EPF Regional Advocacy Seminar
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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

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

      http://ec.europa.eu/

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


Structure of dg sanco

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

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

    www.europarl.europa.eu


Structure of the ep

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

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

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

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

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!

Visit us at:

www.eu-patient.eu


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