WTO Receives Notification From Canada Authorizing Generic Drug Company To Produce Combination Antiretroviral for Rwanda

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).

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

WTO in July in a statement announced that Rwanda plans to override the pharmaceutical patents and import 260,000 packs of Apo-triAvir. 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 public health crisis are allowed to import generic drugs when they cannot manufacture the drugs themselves. According to WTO, Rwanda is the first country to use the waiver, which would allow it to import generic drugs that are manufactured under compulsory licenses in other countries. The TRIPS waiver submission was made last month by the Treatment and Research AIDS Centre. Rwanda plans to import the 260,000 packets during the next two years (Kaiser Daily HIV/AIDS Report, 8/10).

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

According to the Globe and Mail, some HIV/AIDS advocates said the Canadian law that allows authorization of generic drug production needs to be changed if it is going to help other countries in need of generic antiretrovirals. "Even though we have the first compulsory license issued, that doesn't mean somehow that 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 go through this process again," Elliott said (Globe and Mail, 10/6).