Medicines (Specified Biotechnical Procedures)  Amendment Bill — Third Reading 
Medicines (Specified Biotechnical Procedures)  Amendment Bill — Third Reading 
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Medicines (Specified Biotechnical Procedures)  Amendment Bill 
Third Reading 
Hon MITA RIRINUI (Associate Minister of Health) 
 on behalf of the 
 Minister of Health 
: I move  
That the Medicines (Specified Biotechnical Procedures) Amendment Bill be now read a third time 
. This bill extends the period of the current controls on xenotransplantation until 31 December 2006 with the ability for the date to be extended by Order in Council if necessary. The current controls were introduced in response to concerns about the potential threat of xenotransplantation transmitting new infections to recipients and to the wider community. There were also concerns about the adequacy of regulatory review processes and the social and ethical issues associated with xenotransplantation. 
The current controls allow xenotransplantation trials to be considered and approved by the Minister of Health on a case by case basis. Strict criteria must be met before any approval can be given. New Zealand has therefore adopted a rigorous regulatory approach rather than forcing a moratorium. No applications have been made to the Minister of Health under the current provisions. Without this bill the existing additional controls on xenotransplantation will end on 30 June 2005 with the expiry of Part 7A of the Medicines Act 1981. After this date the scientific and integral oversight will return to the controls utilised for clinical trials of medicines contained in section 30 of the Medicines Act. The section 30 controls were previously identified as being inadequate and despite further information on xenotransplantation being published the Minister of Health is advised that there is still a need for additional oversight of this controversial emerging technology. 
Xenotransplantation is currently an experimental technique only. There are only a small number of animal or human studies of possible efficacy and it is far from clear whether a transplanted animal organ could function properly in a human. In the opinion of a number of authorities the transmission of retroviruses to humans via xenotransplantation is a credible potential risk to public health. However the magnitude of the risk is the subject of considerable debate amongst experts. In the view of concerns about the safety and efficacy of xenotransplantation similar jurisdictions including Australia Canada and the UK have stringent controls on xenotransplantation. To the knowledge of the Minister no clinical trials are currently under way in these countries. 
In New Zealand the Bioethics Council is currently undertaking an extensive public dialogue on xenotransplantation. This involves in an open submissions process an online forum and a series of meetings to ascertain the level of public acceptability around this technology. They expect to complete that process and to advise the Government of the outcome in September 2005. Allowing the controls on xenotransplantation to lapse would pre-empt that process. 
The Minister of Health is monitoring international developments and regulatory approaches to xenotransplantation and emerging research on the safety of xenotransplantation. The ministry is also undertaking work on the type of legislation that may be required for this practice in the future. This work has been undertaken as part of the Ministry of Health’s review of the regulation of human tissue and tissue-based therapies. Finally as many of the risks associated with xenotransplantation carry severe consequences and are uncertain this Government is proposing a precautionary and rigorous regulatory approach as already adopted by Australia Canada and the UK. 
Dr PAUL HUTCHISON (National—Port Waikato) 
: 
 My view is that this is a very sad day because the Labour Government is imposing a blanket moratorium on a very promising technique that could help tens of thousands of New Zealanders in about the crudest most unthinking way possible. There is no doubt that a moratorium which is what is being imposed until at least December 2006—and it could be extended—is an absolutely unthinking way to manage critical medical research. We have just heard the Associate Minister of Health say that all xenotransplantation should be basically stopped in New Zealand. He probably has not even bothered to read the Ministry of Health’s report to the Health Committee which describes the vast spectrum of techniques that are available. They do not just include organ transplantation. They include cellular xenotransplantation and external xenotransplantation therapy. 
It seems ridiculous that we have in this country technology that 5 or 6 years ago might have seemed to carry a degree of risk—even though it was used here on six patients some of whom have demonstrated that it is successful and there has been no evidence whatsoever of risk—but that in the meantime has been shown to be much less risky than it was thought to be. Yet the Government instead of being prepared to look at scientific process has put its head in the sand and said that it will not listen and that it will clamp an unthinking moratorium on that technology. That is the level to which this Labour Government has fallen. That is its approach to science. 
Even worse the report of the Health Committee in the name of Steve Chadwick the chairperson stated that the committee considered that the content of this bill was straightforward and uncontroversial. Well the bill is neither straightforward nor uncontroversial and it penalises tens of thousands of New Zealanders who suffer from diabetes and many other conditions. No submissions on the bill were allowed despite requests from the National Party and I believe the ACT party and from bodies like Diabetes New Zealand the Royal Society of New Zealand the New Zealand Association of Scientists and the New Zealand Biotechnology Association all of which are hugely interested in progressing biotechnology in New Zealand. 
Perhaps even more poignant and relevant is a letter I received addressed to the Hon Annette King and dated 13 May from Living Cell Technologies. It is from Dr Tan the managing director and an internationally recognised biotechnologist. The letter states: “Living Cell Technologies understands that the New Zealand Government is reviewing the extension of the moratorium on xenotransplantation. This letter is to update you on current developments relative to the moratorium and urge Government to consider lifting the moratorium with respect to transplantation using cells from animals that are not genetically modified. As an international company Living Cell Technologies has kept up to date on progress in this field in the USA and Europe. In recent years new scientific information supporting the safety of xenotransplantation has been published. LCT wishes to make available its own information and perspective.” 
