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Tuesday, 12 November 2002
Page: 6111


Senator COONAN (Minister for Revenue and Assistant Treasurer) (4:50 PM) —I rise to speak on the Research Involving Embryos Bill 2002, which was introduced into the parliament by the Howard government following a communique of the Council of Australian Governments issued on 5 April 2002. The communique records an agreement reached for nationally consistent legislation that will provide for a regulatory regime allowing research on excess embryos, created in the course of assisted reproductive technology, that are in existence as at April 2002. All states and territories have agreed to introduce complementary legislation or to amend existing legislation to achieve a consistent regulatory scheme operating throughout Australia. The expressed rationale of COAG is to enable Australia to remain at the forefront of research which may lead to medical breakthroughs in the treatment of certain diseases. These are supportable aims.

The scope the bill is to ban certain practices relating to reproductive technologies and to provide the framework for a system of regulatory oversight for the use of excess assisted reproductive technology embryos that would otherwise have been destroyed. The bill provides for a system of licensing administered by National Health and Medical Research Council through the establishment of a NHMRC licensing committee. Assisted reproductive technology, including in-vitro fertilisation, is regulated in Australia through legislation in three states and a voluntary compliance framework, together with a national system of accreditation by the Reproduction Technology Accreditation Committee underpinned by the NHMRC guidelines. There is therefore no Commonwealth legislation covering regulation of ART clinical practice.

The use of embryonic stem cells is currently covered by advice from the NHMRC's Australian Health Ethics Committee. The NHMRC Ethical Guidelines on Assisted Reproductive Technology of 1996 provide guidance on research involving ART embryos surplus to a couple's needs. These guidelines are currently under review. Absent this bill, therefore, there is no comprehensive and consistent national approach to the use of embryonic stem cells for research.

The question is whether the bill, which is founded on the proposition that research should be permitted on embryos that would otherwise have been destroyed, should be supported. Indeed, the fact that there are some thousands of excess embryos in existence that are surplus to IVF requirements and that would be destroyed in any event seems to be pivotal to the thinking of many supporters of embryonic stem cell research. However, this view appears to assume, wrongly in my opinion, that there is no moral difference between removing an embryo from liquid nitrogen and allowing it to succumb, because it cannot survive without being implanted, and removing it from liquid nitrogen and actively destroying it for the purpose of gaining access to tissue or cells as a commodity for the benefit of others. In my view, the active culling of an embryo is of a profoundly different character to its destruction by passive means. Whilst the end result is the same, the route to destruction makes a moral difference and gives rise in my view to serious ethical, legal and practical questions.

I appreciate that the debate on the status of the early embryo up to 14 days is contentious but, however it is regarded, no scientist and certainly no ethicist disputes that the embryo is undeniably human or at least contains human cells and within it the full genetic potential of a human being. Of course, it requires much more to realise its potential. This knowledge no doubt underpins the wide measure of community support for IVF technologies, which of necessity result in the creation of a number of surplus embryos to maximise the potential of a successful pregnancy. Absent other arrangements, surplus embryos will be destroyed. There is not a groundswell of opinion condemning IVF as it is currently practised and there is little or no criticism of those who have found it necessary to avail themselves of IVF technology and the creation of surplus embryos to achieve a much wanted pregnancy. It is widely regarded as an exercise of reproductive rights.

Herein there lies a contradiction. There is little public concern about some forms of embryo destruction but strong interest in other forms of embryo destruction. There is real moral equivalence about, for example, the age at which embryos can be used for research, the prohibition of cloning and the creation of embryos purely for research. Indeed, if the parents of doomed embryos fully understood the range of research purposes to which their surplus embryos could be subject under this bill, including commercial exploitation, many of them might put conditions on their use or not consent at all. As it is, we have the curious outcome that it is said to be acceptable to many to experiment on embryos that are discarded as part of an approved process in IVF procedures but not if they are created solely for the purpose of research. The reason for this reluctance is that experimentation alone goes well beyond the creation of embryos as an exercise of reproductive rights. To my mind, logically, concerns are raised by experimentation on embryos irrespective of the purpose for which they were created. Experimentation on early embryos is a vice, irrespective of how and for what purposes those embryos were created.

These contradictions and attempts to draw legal and technical boundaries around research on surplus embryos suggest that much of the thinking about embryonic stem cell research is based on expedience rather than anchored in any coherent moral philosophy. However, accepting for the purposes of argument that there appears to be broad community support for research on surplus embryos under defined conditions, the question must be asked whether there is real likelihood of significant advances in knowledge about disease that could not be gained from other techniques or whether we have allowed ourselves to become mesmerised by the dazzling potential of new therapies and scientific breakthroughs to treat common or serious recurring conditions. The answers to these questions involve not only evaluating available and recent scientific research but also, of necessity, taking the claims of scientists, some of whom have both their financial and professional reputations at stake, largely on trust. This in turn has implications for both future government funding and private investment.

As the report of the Select Committee on Stem Cell Research in the House of Lords points out, stem cell research is currently subject to very rapid change. Of necessity, consideration of the issues can reflect only the current state of knowledge. There appears to be a consensus in the scientific community that over the next few years most studies in stem cells—whether adult, foetal or embryonic—will be basic research. However the possibilities stack up, it is no exaggeration to say that human stem cells of all types are difficult to handle and that the arrival of effective stem cell therapies to address unmet clinical needs is very far off.

