Draft stem cell laws now out for consultation

National legislation on the use of embryonic stem cells in research is on track to be introduced to Parliament next month.

The National Health and Medical Research Council has completed draft regulations, which will this week go out to external consultation.

But many research groups are likely to be disappointed by restrictions understood to be included in the draft.

Australian Biotechnology News has learned that a three-year moratorium on therapeutic cloning was most likely to remain in place.

Donors could also hold the right to place restrictions on the type of research conducted on their embryos, placing strict limitations on scientists.

A spokeswoman for the National Health and Medical Research Council, which is running the two-week, nationwide consultation process, said key players in medicine, politics, community affairs and religion would be asked their views on the draft.

"This is a targeted consultation, given that there was tremendous public consultation in compiling the report to CoAG (Council of Australian Governments)," Kay McNiece said.

"CoAG asked for nationally consistent legislation that bans human cloning but looks at other ways of regulating research using excess embryos."

She said the bill was on track to be finalised and introduced to Parliament by the end of June.

Those engaged in the consultative process, which kicked off in Melbourne on May 28, said they could not disclose the contents of the draft bill, which has been forwarded to them.

The deputy head of Monash Institute's Centre for Early Human Development, Assoc Prof Martin Pera, would not reveal what he planned to advise the NHMRC, saying only that there were various issues including somatic cell nuclear transfer and the use of frozen embryos.

"I can't comment on the subsequent regulations because they are still under discussion," Pera said.

Asked if he believed researchers would be happy with the outcome, he said, "I hope so."

Asked if he had any reason to think otherwise, he said, "No."

ES Cell International chief operating officer Catriona King said the company was grateful for the opportunity to be part of the process, adding that ESI's work would not be hindered by a short-term ban on therapeutic cloning.

But AusBiotech executive director Dr Tony Coulepis said while his organisation had been delighted with the initial decision allowing access to surplus embryos, it was concerned that opponents had lumped reproductive and therapeutic cloning together.

"Clearly the industry believes what's happened is a step in the right direction and while the vast majority of industry doesn't support reproductive cloning, it believes that therapeutic cloning is something that's not properly understood," Coulepis said.

"While they have common elements, there are significant differences and it would make a difference to medical research if therapeutic cloning was not black-banned for the next (three years)."

He said AusBiotech would discuss the issue at its directors meeting this week to determine its position and devise an education campaign to better inform politicians and lobbyists.

At the April CoAG meeting, state and territory leaders agreed that surplus embryos would be available for medical research with the consent of donors. At the same time it stipulated that the circumstances under which embryos were made available to researchers were to be legislated, closely monitored and reviewed by the NHMRC every three years.

Sources have told Australian Biotechnology News the draft bill outlaws reproductive and therapeutic cloning, as well as research that combines animal and human cells.

It is also understood a licensing system is to be introduced for scientists engaging in stem cell research.