~ Le Viêt Nam, aujourd'hui. ~
The Vietnam News

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Vietnam says Roche to let it make Tamiflu

HANOI - Vietnam has become the first country to announce it agreed in principle with Swiss drug maker Roche to manufacture Tamiflu, the frontline medicine against a feared global influenza pandemic.

"Vietnam will be authorised to produce Tamiflu by Roche, which will help the country acquire sufficient quantities of the medicine in order to face up to a bird flu epidemic," said Cao Minh Quang, director of the health ministry's department of pharmaceutical products management. "Roche will however choose which Vietnamese companies will be able to produce the drug," Quang told AFP.

The Swiss firm's officials in Vietnam did not confirm the comments but said they had held positive talks which would continue with the ministry. In the meantime, Roche has also agreed to supply Vietnam 25 million capsules of Tamiflu before the end of 2006. "Roche will cooperate with Vietnam in order to supply sufficient amounts of Tamiflu in case of a pandemic," Quang said.

Vietnam has reported its first human bird flu death in more than three months to take its official toll to 42, amid fears that the deadly virus could thrive in the coming winter flu season. The country of 82 million people, which accounts for more than two-thirds of total human fatalities from bird flu since outbreaks began in 2003, currently has only 600,000 capsules of Tamiflu. Quang said Tamiflu production could begin in two months but he did not specify the quantity. Late last month he had said Vietnam could even decide to produce the drug without a licence should a pandemic occur.

The head of a state-run drug firm said Vietnam had the production capacity. "We have about 50 establishments in Vietnam which would be capable of manufacturing Tamiflu," said Le Ngoc Phan, the director of a pharmaceutical company in Hanoi. "Once officially authorised, I think Vietnam could produce 15 to 20 million capsules of Tamiflu per year," he said, admitting that would require a massive investment. The World Health Organisation (WHO) spokeswoman in Hanoi, Dida Connor, agreed Vietnam would be able to make the drug. "There is a potential capacity within Vietnam's established pharmaceutical companies," she said. "This needs to be worked out between Roche and the companies."

Thailand said last week that it would begin making its own generic version by February. The country's health ministry said Roche had not patented Tamiflu in Thailand, leaving the government free to make its own version. Last month Taiwan said it was planning a trial production of Tamiflu in December and was pushing for negotiations with Roche centering on compensation if the drug was used prior to approval from the firm.

The WHO in Geneva said earlier this week that it was in talks with Roche on building a second stockpile of Tamiflu. Roche has already pledged to donate to the WHO 30 million Tamiflu doses, enough to treat three million people. The stockpile, which the WHO hopes to have at its disposal in early 2006, would be used in an emergency.

Tamiflu is not a vaccine but a drug that eases the symptoms of flu in an infected person, and thus has a preventative role. It works by inhibiting reproduction of the influenza virus. Roche, which has a years-long backlog of demands for the antiviral drug, said Monday it would boost capacity to produce 300 million doses of Tamiflu annually.

Agence France Presse - November 9, 2005.