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EPF Regional Advocacy Seminar Budapest, 26 October 2010. Patients’ Involvement in EU-level Health Policy Kaisa Immonen-Charalambous, EPF Policy Officer. The Presentation. Overview of the EU’s main institutions EU activities in the field of health

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Epf regional advocacy seminar budapest 26 october 2010

EPF Regional Advocacy Seminar

Budapest, 26 October 2010

Patients’ Involvement

in EU-level Health Policy

Kaisa Immonen-Charalambous, EPF Policy Officer

The presentation
The Presentation

  • Overview of the EU’s main institutions

  • EU activities in the field of health

  • Examples of our key policy areas and recent achievements

European commission
European Commission

  • Independent of national governments, promoting the “common interests of all Europeans”

  • Executive body of the EU, sole legislative initiative

  • 27 Commissioners, Directorates-General for policy areas

  • Directorate-General responsible for Health and Consumers – DG SANCO

    • Divided into units according to area of responsibility

    • Supported by the Executive Agency for Health and Consumers (EAHC) - implementation of health programme through funding & management of EU-funded projects



Structure of dg sanco
Structure of DG SANCO

Director General

Deputy D-G

Consumers & Health

Deputy D-G


Consumer Affairs

Public Health

Animal Health

Food Safety

Food & Veterinary




Strategy & systems

Risk assessment


Health programme


Online eu health resources
Online EU health resources

http://ec.europa.eu/health-eu/europe_for_patients/ index_en.htm

Health EU Portal

  • http://ec.europa.eu/health-eu/

Youth Health Portal

  • http://ec.europa.eu/health-eu/youth

A Europe for Patients

European parliament
European Parliament

  • Directly elected body, represents EU citizens

  • 736 members – MEPs

  • Organised in 7 Europe-wide political groupings

  • Shares legislative power with Council

  • Powers have increased with each Treaty

  • Acts as democratic supervisor of other EU Institutions, decides EU annual budget with Council


Structure of the ep
Structure of the EP








736 MEPS – 7 Political Groupings

Committee Health

Committee Research

Committee Social Affairs

Committee Petitions

… (20)

Meeting in Brussels

Plenary Session


The council
The Council

  • Founded by the Treaties in 1958

  • Meeting place: Brussels or Luxembourg

  • Rotating presidency (6 months) organised in trios – 18- month common programme

  • Current trio – Spain-Belgium-Hungary


  • Council of Ministers and European Council

  • Main decision-making body, representing the inter-governmental aspect of the EU (27 Member States)

Structure of the council
Structure of the Council

EU strategy, top decisions, broad lines

European Council

Adopts legislative and non-legislative proposals in specific policy areas

Council of EU

27 Ministers

10 configurations

Committee of Permanent Representatives – COREPER I, II

Prepares work and tasks for the Council of Ministers

Committees and Working Parties

of the Council of the EU

Articulation of interests and demands (positions) of MS – ”expert level”

Eu legislation
EU Legislation

  • Primary legislation – Treaties (the constitutional law of the European Union)

  • Secondary legislation and non-legislative instruments

    • Regulations – “European laws”, immediately enforceable in all MS

    • Directives – “framework laws”, transposed into national law

    • Decisions – legally binding, addressed to MS or individuals

    • Recommendations – no legal force, but political weight

    • Opinions, white and green papers

Eu legislative process
EU legislative process

European Commission

European Parliament



Health Ministers approve / reject / amend

Draft Directive changed

Public consultation

National patients’ organisations

Draft Directive

Final Directive

Transposition into national law in all MS

Limits of eu action in health
Limits of EU Action in Health

-- non-legislative instruments only

  • Some areas of exception:

    • Medicinal products and devices

    • Safety and quality of blood, tissues and organs

  • Principles of subsidiarity and proportionality

  • Legal basis for actions in public health: Article 168 of the Treaty

  • “A high level of health protection in all EU policies”

  • Responsibility for organisation of health systems and delivery of healthcare is the competence of Member States

  • EU action shall complement and support MS action, foster cooperation between MS

Epf works with all eu institutions
EPF works with all EU Institutions

  • Commission: participation in working groups; consultation and on key patients’ concerns, upcoming legislative proposals, etc.

    • Patient safety working group (DG SANCO), Access to medicines initiative (DG Enterprise), personalised medicine (DG Research)...

  • Parliament: input into legislative process – working with Rapporteurs, involving MEPs into supporting EPF’s work

    • Cross-border healthcare, pharmaceutical package....

  • Council: working through successive EU Presidencies on key priority areas

    • Sweden: VALUE+; Belgium: Cross-border healthcare; Hungary...

Epf patients manifesto campaign
EPF Patients’ Manifesto Campaign

EPF’s major campaign in 2008-2009 targeted at politicians at national and EU levels – called for:

  • Equal and timely access to diagnosis, treatment and support

  • Better information and resources for patients

  • A strong patients’ voice

    More than 100 MEPs committed themselves to supporting EPF

Patient safety and quality of care
Patient Safety and Quality of Care

  • EPF involvement in Patient Safety Working Group

  • Contributed to Commission Communication and Council Recommendation on Patient Safety (June 2009)

  • Meaningful involvement of EPF in this process from the start – a step forward for patients’ involvement

  • Stimulated debate on quality of care – Council supported a Joint Action on Safety and Quality of Healthcare

  • Triple aim: implementation of PS; start cooperation on Quality; promote patient involvement and empowerment

  • EPF involved as stakeholder representing patients

Cross border healthcare
Cross-Border Healthcare

  • Draft Directive launched by EC in June 2008 , first reading by the European Parliament in April 2009

  • Council common position in June 2010

  • Parliament 2nd reading – December 2010

  • EPF position:

    • Rights-based, value-based approach: quality, safety, equity, patient-centred

    • Patients should not pay for treatment upfront

    • National Contact Points – information for patients

    • Importance of eHealth and interoperability

    • More cooperation between MS towards better quality of care for all patients

The pharmaceutical package
The “pharmaceutical package”

Three proposals launched by EC in 2008:

  • Pharmacovigilance – preventing side effects of medicines and harm to patients

    • EPF advocated for direct patient reporting of adverse events – draft Directive endorsed by European Parliament in September 2010

  • Counterfeiting and illegal distribution of medicines

    • EPF promotes patient involvement – ongoing negotiations between Parliament and Council

  • Information to patients on prescription medicines

    • EPF succeeded in shifting focus on patients’ rights – controversial proposal, first reading vote end November

Ehealth and telemedicine
eHealth and Telemedicine

  • EU strategic framework – European eHealth Action Plans

  • Commission Recommendation on interoperability of health systems & Communication on telemedicine for the benefit of patients, health systems, society (2008)

  • eHealth High Level Governance established

  • Council Conclusions on eHealth (2009)

  • Joint Action and Thematic Network (current)

    • EPF leading role with other stakeholders regarding ‘Trust and Acceptability’

  • EPF in several projects – Chain of Trust, CALLIOPE, Renewing Health...

Members input is key
Members’ input is key

  • The EPF Mailing has updates on policy developments and projects, events and topical themes

  • We also send out consultation documents to our members on all major policy issues – recent examples: clinical trials in third countries; initiative on eHealth

  • We welcome your input!

More info
More info?

Thank you!

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