Author:	Sonia Magri BA (Hons), LLB (Hons), Grad Dip LP Sessional Lecturer, University of Melbourne Faculty of Law
Subjects:	Cloning (Other articles) Reproductive technology - Law and legislation (Other articles) Stem Cells (Other articles)
Issue:	Volume 10, Number 4 (December 2003)
Category:	Current Developments

Contents:

• Introduction
• The discoveries
• The Introduction of Australian Federal Legislation
• The Commonwealth Research Involving Human Embryos Act (2002)
• The 5 April 2002 date
• Licensing
• Consent
• How many people donate embryos?
• Draft Revised Ethical Guidelines
• Definitions
• The Prohibition of Human Cloning Act 2002 (Cth)
• International Debate
• The United Nations
• A sample of countries around the world
• Conclusion
• Notes

Introduction

1. Two advances in biotechnology – cloning and stem cell technologies - have changed the world in terms of attitudes towards what we think is scientifically possible, and arguments about how far we think science and medicine should go. With such advances, came the reminder that science and technology do not stand still and that advances in such areas often move faster than the legal world can keep pace.[1] This paper aims to consider the scientific and legal positions of Australia one year after the passing of Federal legislation on research on human embryos, and cloning.[2]

2. The paper begins with a brief review of the scientific discoveries that re-opened the debate on research on human embryos and led to the enactment of the Research on Human Embryos Act 2002 (Cth) (the RIHE Act) and the Prohibition of Human Cloning Act 2002 (the PoHC Act) (‘the Acts’). A brief overview of the political and legislative issues that arose prior to the introduction of the Acts, including a consideration of constitutional issues, is then had. The discussion then turns to a closer consideration of the implementation of the Acts over the past year, and issues such as which embryos may be used for research, the new licensing committee, consent requirements and definitional problems. This discussion leads to a broader look at what is happening around the world, including consideration of the ongoing debate in the UN, an overview of legislation in a sample of countries around the world, and a comparison of Australia’s position with that of the US and the UK. A brief look at the EU and two other member countries also illustrates shifts from conservative to liberal positions (or vice versa). The paper concludes with a return to Australia, one year after the passing of the Acts, summarizing its position and discussing how it may be informed by the various positions taken abroad.

   The discoveries

3. The first advance that astonished the world was published in the February 1997 issue of Nature,[3] and was the cloning of Dolly the sheep. Whilst, in fact, the researchers involved in this cloning were trying to produce a genetically uniform line of farm animals that might have some future use as living ‘factories’ for pharmaceutical products,[4] the implications of Dolly for human reproduction were clear – many asked how long it would be before human cloning took place.

4. Not quite two years later, in November 1998 James Thomson and his team of researchers at the University of Wisconsin announced another world changing scientific breakthrough - they had produced human embryonic stem (ES) cell lines.[5] As yet undifferentiated, but with the potential to differentiate into almost any body tissue (i.e. ‘pluripotent’), and able to reproduce indefinitely in culture, they promised to revolutionise medicine. The significance of such research was unquestionable offering 1) the potential to aid in the understanding, and ultimate prevention of cell abnormalities (and related diseases) by investigating cell development;[6] 2) a more effective way of testing drugs;[7] and 3) the potential for a renewable source of replacement cells and tissue to treat a myriad of diseases, conditions, and disabilities.[8]

5. However, in order to produce the pluripotent ES cell lines, the process implemented by Thomson and his team involved the destruction of human embryos left over from assisted reproductive treatments (ART), and this was found, by some members of the world community, to be highly questionable. The arguments against such use were (and continue to be) based on the premise that an embryo is a person or a potential person, and should therefore be preserved and given the same protection from harm as that given to human subjects in general.

6. Counter arguments focused on the fact that these embryos exist and that, in reality, fertility clinics only store excess embryos for a limited time before their destruction anyway. Thus, rather than allowing such embryos to ‘die’ by thawing, they should be used for developing new stem cell lines that have potentially significant therapeutic value.[9] It was also argued that Australia housed ‘some of the world’s best researchers, and we [were obliged to do all that we could] to keep them here so our citizens are one of the first countries to actually benefit from … new therapies as they are developed.’[10]

7. The debate was added to when it became apparent that embryos created via the cloning techniques used to create Dolly the sheep, might also be used as a source of human embryonic stem cells.[11] An [arguable] distinction was made between ‘reproductive’ cloning, (i.e. cloning to create a whole organism), and ‘therapeutic’ cloning, (i.e. cloning for the purposes of finding therapies for the human race.) Whilst the same somatic cell nuclear transfer techniques were used in both types of cloning, the real distinction was that with ‘therapeutic’ cloning, the transplantation of the embryo into a uterus would not occur. However, the idea of ‘therapeutic’ cloning was, and remains, even more controversial than the use of excess ART embryos. Objections to the creation of embryos purposefully for their destruction, coupled with the fear that ‘therapeutic’ cloning of embryos for stem cell research was just one step closer to cloning humans, were rife.

