Mexico, United States Support Canadian Plan To Manufacture, Export Generic Antiretroviral Drugs to Africa

Representatives of Mexico and the United States on Tuesday at a meeting of the North American Free Trade Agreement commission said that the two countries will support Canada's plan to alter its patent laws to allow the manufacture and export of generic antiretroviral drugs for African nations, Reuters reports (White, Reuters, 10/7). Canadian officials and representatives from the country's drug industry have given their support to a plan allowed under a recently reached World Trade Organization agreement to alter the country's pharmaceutical drug patent laws to allow the production and exportation of generic drugs. Canada would be the first Group of Seven industrialized country to change its patent laws in order to help developing countries that need access to the medications (Kaiser Daily HIV/AIDS Report, 10/2). Although both Mexico and the United States have signed the WTO agreement, the agreement has not been copied into NAFTA, Toronto's Globe and Mail reports (Scoffield/Chase, Globe and Mail, 10/7). Therefore, Canada needed waivers from its NAFTA partners to move ahead with the plan (Chase/Scoffield, Globe and Mail, 10/8).

Reaction
"It is a fine step. We would certainly not take any steps against that," U.S. Trade Representative Robert Zoellick said at the meeting (Reuters, 10/7). Zoellick said that Canada's move to export generic versions of patented drugs is a "perfectly appropriate" response to the WTO agreement, but he added that Canada needs to take measures to control and monitor the shipments to ensure that the drugs reach only patients in developing countries. "We, of course, would expect that Canada, as one of the framers of the rules, would maintain the rules we agreed on," Zoellick said. A senior Canadian official said that the United States did not place any restrictions on the drugs covered under the Canadian plan; however, the drugs produced and exported would only be used to treat HIV/AIDS, tuberculosis, malaria and other public health emergencies, as agreed to in the WTO deal (Globe and Mail, 10/8). Mexico's Minister of the Economy Fernando Canales said, "Mexico would not oppose such an initiative at all." Canadian International Trade Minister Pierre Pettigrew said, "As Canadians, we have a responsibility to push AIDS back, to put this decision in force. We have work to do and we have to consult the industry" (Reuters, 10/7).

Approval Process
Canadian House Leader Don Boudria on Friday said he had obtained the general support of the four opposition parties needed to gain passage of the patent law changes, the Globe and Mail reports. Although the final decision will depend on the wording of the agreement, Canadian Industry Minister Allan Rock, whose department is drafting the legislation, said he hopes to have the process completed before the end of December (Fagan et al., Globe and Mail, 10/4). However, Pettigrew on Tuesday said that one of the difficulties will be respecting drug companies' rights to intellectual property. The goal of the plan is to create legislation that will continue to reward brand-name pharmaceutical companies for their research and development while providing drugs to people in Africa, according to Reuters (Reuters, 10/7). Drug companies have said that it will take more than a year to "get through the red tape of government departments" and to scale up production levels, according to the Toronto Star (Ward, Toronto Star, 10/4). Some drug companies have expressed concern that the generic drugs, which will be sold in Africa at a fraction of their cost in Western nations, will make their way back to North America on the black market (Reuters, 10/7).

AIDS Treatment Advocates Relieved
AIDS treatment advocates on Tuesday "breathed a sigh of relief" at the news that Mexico and the United States would support the Canadian plan with no restrictions, according to the Globe and Mail. "If they are offering (their support) in good faith, then it's welcome news," Richard Elliott, director of legal policy for the Canadian HIV/AIDS Legal Network, said. Elliott said that the most encouraging news was that the United States, which reluctantly agreed to the WTO deal, did not place narrow demands on the Canadian legislation to require that it apply only to specific drugs for specific diseases in specific countries (Globe and Mail, 10/8). African AIDS advocates anticipate that the presence of generic Canadian drugs on the antiretroviral drug market will increase competition, driving drug prices down further and making the drugs more accessible to both governments and individual buyers. Christa Cepuch, a Canadian pharmacist who procures antiretrovirals for 800 Kenyans being treated under a Medecins Sans Frontieres program, said that increased competition from Canadian suppliers could drive the cost of antiretroviral drugs down from the current best price of $280 per patient per year to between $70 and $100 per patient per year (Nolen, Globe and Mail, 10/6).

Regulatory Body Needed, Letter to Editor Says
Although initiatives that increase access to antiretroviral drugs are "welcome," the "widespread use of unregulated generic drugs" could have a "potential negative impact" and is a cause for concern, Terrence Blaschke, a professor of medicine and molecular pharmacology at Stanford University School of Medicine, and Concepta Merry and Mairin Ryan of the department of infectious diseases and pharmacology at Trinity College Dublin in Ireland, write in a Financial Times letter to the editor. Drugs lacking sufficient concentrations of active ingredients could cause treatment failure and promote the emergence of resistant forms of infectious agents, they say. Therefore, although the WTO agreement is an "important step forward, ... it is equally important to establish an appropriate regulatory body which has the authority and expertise to oversee the manufacturing standards of companies and the quality of the medicines they produce," the authors conclude (Blaschke et al., Financial Times, 10/6).