Tuesday, 7 November 2006
Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Bill 2006
Bill—by leave—taken as a whole.
I want to put a few comments on the record. At some stage I will get involved in my role as the Chairman of Committees, so I am grateful that you, Madam Temporary Chairman Troeth, are in the chair. I cannot speak for all my colleagues, but a couple of colleagues share my views. It is certainly not my intention, nor the intention of some of my colleagues—those around here would know who they are—to put forward any amendments to this bill. This bill has now passed its second reading and is into the committee stage. At this time it is certainly not my intention to move amendments. In my view it is very hard to make a bad bill better by moving amendments to it. As I said in my speech during the second reading debate, this bill is about the creation of a human embryonic clone. That in itself is the fundamentally objectionable part to me. Others can speak for themselves. Moving amendments, therefore, will not change the character or the nature of this legislation.
During the committee stage there may be a move by some people to remove what is considered by some people as the ‘yuk’ factor. However, simply removing the ‘yuk’ factor, or the objectionable parts—even more objectionable than human cloning—will not make the bill any more acceptable to me. I understand that a few others share similar views to mine. As I said in my speech during the second reading debate, this bill was about crossing an ethical line. The legislation has now achieved that. It still has to go through the committee stage, and I understand that a range of amendments will be put before this chamber. However, that ethical line has been crossed. I will be awaiting the third reading of this bill, where I will be voting against it. I will not take up the time of the committee arguing about issues that might seek to vary the legislation at the margins.
Could I say at the outset that it would be helpful to get a very clear understanding of what the procedure is from here. The bill has come to the committee stage a bit earlier than people had anticipated. Initially there was a suggestion that we would be doing the second reading stage through until this evening, but obviously we have come to it early, which is fine. As we have just seen, there was a vote, 34 to 31, in favour of the second reading. I appreciate that people like Senator Hogg will vote against the legislation, regardless, at the third reading. I am not one of those. What happens at this stage of the debate will influence my final vote, so I am particularly keen that the committee process, and what amendments are being rolled out when, is made completely clear. Obviously, if only two people shift their vote from what we have just seen we can get a very different outcome.
I understand that there are some amendments before the chamber by Senator Nettle. I am quite happy to proceed with those if it is clear that they are self-contained, if you like, which they appear to be to me. But it would certainly be useful from my point of view to know what else is likely to appear before the Senate by way of proposed amendments so that we have some idea of the totality of the issues that are going to be before us. It is a difficult enough issue as it is, at least for some of us, without having piecemeal amendments rolled out here and there. I am not blaming anybody for that; I am just stating a fact. As one of those people who think the legislation as a whole has a lot of good things in it but who has concerns about one or two components, it would be unfortunate if the piecemeal approach led to greater uncertainty amongst all senators in this place, and certainly for those whose views are somewhere in the middle—between total support and total opposition. We need to be clear about what is going on, particularly as it appears we have a close and finely balanced position here. An indication from somebody about what is to come before us would be helpful. Otherwise, I suggest it may be better if we were to adjourn now and come back once things are all settled, at 4.30 or so.
I am in the Senator Hogg camp—I do not believe you can make a silk purse out of a sow’s ear—and this is certainly a sow’s ear. I will not be moving any amendments. I will be voting against the third reading. I do not think you can improve this bill. You might fiddle at the margins, but it is still cloning. It is the way Dolly the sheep was made. I do not believe that you can do much about the bill other than vote it down, so I certainly will not be moving any amendments.
I want to indicate for the benefit of the committee that Senator Webber and I are moving amendments. We have five relatively minor amendments—perhaps four minor amendments and one a little less minor. They are not new. Anyone who has read the report of the Senate Standing Committee on Community Affairs will know the nature of those amendments. They do not in any way detract from the integrity of this bill—a bill which effectively encapsulates the Lockhart recommendations. Therefore, we hope our amendments value add to the legislation. The legislation in its own right, I think, is an effective and appropriate encapsulation of the Lockhart recommendations and, therefore, should be supported. Our amendments concern just a couple of areas where there is a slight distinction between the bill and the private member’s exposure draft bill that Senator Webber, Senator Patterson and I put forward. Having said that, it achieves the same end, but with a slightly different approach. Our amendments will be circulated well in time for the committee stage after question time. I am happy to discuss them with any senators in the meantime.
