Abstract
Over the last half-century, significant innovations have occurred in the fields of embryology and human assisted reproduction as a result of human embryo research. This dynamic and ethically complex field is generally subject to extensive regulatory oversight. This article examines New Zealand’s legal framework governing such research. It argues that, despite the core legislative objective of establishing a robust and flexible framework, the current legal regime established under the Human Assisted Reproductive Technology Act 2004 is a classic example of regulatory failure. While not a necessary outcome of the devolved, principles-based regulatory scheme, this failure is primarily due to the perceived lack of authority and independence of the statutory policymaking body established under the Act, as well as the broader regulatory environment in which it operates. It argues that a confluence of problems, including Ministerial overreach as well as a lack of transparency and accountability on the part of decision makers, undermine the legitimacy of the current embryo research policy. This regime not only unjustifiably prevents the conduct of valuable embryo research, but also hinders simple quality improvement practices undertaken in the course of ordinary IVF service provision. This article concludes that, given the significance of embryo research as well as the associated ethical and legal challenges, the issue of embryo research should be remitted back to Parliament to legislate directly as a matter of urgency.
Introduction
In 2004, New Zealand (NZ) enacted a specific legislative regime governing the conduct of human assisted reproductive technology and reproductive research in the form of the Human Assisted Reproductive Technology Act 2004 (HART Act). Two laudable objectives of the Act are securing the ‘benefits’ of assisted reproductive technology and research for individuals and society while ensuring a protective framework (particularly for women and children), 1 as well as providing a ‘robust and flexible’ framework for guiding human assisted reproductive technology and reproductive research. 2 However, the extent to which either objective is being met in the context of human embryo research is debatable.
When introducing the HART Act, NZ’s parliament opted for an amalgam of rules-based and principles-based regulation. The Act introduces certain prohibitions and establishes a statutory Advisory Committee on Assisted Reproductive Procedures and Human Reproductive Research (ACART). 3 ACART is tasked with issuing guidelines and providing advice in regard to human assisted reproductive procedures and human reproductive research. 4 Any advice or guidelines promulgated under the Act must be guided by prescribed statutory principles 5 and comply with statutory consultation requirements. 6 This regulatory approach of enshrining some rules in primary law, but otherwise devolving governance and policymaking authority, seeks to enable a flexible and responsive regulatory framework, ostensibly better suited to meeting the challenges of rapidly evolving biomedical technologies than traditional legislative mechanisms. 7
This article is solely concerned with the regulation of human reproductive research. It is set out in three parts. First, it locates this discussion in the broader debate regarding the moral status of embryos and the evolution of the ‘14-day rule’ widely applied in the context of embryo research. It then outlines the significance and spectrum of embryo research, before briefly sketching the regulatory approaches adopted by two comparator jurisdictions, the United Kingdom and Australia. The second part describes the regulatory framework established by the HART Act, before critiquing the policy contained in the Guidelines for Research on Gametes and Non-viable Embryos (Research Guidelines). 8 The third part considers the respective roles of the Minister of Health and ACART, highlighting a troubling pattern of obstruction and obfuscation by officials performing statutory functions under the Act. It concludes that as a result of extensive regulatory failures, a rigorous, principles-based, and transparent review of human embryo research is essential.
Part I: Embryo research debates and the ‘14-day rule’
Although Louise Brown’s birth occurred over four decades ago, the permissible scope of embryo research continues to be widely debated due to competing, and largely irreconcilable, views regarding the moral status of human embryos. Extracorporeal embryos challenge neat ethical and legal categorisation, falling into a metaphorical ‘gray zone, between life and not-yet-life’. 9 Ultimately, views regarding the permissibility of human embryo research depend upon the way in which the moral status of such entities are construed, which varies greatly in a pluralistic society.
There are several accounts as to what accords moral status to an entity. One approach draws on Joel Feinberg’s analysis of rights whereby an entity has moral status if it possesses rights; an entity is a rights-bearer if it possesses interests that society is required to take seriously. 10 On this account, as non-sentient, entities without capacity for further human development via implantation, extracorporeal embryos cannot be said to possess interests of their own, nor will they acquire interests in the future. If this approach is adopted, extracorporeal embryos that are not destined for implantation in a woman cannot be attributed with significant moral status. 11
Another approach is the view that what confers full moral status and moral rights on an entity is membership in the human community. 12 On this account, all human beings possess full moral status and moral rights. 13 The question that logically follows is when does a human being come into existence? For those who consider that a human being comes into existence at the point of fertilisation, an extracorporeal embryo has full moral status, and therefore destructive embryo research is morally wrong. 14 A necessary implication of this view is that if IVF was to be morally acceptable, it would require that every embryo created is implanted for the purpose of gestation to confer a chance of life on all embryos. 15 Such a mandatory transfer rule was initially adopted in Italian legislation, 16 but did not withstand constitutional challenge. 17 In contemporary times, any proposed law that prioritised an ex vivo embryo’s chance of life over a woman’s right to make medical decisions would not be considered a serious proposition. Rather, the reality that IVF may result in the creation and subsequent destruction of surplus embryos has generally been considered an acceptable trade-off in assisted reproduction. However, for a minority who hold the full moral status view, IVF itself is morally wrong because it necessarily involves the creation, manipulation and destruction of human embryos. 18
While some scholars, particularly those writing in the natural law tradition, might argue that at the point of fertilisation an embryo is the equivalent of a born human being, it is not a widely shared view. Even some commentators who consider embryos to be part of the human community do not consider that embryos should be attributed with the same moral status as a born human being, particularly in the very early stages postfertilisation when the embryo constitutes a cluster of ‘undifferentiated cells’. 19 On this so-called gradualist account, moral status is perceived as something that gradually develops and compounds over time. 20 Hence, research on early-stage embryos may be morally permissible if it is offset by benefits accrued from conducting such research. In contrast to this intermediate or gradualist position, those at the very liberal end of the research spectrum consider that embryos are neither persons nor potential persons, hence they should not be afforded protected status. On this account, if research may yield beneficial results, it should be permitted. 21 What may ultimately be concluded is that there is a spectrum of views, reasonably held, regarding the moral status of extracorporeal embryos. Negotiating this ethical pluralism is particularly challenging for regulators tasked with determining the permissibility of embryo research.
