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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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 2020
1.
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 adequately
, the 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 step
s 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 diseases
, due 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
I
institutions need to jointly enhance their capabilities
, both to ensure the
y 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 call
ed for continued and increased cooperation at Union and international level
2,
REAFFIRMS with regard
reference to the
statement of the members of the EU Council of 26
March 2020
3 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 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
a
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 2020
4.
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 framework
, including 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 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 outbreaks
5 and on additional COVID-19 response measures
6.
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 support
ing efforts for a fair and transparent process
within the European Union to ensure that COVID-19 vaccines are available for the
population
s 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 facilitate
ing and foster
ing 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 avert
ing 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 report
, within 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)
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 within the first half of 2021 [and, based thereon, to develop clear
, fast and
efficient mechanisms for the procurement of medical countermeasure
s 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
9
(ECDC) and Decision 1082/2013/EU10 and supplementing , Regulation 726/2004
11 (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
respon
dse 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 A
active P
pharmaceutical I
ingredients (API
s)
, 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. RECOGNIZ
SES 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 M
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
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 Europe
12.
[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, API
s, 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 leading
ers on environmental and
social standards and clean and innovative production
, and STRESSES the need of
for EU
API
s 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
API
s 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 market
s 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 level
s in the supply chain and providing a
n conducive environment
which
is conducive to stimulate
ing innovative and clean production – especially
such as for
of API
s
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 address
ing 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 API
s 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
possibility
ies 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' market
s 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) project
17, 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 A
applications 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. REALI
ZSING 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
a 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 a
Article 40 of the GDPR, and INVITES Member
States to cooperate on
at bilateral and multilateral level
s 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 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
EHDS. 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.
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
support
s 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
harmoni
szed 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 anonymi
szed 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 allow
ing 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 C
conclusions
adopted by the Council and the Representatives
of the g
Governments of the Member States on the role of the EU in strengthening the WHO
as the leading and coordinating authority
19 in
on global health.
19
OJ C 400, 24.11.2020, p.1.
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