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15.17 Research conducted by Australian scientists has made, and continues to make, a valuable contribution to knowledge about human stem cells and the potential applications of stem cell technologies, particularly in relation to adult stem cells.[20]
15.18 Both publicly funded organisations and companies are involved in adult and embryonic stem cell research in Australia. The establishment of the National Stem Cell Centre (NSCC) in 2002 has augmented these research efforts.[21] Australian companies also feature in the international arena in the research and development of stem cell technologies. A 2003 report produced by Invest Australia indicated that these companies include BresaGen Limited, ES Cell International Pte Ltd, Norwood Abbey Ltd, and Stem Cell Sciences Pty Ltd.[22]
15.19 Various aspects of research involving stem cells are subject to Commonwealth, state and territory legislation, and guidelines and standards issued by the Australian Health Ethics Committee (AHEC), which is a Principal Committee of the National Health and Medical Research Council (NHMRC). However, Australia does not currently have a comprehensive legislative scheme, or set of guidelines, regulating all research involving human embryonic and adult stem cells, whether conducted by publicly funded institutions or private entities.
Regulation of the use of excess ART embryos
15.20 In December 2002, the Australian Parliament passed the Prohibition of Cloning Act 2002 (Cth) (Prohibition of Cloning Act) and the Research Involving Human Embryos Act 2002 (Cth) (Research Involving Human Embryos Act).[23] These Acts prohibit certain practices, including human cloning,[24] and regulate uses of excess human embryos created through ART.
15.21 Under this legislation, human embryo research (and, therefore, the use of embryos for the derivation of human embryonic stem cells) is permitted only in limited circumstances. The research may involve only embryos that are ‘excess ART embryos’.[25] It is an offence to use an embryo that is not an excess ART embryo for a purpose other than one relating to the assisted reproductive treatment of a woman. Therefore non-excess ART embryos cannot be used to derive embryonic stem cells.[26] Further, any use of excess ART embryos must either be conducted pursuant to a licence granted in accordance with the procedures set out in the Research Involving Human Embryos Act, or be subject to a statutory exemption, in which case a licence is not required.[27]
15.22 Licences to conduct research involving excess ART embryos are granted by the Embryo Research Licensing Committee of the NHMRC (NHMRC Licensing Committee) in accordance with the procedures set out in the legislation.[28] Only those excess ART embryos created prior to 5 April 2002 may be used if the activities proposed under the licence will involve the damage or destruction of such embryos.[29]
15.23 On 16 April 2004, the NHMRC Licensing Committee announced that the first licences allowing research using excess ART embryos had been issued.[30] One of these licences was issued to Sydney IVF Ltd to isolate human embryonic stem cells for use in research into the diagnosis, and eventual treatment, of diseases such as juvenile diabetes and Parkinson’s disease.[31] Other licence applications are pending.
Regulation of other types of stem cell research
15.24 The regulatory scheme described above is relevant only to the derivation of human embryonic stem cells from excess ART embryos. As noted above, research involving the use of human embryonic stem cell lines, including human embryonic stem cell lines that have been imported into Australia, is not subject to specific legislation. It is, however, covered by guidelines issued by the NHMRC.[32]
15.25 In 2001, AHEC issued an interim advice to human research ethics committees (HRECs) relating to the review of research protocols that involve human stem cell research (AHEC Interim Advice).[33] The AHEC Interim Advice requires that, to obtain the approval of an HREC, stem cell lines proposed for use in research should have been derived in a manner that is consistent with the NHMRC’s Ethical Guidelines on Assisted Reproductive Technology[34] and National Statement on Ethical Conduct in Research Involving Humans.[35] AHEC is in the process of reviewing the Ethical Guidelines on Assisted Reproductive Technology, and related publications, and intends to address the conduct of stem cell research in the revised guidelines that will flow from this review.
