Tuesday, 7 November 2006
Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Bill 2006
My contribution is twofold. First, I wish to address a number of arguments and assertions made in the course of the debate and, secondly, I seek to summarise the major arguments against the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Bill 2006. In short, this is a bill that seeks to legislate to create cloned human embryos for research and their destruction. Before proceeding, however, I seek leave to table a petitioning document that is not in conformity with the standing orders relating to petitions. This document contains 15,820 electronic signatures from all over Australia opposing human cloning, including therapeutic cloning.
I turn first to some incorrect assertions in the debate. It has been suggested that attacks on the members of the Lockhart committee and their recommendations have been personal attacks. There have been serious and genuine critiques of the science, methodology and ethical paradigms employed by the Lockhart committee. A critique is not a personal attack. The angst expressed by supporters of the bill, claiming these attacks are personal, do a disservice to the genuine and legitimate critiques offered by esteemed members of the scientific community and others.
Professor Jack Martin, hailed by then Minister Bishop as one of Australia’s research giants when announcing his appointment to the Human Genetics Advisory Committee, has expressed publicly and repeatedly to the Senate committee that there is no proof of principle about the virtues of embryonic stem cell research. He has cited often, but it seems to have been ignored by many, the remarks of the Lockhart report at page 42:
... at this stage ES cell research has not reached the stage needed to start clinical trials (ie proof of principle of a safe and efficacious treatment in animal models).
This does not constitute an attack on the integrity of the members of the Lockhart review.
It has been stated in this chamber that to claim that this bill will promote further, more radical research, including reproductive cloning, is a reprehensible slur on the advocates of the bill. The sad facts are that the evidence from overseas, especially the UK—which is held up increasingly as the model to follow—confirms that the slippery slope is well greased. There is significant evidence in this regard. For example, Professor Julian Savulescu, of the Melbourne Oxford Stem Cell Collaboration research unit, has already been quoted. His article ‘Should we clone human beings? Cloning as a source of tissue for transplantation’ makes it very clear where this is heading. He gave similar evidence to the House of Representatives Standing Committee on Legal and Constitutional Affairs in 2000 and repeated the same basic line at the National Press Club last year.
Or there is this from University of Melbourne academic D Elsner, who published only late last month in the prestigious Journal of Medical Ethics a piece entitled ‘Just another reproductive technology? The ethics of human reproductive cloning as an experimental medical procedure’, where ‘reproductive cloning’ is promoted as simply ‘an experimental medical procedure’ and part of the armoury of reproductive technology, especially to produce ‘saviour siblings’.
Is this Senate to limit its considerations to an unquestioning acceptance of one committee? Surely not. It is critical on such a groundbreaking proposal which this bill represents, namely the creating of human life so that it can be destroyed in research—a bill which I would remind senators has not crossed the scientific threshold of proof of principle, on the admission of the Lockhart committee itself—that it be rigorously tested and critiqued.
I now turn to the bill and the arguments against it. If someone comes up to you and says: ‘We have this new process. It’s called somatic nuclear cell transfer. We’ll be able to use embryonic stem cells derived from this process to cure all sorts of things,’ then the average person would think: ‘Sure, that sounds impressive—fine, yes, we all want to help people with incurable diseases.’ But if someone comes up to you and says, ‘We want to create cloned human embryos, do research on them for up to 14 days and then get rid of them because it may, maybe in a couple of generations time, help us find cures for all sorts of things,’ then the answer would likely be different. At the very least, that person would ask: ‘Why?’ Fellow senators, this debate is about why. Why do we need to do this? And why do we need to do this now?
Supporters of this bill have followed the edict of the Ethics Committee of International Stem Cell Research when, back in 2004, they posted a statement recommending: instead of referring to cloning, use somatic nuclear cell transfer. This is misleading and intended purely to disguise that this is really about human cloning. No less relevantly, the US President’s Council on Bioethics devotes one whole chapter in the first of its three detailed reports—surprisingly, none of which were referenced by the Lockhart committee—to these definitions. It says that the relevant term should more correctly be described as follows: ‘reproductive cloning’ is ‘cloning to produce children’; ‘therapeutic cloning’ is ‘cloning for biomedical research’. The Lockhart review was able to cite the Indian Council of Medical Research’s draft guidelines for stem cell research, but none of the US President’s council’s three reports, in 2002, 2004 and 2005. Professor Skene told the inquiry that time precluded a comprehensive inquiry into relevant literature.
