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Regulation of Stem Cell Research in Australia

In brief: Articled Clerk James McConvill outlines the current regulation of stem cell research in Australia. He also provides an explanation of the nationally-consistent principles for the regulation of stem cell research agreed to by the Council of Australian Governments on 5 April 2002.

Overview

Presently, the regulation of stem cell research in Australia is confusing, inconsistent and ad hoc. There is no legislation in place regulating research on a national level. There are only three States (Victoria, South Australia and Western Australia) with legislation in place dealing with research involving embryos. In the remaining states and territories (NSW, Qld, the ACT and NT) there is no legislative framework in place regulating embryonic research and regulation occurs through non-legislative means. This primarily involves compliance with the Guidelines on Assisted Reproductive Technology (1996) produced by the National Health and Medical Research Council.

It is the responsibility of research institutions to self-monitor compliance with these NHMRC Guidelines, by establishing and using in-house institutional ethics committees. Infringement of a provision in the NHMRC Guidelines does not constitute an offence; rather, breaching the NHMRC Guidelines may result in loss of funding from the NHMRC, or naming in Parliament. The recent House of Representatives Committee examining the regulation of human cloning and stem cell research, chaired by Kevin Andrews MP, observed in its report that the loss of research funding by the NHMRC has had little influence in ensuring compliance with the NHMRC Guidelines.

The Andrews Committee also suggested the need for a Commonwealth legislative framework to regulate research into stem cells. While the Commonwealth's Gene Technology Act 2000 does prohibit human cloning under s 192B (and reg. 4 of the Commonwealth's Gene Technology Regulations 2001 made pursuant to the GT Act), the GT Act expressly states that it does not regulate stem cell research. The Andrews Committee observed that the only Commonwealth legislation that may be relevant to stem cell research is legislation dealing with product resulting from the research, such as intellectual property under the Patents Act 1990, and the Privacy Act which would protect genetic information and samples from an individual derived from extracted stem cells.

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Victorian position

Out of each of the three states with a legislative framework for regulation of embryo research in place, Victoria's is probably the least effective in dealing with stem cell research. The Infertility Treatment Act 1995 (Vic), which is administered by the Infertility Treatment Authority, deals mainly with the regulation of assisted reproductive technology. However, it also covers experimentation on embryos.

Section 3 defines 'embryo' as 'any stage of human development at and from 'syngamy'. 'Syngamy' is defined as 'that stage of development of a fertilised oocyte where the chromosomes derived from the male and female pronuclei align on the miotic spindle'. While s 22 sets out the conditions under which research into human embryos may be undertaken, and s 24 bans 'destructive research' on embryos, research into stem cells is not covered by the ITA Act. As the ITA noted in its May 2000 'ITA News', stem cells do not fall within the definition of embryo or gamete under the ITA Act, and therefore the ITA has no statutory power under the ITA Act to prescribe certain action or requirements regarding the use of stem cells in Victoria.

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South Australian position

South Australia's Reproductive Technology Act 1988 sets out a much clearer, though quite restrictive, system for the regulation of experimentation involving embryos. Like Victoria, the RTA Act (which is administered by the South Australian Council on Reproductive Technology) mainly regulates assisted reproductive technology, but does set out a licensing procedure for those that wish to engage in experimentation involving embryos. Section 14 prohibits research involving 'human reproductive material' except that which is pursuant to a licence. Human reproductive material is defined widely under s 3 as 'human embryo, human semen and human ovum', yet (like Victoria) it appears that research involving stem cells is not regulated by the RTA Act There are, however, more substantive provisions which do extend to regulating research into, and use of, stem cells contained in the Reproductive Technology (Code of Ethical Research Practice) Regulations 1995, made under the RTA Act.

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Western Australian position

Like Victoria and South Australia, Western Australia's Reproductive Technology Act 1991 deals predominantly with the regulation of assisted reproductive technology, though it does set out a licensing system for those who wish to carry out embryo research. This Act, administered by the WA Commissioner of Health on advice from the Western Australian Reproductive Technology Council, contains strict regulations, which means that very little embryo research is actually approved.

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Council of Australian Governments Agreement

In recognition of the fact that effective regulation of stem cell research cannot be achieved by way of the complicated and inconsistent system that presently exists at both a Commonwealth and State level, on 4 April 2002 the Council of Australian Governments reached an agreement <http://www.pm.gov.au/news/media_releases/2002/media_release1588.htm> that the Commonwealth, States and Territories would each introduce nationally-consistent legislation principally to regulate stem cell research. The nationally-consistent legislation, to be introduced by the end of 2002, will permit research involving the use of excess embryos created during the assisted reproductive technology process (that would otherwise have been destroyed), but it will prohibit the use of human embryos created after 5 April 2002 for the purpose of stem cell research (a practice known as 'therapeutic cloning').

The COAG agreed that research on embryos will only be allowed under a strict regulatory regime, requiring that the consent all gamete providers and their spouses (if any) be obtained (with donors being able to specify certain restrictions on the way in which their embryos are used), and that the embryos to be used must have been in existence at 5 April 2002. The proposed nationally-consistent legislation is to be administered by the NHMRC. The NHMRC will be able to issue a licence for a person to use excess embryos from an assisted reproductive technology program, even though the research or therapy will damage or destroy the embryo. For a licence to be issued, the NHMRC will need to be satisfied that the proposed research or therapy has the approval of an ethics committee established, composed and conducted according to NHMRC guidelines, and that:

  • there is a likelihood of significant advance in knowledge or improvement in technologies for treatment as a result of the proposed procedure; and
  • the significant advance in knowledge or improvement in technologies could not be achieved by other means; and
  • the procedure involves a restricted number of embryos and a separate account of the use of each embryo is provided to the ethics committee and the national licensing body; and
  • all donors involved and their spouses or domestic partners, if any, have consented to research for each embryo used, including restrictions, if they wish, on the research uses of such embryos; and
  • the embryo had been created prior to 5 April 2002.

The regulation requiring all Australian governments to restrict the use at a national level of embryos created after 5 April 2002 will cease to have effect in three years once enacted (unless an earlier time is agreed by COAG).The nationally-consistent regulations will also be reviewed within three years. The COAG also agreed to establish an Ethics Committee to report to COAG within one year on protocols to preclude the creation of embryos specifically for research purposes. COAG has also required that the NHMRC report, within one year, on the adequacy of supply and distribution for research of excess assisted reproductive technology embryos which would otherwise of been destroyed.

An evaluation of the success of COAG's approach to the regulation of research into excess embryos created during the assisted reproductive technology process, which implicitly includes stem cell research, can only be made once the Commonwealth, State and Territory governments legislate in response to the nationally-consistent principles outlined by COAG. The Commonwealth intends to introduce legislation by June 2002. Until then, we can at least be certain that COAG's approach does address the present fundamentally inconsistent system of regulating research into, and use of, stem cells. Indeed, the primary recommendation of the Andrews Committee was that a national uniform legislative approach is needed.

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