Therefore, it is prudent to isolate and investigate the capabilities of both embryonic and adult stem cells, since it may transpire that cells from different sources have specific applications for which they are best suited - horses for courses.[524]

3.35 Dr Simmons 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.[525]

3.36 Professor Williamson, Director, Murdoch Children’s Research Institute and Professor of Medical Genetics, University of Melbourne (and an adult stem cell researcher), stated:

What I believe to be absolutely certain is that there are real benefits in allowing adult and embryonic stem cell research to proceed side by side in the same laboratories, so the experiments cross-refer and so that lessons can be learnt by comparing the two systems.[526]

3.37 Professor Trounson advised the Committee that a key feature of the National Stem Cell Centre will be the integration of researchers in adult stem cells, embryonic stem cells, transplantation biology and tissue engineering.[527]

3.38 Professor Verfaillie has adopted a similar approach. In a recent interview on the ABC she stated

And so I think my message has always been, even though we’re excited about the adult cells, that its too early to say that they will replace embryonic stem cells to the point that our institution, the Stem Cell Institute, we actually recruited and investigated who has extensive experience in human embryonic stem cell work, so we’re now in a position to do ... parallel research and comparing and contrasting the two cell types.[528]

3.39 We conclude that it is a false dichotomy to consider the issue in terms of embryonic stem cells versus adult stem cells. We believe a very strong case has been made to encourage research on both with a view to understanding their relative merits and disadvantages. Moreover, there is a very good case to be made for encouraging productive cross-fertilisation of ideas and methodologies. While not relevant to the Bill as such, we note that this synergy between adult and embryonic stem cell research is a central feature of the National Stem Cell Centre.

Embryonic Stem Cell Research - Broader Than Therapies

3.40 The strongest criticisms of proponents of human embryonic stem cell research (as science) was directed at the claims of the potential for the development of therapies to treat or cure diseases including Alzheimer’s Parkinsons, Motor Neurone Disease and Type 1 diabetes.

3.41 For instance, Emeritus Professor Martin asserted

All the proponents of human embryonic stem cell research rely ultimately on the one argument - that cures for chronic disease are sure to follow.[529]

3.42 In our view, a significant consequence of the focus on potential therapeutic applications was that there was a lack of appreciation that ES research is, in fact, multi-faceted.

3.43 A balanced view needs to be mindful that human embryonic stem cell research is a broad term that encapsulates a range of research projects.

3.44 In the course of the inquiry a number of these were identified including;

• Discovering the factors that influence and regulate cell differentiation and tissue formation[530];

• Developing methodologies to control differentiation

• Understanding how diseases occur and how particular genes lose their regulators and are associated with cancer or are involved in formation of cells of genetic diseases;[531]

• Screening drugs for toxicology and effectiveness on stem cell lines that have differentiated into liver, kidney, heart and other cell types[532] (not to be confused with possible toxicology studies on embryos); and

• Possible therapies including tissue transplant and pharmaceuticals.[533]

3.45 While science does not neatly divide into basic and applied research, there is clearly a spectrum of discovery and application elements to these broad strands of human ES research.

Are more stem cell lines required?

3.46 If, as we have concluded, there is a strong case for ongoing human embryonic stem cell research, there is a question as to whether existing stem cell lines are adequate.

3.47 Throughout the inquiry there was extensive discussion on how many embryos would be required. Oddly, there was little discussion on the more fundamental question of why more embryos might be required.

3.48 It was suggested to the Committee that as there was little prospect of clinical trials using human ES cells in the short to medium term there was no need for additional stem cell lines (thus access to more embryos) because there were adequate existing stem cell lines available for research.