8. With both the futuristic fears of cloning, and concern about destruction of human embryos, the debate on research involving human embryos, and personhood were alive again. The dilemma was how to weigh the potential benefits of such research (both scientifically and economically) against whether or not it was morally, ethically and legally acceptable to conduct such research at all.

   The Introduction of Australian Federal Legislation

9. As the public debate surged over the issue of stem cell research, and other countries implemented more comprehensive legislation, the Federal Government was met with a rather large challenge - it had to effectively consider how it could implement two opposing policies. That is, as a conservative government, the Howard Cabinet had adopted a traditional ethical view on the moral status of the embryo and had been proactive in its protection.[12] On the other hand, the Government was concurrently proactive in maintaining Australia’s position at the forefront of biomedical research, including stem cell technology. As these two positions were somewhat hard to reconcile, they had played a large part in the lack of comprehensive national legislation governing embryo research and cloning in the past.

10. In addition, there was some issue as to whether the Federal Government had the necessary Constitutional power to support the introduction of Commonwealth Legislation. However, this was resolved by reference to the Standing Committee on Legal and Constitutional Affairs’ (Andrews Committee) Report,[13] and digests prepared for debate,[14] which had found the Commonwealth did in fact possess legislative power ‘in many areas that impinge upon the use of cloning [and related research such as that involving human embryos]’.[15]

11. On 5 April 2002 the Council of Australian Governments (COAG) proceeded to call for the Government to introduce ‘nationally consistent legislation’ to:
    • ‘prohibit certain practices associated with reproductive technologies, including cloning of human beings; and
    • regulate activities involving the use of certain human embryos created by ART’[16]

    and, after much drafting, redrafting, some stopgap legislation,[17] and splitting of the original bill,[18] the RIHE Act and the PoHC Act were enacted.[19]

12. However, because the constitutional powers that allowed the passing of Federal legislation were broad, it was also suggested that Commonwealth legislation might not cover individuals, who would therefore be able to challenge the constitutionality of any Commonwealth legislation used to prosecute them.[20] In other words, the Commonwealth does not have the power to comprehensively legislate in the areas of human reproductive technology and embryo research. This was acknowledged by COAG and the States and Territories agreed to introduce complementary legislation to ensure full coverage, within six months after royal assent of the Commonwealth Acts.

13. In fact, a year after the assent[21] only NSW, Victoria, South Australia, Tasmania and Queensland have enacted legislation.[22] The other states and territories are still in the process of development and/or debate– on 11 November 2003, Western Australia referred two state bills[23] to its Standing Committee on Uniform Legislation and General Purposes; on 27 November 2003, the Australian Capital Territory tabled its Human Cloning and Embryo Research Bill 2003 in its lower house; it is unclear at present what the Northern Territory government has done.

14. The states that have enacted legislation have taken a number of approaches. Some have chosen to adopt the Commonwealth Act as state law,[24] whilst others have chosen to pass identical state legislation,[25] or amend previous Acts that governed ART[26] - nonetheless, each state/territory’s legislation closely mirrors the Commonwealth Acts.

15. The rest of the paper considers only the Commonwealth Acts, noting that any such analysis also applies to the state/territory Acts so far as they mirror the Commonwealth legislation.[27]

    The Commonwealth Research Involving Human Embryos Act (2002)

16. The RIHE Act aimed to specifically address the use of excess ART embryos by both publicly and privately funded researchers, and allows research to be conducted on excess ART embryos provided they were created before 5 April 2002, that strict licensing conditions are met, and that the consent of interested parties (such as the woman for whom the embryo was created, her spouse and each person who provided the egg or sperm from which the embryo was created) is obtained.[28] Each of these conditions will be discussed in turn.

