E LAW - MURDOCH UNIVERSITY ELECTRONIC JOURNAL OF LAW ISSN 1321-9247 Volume 9 Number 2 (June 2002) Copyright E Law and author File: gogarty92.txt ftp://law.murdoch.edu.au/pub/elaw-issues/v9n2/gogarty92.txt http://www.murdoch.edu.au/elaw/issues/v9n2/gogarty92.html ________________________________________________________________________ The UK’s Cloning Laws: A View from the Antipodes Brendan Gogarty and Dianne Nicol Centre for Law & Genetics, University of Tasmania Faculty of Law Contents * Introduction o Definitions * The UK Situation * The Australian Regime o Flexible Definitions o Separating the Issues * Conclusion * Notes Introduction 1. On 18 January 2002 the UK Court of Appeal overturned the decision of Justice Crane in Quintavalle.[1] Justice Crane's decision that the Human Fertilisation and Embryology Act 1990 (UK) does not apply to cloned embryos has already generated some attention[2] and there is little doubt that the appeal decision will receive similar academic scrutiny. What we discuss is the resultant legislative regime in the UK and contrast it with that in Australia. 2. Australia has been described as a 'powerhouse' of embryo research[3] but has yet to implement a nationally effective regime to regulate stem cell and cloning technology. Following increased media, public and parliamentary attention on this issue the Federal Government has announced its intention to remedy the situation. We argue that in order to succeed in realising this goal the Australian Government should take note of the example set in both the UK courts and the UK legislature. Definitions 3. Many of the difficulties in this area of debate are matters of semantics. The term cloning is used herein to refer to the technique of cell nuclear replacement (CNR). Reproductive cloning means cloning to produce a live-born child. Stem cell research involves culturing undifferentiated cells that have the potential to differentiate into a range of cell types. Embryonic stem cells may be derived from embryos that are either surplus to artificial reproductive technology programs or specifically created for the purpose.[4] In either case the embryo is destroyed as a result of the extraction process. The term therapeutic cloning is used herein to refer to the use of CNR to produce embryos from which embryonic stem cells can be extracted. The UK Situation 4. The Quintavalle case arose after the UK government released a position paper declaring embryos cloned by the technique of CNR fell within the ambit of the Human Fertilisation and Embryology Act. The Pro Life Alliance (Pro-Life) sought a declaration by the court that this decision was in error. Pro-Life vehemently opposes embryo destruction, so it may seem strange that they sought to create a legal vacuum whereby the creation and use of embryos by CNR would be unregulated. However, this has to be viewed in the context of Pro-Life's broader opposition to the whole regime created by the Human Fertilisation and Embryology Act and administered by the Human Fertilisation and Embryology Authority (HFEA), which permits limited use and destruction of embryos for research purposes. Pro-Life hoped that by showing that a loophole existed in the legislation, especially in such a contentious area as cloning, this would force renewed debate in Parliament and a re-evaluation of the whole HFEA regime. 5. The Quintavalle case centred on whether embryos created by CNR are equivalent to embryos created by fertilisation. The core issue was whether static legislation could prove flexible enough to deal with rapid advances in technology that, while having the same or similar outcomes to traditional methods, achieve those outcomes by novel means. 6. The process of CNR, which is central to cloning, involves removing the nucleus of an egg, which contains the mother's DNA, and replacing it with a donor cell. The two are then fused, creating an embryonic form substantially genetically identical to the donor. Pro-Life argued that the HFEA regime did not cover a CNR embryo. Section 1(1) of the Human Fertilisation and Embryology Act provides that: In this Act, except where otherwise stated - (a) embryo means a live human embryo where fertilisation is complete, and (b) references to any embryo include an egg in the process of fertilisation, and, for this purpose, fertilisation is not complete until the appearance of a two cell zygote. 7. It was submitted that although an embryo created by SCNT resembles a zygote, it does not have the same properties, namely the combination of haploid cells, and does not go through the process of 'fertilisation'. At first instance, Justice Crane adopted a literal approach in interpreting the relevant provisions of the HFEA, finding the restrictive wording precluded him from including what Parliament had not foreseen or intended.