Further the letter states that in 2004 the Government-sponsored body Investment New Zealand introduced Living Cell Technologies to a xenotransplantation company in China China Shanghai SeeinglongBiopharmaceutics Ltd. Living Cell Technologies states it is pleased to support the message that New Zealand is one of the few countries in the world that is free of transmittable spongiform encephalitis in farm animals and hence is an ideal source of high-health-standards animals as a source of cells for medical therapeutics. 
I think it is worthwhile to read out Dr Tan’s concluding remarks: “Rather than maintain the current status in which xenotransplantation is available to New Zealanders who can afford to go to China or Mexico”—known as “xenotourism”—“we respectfully urge Government to review recent information available since the introduction of the moratorium and permit the conduct of clinical trials in xenotransplantation. Such trials would be strictly conducted in a manner regulated and ethically approved by the Department of Health.” That is an eminently sensible approach. It is an approach based on evidence and on risk management. Yet what does this Labour Government do? It imposes a blanket moratorium on hugely legitimate research that should be carried out here in New Zealand. 
It is no wonder New Zealand scientists are heading overseas to work. It is no wonder New Zealand Crown research institutes are finding that because of the regulatory hurdles they just cannot do genomic work in New Zealand—work that in the case of many Crown research institutes like HortResearch AgResearch and Crop and Food Research amounts to something like 60 percent of their work. They have to do that work overseas contracted outside New Zealand and are losing the critical mass of people and the critical skills required to keep up to date in the area. It is important not only for the biotechnology industry but also for all of us in New Zealand to have a critical mass of scientists who are aware of the possible biosecurity problems that we face. We have to be able to recognise things. We were not able to recognise the varroa bee mite until it was endemic in New Zealand. Things like the foot-and-mouth scare could have huge implications. If we do not have a critical mass of scientists who have the ability to recognise those problems then incursions will occur unnecessarily when they could have been prevented. It is the Labour Government’s attitude towards science that perpetuates the problem. 
The letter goes on to state that Living Cell Technologies’ current intention is to conduct Food and Drug Administration - approved trials for a neurological disorder Huntington’s disease and for type 1 diabetes in the USA. However Living Cell Technologies would reallocate its resources towards conducting a trial in New Zealand if such trials were approvable. That is a tragedy for New Zealand. Finally the letter states: “LCT’s technologies are New Zealand inventions and it would give Living Cell Technology’s founders much satisfaction to see these continue to be developed from New Zealand and take advantage of the country’s unique high-health-status animals and high standards of animal care and husbandry.” 
It is with great sadness that I see across the House a Labour Government that is not prepared to look at progress in science. It wants to impose a blanket moratorium on very innovative and ingenious work that has been instigated here in New Zealand. Living Cell Technologies initially had to go to Australia. It still has its biology technology here in New Zealand but it looks as though it will have to do the work in America. That is a tragedy for New Zealand. It is a tragedy for many tens of thousands of diabetics around the world. And that is all being imposed unnecessarily by a Luddite Labour Government that has an absolutely anti-progressive attitude towards science. 
Hon DAVID CUNLIFFE (Minister of Communications) 
: 
 I am not a scientist and I do not pretend to understand the details of xenotransplantation. But I do understand that the Government has taken the best expert advice on the costs and risks of allowing xenotransplantation in advance of other similar countries. The reality is that our friends in Australia have not allowed the types of practices that this bill disallows; nor has the United Kingdom. 
I would like to recall the structure of the argument that has been made by the colleague who has just resumed his seat. He is a former doctor who started off arguing on the basis of human health—that New Zealanders’ health demanded access to xenotransplantation. Yet as a scientist he will be aware of the difference between type A and type B error. Type A is where we do not fix something we should fix—we do not do something—and type B is where we try to fix it but end up with an even worse result. 
The trick with this issue is that the consequences of trying it and getting it wrong would be absolutely horrific. Diseases like porcine endogenous retrovirus have the potential to jump the species barrier from animals to humans and we could have a genetic mutation with the most serious consequences. So I argue that on the first ground—the ground of health—the Opposition’s case has not been made. 
But the previous speaker moved on from that. He was not satisfied that he had convinced people on health grounds so he talked about the need to locate research in New Zealand. I say to the Opposition folks that they should come clean. If you want more subsidies for Crown research institutes or medical laboratories why do you not just come clean and tell us that that is what you are really about? 
The ASSISTANT SPEAKER (Hon Clem Simich) 
: Order! 
Hon DAVID CUNLIFFE 
: Not you Mr Speaker. You of course are like the driven snow. 
More important if the case were about biosecurity which was the Opposition’s third argument then why would the Opposition place New Zealand’s international reputation at risk by taking steps that our closest friends and trading partners have refused to take? 
I believe that the reality here is that the National Party and ACT—not surprisingly in the latter case—have been captured by the narrow interests of one company: Diatranz. They have been hoodwinked that Diatranz has a fully proven medical technology but it is still very much at the experimental stage internationally and has not been proven for New Zealand conditions. If the argument is that Diatranz must be relied upon for a cure for diabetes then I ask National and ACT whether they have heard of Protemix and the excellent work of Professor Garth Cooper and his colleagues. They have not felt the need to leave New Zealand and there is no suggestion that they are the least bit threatened by this bill. 