I just make the point that I hope those listening to this debate understand that when people talk about this being a bad law, obviously that is their perspective on the policy. I just want to make very clear that this is a solid legislative framework. Whether people like it or not is, of course, a matter for debate; I just want members of the public to feel reassured that not only are the Lockhart recommendations effectively enshrined in this bill but this bill is a good bill. Believe me, having proposed an exposure draft, I have gone through the bill with a fine toothcomb to see if there are any problem areas in relation to the regulatory framework.
So I just want to make it very clear that if people have a problem with the policy it is incumbent on them to put forward amendments that would allow the clauses to stand as printed, or amend them. If they have a problem with the strict regulation of this technology you would think that people would put amendments forward to deal with that. The fact that people are not doing that indicates to me that the integrity of this bill cannot be attacked in terms of the regulation that is provided within the bill. I am happy to discuss the amendments in more detail as they come up, but once again I echo my strong support for the legislation.
I might help to get things rolling by moving the Australian Greens amendment (1) on sheet 5112:
(1) Schedule 2, page 19 (after line 26), after item 18, insert:
18A After paragraph 21(4)(d)
(da) the capacity of any scientific advances to be delivered through the public health system and or to reduce the global disease burden;
I will explain what this amendment does. Currently, under the existing Research Involving Human Embryos Act 2002, there is a list of things that the NHMRC, the National Health and Medical Research Council, must consider when making a decision about granting licences to people who wish to do stem cell research. One of the things that they must have regard to is the likelihood of significant advancement in knowledge or improvements in technologies for treatment as a result of the use of excess ART embryos proposed in an application. What this amendment does is insert another issue which they must have consideration of.
I will read out the amendment. I think it is reasonably self-explanatory but I will talk some more to it. It says that the licensing committee of the NHMRC, when making decisions about granting applications for people to do research using stem cells, must consider ‘the capacity of any scientific advances to be delivered through the public health system and or to reduce the global disease burden’.
This proposed amendment was suggested to me by an academic—I think she is from the University of Wollongong—who I had been discussing this issue with. As senators will know, because I indicated this in my speech during the second reading debate, my concerns—concerns that my fellow Greens senators share—relate to the privatisation and commercialisation of this research. So, in all of my approaches to this debate and in all of my amendments I have sought to inject the public domain, as much as possible, into the legislation. It is a difficult thing to do. I acknowledge and accept that it is difficult to try to ensure that the research stays in the public domain. It is not at the moment, and it is a hard thing to do.
I moved a series of amendments in 2002 around this particular issue. In 2002 I moved amendments which said that the licensing committee needed to look at the issue of public interest. That created a difficulty for some people, because people define the public interest very differently. It meant that people had all sorts of different interpretations of what I meant to include by using the term ‘public interest’. So in my deliberations this time, and in wanting to put forward amendments that would allow public concerns to be detailed, I have tried to narrow what I mean by ‘the public interest’ to be public health.
People have a whole range of views about what is in the public interest but I am talking about the issue of health and ensuring that public health is addressed and is central to the research. This goes to the issue that I have spoken of, which is that I would like to see that any benefits that come from stem cell research are able to assist in reducing the global disease burden and in delivering benefits to people through our public health system. That is the philosophy that I bring to how I would like to see this research enacted.
Some people have concerns about this research because they are wary of the profit motive driven by biotech companies that operate in this area, and what they may mean and where it may go. So perhaps these amendments, which seek to ensure that any benefits that come from this are in the public interest and relate to public health, can address some of those concerns that people have.
The way that this particular amendment tries to do that is by talking about this idea of the global disease burden. As we all know, the global disease burden is great, and there are a whole range of diseases that contribute to the global disease burden. This amendment is designed to allow the NHMRC licensing committee to prioritise research that will reduce that global disease burden and provide research benefits and possible cures for diseases that wreak havoc in developing countries—malaria, TB and other things that cause so many needless deaths in our community.
