Canada decides to lead the way in exempting AIDS drugs from patent laws

David Spurgeon, BMJ

Canada’s industry minister says his government will try by Christmas to exempt generic forms of drugs to treat AIDS and other drugs destined for poor countries from patent laws.

His announcement was followed by a statement from the organisation representing Canada’s manufacturers of brand name drugs, saying it would help Canada “to show international leadership” in implementing last August’s World Trade Organization (WTO) agreement to give poor countries access to cheap generic medicines to treat life threatening diseases such as HIV, tuberculosis, and malaria.

The minister, Allan Rock, warned that reaching this goal would not be easy, but he added: “We’ll certainly do our best.”

Murray Elston, president of Canada’s Research-Based Pharmaceutical Companies, said his group “welcomed the WTO decision to strike a balance between addressing the needs of the poorest countries while ensuring the protection of intellectual property.”

Canada’s plan comes after a plea by Stephen Lewis, the United Nations special envoy to Africa on AIDS issues (and himself a Canadian) that Canada should show international leadership in making cheap drugs available to poor countries. Mr Lewis, who had earlier criticised brand name firms for resisting the plan, called Mr Rock’s announcement a “very significant development.”

Some people fear that it will take some time before some Canadian generic drugs can actually be shipped abroad. Jack Kay, president of Apotex, which is based in Toronto and is one of Canada’s largest manufacturers of generic drugs, says manufacturers will probably need 18-24 months to apply for approvals from the federal health department, find raw materials, and set up production lines.

However, in the case of the anti-viral drug zidovudine, Apotex already had received government approval for its generic form and was producing it until last year, when the company lost a patent-infringement suit. Thus Apotex says it could probably start producing zidovudine again in a very short time.

The Canadian Generic Pharmaceutical Association said it was “very pleased” that the Canadian government was responding to its request and that of other organisations and individuals to allow Canada’s generic drug manufacturers to participate in the WTO’s plan.

Critics of the scheme have said that Canadian generic drug manufacturers will be unable to compete with generic drugs produced in India and Brazil. But Mr Lewis says demand for the drugs is rising quickly, and India and Brazil soon will not be able to supply enough. The World Health Organization wants to see three million people in treatment programmes by 2005, including two million people in Africa, where only 50 000 to 75 000 people are being treated now in such programmes. Lewis said he hopes Canada’s move would prod other rich countries to take similar steps.

The plan has the support of the prime minister designate, Paul Martin, as well as the present prime minister, Jean Chretien, who is due to retire next February, and his cabinet.

Source: BMJ 2003;327:832 (11 October)

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