New Zealand has world-class research. This Government is proud of New Zealand’s science establishment and medical researchers and we think the Opposition should stop running down Kiwi science understand the difference between type A and type B error and adopt a cautious prudent and rigorous approach which is exactly what this bill proposes. 
BARBARA STEWART (NZ First) 
: 
 On behalf of New Zealand First I rise to support the Medicines (Specified Biotechnical Procedures) Amendment Bill. This legislation will extend the current controls on xenotransplantation until 31 December 2006 by which time the human tissue legislation should be in place to legislate for this area of biotechnology. The proposed amendment to the Medicines Act currently before us does not call for a ban on innovations in treatment. Instead it puts an onus on the Minister of Health to be satisfied that issues surrounding them have been adequately addressed before the go-ahead is given. 
Xenotransplantation is a complex issue. There is no doubt that this technology is very innovative. It can be used for a wide variety of purposes—Dr Hutchison outlined some of them—from the insertion of animal cells into humans and the growing of human cells on layers of animal cells to whole organ transplants. All those procedures are still developing. Some are much further along than others. It is a technology that in New Zealand both the public and the Government need to be very sure about. We know that we have world-class scientists here in New Zealand. We also know that medicine in various countries around the world uses replacement heart valves sourced from pigs. But those products are all chemically treated and are not functional living tissue. That is what distinguishes them from the various treatments used for xenotransplantation. If xenotransplantation were simply a risky trial treatment it might be that an individual’s consent would be sufficient to justify that risk. However possible risk to human health cannot be justified merely on the grounds of an individual’s consent. If that were the case we would have a set of techniques that potentially could help a large number of people who are badly off but there is also the potential for the health of a very large number of people to be threatened. 
The Bioethics Council has completed its first round of public meetings. A report is to be presented to the Government in I understand August. The council is made up of people who have been given the responsibility for making some initial recommendations about this particular matter. Not one of us in this House is an expert on xenotransplantation and we need to read the report that is currently being written after the recent round of discussions. I have no doubt that we will be very keen to see the report when it is finally produced. It was very interesting to read that since the council released its xenotransplantation discussion paper in February public interest in xenotransplantation and the work of the council has become greater than ever. There was strong participation in the online forum with submissions and in the dialogue event with registrations which shows the interest here in New Zealand. 
When we look at other countries we see that in 2004 Australia announced a 5-year moratorium on clinical trials. In the UK no clinical trials are under way. In Canada clinical trials cannot proceed without the approval of Health Canada. That will be the case here in New Zealand also. We are basically following the line our nearest neighbours are following and that is what we should do. We know that China and Mexico carry out xenotransplantation on a relatively large scale. Those countries do not have the appropriate regulatory authorities to develop guidelines that would safeguard patients and the people with whom they come into contact so of course it is far easier for testing to be carried out in those countries. The risks can be regarded as manageable only if proper monitoring of recipients and family contacts can be undertaken on a long-term basis. 
The last hundred years have witnessed many attempts to carry out animal to human organ transplants. At this point in time all of them have failed. We know that all transplanted organs are liable to rejection. There are no guarantees for anyone. Xenotransplants must also bring about that response perhaps even more so. Significantly we know too that pigs appear to have been the source of deadly new epidemics. The human Spanish influenza epidemic of 1918 which killed between 20 million and 50 million people across the globe was it is believed a mutation of a pig influenza virus that was spread from American pigs by US troops during World War I. We know that some of the viruses carried by pigs are difficult to eradicate. We also know of examples of diseases crossing between species such as the bird flu epidemic in Asia. We have not even found a cure for those diseases. The evidence at this point in time appears to indicate that xenotransplantation carries that risk so we need to take a prudent approach. 
With 30 new diseases having been discovered over the last 20 years most of which have been transmitted from non-humans to humans some scientific commentators have been led to assert that newly emerging viruses are now the biggest threat to mankind. 
Sitting suspended from 6 p.m. to 7.30 p.m. 
BARBARA STEWART 
: Ministry of Health officials advised us during the Health Committee briefing that the human immune system rapidly attacks and rejects tissue from animals meaning that most xenotransplants fail rapidly. We were also advised that scientists are exploring options to try to solve those particular problems. So the technique is still only experimental. Although we acknowledge that infections may be minimised in the same way as for human infections science does not know of all the infectious organisms that may infect humans and definitely what can infect source animals and here we are looking at pigs in particular. Dr Boyd Chief Adviser Ministry of Health said that substantially more informed debate needs to take place than to date and it should involve views wider than those who stand to benefit. 
Although we want to provide lifesaving solutions for New Zealanders we want to be sure that medical procedures provide the best possible medical outcomes for everyone. New Zealand First supports this legislation. 
HEATHER ROY (ACT) 
: 
 I stand to speak on the third reading of this bill. ACT New Zealand is opposing this legislation for several reasons. The first of these is that the bill itself is about extending the moratorium until 31 December 2006. Without this bill the existing additional controls on xenotransplantation will end at the end of June 2005 with the expiry of Part 7A of the Medicines Act. After this date the scientific and ethical oversight will return to the controls utilised for clinical trials of medicines contained in section 30 of the Medicines Act. So that is why we have this legislation before us today. 
