TRIPs mechanism set to fail as Apotex ships ARV

A compulsory licensing mechanism under the World Trade Organization's agreement on Trade-Related aspects of Intellectual Property Rights (TRIPs) looks set to fail, even as its first implementation reaches completion. The use of article 31bis of the document allows a country that does not have a pharmaceutical manufacturing capacity to place an order with foreign companies for a drug, whereas other compulsory licensing arrangements permitted under the TRIPs process must be locally-produced.

The government of Rwanda approached Canada-based generic drugmaker Apotex, to produce low-cost versions of the antiretroviral combination agent Apo-TriAvir (Marketletter October 8, 2007). The product includes three drugs held under patent by UK-based drugmakers GlaxoSmithKline and Shire and Germany's Boehringer Ingelheim. Canada was the first country to implement legislation under the Access to Medicines Regime (CAMR) to allow the article 31bis derogation to be used by locally-based firms (Marketletters passim).

Although Apotex announced the shipping to Rwanda, on September 24, of seven million doses of its agent, the CAMR's operation, criticized as cumbersome by some commentators, seems unlikely to be copied. Elie Betito, the generic firm's director of public affairs, said: "it took us more than four years just to get to this point. It's a huge process, with huge costs involved." Apotex confirmed that, unless the legislation is amended, it will not agree to take part in another such deal. Two years were taken up in negotiations between the copy drug firm and the patent holders, Apotex said.