U.S. Efforts To Shape Drug Patent Laws in Developing Countries, Worldwide ‘Go Beyond Global Standards’
The United States is helping some developing countries rework their drug patent laws in ways that "go beyond global standards" in protecting pharmaceutical companies and that could "undercut" President Bush's five-year, $15 billion AIDS initiative by making antiretroviral drugs more expensive and more difficult to obtain, the Wall Street Journal reports. Bush, who is in Africa this week to promote economic development and the AIDS initiative, is trying to strike a "difficult balance" between African nations that desperately need U.S. assistance and large drug makers that "play a major role" in the U.S. economy and that make major contributions to the Republican party, according to the Journal. "[T]here are many ways that the Bush administration has contravened the letter and spirit" of international efforts to improve access to drugs in developing countries, Asia Russell, international policy coordinator at the Health GAP, said. However, Richard Mills, spokesperson for the U.S. trade representative, said that the United States is taking actions to ensure that developing nations can use special rules allowing them to access generic drugs to treat major epidemics, such as HIV/AIDS, malaria and tuberculosis.
However, U.S. officials working on a project in Nigeria to help the country craft "strict" intellectual property laws have created "controversy," according to the Journal. The U.S. Agency for International Development in 2000 started funding a $1.2 million project administered by the Commerce Department aimed at helping the Nigerian government to strengthen its oversight of publicly financed projects and to rework its regulatory systems, including its patent laws. The United States said that the effort would assist the country in meeting new international intellectual property standards and would help to curb the sale of counterfeit goods. As part of the program, the Commerce Department in 2002 subsidized travel expenses for 100 Nigerian government officials and trade-group representatives to attend two patent-law writing conferences. The Department failed to extend a similar invitation to nongovernmental public-health representatives but allowed the representatives to attend after protests. Olayide Akanni, a representative of the Treatment Action Group, presented an analysis of Nigerian draft patent legislation that found that the measure's protections exceeded those required by the World Trade Organization. The measure would require a complex court process to override international patent laws to license low-cost, generic versions of drugs to treat public health epidemics instead of the simpler governmental administrative process required under WTO rules. In addition, the legislation would impose a four-year waiting period for the issuing of generic licenses not included in WTO rules. Finally, the bill would prohibit nongovernmental health organizations from applying for generic licenses and would impose criminal sanctions on violators; the WTO requires civil sanctions.
Conflict of Interest?
Nnamdi Ezera, the commercial development program manager for the Commerce Department, said that the department "did not influence the process," adding that Nigerian officials and patent lawyers drafted the legislation. AIDS advocates disagreed, questioning whether the United States can provide neutral assistance in light of the large stake that U.S. companies have in the outcome of patent talks, according to the Journal. These suspicions have been heightened by the U.S. stance in stalled WTO talks over enabling developing nations to import or produce generic drugs to combat public health crises (Schroeder, Wall Street Journal, 7/9). 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. The countries hope to reach a compromise before the September WTO ministerial meeting in Cancun, Mexico (Kaiser Daily HIV/AIDS Report, 7/2).