furthermore STRESSES the importance of 
ensuring fair, equitable, transparent and global access to COVID-19 vaccines and to support 
efforts for a fair and transparent process within the Union to ensure that the EU Member 
States receive a share that corresponds to their population size.    
 
7. 
UNDERLINES the need to further strengthen national surveillance measures of the 
occurrence of COVID-19 infections, testing capacities, data sharing and close cooperation 
with the ECDC to ensure prompt and efficient information exchange as well as to continue to 
improve the coordination thereof. 
 
8. 
CALLS UPON Member States and the Commission to cooperate within their respective 
competences with the aim to facilitate and foster the cross-sectoral information sharing 
between Member States and within relevant fora involved in the European Union’s crisis 
management, including the Integrated Political Crisis Response (IPCR), the Health Security 
Committee (HSC), the Early Warning and Response System (EWRS) and the ECDC, in order 
to avoid duplication of work and to ensure the European Union’s efficient, effective and joint 
response to the pandemic. 
 
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9. 
CALLS UPON the Commission  to assess the need for further effective mechanisms aimed to 
avert serious health threats to the EU citizens. This should include the promotion of contact 
tracing applications such as the establishment of a digital single point of entry platform 
working across all Member States modes of transport as well as uniform passenger locator 
forms for the identification of persons arriving from pandemic risk areas and their place of 
residence to ensure compliance with testing and quarantine obligations. Further consideration 
is needed regarding the possible use of passenger contact information to fight the pandemic, 
taking into account possible amendments to Directive (EU) 2016/681 (PNR) and the planned 
revision of Directive (EC) 2004/82 (API). 
 
10.  INVITES Member States to coordinate their efforts when building national reserves and 
stockpiles for crisis relevant goods in full coherence with ongoing work under the EU Civil 
Protection Mechanism. 
 
11.  INVITES the Commission to evaluate the situation and  report on the deployment of different 
mechanisms of emergency support and for the procurement of medical countermeasures  
including the joint procurement procedure (Decision 1082/2013/EU)4 and the Emergency 
Support Instrument (Regulation (EU) 2016/369)5 with respect to, inter alia, governance 
structure, transparency, information exchange between the Commission and Member States 
and interfaces of these instruments within the first half of 2021 [and, based thereon, to 
develop clear fast and efficient mechanisms for the procurement of medical countermeasure 
during a crisis.] 
                                                 
4 
Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 
2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC.  
5 
Council Regulation (EU) 2020/521 of 14 April 2020 activating the emergency support under 
Regulation (EU) 2016/369, and amending its provisions taking into account the COVID‐ 19 
outbreak. 
 
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[12.  WELCOMES the Communication from the Commission to the Parliament, the Council, the 
Economic and Social Committee and the Committee of the Regions from [date] on “Lessons 
learned and Long-term EU Pandemic Preparedness Package” and the legislative proposals for 
long-term EU health preparedness measures with regard to strengthening the ECDC, the EMA 
and health security crisis management through reforming Regulation (EC) No 851/20046
Regulation 726/2004 (EMA) and Decision 1082/2013/EU7.] 
 
[13.  ENCOURAGES the Commission and Member States to ensure the adequate equipment of the 
ECDC to:  
• 
establish a digital surveillance system that is linked with the systems of the Member 
States to simplify the transmission of comparable data while supporting Member States 
in the development of the national digital surveillance systems; 
• 
enhance modelling and forecasting capacities; 
• 
enhance its global visibility, cooperation and activities with partner institutions 
worldwide. ] 
 
14.  INVITES the Commission and Member States to consider to establish a permanent Health 
Task Force in the ECDC for technical support in the field of health security to both Member 
States and third countries. In order to allow for multiple ECDC-teams deployed 
simultaneously this requires ten teams. The Health Task Force’s prime task would be to carry 
out missions in Member States or third countries to support emerging preparedness and 
response planning and implementation with regard to best practice, stronger cooperation on 
EU level and between countries and to support crisis management in case of serious cross-
border health threats that affect multiple Member States and where mutual assistance is 
difficult to carry out. 
                                                 
6 
Regulation (EC) No 851/20046 of the European Parliament and of the Council of 21 April 
2004 establishing a European centre for disease prevention and control. 
7 
Decision 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 
on serious cross-border threats to health and repealing Decision No 2119/98/EC. 
 