This amendment is not designed to say that the NHMRC should only grant licences to people who are proposing to focus on a particular set of diseases. It is not designed to do that at all. It is designed to give the NHMRC licensing committee the opportunity, the option, of prioritising research that is focused on that. I am not trying to say that other research should not happen at all. I am just trying to give the NHMRC a mechanism that they can use to say, ‘We think that this particular type of research should be supported, because we can see the benefits that will come to the whole of the global community by us being able to have treatment, cures or research occurring into these particular diseases.’
The other part of the amendment is about delivering scientific advances through the public health system. This comes to the equity issues. If people have concerns around technology being driven by biotech companies, I do not want to see any benefits that come out of stem cell research only being available to the wealthiest individuals for a massive amount of money. I would like to see any benefits that come from this being able to be delivered across the board. This does not say—and perhaps it is really important that I point this out—that all benefits that derive from stem cell research should be delivered through the public health system. It does not say that. Various senators have made the comment to me that this could cost a lot of money. This amendment does not say that everything has to be delivered through the public health system. What it does is give the NHMRC the opportunity to prioritise research that can be delivered through the public health system.
I put this proposal to a number of witnesses who appeared before the Senate committee inquiry into this legislation to ask them whether or not it was feasible, whether or not it was workable. I was very pleased to hear the comments from the CEO of the NHMRC, Professor Warwick Anderson, who said that if the parliament wanted to put this kind of consideration into the legislation then the NHMRC could enact it and ensure that it was done. I have to keep stipulating that none of this is to say that the NHMRC licensing committee should only give licences to people who look at particular diseases or should only give licences to people who say they will deliver it through the public health system. That is not what it is about; it is just giving them the option to prioritise research that has the potential to deliver that.
One of the issues that people addressed—I raised this in my second reading contribution, and I will raise it again—is that, given that embryonic stem cell research is currently in its early stages, it might be quite difficult for researchers to say, ‘This is what my research is going to produce and therefore it can be delivered through the public health system.’ I accept that. I recognise that it is difficult to do. That is why I have sought to do it this way, which is not to be prescriptive and have the NHMRC licensing committee say, ‘You can only get a licence if you’re going to deliver this thing, it will be available through the public health system and it’s going to be for malaria.’ That is not my intention at all. It is about giving the licensing committee the capacity to do that. That is because I want decision makers, who play a very important role in the whole regulation of this industry and this research—and, currently, the body that does that in Australia is the NHMRC licensing committee—to be able to look at public health benefits and look at reducing the global disease burden.
That is what this provision is in there for. It requires the NHMRC to have regard to these matters. It does not require them to make all their decisions on the basis of them; it just requires them to have regard to them. They currently have to have regard to the likelihood of advances occurring. Clearly, we want the NHMRC in this and in other areas to make decisions on the basis of whether or not they think there are technology and benefits that can be delivered. I am sure we all want them to be able to support research proposals that seem to be able to go somewhere and contribute and deliver benefits. But this brings in that additional level so that, when doing so, they can also look at areas of public health, public interest and the importance that plays. It does not require them to do anything; it just allows them to prioritise and to look at these issues, because there is a range of issues that the NHMRC looks at.
It was interesting during the Senate inquiry that there were some people who were perhaps not quite clear on what the NHMRC do look at. They were asking, ‘Don’t they already look at that?’ They thought that, when the NHMRC were making decisions about which research to fund, they already looked at exactly the issues that I am trying to make sure they do look at. So there did seem to be some lack of clarity about whether perhaps the NHMRC do already look at these issues. It was a shame that there were not more witnesses there from the NHMRC to explain that detail. What this does is stipulate that, yes, we do want the NHMRC to look at the issues of public interest and of public health.
I am very happy to talk to any and every senator about what these amendments do—what they are intended to do, what their purpose is about—and I very much hope that senators are able to support these amendments. I suppose the reason I have had to go down this path with these amendments, and indeed the amendments that I moved in 2002, is that, unfortunately, in Australia the debate now and in 2002 has been around the issue of whether or not we should go down the path of stem cell research and people’s concerns with or support for that research. That has been, understandably, so central to the debate that it has not allowed us to have the discussion that I for one think we should be having, which is: if the research goes ahead, how do we think it should go ahead? That is what I am seeking to do with these amendments. I have the view that it should be done in the public domain as much as possible, that we should ensure that public health is at the forefront of where the research is going and what people are intending to achieve. That was very central to the debate that occurred in the United Kingdom around stem cell research. As a result of that they have their national stem cell bank, which plays an important role in keeping the research in the public domain.
