Rwanda Plans To Import Generic Antiretroviral From Canadian Drug Company

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The World Trade Organization on Friday in a statementannounced that Rwanda plans to override pharmaceutical patents andimport 260,000 packs of Apo-triAvir, a generic HIV/AIDS medication madeby the Toronto-based drug company Apotex, the New Times/AllAfrica.comreports. Apo-triAvir is a fixed-dose combination of the antiretroviraldrugs nevirapine, lamivudine and zidovudine (Gahigana, NewTimes/AllAfrica.com, 7/22).

Under an August 2003 waiver to WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights,known as the "paragraph 6 system," developing countries with a publichealth crisis are allowed to import generic drugs when they cannotmanufacture the drugs themselves, RNA/AllAfrica.comreports. According to WTO, Rwanda is the first country to use thewaiver, which would allow it to import generic drugs that aremanufactured under compulsory licenses in other countries(RNA/AllAfrica.com, 7/23). The TRIPS waiver submission was made lastweek by the Treatment and Research AIDS Centre. Rwanda plans to importthe 260,000 packets during the next two years (New Times/AllAfrica.com,7/22).

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According to Reuters, Oxfamand other development campaigners have said that the TRIPS waiver istoo burdensome because its reporting rules are cumbersome and itrequires exporters of generic drugs to negotiate with patent holdersfor the right to sell the generic versions abroad.

Pascale Boulet, legal adviser for Medecins Sans Frontieres,said developing countries have been reluctant to use the waiver becauseof its difficult procedures. "It is important to keep in mind that thisis just one shipment of one product for Rwanda," Boulet said. Sheadded, "It is a system that works on a country-by-country andcase-by-case basis. It may indeed respond to the needs of Rwanda forthis specific medicine, but this is not a solution to the broaderproblem."

Celine Charveriat, head of advocacy for Oxfam, saidthat Rwanda's experience might determine the waiver's future. "We hopethat Rwanda's action will lead to an increase in the number of poorpeople who can get antiretrovirals," Charveriat said, adding, "If foundunworkable, the provision must be changed." WTO's 150 members haveuntil December to ratify a decision to make the TRIPS waiver permanent,according to Reuters (MacInnis, Reuters, 7/20).
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