WHO Gives Endorsement to Canadian Company’s Combination HIV/AIDS Drug; Health Canada Approval Held Up by Negotiations Between GSK, Apotex
The World Health Organization on Friday gave its approval to Apo-triAvir, a generic HIV/AIDS medication made by the Toronto-based drug company Apotex, a "critical step" in allowing the drug to be exported to developing countries, the Toronto Star reports. Apo-triAvir contains nevirapine and two other drugs in a single-pill format. Rachel Kiddell-Monroe -- head of Medecins Sans Frontieres' Campaign for Access to Essential Medicines, who is scheduled to address the XVI International AIDS Conference in Toronto -- said, "Once a drug is approved by WHO, it can be bought by developing countries who need it, safe in the knowledge that it is effective and safe for their people. Since there are so many different drugs around, many of which are [of] extremely doubtful quality, (developing countries) need somewhere they can look and be sure drugs are appropriate."
Even with WHO's approval, there are "troublesome obstacles to getting the new drug to Africa and elsewhere, not the least of which is faulty federal legislation," the Star reports (Westhead, Toronto Star, 8/12). A nearly two-year-old Canadian law allows drug makers to manufacture and export less-expensive, generic versions of patented drugs -- including antiretroviral drugs -- to developing countries, but so far, no drugs have been exported as a result of the law. 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 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 (Kaiser Daily HIV/AIDS Report, 8/4). The legislation says that talks between the patent holder of a medication and the generic drug company should last at least 30 days before the generic company can seek a compulsory license from Health Canada to bring the generic drug to market. However, the legislation does not set a time limit on how long the talks can last. Discussions between Apotex and GlaxoSmithKline, the patent holder on nevirapine, have "dragged," the Star reports. Lawyers for GSK have said Apotex must show that Apo-triAvir will not resemble comparable drugs in Canada. MSF, which has agreed to pay 38 cents per pill for Apo-triAvir, has criticized the process, according to the Star. Kiddell-Monroe is expected at the International AIDS Conference to call on Canada to address the obstacles in the legislation (Toronto Star, 8/12). In addition, U.N. Special Envoy for AIDS in Africa Stephen Lewis on Wednesday at a press conference in Toronto ahead of the AIDS conference criticized the Canadian government for not supplying developing countries with low-cost medications (Kaiser Daily HIV/AIDS Report, 8/11). Canadian Health Minister Tony Clement has said that he is seeking advice on how to change the legislation with organizations such as MSF and the Canadian HIV/AIDS Legal Network, as well as with Lewis (Teotonio, Toronto Star, 8/14).
Kaisernetwork.org is serving as the official webcaster of the conference. View the guide to coverage and all webcasts, interviews and a daily video round up of conference highlights at http://www.kaisernetwork.org/aids2006.