02.08.2010
15.13 Stem cell research has generated much controversy in Australia and in other countries. In particular, objections have been raised to research involving human embryonic stem cells on the basis that the potential for an embryo to develop into a human being should preclude the use or destruction of embryos in scientific research. Critics of stem cell research also object to the patenting of inventions involving human embryonic stem cell technology.[12]
15.14 More specific objections to the patenting of inventions involving stem cell technologies have also been raised, including that stem cell patents may:
represent an inappropriate commodification of human biological material, and in particular human reproductive material;[13]
violate fundamental principles regarding the ownership of human beings and the free and informed consent of the donor;[14] and
inhibit continued research and development relating to stem cell technologies.[15]
15.15 Some of the ethical objections to patenting human stem cell technologies are similar to those that have been articulated about gene patents. As DP 68 discussed, the ethical concerns that may be raised about whether it is acceptable to grant gene (or stem cell) patents are sometimes based upon objections to the way in which the research is conducted or the way in which patents are exploited, rather than the grant of patents per se.[16]
15.16 The issues surrounding human embryonic stem cell research, and research involving human embryos generally, were considered in the 2001 report of the House of Representatives Standing Committee on Legal and Constitutional Affairs, Human Cloning: Scientific, Ethical and Regulatory Aspects of Human Cloning and Stem Cell Research (Andrews Report).[17] Following this report, a new national regime governing embryo research is being implemented, beginning with Commonwealth legislation enacted in 2002.[18] Corresponding legislation is in the process of being adopted by the States and Territories.[19] Relevant aspects of this regime are outlined in the following section. However, beyond this, the chapter does not address the moral and ethical concerns related to the conduct of human stem cell research.
[12]European Group on Ethics in Science and New Technologies, Ethical Aspects of Patenting Inventions Involving Human Stem Cells: Opinion to the European Commission (2002), 13.
[13]Ibid, 13.
[14]Ibid, 13.
[15]Senate Community Affairs Legislation Committee, Provisions of the Research Involving Embryos and Prohibition of Human Cloning Bill 2002 (2002), [4.56]–[4.61]; M Rimmer, ‘The Attack of the Clones: Patent Law and Stem Cell Research’ (2003) 10 Journal of Law and Medicine 448.
[16] Australian Law Reform Commission, Gene Patenting and Human Health, DP 68 (2004), [3.60]–[3.72]. See Ch 3.
[17]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). See also Council of Australian Governments, ‘Human Cloning, Assisted Reproductive Technology (ART) and Related Matters’, Communiqué, 5 April 2002, <www.pm.gov.au/news/media_releases/2002>; Senate Community Affairs Legislation Committee, Provisions of the Research Involving Embryos and Prohibition of Human Cloning Bill 2002 (2002); National Health and Medical Research Council and Australian Health Ethics Committee, Scientific, Ethical and Regulatory Considerations Relevant to Cloning Human Beings (1998). The ethical and legal issues surrounding stem cell research and cloning technologies have also been considered in other jurisdictions: see President’s Council on Bioethics, Monitoring Stem Cell Research (2004); United Kingdom Department of Health, Stem Cell Research, Medical Progress With Responsibility: A Report from the Chief Medical Officer’s Expert Group Reviewing the Potential of Developments in Stem Cell Research and Cell Nuclear Replacement to Benefit Human Health (2000); Royal Society, Whither Cloning? (1998).
[18]Prohibition of Human Cloning Act 2002 (Cth); Research Involving Human Embryos Act 2002 (Cth).
[19] See, eg, Research Involving Human Embryos (New South Wales) Act 2003 (NSW); Human Cloning and Other Prohibited Practices Act 2003 (NSW) and cognate legislation in Queensland, South Australia, Tasmania, Victoria and the Australian Capital Territory. Bills addressing this issue are also pending in Western Australia.