Law change to protect medical research urged

New Zealand law should be changed to avoid potentially damaging restrictions on medical research arising from overseas genome-related patents, University of Otago researchers recommend.

Adding a "statutory experimental use" exemption to New Zealand patents legislation is one of a series of recommendations made by the Otago University Law Faculty-led Human Genome Research Project, in its third and final report, released yesterday.

The final report draws a line under nearly three and a-half years of research involving the many legal, ethical, medical and cultural issues surrounding the regulation of human genome-based technologies in New Zealand.

Sponsored by the New Zealand Law Foundation, the project has drawn on New Zealand and overseas expertise from a range of disciplines to produce a series of reports totalling 1800 pages.

Project principal investigator and law faculty dean Prof Mark Henaghan said that genetic knowledge was both inspiring and intimidating.

"It taps into our strongest hopes and our deepest fears.

"This knowledge can be used to choose the genes of future children, test for potential diseases in our genetic make-up, find the relationships between illness, genetic profile and environmental influences in a community, and design drugs which are better suited for our particular human genome," he said.

Concerns over potentially costly patent charges for undertaking some future genetic research should be taken seriously.

A patent over a particular use of genetic knowledge could have the effect of making the use of the knowledge too costly, with the consequent loss of opportunity for it to be used, the faculty report noted.

Faculty researchers noted that an Australian biotechnology company had in 2003 made an aggressive attempt to enforce its patents on methods of analysis of a particular type of DNA against multiple organisations in New Zealand.

The affected parties performing research and providing clinical genetic testing services joined forces to negotiate with the company and filed proceedings in the High Court under the Patents Act 1953.

The matter was later settled out of court.

Prof Henaghan said that medical and other scientific research was important for New Zealand, and the ability to undertake genuine experimental research should not be unduly impeded by genome-related copyright.

"We don't want that to be stopped.

"That's one [area] we should start looking at," he said.

"Fortunately, overseas patent holders are not insisting on high premiums for patented techniques and knowledge, but I think we still need to provide some sort of protection for local researchers," he said.

Among its other recommendations, the report also advocates the creation of an independent, non-statutory body to protect consumers when genetic test information was required by insurance companies.

 

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