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Monday, 11 November 2002
Page: 5835

Senator McLUCAS (11:14 AM) —The Prohibition of Human Cloning Bill 2002 is designed to deliver one part of a national regulatory system that will address issues surrounding human reproduction and the use of human embryos. It is designed to prohibit human cloning and other practices that are unacceptable to our society. The bill was referred to the Senate Community Affairs Legislation Committee, along with the Research Involving Embryos Bill 2002, in August. Both bills are the subject of issues with significant ethical and moral dimensions. As a result, many senators and most of the witnesses came to the committee with strongly held views which they wished to put. Given the issues, this was only to be expected, but I have to put on the record that I was disturbed at the way some of our colleagues treated some of the witnesses. This included some very personal attacks and unfair questioning of the motives of some of those who gave evidence. I am also concerned that there are references in some of the additional material to the chair's report which does not accurately represent the intent of some of the witnesses to the committee.

It was made clear to the members of the committee that the chair's report would not make recommendations to the Senate, following similar practice for other bills where a conscience vote was adopted. Rather, it was the intent of the report to `balance the major issues and arguments relating to the subject of the bill without attempting to formulate conclusions or recommendations'. Further, it was also made clear that senators were welcome to make additional commentary through supplementary reports to the chair's report. That is why I was somewhat disappointed that, following the distribution of the chair's draft report, a number of senators sought amendments which significantly changed the balance achieved in the original draft report. Some of the proposed amendments were useful additions and have been included, but the intent of many of the proposals was to skew the report's balance towards one side of the debate. This, I believe, was unfortunate and I note the chair's disappointment in her press release on the release of the report when she made reference to the fact `every effort had been made to accommodate much more of their views than would have been preferred'.

I wish to place on record my recognition of the efforts of the chair of the committee, Senator Sue Knowles. Senator Knowles managed the often divergent views impartially, both during the hearings and in the production of the final report. Additionally, I acknowledge the work of the committee secretariat for their professionalism as well as the long hours they put in during and following the hearings.

I was also disappointed to read Senator Harradine's criticism of the inquiry process in his supplementary comments, given the initial understandings that I believe we all had. With these comments, however, I do commend the chair's report and the supplementary report in favour of the legislation to the Senate.

I now return to the bill. It is important to remember that this bill has been drafted as a result of the decision of COAG of 5 April this year and as such has the support of all the states and territories. It should be noted that the statement of COAG, which is reflected in the two bills, is relatively, in an international sense, conservative. It explicitly and intentionally prohibits a number of practices that are currently legal overseas. This, I believe, is not well understood and it needs to be recognised more broadly in the community. The COAG communique specifically outlines the practices that are to be prohibited. The bill before us faithfully delivers that intent. The COAG statement accurately reflects community opinion on the issue of human cloning for reproductive purposes. For nearly everyone the concept of human reproductive cloning is simply abhorrent. It raises issues of identity, autonomy and kinship. We have a fear of eugenics, the breeding out of specifically engineered inherited characteristics. And beyond the issues of our moral and ethical opposition to reproductive cloning, the science is simply not proven. For these reasons the bill should—and I believe will—be supported.

I do not intend to cover these issues but rather focus on a number of the provisions of the legislation that are of interest. The COAG communique also provides:

The prohibited practices will be comprehensively reviewed within three years of the nationally consistent legislation taking effect, taking into account changes in technology, the potential therapeutic uses for such technology and any changes in community standards.

The bill conveys that principle in clause 25.

Prior to the original bill being split the NHMRC was required to cause an independent review of the act. This was changed in the new bill requiring the minister, with the agreement of the states, to select the individuals to conduct the review. Given that the same people will conduct the review of both acts—as they will be, I hope, at that time— the change seems irrelevant. In part, the COAG statement recommending a review is in recognition of areas of research that are expressly prohibited by the legislation but for which there is some opinion that they will bring desirable health outcomes for certain individuals.

Clause 15 of the bill creates an offence for creating or developing a human embryo containing genetic material provided by two or more people. For most of us, the notion of an individual having more than two genetic parents is unreal, perhaps impossible and, more likely, offensive. However, as the explanatory memorandum explains, this technique will intentionally prohibit the very new ART technique of cytoplasmic transfer. Cytoplasmic transfer involves the addition of some or all of the cytoplasm from a healthy donor egg into the patient's egg prior to fertilisation. The aim of such a procedure is to overcome certain problems that the patient has in achieving pregnancy, or to avoid some heritable disease. Due to the presence of mitochondria in the cytoplasm, which contain small amounts of DNA, the technique may introduce DNA from a third person. However, it needs to be stressed that the nucleus of the cell contains DNA from only two people. The mitochondrial DNA does not code for genes or have a bearing on the integrity of the embryo. This is not a technique that creates some form of genetic monster.

Professor Robert Jansen gave evidence to the Senate inquiry into the bills and suggested that cytoplasmic transfer may have potential benefits for infertile women or women carrying genetic material causing disease. In his evidence to the committee he said:

To me, it means that I will not to be able to investigate cytoplasmic transfer in the part it plays both in families that suffer from rare but unable to be treated in any other way mitochondrial genetic diseases and in why older women from about the age of 35 completely otherwise unexplained infertility begins to occur. By the early 40s, that affects the great majority of women—in other words, well before the menopause. IVF is making no inroads into that at the moment, whereas in every other cause of infertility spectacular inroads have been made. We cannot do so unless we understand which cytoplasmic factor is the limitation. We do not know whether that is the mitochondrial DNA itself or some other catalytic component of the cytoplasm of the egg that is missing. Until we can do that investigation, we will not be able to answer that question and advance the management of such unexplained infertility in women in their latter 30s.

