9. Decisions about Xenotransplantation in New Zealand

In 2001 an application was made to the Ministry of Health to conduct an animal-to-human transplant clinical trial in New Zealand. This application created concern about clinical safety, and about the adequacy of regulatory review processes for the ethical issues involved in xenotransplantation. The application was ultimately declined on clinical safety grounds.

In 2001 the Royal Commission on Genetic Modification released its report, which included reference to xenotransplantation. The Commission recommended that the Bioethics Council develop ethical guidelines for xenotransplantation involving genetic modification.

In response to these events the Government passed an amendment (Part 7A) to the Medicine Act 1981. This amendment allows xenotransplantation trials to be considered and approved by the Minister of Health, but requires strict criteria to be met before an approval is given. No applications have been made to the Minister of Health under this provision.

Part 7A expires in June 2005.

During 2004 the Ministry of Health has been carrying out a review of all legislation relating to human tissues, with a view to developing new legislation. This review includes transplantation of human organs, and it is logical to ensure that new legislation also covers animal-to-human transplants.

New Zealand needs to make decisions about xenotransplantation during 2005.

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