BresaGen calls for more time on stem cell laws

Stem cell company BresaGen has submitted a position paper to the drafting committee responsible for the forthcoming legislation for use of embryonic stem cells for creation of new stem cell lines for research and development.

The paper outlines several issues that BresaGen believes will have a major effect on the effectiveness of the legislation, including the need for embryos harvested under the stringent standards required regulatory agencies and the alignment of State and Federal legislation.

Dr Chris Juttner, BresaGen's manager for clinical development, said that the company had discussed the draft legislation widely.

"It is important to stop and think about the legislation as it seems to be going too quickly," he said. "We don't really understand why it is being rushed so fast."

Juttner said that the company believed the issues at stake were complicated and should be extensively discussed and debated before the legislation was formulated. To do this by the end of June would be too rushed, he said.

He said that while a case had been made for new ES cell lines for research purposes, in reality there were plenty of available lines derived from mouse feeder lines. The development of new lines suitable for therapeutic use in humans could wait a few months more pending the legislation, he said.

BresaGen said embryos harvested before April 5 would not meet standards for safety as demanded by the US Food and Drug Administration (FDA) regulatory requirements. Under the decision made by John Howard and the Council of Australian Governments on April 5, only embryos frozen before that date will be able to be used for embryonic stem cell research.

"The cut-off on April 5 for use of existing embryos is not intelligent, with regard to making the best products," Juttner said.

BresaGen said new ES cell lines must be developed under current Good Manufacturing Practice (GMP) conditions.

"When you produce drugs, and these cell lines can be considered drugs, you have to document everything used in the process," Juttner said.

He explained that while he hadn't explored the issue fully with IVF groups, it was his impression that there were different regulatory requirements to the GMP used for pharmaceutical manufacturing.

Juttner also said that this requirement would not be able to be easily circumvented.

"You can't apply legislation retrospectively, so you can't get around this issue," he said. "When you are real about commercial products, you have to be real about the regulatory barriers."

This would require BresaGen to work with the IVF labs to ensure that procedures followed were GMP compliant, he said.

The position paper also outlines BresaGen's concerns that State legislation should be aligned with the new Federal legislation. Currently Victoria, South Australia and Western Australia have restrictive legislation on the use of IVF embryos.

While the Victorian government has indicated that it is willing to align itself with the Federal legislation, Juttner said the situation wasn't as clear in South Australia, where BresaGen is headquartered.

"If they don't change, we will work in NSW or some other location," he said.

Juttner stressed that BresaGen, which has a facility in Athens, Georgia, would prefer to carry out its stem cell work in Australia rather than the US.

A third point raised by BresaGen was the issue of therapeutic cloning. Bresagen has developed a technique for therapeutic cloning that transfers adult nuclei to ES cells creating cell lines that are not capable of developing into foetuses.

"It doesn't meet the criteria as an embryo so it wouldn't be covered by the legislation," said Juttner.

However, the company is concerned that the proposed blanket ban on therapeutic cloning would limit advances in the use of this approach to create immunologically matched ES cell products. Juttner said there was also a lot of opposition to a ban on therapeutic cloning using oocytes, a process which could create a potentially viable embryo.

He said that a crucial point to understand was that a range of cell lines that represented immunological diversity in the human population was required to circumvent potential problems with rejection of foreign cells by the body.

BresaGen has estimated that 600-1000 lines will be required to adequately represent the world's communities.

According to Juttner, Australia is more likely to have the racial and ethnic groups represented because IVF is open to everyone. In the US, IVF is available primarily to the wealthier white population, he said.

Other issues raised by BresaGen include ethical issues of not using discarded embryos and the need for adequate investment and commercial competence in the development of stem cell treatments.

Juttner said he did not know how closely the government would listen to BresaGen and other Australian stem cell researchers. "We're going to try very hard through our lobbying to get them to listen," he said.