Please note: This is an extract from Hansard only. Hansard extracts are reproduced with permission from the Parliament of Tasmania.
HUMAN EMBRYONIC RESEARCH REGULATION BILL 2003 (No. 59)
Second Reading
Mr LLEWELLYN (Lyons - Minister for Health and Human Resources - 2R) - Mr Speaker, I move -
That the bill be now read the second time.
The Council of Australian Governments at its meeting of 5 April 2002 agreed to prohibit human cloning and to establish a nationally consistent scheme which will regulate research involving human embryos by requiring researchers to be licensed and to use only embryos deemed excess under the legislation.
Tasmania does not have a legislative framework governing the creation, use of, or research involving human embryos. This bill will create a rigorous regulatory regime for the use of excess human embryos, which are important because medical technology is bringing us closer to discoveries that were previously in realm of science fiction. This bill clarifies what is acceptable scientific practice and what is not.
The Government has a strong commitment to ensuring that research which may lead to the discovery of treatment and cures for diseases and other degenerative illnesses such as diabetes, Alzheimer's, cystic fibrosis, spinal cord injuries, burns and certain cancers, is not unreasonably restricted. Governments have a responsibility to act to alleviate human suffering and to preserve human dignity and the legislation will ensure a balance that will allow approved medical research to be carried out within an appropriate and considered framework of regulation.
The States and Territories commitment through COAG to the nationally consistent scheme for the regulation of research involving human embryos has been informed by close analysis of the central ethical, social, legal and moral issues that are relevant to this matter. The Commonwealth Government during the development of its component of this legislative scheme heard the views of key stakeholders in the scientific community in relation to the issues associated with this rapidly developing area of science, as well as the views of ethicists and other community leaders.
Those views led the State, Territory and Commonwealth Governments to the view that a strict regulatory scheme was needed to ensure that all research was ethically based. The licensing arrangements through the NHMRC put in place by the Commonwealth and complemented by State and Territory legislation will achieve that outcome. It is important to emphasise that the Commonwealth legislation itself will cover the greater part of research activities in Australia, but the State and Territory legislation will cover constitutional gaps, provide for uniform regulation, and avoid uncertainty about the application of the regulatory scheme.
The Tasmanian Government recognises the potential of stem cell research and the need to keep research options open. The scientific community is of the view that a nationally consistent regime has the potential to foster the sharing of ideas and generate research collaborations, and possibly hasten the day when new therapies and cures would be available to combat life-threatening diseases.
Many parents and families in Tasmania share the Government's belief in the potential of this research to bring significant health benefits to their loved ones. However they and the Government believe that a strong licensing scheme is needed to ensure the proper attention of researchers and others to ethical standards in relation to the use of human embryos.
The regulatory framework agreed to at the COAG meeting, and to be complemented by this bill, establishes a balance between the need to enable potentially life-saving research and the imposition of the oversight and sanctions necessary to address concerns in our community.
The Commonwealth's Research Involving Human Embryos Act 2002 provides the basis for the national scheme. It received royal assent on 19 December 2002, with the first of its provisions coming into effect early in 2003.
The Tasmanian Government and other States and Territories were involved in extensive consultation on both the Commonwealth bills, providing input into the examination of issues affecting the development and implementation of a national scheme and how this can best be facilitated. Queensland, New South Wales, Victoria and South Australia have already passed complementary legislation. Western Australia has a bill before its Parliament and the Territories are developing their bills.
A key objective in this process is to ensure that the Commonwealth, State and Territory legislation maintains uniformity with the principles agreed to at the COAG meeting. These principles were that human cloning and other unacceptable practices must be prohibited, but that research using early stage ART embryos which were deemed excess to the needs of the prospective parents, and would otherwise be discarded, should be allowed to continue within a rigorous regulatory framework.
Currently in Tasmania, artificial reproductive technology is conducted by two facilities - one in Hobart and the other in Launceston - under a self-regulatory framework through the Reproductive Technology Accreditation Committee and the National Health and Medical Research Council ethical guidelines. While not affecting the services the centres provide to women needing assistance to become pregnant, this bill will add a legislative component to that framework and will also ensure national consistency in accordance with COAG principles.
