Taiwan has decided to request a "coercive authorization" to produce Tamiflu, as the drug's patent holder, Roche Holding AG, is still reluctant to give the nation permission to make the drug that can be used to treat bird flu in people.
Taiwan will send the formal notice to Roche, the second-largest Swiss drugmaker, as soon as next week, Jack Lu (盧文祥), deputy director general of the Intellectual Property Office (IPO), said after concluding a meeting on the issue yesterday evening.
The IPO yesterday invited representatives from the Department of Health, Roche Taiwan, the local office of US biotech firm Gilead that developed Tamiflu, as well as several academics in the fields of public hygiene, patents and international trade to discuss the issues and try to reach a conclusion about licensing.
The authorization, which is also known as a compulsory license, will be valid through the end of 2007, and is expected to help Taiwan prepare for any possible outbreak of avian influenza among humans.
But the authorization is being issued with several conditions, Lu said.
First, any drugs produced under the coercive authorization would be restricted for use in Taiwan, Lu said. In other words, Taiwan could not sell or export the drugs overseas.
Secondly, Taiwan can only start production of the anti-viral drugs when its stocks of Tamiflu and those that have been ordered from Roche are depleted, he added.
Currently, Taiwan has a stockpile of 130,000 doses of Tamiflu, and will receive another 80,000 by the end of January. Another 390,000 are due to be delivered in February, Lu said. In addition, Roche has consented to supply enough of the drug's raw materials to produce 2.3 million doses, enough for 10 percent of Taiwan's population, Lu said.
As Taiwan is still negotiating with Roche about gaining formal permission to produce Tamiflu, once Roche agrees to license Taiwan to make the drug, the coercive authorization will be recalled immediately, he said.
Roche Taiwan said in a statement released last night that it "feels confused and regret" toward the IPO's compulsory license decision.
The company said it is concerned about the quality of vaccine developed by Taiwan's Vaccine Center under the National Health Research Institute.
But to ease public concern, "the company will try its best ... to increase imports of the original Tamiflu from elsewhere around the world to meet Taiwan's demand, and is confident that the company can import enough of the drug to reach a safe level as requested by both the DOH and IPO," Roche said in the statement.
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