Tuesday, 7 November 2006
Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Bill 2006
in reply—I thank honourable senators for their contributions, and there will be no surprise that I will be supporting the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Bill 2006. In 2002 I had carriage of the Prohibition of Human Cloning Bill and the Research Involving Embryos Bill through this place. I foreshadowed then that the legislation required that it be reviewed and I said:
If the review gives rise to possible amendments to the legislation, any such amendments must come before parliament, and at that time whoever is here will have the opportunity to consider in detail any proposed changes to the legislation.
I am bringing to the Senate for decision a bill that reflects the considered recommendations made by the Legislative Review Committee of those two bills.
Before I speak to the bill I want to clear up something which, until now, I have refrained from addressing. During my speech in the second reading debate for the Research Involving Embryos Bill 2002 I made the following statement:
I believe strongly that it is wrong to create human embryos solely for research. It is not morally permissible to develop an embryo with the intent of truncating it at an early stage for the benefit of another human being.
It should be noted that this statement was not made in relation to the Prohibition of Human Cloning Act; it was made in the context of the creation of sperm-and-egg embryos for research, and this bill continues the prohibition of the creation of an embryo using a human egg and a human sperm, except for the purposes of assisted reproductive technology, or ART. I stand by that statement today as being consistent with asking you to vote in favour of this bill.
My statement has been used by some people to discredit this bill by implying that I have changed my mind about issues, but they have quoted me out of context, as I have just indicated. Secondly, even if it can be argued that I have changed my mind, the implication that changing one’s mind is somehow wrong is foreign to me. My mind remains open to learning new things, to considering carefully new points of view and to changing my position on issues where appropriate—something I will always reserve my right to do.
It is interesting that many of those against this bill base their objection to it on the status of an SCNT embryo being equal to that of an egg-sperm embryo. Although they are quite correct that under Australian law, according to the definition created in 2002, an entity created through the SCNT process is classified as an embryo—indeed, a human embryo—I wonder why no-one has mentioned that in 2001 the ProLife Alliance in the UK took the definition of an embryo to their high court to get a ruling that SCNT was not an embryo in an attempt to ensure SCNT research could not happen under their Fertilisation and Embryology Act 1990.
Some might suggest that the sanctity of the status of the embryo is a negotiable commodity and will be sacrificed by those desperate to find ways to block SCNT research. I see a sperm-and-egg embryo as different from a skin cell that is cloned using an egg as an incubator. It is not a fertilised egg, it will never be permitted to develop beyond 14 days and it cannot be implanted in the body of a woman or animal. I consider that I am also amongst the majority of Australians, who are in favour of research using somatic cell nuclear transfer to help us better understand disease processes and hopefully find therapies for human suffering, so long as it is strictly regulated and that reproductive cloning remains prohibited.
I note that some of my colleagues believe that we have not had enough time to consider the issues. The issues contained in this bill have been on the table for around nine years. In that time our parliamentary colleagues in Britain have accepted this type of research. We have had five—not one, as we have just been told—formal inquiries, all of which unanimously recommended prohibition of the cloning of whole human beings and all of which acknowledged the varying views that existed in the community regarding the status of the human embryo. Neither the 1998 AHEC report, nor the 2001 Andrews report, nor the 2005 Lockhart report, nor indeed the recent 2006 Senate committee report on this bill recommended legislation prohibiting cloning of human cells for research. They were indicating that they should be subjected to regulation and regulatory processes.
The initial 1998 AHEC report predicted there would be confusion about the differences between therapeutic and reproductive cloning. Only a few weeks prior to AHEC handing down their report, two labs in the USA announced that they were able for the first time to derive embryonic stem cell lines from human blastocysts. This was significant for two reasons: firstly, it meant that there was potential to use donated surplus IVF embryos to acquire embryonic stem cells; and, secondly, if SCNT research could be applied to human cells then this could be potentially another source of embryonic stem cells. This also meant that therapeutic cloning had an additional meaning. So there was a slight shift in terminology and new things for the House of Representatives Standing Committee on Legal and Constitutional Affairs to consider when they were asked to make legislative recommendations based on the AHEC report in 1999.
The 2001 Andrews House of Reps committee report states under recommendation 5, item 12.44:
The Committee recommends that the Commonwealth regulate human cloning and stem cell research within the strict parameters outlined in paragraphs 12.41-12.43.
Item 12.42, while calling for a moratorium on their creation, recommends:
The creation of embryos by means of somatic cell nuclear transfer ... need not necessarily form part of the legislative ban on the deliberate creation of embryos.
Despite the Andrews report recommending SCNT research not be banned by law, the resultant bill put before the House in June 2002 did propose just that. However, the bills did allow for a review, the recommendations of which we are now considering in this bill.