3.49 Professor Silburn, whilst highly critical of the claims concerning possible therapeutic applications of embryonic stem cells, did not object to ongoing research but questions why more embryos are required.[534]

I think the research should go ahead - absolutely - and it will go ahead whether or not the bill fails ... Parkinson’s Australia is very happy for research to continue, and I will be pleased to report to everybody that if the bill fails that research will continue.[535]

3.50 Professor Good stated:

There are already ES lines that will not be affected by the act, which could be used for research. They are already there, they will not be blocked by the act. So why do they want more embryos? The only reason I can think of is that drug companies may wish to use them for screening.[536]

3.51 There seems to be some difference of opinion on this among scientists. Bresagen, for instance, submitted that there is no current need to derive new human embryonic stem cell lines for research, in part, because, new ESC lines will not be eligible for world wide National Institutes of Health research funding.[537]

3.52 In response to a question from Senator Barnett, Mr Ilyine advised the committee:

You suggested that there are a number of people who provided evidence that said that there were no further cell lines needed more or less forever. I think experience in time has shown that that is not really the correct position, which is that there are in fact additional cell lines needed for all sorts of reasons. We already have made some progress from mouse feeder cell systems to human feeder systems, but I would argue that perhaps that is not far enough either, and that actually the cells in time, to be fully GMP compliant, would have to be able to grown in a fully defined medium where all the components of the medium were known and understood to be safe in their own right.[538]

3.53 In evidence and discussion a range of reasons why new embryonic stem cells were required for research were offered.

• Existing stem cell lines have been created with mouse feeder cells “which produce as yet unidentified substances necessary for stem cell research.[539]
• New stem cell lines will need to be created because 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 so that research conducted with mouse-derived feed cells will need to be repeated with human-derived feeder cells.
• Restricting access to existing SC lines is a problem for obtaining proof of principle because “you do not want to be doing experiments on cell lines that have been passaged for hundreds and hundreds of passages. If one were restricted to a very few lines, whether they be mouse or human, the likelihood of being able to obtain that proof of principle may be difficult. You would want to be dealing with cells that were in the best possible state.”[540]
• As ES research is in its infancy, it is likely that future methodological improvements in initiating and growing stem cell lines will lead to second generation lines with improved properties.[541]
• Where there are commercial barriers to existing stem cell lines, researchers will want to create their own lines[542]

3.54 In addition, a number of reasons why additional stem cell lines were required for therapeutic reasons were identified, including:

• Human ES lines using mouse feeder cells are considered by the FDA to be contaminated by animal pathogens (xenotransplant) and thus not permitted for clinical trials;[543]

• If and when there is a prospect of safe human trials, stem cell lines compliant with the FDA’s current Good Manufacturing Practice (cGMP) guidelines will be required; and [544]

• Clinical therapies using embryonic stem cell lines will have to address immunological rejection and this may require larger panels of stem cell lines.[545]

3.55 Moreover, relying on mouse ES lines is problematic when trying to investigate some diseases. Professor Bartlett informed the committee that:

animal models are in fact deficient in terms of reflecting the actual disease process. This is because we do not actually know what causes Alzheimer’s disease or what causes motor neurone disease. So you have animal models that result in a similar complaint, but they may not reflect the underlying cause of that disease.[546]

3.56 We conclude that a strong case has been made to support the need for new stem cell lines and that existing stem cell lines are not adequate for research and, in the longer term, therapeutic purposes.

How Many Embryos required?

3.57 Recognising that there is an established need for new stem cell lines, the next question - and one that prompted considerable debate during the course of the inquiry - is how many embryos will be required.

3.58 It is likely that the biggest call in the short term will come from IVF Clinics. Professor Jansen advised that hundreds of embryos will be required to develop meaningful results in development of culture medium.[547]

3.59 In respect of embryonic stem cell research, there was a very wide range of numbers offered including 20 - 50 ( Trounson), 600 - 1000 (Bresagen), through to millions (Good).

3.60 There was considerable comment on the disparity of these figures. Professor Silburn stated, for instance, that:

clearly if the point of the bill is how many we need and nobody can agree on how many we need, we are lacking some science here.[548]

3.61 Professor Trounson explained that part of the difficulty in estimating the number of stem cell lines needed in the future was that:

it would depend on the outcome of the research. If the research were shown to be successful in the induction of (immunological) tolerance to embryonic stem cells and their derivatives, we may need a panel of embryonic stem cells, in which case maybe 50 is sufficient. I am not really certain, but it would be a number of them. They would have to give you advice in the future when the research was done.[549]

3.62 Dr Juttner believed that 600 - 1000 such therapeutic lines will provide adequate immunological matching.[550]

3.63 Professor Good disputed these figures and outlined some of the complexities of donor matching: I believe that to get a (stem cell line) bank suitably large enough to guarantee you a reasonable chance of finding a correct tissue typing match, you would need a bank of approximately 10 million.[551]

3.64 Professor Silburn is correct, there is some science missing. What is missing, as discussed above, is certitude as to how or whether immunological rejection of embryonic stem cells can be overcome. That is the fundamental basis of the disparity in the figures.

