Cartwright calamities, Frankenstein monsters and the regulation of PGD in New Zealand

8   Cartwright calamities, Frankenstein monsters and the regulation of PGD in New Zealand

Jeanne Snelling^*

This is a complex Bill about complex matters affecting the future of humanity … We have a potential Cartwright-like calamity on our hands. We have the potential to prevent disease and deformity. We can also venture into Dr Frankenstein-like territory where, as Mary Shelley warned us, in our search to become God we may create monsters.¹

Introduction

In 1996 Dianne Yates, Labour MP and author of the above quote introduced a private member’s bill into the New Zealand Parliament that proposed, for the first time, to establish a specific legislative framework regulating human-assisted reproduction and research. The impetus behind the introduction of the Bill was apparent in Yates’s comments that – with the oblique reference to the Cartwright Inquiry – invoked both the potential for unethical medical research and the spectre of future human monstrosities unless there was immediate legislative intervention.² The parliamentary process that followed resulted in the enactment of the Human Assisted Reproductive Technology Act 2004 eight years later.

New Zealand was comparatively slow to introduce primary legislation governing assisted human reproduction and research. The approach adopted by the government during the 1980s and early 1990s was characterised by a preference for minimal state intervention. This was primarily based on the view that a specific legislative framework was unnecessary, given the particular context of New Zealand, but also implicitly upheld the concept of reproductive liberty by averring that state intervention, particularly in the sphere of private reproductive decisions, required justification. Arguably this reticence, given New Zealand’s track record in matters of reproduction, was uncharacteristic.

The ideologies of pronatalism, social purity and the concept of motherhood as a vocation were characteristic of colonial New Zealand.³ These views converged in the concomitant reluctance to ascribe to women any kind of control over their own fertility. In the early twentieth century, organised campaigns for access to birth control, so that even married couples could space or limit their families to mitigate the effects of uncontrolled fertility, were unsuccessful.⁴ Instead while the Māori population grew, the falling white European birth rate sparked concern that burgeoning numbers in Asian countries could overrun ‘civilised’ society.⁵ This led to exhortations for larger families.⁶ The threat of war in the 1930s served only to further fuel the call to ‘populate or perish’ – an anathema given the poverty experienced by families at the time.⁷

In 1936, faced with evidence that the number of women dying from abortion-related complications was increasing significantly, the government appointed a Committee of Inquiry to investigate the issue of abortion.⁸ The Inquiry estimated that around 6,000 abortions were performed annually in New Zealand, 4,000 of which were criminal.⁹

Although appointed to consider abortion, the Inquiry became a platform for debate over reproductive control in general. With the decline in family size a major consideration, the Committee recommended that the sale of contraceptives to unmarried people should be illegal, and was opposed to any liberalisation of the abortion law.¹⁰ Ultimately the report appealed:

to the womanhood of New Zealand, in so far as selfish and unworthy motives have entered into our family life, to consider the grave physical and moral dangers, not to speak of the dangers of race suicide which are involved.¹¹

The Committee’s report evinced little concern for women’s health, fertility or individual autonomy, which were subjugated to the overriding duty to the state to procreate.¹² Similarly, the abortion law reform undertaken in the 1970s reflected an impoverished view of reproductive liberty. This reform, which resulted in what remains New Zealand’s current abortion law, is largely a result of the 1975 Royal Commission of Inquiry into contraception, sterilisation and abortion, which reported in 1977.¹³

An event that contributed to the Commission’s appointment was the Court of Appeal decision in R v. Woolnough.¹⁴ Although the Crimes Act 1961 established that abortion was a criminal offence, the legislature had left open what constituted the meaning of ‘unlawfully’ procuring an abortion.¹⁵ The Court held that (at least in regard to the early stages of pregnancy) a defence to the crime of abortion was not limited to the doctrine of necessity. Consequently a ‘bona fide intention to preserve the health [as distinct from life] of the mother from serious harm’ constituted justification for lawful abortion.¹⁶ The decision extended lawful abortion beyond instances where the woman’s life was at risk and briefly clarified the scope of lawful abortion in New Zealand, until recommendations made by the Commission of Inquiry were subsequently implemented by Parliament.

