Council of the
European Union
Brussels, 11 November 2020
(OR. en)
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NOTE
From:
General Secretariat of the Council
To:
Working Party on Public Health
Subject:
Draft Council conclusions on COVID-19 lessons learned in health
Delegations will find 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 Organi
zsation (WHO) on 30 January 2020
1.
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 level
2, and 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 cris
ies, 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 outbreaks
4 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 includ
esing the Integrated Political Crisis Response (IPCR), the Health
Security Committee (HSC), the Early Warning and Response System (EWRS)
, and the
ECDC
. ,
The 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 sh
could 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 851/2004
8, Regulation 726/2004 (EMA) and Decision
1082/2013/EU
9.]
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 851/2004
8 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 a
strategy
ies that promotes
ing 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 pharmaceutical
s (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 the
ir 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 prioritise
ation 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
A
applications and to set up an EU gateway server, which could become an important tool to
demonstrate the value and necessity of cross-border exchange of health data in response to the
pandemic.
Lessons learned: Strengthening the EU’s role in global health
THE COUNCIL OF THE EUROPEAN UNION
[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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