3.65 Although it may seem odd, the arguments are entirely consistent. Professor Good is arguing that millions of stem cell lines are likely to be required to maximise a good match to minimise or eliminate immunological rejection if no other techniques are discovered to avoid this.

3.66 Bresagen and Trounson are arguing that they might be able to overcome that by a variety of approaches and if that is successful then they believe considerably less lines will be required.

3.67 While we understand the preference and desire for certitude we see uncertainty as an intrinsic feature of new and complex areas of research. We do not regard the disparity as a defect, but simply underscores the fact that this is emergent research. It does, however, reinforce the argument for good, nationally consistent regulation.

3.68 We find it quite unremarkable that there were divergent and at times strongly held differences between scientists concerning the therapeutic potential of embryonic stem cells. Disputes over the facts and the meaning of the facts is common, typical even, in science, particularly in fields as complex and new as stem cell research.[552]

3.69 It should be noted that COAG requested the NHMRC report within 12 months on the adequacy of supply of excess ART embryos which otherwise would have been destroyed because of the lack of detailed knowledge on the numbers of embryos available for research.[553]

Are there really 70,000 ‘excess’ embryos?

3.70 It was widely claimed in inquiry submissions and by witnesses that there are about 70,000 excess ART embryos. This is not correct.

3.71 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; have not decided that they are no longer required; or if excess, have not determined what they want to do with them.[554]

3.72 It is not known how many of these are excess in any given year or how many would be available for research.

3.73 The NHMRC provided data from the South Australian Council on reproductive Technology which shows that, as of 31 December 2001;

• 5718 embryos in storage
• 1239 were stored for couples who at the time still intended to use the embryos
• in 2001, 423 embryos were destroyed (374 at the couples request)
• 110 embryos donated for use by other couples
• 137 embryos donated for research.[555]

3.74 Professor Peter Illingworth, also provided advice to the Committee that

• 450 letters were sent out to couples with embryos in storage for more than 2 years
• 100 couples responded;
• 50 couples had moved; and
• 250 couples did not respond.

3.75 Only 15 couples (3% of couples written to) decided that their embryos were excess to their requirements. Of these;

• 7 couples requested that their embryos be allowed to succumb; and
• 8 couples indicated an interest in donating their embryos. All attended counselling but only three couples went on to donate their embryos.[556]

3.76 The SA data combined with Professor Illingworth’s experience suggest:

• There are manifestly not 71,000 excess ART embryos;
• The number of embryos available for research and stored prior to 5 April 2002 is likely to be very small;
• It can not be assumed that many couples will seek to donate embryos excess to their requirements.

Creation of excess embryos

3.77 The prospect of creating excess embryos for research was also raised in the context of restrictions on accessing embryos created after 5 April 2002 after three years or earlier if determined by COAG.

3.78 In their submission to the inquiry, the Southern Cross Bioethics Institute asserted;

If embryos created at any time and excess to the requirements are available to researchers, it would not be difficult to create an excess of embryos by simple changes to practice of IVF clinics. This would in effect constitute the de facto production of human embryos deliberately for the purpose of research.[557]

3.79 In a question on notice by Senator Stott Despoja, witnesses were asked

Do you agree with the assertion that creation of excess embryos could be done with ‘simple changes to practices’? It seems to me that there are two elements to this - the regulatory and the medical.

3.80 In response Professor Illingworth advised the committee that:

This assertion is unfounded. I would like to make the following points in response.

