[1] Nicol, D., Chalmers, D., & Gogarty, B. 'Regulating biomedical advances: embryonic stem cell research' in Macquarie Law Journal (2002) Vol 2 p31-59
[2] Research Involving Human Embryos Act 2002 (Cth) and the Prohibition of Human Cloning Act 2002 (Cth)
[3] Wilmut, I. Et al. ‘Viable offspring derived from Fetal and Adult Mammalian Cells’ (1997) Nature 385, 810-813.
[4] Ibid.
[5] Thomson, James A., Itskovitz-Eldor, Joseph, Shapiro, Sander S., Waknitz, Michelle A., Swiergiel, Jennifer J., Marshall, Vivienne S., and Jones, Jeffrey M. ‘Embryonic stem cell lines derived from human blastocysts’ Science, (1998) 282, 1145-1147
[6] National Institutes of General Medical Sciences, ‘Workshop on the basic biology of mammalian stem cells’, 9-10 June 2002, Maryland, < http://www.nigms.nih.gov/news/reports/stemcellworkshop.html>
[7] I.e. drugs could first be tested on such cell lines and only those found to be safe and appearing to have beneficial effects in the cell line would then graduate to further laboratory testing on animals and human subjects
[8] Spiegel, Allen (M.D) and Fischbach Gerald (M.D), ‘Testimony on the Promise of Human Pluripotent Stem Cell Research’ before the United States Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies, April 26, 2000 <http://www.hhs.gov/asl/testify/t000426a.html> at 10 October 2002
[9] Ms Royles, Coalition for the Advancement of Medical Research in ‘Community Affairs Legislation Committee: Research Involving Embryos and Prohibition of Human Cloning Bill 2002: Discussion’, < http://parlinfoweb.aph.gov.au/piweb/Repository/Commttee/Commbill/Linked/1944-2.PDF> at 17 September 2002
[10] ibid
[11] The Royal Society (UK) Stem Cell Research and Therapeutic Cloning: An Update No.4 (Nov. 2000), < http://www.royalsoc.ac.uk/templates/statements/StatementDetails.cfm?statementid=123> at 10 October 2002
[12] Gene Technology Act 2000 (Cth) – s192b; Metherell M and Smith D., ‘Stemming the tide’ , The Sydney Morning Herald 02 March 2002
[13] House of Representatives Standing Committee on Legal and Constitutional Affairs, Human Cloning: scientific, ethical and regulatory aspects of human cloning and stem cell research Commonwealth of Australia: August 2001.
[14] Parliament of Australia, Bills Digest No. 17 2002-03: Research Involving Embryos and Prohibition of Human Cloning Bill 2002, Department of the Parliamentary Library at http://www.aph.gov.au/library/pubs/bd/2002-03/03bd017.htm
[15] House of Representatives Standing Committee on Legal and Constitutional Affairs 'Human Cloning: scientific, ethical and regulatory aspects of human cloning and stem cell research' Commonwealth of Australia: August 2001 at 12.12; The relevant powers relating to import and export of human material, patenting, trade and commerce, corporations and external affairs (see Commonwealth of Australia Constitution Act (1900) ss51(i), (xviii), (xx), (xxix))
[16] House of Representatives, Research Involving Embryos and Prohibition of Human Cloning Act 2002 – Explanatory Memorandum, 27 June 2002 <http://scaleplus.law.gov.au/html/ems/0/2002/0/20020627resem.htm> at 24 August 2002
[17] Gene Technology Act 2000 (Cth)
[18] The Research Involving Embryos and Prohibition of Human Cloning Bill 2002 was introduced into Federal Parliament on 27th June 2002. The Bill was debated by Parliament during August and on 29th August 2002 members used a free vote to split it in two so that research involving embryos and the prohibition of human cloning be treated separately – (See National Health & Medical Research Council, Splitting of the Research Involving Embryos and Prohibition of Human Cloning Act 2002 at http://www.nhmrc.gov.au at 7 September 2002
[19] 5th December 2002
[20] Commonwealth, Senate Committee Hansard, Senate, 29 August 2003
[21] Which occurred on 19 December 2002 for both Acts
[22] Research Involving Human Embryos (New South Wales) Act 2003; Prohibition on Human Cloning and other Prohibited Practices (New South Wales) Act 2003; Health Legislation (Research involving human embryos and prohibition of cloning) Act 2003 (Victoria); Research Involving Human Embryos Act 2003 (South Australia); Prohibition of human cloning Act 2003 (South Australia); Human Embryonic Research Regulation Act 2003 (Tas); Human Cloning and Other Prohibited Practices Act 2003 (Tas); Research Involving Human Embryos and Prohibition of Human Cloning Act 2003 (Qld)
[23] Human Reproductive Technology Amendment Bill 2003 (W.A) and Human Reproductive Technology Amendment (Prohibition of Human Cloning) Bill 2003 (W.A.)
