Controversy over the use of cloning technology in humans has once again arisen with Advanced Cell Technology (ACT) reporting that it has cloned the first early human embryo in Massachusetts, United States. Much attention has focused on how much closer ACT’s research has brought us to the prospect of cloning human beings. The aim of this paper is to:
- Discuss some of the issues specific to ACT’s research – i.e. the cloning of an early human embryo as opposed to the cloning of a living human being; and
- review the current legislative framework in Australia regulating the use of cloning techniques in humans, and whether such a framework would permit ACT’s research to be undertaken in Australia.
Concurrent with the human genome project, which started in 1990, scientists worldwide have been experimenting with cloning technology in a number of species other than humans1. In February 1997, the first adult mammal, a sheep named Dolly, was successfully cloned. Since then, scientists have continued undertaking such research, even experimenting with human genes in species other than humans2. ACT’s claim of cloning the first early human embryos has signalled to many the move to experimentation with cloning technology in human species. Further, while others have previously claimed similar success3, this is the first time that such work will be reported in a scientific journal4.
HUMAN CLONING VERSUS EMBRYONIC CLONING
As stated above, much attention has focused on what ACT’s research, i.e. the cloning of human embryos (which this paper refers to as “embryonic cloning”), means for the prospect of cloning technology being applied to clone entire living duplicates of human beings (which this paper refers to as “human cloning”). A common tendency has been to consider issues relating to embryonic cloning as a subset of the wider issues relating to human cloning. While the concerns related to human cloning are valid, it is important to recognise that human cloning is not yet possible. Rather ACT only claims that it is able to clone a human embryo. It is important that the distinct issues relating to embryonic cloning compared to those relating to human cloning are understood in any debate or legislative proposal on whether embryonic cloning is to be permitted. These distinctions include:
- Therapeutic purposes versus reproductive purposes – Human cloning is generally regarded as cloning undertaken for reproductive purposes. While a successfully cloned embryo is the first step to cloning a live human being - there is also interest in the distinct potential use of embryonic cloning for therapeutic purposes.
- Spinal cord damage, diabetes, Parkinson’s and Alzheimer’s are amongst the medical conditions characterised by irreversible damage to non-regenerative cells. An area of investigation is the implantation of stem cells in diseased tissues. Stem cells possess the ability to divide and transform into a range of cells, including those cells irreversibly damaged in Parkinson’s, Alzheimer’s etc, and are predominantly extracted from embryos. Embryonic cloning is considered a means of obtaining compatible stem cell lines necessary to treat disease or disability in a particular individual.
Other directions in the field of stem cell research in addition to embryonic cloning, include:
- studying stem cells to identify cell signals and triggers that lead to the development of various medical conditions so that such conditions can be diagnosed and prevented in the first place. This research uses stem cells from both cloned and non cloned embryos;
- creating stem cells, independently of embryonic cloning, which are “immunologically silent”, i.e. cells which are engineered in such a way that they will not be rejected by the body; and 5
- using adult organs as a source of stem cells;
The ethical issues in relation to embryonic cloning are the same as those arising generally in relation to the use of embryos in research. Extraction of stem cells from an embryo destroys the embryo. Such destruction, and in the case of embryonic cloning, the creation of an embryo for the purpose of subjecting the embryo to a procedure resulting in its destruction, raises ethical issues. This is not a subject on which there is a clear general consensus. The view that experimentation even on extracted stem cells is unethical (largely because of the derivation from embryos) has also been expressed, however, is outside the scope of this paper. While a general consensus appears to exist in respect of a complete prohibition on human cloning, the division of views on the ethics of dealing with embryos and the therapeutic interest in stem cells has meant that a similar consensus does not exist in respect of embryonic cloning.