[5] 8. The Court of Appeal disagreed.[6] Lord Phillips MR held that there was a 'plain necessity' to broaden the ambit of the Act to cover what Parliament clearly meant to include. Although embryos created by nuclear transfer were not envisaged by the original drafters of the legislation, to include them did not 'strain the language [of the statute] to breaking point'.[7] His Lordship argued that unforeseen developments in the field of human assisted reproduction should not undermine parliamentary intention simply by virtue of their technique and that this extended use of the purposive approach was warranted by virtue of the Human Rights Act 199[8] (UK), which extends purposive interpretation where needs must.8 9. Before the Court of Appeal reached its decision, the UK Parliament passed sui generis legislation to fill the legislative gap created by the decision of Justice Crane. The Human Reproductive Cloning Act 2001 (the Cloning Act) was enacted on 4 December 2001. The Act prohibits the implantation of any embryo created by a process other than fertilisation into the body of a woman.[9] Section 1(1) provides: A person who places in a woman a human embryo which has been created otherwise than by fertilisation is guilty of an offence. 10. Consequently, the UK now has two separate pieces of legislation, one criminalising the use of cloned embryos for the creation of a child (the Cloning Act) and the other regulating the creation of CNR embryos through a licensing system (the Human Fertilisation and Embryology Act). The House of Lords released its Select Committee Report on Stem Cell Research on 13 February 2002. The Report confirms the role of HFEA in regulation of embryonic stem cell research. The Committee recognised the value of CNR as a research tool and concluded that this: is a sufficiently serious and important objective, particularly if the potential of adult stem cells is to be realised, to justify the use of CNR, if licensed by HFEA, provided that (as with embryos created by IVF for research) embryos are not created by CNR unless there is a demonstrable and exceptional need that cannot be met by the use of surplus embryos.[10] 11. This new legislative architecture is beneficial from three core aspects: o it applies a comprehensive regime at the national level; o it utilises flexible definitions, concentrating on purpose rather than technique; and o it separates out therapeutic from reproductive outcomes. 12. These features are absent from the current Australian regime, which has been widely criticised for being ineffectual, confusing and deleterious to research. These sentiments were expressed in a number of submissions to the House of Representatives Standing Committee on Legal and Constitutional Affairs in its inquiry and report, Human Cloning: Scientific, Ethical and Regulatory Aspects of Human Cloning and Stem Cell Research (hereafter the House of Representatives Report).[11] The Australian Regime 13. Despite the fact that Australian State of Victoria enacted the first reproductive technology legislation in the world,[12] the subsequent juridification of reproductive technology and embryo research in Australia has largely occurred in an ad hoc and piecemeal manner. Only two other States, Western Australia and South Australia, followed the Victorian lead by enacting reproductive technology legislation.[13] A number of reports and inquiries into reproductive technology and embryo research have been undertaken by all levels of government in Australia.[14] Nevertheless the majority of jurisdictions have not enacted legislation. Regulation is left primarily to the National Health and Medical Research Council Ethical Guidelines on Assisted Reproductive Technology, 1996 and the National Statement on Research Involving Humans, 1999 (collectively, the NHMRC Guidelines). 14. Each of these separate pieces of regulation contains provisions dealing with stem cell and cloning technology. Generally, some limited research involving embryos is allowed.[15] However, in each case this requires that the embryo's capacity to be reimplanted is not diminished. [16] Hence stem cells could not be extracted from embryos in the three states with legislation. The NHMRC Guidelines are similarly restrictive. Consequently, researchers must source new embryonic stem cell lines from overseas, which effectively means that it is acceptable to destroy embryos as long as they are not 'Australian'. It also ignores the fact that many embryos surplus to reproductive technology programs, are systematically destroyed as a requirement under that same legislation. At the core of this rather paradoxical situation is the dilemma faced by the Federal Government in implementing two opposing policies. As a conservative government, the Howard Cabinet has adopted a traditional ethical view on the moral status of the embryo and have been proactive in its protection.