We are opposed to the extension of this moratorium for the sole reason that it is a matter of political expediency in this election year. We believe that the Government does not want to have the issues around xenotransplantation in particular debated at this time. It would rather kick for touch and extend the moratorium for another 18 months when in fact what we should have—and I agree with Dr Boyd when he gave his advice to the Health Committee—is the wider debate. Rather than delaying that debate we should have it now. He is quite right when he says that it should not be only the people set to benefit who should participate it should be a very wide debate and it should encompass everybody’s views. But we would contend that that debate should happen now rather than delaying it completely. There is no guarantee that the moratorium will not be extended even further than December 2006 and I ask the politicians who do support this: are we ever going to have this debate at all? It should be held right now. 
The bill was raced through the select committee process and other speakers have said that the chair of the select committee said that this was an uncontroversial bill. It is only uncontroversial because all the bill is actually about is extending the moratorium. The issues that are covered here of course are extremely controversial and that is why we see such heated debate about this topic. Again ACT says—and we are joined in this by the National Party—let us have the real debate. Let us have proper consultation from scientists from experts in the field and from the wider community so that the real issues are discussed and we do get that proper rigorous debate that the issues warrant. 
Professor Bob Elliott’s treatment for diabetes and his research have been widely discussed at all points in this debate—the second reading the Committee stage that we had yesterday and in fact again today. There are many things that Professor Elliott in taking his research and treatment offshore has raised. Amongst this the very broad view and I think the most important one relates to the type of environment we have here in New Zealand for science and for research. The Government has repeatedly and persistently declared its belief that biotechnology is a main aspect of what it likes to call the knowledge economy. One hears terms such as “bright future” and the like. I contend that what we have here is the opposite. Where is the basis behind this knowledge economy when our scientists—our best and our brightest—have in fact been forced offshore to do their research? Particularly with Professor Elliott’s treatment for diabetes people are now going to have to go offshore to have their transplants. Professor Elliott’s xenotransplants that have been developed by his company Diatranz would appear to fit the bill. 
I think that in a decade of careful experimentation this prominent medical researcher has developed a very interesting method of dealing with diabetes and one that diabetics in this country are now going to be denied. The method I think is worth touching on very briefly. It is a method of trickling insulin from cells cultured from the pancreas cells of piglets. These are contained within a retrievable tea bag. The interesting thing about this tea bag if one likes is that it floats in the diabetic’s peritoneal liquid in the cavity of the stomach. The cells are coated to prevent immune reactions and the patient’s immune systems are not interfered with at all. We have heard repeatedly from various speakers through the entirety of this debate that we have to worry about immune responses. In this particular area of research and treatment that is not an issue at all. 
The whole debate has raised for me—and I have worked in the area of research myself—concerns about research. I think many people just do not understand what research is all about. We have volunteers who have sought information themselves and who have consented voluntarily to the treatments and to the research that they have undertaken and they are well aware of the consequences of their actions. They know that there are risks associated with the treatment risks associated with research and in fact there are risks associated with life. They take this on board and they make a voluntary conscious decision to participate or to not participate. 
There are many people who decide that the research process is not for them so they agree not to participate. There are others who weigh up the pros and the cons and undertake the research. Many of these volunteers whom we have heard about during the debate have decided that it is the thing for them and have had very good results and in many cases life-saving results. We should not forget this. It is very easy for those of us who do not know much about diabetes and the other terrible diseases that have benefited through the times of history from research processes just to sit here but it is as much a debate about progress as about anything else. 
We have focused heavily in this debate as one speaker did say on Professor Elliott his research and his company Diatranz. But we should note that there are many other companies involved and many other researchers and scientists who also have experienced similar things. They too have been driven offshore to progress their research. The obvious question when we focus on this particular area of xenotransplantation is: is pig insulin safe for humans? The answer is a very obvious one too. The answer is in the decades of injecting millions of diabetics with pig insulin. Now are we about to take that insulin away from people who since the 1950s have had a very valuable lifesaving improvement in their quality of life? I would contend that no we certainly are not. 
The experts in the field as we have heard were not able to be called to the select committee and that is certainly what I would have liked to see. Professor Roger Morris of the New Zealand Veterinary School is a world expert on transfer of animal viruses to humans and I talked about him yesterday. He is a main adviser to the United Kingdom on foot-and-mouth disease and to the Hong Kong Government on duck and hen infections jumping into humans. This is what he has to say about the use of pig cells in New Zealanders. “It’s riskier going to the zoo than to have one of these pancreatic cell transplants.” he declared. He followed that comment with: “I don’t believe it’s risky going to the zoo.” and I would have to say that I agree with him. 
I would like to touch briefly on research in this country. This bill is about delaying science. It is about delaying progress and it is about delaying the ability of New Zealand’s scientists to participate in research. That is one of the main reasons for ACT objecting to this bill and opposing it. I also touched briefly in other stages of the bill—in the Committee stage in particular—on retroviruses. A lot of talk has gone on about this and I described the technique with Professor Elliott’s research. 
The retroviruses are a worry. That is why in this country we have very rigorous regulatory regimes surrounding research projects. They are right and they are proper and we should have some faith in the process. We do not screen our tourists or our immigrants for retroviruses yet we worry inordinately about retroviruses in research where we have very tough regulatory regimes in place. I contend that we should trust our experts a little more. If we have the proper processes and regulatory regimes in place then we should be able to rely on the scientists to fulfil the requirements of those properly. 