The evolution and codification of the ‘14-day rule’ internationally
One of the first jurisdictions to address the permissibility of embryo research was the United Kingdom. Following Louise Brown’s birth, the UK Government appointed a Committee of Inquiry into Human Fertilisation and Embryology in 1982, chaired by Dame (now Baroness) Mary Warnock. 22 Although a philosopher, Warnock considered that philosophy had a limited role in determining law and policy; when it came to making law, the two relevant questions were ‘when does life begin to matter morally’ and ‘should we permit research upon human embryos?’ 23 In this way, instead of acting as ‘moral’ experts, the Committee perceived its role as seeking a ‘middle way’ between competing interests. 24
When making its final recommendations the Warnock Committee drew on the expertise of developmental biologists. 25 The Committee heard evidence that it is generally 14 days after fertilisation that the so-called primitive streak begins to appear, which forms the antecedents of the spinal cord and nervous system. The formation of the primitive streak marks the beginning of individual development and was claimed to constitute an appropriate boundary-marker for permissible and non-permissible research. 26 Ultimately, the Warnock Committee recommended that embryo research should be permitted, but only on embryos less than 14-days postfertilisation. In this way, the rule was pragmatic; it would retain many benefits of embryo research, while offending as few people as possible. 27 However, the Committee concluded that the human embryo had a ‘special’ status, respect for which justified some degree of legal protection and oversight. 28
For some, the view that the embryo does not have full moral status, but yet should be accorded ‘special status’, is incoherent. 29 However, the view that embryos do not have (full) moral status should not be conflated with the idea that embryos lack moral value. Bonnie Steinbock argues that an entity has ‘moral value if there are moral reasons to treat it in certain ways and not in others’. 30 For example, even though a dead human body no longer has moral status, certain moral standards must be observed in the handling of dead bodies. Specifically, the criminal law prohibits the disrespect of human remains. 31 Arguably, dead bodies demand respect because they are symbolic of human life and the prior individual it represents. Similarly, human embryos may be thought to deserve respect because they are ‘a symbol of human existence’. 32 While embryos may not be rights bearers or moral subjects nor are they nothing. 33
The ‘14-day rule’ was subsequently codified by the United Kingdom’s Human Fertilisation and Embryology Act 1990 (HFE Act). It constitutes a pragmatic compromise that enables beneficial research to be conducted, while imposing limits on the use of extracorporeal embryos. 34 This 14-day rule has since been adopted in at least 12 countries, including New Zealand’s HART Act. 35 Despite recent challenges that the rule is too conservative, 36 it is viewed by many as the ‘linchpin of an effective policy compromise between what remain deeply divided moral positions on the human embryo’s status’. 37 For those jurisdictions that have adopted the 14-day rule, the nature of research that may be conducted on embryos less than 14-days postfertilisation varies.
The significance and spectrum of human embryo research
There is a wide spectrum of embryo research, as well as a range of embryos that could, theoretically, be used in such research. Embryo research may be performed to improve knowledge about infertility and to develop more effective ART techniques. 38 Alternatively, embryo research may focus on understanding early developmental biology, 39 or on identifying causes for, and treatment of, serious diseases and other serious medical conditions, 40 or to develop methods for detecting gene, chromosome or mitochondrial abnormalities in embryos prior to implantation. 41 Embryos may also be used to derive stem cells for research into disease and the development of regenerative therapies. 42 More recent developments, although still subject to considerable debate, include research into mitochondrial replacement therapy 43 as well as embryonic gene editing. 44 Predicted research developments include stem cell-derived gametes and embryos. 45
As well as the wide range of possible research, various kinds of embryos may, at least theoretically, be used for research. Research may be performed on ‘non-viable’ embryos that will otherwise be discarded as unsuitable for implantation, as well as ‘surplus’ embryos that are no longer required by an individual/couple following IVF. Additional sources of embryos include those specifically created for research purposes, created using ordinary IVF procedures or by using cloning techniques such as somatic cell nuclear transfer (SCNT). Another source of embryos involves hybrid embryos (embryos containing both human and non-human DNA).
Before considering New Zealand’s ostensibly decentred regulatory framework, 46 the following briefly outlines the regulatory positions adopted in the United Kingdom and in Australian federal law.