CURRENT LEGISLATIVE FRAMEWORK IN AUSTRALIA
The current legislative framework in Australia is characterised by provisions dealing specifically with cloning and provisions dealing generally with research in respect of embryos. The relevant legislation, and key provisions of such are summarised as follows:
- Commonwealth - At the Commonwealth level, the Gene Technology Act (Commonwealth) 2000 prohibits the cloning of “whole human beings”.6 Cloning is described as follows - "Cloning of a whole human being means the use of technology for the purposes of producing, from one original, a duplicate or descendant that is, or duplicates or descendants that are, genetically identical to the original".;7
- Victoria - In Victoria, amongst the procedures prohibited under the Infertility Treatment Act (Victoria) 1995,8 are cloning9 and attempting to form an embryo outside the body of a woman except for the purposes of a treatment procedure to be carried out in accordance with this Act10. Cloning means “to form outside the human body, a human embryo that is genetically identical to another human embryo or person”11. Further, under the provisions dealing with research12 - research which may result in an embryo being unfit for implantation (i.e. “destructive research”) is prohibited and cannot be approved by the relevant Victorian authority, the Infertility Treatment Authority, under this Act.13
- Western Australia - In Western Australia, under the Human Reproductive Technology Act (Western Australia) 1991, it is an offence to carry out any procedure directed at human cloning14. Cloning is defined as “the use of reproductive technology for the purposes of producing, from one original, a duplicate or descendant that is, or duplicates or descendants that are, genetically identical, live born and viable”.15 Research16 on an embryo may be undertaken pursuant to a licence authorised by this Act17. Approval by the relevant Western Australian authority, the Western Australian Reproductive Technology Council, cannot be provided if the proposed research is likely to harm the embryo1. 8
- South Australia - In South Australia, the Reproductive Technology Act (South Australia) 1988 provides that, except in accordance with a licence, research involving experimentation with “human reproductive material” (meaning a human embryo, human semen or a human ovum) is prohibited19. Any licence issued under this Act, by the South Australian Council on Reproductive Technology, is subject to a condition prohibiting research that may be detrimental to an embryo. 20 The Reproductive Technology (Code of Ethical Research Practice) Regulations 1995 made under the Reproductive Technology Act provides that “a licensee must not carry out, or cause, suffer or permit to be carried out, the procedure of cloning”21. Cloning is defined as “. . . any procedure directed at producing two or more genetically identical embryos from the division of one embryo”.22
- New South Wales, Queensland, the Australian Capital Territory and the Northern Territory - In New South Wales23, Queensland24, the Australian Capital Territory and the Northern Territory, there is no legislation regulating embryonic cloning or the wider field of embryonic research.
COMPLICATIONS IN THE CURRENT LEGISLATIVE FRAMEWORK
Based on the above overview of the current legislative framework in Australia, the following comments are made in respect of the regulation of embryonic cloning:
- No legislation in majority of Australia - As there is no legislation in New South Wales, Queensland, the Australian Capital Territory and the Northern Territory, there is no legislative prohibition on scientists undertaking embryonic cloning research in these jurisdictions.
- Legislation governing IVF vs legislation governing research - Each of the Victorian, South Australian and Western Australian legislation has been enacted primarily to govern artificial fertilisation procedures, eg IVF treatments. Regulating embryonic cloning undertaken for stem cell research purposes in the context of such procedures is intertwined with conditions relevant to maximising the development and integrity of embryos for implantation. The common thread of such legislation in prohibiting procedures which destroy or harm an embryo is irreconcilable with embryonic cloning (and for that matter any embryonic research) involving stem cell extraction, as embryo destruction is an unavoidable consequence of stem cell extraction. Further, the focus on fertilisation (i.e. the inclusion of sperm into an egg) also presents definitional difficulties (referred to below) when such legislation is applied to cloning an embryo for research purposes.