JUDY TURNER (Deputy Leader—United Future) 
: 
 I rise on behalf of United Future to speak to the third reading of the Medicines (Specified Biotechnical Procedures) Amendment Bill. I say upfront that United Future is supporting this third reading because this amendment bill extends the expiry date and reflects a desire to put in place sensible legislation designed to facilitate the development of medical science within a safe regulatory framework. The proposal is to have xenotransplantation covered by a new human tissue bill which is well on track to be introduced into the House by the end of this year. 
Missing from the complaints from both National and ACT members was a guarantee that they will welcome that human tissue legislation and allow it to move through the legislative process without any political game-playing. Those sorts of commitments would mean that legislation could be in place well before 31 December 2006. The power to move with responsible speed on this matter could well be within the power of the current Opposition. The National Party which is campaigning to be the Government should include a reassurance in speeches made by its members that the human tissue bill will be its highest priority should it become the Government. 
The issue that has been raised about trusting or distrusting the scientific community is a complete nonsense. Responsible scientists never want to operate outside a clearly defined ethical framework. In fact scientific developments always need to happen within an ethical framework because ethics as we have stated before do not apply just to medical procedures but also include the research processes. As I have said on numerous occasions the means by which we achieve a medical outcome are as ethically important as the end itself. 
If one listens to the Opposition spokespeople one would think that the progress of xenotransplantation is the only pathway forward for diabetics kidney patients and the like when the truth is that there is a raft of other health initiatives such as improving our human organ donation rates in New Zealand that are very commendable and often superior options. 
I would like to mention now—because one does not get a lot of chance—the work of Andy Tookey and the generosity of Peter Jackson in this regard because better registration of human donors and better public health promotion around this issue would make a huge difference to our donation rates. Those kinds of initiatives are ongoing and worthy of development. When we start to see one medical option as the only way forward I think we are in serious strife. 
This amendment bill has three clauses: a title clause a commencement clause and then the one clause clause 3 that is what the bill is really all about. The clause amends the Medicines Act 1981 by deferring the expiry of Part 7A from 30 June 2005 to 31 December 2006. It also allows for that date to be extended by Order in Council should it be necessary. However my expectation—because of the obvious interest across the House on this issue—is that when the human tissue bill comes before the House we will get great support across all parties to send it to the select committee call for submissions and have the whole cause progressed with sensible speed which would mean that this issue would be a non-issue well before 31 December 2006. United Future is more than happy to support this small amendment bill at its third reading. 
SUE KEDGLEY (Green) 
: 
 The Green Party too is very very pleased to be supporting the Medicines (Specified Biotechnical Procedures) Amendment Bill. This bill as the previous speaker pointed out is really a minor technical bill that extends the date of a moratorium. One of the complaints we often hear from the National Party is about rushed legislation coming before the House. Here we have an example of where the Government has said that because it has not completed the legislation it needs more time to get it right. One would think that everyone in this House would support the idea of getting something as complex as regulations and legislation surrounding xenotransplantation right. 
I do not believe that Katherine Rich deep in her heart truly believes that xenotransplantation is some great miracle that is almost devoid of risk which is what she has been arguing. I think her party has told her to say that but that she does not for a moment believe it. I think she knows like all the rest of us that xenotransplantation actually involves huge risks. 
The member from ACT quoted various people. I want to read a couple of quotations. The first is from a virologist from Cambridge University who said that if we go ahead with xenotransplantation it will be a step in the dark because so much uncertainty surrounds it. The second is from a virologist from the University of Texas. He said that it is well established that most new emerging human infectious diseases have their origin in other species and that a direct method of establishing new infectious human disease would be to implant infected tissue from a non-human species into humans and allow viruses direct access to human tissue. He said that seldom if ever have we had as much knowledge to prevent a future epidemic and that what is lacking is the wisdom to act upon that knowledge. 
That I suggest to the National Party is what is needed here. What we need is not great excited shrill calls about the potential of xenotransplantation but some wisdom to understand the risks inherent in it. Whatever we say however lightly those members try to dismiss the risks the truth is that there is the possibility that new infectious organisms not currently known will emerge and infect human beings. 
I might add that if that were the case it would actually threaten the people who receive the pig organs as well as potentially all the rest of humanity. A  
New Scientist 
 editorial stated that nothing could be worse than if in trying to save our lives we inadvertently engineered a plague. So let us not try to dismiss the risks. 
Even the Ministry of Health says that basically the porcine endogenous retrovirus is present in the DNA contained in the nucleus of all pig cells and those emerging viruses would pose a particular problem because they would be difficult to identify. 
Surely we should learn from the past. What was the bovine spongiform encephalopathy Creutzfeldt-Jakob disease crisis if it was not basically the transfer of a disease crossing the species from animals into humans? Surely something like that would give us cause to think that next time for something like this we should get it right. 
We know that both humans and pigs carry viruses within their genes. It is possible that they could combine those viruses to create entirely new organisms. We know that all organs donated—like an organ transplant—are liable to rejection. Even with a human-to-human organ transplant the body’s defence mechanisms attempt to destroy the foreign organ. But in the case of xenotransplantation far more violent responses occur. They are called hyperacute rejections. That is an incredibly strong reaction that destroys the new organ within minutes. 