Medical

1. As outlined in my presentation, due to the variable and highly unpredictable factors involved in the achieving the result of healthy embryos for implantation, current clinical practice is to stimulate the ovaries with the aim of collecting 10 or so healthy eggs in the hope that sufficient will fertilise normally then develop satisfactorily in order to give a chance of a successful pregnancy.
2. The number of eggs is primarily dictated by the number of eggs already growing in the ovary at the time of starting treatment with fertility drugs. The number of eggs already growing in the ovary at the time of treatment cannot be altered by any means currently known to medical science.
3. Thus most patients undergoing IVF already receive a maximal dose of fertility drug and giving a higher dosage will not increase the number of available eggs.
4. There are however a small number of younger patients where a sub-maximal dose is used. This is because the maximum dosage would stimulate a very high number of eggs to grow in these women. This outcome would put those patients at risk of a serious medical condition (called ovarian hyperstimulation syndrome) which leads to accumulation of fluid in the abdomen and sometimes chest with very serious health consequences for the patient.
5. The deliberate and dangerous use of these maximal doses in a minority of younger patients is thus the only way that creation of excess embryos could be initiated

Regulatory

Such a practice would be contrary to explicit RTAC guidelines. As of this year, the data reporting process for IVF clinics to the National Perinatal Statistics Unit has been extended to include a requirement for every clinic to report quite specific information about the number of eggs collected and the number of embryos being collected per treatment cycle for every clinic in Australia. Through this process, these data for each clinic will be compared with natural means. If any clinic did opt for the unethical and unacceptable practice suggested above, this will be readily apparent to RTAC from this data set and RTAC would be able to act accordingly.[558]

3.81 In a subsequent communication to the Committee, Southern Cross Bioethics cited evidence given by Dr Jansen to the Senate Select Committee on the Human Embryo Experimentation Bill 1985 where he stated:

It is a fallacy to distinguish between surplus embryos and specifically created embryos in terms of embryo research ... any intelligent administrator of an IVF program can, by minor changes, in his ordinary clinical way of going about things, change the number of embryos that are fertilised .. it would be but a trifle administratively to make those embryos surplus rather than special.[559]

3.82 Following on, Southern Cross Bioethics stated:

“Presumably, all that would need to change would be more eggs would be collected and fertilised. Coupled with a trend towards less embryos being transferred, it is likely that even more surplus embryos would be created surplus to requirements and therefore able to be used in research.[560]

3.83 This, they stated, was the basis for their statement that it would not be difficult to create an excess of embryos, in their submission (cited above).[561]

3.84 The 1985 quote of Professor Robert Jansen was referred to a number of times during this inquiry, notably by Senator Harradine.

3.85 It is important to note that in his submission to this inquiry, Professor Jansen explicitly refuted his position of 1985.[562] He pointing out he had changed his position of 17 years prior because of advances in scientific knowledge of the ovulation process.[563] In evidence entirely consistent with Professor Illingworth’s and Dr Pope’s, he stated that “the number of eggs and embryos available to the woman also is fixed by physiological processes out of the physician’s control”.[564]

3.86 While we take Southern Cross Bioethics’ point that a trend to less embryos being transferred may increase the number of excess embryos it does not follow that there are medical grounds to reduce the number of ova taken for IVF treatments.

3.87 Professor Jansen advised the committee that “it is not medically possible to vary the numbers of eggs that respond to stimulation upwards at all and it is not possible downwards without compromising the chance of success for the woman.”[565] The clear message being there are good medical reasons for the current numbers of ova utilised for IVF treatment.

3.88 We conclude that there are no grounds to substantiate Southern Cross Bioethics’ assertion that “it would not be difficult to create an excess of embryos by simple changes to practice of IVF clinics... (for) ... the de facto production of human embryos deliberately for the purpose of research”. Moreover, the Bill makes it an offence to deliberately create embryos for research.

3.89 Senator Harradine and a number of witnesses made much of Professor Jansen’s 1985 comments to highlight concerns about deliberate production of excess embryos.[566] We would like to place on record our belief that Professor Jansen’s refutation of his earlier position is highly credible and entirely consistent with the medical and scientific evidence provided by Professor Illingworth and Dr Pope. Consequently, we contend that any further citation of his 1985 statements that deliberately seeks to advance a position contrary to his current view must be considered mischievous.