[24] eg. New South Wales
[25] eg. South Australia, Queensland
[26] eg. Victoria’s Acts in fact amend the Infertility Treatment Act 1995 (Victoria)
[27] Note the Commonwealth Acts override any inconsistent State/Territory laws
[28] Research Involving Human Embryos Act 2002
[29] ibid s21(3)(b)
[30] specifically ss 21(3)(b), 24(1)(c) and 24(3)
[31] Communiqué of the Leaders Forum of 29 August 2003, on Queensland Premier's website <http://www2.premiers.qld.gov.au/about/igr/communiques/ldrs290803.htm> at 10 October 2003; personal email to author on behalf of the WA0 Government dated 2 October 2003
[32] Committee to Revise the Ethical Guidelines on Assisted Reproductive Technology (CREGART) ‘Report on Protocols to Preclude the creation of embryos specifically for research purposes’; National Health and Medical Research Council ‘Report to the Council of Australian Governments on the adequacy of supply and distribution for research of excess assisted reproductive technology embryos by the National Health and Medical Research Council’
[33] BresaGen Limited, Position Paper, http://www.bresagen.com.au/news/positionpaper.html, September 2002
[34] Note Senator Harradine’s motion for the reports to be revealed in the Senate on 28 October 2003
[35] Research Involving Human Embryos Act 2002 (Cth) s25(1)(b); and s25(2) (which list the exceptions)
[36] Ibid ss 11 & 12; s26(1)
[37] Ibid s28 (also see s31 for the details of the persons who will make up the NHMRC Licensing Committee)
[38] ibid s39(3)
[39] ibid s36 (3)(c)
[40] ibid s36 (4)
[41] National Health and Medical Research Council, ‘Report for the NHMRC Licensing Committee for the period 19 December 2002 to 31 March 2003’, Commonwealth of Australia 2003 at www.nhmrc.gov.au
[42] Ibid at p10
[43] The Research Involving Human Embryos Act Regulations 2003 (Cth) at http://www.austlii.edu.au/cgi-bin/download.cgi/download/au/legis/cth/consol_reg/riher2003456.rtf
[44] National Health and Medical Research Council, ‘Report for the NHMRC Licensing Committee for the period 19 December 2002 to 31 March 2003’, Commonwealth of Australia 2003 pp 12-13 <www.nhmrc.gov.au> at December 2003
[45] pursuant to s16(3)(a) of the RIHE Act
[46] pursuant to s21(4)(c) of the RIHE Act
[47] pursuant to s34(2)(a) of the RIHE Act
[48] Nobel, T. 'Embryo research go ahead in weeks' The Age, 3 January 2004 <http://www.theage.com.au/articles/2004/01/02/1072908911785.html> at 3 January 2003; and Nobel, T. 'Scientists prepare for stem cell experiments under eye of cloning police' Sydney Morning Herald, 3 January 2003 <http://www.smh.com.au/articles/2004/01/02/1072908905377.html> at 5 January 2004
[49] Ibid
[50] s24 (2)(a) & (b)
[51] National Health and Medical Research Council, Ethical Guidelines on Assisted Reproductive technology 1996, Commonwealth of Australia, <http://nhmrc.gov.au/publications/pdf/e28.pdf> at 5 January 2003
[52] ibid at 3.1.3
[53] ibid at 3.1.2
[54] ibid at 3.1.2
[55] for example, Monash IVF at http://www.monashivf.edu.au; and The Reproductive Medical Unit at University of Adelaide, <http://www.repromed.com.au/DONOR_SPERM.html > at 4 January 2004
[56] For example, The Reproductive Medicine Unit at the University of Adelaide requires 2 counselling sessions about such issues prior to giving consent to donate embryos for research purposes
[57] IVF Australia - NSW <http://www.ivf.com.au/htmlpages/calendar.html> at 4 January 2004
[58] Note however that in the Monash IVF fact sheet ‘Frozen Embryo Storage Options’, <http://www.monashivf.edu.au/library/factsheets/frozen_embryo.html>, which refers to ‘The NHMRC Ethical guidelines on the use of reproductive technology in clinical practice and research 2003’ which, in fact, only exists in draft format
[59] Kovacs, Gabor T; Breheny, Sue A; and Dear, Melinda J. ‘Embryo donation at an Australian university in-vitro fertilisation clinic: issues and outcomes’ (2003) MJA 178 (3) 127-129, <http://www.mja.com.au/public/issues/178_03_030203/kov10329_fm.html> at 5 January 2004
[60] Ibid
[61] National Health and Medical Research Council, ‘Ethical guidelines for the use of reproductive technology in clinical practice and research: draft for public consultation’ Commonwealth of Australia: February 2003
[62] ibid at 16.2.7
[63] NHRMC National Statement on research involving humans, Part 1 – Principles of Ethical conduct, section 1.7 < http://nhmrc.gov.au/publications/humans/part1.htm#Ethical> at 11 January 2004