The Commission noted in its Report that the role of women in society had changed over time, and that it was generally accepted that a woman had a right to decide whether she married, whether she had children, and if so how many.¹⁷ However, rights claims in respect of an established pregnancy were considered problematic, because the Commission considered that, from the moment of implantation, the foetus had a status entitling it to preservation and protection. This did not confer an absolute right to life, but rather ‘should yield in the face of compelling competing interests’.¹⁸ Consequently it concluded that any rights in relation to an established pregnancy must be ‘considered against the status of the unborn child’.¹⁹ But ‘status’ proved to be a malleable concept for the Commission.

The Commission accepted that abortion should be lawful when the pregnancy posed a ‘serious danger’ to the life of the mother but it was far less sympathetic when there was no such threat to life.²⁰ It was suggested that women in the early stages of pregnancy were prone to biologically induced irrationality and that such psychological stress was insufficient to justify abortion, which should only be available if continuance of the pregnancy would pose serious danger to physical or mental health.²¹ In contrast, the Commission advocated the availability of prenatal testing if there was substantial risk of foetal abnormality.²² Significantly, the Commission rejected abortion on the grounds of rape because a rape provision could be the ‘subject of abuse’ – essentially meaning that some women seeking abortion would lie in order to obtain one.²³ Instead, any claim of rape should merely be ‘taken into account’ by doctors making the abortion decision, but should not be a ground for abortion in itself.²⁴

The Commission expressed a very different view towards incest, as it was considered highly unlikely that ‘unjustified’ complaints of incest would be made. Ultimately it opined that ‘no sanctity can be attached to a pregnancy’ which has resulted from incest.²⁵ Similarly, the pregnancy of a severely subnormal woman or girl had ‘little, if any, status’ and could constitute a ground for abortion.²⁶

Rape, incest and sexual intercourse with a severely subnormal woman or girl were (and still are) criminal offences. Precisely why protected status could attach to a foetus resulting from an alleged rape, but not incest or in the case of a subnormal woman is unclear. A cynical view may be that protected status or sanctity attached only to pregnancies that were considered genetically fit – yet the Commission included non-biological relationships within the incest grounds.²⁷ It may possibly be inferred that incest appeared to transgress social norms to a greater extent than rape and consequently the pregnancy that resulted from incest (even non-biological) was less worthy of protection than was the pregnancy resulting from rape. What is clear is that, apart from instances where a pregnancy posed serious danger to a woman’s life or health or in the case of foetal abnormality, the Commission only contemplated abortion in circumstances when there was an absence of ‘fault’ on the part of the woman.

Evidently a right to reproductive liberty did not figure in the Commission’s report at all but nor, it seems, did a consistent view of the moral status of the foetus. It was expendable in some circumstances, but not others, which seems to incorporate a questionable judgement as to the moral or social ‘worth’ of a pregnancy. There was an appreciable lack of concern for the woman carrying the pregnancy, the focus being rather on whether the foetus had ‘sanctity’ or protected status and on the likelihood of a woman’s veracity regarding the circumstances of conception. It was apparent that a major objective was to inculcate, and enforce, certain moral values and virtues, primarily in respect of women and their reproductive choices.²⁸

The recommendations were eventually codified in subsequent amendments to the Crimes Act 1961 and currently provide the scope of lawful abortion in New Zealand for pregnancies of not more than 20 weeks’ gestation.²⁹ Despite this, New Zealand’s abortion statistics are comparable to Canada and the USA³⁰ because of physicians’ liberal interpretation of what was intended to be very illiberal legislation.³¹ The reality is that most New Zealand women have de facto, if not de jure, access to state-funded abortion. This involves a euphemistic interpretation of abortion on mental health grounds³² assuring access to legal and safe abortion for many women, despite a seemingly restrictive legislative approach, but this arguably also undermines the integrity of the law and diminishes reproductive rights claims.

