Soper Lesley: Human Tissue Bill — Third Reading 
Soper Lesley: Human Tissue Bill — Third Reading 
[Volume:646;Page:15431] 
LESLEY SOPER (Labour) 
: 
 I rise as deputy chair of the Health Committee to speak on the Human Tissue Bill. I thank the Minister for shepherding through this very important bill and the Health Committee gave it very careful consideration. I intend to give the House a bit more background on the wider policy issues that led to the bill’s introduction. I also wish to take a little time to speak on the issue of maximising organ and tissue donation in New Zealand. 
The policy behind the bill was informed by a review which included public consultation undertaken by the Ministry of Health on the regulation of human tissue and tissue-based therapies. The review identified concerns about the current consent framework for the collection and use of human tissue. The Minister has already discussed how these concerns have been addressed in the bill and the amendments recommended by the select committee. The review also highlighted issues relating to the regulation of the non-therapeutic use of human tissue import and export of tissue and trading of tissue. 
The non-therapeutic use of tissue is currently largely unregulated with the exception of the schools of anatomy. The review found general agreement that an overarching standard for the non-therapeutic use of tissue was needed. The reason for such a standard was the need for clarity and consistency and to allow for monitoring of the processes around tissue use. The bill will ensure the safety and quality of the non-therapeutic use of human tissue through standards prescribed or approved by regulation. These standards will apply to the collection and use of tissue for research education audit diagnosis post-mortems anatomical examinations and other non-therapeutic purposes. The bill contains additional requirements for schools of anatomy including licensing of the schools given the invasive nature of anatomical examination and the need for public confidence in that process. 
The ministry’s review found general support for a more comprehensive oversight of the import and export of human tissue to address issues such as safety and ethical concerns. Many respondents supported the import and export of tissue for quality assurance peer review diagnostic purposes and transplantation purposes where adequate safety levels can be assured. The bill provides for regulations prescribing or approving requirements and standards for the import and export of human tissue. This will if necessary permit rigorous monitoring of safety and quality. The bill also provides for requirements relating to informed consent for imported tissue. These provisions will enable more stringent informed consent requirements for particular types of tissue—for example human embryonic stem cell lines. The ministry’s review found general support for a prohibition on the sale and purchase of human tissue but found acknowledgement that there should be some allowance for recovery of reasonable administrative costs associated with the collection analysis and processing of that tissue. The bill repeals Part 3A of the Health Act 1956 which regulates trading in blood and controlled human substances and replaces that with a similar but extended provision covering for example trading in all human tissue. The sale and purchase of human tissue including blood will as a general rule be prohibited. 
I will move on to the maximising of organ and tissue donation. During the select committee process a number of submitters took the opportunity to discuss organ donation and various solutions to increase the donor rate within New Zealand. Much of that comment did not relate specifically to parts of the bill with the exception of an organ and tissue donor register. The key debate raised amongst submitters—and Mr Tookey has been mentioned—was whether there should be a national organ and tissue donor register in New Zealand. It is fair to say that all submitters were united in their desire as was the committee to see the rate of organ donation increase in New Zealand but the views of submitters differed markedly on the best way to achieve that result. 
To provide some context for the debate and to explain to people listening to Parliament what the select committee had to consider as of January 2007 there were 433 people on the waiting list in New Zealand for a kidney transplant 13 for a liver transplant five for a heart transplant eight for a lung transplant and four for a pancreas / kidney transplant. Even if organs were retrieved from every potential deceased donor the supply particularly for kidneys would still fall far short of the demand for them. Kidney transplants from deceased donors can only ever be a small part of the response to growing levels of kidney failure amongst New Zealanders. Only a very small number of New Zealanders die each year in circumstances that allow them to become organ donors and this was something that surprised many of the committee members and many of the members of the public who were there during the submission process as we heard submissions. There is a belief that there are many organs that are just not being harvested in New Zealand. 
Organ donation is possible when an individual is determined to be brain-dead prior to their blood circulation ceasing and this occurs only within an intensive care unit in a New Zealand hospital. A 2002 estimate put the number of medically suitable potential donors per year in New Zealand at approximately 100. In recent years there has been a reduction in brain death rates in intensive care units due to a declining road toll and continuous improvements in clinical practice and survival rates from trauma. Data from Auckland City Hospital for instance shows an overall trend of fewer patients becoming brain-dead with a reduction by about a third between 2000 and 2006. 
When the bill was introduced the Minister encouraged members on the select committee to carefully examine the international evidence on the impact of registers on organ and tissue donation rates. The committee did that and recommends that a register not be established at present. However what we did recommend includes a clause that permits the establishment of an opt-on register by regulation at a later date should it become desirable to do so. We believe that that may happen in New Zealand. It will happen when the international evidence tells us that registers are useful in increasing donor rates. That evidence was not given to the select committee. What we were given was evidence that showed that registers are currently not a significant influence on the number of deceased donors available for transplantation. Other factors such as the religious and cultural views towards death and the body the predominant cause of death and the number and efficiency of the transplantation coordinators make a more significant contribution to the number of organs and tissues available for transplants. 
We had a great deal of evidence to come to the recommendation we made on organ donation. We know that Organ Donation New Zealand is developing a system of death audits in intensive cares units that when implemented will provide more information on processes such as identifying potential donors and requesting donations from families. Although it is reassuring to see that the number of deceased organ donors in New Zealand was higher in 2007 than in 2006 so far none of these approaches will result in a sufficient supply of organs to meet current or likely future demand. The best hope for reducing the excess demand for transplant tissue over time is to reduce the preventable causes of demand for organs such as type 2 diabetes. 
This bill is a very carefully considered bill. We believe that the recommendations we have made to the House to improve the bill are very substantial and we are very proud to commend it to the House.