    The 5 April 2002 date

17. Whilst the RIHE Act stipulates only embryos created before 5 April 2002 may be used for research,[29] s46 of the RIHE Act provides that sections of the Act that make reference to this date,[30] and therefore this date itself, will be repealed either a) on 5 April 2005 or b) if COAG declares an earlier day by notice in the Gazette.

18. A year after the RIHE Act’s enactment, this date remains. However, there has been some talk that s46(b) will be used, and an earlier repeal thus effected. Specifically, both the Western Australian and Queensland Premiers’ departments have made reference[31] to some Leaders being in favour of the early repeal of the sections based on ‘two expert reports [that] were prepared for COAG on matters relating to research involving human embryos’.[32] In particular, the Communiqué of the Leaders Forum of 29 August, 2003 states:

    ‘The first report, prepared by a subcommittee of the Australian Health Ethics Committee of the NHMRC, …, discussed protocols to prevent the creation of embryos for the purposes of scientific research; [and] the second report, prepared by the NHMRC, considered the adequacy of supply and distribution for research of excess assisted reproductive technology embryos which would otherwise have been allowed to succumb….

    [having considered the reports],

    Leaders [with the exception of South Australia and Tasmania] agreed that the restriction on the use of excess assisted reproductive technology embryos for destructive research created after 5 April 2002 should be lifted as soon as the revised Ethical Guidelines are implemented, [noting] the robust regulatory regime in place and that the Licensing Committee has made excellent progress in establishing its monitoring and compliance role…’

19. Such statements have proved controversial. If s46(b) were repealed, research on embryos would not be limited to those created before 5 April 2002. It could be done on ‘surplus’ embryos created after that date or, may lead to embryos being created specifically for research purposes. On the other hand, those in favour of a repeal argue that current excess ART embryos may be substandard – generally being B-grade embryos that are not useful for implantation, and, in the case of stem cell lines that have been developed, may be tainted by the ‘mouse feeder’ cells on which they have been grown.[33]

20. It is difficult however to evaluate the arguments for and against any possible repeal without reference to the abovementioned reports. However, the reports were specifically prepared for COAG, have not yet been released to the public, and have proved inaccessible to members of parliament.[34] At present, the reports have not yet been considered by COAG (which includes the Prime Minister and representation from the Australian Local Government Association, in addition to the Leader’s of the states/territories), and no final decision has been made. That is, the ban on use of excess embryos created after 5 April 2002 remains.

21. Nonetheless, the recognition of such debate is significant in that it demonstrates that issues surrounding research on human embryos (such as which embryos may/may not be used), did not cease with the introduction of the legislation. These issues (and others) are ongoing and evolving, and need to be monitored.

    Licensing

22. The RIHE Act allows research only by those people who hold a licence or when a particular use falls under one of the exceptions in the proposed legislation.[35] Anyone who uses an excess embryo without a licence or breaches the conditions of an issued licence, faces up to five years' jail[36] and/or monetary fines. To obtain a licence a person has to apply to ‘The Embryo Research Licensing Committee’ - a special committee created by the legislation.[37]

23. When applying for a licence that authorises use of an excess ART embryo that may damage or destroy the embryo, the embryo, as mentioned earlier, must have been created before 5 April 2002.[38] Further, the activity or project proposed earlier in the application must have been assessed and approved by a Human Research Ethics Committee (HREC) and be ‘constituted in accordance with, and acting in compliance with, the NHMRC National Statement on Ethical Conduct in Research Involving Humans’.[39]

24. In determining an application the Licensing Committee must consider
    • the HREC’s approval,
    • compliance with the NHMRC guidelines,
    • the number of excess ART embryos likely to be necessary to achieve the goals of the activity or project proposed in the application;
    • the likelihood of significant advance in knowledge, or improvement in technologies for treatment, as a result of the use of excess ART embryos proposed in the application, which could not reasonably be achieved by other means; and
    • any other additional matters (if any) prescribed by the regulations.[40]

25. Whilst limiting the use to only certain excess ART embryos, and requiring strict compliance with both statutory and ethical guidelines, the legislation ultimately allows research on human embryos to be conducted provided consent requirements are also met. One must also keep in mind that the licensing committee is not limited to granting licences for research that promises cures for diseases, but may grant licences for any type of embryo research (for example, examining the effectiveness of a new culture medium used in ART practice; training of clinicians in micro-surgical ART techniques; for improving ART techniques; for toxicology and other drug experimentation) provided the above requirements are met.