The bill adopts the Commonwealth legislation by reference requiring any Tasmanian who wishes to undertake research using excess ART embryos to have a licence from the NHMRC Licensing Committee. The bill applies the Commonwealth embryo research laws as laws of this State, and implements the scheme that is being administered, enforced and monitored by the Commonwealth through the NHMRC. This will ensure the Tasmanian act retains parity with the Commonwealth act and consistency of approach across all jurisdictions. The Commonwealth's embryo research act is treated as an act of this State and any amendments made to that act automatically become law in Tasmania.
The use of the national licensing authority will avoid the need for the establishment of a multiplicity of regulatory agencies operating in each State and Territory. This legislation provides that the National Health and Medical Research Council Licensing Committee established under the Commonwealth act has powers and functions in Tasmanian law and will be the only body issuing licences for the use of excess ART embryos in Tasmania - and as a consequence of the COAG agreement in other Australian jurisdictions.
The Commonwealth act has commenced and the licensing committee has been established. It is currently developing processes for dealing with applications. The committee is chaired by Professor Jock Findlay, a Victorian expert in human reproductive medicine and Chair of the World Health Organisation's Advisory Committee on human reproduction. Professor Don Chalmers, Dean of the University of Tasmania's Law Faculty, and Doctor Christopher Newell, a lecturer in medical ethics at the University of Tasmania, are both members of the licensing committee.
When this bill comes into operation it will be an offence under Tasmanian law to use excess ART embryos if the use is not authorised by a licence or if the use is not an exempt use. The legislation also provides that until 5 April 2005 - unless the COAG agrees to an earlier date - only embryos created prior to 5 April 2002, and deemed excess under the Commonwealth act, will be able to be used for research purposes.
Prohibitions on the deliberate creation of excess embryos is already a condition of accreditation of ART providers and of the NHMRC ethical guidelines under which they operate but the deliberate creation of more embryos than are reasonably needed to assist a woman in becoming pregnant will be an offence under the new scheme. The only activities to be allowed without a licence in relation to excess embryos are storage, removal from storage, or transport of an excess embryo; observation of an excess embryo; allowing the excess embryo to succumb; and certain diagnostic investigations using embryos not suitable for implantation.
The types of research to be allowed by licence under the legislation are not limited directly by the act but in its consideration of the applications for approval the licensing committee has a number of criteria which must be satisfied, including:
appropriate protocols in relation to any aspect of the research;
proper consent to the use of the excess embryos being obtained;
compliance with special rules regarding embryos created before April 2002;
ethical approval to the research having been obtained from a human research
ethics committee;
the likelihood of significant advances in knowledge and treatment as a result
of the use of the embryos; and
compliance with NHMRC guidelines on ethical conduct in research involving humans.
Research could include derivation of embryonic stem cells and associated research activities, and research designed to increase the possibility of creating a viable pregnancy for an infertile woman. Offences against the act, including breaches of any licence issued, will attract penalties of up to five years' imprisonment.
Together, the Human Cloning Prohibition Bill and the Human Embryonic Research Regulation Bill provide a clear message of the Government's commitment to enacting a rigorous legislative framework. Further, this legislation maintains our strong commitment to medical research while at the same time ensuring that the community's interests and values are being wisely safeguarded and fairly served through the provisions in this legislation.
In summary, the Government is introducing in Tasmania complementary legislation which will prohibit unacceptable activities such as human cloning; respond to community concerns that we should rigorously regulate scientific research using excess ART human embryos; maximise our chances of finding cures and therapies for diseases by allowing potentially life-saving research involving excess human embryos which would otherwise be discarded to continue; and ensure a nationally consistent approach to these important matters, as agreed in April last year.
The proposed legislation protects community standards, acknowledges the ethical dimension of this debate, and allows innovations but will ensure the preservation of human dignity. It also keeps open an important research pathway to therapies and cures for debilitating and life-threatening diseases and conditions such as diabetes, Alzheimer's disease and Parkinson's disease.
I commend the bill to the House.
