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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. 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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  1. EPF Regional Advocacy Seminar Budapest, 26 October 2010 Patients’ Involvement in EU-level Health Policy Kaisa Immonen-Charalambous, EPF Policy Officer

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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)

  9. 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”

  10. 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

  11. 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

  12. 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

  13. 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...

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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...

  19. 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!

  20. More info? Thank you! Visit us at: www.eu-patient.eu

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