NHMRC readies itself for new stem cell laws

National Health and Medical Research Council (NHMRC) CEO Prof Alan Pettigrew told a stem cell conference in Melbourne yesterday that the council was already preparing to implement a new embryonic stem cell research and cloning Bill.

The proposed legislation - the Research Involving Embryos and Prohibition of Human Cloning Bill 2002 - will be debated in the next session of the Federal Parliament, starting in mid-August. Both the Coalition and Labor parties have said that members will be given a free vote on the issue.

At the Bill's core is the banning of human reproductive cloning and creation of human embryos specifically for research purposes. The use of excess embryos from IVF procedures for research will be regulated via a licensing process.

"The development of legislation from a clean piece of paper to a Bill introduced in Parliament took a tremendous amount of effort," said Pettigrew, praising the efforts of those involved.

He said that while the Council of Australian Governments (COAG) had provided a clear framework for the Bill, the taskforce was required to engage in extensive consultations with State and Territory governments, scientists, biotechnology companies, and the community to develop the legislation.

"We tried to keep a very fine balance during the process," Pettigrew said.

He said that although the bill still had to be passed, the NHMRC was already preparing for its implementation.

Dr Clive Morris, executive director of the COAG Implementation Task Force, said that under the new regulatory framework researchers wanting to use embryos, for example to create a new embryonic stem cell line, would be required to submit an application to their institutional human research ethics committee for approval before applying for a license from the NHMRC.

Morris said the NHMRC would have the power to set conditions before granting a licence and would require annual reports on the progress of the research. In addition, it would be responsible for monitoring compliance with the regulations.

While the NHMRC would be able to initiate prosecution on researchers who broke the new laws, it would also be able to suspend or cancel licenses for minor breaches of the regulations, he said.