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REVISITING OLD GROUND IN LIGHT OF NEW
DILEMMAS: THE NEED FOR QUEENSLAND TO RECONSIDER THE REGULATION OF ASSISTED
REPRODUCTIVE TECHNOLOGIES
MALCOLM
SMITH[*]
In recent years, there have been many advances in assisted reproductive technology, in terms of both technological advances and changes in social attitudes. The system of regulation in Queensland is in need of review since it was last considered nearly 25 years ago. The need for review is demonstrated by examining the regulation in Australia as a whole and the impact this has on regulation in Queensland. The paper considers two specific issues. The general access criteria are examined in order to determine who is able to gain access to treatment services, together with how this impacts on gaining access to, and the regulation of, in vitro fertilisation (IVF) and pre-implantation genetic diagnosis (PGD). These issues are discussed mainly in the context of creating tissue-matched children that could act as a cure for an existing ill sibling. The recent review of assisted reproductive technologies (ART) regulation conducted by the Victorian Law Reform Commission is also considered in context of how this may impact on the future regulation of other jurisdictions. The main focus however, is on future options available for Queensland should regulation be reviewed in the future.
I INTRODUCTION
The use of ART in new and controversial ways raises a range of moral
concerns and arguably an element of caution on the way that future
regulation of
such practices should progress. It has been nearly 25 years since regulation was
first considered in Queensland, and
no legislation on the regulation of ART has
been passed to date.[1] The current
system in Queensland relies on professional accreditation and guidelines. There
are several problems with such an approach
which will be demonstrated in this
article. In particular, the lack of legislation potentially enables
inconsistencies between clinics
operating within Queensland in relation to some
issues that are not comprehensively addressed by national
guidelines.
There is no regulatory body overseeing developments in ART in
Queensland and this means that new uses of the technology are not monitored.
An
example of this is the use of PGD.[2]
PGD has developed the use of IVF and involves carrying out an embryo cell biopsy
on a number of fertilised embryos in order to genetically
analyse them. This
enables a fertility clinic to determine whether certain genetic characteristics
are present in the embryo, or
more commonly, to ensure that the embryo intended
to be implanted is free from genetically inherited disease. Previously,
abnormalities
could only be discovered during pregnancy. Such advance enables
determination of whether a child is going to be healthy (at least
from a genetic
point of view) before the embryo is even implanted into the womb.
The
use of PGD in IVF treatments to prevent transmitting a genetic disease is not
radically new. However, PGD has also been utilised
to determine the tissue type
of an embryo which can be implanted in order to try and achieve a pregnancy that
will result in the
birth of a child who is a tissue type match to an existing
ill-sibling. Such children have been referred to as ‘saviour
siblings’.[3]
Once the child is born, blood stem cells from the umbilical cord (and
sometimes even bone marrow from the child) will offer the prospect
of a cure for
the ill-sibling who may be, for example, suffering from a rare blood disorder
and require a blood stem cell transplant.
The need for Queensland to
review the current regulatory approach will be demonstrated by examining two
specific issues that impact
on both the availability and regulation of PGD for
the purposes of establishing the tissue type of an embryo. Limits on access to
treatments will be considered generally and then discussed in context of those
seeking access to treatments to create a tissue-matched
child. The way in which
PGD is monitored will also be considered. The regulation of ART is addressed in
different ways throughout
Australia, and drawing comparisons to other
jurisdictions enables establishing the potential options available to Queensland
should
regulation be reconsidered. Therefore, an analysis of the broad
regulatory structure that exists in Australia is first needed to
demonstrate the
complexity of the current approach and how this impacts on regulation in
Queensland.
II REGULATION OF ART IN AUSTRALIA
The regulatory regime of ART in Australia varies significantly. The Fertility Society of Australia (FSA) requires clinics and practitioners to be accredited by the Reproductive Technology Accreditation Committee (RTAC), and the Code of Practice for Assisted Reproductive Technology Units 2005 issued by the RTAC, requires adherence to the National Health and Medical Research Council (NHMRC) Guidelines.[4] The majority of Australian States and Territories have relied on this form of regulation alone and have not passed legislation dealing directly with the issues surrounding ART. The NHMRC guidelines are not comprehensive. This is reflective of the recognition that some of the issues, such as eligibility for treatment, the posthumous use of gametes and embryos, and the use of PGD were originally considered as issues to be left to each State and Territory to decide. The Australian Health Ethics Committee (AHEC), the major committee of the NHMRC responsible for developing the guidelines, considered that these issues were beyond their remit.[5] Furthermore, there was a call for a uniform and comprehensive framework of legislation issued to all States and Territories by the NHMRC in hope that the social and ethical issues that arise with such procedures are directly addressed.[6] There has been some national consideration in response to issues surrounding ART, resulting in several recommendations for a national approach to regulation in Australia.[7]
Commonwealth legislation has been formulated in order to regulate human cloning and the practice of medical research involving human embryos and the use of excess embryos from ART procedures that are no longer needed by the participants.[8]
Many jurisdictions, including Queensland, have also passed legislation on
the subject of surrogacy.[9] Despite
such legislative development, there has been no consistent legislation on those
issues that were considered beyond the remit
of the AHEC and when the NHMRC
re-issued its guidelines in 2004 they specifically dealt with some of these
issues. Szoke et al comment
that these: ‘changes may well be because the
NHMRC’s advice in the 1996 guidelines that reproductive technologies
should
be regulated by statute in each State went
unheeded.’[10]
Only
three States have legislated directly on the
subject.[11] In such jurisdictions,
legislation prevails over both the RTAC Code of Practice and NHMRC
guidelines,[12] although for the
most part legislation on the topic is consistent with them. The structure of
regulation in Australia is far from
straightforward. Szoke comments that
‘[a]rguably, Australia may be described variously as a rich tapestry of
diversity in terms
of the regulatory structure, or a patchwork of regulatory
stitching lacking cohesion and
order.’[13] Furthermore,
Bennett comments that the: ‘regulatory framework for assisted conception
is complicated by Australia’s federal
legal
structure’.[14]
Despite the lack of consistent legislation between Australian jurisdictions, nearly all have considered the subject of ART and have at some point, appointed specialist committees to review the issues raised by the technologies and make recommendations for how regulation should progress.[15] Comprehensive legislation was passed in Victoria,[16] South Australia[17] and Western Australia[18] to regulate ART. These jurisdictions opted to operate on a license-based system with statutory bodies appointed to oversee the regulation in those jurisdictions.
III REGULATION OF ART IN QUEENSLAND
The failure of the Queensland Government to implement ART legislation
means that Queensland relies primarily on professional guidelines.
