The European Commissions Activities in Ethics in Research

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The European Commissions Activities in Ethics in
Research
European Commission Research Directorate-General,
Governance and Ethics Unit Jean-François
DECHAMP Etika v Klinických Studiích, Praha
11.-12. ríjna 2007
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Plan

• 1. The limits of the European Union in ethical
  regulations
• 2. The European Commission and ethics
• 3. Ethics in the Research Framework Programmes
  (FP)
• 4. Ethics reviews of FP projects
• 5. Pan-EU platforms in research ethics
• 6. Ethics, research and globalisation
• 7. Scientific misconduct
• 8. Information
• Disclaimer "The views expressed are purely
  those of the writer and may not in any
  circumstances be regarded as stating an official
  position of the European Commission"

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1. The limits of the EU in ethical regulations

• Differences traditions, cultures, languages
• Shared values democracy, freedom, social justice
• EU defence of those values fostering of
  cooperation among the peoples of Europe
• Promoting unity while preserving diversity

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United in diversity

• EU a family of democratic European countries,
  committed to working together for peace and
  prosperity
• EU ? a State intended to replace existing States
• EU ? an organisation for international
  cooperation
• Member States have set up common institutions to
  which they delegate some of their sovereignty so
  that decisions on specific matters of joint
  interest can be made democratically at European
  level
• Decisions should be taken as close as possible to
  the citizens

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How is the EU organised?

• The European Parliament Voice of the people
• The Council of the European Union Voice of the
  Member States
• The European Commission Promoting the common
  interest
• The Court of Justice The rule of law
• The Court of Auditors Getting value for your
  money

• The European Economic and Social Committee Voice
  of civil society
• The Committee of the Regions The local
  perspective
• The European Central Bank A stable currency
• The European Investment Bank Lending a helping
  hand
• Agencies e.g. European Medicines Agency (London)

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The Council of Europe

• Not an EU institution
• An intergovernmental organization set up in 1949,
  which aims (amongst other things) to protect
  human rights, to promote Europe's cultural
  diversity and to combat social problems such as
  xenophobia and intolerance
• One of its early achievements was to draw up the
  European Convention on Human Rights (To enable
  citizens to exercise their rights under that
  Convention, it set up the European Court of Human
  Rights)

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EU competence on ethics

• Democratic fundamentals through a common European
  framework The Charter of Fundamental Rights of
  the European Union (published 18 December 2000).
• EU does already address ethical issues in
  regulations (patents, clinical trials, data
  protection) and in research programmes (FP)
• However under existing treaties there is no
  specific EU competence on ethics there is
  guidance but subsidiarity applies ? Member States
  and their respective national ethics bodies

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Ethics in European regulations and legislations

• Directive 95/46 on the protection of personal
  data
• Directive 2001/20/EC on good clinical practice
  (EUDRALEX Vol. 10)
• Directive 2001/83/EC on medicinal products for
  human use
• Directive 86/609/EEC on the protection of animals
  used fore experimental and other scientific
  purposes
• Protocol on Protection and welfare of animals
  (Protocol to the Amsterdam Treaty) etc.
• European Parliament resolution on human cloning
• Directive 96/9 on the legal protection of
  databases etc.

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Subsidiarity

• Example the European Union leaves decision on
  stem-cell ethics in their countries to the Member
  States (April 2007)
• Adoption with clear majority, by the European
  Parliament on 25 April 2007, of a report
  rejecting all ethical amendments proposed
  initially to a Regulation on advanced therapy
  medicines, hence supporting EU-wide regulation on
  products or cures derived from human embryonic
  stem cells.
• The decision to allow the use of these treatments
  in respective territories is left to Member
  States.

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2. The European Commission and ethics

• 3 main activities
• Fundamental rights review (ECs Legal Services)
• Opinions of the European Group on Ethics in
  Science and Technology (EGE)
• FPs Ethics review by DG RTD (Unit Governance
  and Ethics) and other activities

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European Group on Ethics in Science and
Technology

• A neutral, independent, pluralist and
  multidisciplinary body, composed of 15 experts
  appointed by the EC
• Opinions n21 Nanomedicine n20 - ICT
  Implants in the Human Body n17 - Clinical
  research in developing countries n16 -
  Patenting inventions involving human stem cells
  etc.
• Consultations e.g. animal cloning for breeding /
  food supply, September 2007

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The European Commission

• Not to carry out, nor to control European
  research!
• To establish the European Research Area (ERA) as
  a framework for political and practical
  cooperation
• Joint Research Centres are an exception

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The Research family

• Research Directorate-General (DG Research / DG
  RTD)
• Science, Economy and Governance Directorate
• Governance and Ethics Unit ? FPs Ethics reviews
• Health Directorate contribution focused on its
  own field of interest (Medical and public health
  research, infectious diseases, health biotech)
• Enterprise Directorate-General medicinal
  products, clinical trials
• Other DGs part of ECs Research family
  (Information Society etc.)

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Unit Governance and Ethics

• Head of Unit Peteris Zilgalvis
• Staff 20 persons
• Policy support to analysis and research, to
  development of processses and strategies etc. ?
  more inclusive and open approach to governance
  and ethics of RTD and innovation in Europe
• Projects (EU funded research projects into
  ethics) e.g. TWR (comparing emerging ethical
  issues and legal differences impacting on
  European clinical trials) etc.
• Ensuring fundamental ethical principles are
  respected in implementation of FPs!