Sorry, before I do that, Mr Speaker, I just wanted to acknowledge that for me this particular issue is a difficult one, as it is for all other members of the House also, and it is one that obviously involves some very critical ethical and moral judgments. To that extent I think the House has been indebted to the paper that Senator Brian Harradine circulated to, I think, most if not all members in the Parliament.
Mrs Napier - Yes, it was very useful.
Mr LLEWELLYN - It involved a lot of the concerns that he has from his own moral and ethical point of view, and some of the issues that were mentioned in that pretty comprehensive paper - from his point of view or from the point of view of a number of people who share his view - I wanted to just read out, not extensively but just some particular points from that paper which I think are of concern and perhaps germane to the debate. I do not want to incorporate the whole paper, although we could, I suppose, seek leave to incorporate it into Hansard .
The first one I wanted to talk about is under the heading 'Broad Scope of the Legislation', and it talks about the range of embryo research permitted by the bill. It says that the Commonwealth bill we are talking about now, to which we are producing complementary legislation:
'includes using human embryos to examine the effectiveness of new culture media used in assisting reproductive technology practice, to assist in understanding embryonic development and fertilisation, training clinicians in microsurgical (ART) techniques, transport, observation and storage of embryos, micromanipulation, lasering, cutting and dissecting, studies in genetic makeup and expression, quality assurance testing to ensure that pre-implantation diagnostic tests give accurate results, drug testing including toxicology studies on human embryos as well as the destructive extraction of embryonic stem cells.'
Now that seemed to be an issue of concern that this legislation extends the provisions in that way, and I heard Ms Putt talk about that aspect of possible extension of research into those particular areas. I think the crux of the moral concern with respect to this issue though is expressed by the Queensland Bioethics Centre in its submission where it says, amongst other things:
'in the case of the frozen embryo a decision is made to cease the extraordinary life support and allow nature to takes its course. This option is to discontinue the life support and allow the embryo to return to as natural a state as possible: a warm, moist environment. Development will be restored for a short time and then nature takes its course. The embryo because of its immaturity and inability to sustain itself dies.
The person who thaws the embryo in this case is not involved in an act of intentionally killing the embryo any more than a doctor who does not initiate futile or overly burdensome life sustaining treatment on a dying neo-nate or who discontinues overly burdensome treatment on a dying patient. On the other hand when someone takes the embryo and extracts its stem cells we do not have a case of nature taking its course. The embryo is carefully and slowly thawed to maintain its viability short term in order that its stem cells can be harvested. It does not die because it cannot sustain itself in this environment the embryo dies because someone has ripped it apart.'
I think that in a sense is the crux of the issue and it is an issue of when life starts and those very complex and concerning aspects. That is an issue of judgment that people have got to make at that particular point. Also a little later on Dr Tonti-Filippini, who is an expert in this particular field, noted that to date no successful therapies for human beings have been published using embryonic stem cells. He says that treatment using a patient's own stem cells has been achieved for many diseases and that was acknowledged in the second reading speech which in fact was an information paper that I read in the first debate but, particularly with leukemia, that issue is very important.
He goes on to say claims about treatments of disease using embryonic stem cells are just hype:
'There is just no such track record of embryonic stem cells; in these circumstances it is ludicrous to be claiming the development of treatments using embryonic stem cells as a reason for passing a bill allowing human embryonic experimentation. There is no such necessity; the truth of the matter is that human embryos and embryonic stem cells have much research and industrial uses.'
That is the other point about the exploitation of this particular issue by corporate interests and whether or not that is an ethical thing to do and that extends into the argument of patent rights and all those other issues which of course are from the point of view of not only stem cells but the human genome. We saw recently the consequences of arguments about people patenting particular accesses to various parts of genetic material through that debate and others here in Australia, concluding that really ought not to happen because it ought to be something that we as a universe, as a human society, ought not to be exploiting but rather we should be working together to try to achieve the outcomes from it.
At the end of that paper, there was a set of conclusions that I will not read into Hansard which elaborate on the concerns that people had at that time. So it is a very complex issue and it is one that is not easily resolved and I find myself in a moral and ethical dilemma as to whether or not some limited use of material there, particularly embryos that have been created for artificial reproductive purposes ought to be used or just allowed to die. They obviously will not be able to sustain or to grow to maturity because they are surplus material, and the option is whether or not you allow those cells to die naturally by exposing them to ambient temperature or whether or not they have value to improve the search for cures for very many diseases that we have.