Looking back, I think that somatic cell nuclear transfer as a source of embryonic stem cells became an unfortunate victim of the fear and confusion about what cloning meant. While the Andrews report recommended a moratorium on licensing SCNT research, I think somehow it got caught up in the quest to prohibit reproductive cloning. Meanwhile, SCNT research has been allowed in countries like the United States, the United Kingdom, Singapore and Sweden, and we have been left behind.
The fourth inquiry was, of course, the Lockhart review. This time, although still complex, the issues were clearer because embryonic stem cell research using excess ART embryos was permitted and there was no doubt about the prohibition of reproductive cloning. The main focus was whether SCNT research should be allowed. The Lockhart committee recommended it should only be permitted in the setting of strict regulatory control. Of course, the majority of the fifth inquiry, by the Senate Standing Committee on Community Affairs, endorsed the findings of the Lockhart committee.
I want to address some specific issues that have emerged as furphies in the arguments against this bill. There is no evidence of a slippery slope. Cloning of whole human beings will continue to be strictly prohibited. Let me repeat that: cloning of human beings will continue to be strictly prohibited. From some of the stuff we have seen in the newspaper and some of the claims that we have heard around the debate of this bill, you would not be aware, nor would you believe, that the legislation continues to prohibit the cloning of whole human beings. Allowing SCNT research, as the bill prescribes, does not take us down that path. The safeguards are the 14-day development limit on SCNT embryos and prohibition of implantation as well as incarceration for up to 15 years for anyone who attempts to break this law.
Some antagonists of the bill have cited a lack of proof of concept as being reason to legislate against SCNT. This is not a scientific argument in this case but, I believe, a thin veil, albeit maybe subconscious, for people who have a moral objection to the research. While SCNT research in humans has not produced embryonic stem cell lines, given the success in animal models this is no reason to ban it. The proof of concept exists. In the words of Professor Martin Pera in response to a question during the Melbourne Senate hearing:
... with respect to the statement that there are no—
and I insert ‘human’ here because that is what he was talking about—
therapies from cloned embryonic stem cells, of course there are not because research has not been done on a human yet that would enable it. However, there is proof of concept in animal studies that you can treat disease with such an approach.
Some claim that embryonic stem cells cause cancer and so the research should cease. Only those who do not understand the science or those deliberately trying to muddy the waters will claim this. Although embryonic stem cells in their primitive state might form teratomas if injected into a person, these people choose to ignore the fact that human clinical trials must conform to recognised safety protocols and pass ethics committees. Secondly, potential therapies developed from these cell types would come from directing them to differentiate into more specialised cells or tissue, giving them the same risk as those derived from adult stem cells. People also forget that even treatments like kidney transplants result in high incidences of cancer in people. There are some treatments in which the benefits sometimes outweigh the associated problems. As I said, these cells will be differentiated into more specialised cells and there are also risks in implanting adult stem cells.
Contrary to claims that there has been no progress since 2002, ample evidence was provided to the Senate committee, and only as recently as mid-October—the very time we were having the hearings—D’Amour et al reported that they had directed human embryonic stem cells to become insulin-producing pancreatic cells. Finally, many opponents fail to accept that it is not only development of therapies for which embryonic stem cell research is needed; they are essential for the elucidation of our limited understanding of early cell differentiation and disease processes.
Some claim embryonic stem cell research is not needed because adult stem cells can provide all the answers. This is not true, but one advantage of adult stem cells is that their use is not weighed down by the same strong differences of opinion. Scientifically we need them both. It is not a competition, as one of my colleagues suggested. We need both embryonic stem cells derived from surplus IVF embryos as well as SCNT and adult stem cells. Adult stem cells are restricted in their scientific use, as the committee report explains, and the claims attributed to Dr David Prentice of 65 diseases being cured by adult stem cells have been seriously challenged in respected journals.
It is vital we pursue SCNT as a source of human embryonic stem cells as it offers a significant advantage over ART embryo derived stem cells in the ability to create disease specific stem cell lines. By taking a cell from an adult with a particular known genetic disease and producing stem cell lines via SCNT, we could have an array of particular cells with known defects. Scientists could research or test drugs on those diseased cells, so hastening the process of understanding and possibly finding therapies for those diseases.
Legitimate concern has been raised about the potential for exploitation of women with regard to egg donations needed in relation to SCNT technology. I believe that the proposed legislation covers this in a number of ways—for example, through banning commercial trade in eggs and through the normal protocols that exist for ova donation and surgical procedures, which adequately cover informed consent. During the Senate committee hearings, several of my colleagues were incensed, as I was, at the implication that women were not capable of informed consent in such a matter. Have we forgotten that women already donate ova for ART either to someone they know or anonymously—it is quite pertinent that we were having that discussion today—and that for this to be achieved ethical consent is covered in the AHEC guidelines? It seems women may be capable of deciding to donate bone marrow or a kidney, both of which have attendant risks, but not ova. Somehow, when it comes to donating our ova, we lose our minds, but we can donate kidneys, bone marrow and other tissue.