From what I have said so far, it will be apparent that I have the gravest reservations about the morality of stem cell research for commercial ends. I am sceptical about some of the claims made in the scientific community—for example, how many surplus embryos beyond those created before April 2002 are likely to be required and under what conditions they will be obtained. Most compellingly, I am not confident that, as a community, we have thought carefully enough about some of the consequences of those hoped for scientific advances.

Many of the pros and cons in this debate have centred on religious convictions or on utilitarian or pragmatic responses. However, the eminent scientific author Dr Margaret Wertheim, in her recent Redmond Barry Lecture entitled `Stemming the Tide: Clones, Stem Cells and the Future of Medicine', has raised more secular concerns. Of particular resonance is her observation that stem cell therapies are not generic treatments. Rather, they are specifically targeted and individualised to meet a patient's requirements. As Wertheim says:

Drugs, at least, can be mass-produced. If we are having trouble providing mass produce-able drugs to all those who need them, how on earth are we going to afford a specialty service like targeted stem cell therapy?

While the allure of miracle therapies and wonder cures is strong and perhaps understandable, this parliament must ask, given the nature of the therapies: will the community actually be able to deliver individualised therapies to those who need them or will these be elite therapies that only the wealthiest among us will be able to access?

There are a number of quite unsettling scenarios, as we imagine unforeseen and unintended consequences, side effects and contingent liabilities that are secular in nature but warrant careful thought about whether the community as a whole will benefit from these potential technologies. The scientific evidence about how many embryos will be required to create new stem cell lines in the future is deeply conflicted and, in the recent Senate committee report, is estimated by the experts to be from about 50 to approximately 10 million. Obviously, low numbers are predicated on the basis that cellular grafts will be successful.

Obviously, no-one knows when or how issues of tissue typing and immunological rejection will be resolved. In the meantime, the need for an extremely large stem cell bank to maximise tissue matching is not far-fetched. This raises some very troubling and so far unanswered questions. How many donor eggs will eventually be required to meet this incredible demand? How will they be obtained, and who will they be harvested from? Donating eggs is an invasive procedure. In the same way that ethical problems are being thrown up around the supply of organs as transplantation becomes more successful, how will we as a society deal with the demand for eggs and embryos should stem cell therapy become the success some of the scientists would have us believe? Will the underprivileged women of the Third World be seen as a potential source of eggs? Will the miracle treatment for a well-to-do patient in the First World be bought at the cost of a desperate individual in the Third World? I do not think any of these questions have been adequately asked or framed, let alone answered.

The current bill, in my view, is seriously deficient in addressing matters of fundamental concern to those who may otherwise support the basic concept of destruction of early embryos for research but who feel distinctly uneasy about the inadequacy of the regulatory regime to deal with new and emerging technologies. The bill makes no provisions for the regulation of harvesting of eggs. It is true that the Reproductive Technology Accreditation Committee guidelines specifically prohibit the practice of deliberately super-ovulating patients in the IVF process, but this is not addressed in the legislation. Although this bill restricts researchers to using embryos created before 5 April 2002, the legislative design provides for the restriction to be removed in three years, subject to a review. What is perhaps illustrative of the inadequacies of the bill is the statement of the Attorney-General during debate on this bill in the House of Representatives, where he said:

These reviews will ensure that strong ethics and research protocols and appropriate safeguards are in place prior to the sunset clause coming into effect.

For my part, I would have thought it was imperative that strong ethics, research protocols and appropriate safeguards are in place prior to the passage of the bill and not three years down the track.

As others have noted, part of the problem with this bill is that it does not actually regulate stem cell research. In a curious omission, the bill leaves it up to the NHMRC to decide for what purposes researchers may access certain embryos. If this bill is passed, research involving embryonic stem cells will be subject to guidelines that are currently under review. It is a regrettable omission that the guidelines that underpin the bill are not yet settled. It is simply not possible to make an informed assessment as to the adequacy of safeguards that should be clear in the guidelines.

Not unexpectedly, this bill has generated, without exception, sincere and well-intentioned contributions. But, as the bill stands, it is difficult to support it. Some experts have given evidence that existing stem cell lines are adequate for the basic research to continue in the near future. If this is correct—and, once again, we have to take a lot of these claims on trust—the bill will have no effect on the use of existing stem cell lines for research and will continue to be regulated by NHMRC guidelines.

Whilst I support COAG's intention for the creation of a consistent national scheme to regulate stem cell research—because a lot of it involves adult stem cell research—the bill does not, in my view, achieve that objective. The full and safe exploitation of stem cells is in its infancy and is unlikely to produce any treatment or cure for individuals for many years to come, even assuming that the costs of making such treatment or cures available can be managed. There is therefore time to pause and consider an improved and focused regulatory regime for stem cell research which better reflects assessment of the ethical, social, scientific and indeed future commercial implications of such research. Again, I refer to Margaret Wertheim, who in concluding her paper said:

Medicine is about more than Nobel Prizes and technological prowess; in the long run, surely, its primary aim must be the promotion of good health and well-being on the widest possible scale. Whether stem cell research will further that aim remains an open question.

We are privileged to have a conscience vote on this very important bill. Conscience is a very private attribute. However, as an elected representative I have very public duties. I feel that I have a broader obligation to try to identify community sentiment on this matter. Despite my personal misgivings, I acknowledge the broad community support for research that may lead to the development of potential stem cell therapies. I would not want to stand in the way of potential medical breakthroughs to alleviate suffering. However, I do not think that this bill has the necessary ethical and legal underpinnings to justify community confidence that we as a parliament have grappled with the issue and come up with the very best possible response. For these reasons, I have decided not to support the bill.