Furthermore,
many clinics in Queensland rely on recommendations made in a report issued in
1984 by a specialist committee appointed
by the Queensland
Cabinet.[19] Importantly, the lack
of legislative action in Queensland has resulted in a system of regulation
enabling the NHMRC to ‘fill
the gaps’ originally intended to be
dealt with by the legislature of each State or Territory. It is submitted that
in light
of developments in reproductive technologies, the regulatory regime is
again in need of review. Not only has the practice of ART
rapidly advanced, but
so too have social attitudes towards assisted conception and alternative family
structures, requiring the issues
to be re-examined. This paper does not seek to
establish exactly how Queensland should regulate the practice of ART, but will
demonstrate
why the current system needs to be reconsidered. After considering
the current approach in Queensland, two specific issues will be
considered to
demonstrate the need for reconsidering regulation. First, limits to accessing
ART services in Queensland will be discussed,
and second, the use of PGD for the
creation of a child with matching tissue to an existing ill sibling will be
considered.
A The Demack Report
The Queensland Cabinet appointed a Committee in 1983 to consider issues
surrounding ART. The report was delivered in 1984 and considered
whether
legislative action was required in relation to a number of issues. The Committee
made several recommendations.
At the time the report was delivered,
control of medical research and treatment was exercised on the basis of
acceptance of ethical
standards and the NHMRC had recommended to the Ministers
of Health of the States and Territories that it should be mandatory that
each
institution undertaking research, maintain an institutional ethics committee.
However, in light of the rapid development of
medical technology, the Committee
appointed in Queensland considered that entrusting issues to ethics committees
alone was insufficient.[20] The
Committee commented:
that the range and complexity of the issues of an
ethical character which have been or are likely to be thrown up by changes in
medical
technology, and the public policy implications of these issues, are such
that it would be insufficient to entrust their resolution
to the ethics
committees of particular organisations or
institutions.[21]
The
Committee therefore recommended that the Queensland Bioethics Advisory Committee
(QBAC) be established. The function of the QBAC
would include an advisory role
in relation to bioethical issues to both the Government and medical
organisations and institutions,
a responsibility to monitor advances in ART, as
well as acting as an educational resource for the
community.[22]
The Committee
also considered that ethical guidelines alone were not a sufficient form of
regulation, and that medical practice on
the topic should be controlled through
guidelines issued by professional institutions, including the proposed
QBAC.[23] Furthermore, it was
considered that legislation may be necessary in order to enforce penalties
should such guidelines be
breached.[24] Proposed legislation
would also address the issue of the status of children born as a result of ART
procedures and the legal liability
of those involved in delivering
them.[25]
The Committee also
advised that treatments should only be available to couples where there is a
known risk of a ‘severe genetic
disease or an obvious and otherwise
irremediable bar to
fertility.’[26] Furthermore,
although the Committee felt that there should be no legislative ban on granting
access to heterosexual de facto couples
in a stable relationship, priority was
to be given to married couples.[27]
The Committee also advised that before any person is admitted on to a treatment
programme, appropriate counselling should be received,
informed consent should
be obtained, and anyone involved in an IVF programme must have the right to
withdraw.[28]
Despite the
recommendations of the Committee to establish statutory regulation of ART in
Queensland, no specific legislation dealing
with ART has been passed. Therefore,
regulation of ART in Queensland relies primarily on the guidelines issued by the
NHMRC.
B NHMRC Guidelines
The guidelines issued by the NHMRC have been described as national
standards of acceptable
practice.[29] Accreditation under
the FSA’s RTAC is mandatory for ART units and requires adherence to both
the RTAC Code of Practice (mainly
addressing standards of clinical practice,
based on a ‘quality management system model of
risk-benefit’)[30] and the
NHMRC guidelines. However, there is some concern expressed with the enforcement
of these provisions. The fact that infringement
of the guidelines is not a legal
offence, like similar provisions existing in the statutory jurisdictions is one
concern. Thus, infringement
will normally lead to a loss of funds from the NHMRC
for the purpose of research or publication of infringement in
Parliament.[31] Some commentators
have stated that therefore, the guidelines are only strictly enforceable against
institutions receiving NHMRC funding
and it is possible that private
institutions not relying on NHMRC funding for research may not adhere to the
guidelines.[32] However, the FSA
considers the meaning of s 11 of the Research Involving Human Embryos Act
2002 (Cth), to encompass the use of human embryos in any way without
RTAC accreditation to amount to a criminal offence under Commonwealth
law.[33] That section states that a
person who ‘intentionally uses, outside the body of a woman, a human
embryo that is not an excess
ART embryo; and the use is not for a purpose
relating to the assisted reproductive technology treatment of a woman carried
out by
an accredited ART centre’, commits an
offence.[34] Therefore, all
clinics must be accredited and adherence to the NHMRC guidelines is required
as part of that accreditation agreement.
The Demack Report
suggested establishing a statutory framework for the regulation of ART in
Queensland, requiring the creation of an independent body
such as the QBAC to
oversee regulation. A statutory footing for ART regulation implementing an
overseeing regulatory body working
on the basis of a licensing system, may
address some of the concerns relating to the enforcement of current standards
and guidelines.
Furthermore, such a body, as was suggested, could play a part in
advising the Government of advances in the field, as well as providing
an
educational resource for members of the community.
Alternatively,
Queensland may consider that a lighter form of regulation is more justified in
light of the fact that the NHMRC guidelines
do address a number of significant
issues, such as: consent to treatment, storage of gametes and embryos,
counselling services for
participants, posthumous conception and the use of PGD.
An example of a lighter form of regulation has been put forward in New South
Wales.[35] The proposed legislation
does not seek to implement a full licensing system similar to that in other
statutory jurisdictions. The
New South Wales Department of Health comments that
a system of ‘registration’ is more appropriate because of the fact
that many issues under the ART scope are sufficiently regulated by national
guidelines.[36]
The proposed system of registration does not require compliance with a list of conditions, but is instead concerned with identifying ‘the providers of ART services in order to facilitate appropriate compliance and enforcement activity in respect of the provisions of the Bill.’[37] The main purpose of the proposed legislation in NSW is therefore to focus on aspects of ART which are currently unregulated or where there is ‘real potential for individual or social harm.’[38] This lighter form of regulation may carry some advantages. In particular, the regulatory framework may be able to respond to advances in technology more effectively, unlike a system of prescriptive legislation which requires statutory amendment and modification.[39] Furthermore, some commentators have noted that the system of accreditation and compliance with national guidelines in conjunction with legislation ‘provides an important model for how self-regulatory mechanisms can be combined with laws to achieve best practice in an area.’[40] If Queensland followed a similar approach to the proposed NSW legislation, then it would first be necessary to identify which elements are currently unregulated as well as considering aspects of ART which involve ‘real potential for individual or social harm’.[41] It is suggested that Queensland might implement a public consultation process to address the latter concerns,[42]
as social attitudes have significantly changed since the subject was first
considered in the early 1980s.
Other commentators have also identified
the need for Queensland to consider the regulation of ART focusing on, as they
were then considered,
some of the more controversial aspects of
ART.[43] These included, who should
be granted access to treatment services, and establishing a method of ensuring
that donor-conceived children
have a right to access information about their
genetic origins.[44] It is not
suggested that such issues are not still fundamental considerations in the scope
of ART. In fact, the former of these issues
is also the subject of discussion in
this paper. There is however, a need to reconsider the regulatory approach in
light of other
emerging dilemmas.