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3. Ethics in the Research Framework Programmes

• Main instruments for funding research
• FP7 (2007-2013) 53.2 billion Euro over 7 years
• Science in Society programme stronger focus on
  globalisation issues and participation of CSOs in
  research activitie Emphasis on multidisciplinary
  and policy-related research
• Call for proposals 1 for research in ethics
  (published in December 2006)
• Call 2 due for publication in November 2007 to
  include inter alia governance in the production
  of health and medical knowledge, and networking
  between advisory structures

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4. Ethics review of FP projects

• Ethical review of Framework research proposals
  for EU-funded projects integral component of
  research proposal evaluation procedure undertaken
  by the EC (For all ethically sensitive FP
  research projects)
• Multidisciplinary and multisectorial panels of
  independent experts (register at
  https//cordis.europa.eu/emmfp7)
• Major objectives
• Facilitate research excellence in FP
• Assure citizens and decision makers that the
  Commission does not fund ethically unsound
  research
• Raise awareness amongst researchers
• Does not replace the need for ethical approval at
  national or local level!

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Ethics review facts (FP6)

• 11 of all funded FP6 projects have undergone an
  ethical review
• Biomedicine and genetics 45
• About 10 each for IT, nanotechnology and food
  and green biotech
• Based on FP ethical rules, supporting both
  subsidiarity and fundamental ethical principles
  (National regulation, EU regulations,
  international agreements)
• Recurring concerns IC, developing countries,
  data protection, children, animals

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Ethics reviews challenges

• New and converging technologies and their
  applications human enhancement, privacy and
  dignity, use of animals in non-medical research,
  chymeric embryos, dual use etc.
• An FP project can be rejected based on ethical
  grounds
• Could the ECJ uphold the decision?
• Probably rejection not problematic provided this
  was justified in term of protecting fundamental
  rights

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5. Pan-EU platforms in research ethics

• NEC Forum of National Ethics Councils
• Independent, informal platform Chairs NEC
  executive secretaries
• Exchange of information and best practices (EGE
  invited)
• EU and MS funded
• 2 conferences / year (Lisbon, 11-12 Oct. 2007)
• Stimulation of the development of / reflection on
  shared fundamental values
• EUREC (Local) Research Ethics Committees
  Conferences
• mutual learning and exchange of best practice
• Est. 2005 10 EU countries, now 25 countries
• EU co-funded network

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6. Ethics, Research and Globalisation

• 50 speakers, gt 150 participants (present), gt 40
  countries
• Africa Benin, BF, Cameroon, Congo, Gabon, GR,
  Gambia, Ivory Coast, Madagascar, Mali, Nigeria,
  Senegal, SA, Tanzania, Togo, Uganda
• America Caribbean Brazil, Canada, Chile, CR,
  Haiti, Jamaica, USA
• Asia China (Taiwan), India
• Europe Russia, CH, Turkey
• Guests EC (CAB, BEPA, DEV), EP, WHO, UNESCO,
  UNAIDS, CoE, WIPO, WMA and many others
  (Academics, CSOs)

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A flavour of the conference (1/2)

• Research in developing countries is an essential
  contributor to their sustained development
  (Guedou, MOH, Benin)
• In 2004, only 13 of the 20 Latin American
  countries had ethics committees, and only 8 have
  national normative documents (Lorenzo, NHC,
  Brazil)
• A University degree in ethics should not be a
  pre-requisite there is a valuable role for lay
  members of ethics committees (Chapuis, EUREC,
  France)
• There is a role for the EC to play in opposing
  double standards and supporting
  consensus-building efforts (Williams, WMA)
• Diversity is not only between e.g Africa and
  Europe there is also diversity within Africa,
  within Europe developed countries should address
  double standards first, before trying to
  eliminate them in the developing world
  (Ravinetto, ITM, Belgium)

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A flavour of the conference (2/2)

• Developing Countries must work on a priority
  setting exercise, identifying the particular
  priorities within their own communities.
  Community involvement should take place at all
  stages of research (Muthuswamy, CMR, India)
• In developing countries, the local population
  bears the burden of clinical trials but they have
  little accessibility to the final products
  (Kilama, AMNT, Tanzania)
• Debate on medical ethics has now gone on to the
  streets and is no longer the exclusive concern of
  academics (Agba, MOH,Togo)
• (About indigenous knowledge) It will be the
  responsibility of the national ethics committees
  to protect the heritage of the Gabonese people
  and defend their human rights and dignity (Ossa,
  M of Education and Research, Gabon)

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7. Scientific misconduct

• Scientific integrity rediscovered fraud,
  falsification, plagiarism
• No (coherent) policy in DG RTD / the EC
• EC PT Presidency event (organised by ESF et
  al.) 1st World Conference on Research Integrity
  (Lisbon, 16-19 September 2007)
• More info on http//esf.org
• Clinical trials Data manipulation!
• Plagiarism among students, peer-review more
  vulnerable etc.
• Antagonisms in approaches (EU, US)

?
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8. Information

• EU research http//ec.europa.eu/research
• Science, Economy and Society http//ec.europa.eu/
  research/science-society
• Seventh Framework Programme http//ec.europa.eu/r
  esearch/fp7
• Research programmes projects
  http//cordis.europa.eu
• ResearchEU http//ec.europa.eu/research/research
  -eu
• Information requests http//ec.europa.eu/research
  /enquiries
• Pharmaceuticals http//ec.europa.eu/enterprise/ph
  armaceuticals/
• index_en.htm

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Thank you

• DG RTD, Science, Economy and Society
• http//ec.europa.eu/research/science-society
• jean-francois.dechamp_at_ec.europa.eu