The Canadian government announced in late September that it would amend patent laws to allow generic pharmaceutical companies to produce and export patent-protected drugs to countries unable to manufacture their own (see, BRIDGES Weekly, 1 October 2003). This initiative spurred a strong response, with Canadian NGOs, international organisations such as UNICEF, and health activists outside Canada in both developed and developing countries welcoming it. In contrast, the International Federation of Pharmaceutical Manufacturers Association criticised the initiative, saying it was premature and unhelpful. Canada's Research-Based Pharmaceutical Companies, the association representing Canada's patented pharmaceutical industry, however said that it would "continue to work with the federal government to frame any legislative proposal to assist in humanitarian relief".

The Canadian government's announcement followed a 30 August decision of the WTO General Council on a mechanism for relaxing the restrictions in the TRIPS Agreement (Article 31) on using compulsory licensing to produce generic medicines in one country for export to another (see BRIDGES Weekly, 4 September 2003). The Canadian initiative responded to calls from Canadian civil society organisations, a request from the country's generic drug industry, and the urging of Stephen Lewis, UN special envoy on HIV/AIDS in Africa.

Since the announcement, Canadian civil society organisations have called on the government to ensure that its legislation will fully implement the flexibility reflected in the August 30 WTO decision, and therefore will not be limited to exporting generic drugs for only certain diseases and only to countries facing health emergencies. They note that statements by government ministers have only referred to "pandemics" such as HIV/AIDS, tuberculosis and malaria, and to helping countries facing "emergencies". In its only public statement, the brand-name pharmaceutical industry association has stated that the August 30 WTO decision "relates to the provision of generic medicines to treat HIV/AIDS and other life-threatening diseases such as tuberculosis and malaria".

Health advocates have pointed out that the August 30 decision does not contain any such restrictions, despite efforts of the US, some other developed WTO Members, and the brand-name pharmaceutical industry to introduce them during the almost two years of negotiations it took to reach the agreement since the Doha Declaration on the TRIPS Agreement and Public Health (14 November 2001). The Doha Declaration promised to come up with a solution to the TRIPS barrier to using compulsory licensing to produce generic medicines for export.

Representatives of the brand-name and generic pharmaceutical industry in Canada met with government representatives at least once (7 October), and civil society organisations met with the government once (8 October), to discuss the details of Canada's amendment. The details of the amendment had not been made public by the time of publication.

Canadian civil society organisations continue to request that the government make a public commitment to an amendment that is no more restrictive than the terms of the August 30 decision of the General Council.

For more information on activities by Canadian civil society organizations regarding proposed amendments to Canada's Patent Act, visit http://www.aidslaw.ca.

Médecins Sans Frontières Canada & Canadian HIV/AIDS Legal Network, MEDIA RELEASES, 26 September 2003 and 1 October 2003; UNICEF PRESS RELEASE, 29 September 2003; Treatment Action Campaign (South Africa), MEDIA RELEASE, 1 October 2003; Canada's Research-based Pharmaceutical Companies, MEDIA RELEASE, 1 October 2003; "Big drug companies embrace AIDS plan", GLOBE AND MAIL, 2 October 2003; Open letter by Canadian civil society organisations to Government of Canada, 14 October 2003.