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[15.  INVITES Member States and the Commission to consider a strategy that promotes the 
coordination of regional and local preparedness plans in cross-border regions, and integrates 
these in the wider EU crisis management mechanisms with a view to achieve coherent, multi-
sectoral, cross-border public health measures in a common EU-approach to manage areas of 
active virus circulation and avoid EU-internal border closures. The strategy should also take 
into account Council Recommendation (EU) 2020/1475 of 13 October 2020 on a coordinated 
approach to the restriction of free movement in response to the COVID-19 pandemics.] 
 
16.  CALLS UPON the Commission to conduct a Joint After Action Review after having 
overcome the COVID-19 pandemic to analyse the actions performed and the need for actions 
in additional areas for future improvement of EU crisis preparedness and response to health 
threats. This should also include a study on the effects of the COVID-19 pandemic on health 
care and treatment of patients, in particular those with cancer and other non-communicable 
diseases. 
 
 
Lessons learned: Ensuring the supply of medicinal products 
 
THE COUNCIL OF THE EUROPEAN UNION 
 
17.  ACKNOWLEDGES that shortages of medicinal products and Active Pharmaceutical 
Ingredients (API) in the off-patent sector and the dependency on third countries and on a few 
manufacturing sites for many products are issues of major concern and UNDERLINES the 
need for action to address the threat posed to the health care systems by those shortages.  
 
[18.  WELCOMES that the Commission has prioritised the issue of continuous and safe supply of 
medicinal products and addresses it with concrete measures in their EU Pharmaceutical 
Strategy to ensure preparedness and resilience and a holistic approach from availability to 
sustainability.] 
 
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[19.  ASKS the Commission to align objectives concerning “Ensuring availability of medicinal 
products in the EU” in the EU Pharmaceutical Strategy with the respective objectives in the 
EU Industrial Strategy, the EU Recovery Plan and the EU Green Deal.] 
 
20.  RECOGNISES that many manufacturers lack competitiveness when producing their 
pharmaceutical raw materials inside the EU and that this is in part due to third countries not 
implementing comparable EU environmental and social standards in the production process 
and at the same time RECOGNISES that in order to maintain the competitive advantage, the 
EU API and pharmaceutical manufacturers need to modernise the industrial base and integrate 
new more efficient manufacturing methods. 
 
21.  ACKNOWLEDGES that the availability of medicinal products is essentially linked with the 
quality of API and raw materials and RECOGNISES that quality issues and  industrial 
accidents increase the risk of shortages while diversification of supply chains helps to 
counterbalance these challenges 
 
22.  STRESSES that continuous and safe supply of medicinal products can only be achieved in a 
medium to long-term strategy based on a multidisciplinary health care policy approach 
including actions aimed to  improve transparency and quality inspections, diversification of 
supply chains and providing financial incentives for maintaining, building and relocating API 
manufacturing sites in the EU. 
 
23.  CONSIDERS that it is important to increase transparency of API manufacturing sites and the 
continuous information exchange at Union level and thus INVITES Member States and the 
Commission to strengthen the dialogue and cooperation, in particular through and within 
existing fora  aimed to address  any shortages of medicinal products, challenges in distribution 
chains and shortages in manufacturing capacities while at the same time maintaining national 
reporting systems on availability or shortages of medicinal products. 
 
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24.  INVITES the Commission to explore the creation of data management tools at EU level to 
collect information to better understand the whole manufacturing chain and the sources of 
supply and global manufacturing sites for API to increase transparency and visibility of both 
unilateral dependencies and important manufacturing sites. 
 
