The Oviedo Convention from the Perspective of DG Research

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The Oviedo Convention from the Perspective of DG
Research
Dr. Lino PAULA European Commission DG Research,
Governance and Ethics Unit
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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
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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
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But close links between EC and CoE (2)
EC - DG RESEARCH and the Oviedo Convention
Article 6 of the Decision n1982/2006/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.
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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.
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Future challenges
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Future challenges
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.
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Future challenges
International research e.g. CoE Conference on
ethics of biomedical research Interesting also
to EC CoEs 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
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Future challenges

• There is plenty of room at the bottom
• Richard Feynman, 1959

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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.?
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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
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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

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The approach of DG Research
Supporting infrastructures and exchange of best
practise Forum of National Ethics Councils
(NEC Forum) 11th NEC Forum 27-28 Feb
2008 Brdo, Slovenia
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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)
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The approach of DG Research

• Supporting research and capacity building
• ECs 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

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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.
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• 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. [phone] Fax. [phone]
• lino.paula_at_ec.europa.eu