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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

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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

  • Examples of our key policy areas and recent achievements


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

      http://ec.europa.eu/

      http://ec.europa.eu/dgs/health_consumer/index_en.htm


Structure of DG SANCO

Director General

Deputy D-G

Consumers & Health

Deputy D-G

FoodChain

Consumer Affairs

Public Health

Animal Health

Food Safety

Food & Veterinary

Information

Threats

Determinants

Strategy & systems

Risk assessment

Pharmaceuticals

Health programme

Law


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

  • 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

    www.europarl.europa.eu


Structure of the EP

BG

RO

SL

HU

CY

GR

...

736 MEPS – 7 Political Groupings

Committee Health

Committee Research

Committee Social Affairs

Committee Petitions

… (20)

Meeting in Brussels

Plenary Session

STRASBOURG


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

www.consilium.europa.eu

  • 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

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

  • 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

European Commission

European Parliament

Council

EPF

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

-- 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

  • 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’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

  • 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

  • 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”

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

  • 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

  • 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?

Thank you!

Visit us at:

www.eu-patient.eu


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