The birth of Louise Brown’s first IVF peer in New Zealand occurred in 1984. It was accompanied by requests³³ for the appointment of an official body to examine the issues raised by assisted reproduction – as had occurred in similar jurisdictions.³⁴ However, the response of New Zealand’s Labour government, a notably less interventionist government than that which had preceded it, was comparatively muted.³⁵

Nevertheless, the Law Reform Division of the Department of Justice released an Issues Paper for public consultation in 1985.³⁶ The tone both of the consultation document and the resulting Summary of Submissions Received on the Issues Paper (Summary) was that assisted reproduction was a reality in New Zealand; that attention should be focused on the issues raised by this rather than on prohibition; and that different moral views could not diminish the ‘deep human need to procreate’.³⁷ The Summary indicated an official view that assisted reproduction was generally considered a primarily private matter and consequently the preference was to take a watching brief and a restrained approach, despite calls for legislative intervention. It was stated unequivocally that:

the waiting lists for IVF at NW’s Hospital suggest very strongly that many New Zealand women do want to take advantage of the new techniques. If this trend is to be reversed, the onus of changing public opinion must rest on those who oppose it. The challenge for policy makers – whether in the field or in government – is how best to respond to the facts that the techniques exist, that they are practiced, and that there is a public demand for them.³⁸

Around the same time that the United Kingdom introduced the Human Fertilisation and Embryology Act 1990, the New Zealand medical profession assumed a proactive position, undertaking two major initiatives of its own volition. Fertility service providers sought voluntary accreditation from the Reproductive Technology Accreditation Committee (RTAC), which was the accrediting body of the Fertility Society of Australia,³⁹ a practice that subsequently became a requirement of their professional body (RNZCOG). In addition, the Medical Council of New Zealand (MCNZ) also commissioned a report into issues involving human-assisted reproduction and research from the Bioethics Research Centre of the University of Otago. The resulting report advocated specific legislative measures and the appointment of a licensing authority to oversee assisted reproductive practice and

research.⁴⁰

The government subsequently established two new committees in 1993. First, the Minister of Health established an Interim National Ethics Committee on Assisted Reproductive Technologies (INECART) to consider applications for assisted reproductive procedures and research (taking over the role of Regional Ethics Committees). Second, a two-person Ministerial Committee on Assisted Reproductive Technologies (MCART) was appointed by the Minister of Justice to report on options for the future.⁴¹

The MCART report was notable for several reasons, not least its strong bi-cultural emphasis, as well as the similarly strong theme that simply ‘transplanting’ a regulatory system from another jurisdiction was not appropriate in the New Zealand context. Also of significance was the formulation of a set of principles not only to guide, but also to justify, any regulatory intervention. These principles included: respect for the dignity of human life; informed consent; a right to know one’s genetic origins; the right to individual autonomy; respect for obligations under the Treaty of Waitangi;⁴² and the paramount importance of the welfare of any child born.

MCART was neither in favour of introducing specific legislation nor of establishing a licensing body such as the United Kingdom’s Human Fertilisation and Embryology Authority (HFEA). The reasons for eschewing a licensing body were strictly pragmatic: New Zealand had only a small number of fertility services and so was in a different position to other jurisdictions such as the UK; a licensing system would merely replicate the accreditation procedures provided by RTAC; it would be difficult to find suitably qualified people to perform licensing functions who were independent of the clinics themselves; and it would be costly to the taxpayer, providers and consumers.⁴³ However, MCART favoured legislative amendments to the Medical Practitioners Act 1968 to enhance the professional self-regulation of fertility services and also recommended that a national advisory body, the Council on Assisted Human Reproduction, be established.⁴⁴

Ultimately, the Department of Justice did not establish a Council on Assisted Human Reproduction. Instead it recommended that the National Ethics Committee on Assisted Human Reproduction (NECAHR), a body that succeeded INECART, perform some of the roles that MCART envisaged for its proposed Council on Assisted Human Reproduction.⁴⁵

Ultimately, MCART’s report established a platform for principled policy-making that relied on professional self-regulation being given greater ‘teeth’, and oversight by an advisory body rather than legislative intervention, with four exceptions potentially justifying parliamentary scrutiny in the future.⁴⁶ It was clearly cognisant of human rights – including autonomy rights and the rights of Māori pursuant to the Treaty of Waitangi – as well as the need for justification of state incursions on reproductive liberty or indigenous culture. Arguably it was a high point in terms of the emphasis it placed on autonomy and rights.

