EU public health

1
EU public health

• Dr. Maria Eva Földes
• European health law ethics summer course, Riga,
  June 2013

2
Overview

• Health systems in Europe common values, shared
  challenges, different solutions
• Emergence of EU competences in public health
  from isolated actions supporting the single
  market creation towards European health programs
• Cross-border care and patient mobility health
  services as part of the internal market
• Post-Lisbon what can the EU do to promote health
  and protect health rights?
• The way forward the Commission proposal for a
  Health for Growth program 2014 2020

3
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
• 
  
  
• 
  
  

4
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 competence to the extent that the EU has not done so or ceased to do so The EU only supports, coordinates or supplements the actions of States
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

5
Cohesion policy Health investments 2007
2013Source European Commission, DG Regional
Development
5.1 billion earmarked to support health
infrastructure 5 billion earmarked for
e-services (including e-health) 1 billion
earmarked for active and healthy ageing, human
resources, etc. of planned health
infrastructure investments in relation to total
amount of Structural Funds
0
lt1
1-2
2-3
3-4
4-5
gt5
6
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!

7
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!
• 
  
• 
  

8
Health systems in Europe Council conclusions on
common values and principles, 2006

• Values shared by Member States
• 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

9
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

10
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

11
Prior to 1986 Isolated health actions supporting
the single market

12
1986 1997 Emergence of EC competence in
public health Three major events (Bernard
Merkel, 2010)

President Mitterands 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

13
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!

14
1997 2008 Expanding competence in healthArt
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!

15
Further to the Treaty of Amsterdam

• Binding legislation on blood, tissues, cells
• Directives on pharmaceuticals, medical devices
• Coordination of surveillance response to
  communicable diseases creation of the European
  Centre for Disease Control
• Open Method of Coordination extended in health
  long-term care
• Two European Public Health Programs 2003-2008
  2008-2013

16
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)

17
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

18
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)

19
Access to cross-border care in the EU Tamara
Hervey (2006)

20
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!

21
Codification of the ECJ case law on
cross-border care - I

• 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

22

Anti-Bolkestein demonstration
(flickr.com) Hands
off public services NO to the Bolkestein


directive
(epsu.org)
23
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)
• Presented as part of the renewed social agenda
  for the EU
• Rhetoric shifted from market integration to
  patient rights
• Passive free movement patients go to
  healthcare providers ? patient mobility

24
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

25
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

26
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

27
Prior authorization when can it be justified?

• 1. Planning requirements cost control
  requirements
• 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!

28

• 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 patients
• medical condition, history probable course of
  illness,
• degree of pain, nature of the disability

29
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

30
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

31
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
• Addressing shortages of human and financial
  resources innovation, e-Health, health
  workforce, health system reforms, active and
  healthy ageing, medical devices
• Access to better and safer health care rare
  diseases, tissues, cells, organs, blood safety,
  pharmaceuticals, information to patients,
  patients rights in cross-border care
• Prevention and health promotion smoking, alcohol
  abuse, obesity, HIV/AIDS, chronic diseases
• Protecting citizens from cross-border health
  threats including communicable diseases better
  preparedness, risk assessment and coordination in
  health emergencies

32
Group work the patient mobility directive

• Objectives
• Think about the impact of the directive in
  practice
• Discuss potential issues, challenges and ways of
  addressing them
• Understand the perspective of different
  stakeholders
• (patients, providers, insurers, Member
  States, EU institutions, etc.)
• Five potential issues and possible ways of
  addressing them

33
Group work tasks

• Familiarize yourself with the 5 issues the
  supporting materials
• Formulate well-founded opinions on each issue
• 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
• 10 minutes presentation
• 20 minutes debate

34
Groups and issues
Group 1 Cross-border hospital care in border regions Iris Bakx Dita Dzerviniece Edit Kovacs Ilze Krilova Vladimirs Pilipenko Lynn Seveke Boris Vranak Group 2 An option to choose your health insurer across borders Ahmed Gishe Toby Hollen Dominika Hula Rasads Misirovs Anna Mondekova Monta Tigere Mariam Tutberidze Group 2 An option to choose your health insurer across borders Ahmed Gishe Toby Hollen Dominika Hula Rasads Misirovs Anna Mondekova Monta Tigere Mariam Tutberidze Group 3 Rare diseases Martins Birgelis Lauris Bocs Youy Chootipongchaivat Jennifer Joel Madara Locane Petra Nastulczykova Kim Vermeulen
Group 4 Qualifications for health professionals Ruth Alderse Baas Janneke van Moorsel Genadijs Rusanovs Dominik Stolarz Ketevan Vardosanidze Ieva Vedike Group 4 Qualifications for health professionals Ruth Alderse Baas Janneke van Moorsel Genadijs Rusanovs Dominik Stolarz Ketevan Vardosanidze Ieva Vedike Group 5 Cooperation on healthcare financing Ahmad Fuady Kristaps Kalass Tinatin Nadareishvili Kristjan Ots Jackielyn Perez Agita Sprude Group 5 Cooperation on healthcare financing Ahmad Fuady Kristaps Kalass Tinatin Nadareishvili Kristjan Ots Jackielyn Perez Agita Sprude