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Isabel Karpin
On 7 November, 2006 the Australian Senate debated the much anticipated Patterson amendments to the Prohibition of Human Cloning Act 2002 (Cth) (PHC Act) and the Research Involving Human Embryos Act 2002 (Cth) (RIHE Act). These amendments were designed to give effect to the recommendations of the Lockhart Committee which presented its report reviewing the Acts in December 2005 (Lockhart Committee, 2005). The primary recommendation was to amend the Acts to enable the creation and use of embryos in certain limited circumstances for the production of stem cells, amongst other things. The Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Bill (2006) as it is called (the Patterson Bill), was passed in the Senate by a narrow vote of 34 to 32 after several amendments and a third reading. At the time of writing the Bill is still to go before the House of Representatives.
Rather than focus on issues that have been well-rehearsed in the media, namely, whether or not embryos should be created for the purposes of research, I want to focus on the research phase following the successful creation of a stem cell line. How are we to ensure that programmes for scientific research flow on to provide public benefits to the community both nationally and globally?
In amongst the lengthy discussions about the moral value of embryos, Senator Kerry Nettle of the Greens moved an important amendment to the Patterson Bill that was roundly defeated. She proposed the insertion of a paragraph that would have added a further subsection to section 21(4) of the RIHE Act which sets out the terms on which a license can be issued by the National Health and Medical Research Council (NHMRC) for the use of embryos. She proposed that prior to a license being issued to a research entity that allows them to use embryos for research purposes there should be an assessment of
The capacity of any scientific advances to be delivered through the public health system and/or to reduce the global disease burden.
Her amendment was soundly defeated – nine senators supported the amendment and fifty opposed it.
Nettle then presented a further two amendments: one aimed at requiring that any stem cell lines derived for research be deposited in a national stem cell bank, and the other requiring that a national stem cell bank be established within two years. These too were defeated, but by a much smaller margin -- 37 to 24 in the first instance and 34 to 30 in the second. These amendments were intended to give effect to Recommendation 47 of the Lockhart Review report that ‘A national stem cell bank should be established’ (Lockhart Committee, 2005: 181). The aim of this recommendation was to deal with concerns about the potential for the privatisation and the commercialisation of this research as well as ensuring transparency as to what cell lines were being created and by whom. A publicly funded national stem cell bank would be one way of tracking the creation and development of stem cell lines derived in Australia as well as ensuring they were available to the domestic and international research community.
A publicly run and funded stem cell bank could ensure fair access to everyone. Arrangements between governments that limited the capacity to attach expensive transfer agreements to stem cell lines would be one mechanism to facilitate this (Lockhart Review, 2005: 149). The Lockhart Committee found that ‘although commercialisation of therapeutic products would be an outcome if research is successful, stem cell banks help to keep research resources in the public domain’ (Lockhart Committee, 2005: 181). Stem cell banks exist or are being planned in countries including the United Kingdom, the United States, Sweden, China, South Korea and the United Arab Emirates.
The United Kingdom Stem Cell Bank, for example is funded by the United Kingdom’s Medical Research Council and Biotechnology and Biological Sciences Research Council. It began operating officially in January 2003 and will ‘curate ethically sourced, quality controlled adult, fetal and embryonic stem cell lines and will be open to academics and industrialists from the United Kingdom and overseas’ (Lockhart Review, 2005:143). The bank does charge users but the charges are based on the nature of the user ranging from marginal cost recovery for academic researchers to full cost recovery for commercial users (Lockhart Review 2005: 144).
If such a bank were established in Australia, it would also be possible for mechanisms to be put in place to enable community involvement in determinations concerning which stem cell lines were established. A submission to the Lockardt Committee argued that this is particularly important
because banking might allow closer matching (and hence likely more effective therapies) for certain ethnic or minority groups (eg Aboriginal and Torres Strait Islander Australians) who might otherwise be disadvantaged if research and future therapies are reliant on the usual sources of donated embryos (given they are currently provided only by those who have undergone ART) or internationally-established lines (such as those in the UK) (Ankeny, Dodds, Rogers, Submission LRC515, 2005)
In the Prime Minister’s press release of 23 June 2006 he indicated support for the establishment of a National Stem Cell Bank, however, it has so far not been included in the amending bill.
Establishing a National Stem Cell bank with mandatory deposit of those stem cell lines derived under license from the NHMRC would have the effect of making stem cell lines developed in Australia available for public use. It is one thing to ensure the benefits flow back to the Australian community, but what are the obligations to the global community more broadly and the developing world in particular?