IV DEMONSTRATING THE NEED TO RECONSIDER REGULATION
A Eligibility Criteria
The NHMRC guidelines do not impose eligibility criteria determining who
may access treatment services and even though there are no
statutory provisions
addressing the issue, there has been some judicial consideration of access to
ART in Queensland. A lesbian woman,
JM, who had been in a 4-year same-sex
relationship, was denied access to treatment by a fertility clinic in
Queensland. JM took action
against the clinic, asserting that the clinic was in
breach of the Anti-Discrimination Act 1991 (Qld) for discriminating
against her on the basis of her sexual orientation. The case was originally
heard before the Anti-Discrimination
Tribunal, which found that there had been
both direct and indirect discrimination by the clinician. It was held that
direct discrimination[45] had
occurred because she was denied treatment on the basis of her same-sex
relationship, and indirect
discrimination[46] had occurred
because the clinic had demanded that consent was required by her male
partner.[47] The latter was
apparently an unreasonable
request.[48]
The Queensland
Supreme Court overturned both findings of discrimination holding that the
clinician had not discriminated directly
against JM on the basis of her
relationship, but on the basis that she was not medically
infertile.[49] The determination of
infertility was to be on the basis of the inability to conceive after engaging
in heterosexual intercourse over
a period of 12 months. The Court also held that
there was no indirect discrimination in requiring JM to provide the name and
signature
of her male partner on the consent form. According to Ambrose J, the
doctor was carrying out his normal procedure in assisting women:
‘to which
he had decided to confine his attention, being women with a problem of
“medical
infertility”’.[50]
Essentially, the question was whether the practice adopted in general (and not
specifically to JM), was reasonable for the clinician
to adopt in the
circumstances.[51] On this basis,
requiring the consent form to be filled out by the male partner did not
constitute indirect discrimination. The issue
was also appealed to the
Queensland Court of Appeal, who agreed that there had been no direct
discrimination.[52] Whether there
had been indirect discrimination was a question of ‘reasonableness’
and the issue was remitted to the Anti-Discrimination
Tribunal to
decide.
When the case was remitted, the Anti-Discrimination Tribunal
considered whether the conduct of the clinician was reasonable and concluded
that it was for a number of reasons. The policy of the clinic was to follow the
guidelines issued by the NHMRC and the Queensland
Health Department. The latter
included recommendations to follow the proposals made in the Demack
Report which therefore focused the delivery of treatments to those who are
at risk of passing on a genetic disease or disorder, or clinically
infertile.
Furthermore, the fact that the clinic had publicised to sperm donors that their
gametes would be used to assist infertile
heterosexual couples was also a
significant factor in determining the reasonableness of the clinician’s
conduct:
Given that the respondent was clearly conducting his practice in
accordance with established medical and ethical guidelines (whether
out-dated,
soundly based, or whether legally binding upon him or not), and was requesting
sperm donations as part of that practice,
the use to which he was obliged to put
the donated sperm cannot be overlooked. It would not be unreasonable to confine
the use of
the sperm to “infertile couples” in accordance with his
representations to the potential donors ... the donated sperm
had been collected
by reference to representations that it would be used for infertile heterosexual
couples, and it is at that time
and in those circumstances that the issue of
reasonableness
arises.[53]
Clinics in
Queensland following the Demack Report will therefore require
participants to be at risk of passing on a genetic disease through natural
conception, or be clinically infertile.
The latter requires an inability to
become pregnant after a 12-month period of unprotected heterosexual sex.
According to Stuhmcke,
this ‘reflects a mainstream heterosexual narrative
as to the ‘appropriate or normal’ manner in which to conceive
a
child.’[54]
Furthermore, Stuhmcke comments that: ‘it is not heterosexuality alone
which qualifies a woman for ART treatment, the pre-requisite
of complying with
the medical definition of infertility is heterosexual intercourse as part of a
longer term heterosexual
couple’.[55]
Despite
the fact that there are no eligibility criteria imposed within Queensland by
legislation or guidelines, the judicial decision
involving JM has declared that
clinics imposing restrictions which can only be met by heterosexual couples are
justified in doing
so, if they are relying on outdated recommendations. Although
it was beyond the scope of the Anti Discrimination Tribunal to examine
the
validity of guidelines issued by the Queensland Health Department, these
guidelines require clinics to deliver cutting edge 21st
century
technology on the basis of a report founded upon social attitudes which are
nearly 25 years in the past.
There is need for Queensland to reconsider
the question of eligibility for treatment and whether the restrictive definition
of infertility
should continue to remain as a justified criterion for clinics to
impose on those seeking treatments. It is submitted that the recommendations
made by the Demack Report are outdated. Legislation preventing access to
ART on the basis of marital status or sexual orientation has been prohibited in
Australia,[56] but the narrow
definition of infertility remains to act as an obstacle for single and lesbian
women seeking access to ART. It remains
to be seen whether the access
requirements will be the subject of further challenge. A wider consideration of
the question of access
is now required to be undertaken.
The issue of
eligibility for treatment has been considered in detail by other jurisdictions
and may be of assistance for reconsidering
future regulation in Queensland. Much
could be learnt from the difficulties faced in those other jurisdictions. An
example of this
is the Victorian Law Reform Commission’s (VLRC) extensive
review of the law relating to ART in Australia, which has recently
published a
Final Report on the
subject.[57] The report concluded:
‘that the marital status requirement is not only inconsistent with the
principle of non-discrimination,
but it also bears no relationship to the health
and wellbeing of children, which must be the paramount concern of the law
governing
ART’.[58]
Furthermore,
the VLRC has also proposed a broader definition of the infertility requirement,
recommending that a:
woman be eligible for treatment if she is unlikely
to become pregnant and that her inability to become pregnant (or to carry a
pregnancy
or give birth to a child, or likelihood of transmitting a genetic
abnormality or disease) be assessed on the basis of the circumstances
in which
she finds herself (whether single, married, in a same-sex relationship,
psychologically averse to having sexual intercourse
with a man, or
otherwise).[59]
If the
subject of access to treatment is re-examined in Queensland, a wider
consideration of the meaning of ‘infertility’
will need to be
considered in context of further potential discrimination challenges and whether
there should be more recognition
given to alternative family
structures.
The approach taken on the issue of access to treatment in
Queensland, if reconsidered, will be largely dependant upon the underlying
approach taken to justifying the use of ART generally. The main justification
for making treatment services available in Australia
has been to alleviate the
harshness of infertility, as well as providing treatment to those who are at
risk of passing on genetic
disease or abnormality through natural conception.
This was the justification for a restrictive meaning of the term
‘infertility’
in Victoria and was the reasoning put forward in the
Demack Report for making treatment services available in Queensland. This
justification has also been expressed in legislation passed in other Australian
jurisdictions.[60] However, in light
of changing social attitudes, a different approach may also be considered.
