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