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Tuesday, 12 November 2002
Page: 6107


Senator McLUCAS (4:30 PM) —The Research Involving Embryos Bill 2002 is the second part of the legislation designed to deliver a national regulatory system to address concerns about scientific developments in relation to human reproduction and the utilisation of human embryos. It regulates the use of certain embryos created by assisted reproductive technology. Like the Prohibition of Human Cloning Bill 2002, this bill reflects the shared views of all of the states and territories as described by the Council of Australian Governments communique of April this year. COAG clearly recognised the need for nationally consistent legislation, acknowledging that, if it is left to the states, a variety of approaches will emerge, leading, as the Queensland government advised the Senate Community Affairs Legislation Committee, to `possible loopholes and safe havens'. The bill before us reflects the intent of the states and territories faithfully.

The consequences if the bill fails to pass should also be recognised. It will have no impact on the rate of production or disposal of ART embryos. If the bill fails to pass, embryonic stem cell research will continue on existing lines, which the committee was advised are not acceptable for future clinical research and are limited for research purposes, as they were created using mouse feeder lines. As most jurisdictions do not ban or regulate the destruction of embryos, if this bill does not pass then retention of the status quo will mean such activities are permissible in all jurisdictions apart from Victoria, South Australia and Western Australia. If the bill fails to pass, the states and territories can determine their own approach and, given the public comments of several of the state premiers, this may result in more liberal regimes than this Commonwealth legislation permits. There will be no central agency to provide oversight, informed monitoring or review. Furthermore, there will be no central data collection agency, and research may be hampered, as researchers will only be able to access existing stem cell lines or lines from overseas—most likely from commercial sources, which may require some rights over intellectual property developed from the research. I suggest national consistency is surely a desirable goal in the delivery of such contentious public policy.

COAG recognised that this is a difficult area of public policy, involving complex and sensitive ethical and scientific concerns. The fundamental question that we in this place have to answer is whether people believe destructive research on excess ART embryos that have been donated with consent and that would otherwise be allowed to succumb is acceptable or not. For every person, the answer to that question ultimately is very personal. As Dr Best, representing Dr Jensen, the Anglican Archbishop of Sydney, pointed out:

The moral status of an embryo is not a fact but a value. We will each decide that which is valuable to us on the basis of our world-views. But we live in a multicultural democracy and world-views abound.

It has been suggested that an embryo that is excess to the needs of the donor parents has the same moral equivalence as an adult. What this position fails to acknowledge is that an embryo that is not going to be implanted in a woman's uterus cannot achieve its potential. The potential for life is present but cannot be fulfilled. During the committee hearings, Ms Sandra Dill from ACCESS— Australia's National Fertility Network argued against the view that the willingness of parents to donate their embryos for research purposes signified a lack of respect or a crude commodification of life. As ACCESS submitted, and these are Ms Dill's words:

Those of us who have created embryos have grappled with the ethical and social implications of what to do with them because we must. They are ultimately our responsibility. Then we live with the decisions we make about them. We care about the fate of the embryos that were created to be our children, to see that their existence has had some meaning. We do not believe that to use them for research would be disrespectful, quite the contrary. For many couples, the opportunity to donate their embryos for ART research gives them some added meaning, as they contribute to scientific knowledge that will lead to improvements in ART practice and ease human suffering. No one else values or respects these embryos more.

This is a personal decision that we all must make and in doing so remain respectful of each other's positions. I move now to some of the elements of the bill. Under clause 39, before an excess ART embryo may be used, each `responsible person' must have given `proper consent' to the use authorised under the licence. That is in addition to the donor's determination that the embryo is excess and their written authority for its use for purposes other than their own ART treatment. The bill provides for informed consent provisions to be applied. Much has been said about the ability of either adult or embryonic stem cells to provide potential therapies for a range of diseases. A number of submissions to the committee argued or implied that recent developments in adult stem cell research and therapies made embryonic stem cell research redundant. This was firmly rejected by a number of scientists specialising in both embryonic and adult stem cell work.

Rather than engage, though, in a tit for tat between the two fields of research—and, I must say, both have the potential to deliver cellular therapies—it is the view of many eminent researchers that both need to be progressed and, further, that there are synergies that will emerge when adult and embryonic research is conducted together. Associate Professor Simmons, of the Peter MacCallum Cancer Institute and a leading stem cell researcher, stated:

... adult stem cell researchers and the embryonic stem cell researchers will benefit from understanding the two systems. In the end we both benefit. I think integration between the two is really ... important. There is a synergy there and it is a driving force for discovery which neither field of stem cell research alone would likely produce.

This was supported in evidence by most respected researchers. There are two main reasons given by scientists for the need to continue research into both adult and embryonic stem cells. Firstly, it is too early to determine fully just what the potential applications of the sets of stem cells are. Secondly, there is a possibility that advances in one field will spur advances in the other.

To correct the record from yesterday, it should be noted that the respected adult stem cell researcher Professor Verfaillie is clearly on the record as supporting the advancing of both areas of research. Some people are, I believe, intentionally overstating her results to indicate that adult stem cell research makes embryonic stem cell research completely redundant. She herself does not make that claim and rejects that such a conclusion can be drawn from her work. It is interesting that people who hold up Professor Verfaillie's work in this manner fail to mention that in fact her results have not been replicated in any other laboratory in the world. I want to make it clear that, as her results are very recent, it would be surprising if they had been reproduced yet. However, I think there is somewhat of a double standard at play in this area in that a number of people have strongly criticised the science of embryonic stem cell advocates without acknowledging the limitations of adult stem cell research as well.