Even if scientists manage to avert an inherent rejection by introducing human genes into pigs the pig organ will still face other rejection processes that scientists believe will be stronger than those faced by human organs. Even if the pig organ survived there is strong evidence to suggest that it would fail to function adequately within the human body. So let us not present this as if it were the magic bullet when indeed it is an extremely risky area. Another issue we need to consider is that rearing pigs under germ-free conditions which is what is envisaged is extremely expensive and time consuming not to mention the cost of monitoring the pigs for the presence of bacteria and viruses. That would involve huge sums of money. 
Given that our health system is already stretched scientists are pointing out and particularly people with an interest in diabetes that even if xenotransplantation were proved to be possible it would take away potentially huge amounts of funds that could be used for the care of patients suffering illnesses that could not be treated by the technology. So even if it were possible it would be enormously expensive and it would also involve turning pigs into spare-part factories and plundering their organs. Genetically mutated pigs would be raised in artificial conditions and those extraordinarily intelligent animals—I see that some members are laughing. The truth is that pigs are intelligent and they would face an unnatural and distressing existence. Do we not need to consider them as well or do we humans have the right to use animals manipulate them in whichever way we would wish no matter how much suffering we may cause them? 
The truth of the matter is that if we are genuine about trying to reduce the epidemic of diabetes in our midst which is really what most people when they talk about xenotransplantation are thinking about we have two things that we should be doing immediately. One has been touched on by the previous speaker which is getting human organs human organ donations—and we have such an appalling record in New Zealand for human organ donations. We have one of the lowest rates of human organ donations in the world. Why are we not trying to do something about that? 
Secondly why are we not trying to do something to prevent the underlying causes of diabetes? Yes we know that more than 120000 New Zealanders suffer from diabetes and we know that lack of exercise and diet are the key causes of type 2 diabetes—particularly fat and foods with a high level of sugar. 
If the National Party and the ACT party were really genuine in their passionate desire to treat diabetes they would be taking strong steps to try to reduce the amount of high-sugar high-fat foods and drinks that our children are eating and drinking in New Zealand. They would be joining in an initiative to take out of our schools all those high-fat pies and those vending machines selling sugary fizzy drinks. We know that they cause diabetes. It would be an incredibly simple step to get them out of our schools to try to do something to work with the food industry to stop them from targeting all that food laden with fat and sugar at our children. That is the single most effective thing we could be doing to reduce diabetes but no we avoid those simple steps and go on about some incredibly risky and expensive technology such as xenotransplantation as though somehow that is the panacea. 
The panacea is right in front of us—that is human organs and improving our diet and exercise. There is no need for xenotransplantation if we were to take those simple cost-effective steps. If the National Party is serious let us see it make some progress on that and not risk humanity by rushing into a science with such enormous risks. 
MARK PECK (Labour—Invercargill) 
: 
 That speech came from a member who was going to join a campaign against dihydrogen monoxide—water. Because dihydrogen monoxide had killed lots of people she thought it was a dangerous substance and when she found out the substance was water she was a little mortified. At least she had the good grace to acknowledge the slip. Anybody who listened to that speech would have thought that some shock horror legislation was being put through the House designed to visit all sorts of unnaturals upon the populace at large. Nothing could be further from the truth. This is simple legislation which the member totally misrepresents. It actually extends the moratorium on xenotransplantation from 30 June 2005 to 31 December 2006. At the very least the member could have welcomed that. She could do that by way of interjection if she wished to. In fact what the extension allows to happen is what the co-leader of the Green Party—which Ms Kedgley belongs to—agrees with which is for an evidence-based approach to be set up for use with regard to xenotransplantation. The member forgets to tell us when she talks about diabetes that there are two types of diabetes one of which can be treated only by some form of treatment like this. I find it incredible that Ms Kedgley can go on in the way she has about this particular technology and science without the slightest bit of understanding of them. That explains why she was going to join a campaign to ban water. She just simply does not understand. 
Fortunately most of the Parliament does understand that this particular bill serves a purpose for now and that we will let the scientists get on with working out whether xenotransplantation is a safe procedure to use in humans over time. 
KATHERINE RICH (National) 
: 
 I agree with the last speaker: let the scientists get on with their work. Let the scientists decide what science that they do. We have heard a lot of talk in the House tonight much of which I do not agree with. We already have frameworks in place. We already have ways of doing science in this country that are ethical well-managed and well-regulated. Judy Turner from United Future said we needed an ethical framework within which to undertake this kind of work. We already have that within the various Acts and regulations that we ask scientists who undertake science in this country to work under. 
Judy Turner also asked that the National Party have some pretty weird priorities when it comes into Government. She asked that our No. 1 priority be legislation to do with human tissue. I have a message for that member: when we become the Government our priorities will continue to be the main areas that Government should be concerned with—health education and the economy. I am not saying that what we are debating here tonight is not important but those are the areas that should be the No. 1 priorities not individual pieces of legislation like this. She also said that she thought this bill was sensible. I challenge her to stand opposite someone who is desperately waiting for a new treatment or for some life-saving operation and explain to him or her why these delays are a good idea. We do not agree. 
