Ethics ART - PDF

Revision
Notes 07/09/2017
Medico Legal
Issues
Prof. Dr. Hakimi Zainal Abidin
Assisted Reproductive Technology

• All treatments or procedures that include
the in vitro handling of human oocytes
and human sperm or embryos for the
purpose of establishing a pregnancy
Prof Dr Hakimi Zainal Abidin 1

Revision Notes 07/09/2017
§ In the last 2 decades we have seen rapid

increases in medical technologies designed
to assist in reproduction.
§ Artificial insemination – AIH, AID
§ In vitro fertilization (IVF)
§ Gamete intra-fallopian transfer (GIFT)
§ Zygote intra-fallopian transfer (ZIFT)
§ Intracytoplasmic sperm injection
(ICSI)
§ Assisted hatching – Embryo
Micromanipulation
§ Freezing
§ Sex selection
Artificial insemination
§ Introduction of washed motile sperm
either into:
§ Vagina – intravaginal
insemination
§ Cervix – intracervical
insemination
§ Uterus - intrauterine insemination
§ Fallopian tube – intratubal
insemination
§ Sperm can either be:
§ Husband – AIH
§ Donor - AID

In utero insemination
S introduction of washed motile
sperm directly into the uterus
S purpose
S to increase the number of
motile sperm reaching the
FT à increase chance of
fertilisation
S average success rate – 10 - Indications for IUI
15% in one cycle • unexplained infertility
• minimal or mild endometriosis
• mild male factor
• coital difficulties
• cervical mucus hostility
• cryopreserved sperm
In vitro fertilasation and embryo transfer

S ovarian stimulation + final maturation with single hCG injection à
removal of multiple oocytes à fertilisation in vitro and incubation à
embryo transferred back to the women’s uterus 2 – 3 days later
S remaining embryos à may be frozen for future use
S overall live birth rates 25 – 30% per cycle

Gamete intra-fallopian transfer

(GIFT)
S oocyte and spermatozoa are
combined in petri dish then
injected into the fallopian tube
via laparoscopy
S low success rate
S not commonly practice
anymore
Zygote intra-fallopian transfer

(ZIFT)
S similar to GIFT except
fertilization took place in vitro
S zygote is the injected in the
fallopian tube

Intracytoplasmic sperm injection

(ICSI)
S injection of single sperm into an
oocyte using a fine glass needle
S subsequent process similar to IVF
S generally embryo are transferred
on Day 2 to 3
S ICSI improves fertilisation rate
compared to IVF alone
S however once fertilisation is
achieved the pregnancy rate is no Indications for ICSI
better than with IVF • severe deficits in semen quality
• obstructive azoospermia
• non obstructive azoospemia
Assisted Hatching
• Small hole is made in the wall of the
embryo using either a needle,
chemical or laser

Storage of Gametes and Embryos - Freezing

§ Embryo freezing US – 400,000 embryos
§ Excess embryos are frozen to be used for stored indefinitely, many of
future embryo transfer which will not be used by
§ Oocyte freezing their genetic parents
§ Not very successful
§ Sperm freezing
§ Stored sperm to be used for artificial
insemination or in-vitro fertilisation
ART - Issues
ART Legislation
§ The continued development of new
technologies in ART means that ART
remains a complex area, scientifically and
ethically, for both clinical practice and
research. à subjected to legislation to
prevent abusing of this innovation,
including surrogacy, and for safe and moral
practice of these services
§ E.g.
§ United Kingdom
§ The human fertilisation and
embryology act 1990
§ Surrogacy arrangement act 1985
§ Malaysia?

ART - Issues
Why some believes that IVF and related
techniques are always wrong
§ Killing embryos is wrong
§ Fertility treatment involve the
production of embryos that are
subsequently not used in treatment and
are destroyed.
§ IVF is unnatural
§ Separate sex from reproduction
§ Alter the nature of traditional
relationships.
§ Enable single women or lesbian
couples to have children
ART - Issues
Why some believes that IVF and related

techniques are always wrong
§ IVF is harmful to marriage
§ Separate the procreative aspect (to
produce) of marriage from the conjugal
(relationship) aspect
§ IVF harms women
§ Men control the technologies, hence
control female reproduction
§ Perpetuate a view that women cannot be
completely fullfilled unless they have
children

ART - Issues
Artificial insemination donor (AID)
• Most religions don’t accept the Paternity issues
impregnation of one’s wife by the • Who is the father of the child if donor
sperm of a third person sperm is used?
• It’s look upon as illegitimate
• Married couple à husband is the legal
father
• Cohabiting couple à the partner is the
legal father
• If the woman received treatment alone
à no legal father
ART - Issues
Gamete Donation
• Donor gametes à donor sperm or donor
oocytes
• Donor sperm since 1800
• Donor oocyte – mid 1980

ART - Issues
Oocytes donor
Issues with oocytes donor
• Requires donor to undergoes ovarian
hyperstimulation and surgical retrival of
oocytes
• Risks of ovarian hyperstimulation syndrome
and surgical risk – must participate voluntarily
and without coercion or undue influence
• Adequate informed consent which should
include outlining: The concept of commodification,
• Associated medical risks that any “buying or selling” of
• Counselling regarding emotional benefits human gametes is inherently
• Financial compensation may leads to immoral, is an additional argument
exploitation used against remunerating women
serving as oocyte donors
ART - Issues
Artificial insemination donor (AID)
Issues with anonymity of the donor
• To what extent the anonymity of the donor
should be preserved?
• Either sperm and oocyte donor may
choose to or not to be anonymous
• Vast majority choose to be
anonymous
• What are the rights of the offspring ? • The need to know
• Rose v Secretary of State for Health [2002] • Sharing medical information
EWHC 1593, the court ruled that based on the with their genetic offspring
Human Rights Act, donor offspring could • Learning about their genetic
obtain information about their genetic parents history directly
despite previously established anonymity • Both donor and offspring have
an inherent right to meet and
develop a relationship

ART - Issues
Commercialisation issues
• AID can be commercialised
ART - Issues
Issues with multiple pregnancies
• ART increases the likelihood of multiple
pregnancies and subsequent increased demand
for obstetrics and neonatal services
• Why?
• Need for better success rate - transfer of
multiple embryos for IVF is an early and
important advance to improve procedure
effectiveness
• Patients choice or pressure
Recommendation on the
number of embryo transfer
American Society of
Reproductive Medicine 2010

ART - Issues
Issues with multiple pregnancies
• ART resulted in high order multiple pregnancy (3
or more) à fetal reduction
• although multifetal pregnancy reduction can
be performed to reduce fetal number, the
procedure:
• may result in the loss of all fetuses
• does not completely eliminate the risks
associated with multiple pregnancy
• may have adverse psychological
consequences
• moreover, multifetal pregnancy
reduction is not an acceptable option for
many women.
• Fetal right to live?
ART - Issues
Average cost per IVF cycle in

Discrimination in the provision of the US USB 9,266
service against poor.
§ Most obvious ethical challenger à
inequitable distribution of access of care
§ Economic barriers à results in
preferential availability of these
technologies to couples in a position of
financial strength

ART - Issues

§ Following IVF
§ IVF cycles often results in transferring US – 400,000 embryos
several embryos and cryopreserving other stored indefinitely, many of
embryos produced during the cycle for the which will not be used by
purpose of future pregnancy their genetic parents
§ Many of the surplus embryos are never
used
§ Preserving female fertility
§ Freezing of sperms, oocytes. embryos
before advanced age or in individuals
affected by cancer
ART - Issues
§ Issues related to preserving woman

fertility
§ Postponement of pregnancy
§ Unnatural
§ Harmful to marriage
§ Expensive à only available to
those with financial means
§ Prone to abuse à possibilities
been used and donated to other
couples / use for research

ART - Issues
Malaysia Guidelines
• couples have the right to determine

the period of storage of the genetic
Issues related to storage material
§ How long to keep? • must be made aware of the period of
maximum statutory period of five (5)
§ ?indefinite
years, which may be extended to ten
(10) years if approved by the relevant
authority, at the present this being the
Ministry of Health
ART - Issues
Malaysia Guidelines
If the frozen gametes / embryos not Can we use the embryo for
used – what to do? research?
§ Thawing and discarding No research or experimentation shall
§ Donating to research be performed using any human oocyte
and/or sperms without the explicit
§ Indefinite storage
consent of the donors and approval of
§ Donating the embryos to another the appropriate authority. At the
couple for the purpose of uterine present time, such research or
transfer experimentation is not permitted in
Malaysia

ART - Issues
Malaysia Guidelines
§ If not used – what to do? Can we donate the frozen gamete
§ Thawing and discarding / embryos?
§ Donating to research Eggs, embryos and sperms can be
§ Indefinite storage donated to treat human sub-fertility in
others with the help of assisted
§ Donating the embryos to
reproductive procedures, provided the
another couple for the purpose
unethical and prohibited factors, as
of uterine transfer
listed in Section 15 of the guideline, are
adhered to.
ART - Issues
Malaysia Guidelines
§ If not used – what to do? Can partner used the stored
gametes / embryos in the event of
§ Thawing and discarding
them getting separated, divorced or
§ Donating to research one of them becoming deceased?
§ Indefinite storage
In the event of them getting separated,
§ Donating the embryos to divorced or one of them becoming
another couple for the purpose deceased, one or the other (next of kin
of uterine transfer in the case of the deceased) cannot use
the stored gametes. The gametes will
then be destroyed.

ART – Ethical Issues
Preimplantation genetic testing (PGS &

PGD)
§ Involves genetic testing and selection of
embryos produced by in-vitro fertilization à
provide unique ability to characterize the
genetic composition of embryo prior to
embryo transfer
§ Once an embryo is created a cell is removed
from the embryo after about three days and
tested for specific genetic abnormalities
§ Benefits à can be used to avoid known sex
linked disorders
Preimplantation genetic testing

Issues:
§ Sex selection à selection purely due to
preference of the parents à skew the gender
proportions in certain nations
§ Genetic sequencing manipulation à designer
baby
Malaysia
At present, it is best that PGD be used for only severe and life-
threatening genetic diseases. It would be unethical to analyse and select
the inherited characteristics of embryos (e.g. intelligence, height, hair and
eye colour); any social or psychological characteristics or any other
condition which is not associated with disability or a serious medical
condition.

Preimplantation genetic testing

More Issues:
§ Moral status of the embryo – potential
human?
No worldwide agreement as to when human life
begins or when it acquires moral significance,
there is no agreement on the moral status of an
embryo
No agreement as to whether discarding
§ Discarding of the embryo prior to an embryo with a genetic disorder prior
implantation à ? abortion to implantation is equivalent of an
abortion
Surrogacy
§ Surrogacy occurs when one woman agrees to

carry to term the fetus for another person
§ Partial – in which the surrogate woman’s
ovum is fertilized by the husband /
partner from the commissioning couple,
either via IVF, AI or sexual intercourse,
so she not only carries the baby, but has a
genetic link with it
§ Full – in which the commissioning couple
provide both the ovum and the sperm, so
that whilst the surrogate carries the child,
it is not genetically related to her – also
known as gestational carrier

Surrogacy
§ In UK comes under the Surrogacy

Arrangement Act 1985
§ An Act to regulate certain activities in
connection with arrangements made
with a view to women carrying
children as surrogate mothers.
Surrogacy
Malaysia
§ Assisted reproduction – Guideline of the
Malaysian Medical Council 003/2006
§ In a surrogate arrangement a woman
agrees to become pregnant and bear a child
for another person/persons and to
surrender it at birth. The above practice is
not acceptable to most of the major
religions in this country. Such a surrogate
pregnancy can also potentially lead to
many legal dilemmas for the persons
involved’
§ National Council of Islamic Religious
Affairs 2008
§ Banned

Surrogacy – Ethical Issues
§ Legality of surrogacy arrangement –

United Kingdom
§ Agreements between.
commissioning couple and
surrogate woman are legal
§ However it is not legally binding in
court even with formal written
consent
§ Family judge must make decisions
on the best interest of the child, and
not the wishes of the parents or
surrogates
Legality of surrogacy arrangement -

Malaysia
• Any surrogacy agreement made • The law leans in favour
between the commissioning parents of the surrogate who would be
and the surrogate mother may be under no contractual obligation
rendered void for being against to hand over the baby to the
public policy under section 24(e) of commissioning parents
the Contracts Act 1950, which • any claim for damages by the
provides that, commissioning parents for
• ‘the court regards it as immoral, or breach of a surrogacy contract
opposed to public policy... Every for expenses incurred would
agreement of which the object or have poor prospects of success
consideration is unlawful is void’.

Issues in Malaysia
• Surrogacy and non-muslim
• any surrogacy arrangement relating
to the status of a child born as a
result of a surrogacy arrangement
remains unclear and there have been
no reported Malaysian cases on
surrogacy arrangements
• A child who is born under a
surrogacy agreement in Malaysia
where the parties are non-Muslims
would be governed by existing
Malaysian legislation
Issues in Malaysia
• Who is the child mother?
• Depends whether the surrogate
mother is married or unmarried
• Married surrogate In favour of the surrogate
• Section 112 of the Evidence mother who decides to keep
Act 1950: the child
• ‘The fact that any person was born The present laws provide her with
during the continuance of a valid suf cient recognition and
marriage between his mother and protection of her rights as a
any man,... mother over that child whose
shall be conclusive proof that he is citizenship would follow the
the legitimate son of that man’. surrogate’s husband.

Issues in Malaysia
• Who is the child mother? The child born is illegitimate
• Unmarried surrogate The surrogate holds sole
guardianship and custodial rights
and the child’s citizenship would
follow hers. The commissioning
In United Kingdom father as the biological father is not
• Surrogacy Arrangement Act vested with any rights over the
(SAA): ‘No surrogacy arrangement child.
is enforceable by or against any of
the persons making it….’
• – thus the surrogate mother
(whatever the genetic relationships)
will remain the child’s mother if she
wishes to be so.

