Which bank? A guardian model for regulation of embryonic stem cell research in Australia A McLennan* In late 2005 the Legislation Review: Prohibition of Human Cloning Act 2002 (Cth) and the Research Involving Human Embryos Act 2002 (Cth) recom- mended the establishment of an Australian stem cell bank. This article aims to address a lack of discussion of issues surrounding stem cell banking by suggesting possible answers to the questions of whether Australia should establish a stem cell bank and what its underlying philosophy and functions should be. Answers are developed through an analysis of regulatory, scientific and intellectual property issues relating to embryonic stem cell research in the United Kingdom, United States and Australia. This includes a detailed analysis of the United Kingdom Stem Cell Bank. It is argued that a “guardian” model stem cell bank should be established in Australia. This bank would aim to promote the maximum public benefit from human embryonic stem cell research by providing careful regulatory oversight and addressing ethical issues, while also facilitating research by addressing practical scientific concerns and intellectual property issues. INTRODUCTION Human embryonic stem cells (hESC) are able to self-renew and generate different cell types, making them potential tools for repairing diseased or damaged tissues. Research in this field of “regenerative medicine” has potential applications in treating conditions such as heart disease, neurodegenerative disorders and diabetes.1 Human embryonic stem cells are isolated from the inner part of an embryo five to six days after fertilisation.2 The cells must then be allowed to multiply to form a population of stem cells. Growth occurs on a layer of “feeder cells” which provide factors required for maintenance of the hESC.3 The early hESC lines were grown on mouse cells. Techniques for using human feeder cells have been developed and the use of synthetic matrices is being investigated.4 “Totipotent” stem cells can give rise to any cell type and can also form the placenta and tissues surrounding an embryo.5 Thus they can independently generate a complete embryo.6 “Pluripotent” hESCs are isolated slightly later in development. They have the capacity to form any cell type in the body, but not a complete embryo.7 * LLB (Hons), BSc (Cell and Molecular Biology); Tipstaff to the Hon Justice NHM Pain, Land and Environment Court of New South Wales. This article is based on a law honours thesis for the ANU College of Law. The author would like to thank Dr Matthew Rimmer for supervising this project and Associate Professor Dr Ian Kerridge for comments on an earlier draft. Correspondence to: [email protected]. 1 Australian Stem Cell Centre, Annual Report 2004 (2004) p 10, http://www.ncss.edu.au viewed 21 September 2005. 2 Australian Stem Cell Centre, n 1, p 11. 3 See Conley BJ et al, “Derivation, Propagation and Differentiation of Human Embryonic Stem Cells” (2004) 36(4) International Journal of Biochemistry & Cell Biology 555 at 556-557. 4 Conley et al, n 3; Australian Stem Cell Centre, n 1, p 19. 5 Medical Research Council, Interim Code of Practice for the UK Stem Cell Bank (2005) p 46, http://www.mrc.ac.uk/index/ public-interest/public-consultation/public-stem-cell-consultation viewed 11 July 2005. 6 Medical Research Council, n 5. 7 Medical Research Council, n 5, p 45. (2007) 15 JLM 45 45 © McLennan A cell “line” is a population of cells of a particular type, such as pancreatic cells, that retain their characteristics when allowed to multiply in culture.8 Cell lines are sources of consistent, well-characterised cells9 used by scientists for research. Pluripotent cells can be caused to form different cell types, a process called “differentiation”. Differentiated cell lines have been developed, including heart, liver and brain cells. Human embryonic stem cells can be derived from embryos left over from assisted reproductive technology (ART) treatment (excess ART embryos). Alternatively, embryos can be created specifically for hESC derivation. This involves taking the nucleus from an adult cell and transferring it to an egg which has had the nucleus removed, then stimulating the egg to divide and form an embryo (somatic cell nuclear transfer or SCNT). This is called “therapeutic cloning” to distinguish it from cloning for the purpose of creating a human being, called “reproductive cloning”. Therapeutic cloning aims to generate hESC with identical DNA to the donor of the adult cell. In Australia, the use of embryos in research is governed by the Research Involving Human Embryos Act 2002 (Cth). Until recently, all cloning was outlawed by the Prohibition of Human Cloning Act 2002 (Cth), s 19. An independent review of the operation of these two Acts was undertaken by the Legislation Review Committee in late 2005. As this Committee was chaired by the late Justice John