- Complications with the definitions of “cloning” and “embryo” - Further, as the prohibitions on cloning are drafted in different terms, this gives rise to a greater opportunity for speculation as to the extent to which embryonic cloning is prohibited under each statute. For example, in Victoria, it is considered that cloning an embryo for any purpose is prohibited, whereas in Western Australia, embryonic cloning is prohibited only if it is undertaken for reproductive purposes. This difference is considered to arise because the Western Australian definition refers to the formation of “… duplicates or descendants that are, live born and viable”, whereas the Victorian definition refers simply to the formation of a “human embryo” without any reference to the embryo being live, born etc.25
The South Australian definition of “cloning” is considered to differ from both of these definitions on the basis that it focuses on the particular cloning technique used to clone an embryo.26 In particular, the reference to “the division of one embryo” has been described as referring to the technique of “embryo splitting”. Accordingly, it is unclear whether the South Australian legislation prohibits all embryonic cloning or only embryonic cloning involving embryo splitting techniques. This would exclude cloning by other techniques such as nuclear cell transfer which involves removing the nucleus of an egg, followed by injecting donor cells into the egg (i.e. the technique used to clone Dolly, the sheep, and referred to as somatic cell nuclear transfer), without necessarily any division of the embryo as occurs in embryo splitting. While the Victorian legislation appears to prohibit embryonic cloning, whether undertaken for therapeutic or reproductive reasons, uncertainty arises in relation to the definition of “embryo” as used in the definition of cloning.
“Embryo” means any stage of human embryonic development at and from “syngamy”, which in turn refers to the alignment of “chromosomes derived from the male and female pronuclei”. How such a definition sits with embryos created other than from eggs being fertilised by sperm or injected with cells from a male donor – for instance, embryos created from eggs injected only with cells from a female donor - is unclear. The Victorian legislation also deals with embryos resulting from the process known as “parthenogenesis”, which is seen as a technique of creating embryos separate from cloning. While creating embryos by parthenogenesis is not completely prohibited, such research cannot be undertaken without the prior approval of the Infertility Treatment Authority.27 The above overview is restricted to the current legislative framework in Australia. Any research involving embryonic cloning should also consider the applicability of other non-statutory guidelines such as the National Health and Medical Research Commission (NHMRC) guidelines, the Reproductive Technology Accreditation Committee Code of Practice and conditions of approval of institutional ethics committees. A consideration of such guidelines is not undertaken in this paper.
RECOMMENDATIONS OF A FEDERAL PARLIAMENTARY INQUIRY
In August 2001, the House of Representatives Standing Committee on Legal and Constitutional Affairs released its report “Human cloning: scientific, ethical and regulatory aspects of human cloning and stem cell research”28 after a 2 year parliamentary inquiry. The Committee recommended that national uniform legislation be established to purely regulate research involving cloning technology, separate from the legislation governing artificial fertilisation programs and also separate from any legislation governing any clinical application of cloning research. The Committee recommended a complete prohibition of research directed at human cloning. The Committee did not, however, recommend a complete prohibition of research involving the use of human embryos. The prohibition in this regard was limited to the deliberate creation of embryos for research purposes. The Committee considered that the potential for treatment of human disease presented by stem cell research outweighed the need for a complete prohibition on research involving the use of human embryos, and that the embryos surplus from artificial fertilisation programs obviated the need to create embryos. In relation to research involving surplus embryos, the Committee recommended that such research should only be permitted in limited circumstances, including:
- any use be subject to the full and informed consent of the donor parents of the embryo;
- there should be no commercial incentive to the donor;
- the minimum number of embryos be used;
- an application be made on a case by case basis to a regulatory body; and
- a criteria for approval include a requirement that the research cannot be achieved by any other means. 29
The Committee did not clearly identify who ultimately controls the surplus embryos. While the consent of donor parents is referred to, it is unclear what rights these individuals actually have in an embryo, given the reluctance of the law to grant property rights in such subject matter. This uncertainty, together with the limited circumstances under which research is to be permitted, suggests that access to surplus embryos for the purpose of undertaking stem cell research may not be as simple an exercise as presented. The Committee noted the importance of a clear definition of cloning, and also urged that the definitions of cloning in the existing legislation be replaced by broader and more effective definitions. In addition to the definitional problems identified above, the Committee also discussed the fact that the current definitions refer to a requirement of “genetic identicality”30, and that such a reference may exclude non identical clones generated as a result of mutations occurring during development.
