Canada first to notify compulsory licence to export generic drug

The World Trade Organisation (WTO) has received from Canada the first notification from any government that it has authorised a company to make a generic version of a patented medicine for export under special WTO provisions agreed in 2003.

The triple combination AIDS therapy drug, TriAvir, can now be made and exported to Rwanda, which is unable to manufacture the medicine itself.

In July Rwanda informed the WTO that it intends to import 260,000 packs of TriAvir a fixed-dose combination product of Zidovudine, Lamivudine and Nevirapine over two years. The drug is to be made in Canada by Apotex and is called ApoTriavir by the manufacturer.

Canada's notification completes the circle. Both notifications were required for the medicine to be exported to Rwanda under an important agreement among WTO members reached on 30 August 2003, which eased the way for countries with public health problems to import cheaper generics made under compulsory licensing elsewhere when they are unable to manufacture the medicines themselves.

The 2003 decision is often called the "paragraph 6 system" because it implements paragraph 6 of the 2001 Doha Declaration on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and Public Health. Canada's notification comes under paragraph 2(c) of the 30 August 2003 General Council decision, which requires exporting countries to supply relevant information on the compulsory licence to the TRIPS Council.

The notification informs WTO members that Canada has authorised the medicine to be produced and exported to Rwanda, including the conditions attached to the compulsory licence and the details of the medicines to be exported under compulsory licence.