4. Impact on IVF Practices

4.1 The committee heard evidence that the legislation would have a significant impact on current IVF practices.[567]

4.2 A major concern is the requirement that training, quality assurance and testing of culture mediums would need to be a licenced activity. These activities are already routine in IVF clinics and “are crucial for maintaining the highest quality care and improving success rates and so impact on couples currently on treatment.[568]

4.3 It was argued that the requirement that these activities be licenced meant the Bill went further than the COAG agreement (also see below).[569] The Committee was advised that these activities should be made exempt from requiring a licence and amendments (the ‘Gambaro amendments’) passed to treat training, quality assurance and testing of culture mediums as exempt items in s.25(2) of the Research Involving Embryos Bill 2002.[570]

4.4 However, the NHMRC advised the committee that

including an exemption for training could create a loophole in the legislation because it would be very difficult to distinguish between training, quality assurance activities and research.[571]

4.5 The committee was also advised that the extension of the licencing requirements to practices that have long been conducted in all jurisdictions was to ensure consistent legal and ethical treatment of different uses of embryos.[572]

4.6 IVF clinics will be entitled to apply for a licence to conduct such activities on excess ART embryos created before 5 April 2002. However, it was argued that the ban on fresh or frozen embryos created after that date would “severely compromise” embryology training programs, laboratory quality assurance processes and embryo culture system improvements.[573]

4.7 An additional matter was raised by Professor Robert Jansen, Sydney IVF, who advised the committee that s.15 of the Prohibition of Human Cloning Bill would ban Cytoplasmic transfer, a new ART technique that may be of significance in treating older women.[574]

4.8 In our view, the new licencing requirements will have an impact on IVF Clinics. At least one consequence will be increased costs for treatments as there will be compliance costs although it is not yet known how much they will be.

4.9 While sympathetic to the IVF Clinics concerns, we conclude that the benefits of including training and other practices in the framework of the licencing arrangements is justified.

4.10 We note the Bill provides for a review (s.61) and it will be useful to gauge what actual impacts the Bill has had on IVF practice.

5. Concerns Over Nature of Evidence

5.1 In many submissions and in oral evidence given to the committee, concerns were raised about the nature and quality of evidence given to the media, Members of Parliament and this Committee during the course of the inquiry. These concerns include allegations of misinformation, misrepresentation of science, deliberate omission of relevant information, creation of false or unrealistic expectations and exploitation of people with disabilities.[575]

5.2 Mr Sullivan, Chief Executive, Catholic Health Australia asserted, for example:

Put simply, there is a ruse being perpetrated by members of the scientific and business community. I would go so far as to suggest that a deliberate campaign of misinformation is being conducted. They have built up false expectations that miracle cures are just around the corner, if only experimentation on embryos can be permitted ... As a consequence, we have COAG making an illogical and rushed decision.”[576]

5.3 While many of the criticisms were directed at Professor Trounson with claims he misled politicians by omitting information (see below), we believe some balance is required.

5.4 Recently, Dr David Prentice of Do No Harm (America) travelled to Australia to lobby against permitting embryonic stem cell research. He presented himself as an independent scientist with expertise in adult stem cell research.

5.5 However, neither in the promotional material provided by Do No Harm or Dr Prentice was his work as an “ad hoc science advisor” to Senator Brownback and Congressman Weldon (the Republican sponsors of an anti-cloning Bill) advised. While this makes no claim on the veracity of Dr Prentice’s scientific arguments, affiliations of this nature are of more than passing interest in the context of a parliamentary debate, particularly as transparency of interests and misleading information have been key topics of discussion.

5.6 Senator McLucas asked Dr van Gend whether Do No Harm funded Dr Prentice’s travel and accommodation. He advised the committee that the visit was initially underwritten for about five thousand dollars by the National Civic Council and this money was largely repaid through Professor Prentice’s public meetings in Australia.[577]

Exploitation and False Hopes

5.7 In his submission, Dr McCullagh was highly critical of proponents of ES cell research accusing them of:

exploitation of highly vulnerable people living with disabilities ... to legitimize ES cell production ... individuals with major chronic disabling conditions are a resource to be manipulated in television studios.[578]

5.8 This was rejected by Ms Knott, Director, Australasian Spinal Research Trust, who responded to Dr McCullagh’s comment, saying:

I think it is very sad that you would try to take an opinion like that without actually living through the condition, but I for one was responsible for founding the Australasian Spinal Research Trust, so no one could say I am being manipulated into doing that.[579]

5.9 Mr Robert Turner, Honorary Chief Executive Officer, Australasian Spinal Research Trust stated:

One of the things ... (people with such diseases) ... fight against is being talked down to like that as though they have not got the ability to discriminate between what is exploitation and what is not.[580]

