MEDICAL ETHICS
M19 Junior Clerkship
Edward Lau
[01] ETHICAL ISSUES & REGULATION OF ASSISTED REPRODUCTION
ASSISTED REPRODUCTION
•
Subfertility/Infertility is defined as the inability to conceive after one year of regular unprotected sex
•
Causes – (1) no ovulation, (2) tubal factors, (3) endometriosis, (4) male factors, (5) unexplained
•
In general, number of eggs collected and pregnancy rate both decrease with aging
REPRODUCTIVE RIGHT
•
Definition [WHO]: ‘The basic right of all couples and individuals to decide freely and responsibly the
number, spacing, and timing of their children and to have the information and means to do so, and the
right to attain the highest standard of sexual and reproductive health. It also includes the right of all to
make decisions concerning reproduction free of discrimination, coercion, and violence.’
•
Supported by the Universal Declaration of Human Rights, the International Human Rights Law, etc.
•
Mostly on negative rights (obligations on society to NOT interfere with you doing something) but limited degree of
positive rights (obligations on society to give you things)
TYPES OF ASSISTED REPRODUCTION
•
Intrauterine Insemination (IUI)
[sperm preparation/selection à timing using hCG à inseminate close to the site of fertilisation]
[Artificial Insemination (AI): cause conception by mechanically delivering sperm to female reproductive tract without sex]
•
In-vitro Fertilisation & Embryo Transfer (IVF-ET), Frozen-Thawed Embryo Transfer (FET)
1)
stimulation of ovaries: achieved by clomid or gonadotrophin, increasing the no. of follicles to 2 to 3
2)
egg collection
3)
fertilisation
4)
embryo transfer
•
Freezing of Gametes/Embryos/Ovarian Tissue
•
Sex Selection
•
Surrogacy
•
Preimplantation Genetic Diagnosis (aka Designer Baby)
Possible Side Effects
Multiple Pregnancies (20%)
Ovarian Hyper-Stimulation Syndrome (4%)
Ectopic Pregnancies (5%)
Bleeding (Ovaries, Pelvic Infection)
Advantages of IVF
Continuation of Bloodline (Concept of Family)
Successor
Fulfilment of Other’s Expectations
A ‘Complete’ Family
ETHICAL CONCERNS
•
Criticism from the Church: ‘Without Edwards, there would be no market for human eggs; without
Edwards, there would not be freezers full of embryos waiting to be transferred to a uterus or, more likely,
used for research or left to die, abandoned, and forgotten by all.’
THE NATURAL-NESS ARGUMENT
•
AI and IVF are both immoral because they are not natural
i.e. the processes of life are self-justifying and natural à no interference can be justified
including surgical birth, birth control, and surgery, etc.
ARTIFICIAL INSEMINATION, AI
•
Major concern is the source of sperm, husband (homologous) or donor (heterologous)
•
Homologous Artificial Insemination (AIH) – objected by only by the most conservative
•
o
Even masturbation is unnatural and immoral
o
Unitive-Procreative Link should be inseparable
Heterologous Artificial Insemination (AID) – with more serious ethical objections
o
Immoral due to the involvement of a third party
o
Identity of the Donor & Ethics of Anonymity
o
Identity Crisis of the Future Child
MORAL STATUS OF EMBRYO
•
Production of excess number of embryos à selection of embryos + discarding of poor-quality ones
[HK allows the transfer of > 3 embryos, some European countries only allow a max. of 2 to avoid multiple pregnancies]
•
The Big Question – when does the moral right to a life begin?
For
Against
Ethics Advisory Board, USA:
Foetus is a Potential Person
‘not the same right enjoyed by a human person’
[Person should not be killed à Foetus should not be killed]
Supported by the UK (Warnock Committee) and
Should not Deprive the Human of a ‘Future-like-Ours’
Canada (The Ontario Law Reform Commission)
[Killing a person does that, killing a foetus does that too]
USE OF EMBRYOS CREATED BY IVF
•
Stem Cell Research requires Surplus Embryos from IVF
à many are trying to disallow the creation of embryos for the harvest of stem cells
à how to ensure there is no coercion or exploitation?
•
Surplus Embryos – should they be kept? should they be used for research?
SURROGATE MOTHERHOOD
•
Biological Mother – the one that provides the egg
•
Gestational Mother – the one that provides the womb (the baby has no genetic link with her)
•
Social Mother – the one that raises the child
•
Surrogacy – full (gestational only), partial/traditional/straight (gestational + biological)
For
Against
Surrogacy is a legitimate business transaction
Oneself cannot be a marketable object, e.g. slavery
(both parties = voluntary)
Surrogacy provides significant help to infertile couples
Degrading one’s human dignity
Encourage a way thinking of one’s body as standing somehow
apart from one’s self
•
Other Controversies
o
Blurring of the Family Boundaries – who is the mum? what if both mothers claim the baby?
o
Emotional Trauma to the Surrogate Mother and the Child – bonding? separation?
o
Rejection of Abnormal Child by Both Parents
o
Short/Long-term Effect on the Child of the Surrogate
o
Long-term Effect on the Child
REGULATION OF HUMAN REPRODUCTIVE TECHNOLOGY (HRT) IN HONG KONG
HUMAN REPRODUCTIVE TECHNOLOGY ORDINANCE (CAP. 561)
•
To regulate HRT, and the use of embryos and gametes for research and other purposes;
•
To confine the provision of HRT procedures to infertile couples;
•
To regulate surrogacy arrangements;
•
To establish a HRT Council;
•
To provide for matters incidental thereto or connected therewith
Significant Prohibitions
•
Provision of HRT to Unmarried Person
•
Sex Selection
•
Using Donated Gametes in Surrogacy Arrangement
•
Commercial Dealings in Gametes or Embryos
•
No creation of human embryos for the purpose of research
Human Reproductive Technology Council
•
Composition
chairperson and deputy, social worker, legally-qualified member, representatives from (1) the specialty of O&G or any relevant
activities, (2) any organised religion, (3) teaching of any theology, philosophy, or ethics, (4) psychiatrist/psychologist, (5)
sociologist, (6) registered nurse, (6) the Secretary for Food and Health, (7) the Director of Health, (8) the Director of Home
Affairs, (9) the Director of Social Welfare
•
Functions
o
To keep under review information about
(1) Embryos and any subsequent development of embryos,
(2) Relevant activities, and
(3) Surrogacy arrangements
o
To regulate and issue licences on HRT and relevant activities
o
To publish lists of licensed premises and relevant statistics and summaries concerning HRT
activities which have been carried on by the centres
o
•
To provide general information about HRT to service providers and the public
Committees
o
Ethics Committee
(1) seek the views of the public on any of the social, moral, ethical, and legal issues that arise from HRT procedures
(2) provide advice to the Council on any of those issues, whether consequence of the committee’s function
(3) liaise and co-operate with any other committee or body concerned with any of those issues
o
Inspection Committee
(1) conduct inspections of premises for the purposes of granting licences
(2) make recommendations to the Council in respect of (1) the grant of licences; and (2) any condition to which
any licence, or class of licence, may be subject
o
Investigation Committee
(1) conduct an investigation into any matter which may give rise to the Council exercising any of its powers to
revoke, vary, or temporarily suspend a licence
Code of Practice on Reproductive Technology and Embryo Research (2013)
[by Council on Human Reproductive Technology – http://www.chrt.org.hk/english/service/files/code.pdf]
•
•
Sets standards in what should be offered by the clinic
o
A guidance for good practice à supporting proper clinical and scientific procedures
o
Safeguards the health and interests of service users
o
Protects the welfare of children born through reproductive technology
100% compliance is not mandatory – some breaches may be more serious than the others
•
Assessment of Donors of Gametes & Embryos (Chapter 4: Assessment of Clients, Donors, and Welfare of Children)
o
4.5
RT centre must ensure that all potential donors are carefully screened
o
4.9
female donors should be below the age of 35 and make donors should be under 55
[for female donors, the age might be exceeded in appropriate circumstances]
•
o
4.10
gametes should not be taken from anyone under the age of 18 unless in exceptional cases
o
4.11
gametes must not be taken from anyone incapable of giving a valid consent
Advice to Donors & Payment to Donors (Chapter 5: Information to Clients and Donors)
o
5.6
RT centres should also advise donors on other relevant information disseminated by the Council such as
(a) protection provided under the Ordinance regarding the anonymity of donors and the confidentiality
of patients; (b) the fact that, under the Laws of Hong Kong, donors will not be regarded as the parents of
child(ren) born from their donated gametes/embryos; (c) the fact that, under the Ordinance and its
subsidiary legislation, RT centres are required to register with the Council certain information on donors;
and (d) the fact that reimbursement may only be made in accordance with the provisions of the Ordinance
20 (please see paras. 5.7 and 5.8 and Appendix II for details).
o
5.7
under the Ordinance, donors should not be paid for the supply of gametes or embryos, except for
reimbursing or defraying – (a) the cost of removing, transporting or storing an embryo or gamete to be
supplied; and (b) any expenses or loss of earnings incurred by the donor
o
5.8
guidelines for payment to donors are at Appendix II. RT centres shall follow the guidelines strictly such
that gamete donors shall not be paid more than the maximum daily payment level
Summaries of Appendix II
Loss of Earning
≤ HKD 380 / day
Travelling Expenses
≤ HKD 300 / day
Miscellaneous expenses, e.g. work cover
≤ HKD 380 / day
Minding services if receipt provided
≤ HKD 240 / day
For oocyte donation,
travelling for person accompanying donor
•
≤ HKD 300 / day
*Medical expenses apply for oocyte donor only
Gender Selection (Chapter 13: Gender Selection)
o
13.1
The use of RT procedures for the purpose of foetal sex selection for avoidance and prevention of the
birth of a child with a severe sex- linked genetic disease should only be offered in cases where not less
than 2 registered medical practitioners each state in writing that such selection is for the aforesaid
purpose and that the disease sought to be avoided or prevented would be sufficiently severe to a person
suffering it to justify such selection
o
13.2
Sex selection for social reasons or for reasons other than the avoidance or prevention of the birth of a
child with a severe sex-linked genetic disease is prohibited under the Ordinance
•
Designated Donation (Chapter 14: Record Keeping and Information Management)
o
14.9
Designated donations of sperm/eggs/embryos should not be permitted unless under special
circumstances. RT centres should report to the Council on such cases in writing within 3 months after
completion of the procedure for each treatment cycle. It is advisable to submit this report together with
the appropriate DC Forms (as in Annex III), as required in para. 14.6. Information should include personal
particulars of the donor(s) and the recipient couple, the approval number for the use of donor
sperm/egg/embryos as provided by the Council, their relationship and detailed justifications as to why the
donation has to be designated
[02] ETHICAL ISSUES IN CLINICAL GENETICS
TESTING THE MOTHER
•
When the mother is diagnosed with BRCA mutation positive, should that information be disclosed to
her relatives, esp. her offspring? Do they have the right to know or is it more important to protect the
mother’s confidentiality?
•
Royal College of Physicians: ‘…the rule of confidentiality is not absolute. In special circumstances, it may
be justified to break confidence where in doing so a serious harm can be avoided.’
Before the breach of confidence, physician should generally:
(1) attempt to obtain consent to disclosure from the patient in question
(2) have discussed the case with experienced professional colleagues
(3) tell the patient they intend to breach this confidence and why
(4) keep any disclosure to that which is strictly necessary for the communication of risk
(5) document discussions with the reasons for disclosure without consent
•
The sharing of family history and clinical information among healthcare professionals is only allowed
for the purposes of healthcare, and disclosure is between the professionals who share in their duty of
confidence
Options of Predictive Genetic Testing
PROS
CONS
Certainty about the future
Uncertainty may be more comfortable
Ability to plan
Difficult to break bad news
Empowerment
Burden of telling significant others
Reproductive choice
Change in family dynamics
Treatment options
Implications in health, psychosocial, and familial issues
Provide information to relatives
TESTING THE OFFSPRING
•
Indirect Genetic Testing – genetic testing by proxy
o
Balance the Rights of those who want to know and those who don’t
o
Counselling on Implications to Relatives à offer supports to them
o
Encourage Communication
•
Canadian Paediatric Society Guideline (2003, re-adopted in 2011)
‘Current guidelines state that genetic testing of children is recommended only under circumstances where a clear medical or
psychosocial benefit to the child can be demonstrated.’
o
The best interest of the child should be the primary consideration
o
Timely medical benefit should guide genetic testing
o
Open, age-appropriate discussion with the family regarding potential psychological and social
risks should be provided
o
For conditions that will not present until adulthood, testing should be deferred until the child
is competent to provide informed consent
o
Carrier testing for conditions that will be important only for reproductive decision-making
should be discouraged until the child is able to participate fully in the decision
o
A competent, well-informed adolescent requesting genetic testing for the purpose of
reproductive-decision making, should receive appropriate counselling
o
Although a physician is not obliged to carry out testing when is no medical or other benefit,
exceptional circumstances exist when not testing may create more harm
o
Infants and children being considered for adoption should not be subjected to testing when
there is no timely medical benefit
•
Factors in Genetic Testing in Minors, e.g. right to know, stigmatisation, distortion of family perception,
anxiety/depression, adverse effect on self-esteem, denial of his future role in decision making
IF SHE WANTS A BABY
•
Reproductive Options
o
Natural Pregnancy
o
Prenatal Diagnosis, e.g. amniocentesis, chorionic villi sampling
o
Pre-implantation Genetic Diagnosis, PGD
[removal of blastomere from blastocyst à embryo transfer]
o
Gamete Donation
o
Adoption
PRE-IMPLANTATION GENETIC DIAGNOSIS (PGD)
•
Primarily used to detect serious early-onset diseases and for which there is no postnatal treatment
e.g. unbalanced chromosome translocation, cystic fibrosis, !-thalassaemia, Duchenne Muscular Dystrophy
•
Advantages: (1) protect future of children, (2) allow parents to choose, (3) avoid termination of
pregnancy, (4) possibility to select for a saviour baby
Concerns about Pre-Implantation Genetic Diagnosis
•
Excessive Embryo Wastage
[e.g. only 50% of eggs can be used in BRCA+ à offends the moral consciousness of women contemplating using IVF-PGD]
•
Eugenic Involvement
st
[21 century eugenics driven by industries-consumers instead of totalitarian governments]
•
Uncertain Effects on Children
[unknown side effects of IVF-PGD on children à ever-expanding list of PGD-screening conditions à ?slippery slope]
•
Unjust Distribution of PGD Service
Concerns about the Detection of BRCA using PGD
•
Lack of Certainty of Definitive Link between the Gene and Disease
[presence of defective gene does not imply the certainty of cancer, esp. for BRCA2]
•
Potential New Therapy
[late-onset à potential to nullify the effects of the gene + not a death sentence if the patient takes steps to prevent disease]
•
False Security
[absence of gene gives a sense of ‘false security’ but the usual rate of CA breast in the general population is around 12%]
•
Burden for BRCA Carrier
[for a carrier to abandon a defective gene-containing egg is telling herself to be ‘not worth the life’]
[many are known to abandon the procedure halfway because of its rigorous demands]
TESTING THE BABY
•
If the mother has no known defective gene but her offspring is found to have it, do we test her?
•
Genomics England – what will we be telling the participants?
Principle – only details about clinically-significant condition(s) are disclosed
o
Information about the patient’s main condition
o
Information about serious and actionable conditions is optional
o
Carrier status for non-affected parents of children with rare disease is optional
NEW TECHNOLOGIES IN GENETIC TESTING
•
Next Generation Sequencing, NGS
the umbrella term for the new technology
•
Whole Genome Sequencing, WGS
the entire genomic sequences of an individual
•
Whole Exome Sequencing, WES
only the exome (all exons) of an individual
•
Targeted Sequencing
based on the clinical manifestation, focusing on disease-associated genes
[03] THE DERIVATION & USE OF HUMAN STEM CELLS
FEATURES AND APPLICATIONS OF STEM CELLS
•
•
•
Features
o
Rare Population
o
Self-renewal
can divide infinite times and undergo asymmetric division
o
Multi-potency
can differentiate into specialised cell lineage, requires ECM niche
o
Quiescence
Natural Sources
o
Embryonic
o
Umbilical Cord/Blood
o
Somatic (Adults)
e.g. bone marrow, skin, brain, adipose tissue
Artificial Sources
o
Somatic Cell Nuclear Transfer (SCNT), or Cloning
o
Cell Fusion, e.g. fusion of differentiated cell and pluripotent cells
o
Cell Extract
o
Induced Pluripotent Stem Cells (IPSC)
[makes use of growth factors, e.g. OCT4, SOX2, c-MYC, and KLF4]
•
Clinical Applications of Stem Cells
o
Cell Replacement, e.g. for transplantation (BM, skin), tissue engineering
[coating stem cells on a synthetic trachea scaffold for implantation à no immune rejection]
o
Gene Therapy, e.g. for congenital and genetic disorders
[makes use of carriers, such as retroviruses]
o
Disease Study & Drug Development, e.g. disease models
[for the study of molecular biology, drug effects & toxicity, and congenital defects, etc.]
ETHICAL ISSUES OF HUMAN STEM CELLS
•
Principles
•
Sources
•
Moral Status & Personhood
•
Applications
PRINCIPLES
•
Beneficence & Non-Maleficence
[e.g. Is it beneficial for the bone marrow donor? Is it bad for the bone marrow recipient?]
•
Autonomy (Informed Consent)
•
Proportionality
[uses of stem cells are only justified if they serve important and worthwhile goals and purposes]
•
Necessity or Subsidiarity
[uses of stem cells are only justified if no ‘reasonably’ suitable alternatives exist]
SOURCES OF STEM CELLS
•
Classified by Contentiousness – different countries allow different levels of contentiousness
Minimally Contentious
non-ESC (embryonic stem cells), e.g. umbilical cord (blood), somatic source
Mildly Contentious
?ESC, e.g. foetal germ cells, foetal stem cells
Moderately/Highly Contentious
ESCs, e.g. IVF surplus embryos, IVF-created research embryos,
SCNT, e.g. using human ovum, using animal oocytes
Minimally Contentious
•
Umbilical Cord (Blood) non-invasive, small amount, mainly HSCs for blood diseases
some mesenchymal & endothelial SCs (e.g. can generate pancreatic !-cells)
•
Somatic Stem Cells
ethically most acceptable as no embryo is involved
technically-promising, more tissues found to have somatic SCs
•
a child who is born to provide an organ/cell transplant to a sibling
Saviour Baby
[In the UK, it is allowed to use IVF procedures to select embryos that will be a genetic match to
older siblings, but only when they have a life-threatening disease, such as rare blood disorders.]
For
Against
Save life of a sibling
Saviour sibling is born for an ‘instrumental’ purpose
Parents are highly committed to the well-being of both children
Creation of so-called ‘designer baby’
Saviour sibling doesn’t mean an unhappy life
Doubtful child welfare (physical/psychological harm)
Moderately/Highly Contentious
•
ESCs are pluripotent – however, similar ethical issues as in abortion and IVF
MORAL STATUS & APPLICATIONS
•
The Argument of Decisive Moment – when does the foetus acquires the partial/full moral status?
Roman Catholic: ‘From the moment of its conception, life must be guarded with the greatest care.’
Judaism: ‘0 to 40 days after conception.’
Islam: ’40 to 120 days after conception.’
Biology: Completion of fertilisation and formation of the human zygotes take around 24 to 36 hours. Early embryo (up to 3
days) depends on maternal mRNA for biosynthesis. Totipotency of early embryonic cells lasts for 4 to 6 days. Twinning and
fusion are possible up to 14 days. Appearance of the primitive streak is around 14 days. Foetal viability ex-utero is around 22
th
to 26 weeks. Complete delivery of the foetus is achieved by 40 week. Infant is conscious, self-conscious, with memory, and
with interests and desire at around 18 months after delivery. Which cut-off should be taken?
•
Surplus Embryos from IVF in Blastocystic Stage (6 days), e.g. should they be donated?
•
IVF-Created Embryos for the Intention of Harvesting, similar argument as mentioned before
For
Against
Less contentious source of embryo
Donation of embryos are reimbursed à sales?
Embryos will never be implanted à ‘nothing is lost’?
SC lines are immortal + Patentable à monetary gains?
Improve humanity
Why surplus human embryos to being with?
Somatic Cell Nuclear Transfer, SCNT (aka Cloning)
•
Fusion of nucleus from the patient and an enucleated oocyte à genetically-identical baby (cloning)
Fertilised Embryo
Cloned Embryo
Created by Conception
No Conception
Genetically Unique
No New Genetic Combination
High Potential to Develop a Normal Baby
Product of Laboratory-assisted Technique
Little (if any) Potential to EVER Develop a Normal Baby
•
Creating Stem Cells by SCNT (Cloning)
[less moral value & right to live, less immunological rejection à still being objected due to possible reproductive cloning]
REGULATIONS IN HONG KONG
•
Regulated by the Human Reproductive Technology Ordinance (Cap. 561)
•
Supervised by the Council on Human Reproductive Technology
SIGNIFICANT REGULATIONS IN THE ORDINANCE
•
No creation of human embryos for the purpose of research
•
All research usage of human embryos outside human body must be licenced by the Council and
approved by the research ethics committee
•
No research is allowed to use embryos after the appearance of primitive streak (day 14)
•
No human cloning (SCNT) or making hybrid embryos
•
Derivation of human ESCs is ethically permissible by using excess embryos from HRT procedures,
provided no alternative sources are available
Alternative Source of hESC – Induced Pluripotent Stem Cells (iPS)
•
Comparable morphology, proliferation, differentiation capacity, and gene expression
•
Can be used in gene therapy, disease models, and drug development
•
Ethical Issues
•
o
No conception and involvement of embryos
o
However, should the ethical issues of ESCs be applied to all other cells?
iPS has been used in clinical trials and shows promising results (very limited data)
APPLICATIONS OF STEM CELLS
•
Being used globally in thousands of clinical trials
•
Possible Novel Treatment of previously-incurable diseases – data remains limited
o
However, it is widely publicised (esp. in the US) as being effective and safe
à lack of peer-reviewed evidence
à apparent non-compliance with the federal regulations
•
•
Stem Cell Tourism
o
Patients travel to countries that allow stem cell therapy
o
Even though the therapy may be costly and possibly harmful, it offers the patients hope
o
Patients are too desperate for the therapies to go through the proper regulatory processes
‘Guidelines for Stem Cell Research and Clinical Translation’, prepared by the International Society of
Stem Cell Research (ISSCR), is now regarded as a guidance for related therapies and research
[04] LEGAL ISSUES IN REPRODUCTIVE MEDICINE
ON ABORTION
•
Considered a Criminal Offence (Section 47 of the Offences Against the Person Ordinance, Cap. 212)
o
Unlawful supply or procure any poison or noxious thing or any instrument
o
Knowing that the same is intended to be unlawfully used with intent to procure the miscarriage of any woman
(whether or not she is with child)
o
•
Offence triable upon indictment, liable to imprisonment for 3 years
Lawful if it is a Medical Termination of Pregnancy (Section 47b)
o
Must be performed by a registered medical practitioner
o
Must be carried out in a government or approved hospital or clinic, unless two doctors are of faith opinion that the
termination is immediately necessary to save life or prevent grave permanent injury to the physical or mental
health of the pregnant woman (Section 47A(3), (4))
•
If the termination is less than 24 weeks (Section 47A(1)),
o
Requires good faith opinion of two doctors that
§
The continuance of pregnancy would involve a risk to the life of the pregnant woman
or of injury to her physical or mental health, greater than if the pregnancy were
terminated; or,
§
A substantial risk that if the child were born, it would suffer from physical or mental
abnormality as to be seriously handicapped
o
Presumption of risk of injury to the health of the woman if
§
Girl under the age of 16, or
§
Victim of sexual intercourse constituting an offence under the OAP Ordinance and
reported to the police within 3 months
•
If the termination is more than 24 weeks (Section 47A(2C)),
o
Lawful only if, in the opinion of two doctors formed in good faith, necessary to save the life of
the pregnant woman
•
o
Need to complete a certificate under Form 2A of Termination of Pregnancy Regulations
o
Certificate not to be destroyed within 5 years of the date of the operation
Gender-based Abortion has no valid ground for termination under legislation
o
If the foetus is ART-conceived, the centre should report such case to the Council on HRT
o
Medical Council also bans such abortion
•
Appropriate Counselling must be given to the woman and, with her consent, her partner
o
Termination on ground of foetal abnormality should be offered only after such counselling according to the Code of
Medical Council
o
Guidelines on Counselling (Paragraph 36.10, Code of Medical Council):
Both pre-test and post-test; trained personnel; preparation for possible psychological sequelae; disclosure of full
information including risks, limitation and re liability; full respect for parental perception of severity of fetal disorder;
pregnant woman’s final decision
o
•
Doctors are not obliged to perform abortion against his own beliefs or views (Paragraph 36.11)
Example – Hospital Authority and Y &Z v. Secretary for Justice
o
A case of IVF gave rise to a twin pregnancy with parents being "-thalassaemia carriers. It turned out that one twin
suffered from Bart’s disease and the other is normal. If pregnancy is to term, there a 70% chance for the mother to
develop pre-eclampsia. If pre-term delivery becomes necessary, the normal twin may be adversely affected.