26. The Licensing Committee itself came into being, and has been functioning since 3 May 2003. The first meeting of the NHMRC Licensing Committee was held on 4 June 2003 [41] and, pursuant to s19(3) of the RIHE Act, the first report was released on 20 June 2003. This report details the future reporting periods of the Committee,[42] its membership, and the Research Involving Human Embryos Act Regulations 2003 (Cth) [43] – the first set of Regulations under the RIHE Act that were gazetted on 27 February, 2003.The report also updates which States/Territories have introduced/amended legislation to mirror that of the Commonwealth and notes key achievements of the NHMRC staff in undertaking a number of initiatives to facilitate the implementation of the legislation.[44]

27. With regard to the RIHE Regulations, and how they affect the licensing committee’s membership and/or decisions:
    • Regulation 2.1 (and Schedule 1) details the bodies from which the Minister must seek nominations before appointing NHMRC Licensing Committee members;[45]
    • Regulation 2.2 provides that the NHMRC National Statement on Ethical Conduct in Research Involving Humans (1999) and the NHMRC Ethical Guidelines on Assisted Reproductive Technology (1996) are the guidelines that the Licensing Committee must consider before issuing a licence;[46] and
    • Regulation 2.3 describes the forms of identity cards to be issued to Inspectors.[47]

28. Whilst no licenses were issued during the first reporting period, at the time of writing this paper, it is anticipated the second report – due to be released shortly - will carry information about the issuing of up to as many as 15 licences.[48] In addition, it is anticipated that the second report will detail the appointment of two Government inspectors, pursuant to s33 of the RIHE Act, whose duty it will be to ensure the laws governing embryo research, and cloning, are adhered to.[49]

29. Whilst the presence of such inspectors may prove valuable in ensuring the laws governing embryo research, and cloning, are adhered to, it will be interesting to see how in fact they will be able to adequately ‘police’ what is happening at cellular levels in petri-dishes and, exactly what their duties will entail. In some senses, the real bar to undertaking illegal activities in Australia will be that unlicensed researchers, or researchers who are conducting prohibited research, would not be able to publish their results without being found out. Nonetheless, the inspectors have been hired, details of them will be released in the upcoming NHMRC Licensing Committee report, and for now, we can only wait to see what their actual roles will entail.

    Consent

30. The RIHE Act provides that the woman for whom the ART embryo was created and her spouse at the time must have either

    (a) ‘given written authority for use of the embryo for a purpose other than a purpose relating to the assisted reproductive technology treatment of the woman concerned, and the authority is in force at that time; or

    (b) have determined in writing that the embryo is excess to their needs, and the determination is in force at that time’,

    in order for an ART embryo to be considered in excess.[50]

31. The Act does not give any further direction about what is required when obtaining consent, other than defining ‘proper consent’ as:

    ‘(a) consent obtained in accordance with the Ethical Guidelines on Assisted Reproductive Technology 1996 [51] issued by the NHMRC [the NHMRC Ethical Guidelines]; or

    (b) if other guidelines are issued by the NHMRC under the National and Medical Research Council Act 1992…’.

32. Part 3 of the NHMRC Ethical Guidelines states that anyone asked to give consent to ART processes, or to donate embryos/gametes,[52] should be provided with both oral and written information – the latter is to be in plain English and account must be taken of any cultural barriers, language difficulties and/or other diversity.[53] In addition, time must be given for the person to take any information away and consider it before giving their consent.[54] Specific guidelines are also given in relation to exactly what research may be conducted on excess embryos in Part 6.

33. One year on, it is found that many ART clinics have implemented additional measures to meet the consent requirements.[55] For example, various clinics have introduced comprehensive consent forms, provide information by way of fact sheets, require a potential donor to undertake counselling sessions concerning the personal, social and legal aspects of donation,[56] run information evenings about IVF in general[57] and/or refer to NHMRC guidelines.[58]

    How many people donate embryos?

34. Given the above guidelines, it is here useful to digress for a moment, and ask the question of how many people actually donate their embryos for research. To answer this, reference is made to a study published in 2003 that reviewed the choices of couples relinquishing frozen embryos and the outcomes of embryo donation at a major ART clinic between the periods of 1991 and 2002.[59] The study found that 89.5% of couples faced with the decision, decided to discard, rather than donate their embryos.[60] That is, slightly over 10% agreed to donate excess embryos for research. The study however, offered no explanation for this statistic.