I think it is really great that we can have that discussion now. I have to say I am pretty disappointed that that has not been able to be central to the debate that has occurred so far. I understand there are other issues that people need to consider, and it is important for them to do so. I appreciate that people have been spending a lot of time doing that. But now, if we can have the opportunity to talk about how any research should go ahead, and what views people have about whether that should be under public control and to what degree, I think that would be really helpful for the debate.
I bring to the attention of the committee that we are addressing amendment (1) on sheet 5512. Senator Nettle has circulated sheet 5512 revised. Senator Nettle has moved amendment (1). I do not think she needs to move the amendment again because the only difference in amendment (1) on sheet 5512 revised is on the second line with the insertion of a slash between ‘and or’.
I was not going to speak to this amendment, but with regard to the NHMRC, licensing and how it affects an embryo I think it should be put on the record that the definition of an embryo in this bill was not endorsed by the NHMRC. It is a definition that comes from a draft paper and it has never been endorsed by the body to which we are putting this position. The reason it is not endorsed by the NHMRC is that it is open to a lot of manipulation. Because the definition deals with movement of an embryo to a favourable environment, if there is not movement to a favourable environment then it is not determined to be an embryo. If that is the case, you can deliberately alter the process of fertilisation so as to disable an embryo so that it will not develop its primitive streak. That is a corruption of the whole process which I believe a lot of people in this place were trying to stop. If you are trying to stand on the strength and technical validity of this bill, you should know that it is not apparent in the most fundamental definition of what we are talking about. The definition of the embryo is flawed.
It is not for me to suggest how you can fix that, but I would have thought that, with all the great forethought that has apparently been put into this process, you would have got the absolute fundamental tenet of what you are talking about correct. If this goes through, you will have a definition of an embryo which you will be referring to in relationships with the licensing agreements that can be manipulated in such a way as to create a huge extension beyond what you all perceived it to be. For a bit of a homework, you should go away and fix it.
I rise to make a brief general contribution to the amendment before us from Senate Nettle. I say at the outset that I welcome a bit more discussion as, even though I have been dealing with this issue for some time, I am still not entirely clear in my mind as to the best path to go down. There is no doubt in my mind that the mere passage of this legislation is an important first step in a public health benefit, and it must be at the forefront of all of our minds that there is a public health benefit in any medical research. For me, the thresholds to absolutely ensure the public health benefit are significant funding for the university and hospital research sector and a very well funded, efficient, effective and modern public health system that ensures that all Australians get access to the best and latest medical technology in the treatment of any of diseases, injuries or other health concerns.
I agree with Senator Nettle that, beyond that, ensuring the public health benefit is something that we have all grappled with and I am not entirely sure how we achieve it. Having said on the one hand that those two things are threshold issues, I think that on the other hand there is a need to have a look at the amount of money these developments in new medical treatments and technologies cost. I would not in any way want to come up with a system that says that that must be entirely funded by the taxpayer or that there should be no private support. It is a matter of finding a balance. As I say, I am not sure how we find that balance, so I would welcome some further discussion on that.
Other issues that Senator Nettle has raised about the national stem cell bank and what have you are open for discussion. Personally, I have no problem with samples of stem cell lines being deposited in a national stem cell bank. I think that is entirely appropriate and guarantees some public good and some equity of access. How we establish a national stem cell bank is important. It is something that the government has hastened slowly on, to be polite. Whilst I support its establishment, I would not in any way want my support for this important research to be seen by the government as my wanting to harm the passage of this legislation. Those are the issues on which I am happy for there to be further open discussion. As I say, the deposit issue is a pretty straightforward one.
I want to look at the effects of Senator Nettle’s amendment in the context of the current act. My understanding is that the current act says that:
In deciding whether to issue the licence, the NHMRC Licensing Committee must have regard to the following ...
So it is prescriptive in that sense. It makes it clear that it is ‘must’; it is not ‘may’. There is a list of matters in the act, most of which those of us who have spent some time involved in this debate would be quite familiar with, and 4(e) on that list says:
- such additional matters (if any) as are prescribed by the regulations.
