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BEPA European Commission

EC policy on hESC: Ethics and Bioethics. BEPA European Commission. EU Directives having relevance to ethics in research include: Charter of Fundamental Rights of The European Union Directive 95/46 on the protection of personal data Directive 2001/20/EC on good clinical practice

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BEPA European Commission

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  1. EC policy on hESC: Ethics and Bioethics BEPA European Commission

  2. EU Directives having relevance to ethics in research include: Charter of Fundamental Rights of The European Union Directive 95/46 on the protection of personal data Directive 2001/20/EC on good clinical practice Directive 2001/83/EC on medicinal products for human use and Directive 2003/63/EC amending Directive 2001/83/EC 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) Directive 90/219/EEC on the contained use of genetically modified micro-organisms. Council Directive 98/81/EC amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms Directive 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work European Parliament resolution on human cloning Directive 96/9 on the legal protection of databases, And others… Relevant EU Legislation

  3. These include: The Helsinki Declaration The Convention of the Council of Europe on Human Rights and Biomedicine signed in Oviedo on 4 April 1997 and its Additional Protocols, The UN Convention on the Rights of the Child, The Universal Declaration on the human genome and human rights adopted by UNESCO, The Universal Declaration on Bioethics and Human Rights (UNESCO, October 2005) UN Biological and Toxin Weapons Convention (BTWC), International Treaty on Plant Genetic Resources for Food and Agriculture, Relevant World Health Organisation (WHO) resolutions International Regulations

  4. Regulation of ethical issues remains the responsibility of individual Member States, reflecting the ethical pluralism and the principle of subsidiarity that characterises the European Union. A common set of basic European values does however exist at the EU level as embodied in the Charter of Fundamental Rights to summarise…

  5. European Group on Ethics in Science and New Technologies (EGE) BEPA European Commission

  6. The EGE is an independent, pluralist and multidisciplinary body which advises the European Commission on ethical aspects of science and new technologies in connection with the preparation and implementation of Community legislation or policies http://europa.eu.int/comm/european_group_ethics/index_en.htm European Group on Ethics in Science and New Technologies (EGE)

  7. European Group on Ethics in Science and New Technologies (EGE) Göran Hermerén, Linda Nielsen, Rafael Capurro,  Inez de Beaufort, Pere Puigdomenèch Rosell and Günter Virt, (from the former EGE) new  members: Emmanuel Agius, Diana Bánáti,  Anne Cambon-Thomsen Jozef Glaza, Hille Haker, Julian Kinderlerer, Krzysztof Marczewski Paula Martinho da Silva.

  8. n° 1 The ethical implications of the use of performance-enhancers in agriculture and fisheries (12/03/1993) n° 2 Products derived from human blood or human plasma (12/03/1993) n° 3 Ethical questions arising from the Commission proposal for a Council directive for legal protection of biotechnological inventions (30/09/1993) n° 4 The ethical implications of gene therapy (13/12/1994) n° 5 Ethical aspects of the labelling of the food derived from modern biotechnology (05/05/1995) n° 6 Ethical aspects of prenatal diagnosis (20/02/1996) n° 7 Ethical aspects of genetic modification of animals (21/05/1996) n° 8 Ethical aspects of patenting inventions involving elements of human origin (25/09/1996) n° 9 Ethical aspects of cloning techniques (28/05/1997) n° 10 Ethical aspects of the 5th Research Framework Program (11/12/1997) OPINIONS GAEIB 1991-1997

  9. n° 11 Ethical aspects of human tissue banking (21/07/1998) n° 12 Ethical aspects of research involving the use of human embryo in the context of the 5th framework program (23/11/1998) n° 13 Ethical issues of healthcare in the information society (30/07/1999) n° 14 Ethical aspects arising from doping in sport (14/11/1999) n° 15 Ethical aspects of human stem cell research and use (14/11/2000) n° 16 Ethical aspects of patenting inventions involving human stem cells 07/05/2002) n° 17 Ethical aspects of clinical research in developing countries (04/02/2003) n° 18 Ethical aspects of genetic testing in the workplace (28/07/2003) n°19 Ethical aspects of umbilical cord blood banking (16/03/2004) n°20 Ethical aspects of ICT implants in the human body (16/3/ 2005) OPINIONSEGE 1998-2005

  10. - Bilateral meetings during each Presidency - EGE Newsletter “Ethically Speaking” providing information on the activities of the national ethics committees - Ad hoc participation of National Committees to round tables and hearings - Links between websites - Contacts with ethics committees of new EU and future Member States - Contacts with relevant bodies such as International organisations (Council of Europe, UN Agencies etc.) Relations with national ethics committees

  11. EC Activities on Ethics and Science and Bioethics BEPA European Commission

  12. 3 types of activities in the field of bioethics: Promotion offundamental rights, in the preparation and implementation of Community legislation or policies, including emerging legislation. In particular the Commission is also ensuring through the ethical review that EU-funded research proposals that do involve issues of major significance on bioethics (e.g. use of human biological material, involvement of vulnerable people in research activities –children, aged peoples etc., use of non-human primates etc.) are ethically sound. Funding ofresearch on ethical, legal and social issuesraised by developments in science and technology, through the Community Research Framework Programmes (FPs).  Promoting Pan European and International dialogueon ethics. Ethics: Types of activities…

