Regulating stem cell research and human cloning in an Australian context: the Lockhart Review

Abstract

In late 2002 the federal Australian government developed legislation explicitly intended to govern both stem cell research and human cloning. Together, the Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002 provided a comprehensive national framework for the licensed use of excess assisted reproductive technology (ART) embryos in research and a complete ban on all types of human cloning. Both pieces of legislation contained review clauses stating that each Act be concurrently and independently reviewed by the same committee in 2005, three years after receiving royal assent. The years between the initialization of the legislation and the outcome of the review process have resulted in some significant transformations in how stem cell science and human cloning are viewed in Australia. This paper will discuss those changes and the shift in attitude they represent.

Keywords:

• stem cells
• regulation
• Australia

Introduction

The Australian stem cell research and human cloning debate emerged in the context of increasing global anxieties surrounding developments in stem cell science and cloning technology during the late 1990s. The stem cell debate has been played out at national, regional and global levels, with regulatory responses to this emerging field of biomedical research variously addressing the ethical, cultural, political, social and financial implications opened up by human embryonic stem cell research and the possibility of human cloning (Salter 2007). The reactions of nation-states to stem cell research and human cloning can be understood as both a reflection of national community attitudes and as sound consideration of economic competition in the international knowledge economy (Waldby 2005, Dickins 2006, Salter 2007). The discussion about stem cell research and human cloning in Australia has been no different, with the federal Australian government seeking to develop a workable policy position that recognizes the scientific, medical and economic potential of stem cell research and also encompasses the attitudes of the Australian community towards both the use of human embryos in research and cloning for reproductive purposes.

The Australian stem cell research and human cloning debate has had many parallels with other discussions on the topic around the world (Harvey 2005). These include: the call for political leadership (Nerisini 2000, Holliman 2004); significant amounts of media coverage (Nerisini 2000, Holliman 2004); the involvement of special interest groups (Downey and Einsiedal 2003, Ganchoff 2004); and the agreement that limits should be placed on research involving embryos (Franklin 1999, Kirejczyk 1999, Nerisini 2000). The final outcome of the debate in Australia was that usage of excess IVF embryos would be allowed for research under strict licensing conditions and that a complete ban on all forms of cloning would be imposed (Commonwealth of Australia 2002a, 2002b). This result was seen as progressive enough to ensure the nation a foothold at the forefront of a new and exciting avenue of biomedicine, while also providing some safeguards against the wanton production and destruction of potential human subjects (Harvey 2005).

Almost five years later, in late 2006, the same Australian government announced some quite significant changes to the legislation. The main point is that it is now legal for researchers to use the technique known as somatic cell nuclear transfer, or SCNT, to create human embryo clones for research (O'Neil 2007). The question is: what does this mean for the Australian community? Does this shift in government policy reflect changing attitudes towards stem cell research and human cloning in Australia?

Background

After a federal parliamentary review on human cloning and stem cell research in 2001 (Commonwealth of Australia 2001), the Council of Australian Governments (COAG) decided that a federal regulatory framework was necessary (Harvey 2005, Dodds and Ankeny 2006). In the absence of any other national legislation effectively governing the use of human embryonic material – and the presence of quite disparate state regulation of assisted reproduction that might potentially do so (Nicol et al. 2001) – the Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002 were concurrently passed by the Parliament of Australia (Harvey 2005). Under the COAG agreement, Australian states and territories were obliged to put into place appropriate legislation that would be consistent with the new national regulations (Harvey 2005, Dodds and Ankeny 2006). All Australian states and territories have subsequently introduced legislation to this effect, with the Northern Territory still in the process of drafting some (www.nhmrc.gov.au).

The Australian position is consistent with several other regulatory regimes internationally (Salter 2007) and is modeled on the licensing system used in the UK. The Australian legislation was designed to actively encourage research while minimizing the ethical dilemma involved in the use of embryos (Harvey 2005). The requirements that research be conducted under license and that only excess IVF embryos be used for research are designed to mitigate the potentially detrimental effects of an unregulated research environment. Overall, support for stem cell research in Australia is quite strong (Biotechnology Australia 2006a) and is based on the perception that the therapeutic possibilities of stem cell research will be significant (Hall 2004).

