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Council of the 
 
 

 European Union 
   
 
Brussels, 11 November 2020 
(OR. en) 
    11528/1/20 
REV 1 
 
 
 
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SAN 344 

PHARM 43 
 
 
MI 404 
IPCR 31 
COVID-19 3 
 
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  enclosed  a  revised  set  of  draft  Council  conclusions  on  COVID-19  lessons 
learned  in  health  prepared  by  the  Presidency  on  the  basis  of  written  comments  received  from 
delegations. This text is intended for discussion at the informal videoconference of the members of 
the Working Party on Public Health on 13 November 2020. 
 
* * * 
 
Changes to the text in document 11528/20 are indicated as follows: 
 
Bold italics = new text. 
strikethrough = deleted text. 
 
 
 
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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  a  health  crisis  that  has  an 
unprecedented  detrimental  impact  on  our  societies  and  economies.  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 Organizsation (WHO) on 30 January 20201
 
Being aware that the epidemiological situation is  still evolving and  likely will so be, until  a high 
percentage  of  the  world  population  is  vaccinated,  immunized  or  can  be  treated  adequately,  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, improving access 
to and sharing of the use of health data which is essential to fight this pandemic, as well as other 
cross-border health threats, 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, inter alia in particular those with cancer and other non-communicable diseases, due to 
either the measures in place to tackle the pandemic or due to the impact of these measures.  
 
It  is  our responsibility in the European Union to  draw the lessons  already learned  and to  emerge 
stronger and more resilient from this crisis to benefit our citizens and patients. 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 while 
preserving an open economy. Acting together. Towards European Health Sovereignty. 
 
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Lessons learned: Improving EU crisis management 
 
THE COUNCIL OF THE EUROPEAN UNION 
 
1. 
RECOGNISES that while health security and pandemic preparedness planning remain 
primarily a Member State competence, the COVID-19 pandemic highlighted the added 
value of and need for solidarity by addressing relevant issues on the European level.  
 
12.  RECALLS its Conclusions adopted on 13 February 2020 on COVID-19 that call for 
continued and increased cooperation at Union and international level2and WELCOMES 
REAFFIRMS with regard to the EU Council of 26 March 20203 the need for solidarity and 
an enhanced cooperation among Member States during the COVID-19 crisies, including joint 
efforts to address remaining bottlenecks in deliveries of medical supplies and provide mutual 
support in treating patients, and APPRECIATES important signs of solidarity and 
cooperation shown so far
 
23.  WELCOMES the proposal by the Commission for a stand-alone health programme 
EU4Health within the Multiannual Financial Framework 2021-2027 as an instrument to  
 
have a Union added value and to complement the policies of the Member States in order to 
improve human health throughout the Union. Specifically, protecting people in the 
European Union from serious cross-border threats to health and strengthening the 
responsiveness of health systems to cope with those threats 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. 
                                                 
2 
https://www.consilium.europa.eu/de/meetings/epsco/2020/02/13/  
3  
reference 
 
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34.  RECALLS the general need to enhance the Union crisis management and preparedness by 
strengthening the EU health security framework, including and the European Centre for 
Disease Prevention and Control (ECDC), the Health Security Committee (HSC) as well as 
the European Medicines Agency (EMA), and HIGHLIGHTS the need to ensure the supply of 
medicinal products in the EU, as well as the need for improvements regarding the exchange of 
comparable health data for the purposes of research, prevention, diagnostics and development 
of new treatments in line with data protection rules
 
45.  STRESSES the importance of the work carried out by the ECDC, especially in providing the 
best available knowledge, as well as by the HSC and TAKES NOTE of the measures outlined 
in the Communication on Short-term EU health preparedness for COVID-19 outbreaks4 and 
on additional COVID-19 response measures5
 
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 a curative treatment or an effective and 
safe vaccine are is key to achieve a permanent solution to deal with 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 European Union to ensure that COVID-19 vaccines are available for the population of 
the EU Member States receive a share that corresponds to their population size.  
                                                 
4 
https://ec.europa.eu/info/sites/info/files/communication_-_short-
term_eu_health_preparedness.pdf 

5  
https://ec.europa.eu/info/sites/info/files/communication-additional-covid-19-response-
measures.pdf 

 
 
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7. 
IS CONCERNED about the continuing disinformation especially in view of the 
development of a vaccine against COVID-19, and ENCOURAGES a more coordinated 
approach of the public communication about health. 
 