Queensland may prefer a more liberal
approach. In New South Wales, following a
review of the regulation in that State, proposed legislation followed such an
approach.
The main purpose of the NSW Bill is to prevent the commercialisation
of human reproduction and protect the interests of those involved
in the
provision of ART treatments.[61]
This can be contrasted with the approach in other statutory jurisdictions and
the recommendations made in the Demack Report, primarily concerned with
alleviating clinical infertility and preventing transmission of genetic
disease.[62]
Furthermore, in
line with the purpose of the proposed legislation, the NSW Bill does not require
participants to meet eligibility
criteria similar to those in the statutory
jurisdictions. The New South Wales Department of Health comments:
The
decision not to include eligibility criteria is based on the notion that it is
not the role of legislation to screen out “good”
prospective parents
from “bad” prospective parents. The law does not impose any
restrictions upon individuals in the
general community who wish to become
parents. Indeed, it is generally considered a fundamental right of individuals
to be able to
have children and form families as they choose. ... The role of
the legislature has not been to make rules regarding classes of persons
who may
or may not become parents (as this is not necessarily a predictor of harm) but
to make rules to safeguard the rights of individual
children whose welfare has
been compromised.[63]
If the
subject of access to ART is reconsidered in Queensland, then many of these
factors will need to be balanced in order to determine
who may be granted access
to services in the future. There is much to be learnt from some of the problems
experienced in defining
the limits and boundaries of access when examining the
regulation in other jurisdictions. A narrow approach to the meaning of
infertility
is likely to lead to further challenges of that definition in the
future. However, at the other end of the spectrum, failing to define
in any
terms the issue of who may access treatment may allow different clinics
operating in the same jurisdiction to place different
barriers on access.
Somewhere in the middle lies the option for the legislature to define in broad
terms exactly who may access treatments.
The broad definition of infertility
suggested by the VLRC may prevent discrimination in the future. However, if a
narrow construction
of eligibility is adopted for future regulation, then it is
also necessary to consider the impact a narrow definition will have on
the
second limb of the eligibility criteria. Namely, that it can be justified where
the participants are at risk of passing on a
genetic disease or disorder if they
were to conceive naturally. This will be considered in context of the use of PGD
for the creation
of tissue-matched children.
B PGD and the Creation of Tissue-Matched Children
Whilst the focus of this paper is to draw attention to controversial
developments in the field of ART and the impact these have on
future regulation,
it does not seek to aim to address exactly how such technologies
should be regulated. The remaining part of this paper will consider the
current regulatory approach in light of developing technologies,
focusing on the
creation of tissue-matched children. As already discussed, IVF procedures for
this purpose require the use of PGD.
It should be noted that whilst PGD is not
radically new, its use has increased in recent years and this may provide some
justification
for a more comprehensive system of
regulation.[64] PGD has also been
utilised by some couples to ensure that their future children will be of the
same tissue type to an existing ill
child. The new child will offer the chance
of a cure for the existing ill child. Thus, not only is the use of the
technology becoming
more popular, it is also being used in new ways, which
perhaps also justify a more comprehensive system of regulation.
As has
been established, Queensland relies directly on the NHMRC guidelines and it is
therefore necessary to examine how they address
the issue of PGD. The current
NHMRC guidelines note that PGD can be used to detect serious genetic conditions
in order to improve
ART
outcomes,[65] and in rare
circumstances, to select an embryo with compatible tissue for a
sibling.[66] The guidelines also go
on to state that pending further community discussion, PGD must not be used to
detect conditions that are
not of serious harm to the person to be born; social
sex selection; or selection in favour of a defect or
disability.[67] The guidelines do
not require clinics to seek permission prior to the use of PGD, except in the
case of selection of an embryo with
compatible tissue for a
sibling.[68] Selection of embryos
for the purpose of tissue compatibility is only permitted in the case of
siblings,[69] and clinics must seek
advice from a clinical ethics committee (or relevant state or territory
regulatory agency) prior to using PGD
for such purpose, who should ascertain
that:[70]
• the use of
PGD will not adversely affect the welfare and interests of the child who may be
born;
• the medical condition of the sibling to be treated is
life-threatening;
• other means to manage the medical condition are not
available; and
• the wish of the parents is to have another child as an
addition to their family and not merely as a source of
tissue.[71]
The guidelines
also require that those seeking PGD must be given access to both a clinical
geneticist and a genetic counsellor in
order that they understand how the
technology works and how it is applied to their
embryos.[72]
Therefore, in
Queensland, the use of PGD generally for reproductive purposes is not monitored,
and the only use of the technology
which requires approval is when using it to
select embryos on the basis of tissue compatibility. One further issue that also
needs
future consideration is interpretation of the NHMRC guidelines for the use
of PGD and particularly, the creation of tissue-matched
children. The NHMRC
guidelines state that pending further community discussion, PGD must not be used
to detect conditions that are
not of serious harm to the person to be
born.[73] Although the guidelines do
state that ‘what counts as a serious genetic condition is
controversial’,[74] there is
no further clarification on interpretation of these terms. Arguably, the
fundamental aim of prohibiting the use of PGD for
conditions that are not of
serious harm to the person to be born is to prevent ethical criticism of the use
of PGD for the screening
out of non-serious disease and avoid the practice of
the selection of embryos on the basis of what some may argue as
eugenics.[75]
Clarification of the term ‘condition’ is needed. Critics may
argue that the use of PGD to establish tissue type is a
use of the technology
for detection of a ‘condition’ that does not seriously harm the
child to be born. Thus, would a
more narrow reading of the terms contained in
the NHMRC guidelines also prevent the use of PGD where the sole purpose is to
establish
tissue type? These are further issues that will be relevant for
consideration should the regulation of ART be reconsidered in
Queensland.
The lack of eligibility criteria under the NHMRC guidelines
also impacts significantly on the use of PGD for the creation of tissue-matched
children. This can be demonstrated by examining the statutory jurisdictions
where eligibility criteria are prescribed in legislation.
In those
jurisdictions, PGD will only be available where the primary purpose is to ensure
that the embryo is free from genetic
disease.[76] If tissue typing is
also conducted, it will be ancillary to the main purpose of PGD. Furthermore, in
Victoria, when using PGD for
establishing tissue type not only must the legal
requirements under the legislation be met (the eligibility criteria), but a
number
of further conditions and ethical considerations are imposed on clinics
as a condition of licence.[77]
Furthermore, for the purpose of creating tissue-matched children, clinics must
gain approval by the Victorian regulatory body, the
Infertility Treatment
Authority (ITA) on a case by case
basis.[78] Thus, the use of PGD in
Victoria is monitored by the statutory body which oversees the regulatory regime
in that State. Similarly,
in Western Australia and South Australia, PGD is only
permitted where the primary purpose is to prevent transmission of a genetic
disease. In Western Australia, all uses of PGD must be authorised by the
statutory body, the Reproductive Technology Council (RTC) and although the issue
of using the
procedure for creating tissue-matched children is not addressed, if
it was to occur it would be monitored by the RTC which is required
to approve
all uses of PGD. Despite the imposition of eligibility criteria in South
Australia, the South Australian Council on Reproductive
Technology (SACRT) does
not monitor the use of PGD in a similar way to the other statutory
jurisdictions. Therefore, in South Australia,
the use of PGD will be monitored
only so far as the NHMRC guidelines require, and this is applicable to all the
remaining jurisdictions
which do not directly address the issue.
