NHMRC statement on xenotransplantation
In 2004, NHMRC recommended that there should be no animal to human transplantation (xenotransplantation) clinical trials in Australia for five years, subject to review in December 2009.
NHMRC Council noted the developments in science and technology since 2004, in particular evidence relating to the risks of transmission of animal viruses, and considers that the risks, if appropriately regulated, are minimal and acceptable given the potential benefits.
NHMRC Council also notes international developments and guidance on the management and regulation of xenotransplantation, including the World Health Organisation (the 'Changsha Communiqué') and guidelines developed by the European Medicines Agency.
Although there are differences of opinion in the community regarding the acceptability of xenotransplantation, NHMRC Council recommended that xenotransplantation research could proceed in Australia when the following conditions are in place:
- The Therapeutic Goods Administration has implemented a robust framework to regulate clinical trials involving xenotransplantation;
- A robust standard of oversight and monitoring is established, including for example, a surveillance strategy and a patient register; and
- NHMRC has issued, using the advice of its Australian Health Ethics Committee and Animal Welfare Committee, guidance for researchers and ethics committees involved in animal-to-human studies.