In general terms, the original debate was universally polarized along pro/anti positions. Mass media representation overwhelmingly focused on white, middle class Australians suffering from debilitating diseases pitched against right-to-life anti-abortion religious zealots (Harvey 2005). Alternative viewpoints were largely either marginalized by the mainstream media as biased by religious beliefs or simply too crazy to take seriously (e.g. the Raelians, a religious group claiming humans were created by aliens and that they can clone human beings: www.rael.org) (Harvey 2005). Susan Dodds and Rachel Ankeny (2006) further argue that homogeneity in the Australian debate was achieved through an absence of “deliberative democracy” and a circumscription of the debate to purely ethical discussion. For Dodds and Ankeny, the development of relevant legislation relied too much on the testimony of specially selected experts delivered to closed shops of government officials to be truly open to discussion and reflection (2006, pp. 100–101). The debate, they argue, was always framed as a “science versus religion” contest (Dodds and Ankeny 2006, p. 107), and in the secular Australian nation-state, rational science wins.

The regulations around the use of embryos mean that Australian embryos have what Sarah Franklin (2006) calls a “double reproductive value”. Under Australian regulations, any embryo not donated to research must be either implanted into the body of a woman for the purpose of achieving a pregnancy, or allowed to die. Embryos are not allowed to be sold, altered, experimented with, tested on, imported or exported (except under ministerial consent for an individual's own fertility treatment), sustained past 14 days outside the body of a woman or implanted anywhere other than the body of a woman (Commonwealth of Australia 2002a). Given this list of uses of embryos, Australian embryos can be considered first and foremost as reproductive material. Once they cease to be valued for their reproductive potential and become surplus, or excess, to reproduction, then and only then can embryos be considered for use in research. On becoming research material, the reproductive qualities of embryos are redeployed into the foundations of regenerative medicine (Franklin 2006). This “double reproductive value” (Franklin 2006) of the embryo recognizes both the inherent specialness of the embryo as a potential human being, and also separates out the qualities that make it a viable medical resource (Waldby 2002).

Spare, or surplus embryos move from one end of the spectrum of reproduction to the other through “the IVF–stem cell interface” (Franklin 2006). IVF and stem cell research are closely interconnected in Australia, with at least one of the biggest IVF clinics (Sydney IVF) also conducting stem cell research (DTI 2006). The Research Involving Human Embryos Act carried this caveat: that only embryos created on or before 5 April 2002 could be used for research (Commonwealth of Australia 2002b). This restriction was intended to prevent the deliberate construction of more embryos than strictly necessary for ART purposes, thereby creating a supply for research (Commonwealth of Australia 2005, p. 37). The ban was removed exactly three years later as specified in the original legislation (Commonwealth of Australia 2002b). The lifting of this embargo did open up new sources of embryos that could potentially be used for research, but there is no evidence to suggest that extra embryos have been deliberately created in order to produce a research supply.

An independent licensing body for research involving embryos was established in 2003 (www.nhmrc.gov.au). The Licensing Committee is administered by the National Health and Medical Research Council (NHMRC), a peak statutory body of the federal government. The NHMRC provides health and medical advice to government, funding to researchers and regulatory and ethical oversight of health and medicine in Australia (www.nhmrc.gov.au). The Licensing Committee is one of the five principal committees of the NHMRC. By contrast, the UK Human Fertilisation and Embryology Authority (HFEA) – the governing body for all UK-based assisted reproduction and embryo research – is a statutory body in its own right. Burying the Licensing Committee within the administrative structure of the NHMRC makes it less publicly visible and therefore less politically engaged in discussion about stem cell research than the HFEA. In this regard then, the Licensing Committee is effectively restricted to purely administrative implementation of the legislation regarding both stem cell research and human cloning.

The first licenses for human embryo research were awarded in mid-2004, and only 10 licenses to conduct research involving human embryos have been awarded so far (www.nhmrc.gov.au). The small number of licenses has been largely attributable to misunderstandings about the requirements of the licensing process and interpretation of the two Acts; the length of time required to obtain a license; a lack of excess ART embryos; and a perception that researchers were holding off applying for licenses until the conclusion of the 2005 review (Commonwealth of Australia 2005, pp. 99–109). One of the legislative requirements was that information about embryo licenses be made public at all times: details of the projects that have been issued licenses can be found on the NHMRC website (www.nhmrc.gov.au).

