DRW Monthly
December 2009
Issue No. 36

NHMRC Lifts Ban on Clinical Trials Involving Xenotransplantation in Australia

Due to Australia's efforts to establish a more well-defined regulatory and surveillance network to support clinical research since 2004, the National Health and Medical Research Council (NHMRC) recently lifted its five-year ban on clinical trials involving animal to human transplantation, also known as xenotransplantation. The Australian Therapeutic Goods Administration (TGA) is currently in the process of implementing a biological framework to address the NHMRC's concerns, particularly those pertaining to minimizing the risks of animal virus transmissions and ensuring public safety in the use of various biological therapies.

The NHMRC also plans to work closely with the Australian Government's Department of Health and Ageing in order to evaluate the surveillance monitoring frameworks that are in development to support clinical trial research connected with animal-to-human studies. Trials will only be permitted to proceed once the Australian Health Ethics Committee (AHEC) and the Animal Welfare Committee (AWC) approve the protocols within the clinical trial regulatory framework involving xenotransplantation to be laid down by the TGA.(1) In addition, in conjunction with the AHEC and the AWC, the NHMRC has issued guidelines for researchers and ethics committees involved in animal-to-human studies and provisions have been made to establish a patient registry database.

Background on Australian Biological Regulatory Framework

The initial collaboration between the TGA and the NHMRC began in April 2003 when they jointly established a Review of the Australian Arrangements for Clinical Trials and Access to Unapproved Therapeutic Goods.(2) The primary goals of this Review were to:

• identify any necessary improvements to the current arrangements, thereby maximizing protection of patient and trial participant safety, and maintaining public confidence;
• assess the need for, and practicability of, a clinical trial register system; and
• identify any barriers to the further development of clinical research.