The National Party does not support the Medicines (Specified Biotechnical Procedures) Amendment Bill that we are debating tonight. Even though it has only three clauses and looks like a very short technical bill the implications are quite far-reaching. The implications will be huge for the scientific community and they will be huge for people who are interested in the outcomes of xenotransplantation. 
Sue Kedgley made some comments in her speech about her disbelief that I would support this kind of bill. I have one message for that member: pig kidneys—bring them on. Four members of my family have been on dialysis. Another 10 are waiting in the wings. It costs the State about $1500 per week for their treatment. Many of them would be more than happy to have a pig kidney if the technology came to fruition. 
We are not presenting this as being a panacea as being something that is a magic bullet for all medical conditions but it is another option. It is really important that we do not try to limit scientific endeavour because while we do that in New Zealand other countries do not. Many of our scientists are already making the choice to go to the UK Canada and other areas where this kind of research can be conducted. So it is not to be presented as something that is easy. I am not a scientist but I know that most Kiwis when they are in the position of having to weigh up their medical options are smart enough to decide whether they can live with the risks. 
Heather Roy made a very pertinent point. She quoted a leading scientist who described one aspect of xenotransplantation as being as risky as going to the zoo. He then went on to say that going to the zoo is not risky either. I do not think we have heard enough of the scientific debate. These are the sorts of things I would dearly love to have asked officials and experts when the bill went through the select committee process. Yes we had access to Ministry of Health officials but we were not able to ask many other groups or experts who I think could have advised the select committee as we made our decisions. We did not ask the National Kidney Foundation we did not ask Diabetes New Zealand we did not ask anyone from the Medical Association. My colleague Paul Hutchison made a specific request that we invite submissions on this bill but that was rejected. So it went through the select committee process at breakneck speed. 
The report from the Health Committee is misleading in my view. The bill is described as non-controversial when in fact there were huge controversy and debate when this issue came up. It is not a minor technical bill. The implications are huge. We are looking at delaying scientific work. When has the answer to a problem of not having all the information been to delay work? I totally understand that we do not know everything about this technology and that there are some very fair concerns about it. But those concerns can be managed by scientists and by people who want to take part in trials who can make up their own minds. We cannot halt the scientific tide and expect the problems to go away. There are issues to be worked out with the technology and some of the comments made about retroviruses etc. are valid. But with the technology and the pace it is moving at there are ways to make sure that cells or organs are taken from animals that have been bred specifically for transplants and that we take the necessary precautions to make it as safe as possible. 
I heard David Cunliffe speak on the bill. I was concerned about some of his comments also. He wanted to give the impression that the National Party had been hoodwinked by one company Diatranz and that we were raising these concerns simply because we were bothered about one corporate that had to make a decision to leave New Zealand to continue its diabetes research. That is not the case at all. If anything we have been trying to put a human face on the problems that will be created by this bill—the people who are waiting for lifesaving operations and treatments. In some cases the treatment might not be lifesaving but a huge change to a patient’s enjoyment of life might result from getting treatment that is far more substantial than having to take insulin every day or dialyse every 3 to 4 days. We need to remember that a lot of people are waiting for these kinds of treatments and operations. When we create more and more barriers and hurdles for scientists to overcome it makes it a lot more difficult for them to carry out this sort of work in New Zealand. Many people in this House have spoken to scientists who now struggle to get the work done in New Zealand. Not only do they spend a lot of time putting together applications and getting projects turned down but once they start the work they have to get through so many barriers that some areas simply are not worth it. It is better for them to go offshore. That is why many of our best and brightest have voted with their feet and gone to continue their scientific career elsewhere. 
In my view this bill is really a Luddite approach to science. It is a Luddite approach to finding solutions for many Kiwis who are very interested in the outcomes of this work and who do understand that there are risks that can be managed. Those Kiwis are interested in progressing science so that over a period of time new solutions are found for people who need them. It is a very expensive issue for New Zealand right now. Diabetes is epidemic within this country. We have a growing problem of shortage of space in renal dialysis units. Unless we look at alternatives we will find things become very very difficult for our citizens. 
Sue Kedgley pretends that a huge number of human organs are available in this country. That is not the case at all. We have a huge shortage of them and many families do not have access to the tissues and organs within their own families either. So to just bat this issue away and pretend that the science is too complex is a bit naive. The people who are involved in medical research of this kind take their responsibilities very very carefully. A strong ethical framework that surrounds this kind of work already exists. A number of regulations that scientists are required to follow in order to carry out this work are already in place. 
This bill is not about logic. There is no logical or scientific basis for putting this moratorium in place. This is more about delaying progress. It is a real shame that Labour is not serving those who are the human face of the issue. 
SHANE ARDERN (National—Taranaki-King Country) 
: 
 I rise to take a call in the third reading of the Medicines (Specified Biotechnical Procedures) Amendment Bill. I do so with some bemusement because the very honourable retiring member from Invercargill Mark Peck got up and gave a very good speech on the reasons why we should not support this bill tonight. Unfortunately the very junior Government whip sitting next to him forgot to tell him that it was actually one of the Government’s bills and that the Government was supporting it. Mr Peck will vote for it in a minute when he gets the chance. I thank him for shedding a bit of light that one or two of the Labour caucus members once they get out from under the ether of socialism and go down south to the fresh air and clear their heads can come back to Parliament and talk sense about what needs to be done. I am with him 100 percent. This is a pro-science debate and an anti-bill debate because the bill delays science. It is that simple. 