In addition it must be noted that, during the Senate committee hearings, researchers emphasised the long-term aim of producing embryonic stem cell lines from somatic cells without the need to use ova and the need to be able to undertake basic human embryo and SCNT research to achieve this goal. I believe that the community attitude to SCNT is clear. Valid surveys show that reproductive cloning is unacceptable and the majority of the community accept that SCNT research is worthy of pursuit. Naturally, this should only occur under strict regulatory control, as proposed in this bill.
Some believe that this bill will take us into Huxley’s Brave New World. But, given the imagery of scary animal-human hybrids, rabbit-people, human cows and all the other things that have been suggested while we have been debating this bill—the sorts of scary images that people are using—maybe they would rather take us back 200 years, when similar fear tactics were used, as Senator Brown has indicated, to ridicule Edward Jenner’s cowpox vaccine against smallpox. In 1798, some tried to generate fear in the public arena that, if used, Jenner’s vaccine would cause people to grow the horns and tail of a cow. Critics warned that ‘transmitting disease from a “brute creature” to human beings was a loathsome, dangerous, and immoral act’. Far from this happening, Jenner’s vaccine proved to be one of the most effective public health instruments of our time. I wish I could be here in 40 years time so that I could look back and see what some of this research will have proved, but I do not think I am going to be able to achieve that.
Some of my colleagues are saying that we have not had enough time to consider the changes this bill proposes to the law. Let us be quite clear: we have been considering these issues since 1998. We have had five formal inquiries—and other countries have accepted the sorts of changes proposed in this bill in the meantime—and we have had the Lockhart committee report to consider for close on a year.
I would like you to remember, as you make your decision on the recommendations of the Lockhart review as reflected in this bill, that this is not a decision about politics. It is about people. It is about hope and it is about trust. A vote against this bill will be a vote to dash the hope that is dearly held by those people watching and listening to us who have medical conditions and who expect nothing from this research for themselves but know that in their cells they have a possible key to understanding their disease which may provide a legacy for future generations of people with this or similar diseases. Why should we restrict their hopes?
A vote against this bill sends a message of no confidence to all those esteemed Australians who sit on expert committees and give their time to assist us in this place to understand complex issues and oversee regulations and protocols to keep Australians safe. Those who cast doubt on the standing of the Lockhart committee also cast doubt on all such committees and on the proper process of this place. The Lockhart committee was properly constituted as prescribed in the acts, and its members discharged their duty with integrity and sensitivity.
A vote against this bill tells young, eager, scientific minds that Australia does not trust them. Senator Fierravanti-Wells indicated that they would be in the dark of night in laboratories, doing terrible things. They can do that if there is no law. They can do that now. What we are saying is, ‘We trust you, but we think there should be boundaries around that trust.’ To say that we do not trust our young scientists gives them the message that our regulatory instruments cannot be relied upon to protect us from unethical behaviour. This bill prescribes harsh jail sentences for offenders, as well as measures for regulatory oversight to ensure accountable and transparent practices in laboratory research.
A vote against this bill sends a message to those with minority views that proper process is irrelevant and facts do not matter. It illustrates to any minority that they can get their way if they have loud enough voices, use enough scary images and can buy enough advertising space. It sends a message that we are not interested in the majority view and can be influenced by undue minority pressure. I believe that with this proposed legislation there is no threat of cloned people, rabbit-men or slippery slopes and that those who speak of hype are in fact themselves guilty of promulgating hype and hyperbole.
A vote for this bill displays trust in the robust nature of this nation’s regulatory systems to allow cautious scientific advancement for the betterment of people. It shows that we make laws based on fact, not on superstition. When—and I predict that it will be when, not if—a treatment or medication is developed using SCNT or knowledge gained from SCNT research in the US, the UK or somewhere else, who in this place, and some of you may still be here, will be the first to legislate to prevent it being used by Australians because it was based on what some—incorrectly, in my opinion—describe as repugnant, immoral research?
Would we have preferred Jenner not to have tested his cowpox vaccine because doing so was a ‘loathsome, dangerous and immoral act’, knowing what we know now—that this dreadful disease has been eradicated? In the 1970s, when for the first time insulin-producing cells were injected into a diabetic mouse, would it have been wrong to give a young type 1 diabetes patient hope that people like him or her in 30 years might be able to have insulin-producing cells from a cadaver pancreas injected which would free them from a regime of testing and needles? I think the answer is no. Is it now wrong to give a young patient with type 1 diabetes, like the children who visited us in the house last week, hope that the knowledge gained from all types of stem cell research—adult, embryo and SCNT—may in due course provide a treatment that could free them from the grind of the insulin regime or, if they had an islet transplant, the burden of antirejection drugs for the rest of their lives? Again, I believe the answer is no. The Andrews report did not recommend legislation to prohibit SCNT research, nor did the Lockhart review, and neither should we.
That this bill be now read a second time.