Ethics of Human Therapeutic Cloning Research in Japan - Current Debate of Drafting the Ethical Guidelines

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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

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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

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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

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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
  patients somatic cell nuclear transfer cell.
• Once ES cell research is permitted,
  therapeutic cloning may not be denied.

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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.
  

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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.

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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.)

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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
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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

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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

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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 Gods field ?
• Insufficiency of accountability of
  scientists
• 3) Impact of Dr. Hwangs case in Korea
• Distrust to scientists
• Self-restraint from scientists side

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Conclusion

1. Well balanced but sometimes very cautious
   approach has so far been taken in bioethical
   discussion.
2. 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.
3. 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.
4. Accountability of scientists is the most
   important.
5. The role of the media should be taken into
   account (not in this presentation)

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Thank you for your attention!

• Thank also to the organizers,
• in particular,
• to Professor Soraj Hongradarom.