35. Clearly, the rates are taken from the ten year period that proceeded the introduction of the new Federal legislation, and, only time will tell, whether higher rates of consent will follow under the new regime. The provision of extensive information about potential research uses and outcomes coupled with legislation imposing strict licensing conditions and governing any research conducted in Australia, may encourage couples to donate embryos. In hypothesising about whether donation rates will increase, it is also important to consider what may be contained in the revised ethical guidelines.

    Draft Revised Ethical Guidelines

36. The Draft Ethical Guidelines on the Use of Reproductive Technology in Clinical Practice and Research[61] (the Draft Ethical Guidelines) were released in February 2003, and although it is unclear when (or if) they will be adopted, they do pre-empt what the reviewed guidelines will contain. To this end, they indicate that in obtaining consent for research on a human embryo, all relevant information will have to comply with the NHMRC National Statement on Ethical Conduct in Research Involving Humans 1999 (the National Statement), including a full explanation of:
    • ‘proposed research activities…;
    • why it [i.e. the research] would represent a significant advance in knowledge or improvement in technologies for treatment’
    • what will happen to each embryo, including where applicable, that embryonal stem cells may be derived… and that any cells or cell lines so derived may be kept for some years;
    • … that the results of the research may have commercial potential…and that donors… will not receive financial…benefits from any such future commercial development; and
    • the arrangements for monitoring and reporting of the research or other activity by the HREC’.[62]

37. Noting the Draft Ethical Guidelines’ reference to the National Statement it is also important to note that the giving of consent must involve:

    ‘provision to participants, at their level of comprehension, of information about the purpose, methods, demands, risks, inconveniences, discomforts, and possible outcomes of the research (including the likelihood and form of publication of research results); and the exercise of a voluntary choice to participate’.[63]

38. Whilst the question is begged regarding who, and how one determines the participant’s ‘level of comprehension’, it is clear that the intention is to provide as much clear information as possible to the donors. It also appears that any new guidelines will be more prescriptive in their requirements for what the people giving their consent must be told. However, whether this will lead to higher rates of donation will remain to be seen, and for the moment, it is important to recognise that as the review of the ethical guidelines is not complete, it is the 1996 guidelines that apply.

    Definitions

39. One of the other major impetuses for ‘nationally consistent legislation’ was that only Victoria, Western Australia and South Australia had enacted reproductive technology legislation.[64] In addition, whilst such legislation imposed strict limitations on research that used human embryos, the scope of such provisions varied according to the definition of embryo and/or cloning in each Act.[65] Such differences highlighted definitional problems and inconsistencies and the new Federal legislation was drafted with the aim of addressing them.

40. However, problems may arise again either because of new biological advances, or because terms used within the legislation itself prove unclear or unconnected to scientific realities.

41. To date, one issue concerning the RIHE Act’s definition of ‘human embryo’ has been identified by the NHMRC. That is, the Act defines ‘human embryo’ as

    ‘…a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro-nuclei or the initiation of its development by other means’.[66]

    However this then implies that ‘a critical issue in deciding whether an activity requires a licence is [therefore] deciding when an embryo is live and when it is dead’.[67]

42. To this end, the NHMRC Licensing Committee has published a directive that, when determining licence applications, they will take the view that:

    ‘An embryo is considered to be a live embryo unless:
    When maintained in suitable culture conditions, the embryo has not undergone cell division between successive observations not less than 24 hours apart, or
    The embryo has been allowed to succumb by standing at room temperature for a period of not less than 24 hours’.[68]

43. However, the inclusion of both options (i.e. that the embryo has not undergone cell division for at least 24 hours or that the embryo has been allowed to succumb) seems to imply that these two things are different. If so, what exactly does ‘succumb’ mean? Does it simply mean an embryo that has been stood at room temperature for no less than 24 hours, or does it entail some other measure (such as lack of cell division – which therefore implies that the first and second directive are not really different at all)? This may prove important, as without clear definitions, confusion ensues.

44. To provide an example of how confusing this might be, this paper now considers what at first appears to be a fairly innocuous statement, but which in fact demonstrates how such questions (and their answers) are important.

