House debates

Thursday, 30 November 2006

Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Bill 2006

Second Reading

9:48 am

Photo of Julia GillardJulia Gillard (Lalor, Australian Labor Party, Shadow Minister for Health and Manager of Opposition Business in the House) Share this | Hansard source

I second the motion to facilitate this House having the debate that it has to have on the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Bill 2006. Almost exactly four years ago, parliamentarians made a landmark decision to allow research on excess assisted reproductive technology embryos so that progress could be made in infertility research and in-vitro fertilisation to assist couples who could not otherwise have children and that research could be undertaken using embryonic stem cells derived from these embryos. That legislation also banned human reproductive cloning and placed a moratorium on therapeutic cloning or somatic cell nuclear transfer. Most importantly, the bills which were enacted into law both clearly mandated an independent review of the legislation within three years to assess the developments in technology in that time period; to assess the developments in medical research and scientific research and the potential therapeutic applications of such research; and to assess any change in community standards.

That independent review was conducted by a committee appointed by the then Minister for Ageing in consultation with the states and territories. The committee that conducted the review were experts in law, science and ethics and were ably chaired by the late John Lockhart. The committee consulted extensively through written submissions, face-to-face meetings, facilitated stakeholder discussion forums, a review website and selected site visits. They also tried to get a handle on public opinion through focus groups and telephone surveys. They conducted a literature review of what had happened in the scientific field since the legislation last passed this House. On this basis, and having regard to their terms of reference, they provided the federal parliament with 54 recommendations.

It is now 12 months since those recommendations were provided to us, and they have now been subjected to further scrutiny through the work of the Senate Standing Committee on Community Affairs. I think we should acknowledge that the bill that we have before the House today is only here because of the hard work of Senator Patterson and her colleagues, especially Senator Ruth Webber and Senator Natasha Stott Despoja, and the willingness of Dr Mal Washer, who spoke before me, to pick up the task in the House of ensuring that we debate this bill today. This bill basically encapsulates the majority of the recommendations of the Lockhart review and it is, in my view, incumbent upon this parliament to deal with those recommendations seriously.

The bill is about a number of important issues. It is not all about stem cells and cloning; it is also about strengthening and improving the current legislative and regulatory regime and about improving methods for achieving pregnancy through assisted reproductive technologies. The bill continues the absolute ban on reproductive cloning to make a whole new human being. I think that is something everyone agrees with. The bill also recommends that clinical practice and scientific research involving assisted reproductive technology and the creation and use of human embryos for research purposes should continue to be subject to specific national legislation.

The bill continues the current ban on the trade and commodification of human eggs, sperm and embryos. The Lockhart review found that an inadvertent effect of the 2002 legislation had been to prevent research into improved methods for achieving pregnancy in ART clinics and that it was inadvertently impeding training and quality assurance activities at these clinics.

This bill enacts a number of recommendations that will address these inadvertent consequences of the last legislation, including permitting procedures to test human eggs for maturity and to test egg and sperm viability—it should be noted that these procedures were allowed prior to the 2002 legislation—and simpler applications for licences where these are solely for training and quality assurance activities in ART clinics.

The bill contains a number of provisions that will improve current licensing arrangements; that will ensure that vacancies on the National Health and Medical Research Council Licensing Committee are promptly filled; that will provide for the inspection of non-licensed facilities to ensure that laws and guidelines are being complied with; and that will impose significant criminal penalties, including up to 15 years jail, for breaking the law.

The bill also requires the minister to report to parliament on the establishment of a national stem cell bank and a national register of donated excess ART embryos. This will help facilitate research and ensure that this research material is used as widely as possible.

The bill will, under stringent licensing conditions, allow for two new activities not previously permitted but recommended by the Lockhart review. The first of these is the use of so-called fresh embryos. Those are embryos generated in the process of IVF that have been found to be unsuitable for transplantation usually because of genetic flaws and, if they were not used for research purposes, they would otherwise be discarded. Arguably the use of these embryos is not permitted under current legislation, and so it is a part of this bill to ensure that the use of fresh embryos is possible. That arises in part because there was an ambiguity in past law and that ambiguity is cured by this bill.

The second new activity not previously permitted but recommended by the Lockhart review is the use of human embryos created by somatic cell nuclear transfer and other techniques that do not involve the fertilisation of a human egg with a human sperm. Such embryos are to be created only for the development of specific embryonic stem cell lines as is currently legally permitted in the United Kingdom, Sweden, Japan and Singapore. It is of course this latter point which has been the subject of most controversy and the most attention, and it is to that which I will now direct my remarks.

In dealing with the ethical issues posed by somatic cell nuclear transfer and by the Lockhart review suggestion that embryos be created by somatic cell nuclear transfer for the purpose of research, I have found it easiest to analyse the issues by concentrating on the definition of an embryo and analysing what this bill permits and does not permit in relation to an embryo. Since the enactment of the 2002 bill, the NHMRC has had an expert group look at the definition of ‘embryo’, and this bill changes the definition to reflect the consensus reached, using terminology that is biologically accurate, clearly understandable and unambiguous. An embryo for the purpose of this legislation is an entity created by a sperm fertilising an egg. Such embryos cannot be created for other than IVF purposes. Under licence, these surplus embryos can be used for stem cell research. In that regard, nothing in this bill changes the current law.

