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Authorise generic avian flu drugs: Researchers

October 27, 2005

Australia must consider locally producing mass supplies of generic drugs to prepare for an avian flu pandemic, according to research by ANU health and legal specialists.

Patents on these antiviral drugs are currently preventing generic production of the drugs, say Dr Buddhi Lokuge, a public health specialist, and Professor Peter Drahos, Head of the Regulatory Institutions Network and Professor of Law at ANU.

"The Commonwealth Government or a State can authorise somebody other than the patent owner to use the patent," Professor Drahos said. "Potentially a local generic manufacturer could be encouraged to make large amounts of the drugs at cheaper prices."

According to the researchers, stockpiles in Australia of drugs to treat avian flu are limited at present because of a severe global shortage brought about by the patents. As a result, a confidential rationing list has been established to determine priority access.

But by issuing compulsory licences, Australia will be able to produce enough antiviral therapies to protect Australians and our neighbours in the event of a pandemic, they say.

"Control of the disease in potential source countries is in Australia's national interest. Australia has an opportunity and a responsibility to promote compulsory licensing and generic production in the Asian region," Dr Lokuge says.

Some countries including Thailand and Argentina have indicated that they will authorise generic manufacture of these antivirals.

In the United States, Democrat Senator Charles Schumer has raised the issue of compulsory licensing and this has led Roche to talk to four generic manufacturers about voluntary licences.

"These countries are playing a smart game. By raising the issue of compulsory licensing they are ensuring that they will get priority ahead of countries like Australia which have remained silent about the issue," Professor Drahos says.

Such action by the Australian Government would be morally defensible. The Australian Government funded much of the early research that led to the development of anti-influenza drugs; and government grants supported the commercialisation of the antiviral Relenza.

According to Dr Lokuge and Professor Drahos, Australia should immediately:
- Ascertain the patent status of influenza therapies in Australia;
- Announce that it will investigate the issue of a compulsory licence and local manufacture;
- Explore the possibility of exporting any generic surplus to neighbouring high risk countries like Indonesia;
- Express public and strong support for countries in the region taking the compulsory licensing route; and
- Raise the issue of a co-ordinated approach to generic manufacture in the region.

Research Australia