Canada to use compulsory licensing to produce HIV drugs for developing world

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Canada’s International Trade and Industry Ministers say that they plan to introduce legislation within weeks to allow generic drug manufacturers in Canada to make generic versions of antiretrovirals for export to developing countries.

The move could substantially increase the volume of generic production, since Canada is home to several very large generic drug manufacturers. One company, Apotex, has already asked the Canadian government to be allowed to produce generic antiretrovirals for sale at manufacturing price in Africa. It follows a challenge by UN Special Envoy Stephen Lewis, who told last week's International Conference on AIDS and Sexually Transmitted Infections in Africa that scaling up treatment would require one of the major developed world nations to permit compulsory licensing for export purposes if Africa is to have a stable, high quality supply of generic antiretrovirals to meet all its needs.

The Canadian initiative has been criticised by Harvey Bale of the International Federation of Pharmaceutical Manufacturers Associations, who told the

Glossary

generic

In relation to medicines, a drug manufactured and sold without a brand name, in situations where the original manufacturer’s patent has expired or is not enforced. Generic drugs contain the same active ingredients as branded drugs, and have comparable strength, safety, efficacy and quality.

capacity

In discussions of consent for medical treatment, the ability of a person to make a decision for themselves and understand its implications. Young children, people who are unconscious and some people with mental health problems may lack capacity. In the context of health services, the staff and resources that are available for patient care.

Toronto Globe and Mail that compulsory licensing will distract attention from debate over the size of Canada’s contribution to the Global Fund to Fight AIDS and TB. He argues that more money is needed for medical infrastructure, and that Canadian manufacturers will be undercut by their Indian rivals.

However, it is by no means certain that manufacturers in Brazil, India and China will have the combined capacity to meet the demand for antiretroviral drugs. The contribution of Canadian companies may be crucial, not only for ramping up production, but also for encouraging governments around the world to use the compulsory licensing route to develop production. Canada's government is less vulnerable to pressure from big pharmaceutical companies than the US, British or French governments, say treatment advocates, and will show developing countries that it is possible to stand up to pressure from industry and from the US government.

Scaling up treatment: what quantity of drugs will be needed?

At last week’s UN General Assembly session on HIV/AIDS, the World Health Organisation gave some insight into plans due to be unveiled by December 1, which will show how WHO intends to increase the numbers on treatment in the developing world. WHO is likely to move rapidly, with very clear guidelines on which drugs to use, together with emergency public health planning techniques developed from experience with SARS and health emergencies in Iraq, Afghanistan and Liberia. Dr Jim Kim of WHO says that existing treatment programmes in the developing world could treat 800,000 by 2005, still considerably short of the `3 x 5` target set by WHO last year.

Further information

Comprehensive background information on the Canadian proposal is available at the website of the Canadian HIV/AIDS Legal Network.