The other troubling aspect is the redefining of ‘embryo’. What is happening here is that the proponents of the bill are saying, on the one hand, the prohibition on reproductive cloning will remain but, on the other hand, they want to change the definition of embryo. In short, they are saying that an embryo is not an embryo for the first 14 days; therefore we can experiment on it and then dispose of it and still say we are not undertaking human cloning. The Australian public need to know, in simple terms, what is happening here. Professor Skene herself stated at the inquiry that a somatic cell nuclear transfer embryo is an embryo. She stated:
We did not shy away from calling it an embryo because it is conceivable, as happened with Dolly the sheep, that if that entity were put into a woman, after a lot of care, it could in fact develop into a foetus. So we did call it an embryo. We still regarded it, as many other people did who made submissions to us, as having a different moral status from the embryos that are created in fertility programs.
Indeed, the new definition recommended in the Lockhart report was not and has not been endorsed by the NHMRC. Hence, it is not only premature but misleading to rely on a definition which has not been endorsed.
This debate is not about the merits of adult stem cell research versus embryonic stem cell research—both are legal. This is about community standards and the dignity of legislation. We need to be sure that the Australian people are prepared to make the quantum leap of creating embryos for the scientific purpose of research and then destroying them—and only four years after this parliament comprehensively rejected it. Unless we can do so with certainty then we must oppose this bill.
The media has portrayed this issue as simply being about finding cures for debilitating diseases, when in fact the evidence before the inquiry suggested that such cures were extremely unlikely from cloning. Cloning raises complex scientific, medical and ethical issues. All are equally important. All deserve consideration. Over the course of this debate we have heard many impassioned speeches about this legislation. Having been a member of the Senate Community Affairs Committee and having been afforded the opportunity to read much of the material and to question all the witnesses who appeared before the inquiry, I am in no doubt that this legislation should be opposed. It crosses a scientific and ethical boundary that should not be crossed. Once crossed, we can never return. Once crossed, no parliamentarian will be able to withstand the next demand and the demands thereafter.
Before summarising the fundamental arguments against the bill, I wish to deal with the deterrence of penalties on research. It has been argued by the proponents of the bill that a 15-year jail term for placing a human embryo clone in a human body or body of an animal is or will be an effective deterrent. I would remind senators that penalties do not deter crime. Take these examples from New South Wales. Trafficking of commercial quantities of heroin and cocaine—at least 250 grams—carries a 20-year jail term, and for one kilogram or more, life. Robbery attracts 14 years, and if aggravated, 20 years. But people still traffic drugs and commit robberies. For greed, people will risk long terms of imprisonment. Many think they will not get caught and will take the risk. In the area of cloning we have already seen examples of fraud and unethical behaviour overseas. I would also remind senators that human or animal cloning is different to other crimes because, unlike robbery or, say, kidnapping, there is no victim and therefore no-one to report the crime. In the privacy of the laboratory, no guarantee can be given that such practices will not be undertaken.
Much has been made of science in this debate, but this is also a debate about money, intellectual property, patents and commercialisation in the biotech industry. There is invariably the potential for conflict of interest whenever researchers are themselves shareholders in biotech companies. This has not been adequately explored, nor declarations of interest sought from researchers, in this debate. The best and most laudable of motives can be coloured by the prospect of significant commercial gains, through intellectual property rights and the international biotech industry. Such was certainly the case with Professor Hwang in Korea.
There are, in my view, 10 basic reasons why the Senate should oppose this bill and I now summarise them. The first is the lack of proof concept. There is a lack of scientific evidence, including a lack of ‘proof of concept’ and a lack of any clinical trials regarding the potential benefits of human embryonic stem cell research, which I referred to earlier, that have been cited by senators in this debate.
The second goes to cancer and the cellular difference between adult versus embryonic stem cells. There are dangers, such as cancer formation, inherent in the research and clinical application of human embryonic stem cells. There was significant evidence from researchers of all scientific persuasions that embryonic stem cells, precisely because of their plasticity, remain so volatile as to have the propensity to produce teratomas.
Third, there is the fraudulent Korean research—part of the failure to reach the evidentiary threshold for change. The Lockhart review relied upon the published work of Korean researchers led by Professor Hwang, who claimed to have perfected human embryo cloning. That research was publicly retracted as fraudulent shortly after the Lockhart report was released last December. It has also been revealed that Professor Hwang pressured some of his female research assistants to ‘donate’ eggs for use in his research. The absence of reliable scientific evidence about cloning alone should be sufficient reason to reject any scientific basis for regime change.
The fourth reason goes to adult stem cell technology offering genuine cures. The significant number of clinical trials already underway around the world in relation to adult stem cells indicate that it is highly unlikely that SCNT—therapeutic cloning—will actually be necessary. The Senate inquiry received evidence that there are approximately 80 therapies currently in place in relation to adult stem cells. There are approximately 1,200 US Food and Drug Administration approved clinical trials. There are no clinical trials in relation to embryonic stem cells.
