Flu drugs: Govts urged to bypass patent laws

As China reported its third outbreak of bird flu in a week, public health groups have urged officials to bypass patent laws and mass-produce generic versions of potentially lifesaving anti-viral drugs.

Under World Trade Organisation rules, countries facing a public health emergency can issue so-called compulsory licenses to legally manufacture and export generic versions of patented drugs under strict conditions.

Health groups, including the medical relief agency Médécins Sans Frontieres, have urged the WTO to simplify the rules to encourage more producers to make generic drugs to ensure they are widely available should the bird flu virus mutate and become easily transmissible between humans.

The campaigners cite Tamiflu, which is produced by Switzerland’s Roche and is considered one of the few drugs likely to be effective in an outbreak of bird flu in humans.

A pair of Australian researchers published a report in the Medical Journal of Australia today warning that the country’s stockpile of influenza drugs will fall short in the event of a bird flu pandemic.

“Australia has an opportunity and a responsibility to promote compulsory licensing and generic production in the Asian region,” one of the researchers, public health specialist Dr Buddhi Lokuge, said in a statement.

Some countries – including Thailand, India and Argentina – have indicated they may authorise the generic production of the anti-viral drugs, the researchers said.

Indian drug maker Cipla – which says it has developed a generic version of Tamiflu – has applied to Roche for permission to copy the flu drug, but has pushed the Indian government to invoke compulsory licensing anyway.

And as countries talked about stockpiling and sharing their stores of Tamiflu, Roche’s Canadian arm announced it was suspending private sales of Tamiflu in Canada until the flu season begins in December because soaring sales threaten to drain supplies.

“What we have seen here in Canada is an unprecedented demand for Tamiflu, presumably as a result of heightened interest around all of the media coverage on pandemic and avian flu,” the vice-president of Roche Canada, Paul Brown, said.

“We have taken the decision to proactively manage our inventory and make sure that that our priorities are those patients who are most at risk at developing complications, so we have decided stop the shipment of Tamiflu until the flu season starts.”