Bioethics and Regulating Reproductive Technology

Dr Heston KWONGAssistant Director of HealthDepartment of Health, HKSAR2 July 2008

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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

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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’

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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

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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

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Why regulate?

Neither against nor for, but should be safe

Informed choice

Child’s welfare

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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

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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

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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

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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)

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Regulation of RT

Statutory provisions Human Reproductive Technology

Ordinance & Regulation

Code of Practice The Code of Practice on Reproductive

Technology and Embryo Research

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HRT Ordinance & Regulation

Regulate RT procedures Regulate the use of embryos and

gametes, for research and other purposes

Regulate surrogacy arrangements

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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Challenges

Unique local situationRT treatment process may be provided in

different premisese.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

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Challenges

Resources constraintManpower Time

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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

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Thank you!