U.S. Trade Officials Seek to Strengthen Patent Protection for Brand Name Drugs, Including HIV/AIDS Treatments, Wall Street Journal Reports

U.S. trade officials are negotiating a series of agreements to strengthen patent protection of brand name drugs, including antiretroviral drugs, the Wall Street Journal reports. In many countries, including the United States, generic drug makers often win approval for their drugs by proving that the products are equivalent to the brand name drug. However, new agreements sought by the United States would prevent countries trading with the United States from approving for five years generic drug applications if data submitted by the generic companies is based on data originally compiled by the brand name manufacturer. The agreements would in effect grant "temporary exclusivity" to brand name drug makers, the Journal reports. U.S. negotiators have reached agreements that include the new provisions with Jordan, Chile and Singapore. Agreements awaiting congressional approval with Australia, Morocco and the six Central American countries -- Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua and the Dominican Republic -- that are part of the Central American Free Trade Agreement also include the provisions. In addition, U.S. negotiators late last month launched trade talks with Thailand seeking similar patent protections, the Journal reports.

Effects
Although there is a "wide consensus by the United States and others that essential drugs must be made available at a low cost," the agreements are "either pushing prices up or preventing their fall," Richard Feachem, executive director of the Global Fund to Fight AIDS, Tuberculosis and Malaria, said. For example, AIDS drugs purchased with Global Fund money in Jordan, which recently signed the trade agreement, cost about $7,000 per person per year, compared with an average price of $250 to $400 per patient per year in other countries that receive fund grants, Feachem said. However, a spokesperson for the U.S. Trade Representative's Office said that the United States has seen a "blossoming of [Jordan's] pharmaceutical industry" since the agreement. In Thailand, where the government provides treatment to 35,000 people annually with domestically manufactured generic antiretrovirals, the proposed agreement would prevent companies from producing generic copies of more recent brand name drugs, the Journal reports. In response, the drug industry has argued that current practices in many countries "simply make it too easy" for generic drug makers to quickly introduce cheap copies of branded products, thus profiting from costly investments in research made by brand name drug makers. The industry also notes that many brand name drug makers provide low- or no-cost drugs for AIDS and other life-threatening diseases to developing countries, according to the Journal. The generic drug issue is expected to be "high on agenda" of the XV International AIDS Conference that will be held in Bangkok, Thailand, July 11-16, according to the Journal (Chase/Lueck, Wall Street Journal, 7/6).

Back to other news for July 6, 2004