Dozens of HIV-positive Guatemalans on Wednesday gathered in Guatemala City to protest a new law approved in early March that is meant to facilitate the adoption of the Central American Free Trade Agreement, a regional trade accord, Reuters reports. The law, which Guatemala passed "[u]nder pressure" from the United States, provides greater protection for patented drugs marketed by multinational pharmaceutical companies, including antiretroviral medication, than current protections, according to Reuters (Daniel, Reuters, 3/30). CAFTA would eliminate tariffs and other barriers to trade in goods, agricultural services, investment and the imposition of intellectual property rights on medicines. AIDS advocates worry that the agreement also could place limitations on compulsory licensing, which allows a government to authorize itself or a third party to make a generic version of a patented product, including antiretrovirals, with payment of reasonable compensation to the patent holder. The deal also would require generic drug makers to redo clinical trials to obtain marketing approval and postpone using the trial results for brand-name company drugs for five years, which could create patent-like barriers to market entry of generics, even where no patent exists (Kaiser Daily HIV/AIDS Report, 12/10/03). The new law allows drug companies to protect clinical drug trial data for five to 10 years, which would slow the rate at which generic drugs come to the market, according to Reuters. Guatemala in December 2004 relaxed rules governing the introduction of generics but repealed the law after the United States said that the rules would prevent Congress from passing CAFTA because of opposition from some legislators who are "favorable to pharmaceutical companies," Reuters reports.

Reaction
"It's outrageous to see a government intervening to that level in a decision of Guatemala especially where a law had been passed with overwhelming majority and signed by the president," Stephanie Weinberg, Oxfam America's policy adviser, said. Brian Henry, spokesperson for the pharmaceutical company Bristol-Myers Squibb, said the new rules "protect innovation," adding, "Intellectual property is the fuel of innovation. Having the main protection on your intellectual property and your data exclusivity is important because it gives us the motivation to be innovative." The Bush administration is expected to submit CAFTA to Congress this spring. There are approximately 80,000 HIV-positive Guatemalans, but only 3,600 have access to antiretroviral therapy, according to Reuters (Reuters, 3/30).

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