Should
the matter be considered in Queensland, there are a number of options available.
Again, these are demonstrated by examining
other Australian jurisdictions.
Between the statutory jurisdictions alone there is a vast difference in
approach, with Western Australia
requiring all uses of the technology to be
approved, Victoria requiring only some uses to be approved (but
monitoring all uses thoroughly), and South Australia requiring no
system of approval or notification. The latter approach is how the regulation
also
operates in the remaining jurisdictions, including Queensland, where the
only check on the use of PGD is when it is used for the
selection of an embryo
with compatible tissue for an ill
sibling.[79] Even then, the only
requirement is that the matter is referred to an institutional ethics
committee.[80]
There are a
number of problems that arise under the current context of regulation in
Queensland. First, the reliance on the NHMRC
guidelines means that there are no
mandatory eligibility criteria imposed. This issue has already been examined in
the context of
the narrow definition given to infertility, but it is also
significant in relation to the use of PGD for creation of tissue-matched
children.
If the parents of an ill child have explored potential avenues
for treatment with no success, and the most probable chance of curing
that child
is to perform a blood stem cell transplant (or in some cases a bone marrow
transplant) from a sibling with compatible
tissue, then the parents may wish to
use PGD to ensure that their next child is a compatible tissue match. In some
instances, the
existing ill child may be suffering from a condition that is not
genetically inherited, but has onset after birth. The parents may
therefore be
at no risk of passing on a genetic disease if they were to conceive naturally.
Thus, as the existing ill child did not
genetically inherit the condition, the
parents are at no greater risk of passing on the condition when conceiving in
the future.
The lack of eligibility criteria in the non-statutory jurisdictions
opens the possibility for accessing the use of PGD for such a
purpose.[81] Fundamentally, access
will not be immediately denied despite the fact that the primary purpose for
seeking the use of IVF is to establish
the tissue type of an embryo to be
implanted, and not for the purpose of preventing transmission of a genetic
disease.[82]
Even if Queensland opted for a more narrow definition of who is able
to access treatments, then there is still the option to make
exception for the
purpose of creating a tissue-matched child. This is demonstrated by the
Victorian Law Reform Commission’s
Final
Report,[83] which notes that the
current system of regulation in Victoria is too inflexible and does not allow
clinics to treat those who may
wish to access treatment for reasons other then
infertility or risk of passing on genetic disease or disorder. On this basis,
the
VLRC has recommended that clinics should allow access to participants on
grounds other than those currently outlined under the legislation,
giving the
example of the creation of a ‘saviour sibling’ as one of those
grounds. If such recommendations were implemented,
there is the potential to
allow access to IVF to use PGD solely for the purpose of detecting the
tissue compatibility of an embryo in Victoria. If Queensland reviews the
regulation and opts to define
who should be eligible for treatments, similar to
the suggestions by the VLRC, there is the potential to allow exceptions to those
criteria in certain cases.
V RECONSIDERING REGULATION
A Time for Queensland to Legislate?
In a recent lecture addressing the ability of the law to keep pace with technology, Justice Michael Kirby commented on the topic of regulation, noting that quite often there is either too much or too little law on a particular topic.[84]
Examining the comparison between the statutory and non-statutory
jurisdictions within Australia provides an example of this, with
some states
regulating the topic in a prescriptive
manner,[85] and others relying on
professional and ethical guidelines. Furthermore, Kirby J went on to comment
that it is very important to realise
that if nothing is done in the face of
science, a decision is made; to do nothing is to make a
decision.[86] The inaction of the
Queensland legislature could be viewed as an endorsement of the current
regulatory approach. With the exception
of the issue of eligibility for
treatment, some may argue that the current state of regulation of ART is
satisfactory.[87] Thus, there is a
high standard of professional regulation and overlap between the accreditation
process administered by the FSA and
the RTAC, and the guidelines issued by the
NHMRC. However, using Kirby J’s analogy, inaction potentially signifies
the endorsement
of an approach that in many respects falls short of even some of
the recommendations put forward in the Demack Report in
1984.[88] This is particularly so in
relation to the use of PGD for the creation of tissue-matched children. The use
of PGD is not monitored
by an independent body in Queensland, such as that
existing in Victoria. The only form of PGD that is required to be monitored in
Queensland is to put the issue of selecting embryos on the basis of tissue type
before an institutional ethics committee under the
NHMRC
guidelines.[89] As already stated,
the Demack Report concluded that entrusting issues to ethics committees
alone was not a sufficient form of monitoring advances in such
technologies.[90] In addition to the
problems outlined in relation to eligibility criteria, this example raises
another need for reconsidering the
current approach in Queensland.
B Significance of the VLRC’s Report
Throughout this article reference has been made to the VLRC’s final
report on the topic of ART. The VLRC has set a benchmark
for review of current
ART statutes in Australia. Of fundamental importance is the fact that the issues
arising in relation to the
Victorian legislation are not exclusive to that
jurisdiction alone. Therefore, the recommendations made will be particularly
significant
to the other statutory jurisdictions in Australia when reviewing
legislation in the future. Furthermore, the issues arising from
the report are
also of importance for other jurisdictions that do not currently have a
statutory system of regulation but may consider
legislating on the topic in the
future.
In Queensland, if the issue of regulation is reconsidered there
are several options open to the legislature in limiting who may gain
access to
fertility treatments. One option is to limit treatments strictly, similar to the
approach adopted currently in Victoria.
This would allow access only to those
who are clinically infertile or at risk of passing on a genetic disease when
conceiving naturally.
The focus of this paper has been to demonstrate that it is
now appropriate to reconsider whether this narrow approach traditionally
adopted
is still justified. Whilst it is acknowledged that the suggestions proposed by
the VLRC are aimed at amending some of the
difficulties of the prescriptive
nature of the Victorian legislation, the proposals may also provide a suitable
option for other
jurisdictions wishing to define who should be able to seek
access to treatments without seeking to limit treatments to a narrow class
of
people. If eligibility criteria were to be imposed under a statutory system of
regulation in Queensland, then the VLRC’s
suggestions could be implemented
to enable a broader meaning to be given to the access criteria.
As
already discussed, the VLRC has noted that there is the potential for an ART
regulatory body to consider whether clinics can allow
for exceptions to the
eligibility criteria in certain cases, such as the creation of tissue-matched
children. This is also a significant
point to be considered should the topic of
legislation be addressed in Queensland in the future.