Further, Professor Jansen suggested that there had not been community debate about the possible health benefits of the technique and as such the technique would be prohibited with a lack of community understanding. He advised the committee that at least 15 children have been born in the United States as a result of the procedure and that, whilst he advised that cytoplasmic transfer was not ready for clinical practice, it should be the subject for scientific and clinical investigation. It should be noted that cytoplasmic transfer technology is permitted in a number of countries, including the United States, Italy, Israel and Taiwan. The NHMRC responded by saying that the technique of cytoplasmic transfer was relatively new and controversial and that the clinical safety and efficacy of the practice was not established. Their views are not totally in conflict. The review process established in clause 25 will allow for thorough examination of the technique's ability to assist women who carry defective mitochondrial DNA.

With respect to the review that is required, I remind the Senate that the supplementary report in favour of the legislation—signed by Senator Webber, Senator Stott Despoja and me—recommends an additional term of reference be applied to the review to investigate the operations and applicability of the UK stem cell bank. The UK has established such a stem cell bank to ensure that researchers can access stem cell lines. It was suggested that such a facility might minimise the number of embryos required to develop new stem cell lines.

Clause 13 of the bill makes it an offence to create or develop a human embryo other than by fertilisation. This clause specifically prohibits embryo splitting, parthenogenesis and, importantly, somatic cell nuclear transfer. Mainly because of its contentious nature, somatic cell nuclear transfer was an area of research that engaged the committee during the inquiry. The aim of the technique is to produce a cell transplant product that is immunologically identical to the donor of the adult cell thus avoiding rejection by creating a human embryo clone to derive stem cells that could be used for patient-specific cell therapies. BresaGen, a company involved in the therapeutic application of embryonic stem cell technology, advised the committee:

There are a large number of scientific hurdles to be overcome before this can be considered a feasible therapy, and using human eggs as the recipient cells is technically infeasible since about 50-100 eggs would be required for each successful reprogramming event.

The company further stated:

... about 10 women would have to donate eggs for each single patient product.

I agree with BresaGen's conclusion that the creation of such a large number of eggs is `ethically unacceptable as well as impractical'. It was therefore concerning that a number of witnesses pursued the issue of hyperstimulation of women in order to produce large numbers of eggs. Ms Riordan, the Executive Director of the Respect Life Office of the Catholic Archdiocese of Melbourne, claimed that the legislation did not address the issue. This is simply not the case. Hyperstimulation is a dangerous and unacceptable practice and, whilst not explicitly banned in the bill, the incentives to hyperstimulate are prohibited. The bill expressly prohibits somatic cell nuclear transfer. It bans commercial trade in human eggs, sperm and embryos, and it bans the creation of embryonic stem cell lines from somatic cell donors. Professor Illingworth advised the committee that it was simply not possible in most patients to hyperstimulate, as for most women `the number of eggs is primarily dictated by the number of eggs already growing in the ovary at the time of starting treatment with fertility drugs'. The number of eggs cannot be altered.

For a small number of younger women, current practice provides that a lesser dose of the fertility drugs be used. Professor Illingworth advised the committee that to use the regular dose would put these patients at risk of serious medical conditions. This would be dangerous in itself, but it would also open up the potential for litigation against clinics for malpractice in the event of medical complications. Further, the Reproductive Technology Accreditation Committee guidelines prohibit such unethical and medically unsound practice as hyperstimulation. Professor Jansen advised the committee:

... it is not medically possible to vary the number of eggs that respond to stimulation upwards at all and it is not possible downwards without compromising the chance of success for the woman.

The clear message is that there are good medical reasons for the current number of ova that are utilised for IVF treatment. Hyperstimulation of women is unacceptable and the bill ensures that the practice will not be allowed. The issues surrounding both this and the Research Involving Embryos Bill are, as I have said, contentious and value laden. During the hearings, much was made of the motivations of various witnesses. Whilst some of these assertions were misguided, the result is that members of the community are tentative about believing information that others say is motivated by other than worthy reasons.

I acknowledge the work of the NHMRC in presenting information that is accurate, but their motives too were questioned during the course of the inquiry. I believe that there is a need for better mechanisms to educate and involve the public in bioethical debates. We need to ensure that the public has access to information, that they are educated about the issues in language they understand and that they are able to make their voices heard on the issues.

For some years now, under Presidents Clinton and Bush, the United States has had a presidential commission on bioethics. It is a model that we could well adopt here. The US commission on bioethics provides a forum for national discussion and exploration of bioethical issues. It is charged with exploring the ethical and policy questions related to developments in biomedical science and technology, and assessing public concerns about these developments. The commission is guided by the need to articulate and present a variety of views rather than by the need to reach a single consensus opinion. Such an institution, properly constituted and, importantly, properly representative of the breadth of views existing in the debates, could help facilitate a greater understanding of bioethical issues and better public debates here in Australia. In conclusion, the Prohibition of Human Cloning Bill 2002 provides conservative and nationally consistent legislation that delivers on the COAG agreement of earlier this year and it should be supported.