At this point there was a clear tension between those advocating immediate and direct legislative action, and the more restrained government approach.⁴⁷ The perceived imperative to impose legislative limits on assisted reproductive technology and research resulted in the introduction of Dianne Yates’s private member’s bill in the mid-1990s.⁴⁸ In the debates that followed, references to reproductive liberty, autonomy and indigenous rights became less apparent.

A tale of two bills and a supplementary order paper: enacting the HART Act 2004

When the Yates Bill was debated, the regulatory framework governing assisted reproduction and research consisted of professional self-regulation (which included a requirement that fertility clinics obtain ethical approval prior to performing new or innovative procedures or research and the requirement that NECAHR consider any such proposals) as well as the general medico-legal regime.⁴⁹

The Yates Bill broadly proposed: a licensing scheme facilitated by a statutory licensing authority that was based on the UK Human Fertilisation and Embryology Authority;⁵⁰ centralising records to enable access to conception information (codifying an existing, voluntary, practice among clinics); a prohibition on the sale of body parts or babies, and commercial surrogacy arrangements;⁵¹ as well as establishing additional criminal offences, such as in respect of cloning.⁵² Sex selection and genetic screening would also be prohibited. While the Yates Bill incorporated some of MCART’s principles,⁵³ attention to the concept of reproductive liberty was extremely muted.

The private member’s bill was unanimously sent to the Justice and Law Reform Committee in 1997, where it remained. A government bill was subsequently introduced to Parliament in the form of the Assisted Human Reproduction Bill in 1998. The Bill covered similar subject matter,⁵⁴ but recommended a different structure for decision-making, delegating guideline development and ethical oversight to NECAHR rather than utilising a licensing regime.⁵⁵ After its second reading, the Bill was referred to the Health Select Committee in 1998.⁵⁶ Somewhat later, the government introduced a Supplementary Order Paper (SOP) in April 2003 that contained substantial amendments to the HART Bill introduced by Dianne Yates. The SOP removed the proposed licensing regime, instituted a different policy-making regime,⁵⁷ and declared different purposes and principles. The revised legislative framework was less prescriptive and prohibitive than the Yates Bill.

Effectively faced with a third bill on assisted reproductive technology, the Health Select Committee called for submissions on issues covered by both Bills and the SOP.⁵⁸ The Health Select Committee presented its report in August 2004, recommending significant amendments to what was referred to as the Human Assisted Reproductive Technology Bill. PGD, which had not been established as a clinical service in New Zealand at that time, attracted significant attention in the parliamentary debates that followed. The HART Act was enacted in November 2004 after a conscience vote resulting in a majority of 102 votes to 18.⁵⁹

The HART Act 2004

secure the benefits of assisted reproductive procedures, established procedures, and human reproductive research for individuals and for society in general by taking appropriate measures for the protection and promotion of the health, safety, dignity, and rights of all individuals, but particularly those of women and children, in the use of these procedures and research.⁶⁰

The remaining purposes are to: prohibit ‘unacceptable’ assisted reproductive procedures and research – which are not defined, although the following purpose of the Act aims specifically to prohibit ‘certain commercial transactions relating to human reproduction’.⁶¹ Another stated purpose is to ‘provide a robust and flexible framework for regulating and guiding’ assisted reproductive procedures and research.⁶² To this end, the Act establishes an Advisory Committee on Assisted Reproductive Technology and Research (ACART) and an Ethics Committee (ECART).⁶³

The HART Act 2004 does not deal comprehensively with every aspect of assisted reproductive technology. Apart from creating certain prohibited offences, it delegates authority to ACART to draft guidelines and provide advice to both the Ethics Committee and the Minister of Health.⁶⁴ All such policy and advice must be developed in accordance with the Act’s guiding principles and stringent statutory consultation requirements.⁶⁵ ECART is required to consider applications to perform assisted reproductive procedures, and may only approve those that are consistent with ACART Guidelines.⁶⁶