5.10 Ms Knott added:

The reality is that we do follow very closely and we have done for a number of years, what research has gone on around the world, and I think we do have a good sense of what is credible and what is not.[581]

5.11 A number of submittees suggested politicians had been notably susceptible to emotive arguments and over-blown claims of cures. Dr van Gend asserted that:

It is vital to realise that the debate has largely been driven among the politicians and the public by the emotional images of suffering patients with afflictions ... we have let loose an army of mothers on all of you politicians, battering down your doors and saying, ‘How dare you get in the way of embryo research when it is going to cure my child of cystic fibrosis?’, or of its spinal injury.[582]

5.12 The Chair rejected this assertion, saying:

I have to say, Doctor, that that is simply not true as I sit here today. There are people who hold hope. They do not hold hope that it is tomorrow or next week or next year. I think it is quite wrong for anyone to come before this committee and tell me that that is what has been put to me... because quite frankly that is not so.[583]

5.13 We can confirm that our experience reflects that of the Chair.

The Trounson Debate

5.14 Strong criticism was directed at Professor Trounson for the way he represented experiments on a rat, by Dr Kerr of Johns Hopkins University, at Parliament House in August 2002.

5.15 As the Chair’s report notes the key criticisms went to him misleading politicians and the media by stating the experiment used human embryonic stem cells when it was subsequently established that they were human germ stem cells and his use of unpublished material (2.20-2.23).

5.16 In evidence to the Committee, Professor Trounson explained his terminology:

I did not mislead members of parliament because the terms ‘embryonic stem cells’ and ‘embryonic germ cells’ are often used interchangeably.

5.17 He provided a number of examples, including:

Firstly, embryonic stem cells are defined as ‘cultured cells obtained by isolation of inner cell mass cells from blastocysts - these are the IVF embryos - ‘or by isolation or primordial germ cells from the foetus’ in the Andrews committee report on human cloning.[584]

5.18 As the Andrews Report (The House of Representatives Standing Committee on Legal and Constitutional Affairs, Human Cloning, August 2001) has been a key reference for parliamentary and public debate on this issue, the failure of the Chair’s report to draw attention to the definition it adopts for embryonic stem cells is a significant oversight.[585]

5.19 Professor Trounson also stated:

Secondly, the primary review of the subject Stem Cells: Scientific Progress and Future Research Directions by the United States Institutes if Health, available on their website, describes the Kerr Research as follows:

Researchers at Johns Hopkins University recently reported preliminary evidence that cells derived from embryonic stem cells can restore movement in an animal model of amyotrophic lateral sclerosis, ALS.[586]

5.20 Professor Trounson went on to address the issue of using unpublished material by stating:

It is not permissible to distribute manuscripts submitted to Nature journals until after publication. This is an undertaking that authors agree to when submitting their papers to these journals. I concluded, therefore, that the manuscript must have been published. ... My error was in assuming, as would thousands of scientists familiar with the publication rules of Nature journals, that the article had been published.[587]

5.21 On this explanation, Dr van Gend, of Do No Harm, stated:

It is a fair comment, I think, to say that he thought it had been sent by Dr Kerr meaning that it must have been published - the fact that it was sent in this way gave him an impression.[588]

5.22 Professor Trounson’s explanation is on the public record.

5.23 This incident provoked strong attacks impugning the motives of Professor Trounson.

5.24 Professor Silburn stated, for instance:

it was said that this was a nave attempt and all that. Professor Trounson is very well regarded, and I do not see how it could be naivety that did that.[589]

5.25 Dr van Gend, claimed:

there is a much more widespread and pervasive distortion of the science (than the rat), which has primarily been carried out by Dr Trounson because he is the main spokesman.”[590]

5.26 However, Dr Tonti-Filippini stated that

it seems to me that this debate has been greatly harmed on both sides by a lack of reference to materials.[591]

5.27 Claims about misrepresentations of aspects of stem cell science in the media functioned as an unexamined, generalised ‘given’ in the inquiry, as very few copies or citations of media stories were provided.

