UNESCO meeting in Cairo 5 th – 7 th May 2007

1. UNESCO meeting in Cairo5th – 7th May 2007 Prof. Dr. I.D. de Beaufort Department of Medical Ethics and Philosophy

2. Thank you for the invitation

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 shared values does however exist at the EU level as embodied in the Charter of Fundamental Rights

5. The European Group on Ethics in Science and New Technologies • The group is an independent, pluralist and multidisciplinary body which advises the European Commission on ethical aspects of science and new technologies.

6. 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.

7. The EGE’s principal features • Independent: Deliberates freely in accordance with Group’s own rules of procedure • Pluralist: Currently 15 members, appointed solely for their expertise and personal qualities • Multidisciplinary body: Experts in various disciplines

8. From GAEIB to EGE • 1991 - 1997 The Group of Advisers on the Ethical Implications of Biotechnology • 1998 - 2000 EGE’s first mandate • 2001 - 2004 EGE’s 2nd mandate • 2005 – 2009 EGE’s 3rd mandate

9. Nomination of the EGE Members • Members appointed by the President of the Commission for a term of four years (renewable) • The Group elects its own President and a Vice-President • Professor Göran HERMERÉN • Mrs Paula MARTINHO DA SILVA

10. Request for an Opinion Provided on the Request of the Commission Provided on the Group’s initiative The Parliament and the Council may also draw the Commission's attention to particular issues

11. Preparation of an Opinion • Working meetings • Hearing of experts • Studies • Public Round Tables

12. Adoption of an Opinion The EGE always endeavours to reach a consensus Opinion However, if disagreement remains regarding specific points in the full Opinion then this disagreement is recorded in the Opinion (as a “minority Opinion”)

13. Official meeting with Dr. Barroso (President of the European Commission)

14. Publication of an Opinion • Every opinion is published immediately after its adoption • Press conference • The Group’s website

15. Problems • A delicate balance: consensus and compromise • Ethics: whose ethics is it anyway? • Depth and timing

16. OPINIONSGAEIB 1991-1997 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)

17. OPINIONSEGE 1998-2000 N° 11 Ethical aspects of human tissue banking (21/07/1998) N° 12 Ethical aspects of research involving the use of human embryo inthecontext of the 5th framework program (23/11/1998) N° 13Ethical 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)

18. OPINIONSEGE 2001-2004 • N° 16 Ethical aspects of patenting inventions involving human stem cells (07/05/2002) • N° 17 Ethical aspects of clinical research in developingcountries (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(16/13/2005) • N°21 Ethical aspects of nanomedicine (2007)

19. Ethical aspects of ICT implants in the human body • -Some Pertinent Questions – How far can such implants be a threat to human autonomy particularly when they are implanted in our brains? How far can ICT implants become a threat to privacy? How far should the use of such implants to enhance human capabilities be allowed?

20. The VeriChip™ • Radio Frequency Identification Device (RFID) • (Contains an unique ID number • How does it work: • Energized by a scanner (RF) • Then emits a radio signal • Transmits ID number to a Database via phone or Internet • Current applications: • Medical records • Personal information • Financial information Current identification device: “human bar coding”

21. Current commodity devices :Smartcard implants

22. OPINION 20 –ICT IMPLANTS The Precautionary Principle “The EGE has stressed that modern information and communication technologies make mankind more powerful but at the same time more vulnerable” and, “has recommended caution as a general ethical principle with regard to information and communication technologies.” “This principle entails the moral duty of continuous risk assessment with regard to the not fully foreseeable impact of new technologies as in the case of ICT implants in the human body.”

23. OPINION 20 – ICT IMPLANTS Public Debate and Information “A broad social and political debate is needed as to what kind of applications should be accepted and legally approved, particularly concerning surveillance and enhancement. A precautionary approach is recommended by the EGE.”

24. fantasticvoyage2

25. The EGE Opinion on the ethical aspects of nanomedicine In its Opinion the EGE acknowledges that nanomedicine offers the possibility of new diagnostic, treatment and preventive methods that may open up promising areas of medicine. The opinion focuses on ethics issues arising from nanomedicine but also discusses a number of problems raised by nanotechnology insofar as they concern primarily health-related issues. The EGE underlines the vital importance of addressing concern for safety with respect to nanomedical developments(and, in fact, nanotechnology in general) and therefore advocates the need to establish measures to verify the safety of nanomedical products and to ensure that nanomedical devices are properly assessed with regard to public health. The Group proposes that institutions already operating at European and national level to protect the safety of patients and citizens should be charged with the additional task of overviewing the safety and security aspects of new tools and devised in nanomedicine. The Group then underlines the need to properly address risk assessment at national and EU level and invites relevant stakeholders to devote adequate efforts to understanding and preventing risks that may be linked to nanomedicine.

26. The EGE Opinion on the ethical aspects of nanomedicine As far as public participation is concerned, the Group argues that transparency (including openness about uncertainties and knowledge gaps) is essential for public trust in nanotechnology. The Group therefore proposes that initiatives should be taken at national and European level to prepare surveys of public perception of the benefits and risks of the applications of nanotechnologies, with special reference to medical sectors, The Group also calls for initiatives to be taken to organise academic and public debates on problems and possibilities of present and near-future nanomedicine.

27. The EGE Opinion on the ethical aspects of nanomedicine Additionally the Group underlines the need for: prospective technology assessment, including consideration of social effects (also in developing countries); interdisciplinary research on the Ethical, Legal and Social Implications (ELSI) of nanomedicine; the establishment of a European Network on Nanotechnology Ethics; and enhanced information exchange between research ethics committees in different Member States or among competent bodies in particular on toxicity studies, ELSI-related aspects of nanomedicine and informed consent procedures with regard to safety.

28. The European Group on Ethics inScienceand New Technologies to the European Commission Web site address: http://europa.eu.int/comm/european_group_ethics

29. Secretary Contact: Maurizio SALVI, PhD, Policy Adviser to the President, Head of the EGE Secretariat, European Bureau of Policy Advisors. (BEPA), European Commission, Rue de la Loi 200, BERL 8/281; B-1049 Bruxelles, Belgium; Tel.: 0032-2-2991179,  Fax: +32(0)2 299 45 65E- Mail maurizio.salvi @ec.europa.eu