The use of excess ART embryos and the licensing conditions were intended to mollify community concerns about the wanton production and destruction of embryos (Harvey 2005). The introduction of a federal regulatory regime for stem cell research in Australia has been quite successful in negotiating the specter of Frankenstein-like horrors of meddling with nature and stem cell research has become an increasingly acceptable practice. In implementing such a structure, the Australian government struck a delicate balance between the needs of medical researchers, patient advocate groups, religious organizations and the broader community. Stem cell science is now a multi-million dollar industry in Australia, with significant government funding, fierce inter-state competition, several private companies, major international collaborations and an environment that encourages companies to base their operations in Australia (Biotechnology Australia 2006b, DTI 2006). Australia's comprehensive and permissive regulations around stem cell research and sophisticated scientific research culture are cited as reasons for attracting foreign business (DTI 2006). Lack of venture capital is currently the only real inhibitor for a globally competitive stem cell industry in Australia (DTI 2006).

The Lockhart Review

In recognition of the fast paced changes in stem cell science, both the Prohibition of Human Cloning Act (Commonwealth of Australia 2002a) and the Research Involving Human Embryos Act (Commonwealth of Australia 2002b) included sunset clauses specifying that they be concurrently reviewed by an independent committee three years after receiving royal assent. A Legislation Review Committee was appointed in mid-2005, chaired by the late John Lockhart AO, QC (www.lockhartreview.com.au). The original terms of reference for the Legislation Review Committee were: consider developments in cloning, stem cell science and assisted reproduction; take into account community attitudes; and discuss the possibility of establishing a national stem cell bank (Commonwealth of Australia 2005, pp. 4–6). Further terms of reference specified for the Committee in 2005 included examining the effectiveness of compliance with national legislation; the role of other bodies in monitoring ART treatment; issues to do with Customs, import, export and trade of embryonic material and material involved with assisted reproduction and stem cell research; and the overall implications for Australian science and economic activity (Commonwealth of Australia 2005, pp. 4–6).

Attuned to the sensitive nature of the debate, the Legislation Review Committee engaged in a wide variety of public consultation, stakeholder discussions and site visits across Australia (Commonwealth of Australia 2005, pp. 17–21). A discussion paper was released and submissions invited from the general public. Meetings were held in all of the state capitals with invited stakeholders that were mostly open to public attendance. Public discussion forums were held in Sydney, Melbourne and Brisbane. Private meetings with government officials and other stakeholders were also held. In addition, the Committee visited two research clinics in NSW (Sydney IVF) and Victoria (Monash University). Over 1000 submissions were made through the Committee's website (www.lockhartreview.com.au), with more than 900 of these coming from private individuals. To further ensure the breadth and accuracy of the information being collected, the Committee also consulted the results of the Public Awareness Program of Biotechnology Australia (www.biotechnology.gov.au). Overall, the Lockhart Review was generally considered to be thoughtful, comprehensive, progressive and significant. Despite disagreement over the outcomes of the Review, opponents of stem cell research also agree that the Review was wide-ranging and inclusive.

One of the criticisms of the original debate leading up to the development of legislation governing human cloning and stem cell research in Australia was that it was done among a select and restricted cohort of stakeholders with little public consultation and was, moreover, circumscribed to a wholly ethical debate (Dodds and Ankeny 2006). The same could not necessarily be said of the Lockhart Review, although there are some conspicuously familiar names and organizations from the 2002 debate appearing in the 2005 legislative review. What is also missing from the Lockhart Review is a more wide-ranging consideration of public opinion that takes in less scientific or mainstream religious discussion. In fact, the legislative review seemed unaccompanied by any of the fanfare of the original debate and had less political impact than the 2002 legislative development.