78.  UNDERLINES the need to further strengthen an efficient information exchange on national 
surveillance measures of the occurrence of COVID-19 infections, testing capacities and, data 
sharing and close cooperation with the ECDC and HSC to ensure prompt and efficient 
information exchange as well as in order to continue to improve the coordination thereof. 
 
89.  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, This includesing the Integrated Political Crisis Response (IPCR), the Health 
Security Committee (HSC), the Early Warning and Response System (EWRS)and the 
ECDCThe aim is in order to avoid duplication of work, also with regard to WHO's 
Regional Office for Europe and to ensure the European Union’s efficient, effective and joint 
response to the pandemic. 
 
10.   TAKES NOTE of the need for efficient and rapid cross-border contact tracing procedures 
in accordance with data security, data protection and privacy rules. 
 
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911.  CALLS UPON the Commission to assess the need for further effective contact-tracing 
mechanisms with regard to all modes of transport aimed to avert serious health threats to the 
EU citizens. This shcould include the promotion of contact tracing applications procedures 
such as digital passenger locator forms the establishment of a and in the long term 
perspective 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. A digital point of entry-platform could implement an 
integrated approach in collecting relevant data contact lists and providing 24/7 access to 
competent national health authorities. The methods of contact-tracing across borders 
should be further evaluated. [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).
 
1012. INVITES the Commission together with Member States to continue their efforts on building 
a common reserve under the EU Civil Protection mechanism, as well as the 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. 
 
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1113. 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 such 
as PPE including the joint procurement procedure (Decision 1082/2013/EU)6 and the 
Emergency Support Instrument (Regulation (EU) 2016/369)7 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.] 
 
[1214. WELCOMES TAKES NOTE of 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 , Regulation 
726/2004 (EMA) and Decision 1082/2013/EU.] 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 851/20048, Regulation 726/2004 (EMA) and Decision 
1082/2013/EU9.] 
 
                                                 
6 
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.  
7 
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. 
8 
Regulation (EC) No 851/20048 of the European Parliament and of the Council of 21 April 
2004 establishing a European centre for disease prevention and control. 
9 
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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 [1315.ENCOURAGES the Commission in collaboration with and Member States to support 
ensure the adequate equipment of the ECDC to:  
• 
establish a digital surveillance system in line with data protection rules that is linked 
with the systems of the Member States to simplify the transmission of comparable data
The ECDC offers assistance to while supporting Member States developing in the 
development of the national digital surveillance systems; 
• 
enhance modelling and forecasting capacities; 
• 
enhance its activities and cooperation with the partner institutions worldwide 
including communication and promotion abilities global visibility, cooperation and 
activities with partner institutions worldwide.] 
• 
make recommendations emitted by ECDC more policy- and action-oriented; 
• 
establish a permanent Health Task Force in the ECDC composed of several teams 
with liaison officers for technical support in the field of health security to carry out 
missions to enhance stronger cooperation on EU level and between countries in times 
of non-crisis and to support crisis management in case of serious cross-border health 
threats when multiple Member States are affected and mutual assistance is difficult. 
This support could be enhanced in light of the results of the different evaluation and 
after action reviews.] 
 
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. 
 
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[1516.INVITES ENCOURAGES Member States and the Commission to consider to develop 
strategyies that promotesing 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, to 
identify and assure the use of critical infrastructure, to enable cross border contact tracing, 
to facilitate mutual assistance in hospital care and to develop bilingual, coherent 
communications concerning all these activities. 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.] 
 