But in the definition of an embryo in this bill is also included an entity created by somatic cell nuclear transfer or other techniques which do not involve a sperm. In particular, an embryo includes the cellular entity formed when an egg, from which the nucleus has been removed, is then combined with material from an adult cell and allowed to divide into a multicell stage. It is not known whether this entity, if it were implanted in a woman, would result in a baby. However, it is the technology used to create Dolly, the sheep, and consequently this entity needs to be acknowledged as having the theoretical potential to create a human life.

The reason for using the technique of somatic cell nuclear transfer is to create an entity genetically identical to the donor of the adult cell. Scientists seek to do this to study disease development by using adult cells from individuals with that disease. The other reason is to generate stem cells genetically identical to the donor with the theoretical capacity to grow into tissue the donor will not reject. This is the debate people would have seen publicly about growing, for example, new spinal cord. It is these embryos—embryos created without a sperm—that under this bill can be deliberately created for research. This is the major change since the last legislation.

It should be noted that, under this bill, embryos, no matter whether they are surplus IVF embryos or embryos created without sperm, must not be allowed to develop beyond 14 days. Those who have objected to the creation of embryos without sperm for the purpose of research have put two main arguments. They argue that embryonic stem cell research is bad science. There are those who argue that we do not need embryonic stem cell research when we have adult stem cells. But this ignores the fact that embryonic and adult stem cells are fundamentally different. We need to understand the basic science of these cells and their differences before we can determine which would be most useful for the many disorders we seek to treat.

The scientific evidence points to the obvious fact that, in such a rapidly moving area of science, we need to support a variety of research efforts within and across embryonic and adult stem cells. There are those who claim that, because the hoped-for breakthroughs in therapy from embryonic stem cells have not occurred in the last three years, we should abandon this approach as fruitless. But scientific breakthroughs do not come as expected or, indeed, as needed: it took 50 years to develop a vaccine against polio; it took around 15 years to develop the new Gardasil vaccine against cervical cancer; and, more than 30 years after Richard Nixon committed $100 million to find a cure for cancer, that has not happened. But, last year, the US government committed over $6 billion to cancer research, because some wonderful progress has been made.

It is easy in politics, I think, to characterise the statement ‘We don’t know what we don’t know’ as a slipshod political statement—indeed, we have had some of that in the House this week—but I think in relation to this bill that it is a true statement: we don’t know what we don’t know. We do not know, unless we could fast forward the clock 50 years, whether scientific progress will have come through embryonic stem cells or adult stem cells. We do not know that now and we cannot know that now. The only way we will ever know is to allow both sorts of research to proceed. No-one could offer an assurance that, if we were to stop embryonic stem cell research, at the end of those 50 years we will have made all of the scientific advancements that we could. We would be shutting off one avenue that may lead to those scientific advancements. Consequently, because we don’t know what we don’t know, I believe that we cannot avert our eyes from embryonic stem cell research. I do not accept the argument that embryonic stem cell research is bad science.

However, that does not resolve the key ethical issue of whether it is right to create an entity that has a theoretical capacity to become a human being, for the purpose of research. I have carefully considered this question, which I acknowledge is most certainly not an easy one. I am assisted by the clear intent of the bill that such an entity would not be allowed to develop beyond 14 days, a stage which is prior to the development of the primitive streak on which all further development would be based. At this stage the embryo, which consists of around 100 cells, is referred to as a blastocyst. I have considered what is right and wrong in this matter. It is a question on which very reasonable people can differ, and I have determined that, in my view, it is ethically permissible to allow the course proposed by the bill to facilitate research that is of unknown and unknowable potential. I do not believe it would be right to not explore the potential of this research to cure the disease and disability which cause so much suffering.

There are some final points I would like to make about Australia’s legislative and regulatory approach to these issues. We should not lose sight of the importance of the fact that Australia has an excellent national legislative regime in this area—one that covers all ART and research activities in Australia, no matter where they are conducted or how they are funded. We should have national legislation in fields such as this. The enactment of this bill will see this regime backed up with very strong oversight and penalties. The regime is also backed up with a series of NHMRC guidelines that address informed consent, institutional ethics approval and the ethics of working with human subjects. Senator Colbeck’s amendment to this bill in the Senate will mean that there will be an opportunity to look at the current state and territory laws which govern the donation of human tissue and organs and their use in research. Finally, because this is an area where science and medicine and public opinion are all moving forward, the bill requires another review, like the Lockhart review, to report to the Council of Australian Governments and both houses of parliament within four years.

In my view, we should not resile from the responsibility to follow the consequences and implications of our votes on this bill and the act it will amend. We should ensure that future reviews are dealt with thoroughly and properly by this House. This is not an easy bill for this parliament to deal with. It is not an easy bill for individual members to make up their minds on. All of the political parties in the parliament have extended to their members a conscience vote, and that is highly appropriate. I think we need to recognise with great courtesy and respect that there are those who cannot support this legislation, and in turn they must acknowledge that in this pluralist society there are many views on these issues and that ethics is not the purview of any one group. The 2001 report on human cloning from the House of Representatives Standing Committee on Legal and Constitutional Affairs addressed this:

One view of the status of the embryo should not be imposed on society as a whole especially when to do so may be to the detriment of those with serious or debilitating illness or disease. There is also a broader duty to society to be taken into account ...

I agree with those words. I believe we need to distinguish the ethical and moral arguments from the scientific and biological ones, and we need to understand that they both have a place and a right to be heard. From time to time in our political lives we are given the opportunity to make important decisions that shape the future and determine what sort of country we will be. I believe this is one of those occasions, and I support the bill.

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