45. In a briefing note[69] prepared by Giz Watson[70] in relation to the WA Greens position on research on human embryos it is stated: ‘70% of frozen embryos survive thawing, [and] 70% of thawed embryos survive growing another 3 days at which point stem cells can be removed’.[71]

46. Emphasising that the scientific validity of such an assertion is debatable,[72] and that the statement here is only being considered in relation to the definition of succumb, if ‘70% of thawed embryos survive growing another 3 days…’ how does one determine whether or not to apply for a licence? It seems common sense that the words ‘survive’ and ‘grow’ imply the embryos are ‘live’, however what needs to happen in order for the embryo to succumb? These ‘surviving’ embryos have been stood at room temperature for no less than 24 hours, so obviously something else needs to happen (or cease). If that something else is the cessation of cell division, then this clearly illustrates that the second part of the NHMRC directive is redundant. If that something else is something different to the cessation of cell division, then what is it that will enable the decision that the embryo has succumbed? Clarification is needed.

47. Following on from the above discussion is also the point that the terminology used both in the Acts and in the NHMRC Licensing Committee directive, implies that research on ‘dead’ embryos is permissible and does not require a licence. Whether or not such research would be of any use, the question still arises as to whether this was in fact, what people wanting to control research on human embryos intended. That is, is it OK to experiment on ‘dead’ embryos? Moreover, do scientists actually consider terminology such as ‘live’, ‘dead’, and ‘succumb’ valid in relation to embryos, or does it just serve to emphasise the legal, moral and ethical views of personhood that underlie the legislation?

48. Such questions serve only to highlight the difficulties in drafting legislation that fits scientific realities, and/or, in this case, legislation that is clear in directing such scientists as to whether or not they need to apply for licenses. The important thing will be to monitor the operation of the legislation, and address issues that prevent or hinder the purpose of either of the Acts. That the NHMRC ‘must cause an independent review of the operation of the Acts as soon as possible after the second anniversary of the day the Act received Royal Assent’[73] is certainly one measure that will address this, and any other issues that might arise.

    The Prohibition of Human Cloning Act 2002 (Cth)

49. The PoHC Act 2002 imposed a three year moratorium expressly prohibiting the creation of a human embryo clone for any purpose.[74] Given the moratorium in Australia, little analysis of this Act in practice over the past year is possible/necessary, other than stating that all types of human cloning (and other practices relating to the creation of human embryo hybrids, chimeras or parthenotes) have been banned in Australia and therefore, as far as is ascertainable, no such research has been conducted. It will be up to the Inspectors appointed by the Licensing Committee described above, to actually ensure this is the case.

50. However, when considering both cloning and related embryonic stem cell research, one cannot limit the discussion simply to what has/has not happened in Australia. The debate continues overseas with various other countries and/or bodies, reflecting different positions as to whether or not they will allow human cloning technologies, and if so, the degree to which they will allow them. This ongoing debate, and scientific work abroad, is extremely relevant to Australia, in that it may provide guidance regarding what happens here, once the moratorium ends. Such debate is therefore now considered.

    International Debate

    The United Nations

51. The issue of whether or not to place a series of checks and balances on human cloning has in fact, been with the United Nations for the past two years. In a key debate by the Sixth (Legal) Committee concerning the future of human medicine, the member countries came head to head over two approaches to the issue: to ban all types of human cloning (i.e. reproductive and therapeutic),[75] or to allow scope for ‘therapeutic’ cloning (i.e. cloning that would be used for medical research purposes).[76]

52. Initially, rather than choose between the two competing proposed bans before the General Assembly on 6 November 2003, the General Assembly voted 80 to 79 in favour of a procedural motion[77] to put off voting on a cloning ban for 2 years, which they said would allow them ‘to study all aspects and ramifications of the issue and come up with a clear view on the subject matter’.[78] However, unhappy with the 2 year delay, Costa Rica pushed for reconsideration, and finally, on 10 December 2003, the General Assembly settled for a one year postponement of the issue.[79]

53. What is of note, is that whilst the UN cannot resolve the issue, member countries are permitted to undertake all types of cloning research unless they have their own governing legislation which states otherwise. As stated by the UK’s deputy ambassador Adam Thomson, those who support the Costa Rican resolution have ‘effectively destroyed the possibility of a ban on human reproductive cloning, an issue on which all countries were agreed’.[80]

54. Watching the position that the UN ultimately takes at the 59th session in October 2004, (if it takes one), may well be one thing that informs Australia as to what to do once the moratorium ends for us in December 2005. In the meantime, a closer look at what is or is not permissible around the world is needed.