In a way it is not unlike, to some extent, the issue of transplantation of organs from one body to another. There are similarities in respect to that, too, when you are talking about allowing organs to die normally or whether or not they are used to achieve a medical outcome. Obviously in that sense, we are only talking about something that is not viable in its own sense.
Mr Michael Hodgman - You and I were little embryos once.
Mr LLEWELLYN - Indeed we were.
Ms Putt - I think probably all of us were.
Mr LLEWELLYN - Amazing as that might be, Mr Hodgman, I do agree you were an embryo at one stage.
Ms Putt - It's a serious matter, isn't it.
Mr LLEWELLYN - Yes, it is a serious matter, and so it is an issue that is of concern to me as it is to other people, and I am sure everyone here in the Parliament. That is why the Labor Party, as we do on these particular issues, has agreed to have a conscience vote on the matter. As I said before, this is probably the bill that is of more concern to people than the previous bill, and the previous bill - human cloning - again I think has been universally considered to be something that is totally undesirable and totally unethical, and so on. So the difficulty in regard to that I think is pretty universal.
In this issue it is the question of human life itself, and the values that might come from this investigation. Other issues were in that paper that I read before about the use of adult stem cells versus embryonic stem cells and the research that might occur over the next little while in that, and I think that was germane to the reason why in point of fact the time limit has been placed on the actual use of this material now because it was said and said very forcefully that things will develop quickly in this area, they believed, and that it may well be possible to not have to embrace this particular concern and moral dilemma because adequate alternative material might be able to be sourced from within adult stem cell research that might occur.
Anyway, I thought it was important to put those other comments on the agenda at this stage, and I remain prepared to adjourn this particular bill when we come to the point where we need to do that, in order for other members who are wishing to address the provisions of this bill with whatever amendments they might have, are able to think longer over those particular amendments. We can return to the bill at whatever stage, as we will have to with the other bill, when we return next week.
[5.25 p.m.]
Mrs NAPIER (Bass) - In the second reading debate on the Human Cloning and Other Prohibited Practices Bill I basically covered most of the points that I wish to make in relation to this bill. I just want to pick out a couple of points that pertain to the licensing process, acknowledging, as I have before, that this is no easy decision and it is about weighing up the fact that you are allowing experimentation and killing embryonic stem cells, rather than just allowing them to succumb, as the minister has just explained. You are balancing that against what good might come for mankind from very careful, conservative research that might be done and that includes the issue of training and learning more about the human reproductive system I suppose.
As far as I am concerned, there is no greater reward in life than being able to have a child and some people do not ever get that chance. It is certainly something that I cherished and for those people who have to go through the IVF procedure it is fairly traumatic; it is a difficult decision and it may not always succeed. I think it is really important to provide loving parents who would love to have a child the opportunity to have that child, even though I know we have a debate about whether the parents should be a man and a woman or otherwise. But we have had that debate on another day.
I read the guidelines that have been established for the NHMRC licensing committee and the kind of steps that would be taken to try to ensure that we are as careful as possible that the taking and using of embryonic stem cells is justified, given the fact that we are identifying that the door has been open for a while and it is about time we brought it back under control and ensured that what is being done or what may be done is in fact ethical and acceptable, certainly as far as most of the community is concerned.
As I understand it, this bill that we are about to pass here, the Human Embryonic Research Regulation Bill, in effect just recognises the Commonwealth legislation. It allows us to do our own review, as I understand it, which would complement the review that has already been done by the Commonwealth. But I have read this through and I do not see that we, as Tasmanians, have a particular role to play beyond ensuring that we have covered the constitutional links between Tasmania's laws and the Commonwealth laws. I do not have any strong disagreement that I have yet identified because time has not allowed me to fully study the Commonwealth bill. I have to hope that the Commonwealth Parliament have got it right and that there are not any loopholes in that legislation, but I am reassured that there is going to be a review in two years' time.
