Thu, Oct 27, 2005 page12

• Groups demand new WTO rules

  INFLUENZA INFLUENCE Fears of a bird-flu epidemic and insufficient anti-virals have prompted demands that the WTO relax its patent rules so generic drugs can be made

  • AP
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  Pressure groups on Tuesday demanded that the WTO simplify the rules under which governments can import and producers export generic copies of drugs under patent, to tackle fears of a flu pandemic.

  The groups, including Medecins Sans Frontieres (MSF), argue that easing the rules would encourage more producers to manufacture generic drugs under so-called compulsory licensing. Urgently needed drugs would become more widely available should the bird-flu virus change so that it can pass easily between humans.

  The campaigners cite Tamiflu, which is produced by Switzerland's Roche Holding AG and is considered the only drug likely to be effective in an outbreak of the bird flu disease in humans. Governments have been scrambling to stockpile the drug in case of a pandemic.

  "Tamiflu illustrates the danger of patent monopolies -- you have a shortage of a drug and don't have an easy remedy for a disease. This is exactly the situation when countries would have to use compulsory licenses for import and export," said Ellen 't Hoen, who directs the campaign for access to essential medicines at MSF, also known as Doctors Without Borders.

  She said WTO rules were "not sufficient and robust enough to deal with public health crises."

  Under WTO rules, countries can issue compulsory licenses to disregard patent rights but only after negotiating with the patent owners and paying them adequate compensation. If they declare a public health emergency, governments can skip the negotiating.

  Initially the production of such generic drugs was strictly limited to domestic use. But in a decision in August 2003, the WTO for the first time allowed generic drugs under compulsory licenses to be exported, albeit under very strict conditions.

  Although the decision was a response to poor countries' growing need for cheap generic drugs to tackle epidemics such as HIV/AIDS, critics now say that the complicated procedure to export such drugs has put off generic manufacturers.

  "The rich countries congratulate themselves ... but in reality it does not bear fruit. In reality it removes the economic incentive for generic production," 't Hoen said.

  Another issue is that many rich countries, including the US and the EU, opted out of the 2003 decision, meaning they would be unable to import generic drugs made under compulsory license even if they wanted to build up stocks against a disease outbreak, such as a flu pandemic.

  Consumers International demands that countries that opted out be allowed to opt back in.

  India has already said that it would consider using compulsory licensing to allow its drugmakers to copy Tamiflu.

  Indian drugmaker Cipla Ltd -- 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.

  A Taiwanese official said the country had no plans to begin manufacture of the Tamiflu because it has not yet received permission from Roche, even though many Taiwanese scientists are reportedly already able to produce Tamiflu copies in the laboratory.

  Roche says it is considering a number of requests to make licensed versions, but did not elaborate.
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