Canada Set to Alter Patent Laws to Allow Production, Export of Generic Antiretroviral Drugs

Canadian officials and representatives from the country's drug industry have given their support to a plan to alter the country's pharmaceutical drug patent laws to allow the production and exportation of generic antiretroviral drugs, making Canada the first Group of Seven industrialized country to do so, the Wall Street Journal reports (Cherney/Chipello, Wall Street Journal, 10/2). Canadian brand-name drug company lobby group Research-Based Pharmaceutical Companies has said that it will work with lawmakers to draft legislation to make generic antiretrovirals available for export from Canada, stating in a press release that the country "has an opportunity to show international leadership" by changing patent laws to improve access to drugs (Scoffield/Knox, Globe and Mail, 10/2). Drafting the legislation likely will involve creating a list of specific patented treatments that can be produced by generic drug makers for a specific group of countries, according to an official familiar with the process. It is unknown how long the process will take, the Journal reports (Wall Street Journal, 10/2). However, Canada's ruling Liberal Party and several opposition parties have said that they are willing to "fast-track" the legislation through Parliament, Reuters reports (Sekhri, Reuters, 10/1). In addition to the cabinet and the pharmaceutical industry, Paul Martin, the recently elected leader of the country's Liberal Party who is expected to become the Canadian prime minister when current Prime Minister Jean Chretien resigns, on Tuesday gave his support to the legislation, Toronto's Globe and Mail reports. The measure also has the support of several United Nations' groups, world health advocacy groups and HIV/AIDS groups (Globe and Mail, 10/2).

Next Steps
Although the legislation is supported by many groups, lawmakers are still trying to figure out how to proceed with the amendment, Reuters reports (Reuters, 10/1). Andre Lemay of the Canadian department of foreign affairs and international trade said that the government wants to be cautious in order to avoid legal challenges, adding, "You want to make sure that what you have is something you can live with, and that it won't come back to haunt you three or four or five years down the road" (Cohen, AP/Austin American Statesman, 10/1). Trade Minister Pierre Pettigrew and Industry Minister Allan Rock are currently exploring ways to amend patent laws in accordance with a WTO agreement, which allows poor countries to import generic drugs if they do not have the capacity to manufacture the drugs domestically (Panetta, CP/Canada.com, 9/30). In addition, lawmakers must make sure the legislation is consistent with other trade agreements, including the North American Free Trade Agreement, the Journal reports (Wall Street Journal, 10/2).

Drug Industry Concern
Some pharmaceutical companies that develop and manufacture brand-name drugs have expressed concern that generic drugs could be reimported to North America and other Western nations. Therefore, the companies are asking that generic production of antiretroviral drugs be allowed for export only in order to protect their patents on AIDS-related drugs in developed nations, according to Reuters (Reuters, 10/1). Harvey Bale, director general of the International Federation of Pharmaceutical Manufacturers Associations, last week said that the Canadian initiative would erode patent protection and "won't solve a thing" (Globe and Mail, 10/2). Some officials said that they hope the measure can become law "in the next month or so," before Chretien discontinues the current session of the House of Commons in preparation for his retirement, the Globe and Mail reports (Globe and Mail, 10/2). Dr. James Orbinski, a former president of Medecins Sans Frontieres, said, "We can't wait another year for legal fineries and want this passed in Canadian Parliament within a week" (Reuters, 10/1). Martin said that he would proceed with the plan when he comes into power, adding, "These drugs must be provided to these countries -- and as quickly as possible and at as low a cost as possible. (It) is not only something that has to be fulfilled, it is something Canada should fulfill" (CP/Canada.com, 9/30).

Reaction
U.N. Special Envoy for HIV/AIDS in Africa Stephen Lewis said that he "hope[s] Canada's initiative may stimulate other G7 countries" to alter their patent laws to allow generic drug production and exportation (Wall Street Journal, 10/2). Lewis last week called on the G7 nations -- the United States, Japan, Britain, Germany, France, Italy and Canada -- to adopt new strategies to allow the production and distribution of generic antiretroviral drugs to African countries hit hard by the AIDS epidemic. Lewis, who is Canadian, specifically called on Canada to take the lead, saying that its large generic drug industry and Chretien's decision to make HIV/AIDS a foreign policy priority make the country a prime candidate for supplying the drugs (Kaiser Daily HIV/AIDS Report, 9/26). Carol Bellamy, executive director of UNICEF, said that the Canadian government's actions are a "path-breaking step in the fight against AIDS" that will "expand overall availability of antiretrovirals in poor countries" (Panafrican News Agency, 10/1). South Africa's Treatment Action Campaign and AIDS Law Project said in a joint release, "We strongly believe that if properly implemented, this brave step will make a significant contribution towards ensuring a sustainable supply of affordable essential medicines in the developing world" (TAC/ALP release, 10/1). Richard Elliott, director of policy and research for the Canadian HIV/AIDS Legal Network, said that the patent law changes should include medicines for conditions other than HIV/AIDS, adding, "We can't deny affordable medicine to people because their disease or their health condition is not on the approved list of the Canadian government" (Globe and Mail, 10/2).

Joint Statement
A group of 26 U.S., African and European HIV/AIDS advocacy groups on Wednesday released a joint statement in support of Canada's intent to amend drug patent laws, according to a Health GAP release. The statement says that Canada's measure would provide the "first 'test'" of the WTO agreement, adding, "As such, the Canadian government will be setting a precedent and must ensure that the amendment to their Patent Act is broad and flexible and does not incorporate any restrictions that contravene efforts to increase access to medicines for sick and dying people." The statement also says that the Canadian government "must ensure that the amendment is not limited to use in situations of emergency, ... to specific diseases ... [or] to a list of potential importing countries and includes the manufacture and export of diagnostics and vaccines, as well as medicines." The groups call on Canada and other governments "to reject provisions in emerging regional and bilateral trade agreements like the Free Trade Area of the Americas, that would eliminate or limit important public health flexibilities in patent laws, like exporting medicines under a compulsory license." The statement calls on other governments to "follow the example of Canada and immediately adapt their relevant national laws in order to implement this [WTO] agreement in a broad, pro-public health manner" (Health GAP release, 10/1).

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