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EU public health

EU public health. Dr. Maria Eva F ö ldes European health law & ethics summer course, Riga, June 2013. Overview. Health systems in Europe: common values, shared challenges, different solutions

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EU public health

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  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% Source:European Commission, EU budget 2013: Investing in growth and jobs, Luxembourg, 2013

  4. Competence allocation between the EU and its Member States after the Lisbon Treaty

  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

  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 togoodquality 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)

  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 toadopt incentive measurestoprotectandimprove human health • Measures setting high standards of quality & safety of organs, substances of human origin, blood, bloodderivatives • “A high level of human health protection shall be ensured in the definition &implementation of all Community policies and activities” • Specialsubsidiarity 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 againstremuneration) 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 Measuresthatprevent 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

  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 reimbursedaccordingto the rules • Patients are informedabouttheirrights &entitlements • Medical follow-up is available • Remote access tomedical 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 patient’s 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 Familiarizeyourselfwith the 5 issues & the supportingmaterials: Formulate well-foundedopinions on eachissue: • Arguments pro & con • Apossiblecompromise Draft a brief proposaltogetherwithyourgroup memberson your issue Prepareto present yourproposalto the othergroupsanddefendit • 10 minutes presentation • 20 minutes debate

  34. Groups and issues

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