25.  UNDERLINES that improved international cooperation on inspections by the EU competent 
regulatory authorities will ensure the API quality more efficiently and continuously and thus; 
 
26.  INVITES the Commission to consider  strengthening  international cooperation within the 
framework of Good Manufacturing Practice (GMP)-inspections with Mutual Recognition 
Agreement (MRA)-partner states, the European Directorate for the Quality of Medicines and 
HealthCare (EDQM) and Pharmaceutical Inspection Co-operation Scheme (PIC/S)-authorities 
and whether the mutual recognition of official GMP documents for manufacturing sites 
outside the territory of the issuing authority can also be supported in MRA-partner states. 
 
27.  INVITES Member States to reflect on the adaptation of national regulations of procurement 
processes, in order to base tender decisions not only on price but  also prioritise suppliers with 
the highest standards of quality together with supply reliability as well as production 
diversification and to utilise state aid frameworks to incentivise the relocation of API 
manufacture to the EU, especially for critical medicinal products while respecting relevant 
EU-legislation on state aid and procurement in order to strengthen the resilience of supply for 
critical medicinal products. 
 
28.  INVITES the Commission to explore the possibility of facilitating the maintenance and 
relocation of API manufacturing sites for critical medicinal products in the EU, by adapting 
and prolonging the “Temporary Framework for State aid measures to support the economy in 
the current COVID-19 outbreak”. 
 
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29.  INVITES Member States and the Commission to review existing financial incentives for 
critical medicinal products in the EU and explore mechanisms to adapt these incentives to 
ensure availability of critical medicinal products while not omitting the pharmaceutical 
industry’s responsibility to ensure timely, safe and qualitative supply of medicinal products to 
the European market. 
 
30.  CALLS UPON the Commission to utilise its regulatory frameworks and global influence to 
achieve a level playing field for EU companies. 
 
 
Lessons learned: Improving access to and sharing of health data 
 
THE COUNCIL OF THE EUROPEAN UNION 
 
31.  NOTES that the COVID-19 pandemic brought the need for easier and more efficient 
processing of health data , demonstrated that aggregated health data can strengthen infectious 
disease surveillance and initiate joint activities to address communicable and non-
communicable diseases, e. g. through common  initiatives like the Lean European Open 
Survey on SARS-CoV-2 (LEOSS) project, and triggered an urgent need for establishing 
further cross-border cooperation between health care services, such as the interoperability 
framework for contact tracing and warning Applications and the EU gateway server. 
 
32.  ACKNOWLEDGES the high sensitivity of health data and emphasises the importance that all 
proposed actions are in full compliance with privacy and data protection rules. 
 
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33.  SUPPORTS the ongoing activities of the European Data Protection Board (EDPB) in 
facilitating a common understanding on the processing of health data between the data 
protection supervisory authorities, including the development of guidelines on health data 
processing for the purpose of scientific research, notably in the context of the COVID-19 
outbreak and CALLS FOR strengthening the role of the EDPB in reaching consensus on the 
application of the General Data Protection Regulation (GDPR)8 in the health sector. 
 
34.  WELCOMES the report “Assessment of the Member States’ rules on health data in the light 
of the GDPR 2019/2020” commissioned by the Commission and the recommendations based 
on extensive surveys and five workshops conducted between January and June 2020, with 
broad participation by experts, representatives of Member States, data protection supervisory 
authorities, stakeholders from the health sector and EU institutions and INVITES the 
Commission to continue the successful exchange of best-practices with the Member States 
through a dedicated expert group on secondary use of health data, involving representatives of 
bodies dealing with secondary use of health data. 
 
35.  STRONGLY SUPPORTS the approach of creating a European Health Data Space to 
strengthen the use and re-use of health data for healthcare, research and innovation, to support 
health authorities and regulatory bodies in evidence-based decision making, and to contribute 
to the competitiveness of the EU’s industry, to support the free movement of digital health 
services and support the development of a framework for AI in health. 
 