The Act distinguishes ‘assisted reproductive procedures’ from ‘established procedures’ by requiring ethical approval to be obtained prior to the former being performed, but not the latter.⁶⁷ Correspondingly, a further purpose of the Act is to prohibit the performance of an assisted reproductive procedure without the approval of the Ethics Committee.⁶⁸ The final purpose is to establish an information-keeping regime so that donor-conceived offspring may access information regarding their genetic origins.⁶⁹

The Act also specifies certain principles that ‘all persons exercising powers or performing functions under the Act must be guided by’.⁷⁰ The first is that ‘the health and well-being of children born as a result of the performance of an assisted reproductive procedure should be an important consideration in all decisions about that procedure’.⁷¹ The following two principles are that: ‘the health, safety, and dignity of both present and future generations should be preserved and promoted’,⁷² and that ‘while all persons are affected by assisted reproductive procedures and established procedures, women, more than men, are directly and significantly affected by their application, and the health and well-being of women must be protected in the use of these procedures’.⁷³

The remaining principles provided that: no assisted reproductive procedure or research should be performed on an individual unless informed consent has been contained;⁷⁴ that ‘donor offspring should be made aware of their genetic origins and be able to access information about those origins’;⁷⁵ that ‘the needs, values, and beliefs of Māori should be considered and treated with respect’;⁷⁶ and that ‘the different ethical, spiritual, and cultural perspectives in society should be considered and treated with respect’.⁷⁷

The Act establishes three broad categories of assisted reproductive procedures and research: those that are prohibited outright under the Act; those that are regulated by ACART and that can only be performed with ethical approval in accordance with ACART guidelines; and those that are declared, by Order in Council to be ‘established’. Established procedures are effectively ‘mainstream’ medical procedures and may be performed as routine clinical procedures. These procedures are listed in a regulatory instrument: the Human Assisted Reproductive Technology (HART) Order 2005. The Minister of Health may recommend that the Governor-General pass an Order if ACART advises him that an assisted reproductive procedure does not need, or no longer needs, to be regulated and thereby subject to ethical approval.⁷⁸

The Act specifically prohibits PGD for non-medical sex selection. No robust explanation was given for introducing this prohibition, despite the fact that breach of the provision renders a person liable to a fine of up to $100,000 and/or imprisonment for up to a year.⁷⁹ It was simply stated that, on the basis of submissions received by the Health Committee, there was a ‘broad level of support’ for adding this prohibition.⁸⁰ However, it was likely a pragmatic compromise designed to ensure the passage of the Bill and a concern not to appear more permissive than other countries.⁸¹

The (minority) Green Party was especially exercised by the prospect of PGD. Not only was PGD perceived to be problematic in general, social sex selection was deemed to be among ‘the worst excesses of artificial reproduction’.⁸² Other parliamentarians endorsed the prohibition on sex selection, on the basis that it was self-evidently wrong, rather than on the basis of reasoned or rational debate as to exactly why it mandated criminalisation. One conservative MP who considered the Act far too liberal nevertheless said that:

[o]ne provision shows a great deal of caution about sex selection. There is no particularly rational reason why we cannot have sex selection – if we can select for other things, why can we not select for gender – but deep in our gut we know that it would be wrong to legislate for sex selection. We just know it is wrong – we do not need to have a PhD to know that.⁸³

However, this sentiment fails to demonstrate an appreciation for the fact that the law, particularly when it is reinforced by criminal sanctions, generally requires more than simple disapproval of, or alleged community distaste towards, a particular act.⁸⁴ For those individuals wanting to utilise PGD for social sex selection, it is arguably consonant with securing the ‘benefits’ of assisted reproduction – a stated purpose of the Act. Consequently, for it to be legitimately prohibited there is a need to indicate what harm the resulting individuals or society must be protected from. If, as Bill English asserted, there is no ‘rational’ objection to sex selection (clearly there might be, but none was raised) the law is obviously enforcing not only a majoritarian moral viewpoint but, contrary to the liberal political tradition, doing so in the absence of evidence of harm.