[17] However the Government has been concurrently proactive in maintaining Australia's position at the forefront of biomedical research, including stem cell technology. These two positions are often hard to reconcile and have played a large part in the lack of comprehensive national legislation to deal with embryo research and cloning. 15. Public concern about the lack of a comprehensive national regime to regulate cloning together with increasing media coverage of these issues led the Federal Government to put in place stop-gap provisions in late 2000. The Senate amended the then Gene Technology Bill to prohibit reproductive cloning and other human related technology,[18] a surprising move given that the Bill was targeted at health and environmental issues arising out of agricultural biotechnology. The Gene Technology Act 2000 (GTA) now contains a provision prohibiting any activity which 'will result in the cloning of a whole human being'.[19] Is this similar to the UK system? We argue that it is not, because it is a single section in an Act unrelated to human reproductive technology and because it is limited in scope. 16. The House of Representatives Report noted that the GTA is limited constitutionally.[20] In order to provide full coverage across Australia the states and territories have agreed to enact mirror legislation. To date, Victoria, Queensland and South Australia all have Gene Technology Acts in force.[21] As such, gaps in coverage are being closed. 17. More importantly, the GTA was never intended to deal with human-related issues. It creates a complex regulatory regime in which a large proportion of risk management is undertaken 'in house' and through institutional biosafety committees. To properly monitor institutions with the capacity to undertake cloning would require all bodies involved in reproductive technology to participate in this arrangement, which does not appear likely. Moreover the Office of the Gene Technology Regulator, created by the Act, does not have the facilities or expertise to monitor reproductive technology. In all, this provides an unsatisfactory system for policing cloning. Flexible Definitions 18. In evaluating the adequacy of reproductive technology legislation in Australia, the Quintavalle decisions provide two important lessons. First, overly restrictive drafting can lead to uncertainty in the application and scope of legislation. Secondly, courts are increasingly willing to apply the spirit of the law, especially where there is a strong public policy to do so. This should encourage legislators to move away from narrow technical definitions focusing on form rather than outcome. 19. The current Australian situation, however, reflects the traditional reluctance on the part of the legislature to leave wide discretion to the courts. All relevant legislation, including the GTA, define a clone as a 'genetically identical' offspring. The phrase is a misnomer because clones created by CNR will always have a degree of genetic difference from the donor of the nucleus.[22] Furthermore, as the House of Representatives Report pointed out, advances in technology may allow for the creation of clones that are purposely genetically dissimilar but have identical physical characteristics.[23] 20. The Report expressed some doubt whether the term 'genetically identical' was legally sufficient to canvas the issues addressed.[24] The GTA also defines a clone as a 'whole human being', which leaves open the debate on the status of the embryo by failing to sufficiently delineate between what is a human and what is merely a collection of cells. The Act does not clarify when a human becomes whole. Various sectors of the community place this crucial transformation at widely differing phases of development ranging from fertilisation, to implantation, to the formation of specific organs and, for some, at birth. 21. Further difficulties are encountered in the State legislation. In the Victorian Infertility Treatment Act, the definition of an embryo focuses on fertilisation using male and female sex cells.[25] As CNR does not require fertilisation it is arguable the definition is not satisfied.[26] In Western Australia, the focus is on a 'born live and viable' clone, hence the creation of a cloned embryo or foetus is not specifically prohibited.