Moreover, where the 2002 debate has been referred to as a primarily ethical discussion (Dodds and Ankeny 2006), the 2005 review is a technical one instead. The imperative to balance the protection of embryos with the needs of medical research was reduced to a detailed scientific discussion of what could and couldn't be permitted under the scope of the Acts and what should be changed. Consequently, the main issues addressed by the Legislation Review Committee included: what is an embryo? How should embryos/embryonic material be obtained? How effective is regulation? And are the original restrictions still relevant?

One of the first actions of the Committee was to commission the National Health and Medical Research Council to develop a working definition of “human embryo” (Commonwealth of Australia 2005, pp. 89–98). The NHMRC decided that a human embryo arises from “the first mitotic division when the fertilisation of a human oocyte by a human sperm is complete”, or, “any other process that initiates the organised development of a biological entity with a human nuclear genome or altered human nuclear genomes” and the entity in question is not more than eight weeks old (Australian Government 2006, p. 27). Although this might seem largely a technical question, it has implications for the kinds of research projects that can be legally conducted in Australia. Misuses of embryos and the creation, use, import, export, sale or supply of prohibited embryos are criminal activities, punishable by lengthy amounts of gaol time (Commonwealth of Australia 2002a, 2002b). The concern about a coherent definition of “human embryo” emerged in the light of disagreement over terms in the classification of pre-embryos, embryos, embryo clones and fetuses (Commonwealth of Australia 2005, pp. 89–90). Clarifying the definition of what counts as a human embryo makes it substantially easier for the Licensing Committee to decide on appropriate research projects using human embryos and gives more strength to the legislative measures adopted against inappropriate uses of embryos.

The Legislation Review Committee also devoted a considerable amount of time to investigating the informed consent procedures for supplying embryos for research (Commonwealth of Australia 2005, pp. 115–120). In a departure from the more usual global understanding of one-off consent for human tissue donation, the Australian 2002 embryo research consent procedures required that consent be obtained for each new project under license (Commonwealth of Australia 2002b). Once embryos were donated to research, they were stored until called upon for use in research, and then all parties responsible for the production of the embryo would be asked to provide consent for their use, with a 14-day cooling off period after (Commonwealth of Australia 2002b). The effect of this project-based approach to gaining consent meant that couples were continually drawn into discussion about their embryos, even though they may have finished IVF treatment long before. Some debate during the Lockhart Review focused on possible emotional distress to couples created by this continual re-contact (Commonwealth of Australia 2005, pp. 117–119).

The Lockhart Review recommended that the donation of excess embryos be addressed at the conclusion of fertility treatment (Commonwealth of Australia 2005). In other words, the Legislation Review Committee suggested that consent to donate embryos to research be the significant concern, not consent for specific research projects. Following organ donation protocols, for example, once embryos are determined to be excess to a couple's fertility treatment, the couple can decide whether or not to donate them to research, but will have no further ability to decide which projects they will support (Commonwealth of Australia 2005, pp. 115–121). The “double reproductive value” (Franklin 2006) of embryos is reinforced by this change in consent procedures and the transition of embryos from one side of the IVF–stem cell interface to the other.

Another major concern for the Legislation Review Committee focused on the role of the Licensing Committee. Substantial examination of the licensing process, the function of the Licensing Committee and the Licensing Committee's scope and effectiveness were undertaken (Commonwealth of Australia 2005, pp. 99–109). The Legislation Review Committee uncovered important problems with the rules and powers of the Licensing Committee as established under the 2002 legislation, and has recommended an overhaul of the licensing regulations (Commonwealth of Australia 2005). Key aspects of the changes recommended for the Licensing Committee included: more efficient and streamlined application procedures to speed up the time taken to issue licenses; broader scope for interpreting legislation and making decisions in regard to appropriate research projects; more effective monitoring powers over licensees; increased power to conduct investigations and recommend criminal proceedings over suspected license breaches; and the capacity to investigate non-licensed activities thought to breach regulatory conditions (Commonwealth of Australia 2005, pp. 99–113). The overhaul of the Licensing Committee recommended by the Lockhart Review will give more power and authority to the Australian stem cell research and human cloning legislation.