Embryo research: United Kingdom and Australia
The UK’s Human Fertilisation and Embryology Act 1990 (HFE Act) as amended in 2008 expressly prohibits certain activities and establishes an independent arm’s length regulatory authority, the Human Fertilisation & Embryology Authority (HFEA), to operationalise the law. 47 While the HFEA is responsible for licensing treatment and research, 48 the HFE Act specifies the purposes for which embryo research may be licenced 49 and identifies permissible sources of embryos for research. 50 The HFEA is responsible for formulating a Code of Practice governing the conduct of assisted conception treatment and research. 51 It is also tasked with advising the public and Government regarding scientific advances, evaluating such developments, and associated decision-making. 52
The HFE Act permits research on embryos less than 14 days old, subject to licensing by the HFEA. 53 It facilitates a wide scope of research, including the creation of embryos for research purposes, but distinguishes between ‘permitted’ embryos that may be used to establish a pregnancy, and embryos that may only be used for research purposes and not implanted. 54 The Act outlines the principal purposes for which embryo research may be licenced by the HFEA, provided it is satisfied that the research is necessary and desirable for those purposes, 55 or for such other purposes as may be specified in regulations. 56 Specified purposes include increasing knowledge about, and treatments for, serious disease or medical conditions; promoting advances in the treatment of infertility; increasing knowledge of the causes of congenital disease and miscarriage; developing methods for detection of gene or chromosomal abnormalities in pre-implantation embryos; and increasing knowledge about the development of embryos. 57
Embryo research in Australia is regulated at the federal level by the Research Involving Human Embryos Act 2002 (RIHE Act) and the Prohibition of Human Cloning for Reproduction Act 2002 (PHCR Act). The RIHE Act adopts a licensing system in conjunction with the National Health and Medical Research Council’s (NHMRC) National Statement on Ethical Conduct in Human Research 2007 (Updated 2018). 58 As in the United Kingdom, the RIHE Act precludes licences being given for any use that would result in embryo development beyond 14 days. 59
The RIHE Act permits the use of donated excess IVF embryos in research, provided consent is obtained from the donors, and the research is authorised by a licence issued by the Embryo Research Licensing Committee of the NHMRC, 60 but does not permit the creation of IVF embryos for research purposes. 61 However, following the Government-appointed Lockhart review in 2005, the permissible scope of embryo research in Australia was expanded to include use of human embryos created other than by other than by fertilisation (such as by SCNT) or the use of hybrid embryos for research purposes. 62 Such research is permissible provided a licence authorising the creation or development, 63 and subsequent research use, 64 of those embryos is obtained. The NHMRC Ethical Guidelines provide criteria that proposed research must satisfy, including: ‘sufficient evidence that the likely benefits of the proposed research cannot be achieved without using human embryos’; there is proof of concept; and the research is ‘justifiable by its potential benefit in improving technologies for treatment of, or knowledge about, human diseases’. 65
A feature of both the UK and Australian regimes is that they proscribe certain activities in statute, but otherwise facilitate embryo research, subject to extensive licensing systems. In both jurisdictions, approval for embryo research requires justification that conducting the research is necessary or desirable to achieve potential health benefits. Also notable is the significant attention that embryo research has received in both the United Kingdom and Australia from legislators, policymakers and academics. In Australia, the federal Government has undertaken several reviews of embryo research. 66 In the United Kingdom, multiple actors have engaged with issues in embryo research, in addition to the Government. 67 For example, prior to the recent introduction of regulations permitting mitochondrial replacement therapy, 68 the HFEA commissioned an expert panel to undertake scientific review of its safety and efficacy, which was updated over several years, 69 as well as conducting a public consultation. 70 In addition, the issue was subjected to independent ethical scrutiny by the Nuffield Council on Bioethics. 71
Having established these two jurisdictions as relevant comparators, the following outlines the regulatory framework established by NZ’s HART Act, before examining the regulatory regime governing embryo research
Part II: NZ’s regulatory framework
When the NZ Parliament introduced the HART Act it opted for a hybrid – rules-based and principles-based – legal regime. Apart from creating a set of prohibited offences, it delegates authority to the statutory Advisory Committee on Assisted Reproductive Technology and Reproductive Research (ACART) to issue guidelines and provide advice in regard to human ‘assisted reproductive procedures’ (ARPs), 72 ‘established procedures’ 73 and ‘human reproductive research’ (HRR). 74 When formulating advice and guidelines, ACART must be guided by specific statutory principles and provisions, including mandatory consultation obligations. 75
The HART Act establishes a two-tier system, distinguishing policymaking processes from approval processes. The Act confers authority on ACART to issue guidelines and give advice to both the Minister and the Ethics Committee on Assisted Reproductive Technology (ECART). 76 ECART is authorised to consider actual applications to perform ‘ARPs’ and ‘HRR’. 77
The purpose and principles contained in the Act signal Parliament’s intentions when introducing the HART Act, and the values that underpin it. At first glance, these suggest a relatively liberal framework was intended.
A ‘robust and flexible framework’, and principles for policymaking
The first purpose declared in the Act is to ‘secure the benefits’ of ART and ‘HRR’ for individuals and society by taking ‘appropriate measures’ to protect and promote the ‘health, safety, dignity, and rights of all individuals, but particularly those of women and children, in the use of these procedures and research’. 78 An additional purpose is to prohibit ‘unacceptable assisted reproductive procedures and…research’. 79 Of greatest significance to this discussion are the following two purposes: the first is to ‘provide a robust and flexible framework for regulating and guiding…assisted reproductive procedures and…human reproductive research’ and to prohibit the performance of non-established ‘ARPs’ and ‘HRR’ without ethics committee approval. 80 Hence in addition to ACART, the Act establishes a statutory ethics committee (ECART). By expressly prohibiting some aspects of ART and ‘HRR’ in legislation, while also conferring policymaking authority on a statutory body, Parliament sought to ensure a flexible framework that could be responsive to the technical and fast-paced field of reproductive technology and medicine.
As noted above, the HART Act expressly adopts the ‘14-day rule’ in regard to ‘HRR’. 81 Thus, it is an offence to intentionally do anything to cause the further development of an embryo beyond 14 days; or to possess it with a view to using it in research; or to use it for research or reproductive purposes. 82 In addition, schedule 1 of the Act also provides a list of prohibited research activities. However, schedule 1 only includes clinical research, meaning research involving an attempt to achieve an actual pregnancy. While the schedule addresses controversial activities such as cloning and genetic modification of embryos, it is only the implantation of gametes or embryos in a human being or an animal following such procedures that is prohibited. These prohibitions do not extend to lab-based or ‘non-clinical’ research not involving implantation in a human being or animal. In this way, Parliament deliberately chose not to foreclose the possibility of allowing such ‘non-clinical’ research to be undertaken should ACART choose to permit it. In this respect, it is significant that NZ departed from the more restrictive approach taken in the equivalent Canadian Act, on which some provisions of the HART Act were modelled. 83
Although the HART Act does not impose express restrictions on pure (i.e. ‘non-clinical’) research involving human embryos less than 14 days postfertilisation, such research is not simply left unregulated. Rather, it may only be conducted if written approval has been obtained from the statutory ethics committee – ECART. 84
Significantly, ECART may only approve applications to conduct proposed ‘HRR’ if satisfied that an application is consistent with the relevant guidelines, or advice, made by ACART. 85 If there are no guidelines governing the particular procedure proposed, ECART cannot approve applications. 86 Further, it is an offence to conduct human embryo research without prior written approval from ECART, with a fine imposed for breach. 87 In addition, every provider and person who is responsible for embryo research that has been approved by ECART is required to take ‘all practicable steps’ to ensure that the statutory 14-day prohibition is not contravened. 88 Although ECART is responsible for vetting applications to perform ‘HRR’, it is not responsible for creating policies governing ‘HRR’, a responsibility which lies solely with ACART.