    A sample of countries around the world

     Table 1: Legislation around the world

    Austria

    Belgium

    Denmark

    Finland

    France

    Germany

    Ireland

    Italy

    Spain

    U. K

    US

    Canada

    China

    Mexico

    Japan

    Singapore

    Allows for the procurement of human ES cells from excess ART embryos by law

    X

    X

    X

    X

    X

    X

    X

    Prohibition of the procurement of human ES Cells but allows importation of ES cell lines

    X

    Prohibition of procurement of human ES cells from human embryos

    X

    X

    X

    X

    No specific legislation regarding research on human embryos

    X[81]

    X[82]

    Allows for the creation of human embryos for research

    X

    X

    X

    Prohibition of the creation of human embryos for research purposes and for the procurement of stem cells by law or by ratification of the Convention of the Council of Europe on Human rights and Biomedicine

    X

    X

    X

    X

    X

    X

    X

    X

    X

    
    

    
    

55. There are many other countries throughout the world that have already passed, or are in the process of considering whether or not to pass legislation on both research involving human embryos and cloning. Whilst thorough consideration of each country’s position is beyond the scope of this paper, again it is important to recognise Australia may be informed by what occurs in countries that either permit practices that we currently ban and/or ban practices that we currently permit.

56. Table 1 [83] above provides an overview of a sample of countries around the world, and highlights that various countries hold different positions. Some permit the use of surplus embryos in certain types of research,[84] and/or allow the creation of human embryos for research purposes,[85] whilst others prohibit either one or both of these practices.[86] Other countries do not have legislation governing embryo research or cloning at all, or are still in the process of developing it;[87] and if one looks closer at certain other countries, it is found to be even more complicated. To illustrate this point, the situation in the US and the UK will be discussed, followed by a brief look at the European Union (EU), and some member countries.[88]

57. When looking at the position in the US a mix of federal and state laws are found. At the federal level, public funding of embryo research is regulated by means of a supplementary note to the Omnibus Consolidated and Emergency Supplemental Appropriations Act [for Fiscal Year] 1999 (which governs the setting aside of money for the US Department of Health and Human Services (DHHS)).[89] The supplementary note effectively bans public funding of research that destroys embryos or that utilises cloning technologies[90] (noting that public funding for research on stem cell lines created prior to 9 August 2001 is actually allowed). Of note is that such laws do not apply to research funded by private sources, which is subject to very few restrictions. Effectively, embryos can therefore be used in privately funded research, whether they are excess or created for research.

58. In addition to this public/private distinction, US state laws vary greatly. According to a survey conducted on behalf of the US National Bioethics Advisory Commission,[91] twenty-four states[92] lack laws governing embryo … research, whilst the others differ greatly in terms of what they do/don’t allow.[93] At present, state laws in California and New Jersey have been passed that permit research on human embryos - including the use of ‘therapeutic’ cloning - and public funding thereof, whilst bills are pending in Illinois and New York.[94] Clearly, the debate in the US, as in many other nations of the world, is ongoing.

59. On the other hand, the position in the UK has been regulated for some time by the Human Fertilization and Embryology Act of 1990 (the HFE Act).[95] In addition, the UK introduced the Human Fertilisation and Embryology Regulations of 2001 (the HFE Regulations),[96] which have had the effect of broadening the scope of permissible research uses for embryos, and allow research on embryos for the following purposes:
    (a) increasing knowledge about the development of embryos;
    (b) increasing knowledge about serious disease; or
    (c) enabling any such knowledge to be applied in developing treatments for serious disease.[97]

60. Like Australia, the UK also has a statutory body that regulates and licenses human embryo research[98] – and, in order to keep, create or, use embryos for research purposes, researchers must apply for a licence.[99]

61. In the UK, consent concerning the donation of embryos to research is also central to the HFE Act and regulations. Consent from the donor must be obtained to use the embryo for research purposes[100] and to store the embryo for the five-year statutory period.[101] The research project must fall within the specific consent given[102] and consent may be varied or withdrawn but not if the embryo has already been used for the purposes of the research project.[103]

62. Under the HFE Act, consent is only considered valid if the donor is ‘given a suitable opportunity to receive proper counselling about the implications of taking the proposed steps, [and] provided with such relevant information as is proper’.[104] However, the UK fails to define what ‘relevant information’ actually means and it appears that the type of information given to potential donors thus varies from clinic to clinic.[105]