[64] Infertility Treatment Act 1995 (Vic); Reproductive Technology Act 1988 (SA); Reproductive Technology (Code of Ethical Clinical Practice) Regulations 1995 (SA); Reproductive Technology (Code of Ethical Research Practice) Regulations 1995 (SA); Human Reproductive Technology Act 1991 (WA)
[65] Standing Committee on Legal and Constitutional Affairs, House of Representatives, Parliament of Australia, Human Cloning: Scientific, Ethical and Regulatory Aspects of Human Cloning and Stem Cell Research (August 2001) at 8.17-8.36 and 8.41-8.67.
[66] Research Involving Human Embryos Act 2002 (Cth), s7
[67] National Health and Medical Research Council, ‘How to decide when an excess ART embryo is alive or dead’ < http://nhmrc.gov.au/embryo/excess.htm> at 12 August 2003
[68] Ibid
[69] Giz Watson ‘Briefing Notes: Greens Position on Proposed Laws Governing Research on Embryos in Western Australia’, <http://www.mp.wa.gov.au/giz-watson/speeches/hrepro.html> at 12 December 2003
[70] member for the WA Greens
[71] ibid
[72] It appears that these statements were an interpretation of figures provided in the Western Australian Department of Health’s ‘Background Briefing: the number of embryos available for research’ which was prepared in relation to the WA Human Reproductive Technology Amendment Bill 2003. In fact, the briefing paper makes no ‘70%’ reference but rather makes the point that at least 30% of embryos would not survive the transition from storage (i.e. thawing), and only a proportion of those that do survive develop into the blastocyst stage.
[73] Research Involving Human Embryos Act 2002 (Cth) - s47(1); Prohibition of Human Cloning Act 2002 (Cth) - s25
[74] Prohibition of Human Cloning Act 2002 (Cth) - s8
[75] Costa Rican draft resolution A/C.6/58/L.2 - This proposal is sponsored by Costa Rica and strongly backed by the United States and at least 61 other cosponsors (mostly developing nations) see http://www.un.org/law/cod/sixth/58/summary.htm#158.
[76] Belgium draft resolution A/C.6/58/L.8 - This proposal was introduced by Belgium and supported by France, Germany, and more than 20 other nations and called for a ban on reproductive cloning only.
[77] Submitted by the Organization of the Islamic Conference (OIC) see <http://www.un.org/law/cod/sixth/58/summary.htm#158>
[78] 'UN delays cloning vote', The Scientist 7 November 2003, <http://www.biomedcentral.com/news/20031107/08> at 7 November 2003
[79] Sura V & Hagen J ‘Sixth Committee: Legal Cloning Concerns’ in The Criminal Court in United Nations Chronicle (online edition), <http://www.un.org/Pubs/chronicle/2003/issue1/0103p21.html> at 11 December 2003
[80] BioNews 238 (Dec) 'UN to revisit cloning in one year' <www.bionews.co.uk> at 16 December 2003
[81] A bill (Bill C-13) has however been passed by the Canadian House of Commons, but still needs to pass through the Canadian Senate
[82] Bill before parliament to ban cloning see 'Japan allows stem cell research' The Age 14 December 2003 <http://www.theage.com.au/articles/2003/12/14/1071336795092.html> at 16 December 2003
[83] Adapted from European Commission, Survey on opinions from National Ethics Committees or similar bodies, public debate and national legislation in relation to human embryonic stem cell research and use - Vol 1 in EU Member States, September 2003. Information gathered from this, and reference to The Human Fertilisation and Embryology (Research Purposes) Regulations, 2001, (Eng.) SI 2001/188, <http://www.hmso.gov.uk/si/si2001/20010188.htm>; Human Fertilisation and Embryology Act 1990 c. 37.; and The President's Council on Bioethics 'US public policy and the biotechnologies that touch the beginnings of human life: a detailed overview', <http://www.bioethics.gov/background/biotechnology.html> at 12 June 2003
[84] Belgium, Denmark, Finland, Spain, United Kingdom, China, Japan and Singapore
[85] Belgium, United Kingdom, China
[86] Austria, France, Ireland, Italy
[87] Canada, Mexico
[88] Noting that the discussion is limited to only a few examples, and that many other countries may be considered elsewhere
[89] The DHHS regulates research that uses human foetuses or the in vitro fertilization of human ova and is charged with ensuring that researchers follow all laws and regulations put forth at the federal level.
