Transcript Slide 1

EU public health
Dr. Maria Eva Földes
European health law & ethics summer course, Riga, June 2013
Overview
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Health systems in Europe: common values, shared challenges, different solutions
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Emergence of EU competences in public health: from isolated actions supporting the single
market creation towards European health programs
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Cross-border care and patient mobility: health services as part of the internal market
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Post-Lisbon: what can the EU do to promote health and protect health rights?
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The way forward: the Commission proposal for a Health for Growth program 2014 – 2020
The EU budget for public health: 2013 data
(1 billion = 1000 million)
Public health & consumers:
€ 100 million ~0.07%
Public health:
€ 55,5 million ~0.04%
Animal & plant health:
€ 300 million ~0.21%
Competence allocation between the EU and its Member States after the
Lisbon Treaty
Exclusive EU competence Shared competence
between the EU & States
Supporting, coordinating
or supplementing
competences of the EU
The EU has all powers to act.
States may only act where
empowered by the EU or for
implementing EU acts
States exercise their
The EU only supports,
competence to the extent that coordinates or supplements
the EU has not done so or
the actions of States
ceased to do so
• customs union
• competition policy
• monetary policy for Euro zone
• common commercial policy
• conservation of marine
biological resources
• internal market
• social policy
• economic, social & territorial
cohesion
• agriculture & fisheries
• environment
• consumer protection
• transport
• trans-European networks
• energy
• freedom, security, justice
• common safety concerns in
public health matters
• protection & improvement of
human health
• industry
• culture
• tourism
• education, vocational
training, youth, sport
• civil protection
• administrative cooperation
Cohesion policy: Health investments 2007 – 2013
Source: European Commission, DG Regional Development
€ 5.1 billion earmarked to support
health infrastructure
€ 5 billion earmarked for
e-services (including e-health)
0%
<1%
1-2%
2-3%
3-4%
€ 1 billion earmarked for
active and healthy ageing,
human resources, etc.
4-5%
>5%
% of planned health infrastructure investments
in relation to total amount of Structural Funds
Health care – a politically sensitive field - I
TFEU: The EU shall respect Member States’ responsibility to:
• define health policy at national level
• determine the mechanisms to finance and deliver health care
• determine health care benefits to which their residents are entitled
Member States: health care should be left to national politics!
Health care – a politically sensitive field - II
Different national health care systems:
• Insurance-based systems – reimbursement or in-kind systems
• National health services – tax-financed
However, health systems are become increasingly interconnected!
Health systems in Europe: Council conclusions on common values
and principles, 2006
Values shared by Member States:
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Universality
Access to good quality care
Equity
Solidarity
Common operating principles:
quality, safety, evidence-based medicine,
ethics, patient involvement, redress,
privacy, confidentiality
Aim: patient-centered health care that is
responsive to individual need
Health systems in the EU – common problems
Pressures on solidarity-based
health systems: how to meet
increasing expectations with
limited resources
Growing costs  controversial
priority-setting and rationing
measures
Emergence of parallel systems
at national level based on
patients’ ability to pay for
services  equity issues
Gradual evolution of EU competences in health
• Prior to 1986: Isolated actions supporting the single market creation
• 1986 – 1997: Emergence of EC competence in public health
• 1997 – 2008: Expanding EC competence
• 2009 – present: Post-Lisbon developments
Prior to 1986: Isolated health actions supporting the single market
1986 – 1997: Emergence of EC competence in public health
Three major events (Bernard Merkel, 2010)
President Mitterand’s secret
Europe Against Cancer program launched in 1989
as the first EC public health program
Prevention, screening, education, training
Emergence of HIV/AIDS - the
threat of a new pandemic
Europe Against AIDS program launched in 1991
Supporting prevention, information, education
projects in Member States
The Treaty of Maastricht with an
explicit article on public health
Article 129 - the first explicit legal basis for EC
action in public health  several health programs
Further to Article 129 of the Maastricht Treaty
Disease prevention, promotion of health research, information, education
Development of public health actions:
– Action Programs (1993 - 2002): health promotion, education & training; cancer
program, drug dependence, AIDS & other communicable diseases, health
monitoring, rare diseases, accidents & injuries, pollution-related diseases
– Blood safety strategy (1994), health status reports
BUT:
– Narrow scope of action, no binding legal measures
– Health systems and services reserved for States!
