Australian stem cell researchers call for less regulatory red tape

With the review the Australian legislation governing the use of human embryos in research under way, Australian stem cell researchers have called for revisions to the legislation to streamline licensing and reduce the administrative burden of conducting embryonic stem cell research.

Speaking in a teleconference organised by the Australian Science Media Centre, Dr Julia Schaft, from Sydney IVF Stem Cells, said that the current system exacts a heavy burden on any organisation that wants to produce stem cells.

"We are working in a very fast paced scientific environment," said Schaft. "We face significant delays caused by this system."

As a case in point, Schaft indicated that when the legislation than enabled stem cells to be derived from embryos came into effect in 2002, and Sydney IVF applied for a licence right away, it still took two years before the license was granted by the National Health and Medical Research Council.

Schaft also said the administrative burden of maintaining the license also places a drag on research organisations, with some smaller institutions unlikely to apply for a license because of the admin requirements.

Sydney IVF Stem Cells employs one full time senior scientist just to deal with NHMRC requirements.

The cost and effort involved in applying for new licenses has also stifled potential research, said Schaft.

"Because the process is so tedious we are thinking long and hard as to whether new projects or variations of existing projects are worth it. More than once we have dismissed a viable scientific option because we didn't have the resources to deal with the administrative burden," she said.

"Any change to the license system that could alleviate this burden of administration would probably create a bit more competition for Sydney IVF, but would definitely be beneficial for research."

The review of the legislation - the Prohibition of Human Cloning for Reproduction Act 2002 and Research Involving Human Embryos Act 2002 - is currently under way, with the reviewing committee appointed last December.

The committee is chaired by the Hon Peter Heerey QC, who is joined by former Australian of the Year Professor Ian Frazer, Lockhart committee member and law ethics expert Professor Loane Skene, Doctor Faye Thompson an expert in midwifery ethics and the Reverend Kevin McGovern, Director of the Caroline Chisholm Centre for Health Ethics.

Submissions from the public are open, and they can be made through the NHMRC web site, closing March 15.

Sydney IVF has made three recommendations to amend the legislation. The first is that there be no change to the way existing excess IVF embryos are used, which will enable existing research to continue.

The second is to loosen the requirements to allow research into fertilisation to improve IVF techniques. Currently this is prohibited because under the current legislation the only reason one can create a fertilised embryo is with the intention to cause pregnancy.

The third amendment is to enable cytoplasmic transfer, which would open up research into mitochondrial disorders.

The current legislation only allows genetic material from a prospective mother and father to be involved in the creation of an embryo. However, as cytoplasmic transfer involves implanting non-defective mitochondrial genetic material from a third individual into a cell with defective mitochondria, it is prohibited.

According to Dr Megan Munsie, Senior Manager - Research and Government, Australian Stem Cell Centre, the existing system functions relatively well, although streamlining it would enable more researchers to apply for licenses.

"We have a very well functioning system, although relatively bureaucratic, but with some refinements that could be improved," she said.

Australia has one of the most permissive regulatory systems in the world, and this has allowed Australian research organisations, such as Sydney IVF, to become world leaders in the production of embryonic stem cells.

The review of the legislation is scheduled to be submitted to the parliament on 27 May of this year.