So there is the potential for the NHMRC Licensing Committee to take into account other matters as prescribed. The amendment before us basically inserts another criterion:
- the capacity of any scientific advances to be delivered through the public health system and/or to reduce the global disease burden.
I think there are probably some very good arguments, certainly those that Senator Nettle has already articulated, for including some of these things when determining a licence.
I think the debate we are about to have here is whether this is the most appropriate place to put such a consideration, and obviously we are trying to determine the effect of such a consideration. I am inclined to believe Senator Nettle’s point. In fact, I think she is spot-on when she talks about the economic impact. That seemed to be something that people were concerned about on the one hand, but that is not really the intent of this amendment. I can attest that Senator Nettle has talked not only in this debate but also in previous times, including in the 2002 debate, about ensuring that the public health good concept is enshrined somewhere in the legislative framework.
Like Senator Webber, we see many positives for the inclusion of such an intent, or at least such a criterion, when assessing licensing conditions. Whether or not this will be too prescriptive, it might be something on which we do seek further information from the NHMRC. Again, it is obviously our role and our prerogative as legislators to determine what they should take into account. Personally, I do not have a problem with that. If there are arguments against it, I am happy to hear them. I suspect there is one argument that I could put forward, which is: where do you stop? This feels like groundhog day, doesn’t it, Jan? Senator McLucas and I were involved deeply in such matters four years ago. But indeed that is why (e) was seen as a positive inclusion at the time. Such additional matters, if any, are prescribed by the regulations.
So, Senator Nettle, there is an argument that there is already the capacity to do it. Having said that, if this is an additional criterion that senators think is worth while, I think there is an argument for the notion of public good, especially when you are taking into account, for example, the likelihood of significant advances in knowledge or improvements in technology et cetera. I think there are arguments for it. Again, I do not want to do anything that necessarily disrupts or detracts from the integrity of this legislation. I do not necessarily think that this amendment does that. Again, there is an argument for value-adding, if you like, but I am happy to be guided on this matter by others in the chamber and, indeed, by Senator Patterson as to what impact she thinks the amendment would have on the legislation before us.
I just want to say that I do understand Senator Nettle’s motivation. It is the same motivation that Senator Stott Despoja, Senator Nettle and I shared in 2002. The fundamental principle is that whatever potential therapy, whatever potential cure—whatever results—ensues from this research if this legislation passes, it should be available to all Australians. I think that is a principle or a tenet that we all agree with.
The question, then, is: do these amendments, as they are framed, deliver that outcome? I am not sure that they do, but I am not sure that they do not. I suppose I am mulling, which is possibly a little naughty. If the NHMRC has to have regard to the capacity of any scientific advances to be delivered through the public health system and/or to reduce global disease burden, I am not sure that it is actually possible for the NHMRC to deliver that. Do they have the capacity to undertake that analysis? It is not the purpose for which the entity was established. It is not a normal principle that they would go through to assess anything. So the question has to be: whilst we understand and agree with the principle, does that actually deliver the outcome we are attempting to achieve?
I now turn to the second amendment. Are we doing this cognately?
I am sorry, Senator McLucas; I did not hear the details because I was concentrating on doing something else. I was wondering whether you would mind indicating to me again your acceptance or otherwise of those amendments.
I confirmed that we were dealing only with the first amendment and therefore made a comment only around that one. My concern is that, whilst I understand the intent of the amendment, I am not sure that it is doable—whether it is possible to be undertaken—or whether it will achieve the outcome that is desired. Given the time and the fact that we are somewhat further down the track than we thought we would be in the course of this debate, I am not sure that the appropriate advices have been received from all parties about whether or not this will achieve the outcome that Senator Nettle intends and which I personally share. Does that help, Senator Patterson?
Firstly, I thank Senator Nettle for her support of the bill and for her constant questioning of people who came to the committee on this issue. I admire her zeal. I suppose a bit of the gloss has gone off my zeal as I have got older, but I hope I still have a bit of zeal left in me. Putting this bill up has indicated that I have a bit of zeal; I thought I had gone into semiretirement but I needed to come out of it to do this, because I felt so strongly about it.