  13. Embedding ethics in EU policies and Facilitating dialogue Research Programme and activities, EGE Opinions The approach chosen… Horizontal approach Vertical approach

  14. The instruments Research Projects and conferences Deepening ELSA and promoting debates Monitoring EU projects Ethical review Participatory Process Contributing to EU and International Decision making

  15. Ethical review of EU Funded Research Ethics and Science European Commission

  16. The Future: FP7 (2007-2013) Budgets of the EU Framework Programmes * * Including 2,75 Billion for Euratom for 2007-2011

  17. The Ethical review, FP6 • FP Article 3: "All the research activities carried out under the Framework Programme 2002-2006 must be carried out in compliance with fundamental ethical principles.” • Rules for participation: “A proposal which contravenes fundamental ethical principles….…shall not be selected. Such a proposal may be excluded from the evaluation and selection procedures at any time.”

  18. Number of FP6 Research Proposals undergoing Ethical Reviews

  19. FP6 Proposals undergoing Ethical Reviews11% of all funded FP6 projects have undergone an ethical review Breakdown of projects having undergone ethical review, by research area

  20. Ethical Review in Context – Balance in the Fields of Expertise 45 % of female experts Balance in fields of expertise: experts from different disciplines such as law, sociology, philosophy and ethics, psychology, IT, medicine, molecular biology, veterinary science

  21. Geographical Balance • Geographical Balance: Experts mainly from the EU Member States, Candidate countries but also from developing countries and emerging economies

  22. ■Seventh Framework Programme (Decision N° 1982/2006/EC), Article 6 (1§): ■ Rules for Participation, Article 10: Legal Basis for Ethical Reviews in FP7 – « All the research activities carried out under the Seventh Framework Programme shall be carried out in compliance with fundamental ethical principles. » « A proposal […] which contravenes fundamental ethical principles […] shall not be selected . Such a proposal may be excluded from the evaluation and selection procedures at any time. »

  23. ■Areas excluded from funding under FP 7, Art. 6 (2§): Legal Basis for Ethical Reviews in FP 7 – A)Research activity aiming at human cloning for reproductive purposes B)Research activity intended to modify the genetic heritage of human beings which could make such changes heritable (Research related to cancer treatment of the gonads can be financed) C)Research activities intended to create human embryos solely for the purpose of research or for the purpose of stem cell procurement, including by means of somatic cell nuclear transfer Research activities that destroy embryos including the procurement of stem cells

  24. SC research funded at EU level FP5 (1998-2002)▪ 50 projects with at least one component of SC research/ EC contribution  € 86 million▪over 95% of projects only involved somatic SC.▪2 projects also involved hESC. FP6 (2002-2006)▪ 100 projects with at least one component of SC research / EC contribution  € 500 million▪ about 80% of projects only involved somatic SC.▪18 projects also involved hESC.

  25. SC research funded at EU level  hESC from less 5% of the total SC projects in FP6 to ~ 17% in FP6  In line with the evolution of the research in this sector (more developments / more legislations in place)

  26. SC research funded at EU level 104 FP6 projects involving stem cells UNDERSTANDING Fundamental knowledge relevant to human health DEVELOPING Tools for new therapies and medicines BUILDING Tissue engineering MODELLING Mathematical & biology models,alternatives to animals testing REPAIRING Pre-clinical & clinical studies for diseases and impairements TREATING Improvement of standard hematopoeitic SC transplantation INTEGRATING Ethics, legal, societal aspects, training

  27. SC research funded at EU level FP6 projects: type of cells/tissues/organs Nervous system & annexes Skin/oth. epithelium tissues Bone/oth. connective tissues Heart & vasculature Digestive & urogenital tracts Blood & immune system Cancer Heritable & Rare Diseases Basic or horizontal issues http://europa.eu.int/comm/research/stemcells

  28. SC research funded at EU level Changes between FP5 &FP6 Change in size significant increase of SC research funded at EU level (~ X 6) • Change in nature • FP6 large projects (25 partners /  €10 million /i.e.  €400 000 per partner/4 years) help to: • Comparison of SC from different origins (adult/fœtal/embryonic) • Translational research  Stem cell research is a field where collaborative research is of clear EU added value

  29. SC research funded at EU level Analysis of the participants who are involved in hESC research funded under FP6 • 10 are from EU: • FI – IT – SE- UK – DE- NL – DK – CZ – FR - BE • this in fact represents 10 out of the 11 EU Member States who are active in this research (just ES is missing) • 2 are from Associated States: • CH - IL

  30. hESC legislation FI, DK, FR, LV, EE, SI, EL, ES, HU, NL, CZ, CH AT,PL,LU LT,SK,MTCYIE,PT* LU BE, SE, UK, Israel IT§ DE European Picture Broader research on hESC No research on hESC Brazil Canada Japan,Taiwan USA non-federal funds, Australia China, India Singapore,South Korea USA federal funds * law expected § law prohibiting procurement but no law on existing hESC

