Shire Supports Generic HIV Drug Plan
Shire’s Canadian subsidiary, Shire BioChem, has agreed to a compulsory license that would go toward allowing Apotex to manufacture a generic combination HIV drug for export to Rwanda under Canada’s Access to Medicines Regime.
Rwanda notified the World Trade Organization (WTO) last month that it plans to import 260,000 packs over two years of a fixed-dose combination product containing zidovudine, lamivudine and nevirapine that will be manufactured by Apotex. Shire holds Canadian patent rights for 3TC (lamivudine).
Canada’s Access to Medicines Regime is based on a 2003 WTO decision to allow countries with public health problems to import generic drugs if they are unable to manufacture the medicines themselves.
Shire said it agrees that the compulsory license will be royalty-free, and that the drug will be sold to Rwandan authorities on a no-profit basis.
Previously, GlaxoSmithKline, which holds Canadian rights to products containing zidovudine and lamivudine, announced that it consented to the plan.
“One of this global pandemic’s greatest challenges is getting essential medicines directly to those people living with HIV/AIDS who need it most and yet have least access to it,” Claude Perron, vice president and general manager for Shire BioChem, said, adding that the agreement “demonstrates that Canada’s Access to Medicines Regime is an effective tool to help people living with HIV/AIDS in resource-limited settings access the treatment they need.”
However, the Canadian HIV/AIDS Legal Network has pointed out that even though the law was enacted in 2004, Rwanda is the first developing country to attempt to import HIV drugs under the Access to Medicines Regime. The group said it has been asking the government since 2004 to simplify and streamline the law to make it easier for countries to use. — Breda Lund
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