Canadian drug company awarded Rwandan contract to provide combination antiretroviral

Rwanda recently accepted a bid from the Toronto-based generic drug company Apotex to supply its fixed-dose combination antiretroviral drug Apo-triAvir to the country, the Toronto Star reports (Toronto Star, 5/9).

According to the CP/Google.com, securing the contract was the final legal step the company had to take in the process of receiving approval from Canada's Access to Medicines Regime. Apotex is the first company to complete CAMR's approval process, which has been criticized by some HIV/AIDS advocates and generic drug manufacturers, the CP/Google.com reports (CP/Google.com, 5/8).

The World Trade Organization in October 2007 announced it had received notification from the Canadian Intellectual Property Office authorizing Apotex to manufacture the drug. GlaxoSmithKline in August 2007 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 2007 to allow Apotex to use nevirapine in the combination.

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 in September 2007 by the Treatment and Research AIDS Centre (Kaiser Daily HIV/AIDS Report, 8/10/07). According to the Star, Apotex plans to send 15.6 million tablets of the drug beginning in October (Toronto Star, 5/9). Apotex will sell the drug for about 19.5 cents per dose, but if purchased separately and from their patent holders, the drugs will total about $6 per dose, the CP/Google.com reports.

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"We're almost there," Elie Betito, director of public and government affairs for Apotex, said, adding, "By October sometime we're hoping that the product will be on a plane on delivery to Rwanda." Betito said that nothing will be final until the drugs are delivered, adding that the patent-holding companies can still withdraw permission for the sale to take place "even on the day we are shipping" (CP/Google.com, 5/8). Betito said that Apotex essentially developed the drug as a goodwill gesture and will not see a return on its development costs at the selling price. He added that the company likely will not go through the CAMR process again unless it is changed (Gandhi, Globe and Mail, 5/8).

Richard Elliott, executive director of the Canadian HIV/AIDS Legal Network, said Apotex's accomplishment is bittersweet. If Apotex is unwilling to go through the process again, other drug companies are unlikely to attempt to try, Elliott said. He added, "I don't think the experience of Apotex is going to inspire [drug companies] to say, 'OK, yeah, now we'll step up to the plate and do it,' unless of course we fix the system and make it much smoother and easier" (CP/Google.com, 5/8). Jeff Connell, spokesperson for the Canadian Generic Pharmaceutical Association, said none of the group's members is willing to go through the CAMR process in its current form (Globe and Mail, 5/8).