o
The parents, therefore, applied for court declaration for Lawful Selective Termination.
o
Application GRANTED – necessary to protect life of mother and the unborn normal twin, saving the later from serious
abnormality and this would be in the best interest of the woman.
ON ASSISTED REPRODUCTIVE TECHNOLOGY (ART)
[Please see details in Lecture 01 – Ethical Issues & Legislation of Assisted Reproduction]
Assisted Reproductive Technology
•
All such procedures are governed by the Human Reproductive Technology Ordinance (Cap. 561)
•
Guidelines and Registration are provided through the Council on Human Reproductive Technology
•
ART should not be provided to those who are unmarried, except
o
Such procedure is provided to a surrogate mother pursuant to a surrogacy arrangement,
o
Such procedure is provided to persons who were parties to a marriage when the gametes or
embryos were placed in the body of a woman pursuant to a procedure,
o
•
Such procedure is provided for the purposed of obtaining gametes
Intrauterine Insemination on same-sex couple does NOT fall within the above exceptions
[position of same-sex couples married overseas is unclear]
Legal Status of Parents (Parents and Child Ordinance, Cap. 429)
•
The Legal Mother is the Gestational Woman – irrespective of the origin and placement of embryo
[unless this is a case of adoption]
•
The Legal Father is the Husband/Partner at the time of Embryo Placement or Insemination
[unless with contrary DNA evidence]
•
Such information should be made available to clients/donors
[incl. legal status of child and parents, and child’s right to access to information on reach the age of 16]
ON GENETIC TESTING
[Please see details in Lecture 02 – Ethical Issues in Clinical Genetics]
•
Example – Surrogacy
o
It was twin pregnancy from ART with antenatal care done in another country and parents were healthy. One of the
twin was IUGR, delivered at 36 weeks in Hong Kong by C-section. The male twin was normal but the female twin had
a low birth weight with cardiac abnormalities and dysmorphic features.
o
The father queried mistake in embryo transfer and requested a genetic testing.
o
Such testing should be provided as requested, irrespective of whether the parents declare a purpose. Even if it was
a mix-up, the legal mother would still be the gestational mother and this was difficult to rebut.
•
Prenatal Screening for Common Genetic Disorder – offered as part of antenatal care
o
The pregnant woman has the right to decline screening (Paragraph 36.3 of Code of MC)
o
The doctor should ensure that the recommended procedure is reasonably safe and will lead to reliable results
[considering the (1) indications, (2) nature of the disease, (3) reliability of diagnosis, (4) risks of the procedure, and
(5) informed consent]
o
Informed Consent should be obtained – the doctor should balance the risks and benefits
o
Both Interests (pregnant woman and foetus) should be taken into consideration
ON EMBRYONIC STEM CELL RESEARCH
[Please see details in Lecture 01 & Lecture 03]
•
Reproductive Technology is defined as a medical, surgical, obstetric, or other procedures bringing about
human reproduction by artificial means
•
Definition of Embryo Research [Human Reproductive Technology Ordinance (Section 2(1))]
o
Any research involving the creation or manipulation of an embryo, whether or not implanted
o
Any procedures specified by the Secretary for Food and Health in a Gazette notice to be embryo
research
•
Licence is granted only if the project is considered necessary or desirable: –
o
To promote advances in treatment of infertility
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To increase knowledge about the causes or treatment of congenital disease or miscarriage
o
To develop more effective techniques of contraception
o
To develop methods for detection of abnormalities in embryo before implantation
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To increase knowledge about the development of embryos
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To enable such knowledge to be applied in developing treatments of serious diseases