  31. hESC EU policy Citizens’ Opinion Extracted from Eurobarometer surveys on biotechnology published in June 2006 (ref. Eurobarometer 64.3)  59 % of the European citizens are supportive provided it is regulated

  32. hESC EU policy • EU has no legal competency to regulate in this sector of ethics • The Commission has the responsibility to implement the EU research programs evenwhere some areas of research raise important ethical issues. • Respect of national rules is a fundamental principle  no research forbidden in a Member State supported by EU funds there

  33. hESCEU policy • same ethical framework in FP7 (2006-2013) than in FP6 with a revision for 2010-2013. • Ciment of the overall FP7 agreement: statements by the Commission as regards article 6 of FP7 (ethical principles) • engagement of the Commission to respect the step by step procedure it established for this research in FP6 and which gave 100% success. In particular, • (12) The European Commission will continue with the current practice and will not submit to the Regulatory Committee proposals for projects which include research activities which destroy human embryos, including for the procurement of stem cells. The exclusion of funding of this step of research will not prevent Community funding of subsequent steps involving human embryonic stem cells.

  34. Specific Procedural Modalities for research involving hESC • Scientific Evaluation: Independent experts assess the necessity of using hESC for achieving the objectives set forth in the proposal. All proposals for funding involving the use of hESC and/or fœtal issues will be automatically submitted to an ethical review panel.

  35. Once the scientific evaluators confirm the necessity of using hESC in the research proposal, the ethical review panel assesses: That the proposal does not include research activities which destroys embryos including for the procurement of stem cells; Whether the consortium has taken into account the legislation, regulations, ethical rules and/or codes of conduct in place in the country(ies) where the research using hESC is to take place, including the procedures for obtaining informed consent* The source of the hESC; The measures taken to protect personal data, including genetic data, and privacy; The nature of financial inducements, if any * Cf. Directive 2004/23/EC Procedural Modalities for hESC

  36. In addition, when research proposals involve the use of hESC, the following procedures are required:  A positive opinion from a Regulatory Committee constituted by Member States’ representatives is required .  Participants in research projects must seek the approval of the relevant national or local ethics committees prior to the start of the research activities (General Clause in the contract!) Procedural Modalities for hESC

  37. Procedural Modalities hESC In conclusion, each research proposal involving the use of hESC, which is supported within FP7, is assessed by at least two independent ethical reviews: one in the country itself where the research will be carried out) and one at the EU level.* No System in the world offers a higher guarantee regarding the respect of fundamental ethical principles. *If the research raising ethical issues is performed in more than one country (i.e. n countries), it implies that more than two ethical reviews will be performed (i.e. in fact n+1 ethical reviews)

  38. Proposal Submission and evaluation in FP7 Eligibility Individual evaluation Security Scrutiny (if needed) Consensus Thresholds Applicants informed of results of expert evaluation* Panel review with hearing (optional) Ethical Review (if needed) Commission ranking • invitation to submit second-stage • proposal, when applicable Negotiation Commission rejection decision Consultation of programme committee (if required) Applicants informed of Commission decision Commission funding and/or rejection decision

  39. hESC EU Policy • Creation of a EuropeanhESC registry: • to gather the information on all the European lines • in order to maximise the use of existing ones • to disseminate the information to all the scientific • community • to favour the comparability of results Consortium with a representative from all EU Member States where this research is performed plus Turkey, Israël and Switzerland  will start in Feb. 2007

  40. ? Why the EC?Why Ethics?Some Responsesto extrapolate…

  41. Europe is a Community of values, based on respect for subsidiarity while promoting shared ethics values. The integration and respect of human rights and ethics is an integral component of hESC governance in the EU Open debate, mutual respect, tolerance are axes on which the EU is focusing efforts, actions and initiatives.

  42. Maurizio SALVI, PhD, Bureau of European Policy Advisors. (BEPA), Head of the EGE Secretariat, Chair EC Inter-service Platform on Ethics and EU Policies European Commission, Rue de la Loi 200, BERL 8/146; B-1049 Bruxelles, Belgium; Tel.: 0032-2-2991179,  Fax: +32(0)2 299 45 65 E-Mail maurizio.salvi@ec.europa.eu Information available: EGE Secretariat e-mail: bepa-ethics-group@ec.europa.eu BEPA homepage: http://ec.europa.eu/dgs/policy_advisers/index_en.htm EGE homepage: http://europa.eu.int/comm/european_group_ethics/index_en.htm FP7 calls: http://cordis.europa.eu/fp7/dc/index.cfm Research on ethics: http://ec.europa.eu/research/science-society/page_en.cfm?id=3120 Conferences on ethics: http://ec.europa.eu/research/science-society/page_en.cfm?id=3131 Ethical review: http://ec.europa.eu/research/science-society/page_en.cfm?id=3115 Personal Contact:

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