36.  WELCOMES the close cooperation between Member States and the Commission in preparing 
the Joint Action for the European Health Data Space "Towards the European Health Data 
Space”, as to ensure continuity in the development of a governance strategy for the secondary 
use of health data at European level and facilitating access to and exchange of health data 
through concrete use-cases. 
                                                 
8 
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on 
the protection of natural persons with regard to the processing of personal data and on the free 
movement of such data, and repealing Directive 95/46/EC (General Data Protection 
Regulation). 
 
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37.  ENCOURAGES the Commission and Member States to identify legislative and non-
legislative actions to support the European Health Data Space, complementing the horizontal 
framework on common data spaces and taking into account governance options developed by 
the future Joint Action for the European Health Data Space “Towards the European Health 
Data Space”, in order to ensure a harmonized approach to health data processing, in 
accordance with Member State competences. 
 
38.  INVITES Member States to cooperate  on bilateral and multilateral level to reduce differences 
in the interpretation and application of the GDPR by exchanging best practices, to enhance 
data quality and make data findable, accessible, interoperable and reusable, and to foster use 
cases of health data for scientific research. 
 
39.  INVITES Member States and the Commission to support  through their respective funding 
instruments the development of tailored European Codes of Conduct for specific categories of 
data controllers or processors and processing activities  in accordance with article 40 of the 
GDPR in order to increase legal certainty and facilitate GDPR compliant secondary data use 
within the European Health Data Space. 
 
40.  ENCOURAGES the Commission to facilitate the access to European health data repositories 
through common rules, instruments and procedures, including the European Reference 
Network registries, and by further initiating and promoting concrete use-cases of EU added 
value, such as clinical expert networks for further diseases and conditions, where European 
exchange of health data is necessary and appropriate, e. g. for the management of severe 
COVID-19 cases. 
 
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41.  CALLS UPON Member States and the Commission to develop a shared European 
management model for processing of person-generated health data, e. g. through lifestyle 
applications, to complement electronic health records based on individual consent (“data 
solidarity”), including the development of common consent templates; and to establish clear 
cross-border rules for business-to-business (B2B) and business-to-government (B2G) data 
access and sharing. 
 
42.  INVITES Member States and the Commission to establish a network of EU-wide accessible 
data donation/solidarity platforms linked to the EHDS infrastructure as key digital interfaces 
between citizens and trustworthy data users to collect donors data, based on their consent and 
facilitating access to personal data in line with the GDPR, and anonymized and aggregated 
data from which both, scientific insights to improve our understanding, especially of chronic 
disease prevalence, and practical tools for public health institutes could be derived. These 
platforms should also inform data donors about the progress and insights that are gained from 
their data. 
 
43.  URGES Member States and the Commission to join forces  in strengthening  data- and 
digital-related competence and building capacity for individuals, professionals, companies, 
public sector entities and decision makers. 
 
44.  ENCOURAGES Member States and the Commission to further strengthen  the eHealth 
Network through supporting its work and coordination  to continue the efforts to establishing 
a common strengthened interoperability coordination governance among Member States and 
National eHealth competence centres, to further implement and also to enhance the eHealth 
Digital Service infrastructure (eHDSI) with new Member States and new use cases to support 
cross border health care and cross border exchange of data to fight cross-border health threats, 
and develop respective scalable interoperability modules to be applied  in the European 
Health Data Space. 
 
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45.  INVITES Member States and the Commission to encourage new countries to participate in 
the EU gateway server for contact tracing and warning mobile applications and WELCOMES 
the intensive efforts undertaken by Member States and the Commission in the eHealth 
Network to introduce an interoperability framework for contact tracing and warning 
Applications and to set up an EU gateway server, which could become an  important tool to 
demonstrate the value and necessity of cross-border exchange of health data in response to the 
pandemic. 
 
 
Lessons learned: Strengthening the EU’s role in global health 
 
THE COUNCIL OF THE EUROPEAN UNION 
 
[46.  WELCOMES and REAFFIRMS the adoption of the Conclusions by the Council and the 
Representatives of the governments of the Member States on the role of the EU in 
strengthening the WHO as the leading and coordinating authority in global health and 
ENCOURAGES Member States to work jointly towards reforming and strengthening the 
WHO.] 
 
 
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