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1 BEPA European Commission Reseach Ethics: EU approach, EC initiatives.

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1 1 BEPA European Commission Reseach Ethics: EU approach, EC initiatives

2 2 ethics of Science and Technology why the EU and why Dev. Countries? The views I express are my own and do not necessarily reflect those of the European Commission ?

3 3 BEPA European Commission European Council's conclusions June 2007

4 4 European Council conclusions advocate protection of human rights as a basis for EU external policy The European Council reaffirms the paramount importance of the ENP, which aims at consolidating a ring of prosperity, stability and security based on human rights, democracy and the rule of law, as well as supporting the process of reform and modernisation of partners in the Union's neighbourhood. EU Policy

5 5 HIV/AIDS remains a matter of serious concern. Action to tackle the global HIV/AIDS pandemic should include broad based prevention programmes, training of health care personnel, awareness raising in all groups of society and tackling the cost of treatment. (…). The pharmaceutical industry should facilitate access to affordable medicines and cooperate in securing distribution channels for drugs against HIV/AIDS together with government institutions and NGOs. EU Policy

6 6 The European Council adopted an EU strategy for a new partnership with Central Asia. This strategy will serve as an overall framework for EU relations with Central Asia, including in the fields of human rights, rule of law, good governance and democracy, education, economic development, trade and investment, energy and transport, environmental policies, migration and inter-cultural dialogue. EU Policy

7 7 The European Council, recalling the development of EU instruments and dialogue fora with emerging economies, welcomes the initiation of the Heiligendamm Process by the G8 Summit in June 2007 launching a new form of dialogue in particular with Brazil, China, India, Mexico and South Africa. (…) The Heiligendamm Process should intensify the political dialogue and foster cooperation with these countries, especially in the fields of innovation and intellectual property, investment conditions including responsible business conduct, energy efficiency and development cooperation EU Policy

8 8 The IGC is asked to draw up a Treaty (hereinafter called "Reform Treaty") amending the existing Treaties with a view to enhancing the efficiency and democratic legitimacy of the enlarged Union, as well as the coherence of its external action. The Article on fundamental rights will contain a cross reference[1] to the Charter on fundamental rights, as agreed in the 2004 IGC, giving it legally binding value and setting out the scope of its application.[1] EU Policy

9 9 –How? Dev. Funds 23 Billion Euro (2007-11) –the EC has launched an EU-Africa Partnership to develop trans-African connections for a total of 5.6 billion (EDF, 2008-2013), in which R&D is a component. FP7 53 Billion Euro –Training (People) –Science and Society –International RTD coopration –EDCTP (300 million in FP6 from EC) EU- Non-EU

10 10 BEPA European Commission Why ethics in EU International policy?

11 11 The EU regulatory frame requires research trials being approved by local research Ethics Committees (REC) and specific ethics guidelines for in introduction in the market of pharmacological products being implemented (EMEA) Legal provisions also cover: data protection, Patenting, tissues banking, EU research (FPs) etc. See EC/20/2001 or EC/44/98, 2004/23/EC etc. EU- non-EU

12 12 BEPA European Commission An example: EU-Africa

13 13 Commission/Council Secretariat Joint Paper Beyond Lisbon making the new EU-Africa strategic partnership work will cover: Democracy, security, energy, enviroment, science (HIV, poverty related diseases, good governance, human rights) EU-Africa

14 14 When? PE: avis (MEP Martens rapporteur) Réunion conjointe PE/Parlement pan-africain COREPER Troïka: octobre 2007 CAGRE: novembre 2007 Sommet: décembre 2007 Adoption: Nos priorités: Suivi et mise en oeuvre EU-Africa

15 15 Research ethics? Training? Capacity building? Gender and vulnerable groups protection? Access to treatment? IPR? EU-Africa

16 16 BEPA European Commission European Group on Ethics in Science and New Technologies (EGE)

17 17 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.

18 18 OPINIONS EGE 1998-2005 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°19Ethical aspects of umbilical cord blood banking (16/03/2004) n°20Ethical aspects of ICT implants in the human body (16/3/ 2005) n°21Ethical aspects of Nanomedicine (Jan. 2007) n°22Recommendations for the ethics review of FP7 hESC Projects (20/6/ 2007)

19 19 n° 17 Ethical aspects of clinical research in developing countries (04/02/2003) Some items: No double ethics standards No financial incentives or inducement Local ethics review Respect for local socio-cultural features Protection of individuals, gender and vulnerable groups Protection of personal data Benefit sharing

20 20 Why the EC? Why Ethics and R&D? Some personal considerations… !

21 21 The views I express are my own and do not necessarily reflect those of the European Commission. NO Yes

22 22 Why ethics at EC level? EU promotes responsible science. Embedding of ethics is required under FP7 and EU regulations on bio-medicine Human rights protection and ethics are policy items of EU policy Specific issues that should be further addressed: »Informed consent »inducement »Standards on collection of biological material »Data sharing and protection of personal data »IPR and benefit sharing »Ethics procedures in multi centres trials »International biobanks »Facilitating local capacities and provisions in REC »Avoiding ethics colonialism.

23 23 Personal Contact: 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 EGE Secretariat e-mail: BEPA homepage: EGE homepage: FP7 calls:

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