Tomorrow in Parliament we will hear Dr Cullen present the Budget. There will be a lot of backslapping and people will talk about the amazing things that will come out of that Budget in terms of it being pro-growth pro-science and pro-development. Tonight in Parliament we are debating a bill that delays science and denies scientists the opportunity to experiment and potentially to produce something that would be beneficial to a large number of people. That is an oxymoron. A Government cannot claim to be pro-growth pro-science pro - economic development and pro-health and vote for such a bill. The two just do not and will not square. I look forward to the honourable member taking another call to explain to me how they do square because I am absolutely astounded by it. 
I want to say to the member that there are a number of experts who have submitted to this debate and this process. One of them Professor Bob Elliott has been talked about in a couple of other debates earlier on along with his company called Diatranz which has developed a unique and world-leading technology to help people who suffer from diabetes—something that is a major health problem in this country. He has been forced along with his company to go offshore—to Australia. He was one of the 600-odd New Zealanders who depart from this country every week. I say to members opposite that this country’s economy and Dr Cullen’s Budget tomorrow are able to exist because of the leading edge biotechnology science that has been a hallmark of this country particularly in the agricultural industries but also in the medical field. This bill is yet another example of how a Luddite Government with its head in the sand will stand in the way of that kind of development. 
I suggest that the members talk to the likes of Professor Bob Elliott and Professor Roger Morris a well-known expert who is hired all around the world. He spends more time out of New Zealand than he does in New Zealand. Although Professor Morris’ skills are recognised internationally back here the Labour Government does not need the advice of somebody like him; it already has its own advisers who just say “Yes sir no sir and what do you want us to do next sir?”. I ask members to listen to the likes of Professor Morris who is a world-renowned expert. He will tell us that pig-tissue transplantation—xenotransplantation as it is known—is something that could hold the key to a range of problems in terms of the medical fraternity. He will also tell us that having a very healthy pig herd in this country is the best way to detect any kind of disease that potentially may infect the human population because pigs are the closest species to humans in terms of that kind of detection. So I ask members to have a talk to him. It is as simple as that. If members ring him up I am sure he will give them a briefing on some of this stuff. 
He has said that the kind of technology that is being proposed in terms of xenotransplantation—and it is not some loony field of new development—is safe and there is no science at all that can tell us that it is not. That is the interesting question. The test that has to be measured is whether it is unsafe. That is what the debate is about. Are we sure that it is unsafe? How can one tell that it is unsafe if there is no science to say that it is unsafe? We know that motorcars are unsafe but we all drive them. We know that an earthquake can kill thousands of people but we still live and work in the capital of New Zealand which is on a fault line. We know a range of things that are unsafe but in this case there is no science and no evidence to say that it is unsafe. 
Yet tonight we are debating the extension of a moratorium so that scientists can presumably go offshore and carry out experiments to develop our technology somewhere else. One of the worst things happening in this country at the moment is that some of the best inventions in the world in a range of scientific areas are being taken offshore because they simply cannot work and survive under the regulatory framework in this country—whether it be tax or whether it be moratoriums on this kind of experiment. 
So I say to members that xenotransplantation is not new. It has been around for a long long time as I have said in every debate in this discussion so far. The first xenotransplantation took place in 1682 on a Russian nobleman who had a fractured skull. That is going back a bit. The first successful organ xenotransplant took place in 1963. The problem has always been as has been mentioned throughout the debate that the human immune system rejects the new material. That is the problem. 
To allow science to find a way around that problem I would have thought would be hugely beneficial not only for medical science but for a range of other potential science experiments as well as producing potential intellectual property that could be worth millions of dollars to New Zealand. But no not with the socialists in charge. If someone wants to muck around with that sort of stuff that does not sound as though it will fit into their little corner of thinking then that person must take it offshore. They will not allow it in this country. 
What we are debating here tonight is legislation that effectively kicks science for touch for a little bit longer until the Government can get past the next election then it will be able to have a look out there and see whether it can round up some votes from the United Future party or whichever party might turn up. In the meantime it will put it in abeyance. The Green Party will certainly not allow the bill to move forward so the Government will kick it out for another few months—that is the politically expedient thing to do—and see whether it can cobble something together at the end. 
Mr Peck’s speech earlier reminds me of the occasion when I was a new member when we were relying on Alamein Kopu’s vote for a piece of legislation. She supported it but the last person who spoke to her disabused her of the notion that she should support it. Halfway through my speech she changed her vote so for half my speech she was for it and for half she was against it. That is one up on Mr Peck who spoke in favour of the bill but who will now vote against it tonight. 
Some interesting things have happened in Parliament. This tonight is not one of them. This bill is another socialist measure to kick the scientists offshore. There is no basis to the argument that has been put forward and we in the National Party will not support the extension of the moratorium. 
A party vote was called for on the question  
That the Medicines (Specified Biotechnical Procedures) Amendment Bill be now read a third time. 
Ayes 83 
New Zealand Labour 51; New Zealand First 13; Green Party 9; United Future 8; Progressive 2. 
Noes 35 
New Zealand National 25; ACT New Zealand 9; Maori Party 1. 
Bill read a third time.