15.26 Research involving tissue from which foetal or adult stem cells may be derived is regulated by a mixture of legislation and guidelines, including:
state and territory Human Tissue Acts, which require consent for the donation of blood, and regenerative and non-regenerative human tissue for research;[36] and
ethical guidelines and policy statements, including the NHMRC’s National Statement on Ethical Conduct in Research Involving Humans.[37]
[20]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), [4.8]‑[4.10]. According to estimates by the University of Adelaide, Australia contributes about 25% of the world’s research on stem cells, compared with about 2.5% of the world’s biotechnology research generally: Invest Australia, Australian Biotechnology (2003), 9.
[21] The NSCC initiative is part of the Australian Government’s Innovation Statement: Commonwealth of Australia, Backing Australia’s Ability: An Innovation Statement for the Future (2001). See also Biotechnology Australia, ‘Centre for Stem Cells and Tissue Repair’, Fact Sheet, <www.biotechnology. gov.au>.
[22]Invest Australia, Australian Biotechnology (2003), 9. ES Cell International is incorporated in Singapore, but has an Australian subsidiary, ES Cell International (Australia) Pty Ltd. Since the publication of the Invest Australia report, BresaGen Limited has entered voluntary administration: BresaGen Limited, ‘BresaGen Appoints Administrator’, Press Release, 20 January 2004, <www.bresagen.com.au>.
[23] There are corresponding requirements in cognate state and territory legislation.
[24]Prohibition of Human Cloning Act 2002 (Cth) ss 9–23.
[25] An excess ART embryo is one that has been determined in writing by the couple for whom it was created to be excess to their needs: Research Involving Human Embryos Act 2002 (Cth) s 9.
[26]Ibid s 11.
[27] Exempt activities include the storage, removal and transport of excess ART embryos, and the use of such embryos by an accredited ART centre to achieve pregnancy for a woman other than the woman for whom the embryo was initially created: Ibid ss 8, 10(2).
[28]Ibid ss 10(1)(a), 12. The NHMRC Licensing Committee is a new principal committee of the NHMRC established by law: Research Involving Human Embryos Act 2002 (Cth) ss 13, 14; National Health and Medical Research Council Act 1992 (Cth) ss 4, 35.
[29]Research Involving Human Embryos Act 2002 (Cth) ss 21(3)(b), 24(1)(c), 24(3). This limitation will, however, be repealed on 5 April 2005, or an earlier date pursuant to a declaration by the Council of Australian Governments: Research Involving Human Embryos Act 2002 (Cth) s 46.
[30] National Health and Medical Research Council, ‘Licences Granted for Research Using IVF Embryos’, Media Release, 16 April 2004, <www.health.gov.au/nhmrc/media/index.htm>. Four licences were granted to Sydney IVF Ltd and one to Melbourne IVF Ltd.
[31] National Health and Medical Research Council and Sydney IVF Ltd, Licence for Development of Human Embryonic Stem Cells (No 309703), 16 April 2004.
[32] The application of NHMRC guidelines and the mechanisms for enforcing compliance with them were considered in Australian Law Reform Commission and Australian Health Ethics Committee, Essentially Yours: The Protection of Human Genetic Information in Australia, ALRC 96 (2003), Ch 13, 14.
[33] Australian Health Ethics Committee, ‘Information for HRECs: Stem Cell Research’, Information Sheet, 1 September 2001, <www.nhmrc.gov.au/issues/hrec5.htm>.
[34] National Health and Medical Research Council, Ethical Guidelines on Assisted Reproductive Technology (1996). See, in particular, ss 6 and 11.
[35] National Health and Medical Research Council, National Statement on Ethical Conduct in Research Involving Humans (1999).
[36] See Human Tissue Act 1983 (NSW) and cognate legislation in other States and Territories.
[37]National Health and Medical Research Council, National Statement on Ethical Conduct in Research Involving Humans (1999); National Health and Medical Research Council, Supplementary Note 5: The Human Fetus and Use of Human of Human Fetal Tissue (1983).