Dyson Ruth: Human Tissue Bill — First Reading 
Dyson Ruth: Human Tissue Bill — First Reading 
[Volume:635;Page:6467] 
Hon RUTH DYSON (Minister of Labour) 
: 
 I move  
That the Human Tissue Bill be now read a first time. 
 At the appropriate time I intend to move that the bill be referred to the Health Committee for consideration. It gives me great pleasure to speak to the first reading of this bill. The Human Tissue Bill provides a framework for regulating the collection storage and use of tissues and organs primarily from the deceased. It also regulates trading in tissue export and import of tissue and the use of tissue for non-therapeutic purposes—for example audit research and post-mortem. 
Once enacted the legislation will repeal and replace the Human Tissue Act 1964. The current regulatory framework for human tissue spans a number of Acts and regulations. This creates confusion and there are gaps in the framework that regulates the use of human tissue. Increasingly issues are raised that either fall outside the scope of the current arrangements or are subject to varying interpretations. The ministry’s 2004 review of human tissue and tissue-based therapies raised a number of issues. The new bill aims to address concerns raised during public consultation including a lack of clarity around the informed consent requirements for the collection and retention of tissue; the role of family members in giving consent for the collection and use of tissue from a person who has died and the lack of individual autonomy in the area; a lack of clarity in relation to the donor status on the national register of drivers’ licences—many people think the register records consent when it records only an indication of wishes—and New Zealand’s organ donation rates which are low compared with other OECD countries. 
The new bill will clarify the consent framework for organ and tissue donation. In addition non-legislative initiatives are currently being undertaken that aim to improve organ donation rates. For example the primary focus of Organ Donation New Zealand set up last year is the improvement of organ and tissue donation processes in the intensive care unit environment. Since early last year welfare assistance in the form of income and childcare assistance has been available to living donors who altruistically donate kidney or liver tissue for transplantation purposes. 
The new bill aims to address the concerns raised during the human tissue review. It also provides a more comprehensive and modern regulatory framework for the collection and use of tissue and organs from deceased people. The objectives are to ensure that the autonomy and dignity of the individual from whom tissue is collected is recognised and respected and that the cultural and spiritual needs of New Zealanders are recognised and respected. Further objectives are to ensure there is clarity for clinicians and the public around the consent process clear mechanisms for the use and management of human tissue for non-therapeutic purposes and consistency with regulations in other related areas. 
The bill includes a broad definition of human tissue and covers any material including human cells from whole bodies and body parts through to blood foetal tissue and human stem cells. It specifically excludes any material covered under the Human Assisted Reproductive Technology Act 2004. The bill will ensure the safety and quality of the non-therapeutic use of human tissue through standards prescribed or approved by regulation. It also enables regulations to be made with regard to the export or import of human tissue if that level of monitoring is considered necessary. The bill contains additional requirements for schools of anatomy including licensing of such schools given the invasive nature of anatomical examination and the need for public confidence in the process. 
 The bill repeals Part 3A of the Health Act 1956 which regulates trading in blood and controlled human substances and replaces that Act with similar but extended provisions that cover for example trading in all human tissue. The sale and purchase of human tissue including blood will as a general rule be prohibited. 
The bill makes informed consent the fundamental principle underpinning the lawful collection and use of human tissue from deceased people. It specifies who may give consent for the collection and use of human tissue. The primary consent will be of the deceased if formally recorded before he or she dies or of someone nominated by the deceased person on his or her behalf. In the absence of formally recorded consent to donation by the individual or by his or her nominee the decision can be made by the immediate family. The bill provides for decision making by a senior available next of kin of the dead individual if the immediate family is unable to agree. 
There was considerable support for the deceased’s wishes to be the primary consent from a broad range of people during consultation on the human tissue review. This approach is consistent with a health consumer’s right to informed consent as expressed in the Code of Health and Disability Consumers’ Rights and the existence of appropriate consent would be sufficient for organ or tissue donation to be lawful. However in practice there may be a number of reasons why donations should not proceed. The organ or tissue may be unsuitable for donation the family may be aware that the person had changed his or her mind since recording consent or the immediate family may be distressed by a decision to proceed with donation. 
The bill provides some exceptions to the general rule that informed consent is required to collect or use human tissue—for example where tissue is collected or used under the Coroners Act 2006 or for criminal justice purposes. The bill also recognises that there are certain limited circumstances where because appropriate safeguards are in place the public good associated with the use of tissue outweighs informed consent requirements as in research approved by an ethics committee for example. 
In general the bill does not cover consent for the collection and use of tissue from living people because that is already covered under existing legislation and common law. However the bill does close an existing regulatory gap in relation to tissue taken from living people. It will include a requirement for informed consent for the analysis of tissue taken from living people where the Code of Health and Disability Consumers’ Rights does not apply and where the analysis is for the purpose of obtaining genetic or other information about a particular condition or trait of the donor. 
The Human Tissue Bill gives recognition to a national organ and tissue donor register. Such a register will support the consent framework in the bill. To ensure that the design of the register is aligned with the consent framework in the bill work on the register will not proceed until the Health Committee has completed its consideration of the bill. The bill requires medical practitioners donor agencies and others involved in the collection and use of tissue to take all reasonably practicable steps including checking the register to ascertain whether consent has been given. 
International evidence is inconclusive regarding the impact of registers on organ and tissue donation rates. Evidence points to increased public awareness improvements in processes around donation and improvements in coordination between agencies as being most likely to lead to improvements in donation rates. A register could potentially have a positive impact by promoting discussion about donation amongst families and by driving improvements in the governance and clinical processes around donation. Without an integrated approach however the establishment of a register could reduce donation rates by failing to register sufficient numbers of people and there is a risk that families may interpret the absence of registration as meaning a “No” to donation and decline to donate. I encourage the Health Committee to examine carefully the international evidence in this area to ensure that New Zealand has an effective and integrated system that is designed to maximise organ and tissue donation. 
In May a member’s bill in the name of Dr Jackie Blue the Human Tissue (Organ Donation) Amendment Bill had its first reading and is currently before the Health Committee. As both bills propose to legislate in the area of organ donation I recommend that they are considered in tandem. The key differences between the two bills are that the Government bill is much broader in scope and has a more comprehensive consent framework than the member’s bill. The Government bill aims for a balance between respect for the wishes of the deceased person and the cultural and spiritual needs of his or her family whereas the member’s bill does not acknowledge the needs of the deceased person’s family. 
I propose that the Human Tissue Bill be considered by the Health Committee. I believe that this bill is a significant and logical step forward in the development of legislation for the human tissue sector. The bill repeals outdated legislation and provides a comprehensive framework for regulating the collection and use of tissue from dead human bodies as well as the trading in tissue export and import of tissue and the use of tissue for non-therapeutic purposes. In addition the bill closes gaps in current regulations around the use of tissue from living people. I commend this bill to the House.