1617. CALLS UPON the Commission and Member States to conduct a Joint After Action Review 
after having overcome the COVID-19 pandemic to analyse the actions performed by all 
actors 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 public health care and treatment of patients, in particular those 
with cancer and other with communicable or non-communicable diseases such as cancer, 
and on antimicrobial resistance (AMR)
 
 
 
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Lessons learned: Ensuring the supply of medicinal products 
 
THE COUNCIL OF THE EUROPEAN UNION 
 
1718. ACKNOWLEDGES that shortages of medicinal products and Active Pharmaceutical 
Ingredients (API) in the off-patent sector and the dependency on third countries a limited 
number of third countries and on a few manufacturing sites for many products especially 
Active Pharmaceutical Ingredients (API) in the off-patent sector are issues of major 
concern, STRESSES the need to secure the EU supply and RECALLS the longstanding call 
of the Council to tackle collectively the shortages of medicinal products and UNDERLINES 
the need for action to address the threat posed to the health care systems by those shortages.  
 
19.  RECOGNIZES that shortages of medical devices and personal protective equipment also 
constituted a high threat to health care delivery at the beginning of the COVID-19-
pandemic and RECALLS that in the future medical devices and in vitro diagnostics deserve 
a specific attention given their growing interactions with medicinal products and the fact 
that no EU Agency has competences in these fields yet. 
 
20.  ACKNOWLEDGES that the Single Market for health-related crisis relevant goods has 
been under considerable strain during the COVID-19 crisis and that restrictions with a 
strong impact on the Single Market have been introduced by Member States and 
UNDERLINES the need to make sure that the temporary measures implemented because 
of the crisis do not lead to permanent distortions in the Single Market. 
 
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21.  ACKNOWLEDGES that the European Council highlighted that achieving strategic 
autonomy while preserving an open economy is a key objective of the Union and INVITES 
the Commission to follow up with priority on the invitation of the European Council of 1 
and 2 October 2020 to identify strategic dependencies, particularly in the most sensitive 
industrial ecosystems such as for health, and to propose measures to reduce these 
dependencies, including by diversifying production and supply chains, ensuring strategic 
stockpiling, as well as fostering production and investment in Europe10
 
[1822. WELCOMES that the Commission has prioritised the issue of continuous and safe supply of 
medicinal products and incorporates addressed it with concrete measures in their EU 
Pharmaceutical Strategy for Europe to increase the knowledge and identify the 
vulnerabilities of the supply chains and ensure preparedness, and resilience and security of 
supply through a holistic approach from availability to sustainability including availability, 
accessibility and affordability of medicinal products, in full respect of the principle of 
subsidiarity.
 
[1923. 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.] 
 
24.   CALLS UPON the Commission to cooperate with the Member States to develop by the end 
of the first quarter of 2021 an ambitious implementation agenda with a clear timeline and 
the necessary long-term financing to implement the concrete legislative and non-legislative 
actions that follow from the Pharmaceutical Strategy for Europe taking into account the 
following priority topics: continuous and safe supply of medicinal products, unmet medical 
needs/ orphan legislation, Advanced Therapy Medicinal Products (ATMP).] 
 
                                                 
10 European Council Conclusions on 1 and 2 October 2020 
 
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2025. RECOGNISES EXPRESSES CONCERN that many some manufacturers may lack 
competitiveness when producing their pharmaceuticals (raw materials, API, intermediates, 
finished dosage forms) inside the EU and that this is may be in part due to third countries not 
implementing comparable high EU production costs. environmental and social standards in 
the production process and at the same time RECOGNISES that in order to maintain the 
competitive advantage, the CALLS upon Member States to stand out globally as leading on 
environmental and social standards and clean and innovative production and STRESSES 
the need of EU API and pharmaceutical manufacturers need to modernise their industrial base 
and integrate new, more efficient and environmentally friendly manufacturing methods and 
technologies. CALLS UPON the Commission to UTILISE its regulatory frameworks and 
global influence to achieve a level playing field for EU companies. 
 
2126. 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 incidents could increase the risk of shortages while diversification of supply chains 
can helps to counterbalance these challenges. Furthermore, the responsibility and 
transparency of manufacturers regarding the availability and continuous supply of 
medicinal products to the market should also be considered. 
 
2227. STRESSES that continuous and safe supply of high quality medicinal products can only be 
achieved in a medium to long-term European strategy based on a multidisciplinary health 
care policy approach including actions aimed to improve transparency and quality 
inspections, diversification of supply chains, building strategic reserves at various level and 
providing a conducive environment to stimulate innovative and clean production – 
especially for API of critical medicinal products – within the EU, including simplified rules 
and procedures. providing financial incentives for maintaining, building and relocating API 
manufacturing sites in the EU. NOTES that the environmental impact and affordability of 
medicinal products remain important factors to be considered in that context. 
 