In summary, while the ‘14-day rule’ serves as the legal demarcation for when human embryo research is absolutely prohibited under the Act, what constitutes permissible research involving embryos less than 14 days postfertilisation and which does not involve the specifically prohibited procedures is delegated to ACART to determine in accordance with the relevant statutory provisions. Given the wide scope of delegated decision-making authority, the Act also provides a set of principles to guide persons exercising powers, or performing functions, under the Act. 89
The HART Act’s guiding principles
The first principle 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’.
90
The following principle states that ‘the human health, safety, and dignity of [both] present and future generations should be preserved and promoted’.
91
The next principle, drawn directly from the comparative Canadian Act,
92
provides 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.
93
Provenance of the research guidelines
Prior to the introduction of the HART Act, the ministerial National Ethics Committee on Assisted Human Reproduction (NECAHR), first established in 1995, 97 was responsible for assessing applications to perform new assisted reproductive procedures and research, provided advice to the Minister of Health, and developed guidelines for fertility providers on ethical issues relating to assisted reproduction. Fertility services were not legally required to bring proposals before NECAHR, although it was required by their professional body. 98
In its 2002 Annual Report to the Minister, NECAHR noted that it had received applications relating to the use of ‘viable’ embryos in research. 99 Although it had previously approved the use of ‘non-viable’ embryos (referred to as ‘those unsuitable for implanting’), it considered the research use of ‘potentially healthy’ embryos attracted significant policy and ethical issues and was likely to be of public interest. 100 NECAHR deferred the applications until it could consider these wider issues and consult with the Minister of Health. Given the pending legislation, it did not wish to ‘pre-empt government policy in this area by approving applications that would be inconsistent with the direction of the legislation’. 101
Given this reticence, it is curious that, with the approval of the Minister of Health, NECAHR published guidelines on embryo research in January 2005, after the introduction of the HART Act. The NECAHR Guidelines for Research on Gametes and Non-viable Embryos Research Guidelines (Research Guidelines) are notable in that they make no reference to the HART Act, its purposes or its principles. 102 The NECAHR Research Guidelines were subsequently elevated from their ethical status to a legal status under transitional provisions contained in the HART Act. 103
NECAHR research guidelines: Designated ‘interim’ ACART research guidelines
Under transitional provisions provided in the Act, the Minister of Health may require an ethics committee to treat specified provisions of any document as interim guidelines issued by ACART for the purposes of the Act at any time during the 3 years after the date on which the Act gained Royal assent. 104 In August 2005, the Minister of Health approved a tranche of guidelines promulgated by NECAHR, including NECAHR’s Research Guidelines, as interim ACART guidelines, under the Act. 105
In accordance with the HART Act, the notice published in the New Zealand Gazette states that the Research Guidelines are effective until 21 November 2007 (3 years after the Act received Royal assent), unless revoked sooner. 106 This indicates an expectation that the interim guidelines would be revised once ACART was established. As this has not occurred, the Research Guidelines have not been effective legally since 2007. If NZ has no legally effective guidelines governing embryo research, ECART does not have legal authority to approve any applications to conduct any embryo research whatsoever. Despite this, the Research Guidelines continue to be treated as legally effective by both ACART and ECART. Given this, the following section considers the substantive content of the Research Guidelines.
A critique of the Guidelines for Research on Gametes and Non-viable Embryos
The Research Guidelines simply contain a selective ‘cut and paste’ from the 2004 version of the Australian National Health and Medical Research Council’s Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research (NHMRC Guidelines). 107 Because these guidelines originated from NECAHR, a Ministerial ethics committee, they were not professionally drafted or subject to the oversight that delegated legislation may receive. 108
Significantly, even though the full title of the Guidelines for Research on Gametes and Non-viable Embryos Research Guidelines refers to ‘non-viable’ embryos, no definition is provided as to what constitutes ‘non-viable’. However, given its prior exchange with the Minister, it is likely that NECAHR intended to narrowly restrict the scope of permissible research to research involving embryos ‘unsuitable for implanting’. 109
The first sentence acknowledges that all of the clauses contained in the Research Guidelines are derived from the Australian NHMRC Guidelines. However, these clauses are selectively extracted from a broader section in the NHMRC document, with no commentary or explanatory notes provided. This ‘cut and paste’ is problematic. The Australian NHMRC Guidelines specify requirements for research using not only human gametes and ‘non-viable’ embryos but also encompasses two further categories of embryo research: research involving ‘viable’ embryos (embryos that are intended to be transferred to a woman) 110 and research involving ‘excess’ IVF embryos (embryos no longer needed by a couple/individual in an IVF programme and subsequently donated to research). 111
Clause 15 of the NHMRC Guidelines provides generic ethical principles for research, expressly including both clinical and ‘non-clinical’ research. Clause 16 provides specific principles for research involving gametes, while clause 17 pertains to research involving embryos (‘viable’, ‘non-viable’ and ‘excess’ embryos).
The NZ Research Guidelines consist of specific provisions extracted from clauses 15 and 16 of the Australian NHMRC’s guidelines. However, the NZ Research Guidelines clauses do not distinguish between research involving gametes and research involving embryos. Somewhat problematically, the NZ Research Guidelines refer to clinical research that results in a pregnancy, despite the fact that ‘non-viable’ embryos, by their very nature, would never be used in clinical care. These generic provisions refer to researchers’ obligations to minimise risks in research involving clinical care, including that they must ‘ensure that any risks of adverse effects to any subsequently created embryo (or to the long-term health of any person born as a result of use of the embryo to achieve a pregnancy) are minimal’. 112 This clause is confusing – given that the title of the guidelines restricts research to use of ‘non-viable’ embryos.
Additional clauses require researchers to keep records, including records of all ‘gametes and embryos in their care’ and to ‘assess, evaluate and monitor outcomes for all participants (including any persons conceived using reproductive procedures, their siblings, where relevant, and the gamete or embryo donors)’. 113 Neither of these provisions are restricted solely to gametes and arguably presuppose the use of ‘viable’ embryos in research. Finally, the Research Guidelines contain a clause enabling conscientious objection. 114 This latter clause is strange – given that it would seem to be most applicable to the use of ‘viable’ embryos in research rather than gametes and ‘non-viable’ embryos. In this way, the guidelines lack clarity and coherence.