However, it was not only social sex selection that concerned some members of Parliament. The purported erosion of the rights of persons with disabilities was also claimed to justify narrowly regulating PGD. One MP claimed: ‘If we allow the technology to advance slowly but surely to the point where parents are allowed to design their children’s genetic inheritance, we threaten those with disabilities and we threaten their right to be born in the future.’⁸⁵ Yet the same MP welcomed the use of PGD to prevent serious genetic disorders or diseases such as cystic fibrosis, haemophilia or muscular dystrophy.⁸⁶ Yet if such a right to be born may be claimed, PGD should surely be banned completely, rather than partially. Instead, the arguments invoked belied the complexity of the disability rights issues that they raise.

Clearly some MPs wished to draw a line between ‘acceptable’ and ‘non-acceptable’ choices, although the merits of such an approach are debatable. Even some of the most ardent disability rights activists resist drawing such (putative) bright lines and indeed challenge the legitimacy of creating a medical–social dichotomy in this context.⁸⁷ This is because creating categories of conditions for which PGD is permissible not only potentially ‘pathologises’ the associated condition, but they argue it devalues those persons actually living with the same conditions when only some selection choices are rendered lawful by the state. Further, there was no apparent appreciation in the debates for the counter-argument that it is prospective parents (who ultimately stand in the closest relationship with the resulting child and assume a responsibility that others simply do not share) who should, in the absence of evidence that such conduct is harmful, be at liberty to make reproductive choices that directly and intimately impact on their lives, including decisions whether to seek to avoid conceiving a child with disabilities.

Slippery-slope arguments were pervasive in the parliamentary debates on the Bill.⁸⁸ PGD was frequently referred to, mostly in the context of sex selection, and often conflated with genetic modification.⁸⁹ Yet the two are very different things. The amount of ‘design’ possible in PGD is limited to selection on the basis of genetic characteristics already present in an embryo – whereas genetic modification involves alteration of the genetic code. This kind of modification was to be prohibited in the HART Act 2004.⁹⁰ While ‘designer baby’ terminology was rife, as was the assumption of the legitimacy of state intervention in reproductive lives, any concept of reproductive liberty, or what its scope might be, was generally absent from the debates.⁹¹ Clearly, there was an implicit view that parent(s) could legitimately avoid conceiving a seriously impaired child utilising PGD, but other matters, either involving less ostensibly serious disease or non-medical selection, were assumed to come within the purview of the state.

The current regulatory framework for PGD was essentially established prior to the appointment of ACART, which is now statutorily responsible for its monitoring and revision.⁹² Before the relevant parts of the HART Act 2004 came into force, PGD was regulated by guidelines formulated by the National Ethics Committee on Assisted Human Reproduction (NECAHR) after the Minister of Health approved the use of PGD in principle in 2003.⁹³ The Guidelines have been partly subsumed by developments since the introduction of the Act. However they are still relevant, primarily in relation to HLA tissue-typing, until such time as ACART replaces them.

As already indicated, the Act prohibits PGD for social sex selection. PGD with preimplantation HLA tissue-typing is a regulated procedure, and may only be performed in the circumstances specified in the Guidelines and with prior ethics committee approval. PGD may be performed as an established procedure (that is, without ethical approval) if it is consistent with the applications of PGD described by the Human Assisted Reproductive Technology Order 2005 (HART Order).⁹⁴ What follows examines these two latter categories of PGD.

The HART Order 2005: legal limbo

The HART Order essentially restricts PGD to the diagnosis of single gene disorders that are inherited in a Mendelian manner and that may cause a future individual to be seriously impaired.⁹⁵ The Order provides that PGD may be performed routinely if all of the following criteria are met: a familial single gene or familial chromosomal disorder has been identified in the family or whānau;⁹⁶ there is a 25 per cent or greater risk of an affected pregnancy; and there is evidence that the future individual may be seriously impaired as a result of the disorder.⁹⁷ In the case of a familial sex-linked disorder, sex selection may only be utilised if there is no available direct mutation test in order to prevent the elimination of embryos that do not carry the sex-linked mutation.⁹⁸