The legal framework for health in the EU

1. The legal framework for health in the EU Fiona Godfrey Consultant in EU policy European Respiratory Society Email: fgodfrey@pt.lu

2. The fundamentals • The legal framework for health in the European Union is provided by • The EC Treaties • Case law from the European Court of Justice

3. Article 3 EC • The activities of the Community shall include...a contribution to the attainment of a high level of health protection

4. Article 95 (3) EC Internal Market The Commission, in its proposals... concerning health, safety, environmental protection and consumer protection, will take as a base a high level of protection, taking account in particular of any new development based on scientific facts. Within their respective powers, the European Parliament and the Council will also seek to achieve this objective.

5. Article 152 EC (public health) 1. A high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities. Community action, which shall complement national policies, shall be directed towards improving public health, preventing human illness and diseases, and obviating sources of danger to human health.

6. Article 152 cont. 2. The Community shall encourage co-operation between the Member States in the areas referred to in this Article and, if necessary, lend support to their action... 3. The Community and the Member States shall foster co-operation with third countries and the competent international organisations in the sphere of public health.

7. Art. 152 (4) The Council shall adopt measures setting high standards of quality in: • Organs and substances of human origin • Blood and blood products • Veterinary and phytosanitary fields which have as their direct objective the protection of public health

8. Art. 152 & subsidiarity 5. Community action in the field of public health shall fully respect the responsibilities of the Member States for the organisation and delivery of health services and medical care.

9. Article 174 (Health & Environment) 1. Community policy on the environment shall contribute to pursuit of the following objectives: • preserving, protecting and improving the quality of the environment, • protecting human health...

10. Article 30 EC • Allows member states to prohibit the marketing of products from other EU countries to protect public health but only where there is scientific evidence in support, and as long as it is not a disguised restriction on trade

11. Other areas where health is mentioned • Articles 39 & 46, free movement of workers • Article 137, workers’ health and safety • Article 153, consumer policy

12. Key areas where health is not mentioned • The Common Agricultural Policy (CAP) • Common Transport Policy

13. Problems with the health competence • With a few exceptions, the EU cannot pass binding laws simply to protect human health • Usually, health measures have to be adopted under Article 95 (Internal Market) • Therefore health measures have to improve the internal market to be legal

14. Proportionality Three tests applied to all EU legislation: • What is the objective of the legislation? • Are the means employed suitable? • Do they go beyond what is necessary to achieve the objective?

15. Subsidiarity • Subsidiarity is the EU principle which states that action should not be taken by the Community unless the objectives of the proposed action cannot be dealt with properly at national level • Used by opponents of EU health policy to say that EU should not have any powers in public health field

16. What this means in practice • A health measure can be declared illegal if it does not improve the internal market • What improves the internal market is often bad for health - e.g. tobacco, alcohol advertising • EU legislation to protect public health has to be creative and is often weak - tobacco advertising I and II • Economic interests are given political priority over health

17. ECJ case law on health BSE (“Mad Cow”) 1998 • ECJ applied the precautionary principle and said that even speculative scientific evidence could justify a world wide export ban on British beef products

18. Tobacco II (2002) • As long as a directive has as its objective the improvement of the Internal Market, “it is no bar that the protection of public health (is) a decisive factor (in the directive)” • Amendment of existing legislation does not necessarily require new scientific evidence. Changes in perceptions or circumstances can be sufficient

19. Denmark v Commission Case C-3/00 • A Member State does not have to prove that it has a specific problem in order to keep its existing legislation • Where a specific problem does exist, the Commission should take account of it • No newscientific evidence is necessary • Divergent assessments of risks can be made without the existence of new evidence • The Member State must prove that its existing legislation ensures a higher level of health protection than the harmonising directive

20. Other health cases • Free movement of patients: • Geraets-Smits July 2001 • Peerbooms • IKA v Vasileios Ioannidis February 2003Clarified the right of EU citizens to travel abroad for health treatment

21. Changing the legal basis for health The Convention on the Future of Europe http://european-Convention.eu.int/ • Essential to ensure health is an objective of the EU and a shared competence of the EU and Member States • We need a flexible, comprehensive legal base for health - not just a “shopping list” as at present

22. Our task • “The EU should have a clear legal base enabling it to exercise its powers in the field of public health. It should be made impossible for the subsidiarity principle to be used as a means for Member States to oppose the development and application of measures…necessary to protect public health.” The Medina Report on the BSE crisis, European Parliament, 1997