[27] However, because the Act also states that embryos created by any means must be reimplanted into a woman, theoretically a clone could be implanted into a woman's body and then terminated prior to birth. In South Australia, cloning is defined as 'any procedure directed at producing two or more genetically identical embryos from the division of one embryo',[28] which would not cover CNR.[29] 22. The decision in the Quintavalle appeal may bolster the capacity of the current regimes to regulate some aspects of stem cell and cloning technology. However, the decision is persuasive not binding, and should not be taken as a guarantee that Australian courts will be similarly liberal. The case demonstrates that ambiguities in the legislation are open to sometimes vastly differing interpretations. 23. The UK Cloning Act avoids altogether use of terms describing the process of cloning. Rather, it focuses on a class of practice. The Act has been criticised for failing to define 'key' terms such as 'fertilisation' and or 'embryo'.[30] However, the strict definitions in the Human Fertilisation and Embryology Act were precisely the reason that it was subject to legal debate. We must accept that the traditional legal paradigm of prescriptive legislation is incapable of adequately regulating technologies that are in a constant state of flux. In this arena, flexibility is warranted because it means the legislation is not encumbered by myopic emphasis on process rather than outcome. In the Quintavalle appeal, the Court of Appeal indicated that it was more interested in the policy behind the law than technical or scientific definitions. Separating the Issues 24. The jurisdictional and linguistic problems entrenched within the Australian regime have attracted criticism from all key sectors of the cloning debate. The House of Representatives Report noted the frustration of many Australians at the lack of progress towards an effective, comprehensive and transparent regime and recommended a rapid replacement of the current system with a nationally consistent scheme to regulate both stem cell and cloning technology. [31] 25. The potential benefits of stem cell research and therapeutic cloning have been well documented. Indeed the public has proven to be quite aware of the benefits of stem cell research. Polls in the UK and Australia indicate support by around two thirds of each population for the use of stem cells from extracted embryos.[32] Nevertheless the public's, the government's and the media's perception of cloning remains focused on reproductive issues.[33] Moreover, the increasing number of media reports on the 'imminent' birth of a human clone has served to instil a sense of urgency to legislative intervention. As one US senator stated: [t]ime is of the essence. This mad science isn't standing still. The Senate shouldn't either. It should act now and decisively pass legislation to ban human cloning.[34] 26. In the US, attempts to ban cloning have languished because they tend be 'all or nothing' documents that fail to separate out stem cell research and therapeutic cloning from reproductive cloning. Perhaps the worst example came in late 2001 when an attempt to pass a cloning moratorium through the US Senate not only conflated therapeutic and reproductive outcomes but was bundled with legislation to allow oil drilling in an Arctic National Park. It was voted down 94 to 1.[35] 27. Rather than following the UK lead of dealing with reproductive and therapeutic cloning separately, the Australian approach has been more akin to that in the US. The House of Representatives Report recommended a single regime to deal with all aspects of stem cell and cloning technology, although there was disagreement as to the acceptability of embryonic stem cell research. In late February 2002 the Federal Cabinet announced their intention to ban all use of embryos for research.[36] 28. This decision would have impacted heavily on any form of stem cell research and drew immediate criticism from the research community. The State governments of Victoria, New South Wales and Queensland announced their intention to block such federal moves,[37] which could have had major constitutional ramifications. The political wrangling that followed forced a hasty intergovernmental meeting where the Commonwealth offered a compromise position: to allow the use of embryos surplus to IVF requirements for the extraction of stem cells in limited circumstances, still to be determined.[38] The Prime Minister made it clear that he would allow members of his party to have a conscience vote on this matter.