Stewart Barbara: Medicines (Specified Biotechnical Procedures)  Amendment Bill — Second Reading 
Stewart Barbara: Medicines (Specified Biotechnical Procedures)  Amendment Bill — Second Reading 
[Volume:625;Page:20546] 
BARBARA STEWART (NZ First) 
: 
 On behalf of New Zealand First I rise to speak to the Medicines (Specified Biotechnical Procedures) Amendment Bill. New Zealand First supports this legislation which will extend the current controls on xenotransplantation until 31 December 2006 due to the ongoing concerns about the safety of this experimental technique. We recognise that biotechnology is advancing very rapidly but we are also aware that bioethics is a very complex field. New Zealand First believes that more research is required before these procedures become an accepted part of transplantation and that we should proceed with caution until we are sure of our ground. It is an important issue and it needs to be right. 
We are also very aware that the Bioethics Council has recently completed the first round of public dialogue meetings in many centres. That produced active participation and debate. I quote from the Bioethics Council’s press release from 15 April 2005 when Chris Nichol who has facilitated quite a number of these public meetings said that “people have really got their heads around this one”. He then went on to say: “No single issue dominated the dialogue events different issues were emphasised in different regions. The Wellington dialogue focused amongst other topics on the regulatory framework of xenotransplantation while Christchurch concentrated on animal welfare humanness and alternative remedies to xenotransplantation. In Auckland participants didn’t agree on the status of animals. Some believed there wasn’t enough dialogue discussion in regards to animal welfare and want to raise it again at the reconvened event in a fortnight. Xeno-tourism has come in for discussion. This relates to people entering New Zealand having undertaken xenotransplantation procedures offshore which are not approved here. The concern is the potential risk to public health.” 
It appears from this that public interest in xenotransplantation and the work of the Bioethics Council is very high. I understand too that the council will produce a report on xenotransplantation that is to be presented to the Government in August. We will be most interested in that. I believe we should have some trust and faith in the Bioethics Council and in the people who are responsible for making decisions about those matters. 
A number of safety and technical concerns have been identified and of course there are only a very limited number of animal or human studies of possible efficacy. During the select committee process Ministry of Health officials advised us that the human immune system rapidly attacks and rejects tissue from animals which means that most xenotransplants fail rather rapidly. I know that scientists are exploring options to try to solve those particular problems. As we can see it is still a very experimental technique. The evidence indicates that xenotransplantation has the potential to be associated with an increased risk of transmission of a wide range of viral bacterial and other infections that are known to occur in the source animals. That means there may be the risk of a new infection jumping the species barrier. We already have one of those uncontrollable infections in the form of bird flu because as we all know there are currently no known antidotes to control avian flu. 
I looked on the Internet to find other examples of new infectious diseases that emerged in other species and were transmitted to humans. They include HIV and the 1918 human influenza virus which was actually a mutation of the swine flu virus. Although we acknowledge that infections may be minimised in the same way as for human infections we also acknowledge that science does not know of all the infectious organisms that may infect humans. Like any other new disease those new viruses will be very difficult to identify—they usually take some time—and there may not be effective medications to help the people who actually have those viruses. What about the transmission of those viruses? That will also be very difficult to identify. 
I know that Dr Hutchison will agree that it is now recognised that pigs carry an inactive retrovirus within their genetic structure. At this stage whether that retrovirus can cause infection in humans is totally unknown. Also those retroviruses may remain dormant in the host for a long time before they actually emerge to cause disease in humans. Although we recognise that there is a chronic organ shortage in New Zealand—as we heard at the select committee and of course from previous speakers—we do not want to see the transmission of retroviruses to humans via xenotransplantation. 
At this stage there is a considerable potential risk to human health and this is one of the areas that the debate is all about along with the ethical spiritual and cultural issues. We believe that the moratorium needs to remain in place until all the issues associated with xenotransplantation are resolved to a far greater degree than they are at present. When we look at some of the countries we often like to compare ourselves with we see for example that in Australia in December 2004 the National Health and Medical Research Council announced a 5-year moratorium on clinical trials of xenotransplantation. In Canada clinical trials cannot proceed without the approval of Health Canada. Ministry of Health officials who briefed the Health Committee were unaware of any clinical trials on humans that had been given approval by Health Canada. Again in the UK there are no trials under way. So the approach that New Zealand is following is in line with that of those countries. We cannot afford to rush in when we have neither the knowledge nor structures in place in our hospitals to assist patients with the problems and challenges they may experience after xenotransplantation. 
We have all told the Minister of Health and we all know ourselves that our hospitals are stretched to the limit so why add another dimension that they cannot cope with at this point in time? We really believe that we should not go out on a limb on this matter. Why rush in where angels fear to tread? We need the widest possible views on this issue—more than just the views of those who stand to benefit if the research leads to future benefits for a particular group. It needs to be right. There is no groundswell of support out in the public arena at this point in time. 
We are also aware that in 2002 a New Zealand company conducted human trials in Mexico and it was proposed that some trials be carried out in the Cook Islands. One of the reasons more than likely that those countries were chosen is the fact that they do not have the appropriate regulatory authorities to develop guidelines to safeguard the patients and the people with whom they come into contact. So it is really much easier for those companies to go overseas and carry out their testing. Of course we have never heard of any results from that testing. 
New Zealand First believes that at this stage the risk has to be weighed against the possible benefit to the recipients. We believe that the studies are inadequate and do not counterbalance the potential risks involved. Human trials are not justified at this point in time. While the research is at an experimental stage we believe the moratorium should remain in place.