63. Since the HFE Regulations were passed, licence applications may also be made for research involving ‘therapeutic’ cloning of embryos.[106] However, the Chief Medical Officer’s Expert Group report recommends that this procedure only be licensed if the applicant shows that no alternative means exists to meet the objectives of the research and that the imposition of criminal penalties for transplanting such an embryo back into a woman’s uterus should continue.[107] It appears that UK lawmakers permit the use of ‘therapeutic’ cloning, believing that their express prohibition on human reproductive cloning sufficiently limits the cloning of human embryos solely for purposes of stem cell research.[108]

64. It is interesting to note that to date, no research group has applied for a licence to conduct research on human embryos created by cloning techniques.[109] This may be because of the adequate availability of other sources of pluripotent stem cells such as excess ART embryos and foetal tissue. Nonetheless, it can clearly be seen that, although the U.K has more codified regulations specifically dealing with embryo research and cloning, these regulations reflect a more permissive attitude toward conducting and funding such research than that shown in either Australia or the US

65. Such examples only highlight the different positions held around the world relating, not only to cloning, but also to research on human embryos generally. The UK although having a highly regulated industry, has a relatively liberal approach to research on human embryos, and is one of the more permissive member countries within the EU, which itself is moving toward a less conservative position[110]

66. For example, in early November 2003, the European Environment Committee voted against proposals that sought to ban embryo stem cell research in the EU member states,[111] while the Industry Committee voted in favour of EU funding for such research.[112] This led the way for a European Parliament vote on 19 November 2003, in favour of allowing such funding, and rejecting a European Commission proposal that would have prevented research on embryonic stem cell lines created after 27 June 2002. All of these votes illustrate a shift from more conservative positions of the past.

67. In contrast other countries within the European Union are shifting towards extremely conservative policies. Italy, for example, which used to be known as the ‘Wild West of assisted reproduction’[113] due to a complete absence of laws, has voted in favour of new laws that are very restrictive, limiting the use of ART to 'stable heterosexual couples', prohibiting research using human embryos, as well as embryo freezing, gamete donation, surrogacy and the provision of any ART to single women or same-sex couples.[114] To a lesser extreme, but still on the conservative side, the lower house of the French government passed a draft bill that would prohibit all forms of human cloning.[115] The proposed law, if passed by the upper house, would make reproductive cloning a 'crime against humanity' and carry penalties of up to 30 years imprisonment and fines of up to 7.3 million Euros) (approximately AUD12 million).[116]

68. What can clearly be seen by looking at examples such as the debate in the UN, the EU and other countries around the world, is that the situation continues to be contentious. Only time will tell whether any consensus will be met. Australia needs to be informed by such debate, as does any review of Australian legislation.

    Conclusion

69. To date, Australia has taken a cautious approach but has not closed its doors with regard to both research on human embryos, and ‘therapeutic’ cloning. As illustrated by this discussion, the Federal legislation (and mirrored State and Territory legislation) which governs embryo research and cloning, allows research on certain excess embryos to be conducted, whilst banning all types of cloning (and various other practices).

70. In accordance with the legislation it is seen that one year on, the Australian NHMRC Licensing Committee has been established, and the first licenses are about to be awarded. Inspectors have also been appointed, licensing committee reporting programs established, and a move towards greater information provision to potential donors has occurred.

71. Around the world, and at home, research continues. Over the past year we have seen reports in the news of the possibility of turning adult cells back into pluripotent cells – which support one argument that in the future, at least in relation to stem cell research, human embryos will not be needed;[117] the use of embryonic stem cells in tissue repair in the heart;[118] doubt cast on the usefulness of adult stem cells;[119] and cells derived from embryos being used to grow sound-detecting hair cells of the inner ear which may one day help in the treatment of deafness.[120] We have also seen human-rabbit embryos created[121] – a practice prohibited in Australia by the PoHC Act – and the negative responses that ensued.[122] The latest controversy surrounds the issue of reproductive cloning and a ‘rogue’ US doctor’s claims to have implanted a human embryo clone.[123] Articles continue to be published debating the pros and cons of ‘therapeutic’ cloning.[124]

72. The current Federal (and corresponding State and Territory) legislation allows Australia to ‘wait and see’ where such research will go. The legislation also leaves Australia in the position of maintaining its spot at the biotechnological forefront by allowing certain research practices. In doing this, Australia will be able to evaluate what happens scientifically, both here and abroad, before any shift its position. Such scientific evaluation, when coupled with a consideration of other legislative positions and the debate that continues to be had around the world, will prove invaluable in both evaluating Australia’s current regulations, and in assessing any necessary changes.