GENEVA – Canada has authorised a company to make a generic version of a patented Aids therapy drug for export to Rwanda, in the first case of a patent waiver under World Trade Organisation (WTO) rules.
According to a notification from Canada to the WTO on Friday, posted on the WTO’s website, Canada will allow Apotex Inc., the largest Canadian-owned pharmaceutical company, to export TriAvir, a fixed-dose antiretroviral drug, to Rwanda.
Rwanda had informed the WTO in July that it intended to import 260,000 packs of TriAvir.
Canada’s notification completes the legal formalities allowing the export, the first under a 2003 WTO agreement making it easier for countries with public health problems to import cheap generics made under compulsory licensing when they are unable to manufacture the medicines themselves.
Development campaigners such as Oxfam have criticised the “paragraph 6 solution”, as this type of waiver is often called, as being too burdensome because of its reporting rules and requirement for exporters to negotiate with drug patent holders for the right to sell generics abroad.
Under WTO rules, countries can issue a compulsory licence to manufacture generic versions of patented drugs deemed critical to public health as long as the medicines are for domestic distribution.