If the issue of
regulation is reconsidered, Queensland may choose not to address the issue of
eligibility as is now the case under
the NHMRC guidelines. Again, as already
discussed, this approach has the potential to result in different clinics
imposing different
access criteria and is a further point of significance for
any future consideration of regulation. Therefore, the importance of the
review
of the VLRC cannot be underestimated and the suggestions made provide a suitable
mid-point for the spectrum of regulating
access to treatments.
VI CONCLUSION
This paper has examined the nature of the regulation existing in
Australia on the topic of ART. It has been established that there
are a broad
range of regulatory approaches varying from legislation, to professional
standards and guidelines. The particular issue
of eligibility for treatment has
been examined in detail and the difficulties faced by other Australian
jurisdictions have provided
examples of the problems faced in limiting access to
treatments. The original consideration of the issues in Queensland resulted
in
no legislative action and since the original review in the early 1980s no
further consideration or consultation has been undertaken.
Not only does this
mean that the proposals made in the Demack Report are not in line with
current social attitudes, but also that there are many practices and emerging
technologies under the ART scope
that were not even contemplated by the
Committee. The definition of the term infertility has been problematic for other
jurisdictions
in Australia, and the VLRC has recently proposed a wider
definition of the term. Similarly, the remaining statutory eligibility criteria
also pose a problem when viewed in the context of selecting embryos in order to
create a tissue-matched child. Similarly, the VLRC
has also proposed that there
should be circumstances other than the traditional strict eligibility criteria
where access to treatments
should be granted, giving the example of creation of
a tissue-matched child as one of those exceptions. Whilst in Queensland, there
are no eligibility criteria imposed by legislation or the NHMRC guidelines, each
clinic may still choose to limit access to treatment
on the basis of its own
policy. This may lead to the result that there is a difference in approach
between clinics operating within
Queensland (or other non-statutory
jurisdictions). The failure to specifically address the issue will continue to
lead to a divergence
of approach as to who may access treatments. Furthermore,
the report recommended that an overseeing regulatory body also be established
to
keep track of such advances, as well as play an educational role for members of
the community. The importance of keeping track
of developments in ART was
stressed in the Demack Report and in Queensland, this has not been done.
This body would have also had the function of approving some controversial uses
of ART,
as it was not considered sufficient to entrust such issues to
institutional ethics committees alone. The lack of action in Queensland
has
endorsed an approach that only recommends the use of ethics committees in
exceptional instances (such as the creation of a tissue-matched
child). These
examples only relate to a limited number of issues under the scope of ART, and
even then, it is easily demonstrated
that reconsideration of the regulation of
ART in Queensland is long overdue.
Queensland could benefit vastly from
some of the material produced by other Australian jurisdictions (particularly
the work of the
VLRC), also faced with difficulties in relation to regulating
ART. With recognition of some of the extremely sensitive issues involved
under
the scope of this topic, perhaps now is one of the best times to move forward
with a national approach to regulating ART. Such
approach would be in line with
recent developments for the national regulation of human embryo research and
cloning, as well as proposals
to consider uniform laws for
surrogacy.[91] Whichever way
Queensland chooses to act, overdue consideration of these issues (at the very
least), will be extremely welcomed.
[*] LLB (Hons) LLM PhD Candidate, Faculty of Law, Queensland University of
Technology. The author would like to thank Dr Ben White for
his comments and
suggestions relating to the drafting of this paper, as well as the helpful
comments suggested by the reviewer.
[1] Legislation has been passed recently in Queensland on the
subject of human embryo research and cloning in response to consideration
of
those topics at a national level by the Council of Australian Governments
(COAG): Research Involving Human Embryos and Prohibition of Human Cloning for
Reproduction Act 2003 (Qld), as amended by the Research Involving Human
Embryos and Prohibition of Human Cloning Amendment Act 2007
(Qld).
[2] For the purposes of
this discussion, the use of PGD is not discussed in the context of human embryo
research which is subject to
statutory regulation under Commonwealth
legislation: Research Involving Human Embryos Act 2002 (Cth) as amended
by the Prohibition of Human Cloning for Reproduction and the Regulation of
Human Embryo Research Amendment Act 2006 (Cth), and also relevant
complimentary State or Territory legislation,
ibid.
[3] The term saviour sibling
is relatively new and has been defined as ‘a
child who is born with genetic characteristics specifically designed to treat
the illness of an existing brother or sister’,
MACMILLAN English
Dictionary <www.macmillandictionary.com/new-words/030627-saviour-sibling.htm>
at 17 July 2007. The term can be criticised on the basis of the implication that
parents wishing to create such children are
doing so only for the purpose
of a potential cure for their existing child. Many parents however, may wish to
have another child in any case. The
ability to determine the tissue type of that
child to potentially cure an existing sibling should not therefore be the only
consideration
when examining the motives of the
parents.
[4] National Health and
Medical Research Council, Ethical Guidelines on the Use of Assisted
Reproductive Technology in Clinical Practice and Research
(2004).
[5] See National Health
and Medical Research Council, Ethical Guidelines on Assisted Reproductive
Technology (1996) v.
[6]
National Health and Medical Research Council, above n 4,
2.
[7] The Family Law Council of
Australia Report on reproductive technology recommended that a
multi-disciplinary body oversee matters
relating to reproductive technology at a
national level (Family Law Council of Australia, Creating Children: A Uniform
Approach to the Law and Practice of Reproductive Technology in Australia
(Australian Government Publishing Service, 1985). The functions of the body
were suggested to include: advising federal and state
governments; monitoring
medical research; analyse the implications of ART for society; provide
information for the community; develop
clear guidelines for ethics, practice
records, access to information and counselling; recommending research on the
ongoing effects
of reproductive technology, and; present an annual report. The
plans to implement such a body were not followed through fully, but
the National
Bioethics Consultative Committee (NBCC) was created, which, according to
Chalmers, had success in focusing debate and
preparing reports, but not in
changing public policy. For a detailed review of the development of such issues,
see D Chalmers, 'Professional
Self-regulation and Guidelines in Assisted
Reproduction' (2002) 9(4) Journal of Law and Medicine 414.
[8] Prohibition of Human
Cloning Act 2002 (Cth); Research Involving Human Embryos Act 2002
(Cth). Both pieces of legislation have recently been reviewed by a Legislation
Review Committee: Australian Government, 'Legislation
Review: Prohibition of
Human Cloning Act 2002 and the Research Involving Human Embryos Act
2002' (2005), and subsequently reformed: Prohibition of Human Cloning for
Reproduction and the Regulation of Human Embryo Research Amendment Act 2006
(Cth). For an overview of some of the issues arising from the review, see D
Cooper, 'The Lockhart Review: Where now for Australia?'
(2006) 14(1) Journal
of Law and Medicine 27.
[9]
Surrogate Parenthood Act 1988 (Qld); Infertility Treatment Act
1995 (Vic); Family Relationships Act 1975 (SA); Surrogacy
Contracts Act 1993 (Tas); Parentage Act 2004
(ACT).
