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Council of the 
 
 

 European Union 
   
 
Brussels, 27 November 2020 
(OR. en) 
    11528/2/20 
REV 2 
 
 
 
LIMITE 

 
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 second 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 after the VTC meeting of the members of the Working Party on Public Health on 
13 November 2020. 
* * * 
Changes to the text in document 11528/1/20 REV 1 are indicated as follows: 
Bold italics = new text 
strikethrough = deleted text 
The text that was set out in bold italics in document 11528/1/20 REV 1 is now presented in normal 
characters and the text that was stricken through is now deleted.  
 
 
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ANNEX 
Draft Council conclusions 
on COVID-19 lessons learned in health 
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  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 Organization (WHO) on 30 January 20201
Being aware that While the epidemiological situation is still evolving and is likely to continue to do 
will  so  be,  until  a  high  large  percentage  of  the  world  population  has  acquired  immunity,  is 
vaccinated, immunized or can be treated adequatelythe European Union, its Member States and its 
citizens  need  to  be  prepared  for  the  future.  The  challenges  which  we  currently  face  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 current crisis and jointly drawing the right consequences are is and 
will be an important steps 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 wide 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 and medical countermeasures in general, improving access to and sharing 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 other patients, inter alia those 
with cancer and other non-communicable diseasesdue to either the measures in place to tackle the 
pandemic or due to the impact of these measures in place to tackle the pandemic
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  the  European 
Iinstitutions  need  to  jointly  enhance  their  capabilities,  both  to  ensure  they  capacity  to  can  act 
effectively in the event of health emergencies and to work towards achieving European autonomy in 
strategic areas while preserving an open economy. 
 
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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 has highlighted the added 
value of and need for solidarity by in the form of addressing relevant issues on the European 
level.  
2. 
RECALLS its conclusions Conclusions adopted on of 13 February 2020 on COVID-19
which that called for continued and increased cooperation at Union and international level2
REAFFIRMS with regard reference to the statement of the members of the EU Council of 26 
March 20203 the need for an enhanced cooperation among Member States during the COVID-
19 crisis, including joint efforts to address remaining bottlenecks in deliveries of medical 
supplies and provide mutual support in treating patientsand APPRECIATES important signs 
of the considerable solidarity and cooperation shown so far. 
3. 
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 
provide Union added value and to complement the policies of the Member States in order to 
improve human health throughout the Union.  Specifically, in particular to protecting 
people in the European Union from serious cross-border threats to health and supporting the 
strengthening and the responsiveness of health systems to cope with those threats and taking 
into account the results of the European Council of 21 July 20204
4. 
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, the European 
Regional Development Fund, the European Social Fund+, Invest EU, as well as targeted 
EU programmes, such as EU4Health, the Digital Europe Programme and Horizon Europe, 
to support the necessary transformation of health and care, including digital health. 
                                                 
2 
https://www.consilium.europa.eu/de/meetings/epsco/2020/02/13/  
3 
https://www.consilium.europa.eu/media/43076/26-vc-euco-statement-en.pdf 
4 
https://www.consilium.europa.eu/media/45109/210720-euco-final-conclusions-en.pdf 
 
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5. 
RECALLS TAKES NOTE of the general need to enhance the Union's crisis management and 
preparedness by strengthening the EU health security frameworkincluding the European 
Centre for Disease Prevention and Control (ECDC), the Health Security Committee (HSC) as 
well as and the European Medicines Agency (EMA) and the Integrated Political Crisis 
Response (IPCR), and HIGHLIGHTS the need to ensure the supply of medicinal products 
medical countermeasures in the EU, as well as the need for further expert discussion on the 
necessary improvements regarding the exchange of comparable health data for the purposes 
of research, prevention, diagnostics and development of new treatments in line while 
complying with data protection rules. 
6. 
STRESSES the importance of the work carried out by the ECDCespecially in providing the 
best available knowledge, as well as by the HSC and IPCR, and TAKES NOTE of the 
measures outlined in the Communication on Short-term EU health preparedness for COVID-
19 outbreaks5 and on additional COVID-19 response measures6
7. 
STRESSES that the development and deployment of rapid and reliable diagnosis, a curative 
treatment or an effective and safe vaccine are key to deal coping with the pandemic. 
Furthermore STRESSES the importance of ensuring fair, equitable, transparent and global 
access to COVID-19 vaccines and to of supporting efforts for a fair and transparent process 
within the European Union to ensure that COVID-19 vaccines are available for the 
populations of the EU Member States. 
8. 
IS CONCERNED about the continuing issue of disinformation, especially in view of 
connection with the existence of the virus, the use of masks and the development of a 
vaccine against COVID-19, and ENCOURAGES a more coordinated approach to of the 
public communication about health taking into account national competencies and contexts
                                                 
5 
https://ec.europa.eu/info/sites/info/files/communication_-_short-
term_eu_health_preparedness.pdf 

6  
https://ec.europa.eu/info/sites/info/files/communication-additional-covid-19-response-
measures.pdf 

 
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9. 
UNDERLINES the need to further strengthen an efficient information exchange on national 
surveillance measures, and on testing capacities and, as well as the need to enhance data 
sharing on agreed indicators with the ECDC, and HSC and IPCR in order to continue to 
improve the coordination thereof. 
10.  CALLS UPON Member States and the Commission to cooperate within their respective 
competences with the aim to of facilitateing and fostering cross-sectoral information-sharing 
between Member States and within relevant fora involved in the European Union’s crisis 
management. This includes Such fora are the Integrated Political Crisis Response (IPCR), the 
Health Security Committee (HSC), the Early Warning and Response System (EWRS), and 
the ECDC. The aim is to avoid duplication of work, also with regard to WHO's Regional 
Office for Europe and to ensure the European Union’s an efficient, effective and joint 
response to the pandemic by the European Union - also with regard to the cooperation with 
WHO's Regional Office for Europe
11.  TAKES NOTE of the need for efficient, secure and rapid cross-border contact-tracing 
procedures in accordance with data security, data protection and privacy rules. 
 
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12.  CALLS UPON the Commission to assess the need for further effective contact-tracing 
mechanisms with regard to all modes of transport, aimed to at averting serious health threats 
to the EU citizens. This could include the promotion of contact-tracing procedures such as 
digital passenger locator forms and, in the long term-perspective, a digital single point of 
entry platform working across all interested Member States 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 to in collecting relevant data contact lists and providing 24/7 access to 
competent national health authorities within 24/7 access. The methods of contact-tracing 
across borders and their impact should be further evaluated. [Further consideration is needed 
to avoid double reporting and administrative burden.  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).] 
13.  INVITES the Commission together with Member States to continue their efforts on to 
building a common European reserve of resources under the EU Civil Protection 
Mmechanism, and INVITES Member States as well as the Member States to share 
experiences and to coordinate their efforts, where relevant, when building national reserves 
and stockpiles for crisis-relevant goods to avoid competition.  
 
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14.  INVITES the Commission to evaluate the situation and reportwithin the first half of 2021, 
on the deployment of different mechanisms for of emergency support and for the procurement 
of medical countermeasures such as personal protective equipment (PPE), including the joint 
procurement procedure (Decision 1082/2013/EU)and the Emergency Support Instrument 
(Regulation (EU) 2016/369)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 countermeasures during a crisis which 
are of additional value to the national structures and procurements.] 
15.  RECALLS the lessons learned of the first wave of the COVID-19 pandemic such as with 
regard to the difficulties of fast submission of comparable data to ECDC within the 
surveillance system, the challenge to develop forecasts based on common modelling 
activities and indicators, the quick translation of changing scientific evidence and 
knowledge in policy- and action-oriented language, the difficulties to understand different 
health systems and their respective needs and approaches to crisis management, difficult 
mutual assistance when multiple Member States are affected and the situation of people 
living and commuting in border regions and facing different non-pharmaceutical public 
health measures and border controls that affected their daily life. 
16.  TAKES NOTE of the legislative proposals for a long-term EU health security framework 
preparedness measures with a view regard to strengthening the ECDC, the EMA and health 
security crisis management through revising reforming Regulation (EC) No 851/2004
(ECDC) and Decision 1082/2013/EU10 and supplementing , Regulation 726/200411 (EMA)
                                                 
7 
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.  
8 
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. 
9  
doc. 12972/20 
10  
doc. 12973/20 + ADD 1 
11  
doc. 12971/20 
 
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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.] 
[1516.INVITES ENCOURAGES Member States and the Commission to consider to develop a 
strategies that promoting 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.] 
 
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17.  CALLS UPON the Commission and Member States to conduct a Joint After Action Review 
after having overcome the COVID-19 pandemic has been overcome, in order to analyse the 
actions performed by all EU institutional actors and the need for additional actions in 
additional areas for future to improvement of the EU's crisis preparedness and ability to 
respondse to future health threats, avoiding duplication with other ongoing reviews. This 
should also include a study of on the effects of the COVID-19 pandemic on public health and 
on treatment of patients, with communicable or non-communicable diseases such as cancer, 
and on antimicrobial resistance (AMR). 
Lessons learned: Ensuring the supply of medicinal products 
THE COUNCIL OF THE EUROPEAN UNION 
18.  ACKNOWLEDGES that shortages of medicinal products and the dependency on a limited 
number of third countries and on a few manufacturing sites for many products, especially 
such as Aactive Ppharmaceutical Iingredients (APIs), in the off-patent sector are issues of 
major concern, STRESSES the need to secure the EU supply, and RECALLS the Council's 
longstanding call of the Council to tackle collectively the for shortages of medicinal products 
to be tackled collectively and UNDERLINES the need for evidence-based action to address 
the threat posed to the health care systems by those shortages. 
19.  RECOGNIZSES that shortages of medical devices and PPE 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 medical 
devices deserve a specific attention given their growing interactions with medicinal products 
and the fact that no EU Agency has competences in these fields yet. 
 
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20.  ACKNOWLEDGES that the Single Mmarket 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 Internal 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 lasting permanent distortions in the Single Internal Market. 
21.  ACKNOWLEDGES that the European Council has 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 as a 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 and fostering production and investment in Europe12
[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.] 
                                                 
12  
https://www.consilium.europa.eu/media/45910/021020-euco-final-conclusions.pdf 
 
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22.  TAKES NOTE of the Pharmaceutical Strategy for Europe13, adopted by the Commission 
and 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).] 
23.  EXPRESSES CONCERN that some manufacturers may lack competitiveness when 
producing pharmaceuticals (raw materials, APIs, intermediates, finished products dosage 
forms) inside the EU and that this may be due in part due to high EU production costs. 
CALLS upon Member States to stand out as globally as leadingers on environmental and 
social standards and clean and innovative production, and STRESSES the need of for EU 
APIs and pharmaceutical manufacturers to modernise their industrial base and integrate new, 
cost-effective, 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. 
24.  ACKNOWLEDGES that the availability of medicinal products is linked with the quality of 
APIs and raw materials and RECOGNISES that quality issues and industrial incidents could 
increase the risk of shortages while diversification of diversifying supply chains can help to 
counterbalance these challenges. Furthermore, the responsibility role and transparency of 
manufacturers with regarding to the availability and continuous and adequate supply of 
medicinal products to Member States' the markets should also be strengthened considered. 
                                                 
13  
doc. 13158/20 + ADD 1  
 
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25.  STRESSES that continuous and safe supply of high quality medicinal products can only be 
achieved within in a medium- to long-term European strategy based on a multidisciplinary 
approach to health care policy approach including actions aimed to at improve improving 
transparency and quality inspections, diversification of supply chains, building strategic 
reserves at various levels in the supply chain and providing an conducive environment which 
is conducive to stimulateing innovative and clean production – especially such as for of APIs 
of for critical medicinal products – within the EU, including simplified rules and procedures. 
NOTES that the environmental impact and ensuring the affordability of medicinal products 
and reducing the environmental impact remain important factors to be considered in that 
context. 
26.  CONSIDERS that in order to tackle shortages, it is important to increase cooperation 
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 at addressing 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.; the information exchange includes relevant information on the APIs 
manufacturing sites submitted by the manufacturing authorisation holder. 
27.  INVITES the Commission to explore the creation of data management tools and appropriate 
procedures and to reinforce existing EU level tools in order at EU level to collect information 
to better analyse and understand on the whole supply chain such as and the sources of supply, 
and global manufacturing sites for APIs and other pharmaceutical substances. This serves to 
increase transparency and visibility of both unilateral dependencies and critical manufacturing 
sites; and UNDERLINES that increasing transparency is a broad instrument that can be 
applied throughout the complete lifecycle of medicinal products is important, thus and 
therefore FURTHER INVITES Member States to share available information and to 
cooperate, where appropriate, across the product value chain., keeping in mind not to place 
unnecessary burden on the industry.  
 
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28.  CALLS UPON Member States MEMBER STATES and the Commission 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. 
29.  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, including by and monitoring and 
mitigating shortages of medicinal products. 
30.  UNDERLINES that improved international cooperation on inspections by the EU competent 
regulatory authorities regarding inspections will ensure enable more efficient and 
continuous the API assurance quality more efficiently and continuously and thus; 
31.  INVITES the Commission to consider strengthening international cooperation by promoting 
high level standards in global cooperation, for such as the guidelines established by the 
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for 
Human Use (ICH)14 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)15 and the Pharmaceutical Inspection Co-operation 
Scheme (PIC/S)16 authorities, and to assess 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. 
                                                 
14  
https://www.ich.org/ 
15  
https://www.edqm.eu/ 
16  
https://picscheme.org/en/picscheme 
 
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32.  NOTES that Member States can adapt to reflect, where appropriate, on the adaptation of 
national regulations of procurement processes, in order to strengthen the resilience of supply 
for critical medicinal products, while also noting that this is an area of national 
competence and taking into account the financial sustainability of Member States' health 
systems. 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. 
33.  INVITES the Commission to explore the all possibilityies of facilitating the maintenance in 
the EU and the relocation to the EU 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. 
34.  INVITES Member States and the Commission to analyse existing and to explore, where 
appropriate, new financial incentives and to assess administrative hurdles regulatory 
requirements for critical medicinal products in the EU and to explore mechanisms to adapt 
these incentives and to alleviate these hurdles  requirements to ensure availability of critical 
medicinal products while not omitting bearing in mind the pharmaceutical industry’s 
responsibility role to ensure timely, safe and qualitative supply of affordable medicinal 
products to the European Member States' markets and to prevent the withdrawal of old and 
effective critical medicinal products from the market. 
35.  INVITES the Commission to explore possibilities to use the EU science hub for research 
needs in case of public health crisis. 
 
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Lessons learned: Improving access to and sharing of health data 
THE COUNCIL OF THE EUROPEAN UNION 
36.  ACKNOWLEDGES that a one lesson already learned from the crisis is that common rules 
and infrastructure for data sharing, as proposed as part of in the European Health Data Space 
(EHDS), 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 of and access to 
COVID-19 data across countries have played a critical role in understanding transmission and 
infection, identifying drug targets, and understanding of disease and vaccine developments. 
37.  NOTES that the COVID-19 pandemic has demonstrated that aggregated health data can 
strengthen infectious disease surveillance and initiate joint activities measures to address 
communicable and non-communicable diseases, e. g. through common initiatives like the 
Lean European Open Survey on SARS-CoV-2 (LEOSS) project17, and has triggered further 
cross-border cooperation between interested member Member States, health care services, 
such as the interoperability framework for contact tracing and warning Aapplications and the 
EU gateway server. 
38.  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 are in line with the division of competences 
between the Union and the Member States. 
                                                 
17  
https://leoss.net/ 
 
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39.  REALIZSING that data controllers and processors conducting analysing cross-border health 
data analysis to fight the COVID-19 pandemic perceived have noted a lack of legal clarity 
and certainty as regards in health data processing, URGES the European Data Protection 
Board (EDPB) to develop a common understanding of on the processing of health data 
between by 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 to reaching consensus on the application of the General Data 
Protection Regulation (GDPR)18 in the health sector. 
40.  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 aArticle 40 of the GDPR, and INVITES Member 
States to cooperate on at bilateral and multilateral levels to reduce differences in the 
interpretation and application of the GDPR in the health sector 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. 
41.  AWAITS the report "Assessment of the Member States’ rules on health data in the light of 
the GDPR 2019/2020commissioned by the Commission and its the recommendations based 
on extensive surveys and five workshops 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. 
                                                 
18 
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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42.  RECALLS that the European Council welcomed in at 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, SUPPORTS measures aiming at increasing the digital maturity of 
healthcare systems, the interoperability of infrastructures and the standardisation of health 
records, to allow the access and exchange of data and information through an EHDS, and 
APPRECIATES NOTES that the European Commission's foresees plans to submit, by the 
end of 2021, a legal proposal on the EHDSEuropean 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. 
43.  CALLS upon the European Commission, the Member States, and all relevant public and 
private stakeholders to jointly collaborate in order to deliver a functioning EHDS European 
Health Data Space that strengthens citizens’ control over their own personal health data, and 
supports the portability, cybersecurity and interoperability of health data, and 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 EHDS European Health 
Data Space can could strengthen the competitiveness of EU’s industry, while respecting the 
ethical dimension of health data use, including for in connection with the use of AI in health 
care. 
 
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44.  WELCOMES the close cooperation between Member States and the Commission in preparing 
the Joint Action for the EHDS European Health Data Space "Towards the European Health 
Data Space”, so as to ensure continuity in the development of a governance strategy for the 
secondary use of health data at European level and in facilitating access to and exchange of 
health data through concrete use-cases, including measures to mitigate the COVID-19 
pandemic, and INVITES the Commission COMMISSION to duly consider the governance 
options developed by the Joint Action when preparing legislative and non-legislative actions 
measures in connection with on the EHDS European Health Data Space, in order to ensure a 
harmoniszed approach to health data processing, which builds upon Member States’ national 
regulations and principles, as well as upon 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 to 
guarantee data security and citizens' public trust. 
45.  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 EHDS European 
Health Data Space infrastructure for secondary use of health data by latest 2025 at the latest
and 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, and where European exchange of health data is 
necessary and appropriate, e. g. for the management of severe COVID-19 cases. 
 
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46.  RECALLING that lifestyle applications can 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, INVITES Member States and the Commission to develop a 
shared European management model for the processing of person-generated health data, to
where appropriate, complement electronic health records based on individual informed 
consent as well as to establish a network of EU-wide accessible data sharing platforms 
accessible across the EU and linked to the EHDS infrastructure to serve as key digital 
interfaces between citizens members of the General Public and trustworthy data users to 
collect shared data, based on their informed consent and facilitating access to personal data in 
line with the GDPR, and generating anonymiszed and aggregated data from which both, 
scientific insights to improve our scientific 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 made and insights that are 
gained by using from their data. 
47.  URGES Member States and the Commission to join forces in promoting strengthening data- 
and digital- and data-related skills to empower 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. 
48.  ENCOURAGES Member States and the Commission to continue supporting the work and 
coordination of the eHealth Network in its efforts to establish 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), and also to collaborate with the dedicated expert group on secondary 
health data use in the EHDS. 
 
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49.  ENCOURAGES Member States and the Commission to support the work under way in the 
context of a secure and trusted EHDS on the European Health Data Space in the 
development of to develop a governance framework linking relevant authorities and bodies in 
Member States and at EU level, with the aim to of allowing the reuse of data in research and 
policy, building a digital infrastructure for secondary use of health data, and supporting cross-
country data-driven international collaboration, informed by related pilot project activities. 
50.  INVITES Member States and the Commission to encourage interested new countries to 
participate in the EU gateway server for contact tracing and warning mobile applications in 
order to where this could strengthen the  Member States' 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 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 relevant data in response to the pandemic. Further INVITES Member States, 
the Commission and the ECDC to work together on better alignment of epidemiological 
datasets for surveillance
Lessons learned: Strengthening the EU’s role in global health 
THE COUNCIL OF THE EUROPEAN UNION 
51.  RECALLS the adoption of the Cconclusions adopted by the Council and the Representatives 
of the gGovernments of the Member States on the role of the EU in strengthening the WHO 
as the leading and coordinating authority19 in on global health. 
 
                                                 
19 
OJ C 400, 24.11.2020, p.1. 
 
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