WTO Announces That Rwanda Plans to Import Generic Antiretroviral From Canadian Drug Company

The World Trade Organization on Friday in a statement announced that Rwanda plans to override pharmaceutical patents and import 260,000 packs of Apo-triAvir, a generic HIV/AIDS medication made by the Toronto-based drug company Apotex, the New Times/AllAfrica.com reports. Apo-triAvir is a fixed-dose combination of the antiretroviral drugs nevirapine, lamivudine and zidovudine (Gahigana, New Times/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 public health crisis are allowed to import generic drugs when they cannot manufacture the drugs themselves, RNA/AllAfrica.com reports. 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 (RNA/AllAfrica.com, 7/23). The TRIPS waiver submission was made last week by the Treatment and Research AIDS Centre. Rwanda plans to import the 260,000 packets during the next two years (New Times/AllAfrica.com, 7/22).

According to Reuters, Oxfam and other development campaigners have said that the TRIPS waiver is too burdensome because its reporting rules are cumbersome and it requires exporters of generic drugs to negotiate with patent holders for 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 because of its difficult procedures. "It is important to keep in mind that this is just one shipment of one product for Rwanda," Boulet said. She added, "It is a system that works on a country-by-country and case-by-case basis. It may indeed respond to the needs of Rwanda for this specific medicine, but this is not a solution to the broader problem."

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

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