DOES AUSTRALIAN LEGISLATION PERMIT THE CLONING OF EARLY HUMAN EMBRYOS IN THE MANNER UNDERTAKEN BY ACT?
In basic terms, ACT’s research consisted of injecting eggs donated by women specifically for ACT’s research, with cells (fibroblast and ovarian cells) from individuals to be cloned. Both nuclear cell transfer and parthenogenesis techniques were used to create embryos. The most successful outcome as reported by ACT was that from the 71 injected eggs, one of these progressed to form a 6 cell embryo before it stopped any further development.31
Whether Australian legislation would permit the cloning activities of ACT may be answered as follows:
- Commonwealth –The prohibition on cloning under the Gene Technology Act does not govern ACT’s research because the relevant prohibition applies to the cloning of “a whole human being”. Cloning a human embryo as reported by ACT, while an essential step in the process is not the cloning of “a whole human being”, and hence not governed at the Commonwealth level.
- Victoria – Possibly - ACT undertook to clone embryos using nuclear cell transfer, including injecting eggs with female donor cells. It is unclear whether the prohibition under the Victorian legislation extends to embryos cloned by injecting eggs with female donor cells This is due to the fact that it is unclear whether the description of “embryo”, which in effect refers to embryos containing “chromosomes derived from the male and female pronuclei”, captures embryos resulting from an egg injected only with cells donated from a female. Therefore cloning of such embryos may not be prohibited in Victoria. Further, creating embryos by parthenogenesis may also be permitted if such research has received the prior approval of the Infertility Treatment Authority.
- Western Australia – Yes – on the basis that the prohibition on cloning, due to the definition of “cloning”, is restricted to cloning undertaken for reproductive purposes. ACT has insisted that its research has been undertaken for therapeutic, and not reproductive, purposes. In this regard, ACT stated: “We are eager for the day when we will be able to offer therapeutic cloning or cell therapy arising from parthenogenesis to sick patients. Currently our efforts focused on diseases of the nervous and cardiovascular systems and on diabetes, autoimmune disorders and diseases involving the blood and bone marrow”.32
- South Australia – Possibly - while research involving experimentation with human reproductive material can be only undertaken if a licence is issued by the South Australian Council on Reproductive Technology, it is arguable that due to the definition of “cloning”, the prohibition on licensees in respect of cloning is limited to embryos created using embryo splitting techniques, which is not necessarily the same as the nuclear cell transfer technique used by ACT.
- New South Wales, Queensland, Australian Capital Territory and the Northern Territory – Yes - as there is no legislation in these states regulating embryonic cloning, scientists are not prohibited by legislation from undertaking such research.
- Parliamentary Committee’s recommendations – No - since ACT’s cloned embryo is a deliberately created embryo, such research would be prohibited in Australia if the Committee’s recommendations were enacted as legislation. Of course, the effectiveness of any such prohibition will depend on what exactly is specified as the “deliberate creation of embryos”, i.e. creation for any purpose, by any technique, whether the resulting embryo is identical or non identical to its descendant etc.
While the Committee acknowledged that the deliberate creation of embryos in order to obtain compatible stem cell lines to treat disease or disability in a particular individual may be an issue in the future, it commented that any such techniques of treatment remain “at best speculative”33. In this regard, the embryos cloned by ACT did not reach the stage of embryonic development required for stem cell extraction. The Committee recommended a 3 year moratorium on the creation of embryos after which the issue can be reviewed by the Australian Health and Ethics Committee of the NHMRC34.
Embryonic cloning vs research on an embryo or an egg
As cloning was not the only element of ACT’s research, it is important that the Victorian, Western Australian and South Australian legislative provisions governing cloning be examined together with the provisions governing:
- research involving the embryos, during and subsequent to their development; and
- research involving the donated eggs.