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2328. CONSIDERS that it is important to increase transparency of API manufacturing sites 
deposited in the authorisation documents - especially for API manufacturing - 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. 
 
2429. INVITES the Commission to explore the creation of data management tools and appropriate 
procedures and reinforce existing tools at EU level to collect information to better analyse 
and understand the whole supply manufacturing chain and the sources of supply and global 
manufacturing sites for API to increase transparency and visibility of both unilateral 
dependencies and critical important manufacturing sites and UNDERLINES that 
transparency is a broad instrument that can be applied throughout the complete lifecycle of 
medicinal products, thus FURTHER INVITES Member States to share available 
information and to cooperate across the product value chain. 
 
30.  CALLS UPON MEMBER STATES and the COMMISSION to strengthen collaboration 
with the European Medical Agency within existing fora to jointly work on a list of critical 
medicinal products (e.g. antimicrobial APIs, APIs for intensive care medicinal products or 
vaccines) to ensure the European Union’s strategic autonomy in the long-term. 
 
31.  INVITES the Commission and the European Medicines Agency to ensure monitoring of 
critical medicinal products during potential future health emergencies and to consolidate 
the mechanisms to prepare for and respond to health crises and monitoring and mitigating 
shortages of medicinal products. 
 
2532. UNDERLINES that improved international cooperation on inspections by the EU competent 
regulatory authorities will ensure the API quality more efficiently and continuously and thus; 
 
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2633.  INVITES the Commission to consider strengthening international cooperation by promoting 
high level standards in global cooperation for such as International Council for 
Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and 
encouraging global partners to comply with these standards and, 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. 
 
2734. INVITES Member States to reflect, where appropriate, on the adaptation of national 
regulations of procurement processes, in order to include as part of their base tender 
decisions not only on price but also and prioritiseation of suppliers a quality assessment with 
the aim to strengthen the resilience of supply for critical medicinal products while taking 
into account the sustainability of Member States’ health systems. 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. 
 
2835. INVITES the Commission to explore the possibility of facilitating the maintenance and 
relocation of API manufacturing sites for critical medicinal products in to the EU, by adapting 
and prolonging the “Temporary Framework for State aid measures to support the economy in 
the current COVID-19 outbreak” and INVITES Member States to utilise existing state aid 
frameworks. 
 
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2936. INVITES Member States and the Commission to review analyse existing and explore where 
appropriate new financial incentives and to assess administrative hurdles for critical 
medicinal products in the EU and explore mechanisms to adapt these incentives and to 
alleviate these hurdles to ensure availability of critical medicinal products while not omitting 
the pharmaceutical industry’s responsibility to ensure timely, safe and qualitative supply of 
affordable 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. 
 
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Lessons learned: Improving access to and sharing of health data 
 
THE COUNCIL OF THE EUROPEAN UNION 
 
37.  ACKNOWLEDGES that a lesson already learned from the crisis is that common rules and 
infrastructure for data sharing, as proposed in the European Health Data Space, where 
data from translational science, clinical trials and health care can inform future research 
and care, are paramount. The ongoing pandemic provides a direct demonstration of how 
data will transform health and care. Rapidly pooling and access to COVID-19 data across 
countries have played a critical role in understanding transmission and infection, 
identifying drug targets, understanding of disease and vaccine developments.   
 
3138. 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 interested member States, health care services, such 
as the interoperability framework for contact tracing and warning Applications and the EU 
gateway server. 
 
3239. ACKNOWLEDGES the high sensitivity of health data and emphasises the importance that all 
proposed actions are in full compliance with Union and Member States’ privacy and data 
protection rules, are voluntary in nature and in line with the division of competences 
between the Union and the Member States. 
 
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40.  REALIZING that data processors conducting cross-border health data analysis to fight the 
COVID-19 pandemic perceived a lack of legal clarity and certainty in health data 
processing, SUPPORTS URGES the ongoing activities of the European Data Protection 
Board (EDPB) in facilitating to develop a common understanding on the processing of health 
data between the data protection supervisory authorities, including the development of 
guidelines on ethical and legal aspects of 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)11 in the health sector. 
 
