Canadian Bill Authorizing Sale of Generic AIDS Drugs in Low-Income Countries Stalled by Technicalities, Restrictions

Nearly one year after Canada amended its patent 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 new law, the CP/Canada.com reports (Bueckert, CP/Canada.com, 5/2). 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, 11/30/2004). Regulations under the Jean Chretien Pledge to Africa Act have yet to be published, and government officials say the legislation has been stalled by technicalities, according to the CP/Canada.com. According to Doug Clark, a senior official at Industry Canada, a committee in the Canadian Senate has discovered a "serious flaw" in the bill, and a new measure is expected to be considered this week, the CP/Canada.com reports. Clark said that the bill might have mistakenly assumed that drug makers would export drugs for humanitarian reasons, according to the CP/Canada.com. "There is room [in the bill] to make some money, but it definitely does not accommodate lucrative transactions," Clark said, adding, "The incentives are simply not significant because the money is not there. There was really no discussion of that at any point."

Critics of Legislation, Delay
Critics of the measure say it "will never have any real impact" because of its restrictions, the CP/Canada.com reports. "There are many, many restrictions on [exporting generic drugs] that are actually not necessary according to the World Trade Organization," Canadian Generic Pharmaceutical Association President Jim Keon said. U.N. Special Envoy for HIV/AIDS in Africa Stephen Lewis said, "I think that the delay on issuing the regulations is just absolutely absurd and, frankly, intolerable," adding, "If in fact there's been no significant initiative for drug production and export thus far under the bill, then I think the bill is in danger of becoming a non-entity because it will be lost in the politics of Canada." Keon said that discussions over the bill are continuing, but that "there are no products waiting to be shipped." He added that the government should provide research funding to develop needed drugs, according to the CP/Canada.com (CP/Canada.com, 5/2).