Comments in relation to research involving the embryos are as follows:
- The Victorian legislation provides in effect that research involving the formation of an embryo cannot be carried out outside the body of a woman unless the research has been approved35 by the Infertility Treatment Authority. Further, as already outlined, the legislation prohibits destructive research on an embryo. Based on earlier comments in relation to the unclear definition of “embryo”, not all of ACT’s embryos are necessarily captured. Consequently, it is unclear whether research relating to those embryos requires the prior approval of the Infertility Treatment Authority or is also prohibited on the basis of its potential destructive consequences.
- The Western Australian legislation provides that any procedure “related to the storage of … an embryo”36 requires a licence from the Western Australian Reproductive Technology Council. The following observations suggest that it is uncertain whether ACT’s research would require such a licence - the provision refers to procedures “related to the storage of” an embryo and not simply any procedures related to an embryo. It is unlikely that ACT’s research can be described only as procedure “related to the storage of” an embryo and the definition of embryo refers to “a live human embryo which occurs from … the completion of the fertilisation of the egg...”37. Importantly, as fertilisation refers to the inclusion of a sperm into an egg, this may mean, as in the case of the Victorian legislation, that not all of ACT’s embryos are captured.
- Under the South Australian legislation, while research involving experimentation with human embryos is prohibited without a licence38, “embryo” is not defined. Given that the primary purpose of the South Australian legislation is to regulate artificial fertilisation procedures involving the creation of an embryo from a male and female donor parents, it is unclear whether the legislation and hence the prohibition is intended to extend to research involving the embryos cloned by ACT using only the cells of a female donor
Comments in relation to research involving the eggs are as follows:
- The Victorian legislation permits research involving the use of an “oocyte” (i.e. egg), provided the consent of the donor is obtained in the requisite form39. Accordingly, as long as the relevant consent is obtained, ACT’s manipulation of the donated eggs in the first place using nuclear cell transfer and parthenogenesis techniques may be undertaken in Victoria.
- The Western Australian legislation requires researchers to obtain a licence from the Western Australia Reproductive Technology Council in respect of, again, “procedures related to the storage” of an egg”40 - it is unlikely that ACT’s manipulation of the eggs can be described as such and research in respect of eggs in the process of fertilisation41 - The definition of fertilisation, as discussed above, may exclude the manipulation of eggs by ACT as these eggs were not injected with sperm. Accordingly, it is unclear whether ACT’s manipulation of the eggs requires a licence from the Western Australian Reproductive Technology Council.
- The South Australian legislation prohibits any research involving “experimentation of a human ovum”42 except in accordance with a licence issued by the South Australian Council on Reproductive Technology. Such a broad provision will most likely capture ACT’s experimentation with the eggs in the first place. Therefore ACT would require a licence from the South Australian Council on Reproductive Technology to undertake its experimentation with the eggs in South Australia. It is noteworthy that “experimentation” is not defined. This is unlike the position under the Victorian and Western Australian legislation where the term “research” is used instead, and defined. 43
From the outset, any advances in cloning technology have been met with a mixture of ethical concerns and scientific excitement. Calls for stricter regulation in this area have also been met by calls that onerous regulation in Australia will hinder international competitiveness of Australian scientists in this area, with wider consequences including Australia missing out on commercialisation and patenting opportunities presented by applications of cloning technology. For regulators in Australia the challenge is to establish a legislative framework which encourages the pursuit of potential therapeutic benefits presented by cloning technology while effectively preventing such technology from being taken too far. Drawing the relevant line will no doubt generate numerous controversies, however, it is essential that any debate or legislative decision:
- maintain the distinction between the issues specific to human cloning and those specific to embryonic cloning; and
- understand the importance of achieving uniformity and consistency in any proposed legislative regime in Australia.
1 July 1998 researchers at the University of Hawaii cloned 50 mice in three generations from a single mouse. April 1999 geneticists at Tufts University in Massachusetts cloned three goats, altering the goats’ genetic code to produce a protein in their milk to treat heart attack and strokes. 2000 Oregon researchers produce a rhesus monkey named Tetra by splitting early stage embryos and then implanting the pieces into the mother. November 2001 Massachusetts research company reports it has cloned the first human embryo, a development it said was aimed at producing genetically matched replacement cells for patients with a wide range of diseases (as reported in the Sydney Morning Herald, “Vital stem cell work held in check” 27 November 2001, page 7).
