Ryuichi IDA, Prof. Kyoto University School of Government

1. Ethics of Human Therapeutic Cloning Research in Japan- Current Debate of Drafting the Ethical Guidelines – Ryuichi IDA, Prof. Kyoto University School of Government Eighth Asian Bioethics Conference (ABC 2007) 19 March, Century Park Hotel, Bangkok, Thailand

2. Itinerary of Discussion and Regulation 1997 Birth of Dolly Announced 1997 Establishment of National Bioethics Committee 2000 Legislation of Reproductive Cloning Ban 2001 Human ES Cell Research Guidelines 2001 Guidelines on Specified Embryos 2003 First ES Cell Lines Derived in Japan 2004 Basic Idea on Treatment of Human Embryo : Decision of authorization of therapeutic cloning research 2005 Working group on human therapeutic cloning 2006 Interim Report of the WG

3. Reason of Reproductive Cloning Ban Human Reproductive Cloning ⇒Act contrary to the human dignity 1) Intrumentalization of Human Being 2) Violation of Individuality 3) Deviation from the concept of human birth leading to social and family disorder Additionally Safety of cloned “human being”

4. May therapeutic cloning be permitted ? 1) The Law bans reproductive cloning only, but not therapeutic cloning. Therapeutic cloning should be regulated by the guidelines of the Min. of Education. = No clear permission nor any rule for therapeutic cloning in the Law. 2) ES cell research is permitted for the purpose of new medical care. = “Regenerative Medicine” The goal is to use ES cell derived from patient’s somatic cell nuclear transfer cell. Once ES cell research is permitted, therapeutic cloning may not be denied.

5. Basic question = Status of embryo in research Principle “Human embryo should not be created for the purpose of research.” “ Human embryo should not be destroyed.” Human embryo has only reproductive purpose. Exception If there is an overriding reason, human embryo may be used for research. (Creation of embryo for research remains prohibited.) Which kind of embryo? = Supernumerary embryo What kind of research? = For new medical care of patients of difficult diseases. Therefore, human ES cell research is permitted.

6. How about therapeutic cloning ? Arguments for permission 1) Need for clinical application, because of immunological reason. 2) Not banned by the Law. 3) Preparedness for clinical application, once ES cell research obtains successful results Arguments against permission 1) Start to instrumentalization of human being 2) Efficiency of ES cell therapy not yet proven (remains theoretical) 3) Insufficient information and clarification on the development of ES cell research and realizability of therapeutic cloning.

7. Decision by the Bioethics Experts Panel of CSTP Permission of therapeutic cloning research Moratory Conditions 1) Establishment of Guidelines 2) Protection of woman donor of unfertilized egg 3) Effective control of ban on reproductive cloning 4) Requirement of scientific evidence (In case the research reveals unsuccessful useless, it should stop immediately.)

8. Ethical Issues of Human Therapeutic Cloning Human embryo should not be created nor destroyed for the purpose of research Research for new medical care of difficult diseases Reproductive cloning Therapeutic cloning research conditions Donation of oocyte Informed Consent Objectives of research Ethical Review ES cell derived from cloned embryo

9. Conditions : Interim Report of the WG 2006.06.20 1)Objective of research : New medical care for difficult diseases only ES cell lines should be derived 2) Donation of oocytes : Strict limitation (see the next slide) 3) Detailed Informed Consent Procedure required Coordinator = liaison function doctor /donor candidate 4) Donation of Somatic cell No new intervention or small intervention of routine kind Anonymity required 5) Strict requirements of research institution Experience required animal cloning, human ES cell derivation, participation of experienced researcher of cloned embryo of primates Appropriate ethical review 6) No permission of voluntary donation of oocytes

10. Possibible donation of oocytes １）Oocytes taken from removed ovary ２）Unfertilized egg obtained for assisted reproduction, but not used ３）Unfertilized egg stored frozen for preservation, but become disused ４）Case of death of the woman whose ovary or unfertilized egg was stored frozen

11. Factors taken into account 1) Dichotomy of opinions regarding status of embryo statistics : 70% of population think that human life begins at fertilization (little religious background) 2) Anxiety of the public toward scientific development Intrusion of science into God’s field ? Insufficiency of accountability of scientists 3) Impact of Dr. Hwang’s case in Korea Distrust to scientists Self-restraint from scientists’ side

12. Conclusion • Well balanced but sometimes very cautious approach has so far been taken in bioethical discussion. • Scientists often find these regulations too restrictive and claim the importance of freedom of research and their respect of human dignity and human rights in good faith. They are afraid of getting behind in scientific competition. • The public seems not so interested in this particular field of research. It is difficult for the public to grasp the scientific and technological as well as ethical issues concerning therapeutic cloning. • Accountability of scientists is the most important. • The role of the media should be taken into account (not in this presentation)

13. Thank you for your attention! Thank also to the organizers, in particular, to Professor Soraj Hongradarom.