Xenotransplantation ban lifted in Australia

The National Health and Medical Research Council (NHMRC) has given the go ahead for animal-to-human transplantation (xenotransplantation), ending a five year moratorium.

The NHMRC Council referenced developments in the science and technology since the ban was put in place in 2004, particularly in terms of the risks of transmission of animal viruses.

The NHMRC said in a statement that it "considers that the risks, if appropriately regulated, are minimal and acceptable given the potential benefits."

It also referenced international developments and guidance on the management and regulation of xenotransplantation by the World Health Organisation and the European Medicines Agency.

Research involving xenotransplantation will be able to begin in Australia once the Therapeutic Goods Administration (TGA) has implemented an appropriate framework for conducting clinical trials and a standard of oversight and monitoring is established, including a surveillance strategy and a patient registry.

The NHMRC has issued guidance for researchers and ethics committees involved in xenotransplantation studies, drawing on advice from its Australian Health Ethics Committee and Animal Welfare Committee.

Dr Paul Tan, Chief Executive Officer of New Zealand-based biotechnology company, Living Cell Technology (LCT), has welcomed the announcement.

“We very much welcome the decision by the NHMRC and are pleased that their original concerns have been satisfied. This is in keeping with recent scientific data and the increasing acceptance of current international guidelines for the safe use of animal tissue to treat human disease. This decision opens up significant opportunities not only for LCT, but for the wider medical science community and people with life threatening diseases,” he said in a statement.

LCT founder, Dr Bob Elliott, recently advocated that xenotransplantation should be allowed in Australia, suggesting that the benefits outweigh the minimal risks if conducted properly.

LCT is currently undertaking trials in New Zealand of its Diabcell technology, which involves transplanting pig cells in to diabetes patients to reduce or obviate the need for insulin injections.

The company has stated its intention to begin clinical trials in Australia once the appropriate regulatory framework has been put in place by the TGA.