Implications of the ‘interim’ Research Guidelines
As noted above, before a researcher may lawfully conduct ‘HRR’, they must obtain written ethical approval from ECART. 115 ECART may only approve an application if it is consistent with ACART’s guidelines. 116 Therefore, ECART may only approve embryo research applications involving ‘non-viable’ embryos.
Distinct problems arise from restricting research solely to ‘non-viable’ embryos. The first is definitional. Although not defined, it is likely that ‘non-viable’ is meant to denote embryos that are not likely to implant due to poor morphological qualities or that have been diagnosed by pre-implantation genetic diagnosis as carrying serious genetic mutations and therefore deemed ‘unsuitable for implantation’. Yet, it may also be argued that any embryo that is not destined for implantation, whether due to poor morphology or because of a choice made by its progenitors not to implant it, may be considered to be ‘non-viable’ because it is not on a trajectory of implantation and potential foetal development.
A different issue arising from restricting research to ‘non-viable’ embryos is that it may limit the generalisability of any research results. Although it is not suggested that ‘non-viable’ embryos are of no value to research, the majority of embryo research requires the study of healthy embryos. 117 An additional issue is that limiting research to ‘non-viable’ embryos narrows the options available for individuals, in particular women, who must make decisions regarding disposition of their ‘surplus’ embryos.
It is not uncommon for couples to be left with embryos that are ‘surplus’ to their reproductive requirements, for various reasons, following IVF. They may have completed their family or may no longer want to pursue IVF. ‘Excess’ embryos cannot be cryopreserved indefinitely; the HART Act imposes a 10-year limit on storage, at which point a decision must be made regarding embryo disposition. 118 For some, donating their ‘excess’ embryos to research, rather than having them destroyed or donated to another couple, may be preferable. 119 While in Australia and the United Kingdom, couples or individuals may donate their ‘surplus’ or ‘excess’ embryos to research this is not an option in NZ. Under the Research Guidelines, ECART is unable to consider any proposed research involving ‘surplus’ donated embryos. By default, such research is impermissible under the HART Act. Consequently, the choice of embryo disposition is denied to the very individuals who have expended significant emotional, physical and financial labour in their creation.
Although no justification was provided for this, scholars elsewhere have argued that limiting research to ‘non-viable’ embryos may allay the concerns of those individuals who would ascribe full moral status to the embryo. 120 However, this approach is problematic. First, by preventing the use of ‘surplus’ ‘viable’ embryos, it implies that policy makers endorse the full moral status argument. Yet, if this were the case, IVF should be prohibited, as it routinely involves the creation and destruction of (surplus) embryos. However, the embryo loss involved in IVF is generally accepted as justifiable in the circumstances, an acceptable trade off given the benefits of assisted reproduction. Further, it is questionable whether requiring the destruction of a ‘surplus’ embryo is less morally problematic than allowing it to be donated for use in beneficial research. Significantly, the current policy position does not prevent the loss of any ‘surplus’ embryos, it merely prevents their use in research. It precludes research that may benefit other individuals undergoing IVF and/or may prevent broader research, potentially undermining one of the purposes of the HART Act – to secure the benefits of ‘HRR’ for individuals and society. 121
Another highly problematic outcome of restricting research to ‘non-viable’ embryos is that ECART has no capacity to approve research involving ‘viable’ embryos conducted in the course of providing IVF, 122 such as research into the effects of using different embryo culture media on embryo development, implantation rates and pregnancy outcomes. 123 In the context of a well-designed study, this kind of clinical research is an important aspect of quality improvement. The implications of this are exemplified by the recent attempt of local researchers to conduct a study into embryo transfer practices. 124
A case of regulatory failure: The day of transfer study
Embryo transfer, which involves the transfer of an IVF embryo to a woman’s uterus, is an ‘established procedure’ under the Act, consequently it does not require ECART approval but can be performed as a routine clinical procedure. 125 In practice, fertility providers may choose whether to transfer an embryo to a woman’s uterus on day three or day five. In the proposed ‘Day of Transfer’ (DOT) study, researchers wished to compare pregnancy and birth outcomes following different transfer times to obtain evidence as to which had the better outcome in terms of improving pregnancy rates and neonatal outcomes. 126 The study, which excluded any women with fewer than four embryos who might be disadvantaged if included, involved all women receiving standard care, but randomised whether they had a day three or day five transfer. 127 To be clear, the study intervention did not depart from standard practice but sought to better inform standard practice.
‘HRR’ is defined in the HART Act as ‘research that uses…a human embryo’. 128 On the basis of legal advice obtained first from Health Legal (the legal arm of the Ministry of Health) and then Crown Law, ECART declined the study, essentially because the Research Guidelines only confers authority to approve research involving the use of ‘non-viable’ embryos. While this interpretation of ‘use’ may be reasonable given that the DOT study was an interventional study, the implications of the restriction of research to ‘non-viable’ embryos is perverse. It prevents two procedures, where there is genuine uncertainty as to which has the better outcome, from being compared, and thus prevents the derivation of valuable clinical data.
In the event, the researcher questioned the interpretation adopted, requesting copies of the legal opinion relied upon by ECART under the Official Information Act 1982 (OIA).
129
The Ministry declined the request on the basis that the legal opinions obtained were subject to legal privilege,
130
following which the researcher complained to the Ombudsman.
131
After investigation, Ombudsman Judge Peter Boshier concluded that the research proposed:
132
is a matter of considerable public importance and interest. It seems to me that it is incumbent on the Ministry to do everything it can to assist researchers adopt correct procedures and to ensure that the best first hand information is made available. I can think of no plausible reason why the Ministry would seek to withhold from a senior health researcher advice, whether privileged legal advice or not, about the interpretation of a crucial term in the governing legislation. promote the accountability of the statutory decision maker, enable more effective participation by concerned or affected citizens in the administration of the HART Act and the making of policies by ACART and thereby enhance respect for the law and to promote the good government of New Zealand.
