Canadian Law Authorizing Sale of Generic Drugs in Low-Income Countries Has Not Helped Export Drugs

Almost two years after Canada amended its laws to allow drug makers to manufacture and export less-expensive, generic versions of patented drugs -- including antiretroviral drugs -- to developing countries, no drugs have been exported as a result of the law, the Toronto Star reports (Hall, Toronto Star, 8/3). The Canadian Senate in May 2004 approved Bill C-9, which former Canadian Prime Minister Jean Chretien introduced in November 2003 in the House of Commons (Kaiser Daily HIV/AIDS Report, 5/2/05). The law, which was modeled after an agreement signed by World Trade Organization officials in 2001, says that generic manufacturers must charge developing countries who request low-cost medicines 25% of the Canadian market cost of their brand-name equivalents, the Star reports. The law was meant to take advantage of a WTO agreement provision that allows countries signing the agreement to grant compulsory licensing of drugs during national health emergencies, according to the Star .

Criticism, Government Plans
Rachel Kiddell-Monroe, the Canadian head of Campaign for Access to Essential Medicines, said Canada's law on drug patents is more confusing than the WTO agreement, adding that a primary problem is the law says brand-name patent holders and generic manufacturers must have voluntary negotiations before the government ordering the less-expensive drugs can receive a compulsory license. "And voluntary negotiations between (these competing) companies are always going to be difficult because, unless the companies want to give each other permission, ... they're going to bring in the lawyers, and it's going to get complicated," Kiddell-Monroe said. She added that there should be an automatic process, where if a country requests a generic drug from a manufacturer, the government grants the compulsory license. In addition, Kiddell-Monroe said that the law requires "bureaucratic and administrative procedures" that make it too slow to effectively fight the spread of HIV. Kiddell-Monroe is scheduled to appear at the XVI International AIDS Conference in Toronto, where she is expected to call for the streamlining of this legislation. She is also expected to urge the international community to pass legislation that would speed the delivery of drugs to developing nations. Erik Waddell, spokesperson for Health Minister Tony Clement, said the government is "actively reviewing the program right now," adding that improvements will be made if they are necessary. He added, "Obviously there's an interest in helping victims of HIV and AIDS get the help they need, and we're interested in providing that help where we can, and we're going to look at the current legislation" (Toronto Star, 8/3).

The XVI International AIDS Conference program is available online.