But it seems to me it would be very difficult to bring in any amendment to these bills that would tidy up the Federal legislation beyond the debate that we have had similar to the previous bill in relation to the review and public consultation, although I will make some comments about the issue of consent. The issues of production and over-production will be the two main points that I would make comment on. I note that in issuing any kind of licence, the licensing committee of the NHMRC have to observe that appropriate protocols are in place to enable proper consent to be obtained and if the proposed use of the excess ART embryos may damage or destroy the embryo, that appropriate protocols are in place there too. I note that each project has to be approved by the Human Research Ethics Committee. For a while I was on the university ethics committee that looked at all research that might be being done with animals and people, where we would deal with anything from psych experiments through to fish or frogs or whatever it might have been. We used to spend quite some time looking at issues that might emerge and developing protocols that might be adopted by departments, whether it was in a teaching or research process. I quite appreciated the opportunity to be involved in that but I have to say there were many times when you went home and spent a few sleepless nights just thinking about some of the dilemmas that you were dealing with. So I take my hat off to anyone who goes onto any kind of ethics committee that deals with those kinds of issues.
I am very pleased to see that Don Chalmers and Christopher Newell - I have great faith in the work of both - are actively involved in the process. I was reading that the licensing committee must also consider the minimum number of excess ART embryos that are likely to be necessary to achieve the goals of the research or activity proposed. I know that in Senator Harradine's very good paper that we have alluded to - I do not intend going through all of the arguments - I did think it was a very well researched paper and presented arguments on both sides but you could very clearly see that he is not alone in his views. But I am concerned when I read in some of the material about the extent to which some clinics would appear to have developed huge collections of embryonic stem cells. That is a concern to me, that it has not necessarily been under control.
The committee also has to look at the likelihood of whether the advance in knowledge or the improvement in technology for treatment would mean that the result of the use of those embryos proposed in the application could reasonably be achieved through other means. I think that is a really important thing to consider. I would assume that we can achieve a great deal through the use of adult stem cells. In fact, I mentioned earlier that umbilical cord blood can be used in research as well. One would assume that if the research could be well done by using that method, that would be preferred, rather than using newborn embryos. So I read that and that was really important to me. I guess I am putting on the record that I would always be of the view that if research could be well done using adult stem cells then that is the way that I would want it done, not by using embryo cells.
I notice the licensing committee must also consider the various guidelines that have been developed in assessing that application. One of the issues that is raised in Senator Harradine's paper is the issue of informed consent. His paper puts forward a number of arguments about whether you can adequately and appropriately inform parents of embryos, noting that it is also not just the parents of the embryos who have a say, it is also the partners of those parents whose embryo it might be. The issue is whether people are going to be given adequate information or control over the end-uses of their embryos. Some people might say, 'I don't want to know what happened in the end', but others might want to know. So that might influence others' decisions and that might actually be part of the review process where people make informed consent about what information they were provided with as to how their embryos would be used. If they gave directions as to what kind of research or training or whatever they wished them to be used for, and then if they found that that was abused or if the project might have been inappropriately assessed or if it had not been adequately monitored or something like that, it may well influence their view about whether they would recommend that others give consent, and that would in turn influence policy.
Minister, you might have a better idea than I as to what the Commonwealth legislation says about that, because I did not have time to pick it up exactly in the legislation as to how that is covered. All I know is that in reading from the web site there were a whole series of papers on there about how the licensing was to be done, what you have to do and so on. I could not actually find in there - you might like to direct me to the spot - where it actually identifies what kind of information a donor has to be provided with, and whether there is an option of follow-up. Can I as a donor ask that there be follow-up information and feed-back? I might actually say, 'I do not want to know. That is it, that is over', but I just think it would be useful for us to know what follow-up there might be.
Mr Llewellyn - I will get you a response to that when I sum up, if you like.
Mrs NAPIER - That would be appreciated, because I think it is a point that is well raised. I am not saying that I necessarily want to amend the legislation. All I am saying is I think that is an important quality control issue that we need to know is covered, and if necessary if we feel that there is a concern then maybe we can also communicate to the NHMRC that we think that protocol ought to be strengthened, and whether it needs to be strengthened through legislation or by State ministers agreeing that it should be built into the system. That would probably overcome it.