2 July 1987 Scottish scientists cloned Polly, a lamb, from skin cells grown in a lamb and genetically altered to contain a human gene (as reported in the Sydney Morning Herald, 27 November 2001, page 7)
3 The Australian, “The great stem-cell hard sell”, 27 November 2001, page 13, reported that “researchers at Kyunghee University in South Korea claimed back in December 1998 to have produced the first human embryo clone which they hurriedly destroyed after it divided several times.”
4 Proposed to be reported in the January 2002 edition of Scientific American.
5 Discussed in New Scientist, “Special Report on Human Cloning”, 1 December 2001, page 4.
6 Section 192B.
7 Section 192B.
8 Part 5.
9 Section 47.
10 Section 49.
11 Section 3.
12 “research includes: (a) An experimental procedure or clinical trial; and (b) The activities referred to in sections 22(2)(a) and (b).” (section 3) The activities referred to in sections 22(2)(a) and (b) are parthenogenesis related research
13 Sections 24 and 25.
14 Section 7(1)(d)(i).
15 Section 3.
16 “research means systematic investigations carried out for the primary purpose of adding to general knowledge but includes the carrying out of an experiment, and “project of research” shall be construed accordingly.” (section 3)
17 Section 7(1)(a).
18 Section 14(2).
19 Section 14(1).
20 Section 14(2)(b).
21 Regulation 6.
22 Regulation 2.
23 New South Wales Health Minister Craig Knowles will introduce to Cabinet next month a plan to regulate cloning – but Knowles’ spokesman declines to say exactly what the draft legislation will mean (as reported in The Australian, “Calls for uniform national laws on human cloning”, 27 November 2001, page 13).
24 The Queensland government will this week become the fourth State to introduce new laws into State parliament to make human cloning a criminal act punishable with ten years jail – but stem cell research will not be banned (as reported in The Australian “Calls for uniform national laws on human cloning,”, 27 November 2001, page 13).
25 Page 134 of the report by the House of Representatives Standing Committee on Legal and Constitutional Affairs referred to in footnote 28.
26 Page 134 of the report by the House of Representatives Standing Committee on Legal and Constitutional Affairs referred to in footnote 28.
27 Sections 22(2)(a) to (c)
28 The report “Human cloning: scientific, ethical and regulatory aspects of human cloning and stem cell research" can be accessed from http://www.aph.gov.au/house/committee/aca/preving.htm.
29 Page 124 of the report by the House of Representatives Standing Committee on Legal and Constitutional Affairs referred to in footnote 28.
30 Page 137 of the report by the House of Representatives Standing Committee on Legal and Constitutional Affairs referred to in footnote 28.
31 As reported by ACT in the report entitled “The First Human Cloned Embryo”, accessed from http://www.sciam.com/explorations/2001/112401ezzell/.
32 Page 4 of the report by ACT referred to in footnote 31.
33 Page 122 of the report by the House of Representatives Standing Committee on Legal and Constitutional Affairs referred to in footnote 28.
34 Page 122 of the report by the House of Representatives Standing Committee on Legal and Constitutional Affairs referred to in footnote 28.
35 Section 22(1)(a)
36 Section 6(1)(a)(iii)
37 Section 3
38 Section 14(1)
39 Section 22(3)
40 Section 6(1)(a) (i) and (ii)
41 Sections 7(1)(a), 7(1)(b), 7(1)(e), 7(1)(g), 7(1)(h) and 7(1)(j)
42 Section 14(1)
43 Refer to footnotes 12 and 16
This newsletter provides a summary only of the subject matter covered, without the assumption of a duty of care by Freehills. The summary is not intended to be nor should it be relied on as a substitute for legal or other professional advice.