ABC Science Online, Australia

NEWS ANALYSIS

US deal may hurt stem cell research

Judy Skatssoon

23 August 2005

The free trade agreement (FTA) with the US could stifle Australian stem cell research, scientists and legal experts say.

Dr Thomas Faunce, a senior lecturer at the Australian National University medical school and law faculty, said he was concerned about the impact of the deal at a recent public forum on stem cells hosted by Sydney’s Garvan Institute.

The forum was held as Australia reviews its laws on embryonic stem cell research and therapeutic cloning.

By the end of this year the independent Lockhart Review will decide on a number of key issues, including the establishment of a national stem cell bank, and whether to lift the ban on therapeutic human cloning, which would bring Australia in line with the UK, Singapore, Israel and Korea.

Faunce, who is also project director of an Australian Research Council grant to examine the affect of trade agreements on access to medicines, says Australia needs to be "extremely wary" of the FTA.

"It could be that ... our regulatory regime shifts towards the US in terms of protecting the property rights of certain areas ... as a result of that regulatory changes could be implemented [in Australia]," he says.

Restrictions on public research

Faunce says a key area of concern is a provision in the FTA requiring harmonisation of intellectual property (IP) laws between the US and Australia.

This could put the brakes on stem cell research carried out in publicly funded Australian universities, which he says may find themselves having to pay royalties to private companies.

At present, Australian researchers working in universities do not have to pay royalties for working with patented things because of an experimental research exemption.

But a recent US court ruling has established that US university researchers have to pay royalties to patent holders.

If IP laws are harmonised Australia could find itself in the same boat, Faunce says.

"Frankly, I don’t think the Americans will let us get away with having an advantage in publicly funded universities. There could be a stifling of public research."

The Australian Law Reform Commission is currently looking at formalising the research exemption but the FTA could put a dampner on that process, he says.

The provisions also strongly advantage the holders of IP, and this means Australia needs to get in early to develop its stem cell industry and be the first to lock in patents, Faunce says.

"We’ve only got a very small window of opportunity and unless we start being a lot more aggressive and sewing up IP in the stem cell area the FTA could very much act to our detriment.

"We’ll be paying rent for the stem cells rather than being the people who get the rent."

A question of values?

Faunce says there is also a risk of US religious opposition to stem cell research infiltrating Australia via the FTA.

"I think you have to realise that the trade deal is a fluid mechanism by which all sorts of US values can infiltrate into our society," he says.

"If our government feels it needs to go along with this [agenda] as well as [US] military ideology that’s a concern because I don’t think it’s a balanced approach to stem cell research."

And if the religious lobby does succeed in holding back stem cell research in the US, Faunce says this could have a flow-on effect in Australia.

He says if a decision was made to harmonise the regulatory structures of both countries then Australia could find itself regulated out of the race.

"The [US] industry will look across to Australia and say ’we don’t want you to have the advantage’," he says.

Researchers are worried

Stem cell researcher Dr Bernie Tuch, of Sydney’s Prince of Wales Hospital, is working with a group that holds one of Australia’s nine licences to extract stem cells from embryos left over from artificial reproductive technology.

He says the FTA could potentially stall his work by limiting access to the stem cell lines he needs to create the insulin-producing cells he hopes will cure people of type 1 diabetes.

"I would be concerned if Australia was limited in its utilisation of human embryonic stem cell lines ... because of a free trade agreement," he says.

He’s also warned of the danger of losing young researchers to other countries, such as Singapore or Korea, where stem cell laws are more liberal.

Government reassurances
A spokesperson for trade minister Mark Vaile says the FTA includes "language on greater efforts to harmonise our respective approaches to intellectual property".

But this could also mean the US will move closer to the Australian system, he says.

He says the FTA allows diagnostic, therapeutic and surgical inventions to be exempt from being patented and the research exemption still gives scientists the right to use copyrighted research without a licence.

The government’s position on stem cell research will be determined by Australian interests and circumstances, the spokesperson says.

"The FTA has had no impact on Australia’s approach to stem cell research."