133
Crown Law noted that if ECART is unable to approve an activity because it is not covered by a guideline, it must not only decline the application, it must also refer the matter to ACART. 134 However, what is most significant is the following, and manifestly reasonable observation by Crown Law that after referring the matter to ACART ‘presumably the advisory committee may then give relevant advice or issue applicable guidance’. 135 As the following section explains, despite statutory provisions appearing to delegate policymaking authority to ACART, there are significant barriers to ACART discharging its obligations to provide advice, guidance and issue guidelines under the Act.
Part III: ‘Interim’ Guidelines? A troubled regulatory relationship
A specific function of ACART is to provide the Minister with advice on issues arising out of ‘ARPs’ and ‘HRR’ and, without limitation, advice as to whether a moratorium should be imposed in relation to these activities. 136 In addition, section 37(1) provides that ACART must, within agreed time frames, provide information, advice and, if it thinks fit, recommendations in relation to the use of embryos in ‘HRR’. 137 Soon after it was established, in 2005, ACART prioritised reviewing the Research Guidelines in its work programme. In doing so, it partnered with the National Bioethics Council: Toi te Taiao, a Government-appointed body which has since been disestablished. 138
Given that Parliament empowers ACART with policymaking authority, extensive consultation requirements are imposed to facilitate deliberative democracy. 139 This reflects the view that in the case of controversial biotechnologies, regulators are required to engage directly with the public, ensuring respect for the status of citizens as stakeholders. 140 Before giving significant advice under section 37 of the Act, ACART must give interested parties and members of the public a reasonable opportunity to make submissions and are required to take such submissions into account. 141 When ACART considers giving significant advice, it must undertake active public engagement and enable public meetings to facilitate oral submissions if ACART believes a considerable number of people would wish to do so. 142 In addition, section 41 of the Act requires that, before ACART gives advice to the Minister or issues guidelines to ECART, ACART must ‘consult’ with any members of the public, government departments and agencies, or any other person ACART considers appropriate. Further, before ACART issues guidelines, it must ‘consult on the proposed guidelines with the Minister’. 143
ACART commenced its review of the Research Guidelines in 2006, in partnership with the Bioethics Council. In July 2006, the Bioethics Council published a booklet to facilitate public dialogue about the use of human embryos in research: focusing on cultural, ethical and spiritual aspects. In that same year, ACART released a public consultation document inviting written submissions from the public. 144 ACART also conducted eight public meetings to receive oral submissions, including hui (to obtain the views of Māori) and fono (to obtain the views of Pacifica peoples). This was supplemented by independent research commissioned by ACART, which utilised focus groups to canvass the views of five particular groups: young people; women; people with experience of infertility; people with experience of genetic disorders and Chinese and Indian ethnic groups. 145
ACART sought public views regarding the moral status of the embryo and what kind of embryo research, if any, should be permitted in NZ including research involving basic science, research into fertility and infertility, research into the prevention of hereditary disease and research concerned with treating disease. For those participants who were not opposed to embryo research, ACART sought views regarding what sources of embryos were considered acceptable, with the options being ‘non-viable’ embryos; 146 ‘surplus’ embryos; and embryos created specifically for research, including hybrid embryos and embryos created using IVF or therapeutic cloning via SCNT. ACART also sought views about how Tikanga Māori (Māori cultural values) might apply to human embryo research, as well as different ethical, spiritual and cultural perspectives held by the public.
ACART received 345 written submissions. A further nine oral submissions were heard at public meetings. Approximately 160 people attended the public consultation meetings, including hui with Māori and fono with Pacific communities. 147 Two broad positions in relation to the use of embryos in research were identified in the submissions: (a) complete opposition on the grounds that embryos are human life and any intervention (including IVF) is akin to murder; and (b) support for some research ‘on the grounds that they have a lesser moral status than persons who have been born, provided that such research has scientific merit and potential to benefit human health’. 148 In respect to Māori views, the submissions reflected a wide range of attitudes to the use of embryos in research. Overall, there was a sense that more time and a greater degree of engagement at an iwi level (the wider kinship group) was needed to discuss the issues. Similar views have been expressed in more recent discussions. 149
In its analysis of submissions, ACART stated that it had ‘considered not only the strength of public opinion, but also the strength of the arguments made’. 150 ACART subsequently provided the Minister with recommendations regarding reform and advice regarding further work and consultation. However, there is no public record of ACART’s recommendations to the Minister, nor has ACART commenced any further work in this area. The destination of ACART’s advice can only be pieced together from snippets of redacted information obtained under the OIA.
Ministerial mandate, or obstruction and obfuscation?
According to documents accessed under the OIA, ACART provided advice to the Minister of Health in June 2007, 151 proposing only modest immediate reform. 152 It recommended the development of guidelines enabling the use of both ‘non-viable’ embryos and donated ‘surplus’ IVF embryos for research. 153 It also advised the Minister that guidelines should not permit the creation of embryos specifically for research or the genetic modification of embryos in research – but that these activities should be subject to an 18-month moratorium. 154 Under the Act, the Minister may recommend to the Governor General that an Order in Council be passed declaring an activity to be subject to a moratorium, for up to 18 months, ‘for the purpose of allowing time for the development of advice or guidelines, or both’. 155 After a moratorium is imposed, ACART must agree on a date with the Minister as to when it will provide the Minister with ‘information, advice, and, if the committee thinks fit, recommendations’. 156
ACART subsequently met with then Minister of Health, David Cunliffe and his Associate Minister to discuss ACART’s recommendations in May 2008. The Minister was clearly not receptive to ACART’s advice. Nevertheless in subsequent written correspondence, ACART reiterated that it wanted to proceed with guideline development, stating:
157
…the [current] guidelines themselves do not reflect the values that New Zealanders have told us are important to see implemented in the conduct of human reproductive research. I would, therefore, like to begin work on new guidelines…Finally, ACART feels strongly that it owes members of the public a response to the input they had as part of our consultation on embryo research…We would, therefore, like your agreement to publishing our advice on embryo research on our website.
