GSK Gives Consent to Canadian Drug Company To Manufacture Generic Antiretroviral for RwandaGlaxoSmithKline on Wednesday announced that it has given consent to Toronto-based drug company Apotex to use two of its patented antiretroviral drugs, lamivudine and zidovudine, to manufacture Apo-triAvir -- a fixed-dose combination of the two drugs and the antiretroviral nevirapine -- for Rwanda, the Toronto Star reports. According to the Star, consent was given through Canada's Access to Medicines Regime (Talaga, Toronto Star, 8/9).
The World Trade Organization last month 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, 7/25).
GSK in a press release said it has agreed to waive royalties on the basis that Apo-triAvir will be supplied to Rwanda on a not-for-profit basis. German pharmaceutical company Boehringer Ingelheim agreed last month to allow Apotex to use its antiretroviral nevirapine in the combination therapy, the Star reports (Toronto Star, 8/9). According to Elie Betito, director of public and government affairs for Apotex, there still are outstanding issues that need to be addressed, including the need to reach an agreement with one group of patent holders associated with nevirapine. "The bottom line is that the patentees have not lifted all of the barriers to shipment," Betito said.
According to the Globe and Mail, if the agreement is approved, 15 million to 16 million tablets of Apo-triAvir will be manufactured and sent to Rwanda. That will be enough to provide 21,000 HIV-positive people in Rwanda with treatment for one year or 200,000 for one month, Betito said. He added that it will cost about 40 cents to make one tablet and that the drug will be sold on a not-for-profit basis.
Although CAMR was created three years ago with the aim of supplying inexpensive drugs to developing countries, no drugs have been exported under the law, according to the Globe and Mail (Priest, Globe and Mail, 8/9). Joanne Csete, executive director of the Canadian HIV/AIDS Legal Network, said, "What we've learned from this three-year, incredibly cumbersome process is that" CAMR is "not working well." She added, "It's almost a miracle Rwanda may be getting any drugs under this law." Stephen Lewis, former United Nations Special Envoy for HIV/AIDS in Africa, said this is a significant step, adding, "Forgetting all the negotiations and shenanigans over the last few years, we can begin to save lives. That is what is crucial."
Darren Cunningham, director of parliamentary affairs for Canada's Minister of Industry Maxime Bernier, said that the issue now is how to get the drug distributed to people in need in Rwanda. "One of the big concerns is diversion of drugs," he said, adding, "That would be worked out with the patentees and the generic company ... But we haven't seen what the arrangement is at this point." According to Cunningham, Boehringer has not notified the federal government that the process is moving forward. "We haven't seen anything official like we have today with GSK," he added (Toronto Star, 8/9).