The final area of concern for the Legislation Review Committee was to review the changes in the scientific terrain in assisted reproduction, stem cell research and human cloning since the 2001/2002 debate (Commonwealth of Australia 2005, pp. 25–67). What the Committee found was that, in effect, the science had changed enough by 2005 to warrant serious investigation of the techniques prohibited by the original legislation. A raft of changes to the legislation was recommended by the Legislation Review Committee, only some of which were later adopted (Commonwealth of Australia 2005, pp. xxii–xxvi).

The restrictions in the 2002 legislation are widely argued by scientists involved in assisted reproduction research and human embryonic stem cell research to have placed major constraints on the conduct of both kinds of research in Australia (Commonwealth of Australia 2005, pp. 29–38, 63–64). One of the concerns resulting from the 2002 legislation was that Australia would lose key stem cell scientists to overseas organizations (Commonwealth of Australia 2005, pp. 137–138).1 Another concern was that Australian science would fall behind in the international arena (Commonwealth of Australia 2005, pp. 138–139). The Lockhart Review thus recommended that loosening restrictions on stem cell research would have significant benefits for the Australian community. Apart from the obvious therapeutic potential of a more permissive approach to stem cell research and research in assisted reproduction, other benefits include increased economic prospects through making Australian stem cell research look like an attractive proposition for scientific and commercial development. The Victorian, New South Wales and Queensland state governments have taken the economic aspects of this multi-billion dollar industry seriously and compete with each other to attract stem cell business to their territories (DTI 2006).

The Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002 specifically banned: the creation of a clone or chimera of any kind (therefore restricting the use of somatic cell nuclear transfer or SCNT); the creation of an embryo by any means other than fertilization of a human egg with a human sperm; the creation of an embryo for any purpose other than the reproductive treatment of a woman; the development of embryos outside of a woman's womb beyond 14 days; the creation of hybrid entities; and the creation of embryos containing genetic material of more or less than two people (Commonwealth of Australia 2002a, 2002b). The Legislation Review Committee found that all the regulations of the original legislation were still relevant, but proposed these changes: that fresh ART embryos unsuitable for implantation also be used in research (subject to license); and that somatic cell nuclear transfer be permitted under license too (Commonwealth of Australia 2005, pp. xxii–xxvi).

Other recommendations of the Lockhart Review included: that suitable criteria for determining non-implantation potential of embryos be developed; that chimeras and partial-human embryos be made available for use in research; that embryos containing genetic material of two or more people be made; and that parthenogenesis and nuclear transfer be used as an alternative form of fertilization of embryos for research (Commonwealth of Australia 2005, pp. xxii–xxvi). The Lockhart Review also recommended that using embryos for research in assisted reproduction be permissible (Commonwealth of Australia 2005, pp. xxii–xxvi).

In sum, the Legislation Review Committee concluded that national legislation governing assisted reproduction, the use of human embryos in research and the banning of human cloning was necessary, and that the existing legislation should be adapted to respond to social, ethical and scientific developments in these areas. By 2005, the issue was no longer about whether or not stem cell research should proceed (Harvey 2005), but exactly how it should be done. Susan Dodds and Rachel Ankeny point out that the Legislation Review Committee took the earlier 2002 debate as prima facie evidence that the Australian community was happy for human embryonic stem cell research to proceed (2006, pp. 100–101). The Lockhart Review focused almost exclusively on the procedural aspects of conducting controversial scientific research in Australia, highlighting and emphasizing that scientific knowledge is valued above any other considerations. The changes recommended by the Lockhart Review reflected a commitment to an expansion of the research agenda that was in keeping with the Australian stem cell research communities' profile as cutting-edge and globally competitive. Overall, the Legislation Review Committee was limited to highlighting the best path for enhancing the scientific and economic focus of the Australian stem cell industries by suggesting that restrictions be lessened and regulatory control be streamlined.

Debating the Lockhart Report

The recommendations of the Lockhart Report were fiercely contested in the Australian Parliament during 2006, resulting in the development of two separate pieces of legislation and a further parliamentary inquiry (Commonwealth of Australia 2006b). The continuation of the debate resulted when the Prime Minister rejected the Lockhart Review's recommendations with the declaration that nothing needed to be changed about regulations governing stem cell research or human cloning. This unilateral decision provoked a parliamentary backlash and produced several attempts to devise legislative amendments which would reflect the changes suggested by the Lockhart Review. Political debate over the proposed amendments led to a parliamentary review in the upper house of the Australian Parliament. The Senate Committee for Community Affairs embarked on a similar program of nationwide public consultation as the Legislation Review Committee, although on a much smaller scale and within a comparatively short timeframe. A modified version of the Legislation Review Committee's recommendations eventually passed through the Australian Parliament in late 2006. The Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006 (Commonwealth of Australia 2006a) updates the 2002 laws and makes some minor changes to other relevant Acts.

The Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006 represents a much dampened incorporation of the recommendations of the Legislation Review Committee and shows a far more circumscribed approach to cloning and human embryonic stem cell research than is contained in the Lockhart Report. Weighing more heavily on the side of ethics and community concerns rather than advantage for Australian science, the Amendment Act 2006 provides a counter-balance to the enthusiasm for scientific progress demonstrated by the Legislative Review. Although some of the key changes introduced into the legislation of human embryonic stem cell research in Australia are significant, the overall limitations still reflect a cautious (Salter 2007) regulatory approach to the stem cell industries.

The final outcome of the 2005/2006 debate on stem cell research and human cloning in Australia is that all the previous prohibitions regarding human cloning or the misuse of embryos continue to stand, with the exception of the creation of human embryo clones through somatic cell nuclear transfer. While almost all the procedural aspects of the Legislation Review Committee's recommendations have been accepted, exceptions were made over some of the suggestions for lifting restrictions placed around what kinds of research could be conducted. No chimeras or hybrids of any kind are allowed to be created except under license, and no human embryo clones or embryos not created by the fertilization with a human egg with a human sperm will be allowed to be implanted into the body of a woman or developed beyond 14 days (Commonwealth of Australia 2006a). Parthenogenesis and creating human embryos or human embryo clones containing genetic material from more than two people or genetic material from non-human sources are also banned (Commonwealth of Australia 2006a). There will also be an overall increase to 15 years' imprisonment for most violations of laws regarding the creation, use, import and export of human embryos and human embryonic material (Commonwealth of Australia 2006a).

The main concern of the 2006 parliamentary debate was over the use of animal eggs and the fears that part-human, part-animal hybrids would be created. While the Legislation Review Committee recommended that animal eggs be used to minimize demand for human oocytes and consequently potential exploitation of the women who provide them, the use of animal eggs was ultimately seen to be much too controversial to include in the Amendment Act 2006. Although the use of animal eggs for somatic cell nuclear transfer is now permitted in the UK (HFEA 2007), the Australian government is not yet prepared to take this step towards mitigating the effects of human embryonic stem cell research on Australian women.

Conclusion

The years since the implementation of the Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002 have seen some subtle transformations in the way human embryonic stem cell research is considered by the Australian community. Whereas the earlier debate focused on whether or not stem cell research and human cloning should proceed, the 2005 Legislative Review addressed the more nuanced details about how stem cell research and human cloning should be regulated. The fundamental concerns at the heart of the debate have shifted from being a question of when is it appropriate to use potential human subjects as resources for others (Harvey 2005), to now include questions such as how do we provide the right level of ethical safeguards and legal protection for the conduct of research? In other words, no longer simply about the possibilities for the exploitation of potential human subjects (clones or embryos), the Australian stem cell research and human cloning debate now addresses the more technical questions of the best way to regulate the research environment without undermining the potential for scientific and commercial success.

Significant achievements in both assisted reproduction and stem cell research in Australia have provided the groundwork for the legitimation of research involving human embryonic material. Stem cell research is an established field of scientific endeavor in Australia, with promising developments in the treatment of conditions such as diabetes, Alzheimer's disease and prostate cancer (DTI 2006, Anon 2007). The final outcome of the debate represents a progressively changing approach to stem cell science within the Australian community. The steady normalization of something once regarded as Frankensteinian science has meant that, by early 2007, the embryo is increasingly being seen as a therapeutic entity, no longer explicitly associated with an intrinsically inviolable human identity. Given this, a more permissive regime around stem cell research and human cloning in Australia will result in substantial economic benefits for the Australian community.

Notes

1. Two Australian stem cell researchers have already gone to the US (Riley 2006).