5.28 In our view, the evidence provided to the committee by scientists supporting embryonic stem cell, notably Dr Juttner, Associate Professor Martin Pera, Dr Simmons, Professor Williamson, Dr Stanley and Dr Elefanty were measured, supported and realistic. On the basis of the evidence they provided to the Committee, we do not feel that they, or Professor Trounson, can be accused of building “up false expectations that miracle cures are just around the corner, if only experimentation on embryos can be permitted.”[592]

5.29 Nor did representatives from groups with disease or disability over-estimate ES research.

5.30 James Shepherd, a 13 year old who has lived with Juvenile Diabetes since he was 5 years old, told the committee:

There are approximately 100,000 juvenile diabetics in Australia, and there are more being diagnosed each year. I think all of us deserve a chance for a cure... the cure could lie in adult stem cells or embryonic stem cells or it could lie in one of the many other types of research, but I think that every possibility for a cure should be fully explored before it is banned completely.[593]

5.31 Ms Knott, Director, Australasian Spinal Research Trust, said:

It is imperative that we protect important areas of medical research that we offer hope to hundreds of thousands of Australians. I do not expect a cure tomorrow or even next year, and I do not intend to overstate the promise of research, but how can you overstate hope?[594]

Public involvement in bioethical issues

5.32 Evidence given to the inquiry shows that there is a need for better mechanisms to educate and involve the public in the bioethical debates. We need to ensure that the public has access to information, that they are educated about the issues in language they understand, and that they feel able to make their voices heard on the issues.

5.33 For some years now, under both Clinton and Bush, the United States has had a Presidential Commission on Bioethics. It is a model we could well adopt here.[595]

5.34 The US Commission provides a forum for a national discussion and exploration of bioethical issues. It is charged with exploring the ethical and policy questions related to developments in biomedical science and technology and assessing public concerns about these developments.

5.35 The Commission is guided by the need to articulate and present a variety of views rather than reaching a single consensus opinion.

5.36 Such a process, properly constituted, could help facilitate a greater understanding of bioethical issues and a better public debate here in Australia.

6. Specific Issues Related To The Bill

Scope of the Bill

6.1 A concern raised by a number of submittees to the Committee was the Bills went further than the intent of the COAG agreement.

6.2 Dr Best, representing Dr Jensen, the Anglican Archbishop of Sydney stated

My understanding was that the object of the act was to allow frozen excess embryos in ART labs around the country to be used to derive embryonic stem cells specifically; but that is not specified in this legislation. In fact, any use of human embryos which the NHMRC Licencing Committee feels is worth while is approved, under this legislation. ... If the legislation is to be passed, I would be much happier if there were tightening of the legislation so that the human embryos currently frozen in ART labs can only be used for the extraction of human embryonic stem cells.[596]

6.3 The Research Involving Embryos Bill 2002 requires all proposed research activities using excess ART embryos are assessed and licenced by the licencing committee and that licences must satisfy;

• consent provisions (36(3)(a) also 39(1)(a) )
• embryos must be created before 25 April 2002 if the research will damage or destroy the embryo (36(3)(b); and
• the proposal has been assessed and approved by the local Human Research Ethics Committee (36(3)(c)).

6.4 The bill permits some activities to be exempt from requiring a licence (25(2)) including the storage, removal (from storage), transport and observation of excess ART embryos.

6.5 According to the Explanatory Memorandum activities that would need to be licenced include;

• For research (for example, to derive stem cells or to improve ART clinical practice)
• To train people in ART practice
• For quality assurance testing to ensure that pre-implantation diagnostic tests give accurate results; and
• To examine the effectiveness of new culture medium.[597]

6.6 Dr Clive Morris, NHMRC, informed the committee that research could also include understanding embryonic development and fertilisation, studies in genetic make-up and expression and drug testing including toxicology providing any such proposal met the licencing requirements and would be subject to whatever the conditions the licence requires.[598]

6.7 The net affect is to ensure all uses of excess ART embryos are prohibited unless they are licenced or exempt.

6.8 In the introduction to the COAG communiqu, it is stated that:

the Council agreed that research be allowed only on existing excess ART embryos, that would have otherwise been destroyed, under a strict regulatory regime ... donors will be able to specify restrictions, if they wish, on the research uses of such embryos.[599]

6.9 In the appendix to the communiqu (that provides more detail on the contents of the framework), the relevant points are:

A nationally-consistent approach to research involving human embryos