Council of the
European Union
Brussels, 27 October 2020
(OR. en)
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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 2020
1.
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 level
2 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 outbreaks
3.
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 851/2004
6,
Regulation 726/2004 (EMA) and Decision 1082/2013/EU
7.]
[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 851/2004
6 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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