WTO To Produce Combination Antiretroviral For Rwanda

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Antiretroviral Drug

The World Trade Organization on Friday announced it had received notification from the Canadian Intellectual Property Office authorizing Toronto-based generic drug company Apotex to manufacture its fixed-dose combination antiretroviral drug Apo-triAvir for Rwanda, Toronto's Globe and Mail reports (Gandhi, Globe and Mail, 10/6). According to WTO, Apo-triAvir now can be manufactured and exported to Rwanda (Higgins, Associated Press, 10/5).

GlaxoSmithKlinein August announced that it had given consent to Apotex to use two ofGSK's patented antiretroviral drugs, lamivudine and zidovudine, tomanufacture Apo-triAvir -- a combination of lamivudine, zidovudine andnevirapine. Boehringer Ingelheim agreed in July to allow Apotex to use nevirapine in the combination.

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WTO in July in a statementannounced that Rwanda plans to override the pharmaceutical patents andimport 260,000 packs of Apo-triAvir. Under an August 2003 waiver toWTO'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. According to WTO, Rwanda is the firstcountry to use the waiver, which would allow it to import generic drugsthat are manufactured under compulsory licenses in other countries. TheTRIPS waiver submission was made last month by the Treatment andResearch AIDS Centre. Rwanda plans to import the 260,000 packets duringthe next two years (Kaiser Daily HIV/AIDS Report, 8/10).

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Elie Betito, director of public and government affairs for Apotex, saidthe company is "in the final processes of the development of[Apo-triAvir] now, so we should be in the production stages soon." Headded, "If everything goes as planned, by mid-December we should haveproduct flowing to Africa."

According to the Globe and Mail,some HIV/AIDS advocates said the Canadian law that allows authorizationof generic drug production needs to be changed if it is going to helpother countries in need of generic antiretrovirals. "Even though wehave the first compulsory license issued, that doesn't mean somehowthat there's no problem with the legislation," Richard Elliott,executive director of the Canadian HIV/AIDS Legal Network,said, adding, "It took nearly three years to get to this point." It is"unlikely that Apotex, or any generic manufacturer, will want to gothrough this process again," Elliott said (Globe and Mail, 10/6).

Reprinted with permission from kaisernetwork.org. You can view theentire Kaiser DailyHIV/AIDS Report, search the archives, and sign up for email delivery at kaisernetwork.org/email . TheKaiser Daily HIV/AIDS Report is published for kaisernetwork.org, a free service ofThe Henry J. Kaiser Family Foundation.

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