At trade talks, generic-drug issue key

One unexpected beneficiary of the US-led war on terrorism may be the millions of Africans, Indians, and others from impoverished countries besieged by the AIDS epidemic. For years, developing nations have fought with little success for the right to produce generic versions of costly, patented medications developed in the US and Europe.

But a group of more than 60 developing nations may have new leverage, heading into negotiations this weekend with the 142-member World Trade Organization, which requires consensus among members. The five-day meeting, which opens tonight in Doha, Qatar, aims to finalize an agenda for a formal round of negotiations to lower global trade barriers.

Developing nations want a guarantee that an agreement known as Trade Related Aspects of Intellectual Property Rights (TRIPS) will allow them to import generic medicines for AIDS and other epidemics.

"The issue of TRIPS and public health - this could well be the deal breaker at this conference," said Mike Moore, director general of the Geneva-based WTO. "It is an important issue, and it is, I think, turning into one of the most difficult subjects we have in front of us."

Pharmaceutical giants, which spend billions of dollars developing medications, say loosening patents threatens their ability to cover their expenses.

The staunchest hold-out against easing patents has been the US. But AIDS groups here in South Africa note the paradox of US actions. As soon as it had an anthrax scare on its own soil, the US threatened to violate the patent of Cipro, an antibiotic used to treat the disease, to make it more widely available.

"It's a very timely example of the double standard that exists," says Seco Gerard, the EU liaison on medical-access issues for the agency Medicines Sans Frontiers, which is on the front line of this battle.

Accused of hypocrisy by AIDS groups and developing nations, the US is now backing off on its hard-line stance on drug patents, offering new hope for AIDS-ravaged countries such as South Africa.

Developing nations won a major victory earlier this year when a coalition of global pharmaceutical companies dropped their lawsuit challenging a South African law that allowed the production and importation of generic versions of patented AIDS drugs, and the parallel importation of drugs sold more cheaply in other countries. Now they want that principle enshrined in law.

The TRIPS agreement currently protects the patents of drug companies. Developing nations want a loophole allowing them to import generic drugs in the case of major health epidemics such as AIDS, tuberculosis, and malaria.

"We want to tighten the interpretation so that it's clear that issues of national interest come first," says Edwin Smith, a spokesman for the South African Minister of Trade and Industry and a member of that country's delegation this weekend.

"The general concern of developing governments is that the TRIPS agreement was imbalanced, and that it favored multinational interests - that it was structured in favor of the protection of patents against the need for cheaper and more affordable medicines for the poor," says Faizel Ismail, a member of South African delegation to the meeting. "Of course, developing countries are interested in protecting international property rights. They just want to create a balance."

In the wake of the anthrax scare, the US has signaled it may be willing to compromise. In a speech last week, US Trade Representative Robert Zoellick said the US would support offering least-developed nations an additional 10 years to come in line with TRIPS, instead of broadening the loophole language. Right now, they are expected to comply with TRIPS by 2006.

Mr. Zoellick also said the US would propose a five-year moratorium on WTO challenges against sub-Saharan African nations violating TRIPS as part of their battle against AIDS.

But Ms. Gerard of Medicines Sans Frontiers says that is just a Band-aid approach. She also says that provisions for the 10-year extension are already in the TRIPS agreement, and that by targeting only least-developed nations, it would fail to help middle-income countries such as South Africa that have better medical infrastructures and therefore the best chance of addressing AIDS.

"Even if you give countries another 10 years, you still haven't had a substantive change in law. If you look at South Africa, it's clear that there are companies ready to contest these laws," she says. "What happens after 10 years?"

Mr. Ismail and others who will be lobbying in favor of a more flexible interpretation of TRIPS say the Cipro case in the US has made clear to the world that the health of citizens should come before patent laws.

"Clearly, what it demonstrates is that, in the case where there are concerns about public health and the lives of people, we will have to ensure that actions by governments are taken which will give a way to any overriding rights of protection that multinationals and protectors of patents have," he says. "That's basically the point we've been making in the developing world. In that sense, our argument is strengthened."

Other contentious issues on the table include agriculture-export subsidies, implementation of previous commitments made by WTO members, environmental provisions, labor rights, competition policy, and investment regulations.

For his part, