Regulating In-Vitro Fertilisation Treatment in Malaysia:

Obligations to Protect and Assist the Parties

Noraiza Abdul Rahman, Mazlifah Mansoor, Mazlina Mohamad Mangsor

Faculty of Law, Universiti Teknologi MARA, Shah Alam, Selangor, Malaysia

Keywords: Harms, In-vitro fertilisation, legislation, needs, risk.

Abstract:

 The reproductive technology of in-vitro fertilisation (IVF) demands substantive response from legislators who

wish to regulate the use of this important technology, and the existing guidelines may require revision and

development in order to deal with the particular ethical issues that this technology raises. This paper aims to

explain the risks as well as the types of harms which relate to the shared morality of Malaysian society, the

parties involved and the resulting children born as a result of IVF, and further delineates why the Guideline of

the MMC on Assisted Reproduction does not adequately address these harms. In prioritising the health of the

resulting child, I advocate that the risks are of equal concern and it is appropriate for the Government to call

for legislation. It is my contention that if the protection of these identified groups is dealt with conscientiously,

and new laws are introduced, this will help to achieve the intended goal of introducing robust IVF legislation

in Malaysia. This paper will conclude that only through the enactment of legislation which accurately reflects

the cultural and religious values and the shared morality within Malaysian society, will the Government instil

public confidence in medical law in Malaysia, particularly in IVF.

1 INTRODUCTION

Today, assisted reproductive technologies (ARTs) are

available throughout most of the world and the

practice has gradually developed and is now largely

different from that used during the early days because

of refinements in laboratory technology and clinical

practices. As a result, the technologies bring with

them many new and challenging legal and ethical

issues, some of which will be highlighted throughout

this paper. This paper aims to highlight the question

of why Malaysia has to balance the IVF needs, risks

and harms in regulating the IVF practice in a way that

suits the country’s needs, cultures and religions.

Nonetheless, this paper attempts to explain the

physical and psychological risks as well as the types

of harms that relate to the parties involved and the

resulting children born as a result of IVF, and further

delineates why the Guideline of the Malaysian

Medical Council (MMC) on Assisted Reproduction

does not adequately address these harms in order to

protect and assist the parties.

2 MATERIALS AND METHODS

This paper employs a qualitative and doctrinal

research method through content analysis approach

where the Guideline of the MMC on Assisted

Reproduction is examined. It comprises of primary

and secondary sources through the library-based

research. Whilst the first encompasses of Malaysian

legislation, policies and judicial decisions, the latter

constitutes a significant proportion of online

databases content including LexisNexis, Westlaw and

others.

3 RESULT AND DISCUSSION

It is clear that ARTs are designed to address the

traumatic problem of infertility and offer powerful

techniques to help people to have biologically related

children. At root, there are three main types of fertility

treatment: medical treatment (such as use of drugs for

ovulation induction); surgical treatment (for example,

laparoscopy for ablation of endometriosis); and

assisted reproduction such as IVF and other

Rahman, N., Mansoor, M. and Mangsor, M.

Regulating In-Vitro Fertilisation Treatment in Malaysia: Obligations to Protect and Assist the Parties.

DOI: 10.5220/0010054700680073

In Proceedings of the International Law Conference (iN-LAC 2018) - Law, Technology and the Imperative of Change in the 21st Century, pages 68-73

ISBN: 978-989-758-482-4

techniques. Assisted reproduction frequently

involves the handling of gametes or embryos and

offers a wide range of methods to circumvent human

infertility including IVF, embryo transfer,

intrauterine insemination (IUI); donor insemination

intracytoplasmic sperm injection (ICSI), gamete

intra-fallopian transfer (GIFT), and zygote intra-

fallopian transfer (ZIFT), and many of these

procedures are combined with IVF. Since IVF

technology is currently the most popular and common

procedure used in public and private hospitals in

Malaysia, to overcome infertility.

Undoubtedly, the technical aspects of IVF were

first pioneered and developed by Robert Edwards and

Patrick Steptoe in Oldham General Hospital in

England, culminating in the first IVF baby in 1978

(Vaughn: 2010). The science of IVF has improved

considerably in more than 30 years since the first IVF

baby was born. Originally, this technology was

designed for women with tubal factor infertility, but

now has become the most common treatment for all

causes of infertility. Thus, it is evident that since the

arrival of the first IVF baby in the UK in 1978, IVF

technology has opened the door to a solution that

gives infertile couples hopes that infertility problems

can be overcome (The Warnock Committee: 1984).

However, whilst the point of this advancement,

particularly in relation to in vitro fertilisation (IVF)

technology is widely understood, its uses are

controversial and concerns pertaining to the

appropriate use of IVF are one of the vital matters for

public policy in Malaysia. The reproductive

technology of in-vitro fertilisation (IVF) demands

substantive response from legislators who wish to

regulate the use of this important technology, and the

existing guidelines may require revision and

development in order to deal with the particular

ethical issues that this technology raises.

The term in vitro fertilisation scientifically refers

to the uniting of sperm and egg in a laboratory dish,

instead of inside a woman’s body, to create embryos

that can be transferred to the woman’s uterus after

going through certain developmental stages outside

the body. The IVF technique itself is now well-known

among infertile couples and is fast becoming a routine

part of infertility treatment in many countries. On the

first day of IVF, an infertile woman will be given

hormone treatment which may include either pills of

clomiphene-citrate, or injections, to induce her

ovaries to produce more than one egg in her next

cycle. Having removed the eggs from the woman’s

ovaries, they then will be placed in culture in small

glass dishes known as petri dishes. Interestingly, there

are no test tubes involved in this procedure despite the

popular label of test tube babies. Sperm is then

prepared and obtained from the male partner by

means of masturbation and insemination, allowing

fertilisation to take place in at least 80 percent of the

ripe eggs. Not more than a specified number of the

selected embryos are transferred to the woman’s body

with the hope that all or at least one of them will

implant in the lining of the uterus and develop

successfully to be born nine months later. Regarding

the transfer, when the embryo(s) is or are in the

uterus, the remainder of the process is effectively out

of the hands of medical science, and it is at this point

that things are most likely to go wrong. Even with the

most experienced IVF teams, there are cases where

the majority of embryos transferred, fail to implant in

the uterus. Given that the success rate of IVF

relatively differs from one patient to another patient

depending on their age, diagnosis and length of

infertility, this means that sometimes the procedure

may have to be repeated many times and this is one

of the greatest risks attached to IVF for those

undergoing treatment (Deech and Smajdor: 2010).

This might explain why it can be physically,

financially and emotionally burdensome, but still

those burdens are often regarded as a price worth

paying to those who seek treatment, in order to have

own biological children.

3.1 The Risks to the Mother

Like any other form of reproductive technology, IVF

brings with it a long list of risks – most of which have

provoked a raft of thorny ethical questions related to

issues such as multiple births and the use of gamete

donation in Malaysia. These have led to the

introduction of legislation and other legal controls.

On the other hand, IVF is undoubtedly a great

technology which could be used to help many

infertile couples overcome their infertility and enable

them to have their own biological children. But what

few couples may not fully comprehend until they

undertake the actual process of IVF is that there are

very real risks involved. The risks are necessarily

different and asymmetrical for a couple: generally,

the woman will suffer more compared to the man as

he does not have to undergo any invasive procedure

or take drugs for superovulation as she does. She

therefore is the person who must bear the burden of

intervention and inconvenience in the IVF process

because, in IVF, the woman’s body is the focus of

medical intervention and monitoring, regardless of

the cause of infertility within the couple (De Lacey et

al: 2009). However, the stresses and emotional

pressures involved in IVF may affect men as well as

Regulating In-Vitro Fertilisation Treatment in Malaysia: Obligations to Protect and Assist the Parties

women especially after an unsuccessful IVF

procedure. These pressures in themselves are of

sufficient seriousness to justify legislation in this field

to protect the parties.

Studies have shown that there is a direct causal

link or significant relationship between stress and

reproductive failure (Nakamura et al: 2008). In

approximately 90 percent of unsuccessful IVF cases,

the patients are likely to experience a sense of failure,

loss and grief as well as, quite possibly, anger and

depression (Sutton: 2004). To support this, De Lacey

et al. (2009) assert that “the experience of infertility

and the escalating series of interventions involved in

diagnosis and treatment culminating in IVF

procedures is widely recognised to represent an

unforeseen source of stress for the majority of

couples”. Sometimes, the procedures involved can

put a strain on relationships and men may experience

feelings of stress, guilt or anxiety. For women too, the

tensions and uncertainties involved may take a toll.

During these difficult times, support should be

provided by the staff of the infertility unit, and usually

patients may find benefit and get advice from

counselling. For instance, the European Commission

in July 2008 issued a proposal for a directive of the

European Parliament and of the Council on the

application of patients’ rights in cross-border health

care, which states that a physician has a partial

responsibility for the patient he/she refers, especially

regarding the provision of information and

counselling (Pennings: 2008). It is suggested that this

requirement should also be extended to all countries

that offer IVF across the world. Hence, patients

should be able to receive counselling in any country

they are receiving IVF in, as it is vital for them to fully

understand the effects and consequences of the

treatment. Thus, it is true to say that whilst embarking

on IVF may ultimately fulfil the couple’s quest for a

child, in the meantime, it is likely to involve physical

risks and negative emotions during the process.

The evidence on IVF techniques and procedures

shows that IVF cycles can pose severe health risks for

the mother. The whole procedure of IVF (the

superovulation, the surgery, the monitoring, the

transfer, the waiting) and then any subsequent

pregnancy and delivery, demands physical and

emotional strength and can be uncomfortable,

inconvenient and stressful (Vaughn: 2010). There is a

chance of complications from taking the fertility

drugs to stimulate ovaries, including abdominal pain,

memory loss, mood swings and headaches; and the

surgery itself comes with a risk, however low, of side

effects such as bleeding, infection and damaged tissue

(Sutton: 2004). Perhaps the most worrisome among

these is a rare, but potentially dangerous condition

known as ovarian hyperstimulation syndrome

(OHSS), characterised by swollen and painful ovaries

caused by the drugs used for superovulation. In its

severe form, OHSS can cause nausea, vomiting,

sudden weight gain and fluid retention, difficulty in

breathing, the formation of blood clots and, very

rarely, death (Deech and Smajdor: 2015). In relation

to these risky circumstances, there was a case in the

UK where a woman named Temilola Akinbolagbe

suffered a massive heart attack two days after she

began IVF treatment. It was discovered that her body

reacted fatally to the drugs given for ovarian

stimulation and sadly her life-support machine was

switched off five days after she was admitted to a

hospital in London. She had been a healthy young

woman who had simply yearned for a child via the

treatment. Similarly in Malaysia, a newspaper report

recently revealed that a young woman died after

going through an intrusive IVF treatment in a fertility

clinic. The cause of death was due to her “multi-organ

failure secondary to ovarian hyperstimulation

syndrome” (Khoo: 2011). It was believed to be the

first death in the history of IVF in Malaysia.

Besides the risks attached to mother, there are also

concerns that IVF may lead to birth defects, low birth

weight and diseases such as cancer, for the potential

future children. Multiple pregnancy, which is a

common result of IVF transfer involving more than

one embryo, potentially raises the risks to children’s

life and health by increasing the chances of high

blood pressure, anaemia and gestational diabetes.

Having already examined the risks involved in IVF,

it is evident that multiple births resulting from IVF

can carry risks for both mother and child. For

instance, it can increase the health hazards to the

mother and her unborn children who are more likely

to be medically aborted or to be delivered

prematurely with all the attendant complications of

prematurity. Also, the children's health and

development can be affected: they have an increased

risk of cerebral palsy and they are more likely to die

around the time of their birth.

3.2 The Harms to the Resulting Child

Whilst it may be the case that no doctor wishes to

expose patients and potential children to physical

harm or psychosocial stresses involving the feelings

of failure, loss and grief, as well as anger and

depression, especially after an unsuccessful IVF

procedure, it is well-known that IVF has inherent

risks which can be minimised by adequate legal

protection. One of the serious risks associated with

iN-LAC 2018 - International Law Conference 2018

IVF is the increased chance of having a multiple

pregnancy, which can significantly increase the

development of complications for mother and baby.

It must be highlighted that ensuring safe and

effective use of IVF is the goal of ethical practice and

sound public policy in Malaysia. Enabling a child to

be born via IVF when there is a proportionate risk that

the child will be born harmed or damaged, would

raise significant public concerns. For instance, Kew

argues that the public in Malaysia expect safe and

ethical practices from all doctors, and that the public

has been critical of the medical profession,

particularly in terms of having adequate regulation

and addressing problems which are important to the

society. Yet it is not easy to determine what kind of

ethical and legal policy would be acceptable given the

wide variety of situations potentially involving harm

to IVF children. In order to identify this, a firm

understanding of the potential harm must be well

established. In other words, an analysis of the

potential harm and risk situations for the child in IVF

procedures must be developed.

Following the earlier discussions in relation to the

risks and harms in IVF and pertaining to multiple

pregnancy, miscarriage and birth defects, the

potential harm associated with its use can be regarded

as physical damage that may affect the child born as

a result of this type of treatment. It is evident that the

higher rate of multiple births in IVF due to the

implantation of several embryos in the uterus at any

one time, contributes to an increased rate of

miscarriages as well as pre-term and low birth weight

babies.

In fact, according to the UK’s Human Fertilisation

and Embryology Authority (HFEA), as IVF has

become more successful, the number of multiple

births has increased. Statistics in 2007 showed that

around 40 percent of IVF babies are twins, and

therefore three times more likely than single babies to

be stillborn. An increased rate of twin births

represents IVF's biggest risk for mothers and babies

because twin births significantly raise the chances of

mortality, prematurity, low birth weight and cerebral

palsy for babies. However, with the introduction of

single embryo transfer (SET) in 2007, the HFEA

reports that the figure dropped to 22 percent based on

the data for the first half of 2009. This shows that

clinics have been working hard to reduce the number

and risks of the multiple births in the UK. With regard

to that, Hamilton states that the biggest risk to the

health and welfare of the child born as a result of IVF

is the hazards of multiple pregnancies. These are

associated with an increased incidence of blindness,

learning defects, lung problems and other ailments. A

recent study also reveals that children in multiple

births have a greater risk of serious health problems

that can develop into lifelong impairments.

It is not only the children who are at risk - multiple

pregnancies also pose risks to mothers, including pre-

eclampsia, diabetes and heart disease. Although

Robertson (2004) believes that in order to prevent the

feared ‘injury’ to the child, parents should give up the

uses of IVF that pose those risks, I am of the opinion

that a better solution is to ensure the efficacy and

safety measures of clinical and laboratory practices in

order to reduce the burden of multiple pregnancy.

Notably, Robertson (2004) offers no explanation

pertaining to the definitions and assessment of risks,

harm and feared injury to the child that should prevent

would-be parents from using IVF and assisted

reproduction treatments. Consequently, this might

lead to an argument that giving up the treatment

merely to prevent injury is not necessarily sufficient.

an assessment of the risk of harm to the child should

be made, alongside ensuring safety measures are in

place in clinical and laboratory practices in IVF

legislation in Malaysia to ensure that the future IVF

children are afforded the maximum chance of a

healthy start in life.

Studies from the UK and Australia also suggest

that some drugs which are used to stimulate women’s

ovaries to produce multiple oocytes in IVF

procedures increase the risk of serious birth

impairments in the resulting children. Other long-

term studies have been undertaken to show the kinds

and rates of physical diseases and abnormalities

incurred by children born of IVF technology. A

cohort study shows that the rate of birth defects in IVF

children rises to around 50 compared to 35 in non-

IVF children, out of every 1000 conceived babies

(Derbyshire: 2010). The evidence also indicates that

the children born as a result of this treatment are two

or three times more likely to suffer serious diseases

such as spina bifida, heart disease and diabetes

compared to naturally conceived children. More

recently, a study has indicated that the rate of multiple

births and the risks they bring to women and the

potential children is disproportionate for all types of

fertility treatment, but especially IVF. In order to

reduce the harm and risks of IVF procedures to the

resulting children, a detailed and proper scrutiny of

IVF procedures is urgently required along with the

adoption of a regulatory framework. Peters (2004)

voices his concerns regarding the issue of harm raised

by the use of IVF technology, stating that:

Because the welfare of future people

matters, we all have a prima facie obligation

to avoid the infliction of unjustified harm on

Regulating In-Vitro Fertilisation Treatment in Malaysia: Obligations to Protect and Assist the Parties

our future children. And because their

welfare matters, lawmakers must take their

interests into account when deciding

whether to regulate a risky reproductive

procedure.

Based on Peters’ arguments it is clear that states

have responsibilities to safeguard potential children

against the harmful consequences of assisted

reproductive procedures (Peters: 2004). As of yet,

there is no standardised legislation in Malaysia to

protect IVF children from the risks of the procedures.

Rosato (2004) believes that law is the only way to

prevent this harm. She further explains that although

there is self-regulation provided by medical

professional organisations to govern fertility

practices, the system is insufficient to prevent

harmful and unethical activities. To justify this, the

assessment of harm in this legal context must strike a

delicate balance by protecting children while

respecting the parents’ autonomy and consent to IVF.