When you look at the people that have to be informed and have to give permission, it does certainly make it clear that the responsible person includes the person who provided the egg or sperm from which the embryo was created, the woman for whom the embryo was created for the purpose of achieving her pregnancy, and any person who was the spouse of the person at the time the egg was provided, and also any person who was the spouse of the woman at the time the embryo was created. I satisfied myself that anyone who might be directly involved in that would be required to give permission, so that is quite a few people who are potentially to have a say, so it is no light decision in that sense. I also note that legislation requires that the use of excess embryos must be in accordance with any restriction determined by the responsible persons who gave consent to the use of the embryo. Presumably that would influence the research, too, as to whether the restriction was such that it was not justifiable to use the embryo. If the licence authorised the use of an excess ART embryo that might be damaged or destroyed the licence was subject to the condition that it only applies to embryos created before 5 April 2002. So concerning consent I certainly have some issues.
I had a look at the section on licensing and the guidelines for people who might be applying for licensing, and I noticed that you have to get difference licences for different purposes. You cannot get open licences. So if you have the one organisation or clinic or research centre that might be doing a number of things, if you want some for training you have to apply for that, if you want some for one particular research project you have to apply for that, and if you have other research projects you have to apply for those. They seem to be fairly strict processes for the approval of each one, and that is the way it ought to be. I would not want to see any blurring of approvals for the use of embryos across projects and I think that seems to be covered. I think that is an important part of recognising that this is a new step, recognising that this can go on and probably is going on. I think Parliament is making a decision that we approve of that on the balance of what good and bad there might be and we have proof of that. But we are being very conservative in that sense because we are going to review it. We want to ensure that there is overall good for humanity that would emerge from that and it is being ethically applied. There will be another day when we can have look at what the consequences might be of that step that we have taken.
[5.40 p.m.]
Ms PUTT (Denison - Leader of the Greens) - Mr Speaker, I voiced my main concerns in regard to this legislation in the contribution I made on the previous bill in regard to human cloning and many of those comments were more specifically about the use of human embryos on research.
I am not going to go back over all of that but to reiterate of course that I raised concerns in the areas of the patenting of elements of human life and the commercialisation of products and knowledge which flows from the donation of an embryo to scientific research by people who consider that is something they want to do. There are real issues about a situation in which the resultant technologies and treatments that become available may not be generally available to people who cannot afford to pay for them. There is the need for us to regulate in that area to ensure that we do not get a situation where, because of commercialisation and the profitability of the biotech industry, we have freed up legislatively or perhaps endorsed a system that has been working informally.
At any rate we have ensured that there is a system by which the male and female contributors to an embryo are able to determine, if it is no longer for the purpose for which it was produced, to enable a couple to have a child, that it then could be used for experimentation rather than to succumb. People would be doing that of course under the notion that that is going to be for the greater human good. If then we have a situation where it is only for the good of the people who can afford to pay, then I think we have a real ethical and moral difficulty. I know it is not addressed in this legislation and I know it has not actually been addressed adequately at the Federal level and again I draw the attention of the House to that.
I realise that another bill would be needed to deal with that and it would need to be considered nationally, but I think that it is a very important missing part of what we are considering in this debate and I want to stress that.
The other matter that concerns me is one that has already been canvassed to some degree by the previous speaker and that is the matter of the licensing that will occur and the powers and functions of the National Health and Medical Research Council, who are determined to be the body that has a lot of the controlling say in what is going to happen in respect to experimentation on human embryos.
There are some very real concerns about the fact that it is left to the NHMRC to decide for what purposes researchers may have access to these embryos. I think that it is important to make the observation that while the research involving embryonic stem cells will be subject to guidelines and the council's approval, this is not regulation. It is not the same as government regulations and I think that we should have something more stringent.
I was particularly concerned when I read the material that came forward to the Senate committee that considered this bill and which has been summarised for us by Senator Harradine, and when I read what was put before that committee, including from the Gene Ethics Network which of course is a body that I have worked with quite extensively at various times in relation to other aspects of gene technology. But I know that there would not be an objection made by Bob Phelps and the Gene Ethics Network unless they felt there was some strong basis, and I have never found him to be anything other than very knowledgeable in these areas because he does of course devote his entire working life to it.