The fifth is that the commercial driver for change is assisted reproductive technology—and not medical cures—which, again, is part of the failure to reach the necessary threshold for change. Only a very small number of licences—nine—have been granted by the licensing committee since the establishment of the current regulatory regime established under the 2002 legislation. There have been an even smaller number of licences granted for research into human disease. Indeed, as the NHMRC advised the Senate inquiry, there is only one such licence, issued to IVF Australia, aimed at treating a specific condition.
The majority of licences issued—five—relate to artificial reproductive technology research. If human embryonic stem cells are so efficacious and safe, why so few licences, and why even fewer specifically for research into disease? Therefore, the Senate can legitimately ask why, for example, the Monash researchers, led by Professor Trounson, according to their submission to the inquiry, wish to conduct research into a very large number of medical conditions—yet there is just this one licence, issued to IVF Australia.
The point is simply that there is a significant disjuncture between what the researchers say they want under this bill and what they have done since the establishment of the current regulatory regime. They have not exactly beaten a path to the door of the licensing committee seeking to use some of the 104,000 excess ART embryos for research to rid the earth of any of the terrible diseases that afflict humanity.
The sixth reason relates to ethical boundaries. There is an ethical boundary, long-recognised in medical research codes, that would be crossed in legislating to allow the creation of cloned human life exclusively for the purpose of its being destroyed in the pursuit of knowledge. Medical research codes—from the Nuremberg Code in 1948, to the Declaration of Helsinki in 1964 and re-endorsed by the World Medical Association in 2000, to the Council of Europe’s 1997 Convention on Human Rights and Biomedicine, including its 1998 Additional Protocol on the Prohibition of Cloning Human Beings, to the 2005 UN declaration against cloning—all prohibit cloning.
The seventh reason relates to very important women’s issues. There are health risks to women in egg harvesting, as well as the risk of exploitation of women to gain access to more human eggs. The committee received evidence about the risks to women in two respects. First, there is the process of super-ovulation, requiring administration of drugs, prior to the medical procedure of the extraction of eggs. There are, of course, the risks associated with the medical procedure of the extraction of eggs in addition to the use of super-ovulants. Secondly, there are the risks associated with the demand for eggs for therapeutic cloning research—a point well made by Women’s Forum Australia at the hearing.
Proponents of the bill have claimed that opponents of the bill have been scaremongering and making outrageous claims. So let me note two things. The Lockhart report raises concerns about the availability of human eggs. At page 176 of the report it canvassed obtaining eggs from cadavers. But the bill goes further, in a most chilling manner, in an attempt to deal with the well-recognised shortage of eggs. Clause 23A expressly proposes the use of precursor cells from a human embryo or a human foetus. Such a proposal was canvassed by the Human Fertilisation and Embryology Authority in the UK in 1994, but it was also the subject of a study at Monash University in 1994. It was entitled: ‘Proposed regulation in Victoria of the use of donated foetal ovarian tissue for assisted conception or my mother was an aborted foetus’. Such is the world opened up by this legislation.
No-one was prepared to advise the committee how many eggs would be required to conduct research for any medical condition. Researchers from Monash Immunology and Stem Cell Laboratories simply agreed that there were not enough eggs to do all the potential research that they wanted to do. It should be stated here that the Lockhart review also strongly recommended that there be interspecies fertilisation. In newspaper comment, Professor Schofield acknowledged that there was a significant ‘yuk’ factor in relation to the recommendation in favour of interspecies fertilisation.
The eighth reason is the MP Consulting report, which again is a summary of the failure to reach the necessary threshold for change. The independent MP Consulting report, prepared for the Department of the Prime Minister and Cabinet and released by the Prime Minister on 31 August 2006, found:
On each of these issues—
the definition of ‘human embryo’, the creation and use of embryos for assisted reproductive technology research and the creation of embryos for stem cell research—
there has not been any significant change in the state of play since 2002.
The ninth reason is the slippery slope. There is a risk that, just as those in the current debate have changed their mind from opposing therapeutic cloning in 2002 to promoting it in 2006, the current ban against reproductive cloning and on growing cloned embryos beyond 14 days could equally, in a few short years, be lifted because sections of the scientific community, using the same arguments advanced today, argue that it would facilitate the pursuit and accumulation of knowledge. It is being proposed that we now have a limit of 14 days. How will we reject a demand from science for the limit to move to 28 days or beyond?
The 10th reason is ethical issues—again, part of the argument of the failure to reach the evidentiary threshold for change. The complexity of issues, the speed of examination and the highly contested case—medically and ethically—that promotes change are not an adequate foundation to alter the current legislative framework. I submit that these reasons compel this parliament to oppose the bill.