Harm to individuals and society must be a real

potential harm, although not necessarily

demonstrable and imminent as argued by Dworkin

(1978). Although the risk of harm to the child need

not be imminent, it should be at least significant and

serious. An undefined fear, or one that would not

result in serious injury, is insufficient to be used as a

justification to restrict access to IVF. There is a clear

indication that the harm posed to IVF children by

multiple births, miscarriage and birth defects is

significant and serious. As previously mentioned, in

the UK, for example, the use of multiple embryos has

been restricted since January 2009 in recognition of

the risks posed, through the introduction of SET by

the HFEA.

Since there are risks and harms associated with

IVF, particularly during and after the treatment, there

should be legislation to protect both mothers and the

potential children because the existing guideline in

Malaysia currently is inadequate to provide such

protection. Although these issues have been

addressed in the current Malaysian Guideline,

unfortunately they are not being observed and

updated appropriately, so consequently, the harms in

IVF continue to occur with no protection. It is

arguable that on the basis of the same reasoning

pertaining to the potential for harm that has been

acted upon in the UK, a law is required to ensure

compliance with the safety features contained in the

Guidelines. In a similar vein, Malaysia should adopt

similar safeguards such as the introduction of SET in

all clinics. Such safeguards will also help to alleviate

concerns regarding the roles of medical practitioners

and the State authorities in allowing parents with high

risk factors to undergo IVF, knowing that it would

pose the potential of real harm for the future child.

3.3 Why the Guideline of the MMC is

Insufficient

There are several reasons why the current MMC

Guideline in Malaysia is insufficient to govern the

provision of IVF technology in Malaysia. The

Guideline does not have the force of law behind it and

therefore is open to interpretation in the clinical

context, which means that it can be disregarded. This

has potentially deleterious consequences. Patients

may be offered treatments that are ill suited to their

clinical needs and the lack of legal enforceability of

the Guideline may lead to a failure to safeguard the

interests of the patients and the potential child,

whether these interests are medical, cultural or

religious. Hence, it is arguable that the lack of

enforcement in the Guideline can seriously affect the

quality of the IVF services provided in Malaysia.

Further, private IVF clinics are under no

obligation at all to abide by the recommendations in

the Guideline, allowing them to prioritise the obvious

financial advantages that accompany the provision of

treatment to couples from outside Malaysia, even if

such patients do not conform to the religious and

cultural concerns expressed in the Guideline. For

example, the MMC Guideline clearly stipulates that

ART should only be offered to married couples due

to the prevailing religious and cultural norms of

Malaysians, but the same condition is not

incorporated into the private hospitals’ guidelines,

with the result that IVF treatment is offered to any

couple regardless of their marital status, provided that

they have financial means to get the treatment.

In this environment, alongside concerns about

parity of access to treatment, it is important to ensure

that the treatments that are provided meet clinically

and ethically accepted standards. At present this

cannot be guaranteed because of the lack of effective

regulation. The MMC Guideline only provides that

the medical practitioners should have an effective

system for monitoring and assessing laboratory and

clinical practice, but the way in which the accepted

standard of clinical practice and the level of

satisfaction for the assessment should be interpreted

are not explained, thus leaving room for the question

as to what exactly the standards means. Schenker and

Shushan advocate that due to the fact that there is no

adequate supervision in IVF, some kind of quality

control should be urgently instituted in all clinics

offering IVF in Malaysia, since the technologies

iN-LAC 2018 - International Law Conference 2018

involve such complicated and sensitive issues

(Schenker and Shushan: 1996).

There is of course no certainty that the enactment

of a statute modelled on other legislation such as the

UK’s Human Fertilisation and Embryology Act 1990

would provide standardisation, safe and effective

treatments, or ensure equality of access. However,

given the above, it seems likely that if such a law were

enacted and properly enforced it would be an

improvement on the current position.

4 CONCLUSIONS

In prioritising the health of the woman and the

resulting child, I advocate that the risks and harms to

Malaysian society are of equal concern and it is

appropriate for the Government to call for legislation.

It is my contention that if the protection of these

identified groups is dealt with conscientiously, and

new laws are introduced, this will lead not only to

more effective control of IVF technology but will also

help to achieve the intended goal of introducing

robust and appropriate IVF legislation in Malaysia.

To sum up, it is concluded that only through the

enactment of legislation which accurately reflects the

cultural and religious values and the shared morality

within Malaysian society, will the Government instil

public confidence in medical law in Malaysia,

particularly in the areas of assisted reproduction and

IVF.

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Regulating In-Vitro Fertilisation Treatment in Malaysia: Obligations to Protect and Assist the Parties