Although Brazil's aggressive efforts to provide AIDS drugs to those in need did not immediately raise eyebrows internationally, they would eventually land the country in an international patent dispute. Brazil's pioneering efforts helped spark a debate over how drug companies could be given incentives to innovate, while allowing poor countries access to desperately needed drugs.

Patents on AIDS drugs had expired or were not in effect when, in 1994, a Brazilian public lab began producing medicine to combat the disease. Even after a 1996 law was passed that recognized pharmaceutical patents, the country was able to continue manufacturing many key AIDS drugs because of a loophole in that legislation.

Before that law went into effect on May 15, 1997, drugs sold anywhere commercially before were not covered under the legislation, and thus did not have Brazilian patent protection. This meant that many antiretroviral drugs, including AZT, were not patent-protected in Brazil.

In the late 1990s, Brazil gained international attention when it threatened to produce generic versions of two AIDS drugs, Merck's form of efavirenz, Stocrin, and Roche's nelfinavir. In the end, Brazil negotiated 40 to 65 percent discounts in the prices of those drugs and continued to import them.

In early 2001, in response to Brazil's actions, the U.S. filed a complaint with the World Trade Organization saying Brazil had violated the 1994 Agreement on Trade-Related Aspects of Intellectual Property Rights, known as TRIPS. This move spurred the WTO to re-examine the agreement, which protects intellectual property rights, including pharmaceutical patents. The U.S. withdrew the complaint in June 2001, with U.S. Trade Representative Robert Zoellick saying that he would "hash out the dispute directly with Brazil."

The U.S. came under harsh criticism for challenging Brazil. In April 2001, all members of the U.N. Human Rights Commission -- except the U.S. -- voted to approve a Brazilian resolution asking nations not to "deny or limit equal access for all persons to preventive, curative or palliative pharmaceutical or medical technologies used to treat pandemics such as HIV/AIDS."

Less than a year after the U.S. filed its complaint, the WTO sought to clarify the TRIPS provision permitting nations to copy patented material -- such as medicine in the event of "a national emergency or other circumstances of extreme urgency" -- during their general council meeting in November 2001.

"Each [WTO] member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency," the decision read.

When the deal was announced, U.S. drug firms shrugged it off, saying it did not substantively change the original TRIPS agreement. Brazil's negotiating team, however, countered that the declaration's wording would give them more flexibility to produce drugs.

"This is the culmination of a long process...which Brazil mobilized and vindicated in the name of all developing countries," Paulo Teixeira, the director of Brazil's AIDS program, told Reuters when the agreement was adopted.

While the negotiators settled on wording for the agreement section referring to domestic production of patented medicine, they tabled the question of how to get patent-protected medicine to the citizens of countries too poor to manufacture their own pharmaceuticals. The final agreement asked the group to "find an expeditious solution to this problem" by the end of 2002.

WTO talks in December 2002 aimed at resolving the issue broke down without an agreement over whether to allow poor nations to import cheap, generic drugs that they are not equipped to produce. Washington blocked a proposal the other 143 member countries participating in the negations backed out of concern it would allow poor nations to import cheap versions of drugs for non-infectious diseases such as cancer instead of simply helping them respond to AIDS and other epidemics.

"There is no way to sugar coat this bitter pill," Sergio Marchi, the Canadian ambassador who chairing the TRIPS council, said. "We are disappointed…143 countries stood on the same ground, we were hoping to make that unanimous."

After the talks ended, the Office of the U.S. Trade Representative issued a statement saying the U.S. could not support the resolution, because some countries in the negotiations had attempted to "expand the targeted 'poor country epidemic' focus of [the 2001 negotiations] to allow much wealthier countries to override a wide range of drug patents, for example, Viagra."

This, the U.S. argued, would "seriously undermine the WTO rules on patents that provide incentives for development of new pharmaceutical products, including those to treat diseases of a non-epidemic nature."

Critics of the U.S. position countered that Washington should not be allowed to define other countries' public health priorities.

"We're saying it is not the business of the WTO or trade representatives to identify what countries' public health priorities ought to be," Rachel Cohen, a spokeswoman for Doctors Without Borders, told the Hackensack, New Jersey newspaper The Record.

As the talks ended, Washington said it would not bring complaints against WTO members, such as Brazil and India, that export drugs for epidemics to developing countries.

In response to the stalemate, WTO chief Supachai Panitchpakdi expressed disappointment over the group's failure to resolve the issue, but said he was "hopeful a solution can be found in the early part of 2003.” As of June 2003, however, no agreement had been reached.

Meanwhile, Brazil has offered to help other countries meet the needs of their HIV-positive citizens, although Brazil's health minister told the NewsHour in May 2003 that his country produces antiretroviral drugs for its own citizens and does not intend to sell them to other nations.

Instead, the country is offering to share its expertise in manufacturing and distributing AIDS drugs with developing countries. Brazil is already creating pilot programs to train health professionals from ten other Latin American and African nations to administer and monitor antiretroviral drug treatments.

As part of these programs, Brazil is providing AIDS drugs for 100 patients in each of these ten countries. Rosemaire Munhoz, a Brazilian official overseeing this effort, told the NewsHour that the donations will give health workers in these ten countries experience in monitoring drug treatments and allow their governments to see the dramatic results the medicine can have for patients.

-- By Karyn Schwartz, Online NewsHour