13 May 2004

Submissions close 4 June 2004 on the Ministry of Health's Review of the use of human tissue for therapeutic and non-therapeutic purposes. In an area that has considerable issues related to tikanga Maori, the review covers many issues, including informed consent, the safety of tissue-based therapies, and the legislative arrangements for organ and tissue donation. There is a discussion paper associated with the review.

Note: The discussion paper proposes that human tissue be defined as: the whole body or part of a body; bone; a whole organ such as the heart; parts of organs, such as heart valves; other tissue, such as corneas or skin; tissue specimens; foetal material; cellular material; and cell lines.

Currently, the regulation of human tissue related issues is spread across a number of different Acts and regulations. Some matters aren’t well covered and other parts of the legislation are out of date. It is expected that new legislation will come into being by June 2005.

This review would provide the framework for the new legislation, with the aim of updating the regime consistent with current practice and the expectations NZers have of the health and disability system. It is proposed the new legislation would cover:

• provisions for the collection of tissue for therapeutic purposes – organ and tissue donation;
• consent for the collection of tissue for research and education;
• consent for non-coronial post-mortem examinations;
• definitions of who is able to give consent for tissue use on behalf of a deceased person;
• provisions regarding the sale and purchase of tissue;
• provisions that allow new tissue-based technologies to be controlled while they are assessed for acceptability and safety; and
• consent for the collection of tissue for research and education.

The discussion paper suggests that formal standards could be developed for tissue banking and organ donation. The standards would be based on voluntary codes and standards that have been developed by people involved in these services.

The document also asks for comments on privacy and the use of genetic information (specimens in particular), the use of foetal tissue, and controls on xenotransplantation.

Xenotransplantation is the transplantation of live cells, tissue, or organs from another species (e.g., pigs) into humans. Xenotransplantation is not currently happening in NZ and under the Medicines Act 1981, no one can carry out xenotransplantation without the Minister of Health’s permission.

To view the discussion paper & make an online submission see the Ministry of Health website www.moh.govt.nz or send to: The Human Tissue Review, Sector Policy Directorate, Ministry of Health, PO box 5013, Wellington