Media Release
2 April 2004
Review of human tissue uses
The use of human tissue for therapeutic and non-therapeutic purposes is being reviewed by the Ministry of Health.
The review covers many issues, including informed consent, the safety of tissue-based therapies, and the legislative arrangements for organ and tissue donation.
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 Some matters aren't well covered and other parts of the legislation are out of date.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.
The Ministry's Deputy Director General, Sector Policy, Dr Gillian Durham says
"The review aims to have a comprehensive regulatory regime for tissue use that covers both the use of tissue as a therapy - organ transplantation for example, and the use of tissue for non-therapeutic purposes such as research or education. "
"This review will provide the framework for new legislation, with the aim of updating the regime consistent with current practice and the expectations New Zealanders have of the health and disability system - these expectations have changed since some of the current legislation was passed - the Human Tissue Act 1964 for example. We are also aware of new tissue-based therapies that are, or soon will be, on our doorstep and we need to make sure that we have safety arrangements in place for them – stem cell therapies for example."
It is proposed the new legislation will 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
- consent for the collection of tissue for research and education.
Dr Durham says
"The Ministry is releasing the discussion document because this is a very sensitive area, focusing largely on people who have died, and public input is important. Internationally there has been a lot of attention on tissue matters and we want the best system possible for New Zealanders."
Safety of tissue-based products and services is also addressed. When the Health and Disability Services (Safety) Act was developed it was anticipated that tissue-based services would be regulated in the future and provision was made for standards to be developed for this purpose. "This document 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.
The Ministry of Health is holding a series of consultation workshops in Auckland, Wellington, Christchurch and Dunedin as well as hui in April and May. Submissions close on Friday 4 June 2004.
All submissions received will be considered before policy advice is developed for the Minister of Health. It is expected that new legislation will be in place by June 2005.