41.  WELCOMES the intention of the Commission to support 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, and 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, to foster use cases 
of health data for scientific research and to clarify the differences between sensitive health 
data and non-personal data, especially open data. 
                                                 
11 
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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3442. WELCOMES AWAITS 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. 
 
43.  RECALLS that the European Council welcomed in its special meeting on the handling of 
the COVID-19 pandemic on 1 and 2 October 2020 the creation of common European data 
spaces in strategic sectors, and in particular invited the Commission to give priority to the 
health data space, APPRECIATES that the European Commission foresees to submit by 
end of 2021 a legal proposal on the European Health Data Space, and SUPPORTS the 
digital maturity of healthcare systems, the interoperability of infrastructures and the 
standardization of health records, to allow the exchange of data and information through 
the creation of a European Health Data Space. 
 
44.  CALLS upon the European Commission, the Member States, and all relevant public and private 
stakeholders to jointly collaborate in order to deliver a functioning European Health Data Space 
that strengthens citizens’ control over their own personal health data and support the portability 
and interoperability of health data, contributes to the cross-border use and re-use of health data for 
better healthcare, better research and better policy making and regulatory activities, and NOTES 
that a working European Health Data Space can strengthen the competitiveness of EU’s industry, 
while respecting the ethical dimension of health data use, including for the use of AI in health care. 
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. 
 
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3645. 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, including measures to mitigate the COVID-19 pandemic, and 
INVITES the COMMISSION to duly consider the governance options developed by the 
Joint Action when preparing legislative and non-legislative actions on the European 
Health Data Space, in order to ensure a harmonized approach to health data processing, 
which builds upon Member States’ national regulations and principles, as well as local 
conditions, such as existing data infrastructure and national initiatives, and fully respects 
Member State competences and capacities. For sensitive personal data collected by the 
public sector, it is essential that the public authorities in Member States maintain control 
over the use of data for the purpose of data security and citizens' trust. 
 
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. 
 
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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. 
 
46.  INVITES Member States and the Commission to make use of funding opportunities linked 
to the COVID-19 pandemic, such as the Recovery and Resilience Facility, European 
Regional Development Funds, European Social Funds+, Invest EU, but also targeted EU 
programmes, such as EU4Health, Digital Europe Programme, Horizon Europe, to support 
the digital transformation of health and care. 
 
4047. ENCOURAGES the Commission to initiate and fund pilot projects on health data exchange 
in collaboration with national authorities in 2021, to set up an interoperable European 
Health Data Space infrastructure for secondary use of health data by latest 2025, and 
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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4148. RECALLING that lifestyle applications gather relevant health data, which is not yet 
accessible for healthcare purposes and for public health measures addressing COVID-19 
and other cross-border health-threats, CALLS UPON INVITES 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. as well as to establish a 
network of EU-wide accessible data sharing platforms linked to the EHDS infrastructure as 
key digital interfaces between citizens and trustworthy data users to collect shared 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 persons sharing their 
data about the progress and insights that are gained from their data. 
 
4249. 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, as well as in reducing digital divides, including 
differences regarding inter alia coverage, equipment, accessibility and literacy. 
 
4450. ENCOURAGES Member States and the Commission to continue supporting the work and 
coordination of further strengthen the eHealth Network through supporting in 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 to and also to enhance the eHealth Digital Service infrastructure (eHDSI) 
also to collaborate with the dedicated expert group on secondary health data use 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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51.  ENCOURAGES Member States and the Commission to support the work on the European 
Health Data Space in the development of a governance linking relevant authorities and 
bodies in Member States and EU level, with the aim to allow the reuse of data in research 
and policy, building a digital infrastructure for secondary use of health data, supporting 
cross-country data driven collaboration, informed by related pilot project activities. 
 
4552. INVITES Member States and the Commission to encourage new countries to participate in 
the EU gateway server for contact tracing and warning mobile applications in order to 
strengthen the capacity of Member States to contain the spread of the pandemic 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 
Aapplications 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 
 
[4653. WELCOMES and REAFFIRMS RECALLS 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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