Issues in Malaysia
• Legal rights over the child born out of surrogacy
• If the surrogate mother is willing to give
up the child à an adoption order is
required
• Section 2 of the Adoption Act 1952 Payment or reward in
provides that: ‘Father” in relation to an consideration of the adoption
illegitimate child means the natural father’. of the child is forbidden
à hence the commissioning parents (and under section 6(c) of the
natural father) may adopt the child. Adoption Act 1952
• In a proposed adoption, the written the fees to be paid to the mother
consent of the surrogate mother is of a child to be given up for
required and the child and proposed adoption are limited to
adoptive parents must be ordinarily pregnancy- and birth-related
resident in West Malaysia. medical expenses

Issues in Malaysia
• Child birth certificate – mother’s name
• Mother’s name à should be the
surrogate mother’s name
• There have been instances of
commissioning parents acting in concert
with the surrogate to falsify the
registration and birth of the child to
reflect the commissioning parents’ name
• It’s a criminal act under section 466 of
the Penal Code that carries a maximum
seven-year prison sentence or fine.
Ethical Issues
Statement
“The reproductive rights rest on the
recognition of the basic right of all
couples and individuals to decide
freely and responsibly the number, Should you provide the service?
spacing and timing of their children
and to have the information and 60 year old woman requested to
means to do so, and the right to attain have assisted reproduction in
the highest standard of sexual and order to achieve a pregnancy
reproductive health”
Ethical guidelines on assisted reproductive
A lesbian couple wanted a child
technology. National Health and Medical using AID
Research Council, Commonwealth of Australia,
1996

References
1. Assisted reproduction – Guideline of the Malaysian

Medical Council 003/2006
2. Surrogacy Arrangement Act 1985
3. Ethical guidelines on the use of assisted
reproductive technology in clinical practice and
research June 2007. Australian government,
National health and Medical Research Council
4. The potential risks of surrogacy arrangements in
Malaysia. Goh Siu Lin. Shook Lin & Bok
5. Medical ethics and law, 2nd edition. Tony Hope,
Julian Savulescu, Judith Hendrick. Churchill
Livingstone Elsevier

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Revision

Assisted Reproductive Technology

Assisted Reproductive Technology

Prof Dr Hakimi Zainal Abidin 1

Assisted Reproductive Technology

§ In the last 2 decades we have seen rapid

Assisted Reproductive Technology

Prof Dr Hakimi Zainal Abidin 2

Assisted Reproductive Technology

Assisted Reproductive Technology

In vitro fertilasation and embryo transfer

Prof Dr Hakimi Zainal Abidin 3

Assisted Reproductive Technology

Gamete intra-fallopian transfer

Assisted Reproductive Technology

Zygote intra-fallopian transfer

Prof Dr Hakimi Zainal Abidin 4

Assisted Reproductive Technology

Intracytoplasmic sperm injection

Assisted Reproductive Technology

Prof Dr Hakimi Zainal Abidin 5

Assisted Reproductive Technology

Storage of Gametes and Embryos - Freezing

Prof Dr Hakimi Zainal Abidin 6

Why some believes that IVF and related

Prof Dr Hakimi Zainal Abidin 7

Prof Dr Hakimi Zainal Abidin 8

Prof Dr Hakimi Zainal Abidin 9

Prof Dr Hakimi Zainal Abidin 10

Average cost per IVF cycle in

Prof Dr Hakimi Zainal Abidin 11

Storage of Gametes and Embryos - Freezing

Storage of Gametes and Embryos - Freezing

§ Issues related to preserving woman

Prof Dr Hakimi Zainal Abidin 12

• couples have the right to determine

Prof Dr Hakimi Zainal Abidin 13

Prof Dr Hakimi Zainal Abidin 14

ART – Ethical Issues

Preimplantation genetic testing (PGS &

ART – Ethical Issues

Preimplantation genetic testing

Prof Dr Hakimi Zainal Abidin 15

ART – Ethical Issues

Preimplantation genetic testing

§ Surrogacy occurs when one woman agrees to

Prof Dr Hakimi Zainal Abidin 16

§ In UK comes under the Surrogacy

Prof Dr Hakimi Zainal Abidin 17

Surrogacy – Ethical Issues

§ Legality of surrogacy arrangement –

Surrogacy – Ethical Issues

Legality of surrogacy arrangement -

Prof Dr Hakimi Zainal Abidin 18

Surrogacy – Ethical Issues

Surrogacy – Ethical Issues

Prof Dr Hakimi Zainal Abidin 19