This exchange is concerning in several respects, primarily because it reflects a seeming disregard for the statutory framework and the respective roles of ACART and the Minister. While ACART has statutory obligations to ‘consult’ the Minister, its primary statutory obligations are in regard to developing policy advice and guidelines in accordance with the purposes and principles of the Act. In developing its advice and recommendations, ACART clearly discharged its obligations to consider the HART Act principles and undertake public consultation. While the Minister may not have liked ACART’s advice, it was made in accordance with the statutory provisions.
Although the Minister may not agree, there is arguably no statutory mandate for the Minister to simply reject ACART advice, certainly not without explanation or justification. More importantly, the Act does not confer a Ministerial power to unilaterally demand ACART introduce certain prohibitions, particularly when such a prohibition is inconsistent with what, after undertaking substantial consultation, ACART considers appropriate. While the Minister’s demand that ACART introduces explicit prohibitions on the use of certain types of embryos was simply ultra vires it was, in any event, it was unnecessary. The effect of the Research Guidelines is that they prevent the very activities that the Minister wished to see explicitly prohibited. If a particular type of ‘HRR’ is not permitted by the Research Guidelines, ECART cannot approve it, and by default it cannot be lawfully performed.
That said, the Act clearly requires ACART to ‘consult’ with the Minister prior to issuing significant advice, or guidelines to ECART. 161 Although the Act does not define ‘consult’, the common law approach adopted by the High Court in Air New Zealand Limited v Wellington International Airport Ltd is applicable. 162 When considering the nuances of a statutory duty to ‘consult’, McGechan J observed that the essence of ‘consult’ is ‘not merely to tell or present. Nor, at the other extreme, is it to agree. Consultation does not necessarily involve negotiation toward an agreement, although the latter not uncommonly can follow’. 163 In other words, consulting is the ‘statement of a proposal not yet finally decided upon, listening to what others have to say, considering their responses and then deciding what will be done’. 164
Although the purpose of the statutory consultation requirements is to impose constraint on ACART, this arguably does not equate to providing the Minister with a power of veto. On the face of the Act, ACART has authority to give advice and to issue guidelines, provided it has discharged its statutory obligations. This approach is strengthened by the purpose of the Act, which is to provide a ‘robust and flexible framework’, 165 and to delegate policymaking authority and ethical review to two statutory bodies. 166
Not only is it arguable that the Minister exceeded his statutory power in vetoing ACART’s recommendations and demanding express prohibitions, also troubling is the Minister’s obfuscation of ACART’s advice by refusing to agree to ACART publishing its advice on its website. This lack of transparency undermines the objectives of the Act, specifically establishing a robust, flexible framework, and fails to ensure transparency and accountability of regulators to the public.
Options for ACART
As a result of the current impasse, NZ’s embryo research policy which has not been legally effective since 2007 continues to prevent potentially valuable embryo research, despite ACART’s efforts to review it. It is arguable that ACART could, despite ministerial opposition, publish its advice on its website and proceed with developing and consulting on new embryo research guidelines. As noted above, apart from the consultation obligations, the Act does not require that the Minister agree with advice or approve ACART’s guidelines. The Act simply requires that, following the mandatory consultation, when issuing guidelines ACART must give copies to the Minister, the Director-General of Health, ECART and providers and publish the guidelines on the Internet. 167 The Act states that as ‘soon as practicable’ after receiving a copy of the guidelines, the Minister must present a copy to the House of Representatives. 168
This statutory power does not mean, however, that guidelines issued by ACART under the HART Act should not be subject to external oversight and scrutiny. It is a core democratic principle that any delegation of Parliament’s lawmaking power should be subject to review. However, this requires determining how the Research Guidelines should be characterised in the legislative and regulatory landscape.
External scrutiny: Constraints on ACARTs power to issue guidelines
A variety of terms may be used in relation to the products of lawmaking powers that are delegated under an empowering Act, for example, a ‘regulation’, a ‘code’, a by-law or an ‘order in council’, all of which fall under the umbrella concept of ‘delegated’ or ‘subordinate’ or ‘secondary’ legislation. 169 While not specified on the face of the HART Act, it is arguable that the Research Guidelines fall within the category of subordinate legislation referred to in the Legislation Act 2012 (LA) as a ‘disallowable instrument’. 170
A ‘disallowable instrument’ is subject to the House of Representatives power to disallow (or amend, revoke or replace), 171 enabling the House of Representatives to supervise Parliament’s delegations of lawmaking power. 172 The LA deems an instrument made under an enactment to be ‘disallowable’ if it fulfils one or more of three criteria. 173 One criterion is that the instrument has a ‘significant legislative effect’. 174 The LA specifies that an instrument has a ‘significant legislative effect’ if the effect of the instrument is to both ‘create, alter, or remove rights or obligations’ and ‘determine or alter the content of the law applying to the public or a class of the public’. 175 The Research Guidelines clearly satisfy this definition: they create legal obligations for researchers and providers, which are statutorily enforced by a penalty if a person breaches the guidelines. 176 Further, by establishing the lawful scope of embryo research, the guidelines determine the law applying to fertility service providers, patients and researchers. 177 There is undoubtedly a strong case for finding the Research Guidelines fall within the category of secondary legislation referred to as disallowable instruments in the LA. However, proposed new legislation that seeks to simplify and remove uncertainty regarding the boundaries of secondary legislation by clearly identifying secondary legislation does not (as yet) expressly include the HART Act Guidelines. 178 While this is likely an oversight, it creates residual uncertainty as to whether the Research Guidelines constitute delegated legislation.
If ACART were to issue new guidelines, the Minister is required to present them in the House, even if he does not endorse them. 179 However, if there are concerns regarding the guidelines, and if it is accepted that they constitute a disallowable instrument, they may be referred to the Regulations Review Committee. The Regulations Review Committee may review ‘disallowable instruments’, but it focuses on procedural issues rather than the substantive content/policy of subordinate legislation. 180 Alternatively, Parliament's Standing Orders give subject select committees, including the Health Select Committee, power to initiate an inquiry into subject matter that falls within their terms of reference. 181 Hence, it would be open to the Health Select Committee to undertake a review of any tabled guidelines. Following review, it may recommend to the House of Representatives that a resolution be passed to disallow any provision(s). 182 This would provide a formal oversight mechanism for any guidelines issued by ACART that do not have the support of the Minister.