While the Patterson Bill makes provision in proposed subsection 23C of the PHC Act to enable researchers to access embryonic stem cell lines from overseas provided they were derived in a manner consistent with Australian legislative requirements, until a national stem cell bank is established the reciprocal capacity to access and export human embryonic stem cell lines derived in Australia, also allowed in section 23C, will be ad hoc and commercially driven. Monash Researchers indicated in their submission to the Senate Inquiry that the ‘international exchange of stem cell resources should indeed be facilitated’ noting that it ‘is a global research priority to derive pluripotent stem cells with a broad range of diseases for scientific study’ (Senate Committee on Community Affairs, 2006: 39). Sharing stem cell lines derived in Australia with the global community, is not directly addressed in the legislation except through section 23C and some argue that the failure to ensure the non-commercialisation of these cell lines will be detrimental to any future global resource sharing arrangements. The failure to establish a National Stem Cell Bank would seem to be inconsistent with Australia’s commitment to the International Stem Cell Forum which was established in January 2003. The forum is aimed at establishing Stem Cell Debate an international collaboration of research laboratories from member countries working with human embryonic stem cell lines contributed by those members (Lockhart Review, 2005: 143).
There is a growing sense that the capacity to manipulate genes, of which the creation of stem cells is just one aspect, must be understood in light of the view that genes belong to all humanity. The Universal Declaration on the Human Genome and Human Rights (1997) (UDHGHR) states in Article 1 for instance that:
The human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity. In a symbolic sense, it is the heritage of humanity.
Similarly, the Human Genetics Commission of the United Kingdom has suggested we adopt a concept of genetic solidarity and altruism when dealing with these technologies (Human Genetics Commission, 2002: 9).
There are several international instruments dealing with these concerns that stem from an ideology of genetic interconnection. Nikolas Rose and Carlos Novas call this a kind of ‘biological citizenship’ (Novas and Rose, 2005) but one might also call it a genetic citizenship. Rose sees in this a new legal species of human rights based on simple existence – one that must be afforded to all humanity and cannot be realised through the structure nationhood (Rose, 2001, 18).
The UDHGHR was the first in a series of international instruments that sought to directly address the new genetic order. Most recently we have the Universal Declaration on Bioethics and Human Rights (UDBHR), concluded by UNESCO in 2005. It is written in broad and general terms, but it pays particular regard to our genetic interconnection. Article 16, for instance, titled ‘Protecting Future Generations’, requires that ‘The impact of life sciences on future generations, including on their genetic constitution, should be given due regard.’ Article 17, titled ‘Protection of the Environment, the Biosphere and Biodiversity’, requires that ‘Due regard is to be given to the interconnection between human beings and other forms of life, to the importance of appropriate access and utilization of biological and genetic resources, to respect for traditional knowledge and to the role of human beings in the protection of the environment, the biosphere and biodiversity.’
Perhaps most importantly however, Article 15 requires that ‘Benefits resulting from any scientific research and its applications should be shared with society as a whole and within the international community, in particular with developing countries.’
While the Declaration is not a treaty it does represent an aspirational statement produced under the auspices of UNESCO and after significant consultation with member states. It has been criticized for its attempt to meld human rights and bioethics, some regarding the former as positive declarations of what is obligatory and the latter as exploratory and speculative in nature (Wolinsky, 2006: 355). However, there are others who see it as a necessary corrective to the lack of attention to providing ethical guidelines for the newly globalised and internationalized scientific research framework.
Unless developed nations, such as Australia, set up legal structures to ensure that stem cell research is made available to the public and can be shared with the global community we will fail in our responsibility as global genetic citizens. This is why the amendments that Kerry Nettle proposed to the Patterson Bill had the potential for a profound effect. Once legislation is passed that enables this new research phase on stem cells to progress, it is important that the parliament and the Prime Minister move quickly to establish a national stem cell bank with relevant safeguards to ensure, transparency, public accessibility and community participation. It is unfortunate that a national stem cell bank was not part of these recent amendments and action needs to be taken to rectify this omission before too many stem cell lines have been privatised and the benefits of the research commericalised.
Isabel Karpin is a senior lecturer in the Faculty of Law, University of Sydney.
References
Ankeny, R., Dodds, S. and Rogers,W. (2005) “Submission 515”, Lockhart Review Committee Human Genetics Commission, Inside Information: Balancing Interests in the Use of Personal Genetic Data May, 2002 Lockhart Committee, Legislation Review (2005): Prohibition of Human Cloning Act 2002 and Research Involving Human Embryos Act 2002, Legislation Review Committee Reports (2005) Prime Minister’s Press Release ‘Lockhart Review’ <http://www.pm.gov.au/news/media_Releases/media_ Release1989.html> Rose, N (2001), ‘The Politics of Life Itself’, Theory Culture and Society 18, 1-30 Rose, N & Novas, C (2005) ‘Biological citizenship’, in Ong, A & Collier, S (Eds), Global Assemblages: Technology, Politics and Ethics as Anthropological Problems, Malden MA Blackwell Publishing Senate Committee, Community Affairs ‘Legislative Responses to Recommendations of the Lockhart Review’ October 2006, The Senate, Commonwealth Of Australia Wolinsky, H (2006), ‘Bioethics for the World’, European Molecular Biology Organization Reports, 7, 4
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