1. Bioethics and Regulating Reproductive Technology Dr Heston KWONG Assistant Director of Health Department of Health, HKSAR 2 July 2008

2. 2 Reproductive technology (RT) A complex and sensitive subject Involves wide-ranging social, moral, ethical & legal implications  Moral consideration: respect of human life  Personal autonomy, human integrity  Basic community values such as family and parental responsibility  Child welfare

3. 3 Respect for Human Life Centred on ‘parenthood’ When will become a person? Judging from the ability to sense and value life? Some laws and views: A fetus can possess difference rights as it moves towards birth Some abortion law – ‘capable of being born alive’ & ‘viability’

4. 4 Personal Autonomy Procreative autonomy  A right to control their own role in procreation unless the state has a compelling reason for denying them that control ?  A duty to supply a service on demand ? Reproductive choice’s impact on others should not be ignored

5. 5 Ethics of Care That moral reasoning is not solely or even primarily a matter of finding rules to arbitrate between conflicting interests? Or try to find creative solutions that can remove or reduce conflict rather than simply ranking interests or setting one’s priority? Priority is to foster dignity of individual and welfare of child Intervention must avoid harm to human relationships

6. 6 Why regulate? Neither against nor for, but should be safe Informed choice Child ’ s welfare

7. 7 Aim of regulation To ensure the safe and informed practice of reproductive technology (RT) In a way which respects human life, the role of family, the rights of service users and the welfare of children born through RT

8. 8 History Donor insemination and artificial insemination by husband are available since 1970’s IVF since 1986 1987, Committee on Scientifically Assisted Human Reproduction (SAHR) was established Interim report on surrogacy and artificial insemination

9. 9 Recommendations by Ethics Committee Storage and disposal of embryos Embryo research Welfare of child Posthumous use of gametes and embryos Sex selection and use of fetal ovarian, testicular tissue in infertility treatment and research Genetic manipulation the embryo research

10. 10 Council on Human Reproductive Technology (CHRT) CHRT established under HRTO in 2001 3 statutory committees-  Inspection Committee (2001)  Investigation Committee (2001)  Ethics Committee (2001) 3 working groups (WG)-  WG on Code of Practice (2001)  WG on New Development in RT (2001)  WG on HRT Activities Information System (2005)

11. 11 Regulation of RT Statutory provisions  Human Reproductive Technology Ordinance & Regulation Code of Practice  The Code of Practice on Reproductive Technology and Embryo Research

12. 12 HRT Ordinance & Regulation Regulate RT procedures Regulate the use of embryos and gametes, for research and other purposes Regulate surrogacy arrangements

13. 13 Activities that are prohibited Commercial dealings in gametes, embryos, fetal ovarian or fetal testicular tissue Sex selection achieved by RT - unless to avoid a sex-linked genetic disease In connection with embryos, e.g. creation of embryo for research; cloning of embryo Surrogacy arrangements on commercial basis Using donated gametes in surrogacy arrangement Provision of RT procedures to unmarried persons

14. 14 The Code or Practice To supplement the statutory requirements in the HRT Ordinance and Regulation Sets minimum standards which aim to support best clinical and scientific practice  To safeguard the health & interest of service users  To protect welfare of children born through RT Will take COP into account when consider granting, renewal, variation, revocation or suspension of license

15. 15 Sex selection NOT allowed for social reasons Only for avoiding the birth of a child with severe sex-linked genetic disease To prevent abuse, require not less than 2 registered doctors to certify the need Report to CHRT within 3 months after the procedure

16. 16 Surrogacy NO commercial surrogacy NO donated gametes in surrogacy arrangement Counseling for commissioning couple and surrogate mother (and her husband, if any)  doctors to explain medical implications and consequences  legal advisor to explain the legal implications  social worker and/or clinical psychologist to explain the social and moral impacts

17. 17 Surrogacy (cont’d) Assess suitability of surrogate mother by a registered doctor not responsible for the RT for surrogacy In assessing surrogate mother (and her husband, if any), welfare of child is of paramount importance Report to CHRT within 3 months after the procedure

18. 18 Donation Gametes/embryos from any single donor should not be used to produce more than 3 live birth events in Hong Kong To minimize risk of inadvertent incest in the offspring Report to CHRT within 1 week after the donor’s gametes/embryos are used and report any successful pregnancy and birth

19. 19 Register A CHRT keeps identifying information of donors, recipient couples and children born from donated gametes/embryos for 80 years Without disclosing the identity of the donor, an adult (aged 16 years or older) has the right to ascertain whether –  he/she had been conceived from the donated gametes as a result of RT procedure; or  he/she and a person he/she proposes to marry might be related To avoid the possibility of accidental incest

20. 20 PGD NOT for selecting a baby with abnormality or with some desired social, physical or psychological characteristics Only for detection of serious genetic conditions or abnormalities that significantly affect the health of an individual who might be born PGD + tissue typing will be considered by CHRT on a case by case basis

21. 21 Embryo research To respect human life and protect dignity of human NO creation of an embryo for research, keeping or using an embryo after the appearance of the primitive streak, combining human and non- human gametes/embryos, cloning, etc Only essential embryo research will be granted

22. 22 Challenges Licence applications  Licensing system completely new system in Hong Kong  RT practitioners may not be familiar with requirements for submission of applications  Require clarifications/requests for supplementary information from applicants  May lengthen the licensing process

23. 23 Challenges Unique local situation  RT treatment process may be provided in different premises  e.g. AIH license : Assessment, counseling and insemination in clinic while sperm-washing done in separate laboratory  e.g. Treatment licences: IVF centres with “satellite centres” / associated practitioners

24. 24 Challenges Resources constraint  Manpower  Time

25. 25 Challenges RT is a fast developing area New developments in RT Need re-examining RT practices in view of changing societal norms, values and overseas trends

26. 26 Thank you!