One of the matters that I think is of concern is that in the evidence, according to the summary that we have, Dr Morris from the NHMRC advised the Senate committee that there is nothing to prevent a person from taking stem cells from a human embryo and them selling them for profit overseas. So whilst the embryo cannot be sold overseas, there seems to be a potential for the use of cells derived from any tissue to be permitted to be sent overseas. The previous speaker is right, we simply have a set of references to provisions that are in the Federal act, but we do not necessarily understand everything that is in the Federal act. But the evidence that Dr Morris gave was that the legislation does not prohibit any uses of embryonic stem cells. That is fairly interesting. Clearly, it is then going to be the NHMRC, I suppose, who restricts the uses, but again, we have a potential difficulty there.
Dr Morris goes on to say - and I will quote from this -
'Among other interesting omissions in the Chair's Report is the fact that literature from biotechnology academics has noted the relevance of other statutory regimes concerning the regulation of matters relevant to ART. Other relevant regimes include not only the Trade Practices Act, but matters relating to intellectual property.'
Again, as I was saying, there are other forms of regulation that need to be applied which simply do not occur. It goes on to say -
'In further evidence before the committee, Dr Neville argued that given that the legislation provides for the concealment of confidential commercial information, other ways of keeping the embryo research industry accountable to the public might include the Trade Practices Act and anti-discrimination legislation.'
But again, we do not have a reference to that in what we are looking at today; it does not seem to be brought into play. I have not seen the NHMRC guidelines and this does make things particularly difficult and because of the short period we were given before this debate at the time when we had the briefing, I really did not know the questions I needed to be asking, so we are rather doing this on the run. But again, I will go to the paper from Dr Morris where he says -
'In relation to clause 28' -
And of course he is referring to the Commonwealth legislation -
'which establishes the NHMRC Licensing Committee, there was evident given to the Committee that it was inappropriate for the Licensing Committee to be located within the administration of the NHMRC. The ACF Gene Ethics Network' -
And this is the body that I have worked with extensively and know well -
'commented that.
The NHMRC is impenetrable and effectively answerable to no-one outside. GTRAP and AHEC are examples of NHMRC with whom we have attempted to engage over many years, with very little success. We propose that this licensing function be vested in the Office of Gene Technology Regulator who has statutory responsibilities and authority commensurate with the importance of this licensing work, and has processes and mechanisms to engage with the interested and general publics.'
I think I agree with that. I know through personal experience that there was a lot of public input, consultation and argument about the Office of the Gene Technology Regulator and about ensuring that there would be strong statutory powers and authority and that the processes and mechanisms that would be put in place within the Office of the Gene Technology Regulator would genuinely ensure that interested parties and the general public did have the ability to comment upon and have real interaction with decisions that were made. We have no assurance that that is occurring with the NHMRC.
I want to make it clear that I am not casting any aspersions on people like Don Chalmers or Christopher Newell. The fact that they are on the ethics committee indeed gives me a degree of confidence. It is more the administrative arrangements that have been set up that I have some problems with. Indeed, Dr Tonti-Filippini drew attention to the inappropriateness of having the National Health and Medical Research Council as the parent body for the licensing authority. He said:
'We do have a culture here with the Human Research Ethics Committee and the NHMRC, and now the licensing authority ... There is not openness in reporting or stringent reporting requirements, so you have got no reporting of, for instance, the Human Research Ethics Committee's decisions or anything like that. The public does not have access to those. So we have got a fairly secretive culture, a non-consultative culture. In fact, the institutions will defend that in terms of their own commercial interest and so on and also the interest in not having public scrutiny.'
That gives me cause for real concern.
Mr Llewellyn - Perhaps we need a parallel process to the gene area where we have State's rights policy principles to determine things.
