Miami Herald | By JOHN DORSCHNER | November 9, 2003
MIAMI - Access to prescription drugs may be one of the hottest and most contested topics in the free-trade conference coming up in Miami later this month.
A vast array of major U.S. corporations and trade groups - including the National Association of Manufacturers - support or want to strengthen the present draft about protecting drug patents.
They're opposed by a disparate group that includes Brazil, some Latin American pharmaceutical groups, humanitarian groups like Doctors Without Borders and the U.S.-based Generic Pharmaceutical Association.
The Doctors group, winner of the Nobel Peace Prize in 1999, says the present draft agreement for the Free Trade Area of the Americas "will be bad for the health of of people in the Americas," particularly for impoverished HIV/AIDS patients.
Mark Grayson, a spokesman for the U.S. pharmaceutical industry, said the Doctors group and others want to destroy patent rights that manufacturers need to recover their tremendous research costs.
"Basically, they don't want intellectual property," says Grayson, who works for the trade group Pharmaceutical Research and Manufacturers of America. "But intellectual property, whether it's music or drugs or movies, recognizes the rights of the ones who created the property."
The key issue is how fast, and under what circumstances, cheaper generics can be substituted for branded drugs.
One provision in the FTAA draft would allow a manufacturer, regardless of patent rights, to withhold its research data on a drug for at least five years.
"That basically delays market entry of generics," says Tanja Sturm, a Latin American specialist with the World Markets Research Centre, an analysis and research group based in London.
The reason is that the research data is crucial for generics to show that their versions are bio-equivalents of the branded versions in their structure and effects.
"Funny enough, the average person with HIV lives just five years," the length of the proposed data delay, says Luis Villa, a physician in charge of the Doctors program in Guatemala.
"The U.S. is trying to negotiate more protection for Big Pharma," Villa said. "This is life-or-death for 67,000 people here who are HIV-positive."
Many trade groups think such protections are necessary.
The International Intellectual Property Alliance, a coalition of six U.S. trade groups, is asking the FTAA for "the highest levels of protection" to assure the safety of corporate investment.
Worldwide, the debate over drugs has focused on AIDS/HIV cocktails, which are now saving lives in Europe and the United States, but are largely unaffordable in places like Africa, where millions are dying of the disease.
In Latin America, Brazil has led the push for cheap AIDS drugs. "They have quite a big and robust pharmaceutical industry," Strum said, "and that gives them clout." By threatening to ignore patents on AIDS-related drugs, Brazil has been able to negotiate considerably cheaper prices with U.S. manufacturers.
In 2001, the World Trade Organization worked out an intellectual properties agreement at a meeting in Doha, Qatar, that allowed poor countries to ignore pharmaceutical patents in emergency situations and issue generic licenses for drugs, as long as the generics were manufactured and distributed in the country with the emergency.
That caveat was demanded by Big Pharma, which feared that cheap exported generics would find their way back to Europe and North America.
The problem was that many impoverished nations had no pharmaceutical manufacturing capability and therefore weren't helped by Doha.
WTO attempted to resolve their complaints in August at a Geneva meeting, where an agreement was hammered out that allowed, under certain conditions, poor countries without drug-making plants to import cheap generics.
U.S. negotiators hailed the agreement as a success, and so did PhRMA.
However, Doctors Without Borders, speaking for many international groups, said the latest modification "does not provide a workable solution," because its many bureaucratic requirements would stop poor countries and manufacturers from pursuing generics.
For FTAA, Brazil and many Latin American groups, including the Asociacion Latinoamericana de Industrias Farmaceuticas, want the standard of the original Doha agreement to apply.
The Generic Pharmaceutical Association focuses its objections on one item: it wants the five-year data exclusivity removed. For Brazil, the motive is to help its manufacturers - and also support African nations, with which it has long-standing ties.
Other U.S. manufacturing groups, meanwhile, want the Doha provisions changed to strengthen patent rights.
In poor places like Guatemala, the price difference between branded and generics are crucial. A cocktail of AIDS-fighting brand drugs that cost $10,000 a year in 2000 now costs $700 because of generic competition.
Villa says that the generic equivalent is $400, and Doctors Without Borders can get generics from India for $300.
Even with all these savings, in a country where the average worker earns under $100 a month, Villa says, only 1,500 of the 67,000 HIV-positive patients in Guatemala are being treated.
"Our only barrier is money," Villa said.Miami Herald:
