Ceci est une version HTML d'une pièce jointe de la demande d'accès à l'information 'Working Party on Public Health'.


 
  
 
 
 

Council of the 
 
 

 European Union 
   
 
Brussels, 18 December 2020 
(OR. en) 
    14196/20 
 
 
 
 
 
 
SAN 485 

PHARM 74 
 
 
MI 587 
IPCR 51 
COVID-19 64 
 
OUTCOME OF PROCEEDINGS 
From: 
General Secretariat of the Council 
To: 
Delegations 
No. prev. doc.: 
13552/20 SAN 438 PHARM 64 MI 540 IPCR 42 COVID-19 45 + COR 1 
Subject: 
Council conclusions on COVID-19 lessons learned in health 
 
 
Delegations will find in the annex the Council conclusions on COVID-19 lessons learned in health, 
approved through a written procedure completed on 17 December 2020. 
 
 
14196/20  
 
ACZ+MAV/ads 

 
LIFE.4 
 
EN 
 

  
ANNEX 
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. It still remains a Public Health Emergency of 
International Concern, declared by the World Health Organization (WHO) on 30 January 20201
While the epidemiological situation is still evolving and is likely to continue to do so, until a large 
percentage  of  the  world  population  has  acquired  immunity,  is  vaccinated,  or  can  be  treated 
adequately, the European Union, its Member States and its citizens need to prepare for the future. 
The challenges which we currently face can only be effectively tackled together. This requires close 
collaboration  and  coordination  between  Member  States,  the  institutions  of  the  European  Union, 
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) 

 
14196/20  
 
ACZ+MAV/ads 

ANNEX 
LIFE.4 
 
EN 
 

  
Learning lessons from the current crisis and jointly drawing the right consequences are and will be 
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 
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 diseases, due to the impact of 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 institutions 
need to jointly enhance their capabilities, both to ensure they can act effectively in the event of 
health emergencies and to work towards achieving European autonomy in strategic areas while 
preserving an open economy. 
 
14196/20  
 
ACZ+MAV/ads 

ANNEX 
LIFE.4 
 
EN 
 

  
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 in the form of addressing relevant issues on the European 
level. 
2. 
RECALLS its conclusions of 13 February 2020 on COVID-19, which called for continued 
and increased cooperation at Union and international level2, REAFFIRMS with 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 patients, and APPRECIATES 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 
provide Union added value and to complement the policies of the Member States in order to 
improve human health throughout the Union, in particular to protect 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
                                                 
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 
 
14196/20  
 
ACZ+MAV/ads 

ANNEX 
LIFE.4 
 
EN 
 

  
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. 
5. 
TAKES NOTE of the general need to enhance the Union's crisis management and 
preparedness by strengthening the EU health security framework, including the European 
Centre for Disease Prevention and Control (ECDC), the Health Security Committee (HSC) 
and the European Medicines Agency (EMA) and the Integrated Political Crisis Response 
(IPCR), and HIGHLIGHTS the need to ensure the supply of 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 while complying with data protection rules. 
6. 
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 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 coping with the pandemic. Furthermore 
STRESSES the importance of ensuring fair, equitable, transparent and global access to 
COVID-19 vaccines and 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. 
                                                 
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 

 
14196/20  
 
ACZ+MAV/ads 

ANNEX 
LIFE.4 
 
EN 
 

  
8. 
IS CONCERNED about the continuing issue of disinformation, especially in 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 public communication about health 
taking into account national competencies and contexts. 
9. 
UNDERLINES the need to further strengthen efficient information exchange on national 
surveillance measures, and on testing capacities as well as the need to enhance data sharing on 
agreed indicators with the ECDC, HSC and IPCR in order to continue to improve the 
coordination of their activities in this field. 
10.  CALLS UPON Member States and the Commission to cooperate within their respective 
competences with the aim of facilitating and fostering cross-sectoral information-sharing 
between Member States and within relevant fora involved in the European Union’s crisis 
management. Such fora are IPCR, the HSC, the Early Warning and Response System 
(EWRS), and the ECDC. The aim is to avoid duplication of work and to ensure 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. 
 
14196/20  
 
ACZ+MAV/ads 

ANNEX 
LIFE.4 
 
EN 
 

  
12.  CALLS UPON the Commission to assess the need for further effective contact-tracing 
mechanisms with regard to all modes of transport, aimed at averting serious health threats to 
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 single point of entry platform could implement an integrated 
approach to collecting relevant contact data lists and providing competent national health 
authorities with 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. 
13.  INVITES the Commission together with Member States to continue their efforts to build a 
European reserve of resources and INVITES 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. 
14.  INVITES the Commission to evaluate the situation and report, within the first half of 2021, on 
the deployment of different mechanisms for emergency support and for the procurement of 
medical countermeasures such as personal protective equipment (PPE), including the joint 
procurement procedure (Decision 1082/2013/EU)7 and the Emergency Support Instrument 
(Regulation (EU) 2016/369)8 with respect to, inter alia, governance structure, transparency, 
information exchange between the Commission and Member States, and interfaces of these 
instruments 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. 
                                                 
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. 
 
14196/20  
 
ACZ+MAV/ads 

ANNEX 
LIFE.4 
 
EN 
 

  
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 with 
a view to strengthening the ECDC, the EMA and health security crisis management through 
revising Regulation (EC) No 851/20049 (ECDC) and Decision 1082/2013/EU10 and 
supplementing Regulation 726/200411 (EMA). 
17.  CALLS UPON the Commission and Member States to conduct a Joint After Action Review 
after 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 to improve the EU's crisis 
preparedness and ability to respond to future health threats, avoiding duplication with other 
ongoing reviews. This should also include a study of 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). 
                                                 
9 
doc. 12972/20 
10 
doc. 12973/20 + ADD 1 
11 
doc. 12971/20 
 
14196/20  
 
ACZ+MAV/ads 

ANNEX 
LIFE.4 
 
EN 
 

  
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 manufacturing sites for many products, such as active 
pharmaceutical ingredients (APIs), in the off-patent sector are of major concern, STRESSES 
the need to secure the EU supply, RECALLS the Council's longstanding call for shortages of 
medicinal products to be tackled collectively and UNDERLINES the need for evidence-based 
action to address the threat posed to health care systems by those shortages. 
19.  RECOGNISES that shortages of medical devices and PPE 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 diagnostic medical devices deserve attention. 
20.  ACKNOWLEDGES that the 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 Internal Market have been introduced by Member States, and UNDERLINES the need to 
make sure that measures implemented because of the crisis do not lead to lasting distortions in 
the 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, 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, and 
fostering production and investment in Europe12
                                                 
12 
https://www.consilium.europa.eu/media/45910/021020-euco-final-conclusions.pdf 
 
14196/20  
 
ACZ+MAV/ads 

ANNEX 
LIFE.4 
 
EN 
 

  
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 an ambitious 
implementation agenda with a clear timeline and the necessary long-term financing to 
implement concrete actions that follow from the Pharmaceutical Strategy for Europe. 
23.  EXPRESSES CONCERN that some manufacturers may lack competitiveness when 
producing pharmaceuticals (raw materials, APIs, intermediates, finished products) inside the 
EU and that this may be due in part to high EU production costs. CALLS upon Member 
States to stand out as global leaders on environmental and social standards and clean and 
innovative production, and STRESSES the need 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 diversifying supply chains can help to counterbalance 
these challenges. Furthermore, the role of manufacturers with regard to the availability and 
continuous and adequate supply of medicinal products to Member States' markets should be 
strengthened. 
                                                 
13 
doc. 13158/20 + ADD 1 
 
14196/20  
 
ACZ+MAV/ads 
10 
ANNEX 
LIFE.4 
 
EN 
 

  
25.  STRESSES that continuous and safe supply of high quality medicinal products can only be 
achieved within a medium- to long-term European strategy based on a multidisciplinary 
approach to health care policy including actions aimed at improving transparency and quality 
inspections, diversification of supply chains, building strategic reserves at various levels in 
the supply chain and providing an environment which is conducive to stimulating innovative 
and clean production –such as of APIs for critical medicinal products – within the EU, 
including simplified rules and procedures. NOTES that 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 and 
continuous information exchange at Union level, in particular through and within existing fora 
aimed at addressing 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 to collect information on the 
whole supply chain such as sources of supply, global manufacturing sites for APIs and other 
pharmaceutical substances. This serves to increase transparency and visibility of both 
unilateral dependencies and critical manufacturing sites; UNDERLINES that increasing 
transparency throughout the lifecycle of medicinal products is important, 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. 
 
14196/20  
 
ACZ+MAV/ads 
11 
ANNEX 
LIFE.4 
 
EN 
 

  
28.  CALLS UPON Member States and the Commission 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 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 monitoring and mitigating shortages of medicinal 
products. 
30.  UNDERLINES that improved international cooperation by EU competent authorities will 
enable more efficient inspections and thus ensure continuous API quality. 
31.  INVITES the Commission to consider strengthening international cooperation by promoting 
high level standards in global cooperation, 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. 
32.  NOTES that Member States can adapt 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. 
                                                 
14 
https://www.ich.org/ 
15 
https://www.edqm.eu/ 
16 
https://picscheme.org/en/picscheme 
 
14196/20  
 
ACZ+MAV/ads 
12 
ANNEX 
LIFE.4 
 
EN 
 

  
33.  INVITES the Commission to explore possibilities of facilitating the maintenance in the EU 
and the relocation to the EU of API manufacturing sites for critical medicinal products. 
34.  INVITES Member States and the Commission to analyse existing and to explore, where 
appropriate, new incentives and to assess regulatory requirements for critical medicinal 
products in the EU and to explore mechanisms to adapt these incentives and alleviate these 
requirements to ensure availability of critical medicinal products while bearing in mind the 
pharmaceutical industry’s role to ensure timely, safe and qualitative supply of affordable 
medicinal products to 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. 
Lessons learned: Improving access to and sharing of health data 
THE COUNCIL OF THE EUROPEAN UNION 
36.  ACKNOWLEDGES that one lesson already learned from the crisis is that common rules and 
infrastructure for data sharing, as proposed as part of 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. Rapid 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 disease and vaccine developments. 
 
14196/20  
 
ACZ+MAV/ads 
13 
ANNEX 
LIFE.4 
 
EN 
 

  
37.  NOTES that the COVID-19 pandemic has demonstrated that aggregated health data can 
strengthen infectious disease surveillance and initiate joint 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 States, such as the interoperability framework for 
contact tracing and warning applications and the EU gateway server. 
38.  ACKNOWLEDGES the 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. 
39.  REALISING that data controllers and processors analysing cross-border health data to fight 
the COVID-19 pandemic have noted a lack of legal clarity and certainty as regards health data 
processing, URGES the European Data Protection Board (EDPB) to develop a common 
understanding of the processing of health data 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 and CALLS FOR the EDPB to reach a consensus on the 
application of the General Data Protection Regulation (GDPR)18 in the health sector. 
                                                 
17 
https://leoss.net/ 
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). 
 
14196/20  
 
ACZ+MAV/ads 
14 
ANNEX 
LIFE.4 
 
EN 
 

  
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 Article 40 of the GDPR, and INVITES Member 
States to cooperate 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 2019/2020" commissioned by the Commission and its 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. 
42.  RECALLS that the European Council welcomed 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 NOTES that the 
European Commission's plans to submit, by the end of 2021, a legal proposal on the EHDS. 
 
14196/20  
 
ACZ+MAV/ads 
15 
ANNEX 
LIFE.4 
 
EN 
 

  
43.  CALLS upon the Commission, the Member States, and all relevant public and private 
stakeholders to collaborate in order to deliver a functioning EHDS that strengthens citizens’ 
control over their own personal health data, 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 could strengthen the competitiveness of EU industry, while 
respecting the ethical dimension of health data use, including in connection with the use of AI 
in health care. 
44.  WELCOMES the close cooperation between Member States and the Commission in preparing 
the Joint Action for the EHDS "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 to duly consider the governance options developed by the Joint Action when 
preparing legislative and non-legislative measures in connection with the EHDS, in order to 
ensure a harmonised 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 to guarantee data 
security and public trust. 
 
14196/20  
 
ACZ+MAV/ads 
16 
ANNEX 
LIFE.4 
 
EN 
 

  
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 infrastructure 
for secondary use of health data by 2025 at the latest, and to facilitate 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. 
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 data sharing platforms accessible across the EU 
and linked to the EHDS infrastructure to serve as key digital interfaces between 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 
anonymised and aggregated data from which both, insights to improve 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 gained by using their data. 
47.  URGES Member States and the Commission to join forces in promoting digital- and data-
related skills to empower 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. 
 
14196/20  
 
ACZ+MAV/ads 
17 
ANNEX 
LIFE.4 
 
EN 
 

  
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 and 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. 
49.  ENCOURAGES Member States and the Commission to support work under way in the 
context of a secure and trusted EHDS to develop a governance framework linking relevant 
authorities and bodies in Member States and at EU level, with the aim of allowing the reuse of 
data in research and policy, building a digital infrastructure for secondary use of health data, 
and supporting data-driven international collaboration informed by related pilot project 
activities. 
50.  INVITES interested new countries to participate in the EU gateway server for contact tracing 
and warning mobile applications where this could strengthen Member States' capacity 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. 
 
14196/20  
 
ACZ+MAV/ads 
18 
ANNEX 
LIFE.4 
 
EN 
 

  
Lessons learned: Strengthening the EU’s role in global health 
THE COUNCIL OF THE EUROPEAN UNION 
51.  RECALLS the conclusions adopted 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 authority19 on global health. 
 
                                                 
19 
OJ C 400, 24.11.2020, p.1. 
 
14196/20  
 
ACZ+MAV/ads 
19 
ANNEX 
LIFE.4 
 
EN