Tue, Nov 01, 2005 page2

• Taiwan to start pushing Roche

  TIME TO ACT The Department of Health will use a national-emergency clause in WTO regulations to begin making the anti-viral drug, even if the drugmaker doesn't approve

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  Taiwan plans to take steps to force the Swiss pharmaceutical company Roche to let the country produce the anti-bird flu drug Tamiflu, the health minister said yesterday.

  The move is part of a "two-track" approach for obtaining a Tamiflu license so Taiwan can combat a possible bird-flu outbreak, Department of Health Minister Hou Sheng-mou (侯勝茂) said.

  Hou said his ministry has asked the bureau in charge of intellectual property rights to request a "coercive authorization" for the drug's production, citing a national emergency clause.

  "The Department of Health, while seeking approval from Roche, has asked the Economic Ministry's Intellectual Property Office [IPO] for compulsory licensing to produce Tamiflu," Hou told the Legislative Yuan.

  "The license could be granted by the end of November at the earliest," he said.

  "The production will boost our stockpile of Tamiflu to enough for 3 million people," Hou said.

  The bureau is expected to contact Roche to learn its position on the issue before making a judgment in about a month, he said.

  WTO regulations allow for drug patents to be violated in the event of medical emergencies, providing that the patent holder is compensated at a later date.

  Taiwan submitted an application to Roche on Oct. 17 for a sublicense to produce its version of Tamiflu. Roche said later that it was willing to discuss details with Taipei.

  The two sides are scheduled to hold their first talks on Nov. 8.

  Roche has said it is willing to negotiate on Tamiflu manufacture with countries or companies able to produce large amounts of the drug if they meet appropriate quality specifications, safety and regulatory guidelines.

  The government recently said it has succeeded in developing a generic version, which it said is 99 percent akin to Tamiflu, and has bought 3 tonnes of shikimic acid, which is the raw material for making Tamilfu and is enough to make the drug for 2.3 million people -- about 10 percent of the country's population.

  Premier Frank Hsieh (謝長廷) has said that Tamiflu production could begin next month and that the drug could be produced in about a month.

  The next step in Taiwan's efforts to produce its own version of the drug, which doesn't cure bird flu but can ease and shorten its symptoms, is in the IPO's hands. Upon receiving the application for compulsory licensing, the office will send a duplicate copy of the the application to Roche to request a response.

  If no response is given, the office will grant the compulsory license.

  An IPO official told reporters that the standard time for the patent holder to respond is three months.

  "But in a case of emergency, it could be a few days or even one day," the official said.

  As for the amount of compensation, "it is up to the applicant and the patent holder to discuss," the official in the IPO's legal affairs department said. "If they have failed to reach an agreement, IPO will make a ruling."
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