World Trade Organization Envoys Near Compromise on Generic Drug AccessWorld Trade Organization negotiators have said that they hope this week to reach an agreement on access to generic drugs in developing countries, the Financial Times reports (De Jonquieres et al., Financial Times, 8/26). WTO talks over generic drug access have been stalled since members missed a Dec. 31, 2002, deadline to reach an agreement. U.S. negotiators in February refused to sign a deal under the Doha declaration to allow developing nations to override patent protections to produce or import generic versions of drugs to combat public health epidemics, including HIV/AIDS, unless wording was included to specify which diseases constitute a public health epidemic. However, the United States in June made a concession by dropping its demand that the agreement apply only to a specified list of diseases. Carlos Perez del Castillo, ambassador from Uruguay and chair of the WTO General Council, on Sunday distributed copies of a proposed compromise on the overall Doha declaration to be considered at the WTO meeting in Cancun, Mexico. However, the proposed compromise offered no agreement on access to generic drugs (Kaiser Daily HIV/AIDS Report, 8/25).
Negotiators are currently considering a draft of a "chairman's statement" that would accompany the Doha agreement and would outline specifics on how the drug access program would work (Koppel, Associated Press, 8/27). Under the proposed compromise, countries would agree to use patent waivers only "in good faith to protect public health" and not as "an instrument to pursue industrial or commercial policy objectives." Trade officials hope that the concession will satisfy concerns raised by U.S. pharmaceutical companies that countries might use the concessions to produce generic versions of patented drugs, like Viagra, that are not aimed at a public health epidemic, the Wall Street Journal reports. The draft also calls for special measures -- such as special packaging or specially colored tablets -- to prevent the reimportation of generic drugs into wealthy countries. In addition, developed countries would not be permitted to override patents, and the richest developing nations -- Taiwan, Hong Kong, South Korea, Israel and Mexico -- would only be allowed to use the measure in "situations of national emergency," according to the Journal (Newman, Wall Street Journal, 8/27).
Trade envoys hope to reach a compromise on the drug access issue -- which some say is crucial to restoring faith in the WTO -- ahead of next month's meeting in Cancun, the AP/San Francisco Chronicle reports (AP/San Francisco Chronicle, 8/26). A U.S. senior official, who spoke on the condition of anonymity, earlier this week said that the U.S. delegation was reviewing the proposed agreement but that it was "not entirely satisfied with it" (Associated Press, 8/26). However, Richard Mills, spokesperson for the U.S. Trade Representative's Office said, "We've made some progress and we hope we are moving closer to a resolution" (Wall Street Journal, 8/27). Vanu Gopala Menon, Singapore's WTO ambassador, yesterday said that he hopes to reach a compromise today so that the statement could be endorsed by the general council before the end of its session this week (Financial Times, 8/26). Advocacy groups have said that they would be unhappy if the draft version of the statement gets passed. "The proposed deal poses so many hurdles and hoops to jump through that we are really worried it may not work at all," Ellen 't Hoen, a spokesperson for Doctors Without Borders, said, adding, "By continually demanding more restrictions, the United States seems to be pushing for a watertight system so that no generic drugs ever get through to the patients in developing countries who desperately need them" (AP/San Francisco Chronicle, 8/26). "We shouldn't make it so difficult for countries with no production facilities" to obtain generic drugs, Nelson Ndirangu, the Kenyan negotiator, said (Wall Street Journal, 8/27).
Nigerian Treatment Program
Nigerian doctors said yesterday that the resolution of the drug access issue is "critical" for Nigeria's antiretroviral drug treatment program, Agence France-Presse reports (Clark, Agence France-Presse, 8/27). The program involves the distribution of generic antiretroviral drugs from India to 10,000 Nigerian HIV/AIDS patients through 25 drug units across the country. The drugs are obtained for about $90 per person and provided to patients for $10 annually; however, patients also have to cover additional costs of approximately $50 for tests performed three to four times annually (Kaiser Daily HIV/AIDS Report, 8/8). However, the pilot program has "failed to make a broad impact," reviving the debate about generic drug access in the country, according to Agence France-Presse. "Africa should have followed the example of Brazil and insisted on a clause exempting itself from trade laws in the case of 'dire medical emergency' before signing up to the WTO," Dr. Remi Kalejaiye, an AIDS specialist at Lagos' military hospital, said. Even with increased access to low-cost medications, the country would need to overhaul its health care infrastructure in order to take advantage of the concession, according to Agence France-Presse (Agence France-Presse, 8/27).