[10] Helen Szoke, Lexi
Neame and Louise Johnson, ‘Old Technologies and New Challenges: Assisted
Reproduction and its Regulation’
in Ian Freckelton and Kerry Petersen
(eds), Disputes and Dilemmas in Health Law (2006) 187,
197.
[11] Infertility
Treatment Act 1995 (Vic); Human Reproductive Technology Act 1991
(WA); Reproductive Technology (Clinical Practices) Act 1988
(SA).
[12] In Victoria for
example, ‘where the requirements of the Act are different to those of the
RTAC Code of Practice for Assisted Reproductive Technology Units
(2005), then the requirements of the Act take precedence and will be
enforced’ and similarly, ‘where NHMRC Guidelines
are inconsistent
with the Victorian legislation, the Act takes precedence and over-rides the
NHMRC Guidelines.’ Infertility
Treatment Authority, Conditions for
Licence. Clinics, Hospitals and Day Procedure Centres,
(7th ed, 2006)
9.
[13] Helen Szoke,
‘Australia – A Federated Structure of Statutory Regulation of
ART’ in Jennifer Gunning and Helen
Szoke (eds), The Regulation of
Assisted Reproductive Technology (2003) 75,
75.
[14] B Bennett, 'Symbiotic
Relationships: Saviour Siblings, Family Rights and Biomedicine' (2005) 19(3)
Australian Journal of Family Law 195.
[15] Demack J, Report of the
Special Committee appointed by the Queensland Government to Enquire into the
Laws Relating to Artificial Insemination,
In Vitro Fertilisation and Other
Related Matters, (Qld Parliament, Brisbane, 1984); New South Wales Law
Reform Commission, Artificial Conception – Human Artificial
Insemination, Report No 49 (1986); New South Wales Law Reform
Commission, Artificial Conception – In Vitro Fertilisation,
Report No 58 (1988); New South Wales Law Reform Commission, Artificial
Conception – Surrogate Motherhood, Report No 60 (1988); D Chalmers,
Committee to Investigate Artificial Conception and Related Matters
(Hobart, 1985).
[16]
Infertility Treatment Act 1995
(Vic).
[17] Reproductive
Technology (Clinical Practices) Act 1988
(SA).
[18] Human Reproductive
Technology Act 1991
(WA).
[19] Demack, above n
15.
[20] Ibid
46.
[21]
Ibid.
[22] Ibid
46-8.
[23] Ibid
49.
[24]
Ibid.
[25] Ibid
50.
[26] Ibid
81.
[27] Ibid
82.
[28]
Ibid.
[29] Chalmers, above n 7,
418.
[30] Reproductive
Technology Accreditation Committee, Fertility Society of Australia, Code of
Practice for Assisted Reproductive Technology Units (4th
revision, February 2005) 9.
[31]
Chalmers, above n 7, 418.
[32]
Ibid.
[33] Reproductive
Technology Accreditation Committee, above n 30,
8.
[34] Section 8 of the
Research Involving Human Embryos Act 2002 (Cth) defines an
‘accredited ART Centre’ as a: ‘person or body accredited to
carry out assisted reproductive technology
by the Reproductive Technology
Accreditation Committee of the Fertility Society of
Australia’.
[35] The
Assisted Reproductive Technology Bill 2007 (NSW) has recently been re-introduced
to Parliament and replaces the proposals put forward in the Assisted
Reproductive Technology
Bill 2003 (NSW). New South Wales, Parliamentary
Debates, Legislative Assembly, 7 November 2007, 1 (Reba Meagher, Minister
for Health).
[36] New South
Wales Department of Health, Consultation Draft, Assisted Reproductive
Technology Bill 2003, Information Guide, (2003) 3.1
<http://www.health.nsw.gov.au/legal/pdf/Informationguide.pdf>
at 17 July 2007.
[37] Ibid
3.2.
[38] Ibid
3.1.
[39] See Szoke, Neame and
Johnson, above n 10, 199. For a discussion of different ART regulatory
approaches, see Loane Skene, ‘Why
Legislate on Assisted
Reproduction?’ in Ian Freckelton and Kerry Petersen (eds),
Controversies in Health Law (1999) 266; and Chalmers, above n
7.
[40] Szoke, Neame and
Johnson, above n 10, 199.
[41]
See New South Wales Department of Health above n 36,
3.1.
[42] For a critique of
public consultation processes, see L Cannold and L Gillam, 'Regulation,
Consultation and Divergent Community Views:
The Case of Access to ART by Lesbian
and Single Women' (2002) 9(4) Journal of Law and Medicine
498.
[43] LWillmott and S Kift,
‘Assisted Reproductive Technology: Legislators Please Legislate!’
(2000) Proctor 22.
[44]
Ibid.
[45] Section 10 of the
Anti-Discrimination Act 1991 (Qld) states: '(1) Direct discrimination on
the basis of an attribute happens if a person treats, or proposes to treat, a
person
with an attribute less favourably than another person without the
attribute is or would be treated in circumstances that are the
same or not
materially different. (2) It is not necessary that the person who discriminates
considers the treatment is less favourable.
(3) The person’s motive for
discriminating is irrelevant. (4) If there are 2 or more reasons why a
person treats, or proposes to treat, another person with an attribute less
favourably, the person
treats the other person less favourably on the basis of
the attribute if the attribute is a substantial reason for the treatment.
(5)
In determining whether a person treats, or proposes to treat a person with
an impairment less favourably than another person is or
would be treated in
circumstances that are the same or not materially different, the fact that the
person with the impairment may
require special services or facilities is
irrelevant.'
[46] Section 11 of
the Anti-Discrimination Act 1991 (Qld) states: '11(1) Indirect
discrimination on the basis of an attribute happens if a person imposes, or
proposes to impose, a term
— (a) with which a person with an attribute
does not or is not able to comply; and (b) with which a higher proportion of
people
without the attribute comply or are able to comply; and (c) that is not
reasonable. (2) Whether a term is reasonable depends on all
the relevant
circumstances of the case, including, for example: (a) the consequences of
failure to comply with the term; and (b)
the cost of alternative terms; and (c)
the financial circumstances of the person who imposes, or proposes to impose,
the term. (3)
It is not necessary that the person imposing, or proposing to
impose, the term is aware of the indirect discrimination. (4) In this
section
— “term” includes condition, requirement or practice,
whether or not written.'
[47] JM v QFG, GK and State
of Queensland [1996] Queensland Anti-Discrimination Board, No H38 of 1996
(Unreported, President Atkinson, 31 January 1997). According to that
decision,
the fact that the clinic demanded consent from the applicant’s male
partner was an unreasonable
request.
[48]
Ibid.
[49] QFG & GK v JM
[1997] Supreme Court of Queensland, No 1877 of 1997 (Unreported, Ambrose J,
24 October 1997).
[50]
Ibid.
[51]
Ibid.
[52] JM v QFG
[2000] 1 Qd R 373.
[53]
Morgan v GK [2001] QADT 10,
24.
[54] A Stuhmcke, 'Limiting
Access to Assisted Reproduction: JM v QFG' (2002) 16 Australian
Journal of Family Law 1,
5-6.