[90] Flannery Ellen J. & Javit, Gail H. ‘Analysis of Federal Laws Pertaining to Funding of Human Pluripotent Stem Cell Research’ in National Bioethics Advisory Commission Ethical Issues in Human Stem Cell Research: Commissioned Papers D-1, D-6 (2000), < http://bioethics.georgetown.edu/nbac/stemcell2.pdf>
[91] Andrews Lori B. ‘State Regulation of Embryo Stem Cell Research’, in National Bioethics Advisory Commission Ethical Issues in Human Stem Cell Research: Commissioned Papers (2000), <http://bioethics.georgetown.edu/nbac/stemcell2.pdf>
[92] Alabama, Alaska, Colorado, Connecticut, Delaware, Georgia, Hawaii, Idaho, Iowa, Kansas, Maryland, Mississippi, Nevada, New York, North Carolina, Oregon, South Carolina, Texas, Vermont, Virginia, Washington, West Virginia, and Wisconsin
[93] Nine states (Florida, Louisiana, Maine, Massachusetts, Michigan, Minnesota, North Dakota, Pennsylvania, and Rhode Island) completely ban the use of IVF embryos for research - the penalties in some of these jurisdictions include imprisonment.
[94] ‘State governor signs controversial law’ MSNBC News, 5 January 2004, <http://msnbc.msn.com/id/3879058/ >
[95] Human Fertilisation and Embryology Act 1990 c. 37 (Eng.) (28 Halsury’s Statutes of England and Wales 289-290 (2001 Reissue)
[96] The Human Fertilisation and Embryology (Research Purposes) Regulations, 2001, (Eng.) SI 2001/188, <http://www.hmso.gov.uk/si/si2001/20010188.htm> at 13 September 2002
[97] ibid
[98] the Human Fertilisation and Embryology Authority (HFEA)
[99] Human Fertilisation and Embryology Act 1990 c. 37 (Eng.), Schedule 2 & 3(1). Note - these licences are good for a maximum period of three years or as specified in the licence. Additionally, the HFEA will only grant a licence if satisfied that the use of the embryo is necessary for the purposes of the research and if the embryo is not to be used for any other purpose. When a researcher submits a proposal for a project, the HFEA chooses a peer group of appropriate academic referees and submits the proposal to that group for review.
