The Oviedo Convention from the Perspective of DG Research Dr. Lino PAULA European Commission DG Research, Governance and Ethics Unit

2 EC and CoE are distinct international organisations The EC and the COE: ■ Legal instruments of the two organisations take effect independently of each other (CoE conventions are, as such, not binding foundations for EU legislation) ■ EU legislation takes effect in all EU Member States, whereas CoE conventions, only take effect in those Members States that have signed and ratified them ■ CoE having as members all EU Member States but also members that are not EU Member States

3 But close links between EC and CoE EC and the Oviedo Convention: ■ In EU Member States the conventions of the CoE can be applied via EU legislation in which reference is made to CoE Conventions - such as the Directives 98/79/EC on IV Diagnositics Medical Devices, 2004/23/EC on donation, etc. of human tissue and Regulation 1394/2007 on advanced therapy medicinal products, where reference is made to the Oviedo Convention

4 But close links between EC and CoE (2) EC - DG RESEARCH and the Oviedo Convention: ■ Article 6 of the Decision n°1982/2006/EC, which decision adopt the Seventh Framework Programme (FP7), states that: "All the research activities carried out under the Seventh Framework Programme must be carried out in compliance with fundamental ethical principles." ■ The various EU Council Decisions pertaining to the Specific Programmes implementing FP7, describe these principles further in their Annexes. The description explicitly stipulates respect for the principles addressed in the Oviedo Convention and its Additional Protocols. ■

5 But close links between EC and CoE (3) EC - DG RESEARCH and the Oviedo Convention: ■ Therefore, research funded by the EC must always be carried out in compliance with the provisions of the Oviedo convention. ■ However, for research carried out in a EU Member State without EU funding, and to the extent that it concerns research not affected by EU legislation that makes reference to the Oviedo Convention, the principles of the Oviedo Convention are binding only in those countries that have ratified the Convention.

6 Future challenges

7 European and global coherence: ■ Pan-European support for additional Protocols is important to maintain a common ‘acquis’ ■ European countries can advance the role of ‘Oviedo values’ in the world ■ International research: article 29 of the Additional Protocol on Biomedical Research to the Oviedo Convention: Sponsors or researchers within the jurisdiction of a Party to this Protocol that plan to undertake or direct a research project in a State not party to this Protocol shall ensure that, without prejudice to the provisions applicable in that State, the research project complies with the principles on which the provisions of this Protocol are based. Where necessary, the Party shall take appropriate measures to that end.

8 Future challenges International research: e.g. CoE Conference on ethics of biomedical research Interesting also to EC: ■ CoE’s legislative reach in bioethics ■ No double standards in research; EC funded research conducted in partner countries should comply with fundamental ethical principles ■ Setting high “European” ethics standards internationally

9 “There is plenty of room at the bottom” Richard Feynman, 1959 Future challenges

10 Future challenges Converging Technologies: ■ New technologies such as nanotechnology, ICT and synthetic biology have in common that they operate at the convergence of ‘traditional’ disciplines, which make them inherently complex both in terms of scientific and societal impact. ■ Converging technologies are also rapidly ‘moving targets’ which are hard to confine and define ■ Can such rapid and complex developments be timely and adequately regulated via Conventions, Directives, etc.?

11 The approach of DG Research General philosophy: ■ ’Upstream’ two-way dialogue with all stakeholders to internalise ethics in the design of new products and practises

12 The approach of DG Research (Soft-)law and self regulation: ■ EC Ethical Review  Carried out on all EC funded research projects that are ethically ‘sensitive’ ■ Code of Conduct for Responsible Nanotechnology  Adhering to general principles like sustainability, precaution, inclusiveness, responsibility ■ European Group on Ethics (:BEPA)  Independent and multidisciplinary advisory body which reports to the President of the European Commission  Its Opinions provide guidance to EC funded research and beyond

13 The approach of DG Research Supporting infrastructures and exchange of best practise: ■ Forum of National Ethics Councils (NEC Forum) 11th NEC Forum Feb 2008 Brdo, Slovenia

14 The approach of DG Research Supporting infrastructures and exchange of best practise: ■ Forum of National Ethics Councils (NEC Forum) ■ European Network of Research Ethics Committees (EUREC) Networking and providing training for members of Research Ethics Committees (RECs)

15 The approach of DG Research Supporting research and capacity building: ■ EC’s Framework Programme for Research (currently FP7) ■ ‘ELSA’ research projects focusing on nano, ICT, synthetic biology, etc. – their impact and frameworks for assessment ■ ‘Support Actions’ focusing on capacity building, infrastructures and networks, e.g.  EC-UNESCO Conference ‘Joint Action for Capacity Building in Bioethics’  Global Forum on Bioethics in Research

16 This approach is also implicit in the Oviedo Convention Oviedo Convention, Article 28 - Public debate ■ Parties to this Convention shall see to it that the fundamental questions raised by the developments of biology and medicine are the subject of appropriate public discussion in the light, in particular, of relevant medical, social, economic, ethical and legal implications, and that their possible application is made the subject of appropriate consultation. ■ The Oviedo Convention “provides a framework for the protection of human rights and human dignity by establishing fundamental principles applicable to daily medicine as well as to new technologies in the fields of biology and medicine”.

17 Contact: Dr. Lino Paula Policy Officer, Governance and Ethics Unit European Commission, Research Directorate-General Directorate L: Science, Economy and Society SDME 7/80 Tel. (+32-2) Fax