Lockhart, the review is known as the Lockhart Review. This Review was required to report on the scope and operation of these Acts, including the applicability of establishing a National Stem Cell Bank (National Bank).10 The report from this inquiry, the Lockhart Report, recommended that a “national stem cell bank should be established”.11 In December 2006, Parliament passed an Act designed to implement the Lockhart recommenda- tions.12 Among other things, this Act amends the Research Involving Human Embryos Act 2002 (Cth) so that therapeutic cloning is permitted under licence, as recommended by the Lockhart Report.13 The Act also provides that the Minister must prepare a report on “the establishment of a National Stem Cell Centre and a national register of donated ART embryos”.14 This article focuses on the issue of establishing a stem cell bank (bank) in Australia to store and manage cells for use in research. The world’s first publicly funded bank was established in the United Kingdom in 2003.15 There is a bank in Sweden and plans to establish a Spanish bank.16 A global bank was established in South Korea in late 2005.17 However, a key scientist in this project, Dr Woo Suk Hwang, was subsequently found to have engaged in serious scientific fraud and so the future of this bank appears uncertain. 8 See Medical Research Council, n 5, p 34. 9 Medical Research Council, n 5, p 41. 10 Research Involving Human Embryos Act 2002 (Cth), s 47(4)(d); Prohibition of Human Cloning Act 2002 (Cth), s 25(4)(d). 11 Legislation Review Committee, Legislation Review: Prohibition of Human Cloning Act 2002 and Research Involving Human Embryos Act 2002 (2005), Recommendation 47. 12 Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006 (Cth). 13 Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006 (Cth), s 22; Legislation Review Committee, n 11, Recommendation 23. 14 Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006 (Cth), Sch 2, Item 47B (1)(a). 15 National Institute for Biological Standards and Control, The UK Stem Cell Bank at NIBSC: An Overview, http://www.nibsc.ac.uk/divisions/cbi/stemcell.html viewed 11 July 2005. 16 Bosch X, “Spanish Stem Cell Battle” (2003) The Scientist, http://www.the-scientist.com/news/20031027/04 viewed 26 October 2005; CellNews, Sweden’s Stem Cell Success (2002), http://www.geocities.com/giantfideli/CellNEWS_Swedens_ stem_cell_success.html viewed 7 August 2005. 17 BBC News, International Stem Cell Bank Opens (2005), http://news.bbc.co.uk/2/hi/health/4355722.stm viewed 26 October 2005. © 46 (2007) 15 JLM 45 Which bank? A guardian model for regulation of embryonic stem cell research in Australia By contrast, “registries” list the source and characteristics of hESC lines. The United States National Institutes of Health (NIH) maintains a hESC registry18 which will be analysed below. The development of banks and registries can be seen to arise from researchers’ need to comply with regulatory requirements and collaborate in their research.19 In discussions about stem cell banking, assumptions are commonly made about the functions a bank would perform. For example, some have assumed the role of a bank would be to provide cells for treating patients. By contrast, scientists tend to assume that the role of a bank would be to provide cells for their research. A range of possible functions for a stem cell bank are set out in Table 1. TABLE 1 Possible functions of a stem cell bank Function Explanation Registration of stem • Lists available cell lines including their origin and derivation method cell lines Curation and • Collects cell lines distribution of cell • Distributes cells to scientists lines for research Characterisation and • Characterises and compares curated cell lines Quality Assurance • Conducts tests to assure quality of cells International Projects • Participates in collaborative International Projects Regulation of stem cell • Assesses applications to deposit cell lines and use banked cell lines use Management of • Negotiates standard terms of access to banked cell lines intellectual property • Other IP policy and management activities Provision of medical • Provides cells for treating patients services These functions can be combined to form various models for a stem cell bank. Possible models for an Australian bank are set out in Table 2. At its most simple, a bank could comprise an online registry (“registry” model). A “research hub” model would aim to advance hESC research by curating and distributing quality-controlled cells. A “guardian” model would aim to promote the maximum public benefit from hESC research by providing careful regulatory oversight and addressing ethical issues, while also facilitating research. A “therapeutic resource” model would aim to assist the treatment of patients. This kind of bank is not currently feasible but may become relevant when stem cell research has progressed further.