[100] Op Cit - HFE Act Schedule 3 s1
[101] Op Cit - HFE Act Schedule 3 s8(3)
[102] Op Cit - HFE Act Schedule 3 s2(1)(c)
[103] Op Cit - HFE Act Schedule 3 s4
[104] Op Cit - HFE Act Schedule 3 s3(1)
[105] For example, ‘relevant information’ has been considered to encompass general information about the type of research that will be performed on the embryo; to be detailed information outlining the specific research project as well as the purposes and objectives of the project; or to include information about two or three specific research projects allowing donors to choose a particular project - see Nuffield Council on Bioethics Stem Cell Therapy: The Ethical Issues, Executive Summary 2000 <http://www.nuffieldfoundation.org/bioethics> at 13 October 2002
[106] Ross, Emma Brits to Relax Stem Cell Research Rules, Opponents Say Move Could Lead to Cloning, Associated Press, 20 December, 2000, < http://www.abcnews.com/sections/living/DailyNews/stemcellThe United Kingdom001220.html>
[107] Department of Health (England), 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) <http://www.doh.gov.uk/cegc/stemcellreport.htm>
[108] Op Cit Ross (at n106); see also see also Human Reproductive Cloning Act 2001 c. 23 (Eng.) (Dec. 4, 2001) which states ‘A person who places in a woman a human embryo which has been created otherwise than by fertilisation is guilty of an offence’ <http://www.hmso.gov.uk/acts/acts2001/20010023.htm>
[109] Department of Health (UK) Stem Cell Results and Progress <http://www.doh.gov.uk/cmo/progress/stemcellresearch/stemcellprogress.htm> at 5 October 2002
[110] European parliament 4/11/2003 'European parliament news report' <http://www2.europarl.eu.int/omk/sipade2?PUBREF=-//EP//TEXT+PRESS+NR-20031104-1+0+DOC+XML+V0//EN&L=EN&LEVEL=2&NAV=X&LSTDOC=N#SECTION3> at 4 November 20
[111] ibid
[112] ibid
[113] Lorenzi, Rosella ‘Italy faces strict embryo laws’ The Scientist: Daily News, 5 December 2003 <http://www.biomedcentral.com/news/20031205/06/> at 5 December 2003
[114] Lorenzi, Rosella ‘Italy approves embryo law’ The Scientist: Daily News 12 December 2003 < http://www.biomedcentral.com/news/20031212/04> at 12 December 2003
[115] Reuters 'French parliament backs human cloning ban', 11 December 2003 <http://www.reuters.com/newsArticle.jhtml?type=topNews&storyID=3979005> at 16 December 2003
[116] ibid - A vote is scheduled in the upper house for February 2004, noting that the French upper legislative body is, like the lower house, said to be ‘dominated by President Chirac's ruling conservative party’
[117] ‘Hope for new source of stem cells’ BBC News, 24 December 2003 at http://news.bbc.co.uk/go/pr/fr/-/1/hi/health/3346063.stm>
[118] Passier, R. & Mummery, C. 'Origin and use of embryonic and adult stem cells in differentiation and tissue repair' in Cadiovascular Research 58 (2003) pp 324-335; Pearson, Helen 'Long -lived stem cells heal heart attacks' Nature: Science Update, 11 August 2003 <http://www.nature.com/nsu/030804/030804-15.html> at 11 August 2003; Farley, Peter 'Inserted gene helps stem cells heal heart' New Scientist.com News service, 11 August 2003, < http://www.newscientist.com/news/news.jsp?id=ns99994039> at 11 August 2003
[119] Stanford University Medical Center 'Bone marrow fusion with nerve cells may repair damage, Stanford researchers say' <http://mednews.stanford.edu/news_releases_html/2003/octrelease/purkinje.htm> at 15 October 2003; 'Doubt cast on adult stem-cell plasticity studies' , AScribe 13 October 2003 <http://www.ascribe.org/cgi-bin/spew4th.pl?ascribeid=20031013.074605&time=09%2030%20PDT&year=2003&public=1> at 13 October 2003
[120] Singer, Emily 'Sound-detecting hair cells grown in lab', New Scientist.com News Service 27 October 2003 < http://www.newscientist.com/news/news.jsp?id=ns99994311 > at 27 October 2003
[121] Cohen, P. 'Human-rabbit embryos intensify stem cell debate' in NewScientist.com (15 August 2003) <http://www.newscientist.com/news/print.jsp?id=ns99994060> at 1 December 2003
[122] Sample, I. & Boseley, S. Human fertility scientists under pressure to rein in unethical work of mavericks in The Guardian 5 July, 2003 <http://education.guardian.co.uk/higher/news/story/0,9830,993077,00.html> at 5 July 2003; Robert, JS & Baylis F., A response to Commentators on ‘Crossing Species Boundaries’ in The American Journal of Bioethics, (3)(3) 2003 <http://bioethics.net/journal/correspondence.php?vol=3&issue=3&art> at 9 December 2003
[123] Fray, P. ‘Dismay at report of implanted human clone’, Sydney Morning Herald 19 January 2004, <http://www.smh.com.au/articles/2004/01/18/1074360636506.html> at 19 January 2004
[124] Nippert, I. 'The pros and cons of human therapeutic cloning in the public debate' in Journal of Biotechnology 98 (2002) pp 53-60; Reiss, M.J. 'Ethical Dimensions of therapeutic human Cloning' in Journal of Biotechnology Volume 98 (2002) pp 61-70