[55] Ibid
6.
[56] See for example:
McBain v The State of Victoria & Ors [2000] FCA 1009; (2000) 99 FCR 116; Pearce v
South Australian Health Commission and Others [1996] SASC 5801; (1996) 66 SASR
486.
[57] Victorian Law Reform
Commission, Assisted Reproductive Technology & Adoption, Final
Report, Report No 10 (2007)
67.
[58]
Ibid.
[59] Ibid
68.
[60] For example in Western
Australia, the preamble of the Human Reproductive Technology Act 1991
(WA) states: 'Parliament considers that the primary purpose and only
justification for the creation of a human embryo in vitro is
to assist persons
who are unable to conceive children naturally due to medical reasons or whose
children are otherwise likely to
be affected by genetic abnormality or disease,
to have children, and this legislation should respect the life created by this
process.'
[61] Clause 3 of the
Assisted Reproductive Technology Bill 2007
(NSW).
[62] Demack, above n
15.
[63] New South Wales
Department of Health, above n 36, 4.3.
[64] For example, in 2005, 69
women in Victoria underwent IVF with PGD in order to ensure that the embryo was
free from a known genetic
disease, and in that same year, 131 women in Victoria
also used PGD for recurrent pregnancy failure (see below n 65). The total number
of women who underwent IVF in Victoria in 2005 in licensed clinics was 4869,
Infertility Treatment Authority, Annual Report (2006) 26. On this basis
it could be argued that the proportion of those patients who actually use PGD is
relatively small in comparison
to the number of women who undergo IVF. This can
be compared to data from five years previously, which shows that 3449 women
underwent
IVF, and only 75 of those also underwent PGD: Infertility Treatment
Authority, Annual Report (2000) 22-8.
[65] Many women suffer from
recurrent pregnancy loss (RPL) which can happen for a number of reasons, but one
cause is a result of chromosome
abnormalities (aneuploidy) in embryos. PGD can
be used to genetically analyze the embryos of women who suffer from RPL and
those
embryos that do not show abnormalities can be implanted in order to try
and achieve a higher pregnancy rate. See Patrizio et al, ‘High Rate
of Biological Loss in Assisted Reproduction: It is in the Seed, Not in the
Soil’ (2007) 14(1) Reproductive BioMedicine Online
92-5.
[66] National Health and
Medical Research Council, above n 4,
12.1.
[67] Ibid
12.2.
[68] Ibid 12.
[69] Ibid
12.3.
[70]
Ibid.
[71]
Ibid.
[72] Ibid 12.4-12.5.
Clinics are also required to give up-to-date, objective, and accurate
information in line with the ‘information
giving’ section of the
guidelines (9.1 and 9.2), and that those seeking the treatment should be
encouraged to consider the
following factors when deciding the appropriateness
of PGD: information regarding the reliability of results; genetic and clinical
information about the condition; the clinic’s previous reproductive
experience; information regarding the condition being tested
for including the
range of effects of the disease or abnormality; the experience of families
living with the condition and how it
can be managed; and also the extent of
social support available:
12.5.1.
[73] National Health and
Medical Research Council, above n 4,
12.2.
[74] Ibid
12.1.
[75] For a discussion of
the ethical issues involved in the selection of embryos, see R Scott, 'Choosing
between Possible Lives: Legal
and Ethical Issues in Preimplantation Genetic
Diagnosis' (2006) 26(1) Oxford Journal of Legal Studies
153.
[76] Section 8(3) of the
Infertility Treatment Act 1995 (Vic) states: 'In the opinion of a doctor,
she must be unlikely to become pregnant with her own egg and her husband’s
sperm
other than by a treatment procedure, or; in the opinion of a doctor with
specialist qualifications in human genetics, she must be
likely, if she became
pregnant with her own egg and her husband’s sperm, to give birth to a
child with a genetic abnormality
or risk communicating a disease to a child
unless she undergoes a treatment procedure.' Section 23(a) of the Human
Reproductive Technology Act 1991 (WA) enables access to ART services where
it: ‘would be likely to benefit’ a woman or a couple who are unable
to conceive
‘due to medical reasons’, or ‘whose child would be
likely to be affected by a genetic abnormality or disease’.
Section 13(3)
of the Reproductive Technology (Clinical Practices) Act 1988 (SA) allows
treatment where the licensee has been given a letter by a medical practitioner
stating either: (i) that the male or female
(or both) are infertile; or (ii)
there is a risk that a genetic disease or abnormality would be transmitted to a
child conceived
naturally.
[77]
Infertility Treatment Authority, Genetic Testing and the Requirements of the
Infertility Treatment Act 1995: Policy in Relation to the Use of
Pre-implantation Genetic Diagnosis (PGD) (2006); Infertility Treatment
Authority, Tissue Typing in Conjunction with Preimplantation Genetic
Diagnosis (2004).
[78]
Infertility Treatment Authority, Tissue Typing in Conjunction with
Preimplantation Genetic Diagnosis, above n 77.
[79] National Health and
Medical Research Council, above n 4,
12.3.
[80]
Ibid.
[81] M Taylor-Sands,
‘Selecting “Saviour Siblings”: Reconsidering the Regulation in
Australia of Pre-Implantation Genetic
Diagnosis in Conjunction with Tissue
Typing’ (2007) 14 Journal of Law and Medicine 551,
560.
[82] For a detailed
overview of this distinction, see S Sheldon and S Wilkinson, 'Hashmi And
Whitaker: An Unjustifiable and Misguided
Distinction?' (2004) 12(2) Medical
Law Review 137.
[83]
Victorian Law Reform Commission, above n
57.
[84] Justice Michael Kirby's
recent lecture on Technology and the Law: Can the Law keep Pace with
Nanotechnology? (2007) Queensland University of Technology
<http://www.law.qut.edu.au/community/lectures/kirby.jsp>
at 8 October 2007.
[85] For a
discussion of the prescriptive nature of the Victorian legislation in comparison
to other jurisdictions, see K Petersen, 'The
Regulation of Assisted Reproductive
Technology: A comparative Study of Permissive and Prescriptive Laws and
Policies' (2002) 9(4) Journal of Law and Medicine 483; H W G Baker,
'Problems with the Regulation of Assisted Reproductive Technology: A Clinician's
Perspective' (2002) 9(4) Journal of Law and Medicine 457; and H Szoke,
'The Nanny State or Responsible Government?' (2002) 9(4) Journal of Law and
Medicine 470.
[86] Kirby,
above n 84.
[87] See Chalmers,
above n 7.
[88] Demack, above n
15.
[89] National Health and
Medical Research Council, above n 4,
12.3.
[90] Demack, above n 15,
46.
[91] The Standing Committee
of Attorneys General (SCAG) has agreed to consider drafting uniform laws for
surrogacy across all states
and territories: Attorney-General Phillip Ruddock,
‘Nationally Consistent Surrogacy Laws a Step Closer’ (Media Release
210/2006, 10 November 2006).
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