[39] A number of members, including the Deputy Prime Minister, have voiced their opposition to destructive embryo research.[40] The Catholic Church continues to lobby members of cabinet and the public.[41] In all, the debate ahead looks lengthy and it may take some time for all parties to agree on the exact nature of the legislative system. Meanwhile, the issue of reproductive cloning languishes in the shadow of the stem cell debate. 29. In conflating stem cell research and cloning, a rather interesting impasse has arisen. On the one hand, the debate over stem cell research is caught up in the impetus to ban reproductive cloning. Hence, the opportunity for informed and measured debate on that matter is diminished. On the other hand, the immediate realisation of the ban on reproductive cloning has been stymied by a failure to reach agreement on the appropriate regulation of stem cells and therapeutic cloning. The irony is, that the disagreement on how to move forward on stem cells and therapeutic cloning arises out of what many see as a lack of informed and measured debate on this issue. Conclusion 30. The implications of reproductive cloning have been widely debated since the birth of Dolly. A swathe of reports from governments and key institutions in several countries has condemned the practice in humans. The public and the media, together with the majority of mainstream clinicians and researchers, have also made their opposition to reproductive cloning known. Some of this resistance to reproductive cloning may not be easy to pigeonhole into recognised ethical categories.[42] However, this does not diminish the degree, validity or universality of this opposition, which centres on inherent human notions of morality, individuality, family, community and self. While has been noted that the moral majority does not always reflect what is morally appropriate,[43] the views of the majority should not always be ignored, particularly when the alternative viewpoint would benefit few, if any. Simply put, there are insufficient public benefits to be derived from human reproductive cloning. The time for debate on that issue is over, it is time to move on to stem cells and therapeutic cloning. 31. In combination, the UK Cloning Act and the Human Fertilisation and Embryology Act effectively separate therapeutic and reproductive outcomes by differentiating between the creation and the gestation of an embryo. As a result of the Quintavalle appeal, it may be possible to clone embryos but only under the HFEA licensing regime. However, implantation of a cloned embryo is prohibited under the Cloning Act. As such, cloned embryos can only be used for therapeutic purposes in the UK. 32. Some commentators have criticised the rapid enaction of the UK Cloning Act. For example, it has been said that the Act leaves open the creation of cloned embryos.[44] However, it was not the intention of Parliament to deal with therapeutic cloning through this legislation. Swift reaction is not always 'knee-jerk' reaction. The public tends to demand prohibition of conduct that is universally opposed, but expects issues of moral ambiguity to be regulated.[45] Regulation takes time and political willpower to implement because it inevitably impacts on the rights of various constituencies. We argue that by dealing promptly with reproductive cloning the UK has assuaged the public desire for this technology to be effective and immediately banned. This provides much needed space for debate on the significant public issues associated with stem cell research and therapeutic cloning and the appropriate level of regulation of these practices. Australia would do well to take note of this experience. Notes [1] The Queen on the application of Bruno Quintavalle on behalf of Pro-Life Alliance v Secretary of State for Health [2001] EWHC Admin 918 (hereafter Quintavalle) overturned in R (on the application of Quintavalle on behalf of Pro-Life Alliance) v Secretary of State for Health [2002] EWCA Civ 29 (hereafter Quintavalle appeal). [2] C Foster, 'The HFEA 1990 Begins to Leak: ex parte Quintavalle and the Human Reproductive Cloning Act 2001' (2002) 2(4) Genetics Law Monitor 1; S McLean, 'What is Wrong with Reproductive Cloning?' (2002) 2(4) Genetics Law Monitor 6. [3] R Nowak, 'Australia Stops Short of a Ban on Therapeutic Cloning' New Scientist 29 September 2001. [4] There is extensive debate as to both the ethical appropriateness and lawfulness of each of these options. [5] Quintavalle para 57. [6] Quintavalle appeal. [7] Quintavalle appeal para 27. [8] Quintavalle appeal. His Lordship did not expand on the basis for or the extent of this extension [9] Sub-section 1(1) Human Reproductive Cloning Act 2001 (U.K). [10] Recommendation 