1997 – 2008: Expanding competence in health
Art 152 of the Treaty of Amsterdam
 Legal basis to adopt incentive measures to protect and improve human health
 Measures setting high standards of quality & safety of organs, substances of human
origin, blood, blood derivatives
 “A high level of human health protection shall be ensured in the definition &
implementation of all Community policies and activities”
 Special subsidiarity clause on healthcare:
“The Community shall take action […] only and so far as the objectives of the
proposed action cannot be sufficiently achieved by the Member States and can […]
be better achieved by the Community”
Harmonization in health care organization & delivery excluded!
Further to the Treaty of Amsterdam
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Binding legislation on blood, tissues, cells
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Directives on pharmaceuticals, medical devices
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Coordination of surveillance & response to communicable diseases – creation
of the European Centre for Disease Control
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Open Method of Coordination extended in health & long-term care
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Two European Public Health Programs: 2003-2008; 2008-2013
Cross-border care: health services as part of the internal market
The European Court of Justice rulings:
Health care is an economic activity
(transaction against remuneration) no matter
how & by whom it is financed & provided
Health care services are economic services
 the freedom to provide services applies
to all health services & health systems in the EU
“The freedom to provide services includes the freedom for persons to
receive medical treatment in another Member State” (ECJ, 1984)
The European Court of Justice rulings
Measures that prevent or impede (1) individuals
in obtaining healthcare in another Member State
or (2) providers in offering health services in
another Member State, are
obstacles to free movement
Example: the prior authorization requirement
Impediments may be justified if they are necessary & proportional
to achieve a public interest objective – i.e., protecting public health,
ensuring sustainability of social security systems
Cross-border health care – the ECJ cases
C-158/96 Kohll (1998)
C-120/95 Decker (1998)
C-357/99 Smits/ Peerbooms (2001)
C-385/99 Müller-Fauré/ Van Riet (2003)
C-371/04 Watts (2006)
C-368/98 Vanbraekel (2001)
C-56/01 Inizan (2003)
C-8/02 Leichtle (2004)
C-145/03 Keller (2005)
C-466/04 Herrera (2006)
C-444/05 Stamatelakis (2007)
C-208/07 Petra von Chamier (2009)
C-211/08 Commission vs Spain (2010)
C-173/09 Georgi Ivanov Elchinov (2010)
C-512/08 Commission vs France (2010)
Access to cross-border care in the EU Tamara Hervey (2006)
The cross-border care rulings – reactions of Member States
The health sector is different from
other sectors!
Healthcare is a national issue!
Healthcare should be out of
the reach of Community law!
Codification of the ECJ case law on cross-border care - I
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Uneven implementation of case law, legal uncertainties
States reluctant to accept the “activist” approach of ECJ
 Call for codification
First attempt:
Article on health care included in the draft 2004 services directive (Bolkestein)
 Perceived tensions between health system objectives and single market
 Lack of support in the European Parliament and Council
Health care dropped from the services directive in 2006
Anti-Bolkestein demonstration (flickr.com)
Hands off public services – NO to the Bolkestein
directive (epsu.org)
Codification of the ECJ case law on cross-border care - II
Second attempt:
Proposal of the Commission for a directive on the application of patients’
rights in cross-border health care (2008)
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Presented as part of the renewed social agenda for the EU
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Rhetoric shifted from market integration to patient rights
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‘Passive’ free movement – patients go to healthcare providers  patient mobility
Directive on the application of patients’ rights in cross-border
healthcare
Adopted in March 2011. Deadline for transposing into national law: October 2013
Three main areas:
 Rules on reimbursement – increasing legal certainty
 Consumer protection – ensuring safety & quality of cross-border care
 Establishing formal cooperation between health systems
 Duty of co-operation and mutual assistance
 Specific issues: medical prescriptions, e-health, European reference networks, rare
diseases, co-operation in border areas, HTA, etc.