Ms PUTT - Yes, maybe. I would need to think about that and consider it - I do not know. As I say, it is very difficult to do this on the run and it is very difficult when really all we are being asked to do in this legislation is sign off on a regimen that has already been put in place by the Commonwealth. We cannot now try to change it here where we see deficiencies. That is particularly awkward when we know that some regulation is better than no regulation, so you cannot really vote 'no.' We are really on the horns of a dilemma and I feel that most acutely in this bill and in these particular provisions, because I want to make sure that there are strong lines of accountability where the decisions are being made about what experiments will and will not take place. I do not want people to say, 'Just trust us', I am afraid. I feel that is just not good enough where we are dealing with such incredibly complex emotive, moral and ethical issues.
It is very difficult for many people, on balance, to even think that we need to go ahead with this. We have heard already expressed in this Parliament today the hope that the necessary research can be used through using adult stem cells and umbilical cord cells rather than having to go to embryonic stem cells. So there is a real wish not to have to go to embryonic stem cells if we could do it any other way because people because people do not necessarily want to have to say 'yes' to that, but on balance will say 'yes' because of the greater human good. But we have to have proper regulation and accountability if that is what we are going to do and I am not sure that this is not too loose and too much along the lines of, 'Trust us, we're the experts.'
At the same time I recognise it is a really complex area. It is difficult for the layperson to be an expert, but that is never a good reason to exclude people from this form of decision-making. Never underestimate the extent to which people will get to grips with something if they regard it as so important in terms of the decision-making that our society is determining.
I also am concerned about the repercussions for people who donate excess embryos. At first I thought that surely people who really wanted a child so much that they were prepared to go through the IVF program would be the ones who would have most reservations about saying, 'Enough - we've done what we need to do. These embryos are now excess. We will allow them to be used for experimentation'. Surely those people of all people would be the ones who would have the most reservations about actually doing that.
But then as I read the debates and the literature I began to realise that we do not have reassurances that these people who give consent will get information about what happens. They can say what they would want to happen and they are told that is how it will be, but I do not see anywhere that there is a report back to them about what actually happened and I certainly do not see any provision that they have some course of action that is set up and guaranteed that they can take if their restrictions are not observed. What will they do? What can they do, under the law that is being proposed, if they are not given any power to initiate action if the wrong thing is done that does not accord with their wishes?
Now I hope that never happens; I hope the safeguards are stringent enough and I would like to have faith that they are. But the one way you can make sure that you can have faith in that is to see that you have a regulated system that is enforced by law, not simply the system that is being proposed here with guidelines but actual proper regulation. Unless you have that I do not know whether you have the assurance that you need.
So I have real difficulties with this part. I really would like to see, I think, what the Gene Ethics Network recommended, which is the licensing function being vested in the Office of the Gene Technology Regulator who has all those statutory responsibilities and so on. I know that will require a whole lot of legislative alterations to what the Gene Technology Regulator does and I know that is pursuant to Federal legislation which we have then mirrored in the States in relation to genetic engineering of plant materials and so on. So it is not an easy ask, but I simply have to say I do not think this business with the NHMRC is good enough.
Mr Llewellyn - There was the ministerial council with the Gene Technology Regulator as well, specifically on that particular issue, and the policy principles have derived from that ministerial council.
Ms PUTT - That is right, yes. So there is an ongoing oversight by the relevant ministers from the different administrations and obviously the ability for those ministers to bring forward the concerns that are being expressed in their jurisdictions, and the ability to formulate these policy principles which allow a degree of autonomy within the jurisdictions. We do not have any of that.
Mr Llewellyn - Which we did at the last ministerial council, fortunately.
Ms PUTT - Did you? I am glad to hear that and I will ask you about that later. But as I say, I am just not satisfied that this is good enough. I think it has to be the absolute best. We have to have the Rolls Royce of regulation and I do not think we have, which is unfortunate. So I think when we get to part 3 which deals with these matters, I will vote 'no' to that part because I want to see something more stringent in place, but I am in no position to try to insert something here. It needs to be inserted into the Commonwealth legislation. So I just wanted to make clear to the House that it does not mean I do not want regulation, it means I want better regulation and I can see no other way that I can express it other than to make this statement here and then to take that position when we come to that particular part of this bill when we are going through the clauses.
The other matter I have already raised is in relation to the review and it is in this bill that I want to include not only that the review be publicly consulted, so that we can be assured of that but -
Debate adjourned.