EPF Regional Advocacy Seminar
Budapest, 26 October 2010
Patients’ Involvement
in EU-level Health Policy
Kaisa Immonen-Charalambous, EPF Policy Officer
The Presentation
1. Overview of the EU’s main institutions
2. EU activities in the field of health
3. 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
o Divided into units according to area of responsibility
o Supported by the Executive Agency for Health and
Consumers (EAHC) - implementation of health
programme through funding & management of EUfunded projects
http://ec.europa.eu/
http://ec.europa.eu/dgs/health_consumer/index_en.htm
Structure of DG SANCO
Director General
Food &
Veterinary
Law
Food Safety
Pharmaceutic
als
Strategy &
systems
Animal
Health
Determinants
Threats
Public
Health
Information
Health
programme
Consumer
Affairs
Deputy D-G
Food Chain
Risk
assessment
Deputy D-G
Consumers & Health
Online EU health resources
A Europe for Patients
http://ec.europa.eu/healtheu/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
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
Meeting in Brussels
Plenary Session
STRASBOURG
Committee
Petitions
… (20)
The Council
 Council of Ministers and European Council
 Main decision-making body, representing the intergovernmental 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 – 18month common programme
 Current trio – Spain-Belgium-Hungary
www.consilium.europa.eu
Structure of the Council
European
Council
EU strategy, top decisions, broad lines
Council of EU
27 Ministers
10 configurations
Adopts legislative and non-legislative
proposals in specific policy areas
Committee of Permanent
Representatives –
COREPER I, II
Committees and Working Parties
of the Council of the EU
Prepares work and tasks for the
Council of Ministers
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
o Regulations – “European laws”, immediately enforceable in
o
o
o
o
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
Public
consultation
EPF
National
patients’
organisations
European
Parliament
Draft
Directive
changed
Council
Health
Ministers
approve /
reject /
amend
Draft Directive
Final Directive
Transposition into
national law in all MS
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
EPF works with all EU Institutions
 Commission: participation in working groups; consultation
and on key patients’ concerns, upcoming legislative
proposals, etc.
o 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
o Cross-border healthcare, pharmaceutical package....
 Council: working through successive EU Presidencies on
key priority areas
o 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:
o Rights-based, value-based approach: quality, safety, equity,
o
o
o
o
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
o EPF advocated for direct patient reporting of adverse events
– draft Directive endorsed by European Parliament in
September 2010
 Counterfeiting and illegal distribution of medicines
o EPF promotes patient involvement – ongoing negotiations
between Parliament and Council
 Information to patients on prescription medicines
o 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