At the committee hearings on 19 September, Professor Bartlett, the Foundation Professor of Molecular Neuroscience at the University of Queensland, outlined very clearly some of the difficulties he believes confront embryonic stem cell researchers if they are to achieve therapies. He concluded:

... in no way am I suggesting that we should not have a shot at seeing if embryonic stem cells really can fulfil a potential that these other cells cannot ... as a scientist I know that discoveries do not often come in a linear manner; they come from left or right field. So I would never cut off a potential cure base or a potential discovery because of the thought that you know the answer.

I think that is a really important point. Professor Bartlett, I think it is fair to say, is sceptical of the therapeutic potential of embryonic stem cells because of immunological difficulties. However, he clearly understood that science, medical science, is unpredictable. More to the point, he was not dogmatic. He was not so arrogant as to believe that he knew the answers. In my view, Professor Bartlett showed humility towards the intrinsic nature of knowledge and the pursuit of knowledge that others could learn from.

There is a question as to whether existing stem cell lines are adequate. It has been suggested a number of times in this chamber and in the inquiry that, as there is little prospect of clinical trials using human embryonic stem cells in the short to medium term, there is no need for additional stem cell lines because there are adequate existing lines available for research. I do acknowledge that there seems to be some difference of opinion on this matter among scientists.

However, in the inquiry there were a number of very good reasons put forward about why new embryonic stem cells were required for research. They included: existing stem cell lines have been created with mouse feeder cells and these create unidentified effects. In addition, feeder layers give signals to the cells to allow them to change from inner cell mass lines to cell lines but it is likely that those cell lines will behave differently with mouse feeder cells, as they would with human derived feeder cells. This means that the research conducted with mouse derived feeder cells will need to be repeated with human derived feeder cells. Long established cell lines that have been used for hundreds and hundreds of passages are not likely to give as clean a result as is required for research. Scientists need cells that are in the best possible state. As embryonic stem cell research is in its infancy, it is likely that future improvements in initiating and growing stem cell lines will lead to second generation lines with improved properties. Where there are commercial barriers to existing stem cell lines, researchers will want to create their own lines.

In addition, a number of reasons why additional stem cell lines were required for therapeutic reasons were identified. They included: human embryonic stem cell lines using mouse feeder cells are considered by the FDA to be contaminated by animal pathogens. That means that they cannot be used for clinical trials. If—and I said `if'— and when there is a prospect of safe human trials, stem cell lines compliant with the FDA's current good manufacturing practice guidelines will be required. Further, clinical therapies using embryonic stem cell lines will have to address immunological rejection and this may require larger panels of stem cell lines. The committee was also told that relying on mouse embryonic stem cell lines creates problems when trying to investigate some diseases. In my view, a strong case has been made that we should support the need for new stem cell lines and that relying on existing stem cell lines is not good enough for ongoing research, let alone possible therapeutic purposes.

Much has been said about the number of embryos available for research. Even in this week's press, and again in the chamber yesterday, last night and again today, there have been references to there being over 70,000 embryos available for research. This is simply just not true. I am continually annoyed that the people saying it are people who should know better. They are senators who attended the hearings, they are senators who received the evidence from a range of people, and they are senators who know that there are not 70,000 embryos available for research.

The committee was advised that there are 71,176 ART embryos in storage because the couples for whom they are created either still want them—they have not decided that they are no longer required—or, if they are in excess, have not determined what they want to do with them. It is just not known exactly how many of these are excess in any given year or how many would be available for research. However, we received very good evidence at the committee hearings that would indicate to those senators who continually use that figure the sorts of numbers that may be available. The NHMRC provided data from the South Australian Council on Reproductive Technology which shows that on 31 December 2001 there were 5,718 embryos in storage—1,239 of those were stored for couples who at the time still intended to use the embryos. In 2001, 423 embryos had been destroyed—374 of those at the couple's request. There were 110 embryos donated for use by other couples, and 137 of the approximately 7,000 embryos were donated for research.

Professor Peter Illingworth from the Westmead Fertility Clinic also provided evidence to the committee that 450 letters were sent to couples who had used the clinic and who had embryos in storage for more than two years. A hundred of those couples responded—a number had moved and a number of couples did not respond because I think they had lost contact. Fifteen couples— three per cent of the couples who were written to—decided that their embryos were excess to their requirements. Of these, seven requested that their embryos be allowed to succumb and eight couples indicated an interest in donating their embryos. All of those people attended counselling but only three of the 450 couples went on to donate their embryos.

The South Australian data combined with Professor Illingworth's experience indicates that there simply are not 71,000 excess ART embryos available for research. The number of embryos available for research and stored prior to 5 April is likely to be very small, and it cannot be assumed that many couples will seek to donate embryos excess to their requirements. So it is simply misleading to say that there are over 70,000 embryos available for research, and I urge senators to be careful with their language.

During the course of the inquiry it was suggested that Australia could use the model recently adopted in the United Kingdom of a national stem cell bank. Mr Ilyine of Stem Cell Sciences suggested that such a facility might minimise the number of embryos that may be required to create new stem cell lines. Furthermore, he said that the UK National Stem Cell Bank was established to hold all the stem cell lines in a central point where there would be free and unencumbered access to those stem cell lines to qualified researchers.

This proposal seemed to a number of the senators at the inquiry to have merit, but I have to say it was not discussed at length by other witnesses. Given that the UK experience is so new and there seemed, albeit from limited evidence, some merit in the proposal, Senator Stott Despoja and I recommended in our additional comments to the inquiry an amendment—and we have subsequently circulated it—which would require the review that is to be conducted in the third year of the operation of the act to include a new term of reference. This term of reference would require the independent review—and I remind the Senate that it is an independent review— to assess the applicability of establishing a national stem cell bank here in Australia along the lines of the UK model. In conclusion I must say the legislation is supported by all states and territories as a national regulatory framework. It is careful and conservative legislation. It is sound legislation, and I will be supporting it and suggest it should be supported.