I can understand what Senator Nettle is saying. One of the things that absolutely stunned me when I was health minister was finding out about an enzyme deficiency disease which about 10 or 15 Australians suffer from. Scientists have developed an enzyme which acts as a replacement and these people have a significantly better quality of life. It was assessed as being efficacious through our normal procedures. I cannot remember exactly what it costs—I was going to try to find out, but I have been busy this week—but each year the health minister signs off on treatment for people with this particular enzyme deficiency; it requires ministerial approval and the minister signs a document. I think I would not be misleading the Senate to say that the cost for one person was over $200,000 for one year. Each year they get reassessed and the doctors estimate how much of this enzyme a person will need and what it will cost for the following year. It is something in the order of about $146,000 or $150,000 per person per year.
Because there are so few people across the world with this disease, all the investigation and research that goes into the production of this enzyme is built into the cost. I used to marvel as I signed these documents, for about 10 or 15 patients, at what an amazing country we live in such that someone with this sort of enzyme deficiency who required treatment could have it. People have views about pharmaceutical companies but this enzyme was discovered, put through clinical trials and is available. So we do have a system where if a procedure or treatment is efficacious then it is made available.
I see the sort of goal that Senator Nettle has in getting the NHMRC to focus, when they are approving licences, on taking these issues into account. Now, as Senator McLucas said, this has gone a little faster than we thought. We did not think we would get to the committee stage until tomorrow. I have actually asked the minister if we could get somebody from the NHMRC to comment in a technical way on the doability—if there is such a word—or otherwise of this. So if I, and others, can keep talking until we get to question time, we can actually have the opportunity of asking the NHMRC, because I think it has been approved, about the technical detail of this.
I was going to do that but then it will take us on to the next amendment and we still have to discuss that one. One of the problems is that we have these amendments. I have to say Senator Nettle indicated there were going to be amendments in the committee hearing. She showed courtesy to the chamber in that she foreshadowed these. She was the first one out of the block with amendments drafted. I had hoped that we would be able to have an answer to her as soon as we got into the committee stage, but let me just say that I hope Senator Nettle is prepared for us to actually seek advice as to the doability of this amendment because I would like to be able to address her concerns. I am sure Senator McLucas—I will not put words in her mouth—would appreciate the opportunity to do that. If Senator Nettle is prepared to defer that amendment until we seek that advice then we can have a more informed discussion and decision.
Can I suggest that, given we are about to adjourn for question time, we may actually have the time that we need. So rather than postponing that amendment for now, should we just go with the flow and see whether we have the necessary advice or information? I just want to make very clear that I am happy to support the amendment before us. I do not see it as a problematic amendment. I am happy to take advice, however, from the NHMRC. I do think it is the prerogative of the parliament to decide what criteria are used in the assessment of licences.
This is obviously a new criterion that has been suggested by Senator Nettle. I think she has spent some time appropriately refining that criterion. There were a couple of versions that were discussed previously that I was a little ‘uh-oh’ about but I think this is an agreeable amendment so I am happy to state that as my position on record. I am not sure if there is a nod there—through you, Mr Temporary Chairman—from Senator Webber but we will see what other people think. I look forward to that information but at this stage I am happy to debate any or all of the amendments and I am sure after question time I will have my own and Senator Webber’s amendments to add to that list.
As with most things on this legislation, I agree with Senator Stott Despoja. With a closer examination of the wording of Senator Nettle’s amendment—as I said before, I absolutely support the sentiments behind it—I now do not see any great problem with supporting the amendment itself. However, I do have a question for Senator Nettle or for others involved. The words themselves about ‘the capacity for the scientific advances to be delivered through the public health system and/or to reduce the global disease burden’ look fine. I am sure that is something that we would all support. However, I would like a bit more detail about just how we define that capacity and how we look at tying that to any licence that is granted.
I would not in any way, as I say, want to have a very narrow definition of what that capacity is or what those perceived benefits in reducing the global disease burden are at any one time that would stymie any development or research into the future. We have discussed long and hard in the second reading debate in this place the fact that none of us know exactly what the future holds in any of this research. So I would not want to have too restrictive a definition of how we define advances or benefit when, as we all know, scientific research is a leap into the unknown and therefore we have to put a lot of faith in what people say is possible and probable. We have to find that balance and therefore I would not want to say that perhaps the NHMRC or others were restricted in granting licences because we could not come up with a strictly defined definition.