1. Patients’ Involvement in EU-level Health Policy
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

4. Structure of DG SANCO Director General Deputy D-G Consumers & Health
Food Chain
Consumer Affairs
Public Health
Animal Health
Food Safety
Food & Veterinary
Health programme
Information
Threats
Determinants
Strategy & systems
Risk assessment
Pharmaceuticals
Law

5. Online EU health resources
A Europe for Patients
eu/europe_for_patients/ index_en.htm
Health EU Portal
Youth Health Portal

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

7. 736 MEPS – 7 Political Groupings Committee Social Affairs
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 Council of Ministers and European Council
Main decision-making body, representing the inter- governmental aspect of the EU (27 Member States)
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

9. Structure of the Council
Committees and Working Parties
of the Council of the EU
Committee of Permanent Representatives – COREPER I, II
Council of EU
27 Ministers
10 configurations
European Council
EU strategy, top decisions, broad lines
Adopts legislative and non-legislative proposals in specific policy areas
Prepares work and tasks for the Council of Ministers
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
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
-- non-legislative instruments only
Some areas of exception:
Medicinal products and devices
Safety and quality of blood, tissues and organs

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 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!
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