While this option, which depends upon the Research Guidelines being deemed to be a ‘disallowable instrument’/secondary legislation is potentially available to ACART, forcing the issue in this way may not be a particularly attractive or feasible option. The Minister appoints, and has the power to terminate, ACART members. 183 In addition, ACART is not well resourced. It is dependent upon limited secretariat support and funding from the Ministry of Health. Consequently, ACART has sought agreement from the Minister when formulating its work programme. Given this relationship, it would be understandable if ACART wished to avoid antagonising the Minister. However, it remains that ACART’s primary obligations under the Act are to patients, providers and the public in general. 184 Clearly, this would be an easier task for ACART if it were established as an arm’s length body similar to the UK’s HFEA, with independent resources. While this analysis has suggested that the HART Act does not empower the Minister to dictate ACART policy, it must also be acknowledged that there are features of the regulatory environment that affect ACART’s ability to act independently, including resource issues and a lack of will across the political spectrum to prioritise the issue of embryo research.
The impasse between the Minister and ACART has never been resolved. Since its early efforts, ACART has unsuccessfully sought approval from consecutive Ministers to revisit the issue of embryo research. After a National-led coalition government was formed in 2008, Tony Ryall replaced David Cunliffe as Minister of Health. ACART, once again, sought agreement to commence a review of embryo research, but it was never obtained. 185 In 2014, ACART noted in its briefing to Jonathan Coleman, the incoming Minister, that reviewing the Research Guidelines was a ‘priority item’ in regard to its work programme, subject to ministerial agreement, which again did not eventuate. 186 In 2017, a Labour-led coalition government was formed, with a majority Labour government following elections in 2020 . As yet no announcements have been made regarding review of the Research Guidelines.
Conclusion
This article makes two distinct claims. First, that the policy contained in the Research Guidelines is insufficiently justified and substantively flawed, with adverse consequences for research and the provision of fertility services. Second, that while the HART Act’s principles-based framework may be superficially appealing, the current regulatory environment fails to enable the core regulatory values of procedural legitimacy, effectiveness, transparency and accountability of regulators. 187 Despite the deficiencies of the Research Guidelines and repeated attempts by ACART to engage with this issue, successive Ministers have actively prevented policy review in this area.
On the face of it, NZ’s HART Act establishes a flexible, but protective, regulatory framework, introducing specific prohibitions in regard to embryo research, 188 but otherwise delegates policy development, in the form of advice and guidelines, to ACART. 189 By permitting IVF to be performed routinely, and by endorsing the ‘14-day rule’ in primary legislation, NZ has implicitly adopted a nuanced or gradualist approach to the embryo. Despite the fact that the HART Act seeks to facilitate flexible, principles-based regulation, outdated Research Guidelines made prior to the introduction of the Act remain in use. Yet is is trite that when regulating modern technologies, regulators may be called to account if the regulatory objectives being pursued are not perceived to be ethically legitimate; if regulatory interventions are ineffective in practice; or if regulation fails to appropriately connect to a regulatory target. 190 This analysis suggests that while the regulatory objectives set out in the HART Act are defensible, they are not being achieved in practice, and regulators are failing to meet required standards.
The current policy that narrowly restricts embryo research adopts an extremely conservative position on the ethical spectrum that is difficult to reconcile with the purposes and principles of the HART Act. Arguably, demonstrating respect for human embryos as a form of human life does not require treating them as inviolable, prohibiting all embryo research. Demonstrating respect for human life does not preclude their use in significant and beneficial research. Rather, it requires careful regulation regarding their use. Further, restricting research to ‘non-viable’ embryos does not prevent the destruction of any embryos, and it comes at significant cost to beneficial research. A recent survey provides evidence that New Zealand researchers would, if legally permitted, conduct research into improving fertility rates and/or increasing understanding of embryo biology. 191 Ultimately, fertility service patients, and society in general, are denied the benefits that may be derived from embryo research.
In a pluralist and largely secular society, individual views may differ as to what kind of research should be permissible. However, at a minimum, fertility service providers should be able to conduct well-designed clinical research into fertility treatment. To prevent such research is to prevent the development of good quality services. This predominantly disadvantages the women who undergo, and children born as a result of, IVF procedures, contrary to the purposes and principles of the HART Act. Significantly, couples/individuals who have completed their reproductive treatment are denied a choice as to how their embryos will be disposed of when embryo storage limits expire. It is reasonable to suggest that couples who must decide the fate of their stored ‘surplus’ embryos should be able to decide whether they are simply destroyed or used for research purposes. To require a disposition decision to be made, but to limit it to destruction, simply cannot be justified when alternatives exist.
It is certainly true that embryo research exists on a spectrum in terms of the type of research that may be performed and the type of embryos that may be used. These are the very questions that ACART is mandated to explore under the HART Act. However, despite appearing to have considerable authority under the Act, it is clear that ACART is subject to ministerial control. This article has identified a concerning pattern of obstruction and obfuscation, preventing ACART from discharging it statutory duties, and ultimately undermining the effectiveness, transparency and accountability of ACART as regulators.
In practice, ACART lacks independence, and the issue of embryo research remains politicised. ACART, by seeking agreement from consecutive Ministers to proceed with the review of the guidelines governing embryo research, appears to have ceded control to the Minister. These problems are compounded by the fact that, due to the expiry of the interim period, the current Research Guidelines are no longer legally effective. This results in two things: ACART failing to discharge its statutory obligations by not reviewing guidelines that it considers are inadequate 192 and wrongly suggesting that the Minister has statutory authority over ACART.
Ultimately, it is apparent that the HART Act is not functioning as intended, a problem that extends beyond the regulation of human embryo research. Given this it is arguable that, in the interests of transparency, accountability and regulatory legitimacy in general, the HART Act should be reformed and Parliament should assume direct responsibility for determining these matters.
Footnotes
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