! Respecting national competencies in organizing & delivering healthcare
Consumer protection under the directive
- Quality and safety standards
- Access to information to enable informed choice:
Treatment options, availability, quality, safety, prices, authorization status, insurance
coverage, protection with regard to professional liability
- Transparent complaints procedures & remedies for harm
- Systems of professional liability insurance
- Privacy & protection of personal data
- Access to personal medical records
- Non-discrimination with regard to nationality; no discriminatory prices
Member States of affiliation shall ensure that:
• The cost of cross-border care is reimbursed according to the rules
• Patients are informed about their rights & entitlements
• Medical follow-up is available
• Remote access to medical records (or copies) is available
National Contact Points shall help patients make informed decisions
Prior authorization –
when can it be justified?
1. Planning requirements; cost control requirements &
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Hospital accommodation for min. 1 night
Highly specialized, cost-intensive medical infrastructure/ equipment
2. Treatment abroad presents a particular risk/ safety hazard
3. Serious, specific concerns of quality and safety related to the healthcare provider
It shall be restricted to what is necessary & proportionate!
No arbitrary discrimination!
Decisions should be timely & subject to review!
Authorization MAY NOT be refused if:
The patient is entitled to the healthcare in question and
Healthcare cannot be provided within a medically justifiable time limit
Objective medical assessment of the patient’s
medical condition, history & probable course of illness,
degree of pain, nature of the disability
2009 – present: further to the Lisbon Treaty
New Public Health Article – Art 168 of TFEU
Expanding further the scope of EU action in health
BUT
Strengthening at the same time the subsidiarity article
Member States remain responsible for defining health policies, organizing
& operating health services, allocating resources, defining entitlements
Further to Lisbon - from public health towards health in general
Charter of Fundamental Rights of the EU – health-related rights including also
the right of access to preventive healthcare & the right to benefit from medical
treatment (Art. 35) – impact??
Integration of health concerns into
all policies at Community,
Member State & regional levels, including
Impact Assessment & evaluation tools
2014 – 2020: Commission proposal for a Health for Growth program
Budget : € 446 million for 2014 - 2020 (~ 63.7 million € per year, ~ 0,12 € per person)
Funding priorities:
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Addressing shortages of human and financial resources: innovation, e-Health, health
workforce, health system reforms, active and healthy ageing, medical devices
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Access to better and safer health care: rare diseases, tissues, cells, organs, blood safety,
pharmaceuticals, information to patients, patients’ rights in cross-border care
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Prevention and health promotion: smoking, alcohol abuse, obesity, HIV/AIDS, chronic diseases
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Protecting citizens from cross-border health threats including communicable diseases:
better preparedness, risk assessment and coordination in health emergencies
Group work – the patient mobility directive
Objectives:
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Think about the impact of the directive in practice
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Discuss potential issues, challenges and ways of addressing them
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Understand the perspective of different stakeholders
(patients, providers, insurers, Member States, EU institutions, etc.)
Five potential issues and possible ways of addressing them
Group work – tasks
Familiarize yourself with the 5 issues & the supporting materials:
Formulate well-founded opinions on each issue:
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Arguments pro & con
A possible compromise
Draft a brief proposal together with your group members on your issue
Prepare to present your proposal to the other groups and defend it
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10 minutes presentation
20 minutes debate
Groups and issues
Group 1
Cross-border hospital care
in border regions
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Iris Bakx
Dita Dzerviniece
Edit Kovacs
Ilze Krilova
Vladimirs Pilipenko
Lynn Seveke
Boris Vranak
Group 2
Group 3
An option to choose your
Rare diseases
health insurer across borders
 Martins Birgelis
 Ahmed Gishe
 Lauris Bočs
 Toby Hollen
 Youy Chootipongchaivat
 Dominika Hula
 Jennifer Joel
 Rasads Misirovs
 Madara Locane
 Anna Mondekova
 Petra Nastulczykova
 Monta Tigere
 Kim Vermeulen
 Mariam Tutberidze
Group 4
Qualifications for health professionals
Group 5
Cooperation on healthcare financing
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Ruth Alderse Baas
Janneke van Moorsel
Genadijs Rusanovs
Dominik Stolarz
Ketevan Vardosanidze
Ieva Vedike
Ahmad Fuady
Kristaps Kalass
Tinatin Nadareishvili
Kristjan Ots
Jackielyn Perez
Agita Sprude