8. [11] See generally House of Representatives Standing Committee on Legal and Constitutional Affairs Human Cloning: Scientific, Ethical and Regulatory Aspects of Human Cloning and Stem Cell Research (2001) Chapter 9. [12] The Infertility (Medical Procedures) Act 1984, subsequently replaced by the Infertility Treatment Act 1995. [13] Human Reproductive Technology Act 1991 (WA); Reproductive Technology Act 1988 (SA). [14] For an analysis of the contents of these reports see D Chalmers, 'Professional Self-regulation and Guidelines in Assisted Reproduction' (2002) 9 Journal of Law and Medicine in press. [15] House of Representatives Report para 8.43. [16] Section 14(2)(b) Reproductive Technology Act 1988 (SA); Human Reproductive Technology Act 1991 (WA); section 25 Infertility Treatment Act 1995 (Vic). [17] M Metherell and D Smith 'Stemming the tide' Sydney Morning Herald 02/03/02 ; R Kerin 'Stem-cell vote urged' The Australian 04/04/02. [18] Senate Hansard, Gene Technology Bill 2000, Gene Technology (Consequential Amendments) Bill 2000, Gene Technology (Licence Charges) Bill 2000. [19] Section 192B Gene Technology Act 2000 (Cth) [20] Se above n11. Specifically the Act is limited to corporations, things done in the course of trade and commerce and to actions by the Commonwealth or its Commonwealth authorities. [21] The South Australian Act excludes the prohibition on cloning, presumably because its Reproductive Technology Act covers this issue. The Tasmanian Parliament has also passed an Act, but it has not yet entered into force. [22] A cloned embryo will have some of its mother's genetic material, carried in the cytoplasm of the egg cell. It is also likely to have some mutations in its genetic code. See AD Klotzko 'The Debate About Dolly' (1997) 11 Bioethics 427. [23] House of Representatives Report para 8.35. [24] Para 8.4 [25] Sections 3 and 47 Infertility Treatment Act 1995 (Vic) [26] Similar terminology was considered in Quintavalle. [27] Human Reproductive Technology Act 1991 (WA) [28] Reproductive Technology (Code Of Ethical Research Practice) Regulations 1995 reg 6 [29] Note that a later amendment added reg 9, which proscribes the replacement of 'the nucleus of a cell of an embryo, or of an ovum in the process of fertilisation, with another nucleus'. However, it is still questionable whether this would include CNR involving an enucleated egg cell. [30] C Foster 'The HFEA 1990 Begins to Leak: ex parte Quintavalle and the Human Reproductive Cloning Act 2001' (2002) 2(4) Genetics Law Monitor 1. [31] House of Representatives Report para 9.50. [32] Australia (72%), UK (62%) Roy Morgan Research, Finding No. 3421. See 'Four-nation Study Finds Support for Controversial Treatment' The Bulletin 24 July 2001. [33] See House of Lords (UK) Debate, 26 November 2001, Cols 10-60. See also 'Doctor to Exploit Cloning Loophole' BBC News Online 16 November 2001 GMT http://news.bbc.co.uk/hi/english/sci/tech/newsid_1659000/1659216.stm; V Collins and C Simpson 'Italian Doctor Plans to Clone Baby in Britain' The Herald (UK) 16 November 2001; S Morris 'Loophole Allows Human Cloning' The Guardian (UK) 16 November 2001. [34] J Miller and R Ponnuru 'The Senate Punts on Cloning' Washington Bulletin: National Review 1 November 2001 http://www.nationalreview.com/daily/nr110101.shtml [35] H Dewar 'Energy, Cloning Fights Sidetracked, Fearing Defeat' Washington Post 4 December 2001. [36] 'Stem Cell Ban Hits Research' The Age 26 February 2002. [37] D Smith 'Banning stem cells a mistake: Premier' Sydney Morning Herald 28/02/02 ; Ed. 'Embryo stem cell ban put on hold', The Courier Mail 27/02/02 ; J Kerin, I Henderson 'Premiers Approve Stem-cell Research' The Australian 01/04/02 ; P Hudson 'Victorian MPs Back Embryo Research' The Age 10/04/2002 [38] Ed. 'Stem cell go-ahead' News Interactive 05/05/2002 (10/05/2002). Federal, state and territory leaders have agreed on a national framework to allow stem cell research. [39] Ed. "PM Gives Backing for Embryo Use' AAP 04/05/02 (10/05/02) [40] Stem cell debate hots up AAP 04/05/02 (10/05/02) [41] 'Church Pledges Stem Cell Funds' AAP 09/05/02 < http://news.com.au/common/story_page/0,4057,4079571%255E20161,00.html> (10/05/02); Ed. 'PM Defends Stem Cell Stance' AAP 05/05/02 (10/05/02) [42] See the House of Representatives Report chapter 6. [43] See S McLean 'What is Wrong with Reproductive Cloning?' (2002) 2(4) Genetics Law Monitor 6, 8. [44] C Foster 'The HFEA 1990 Begins to Leak: ex parte Quintavalle and the Human Reproductive Cloning Act 2001' (2002) 2(4) Genetics Law Monitor 1, 3. [45] D Stone, Where the Law Ends. The Social Control of Corporate Behaviour (Harper and Row New York 1975) 97.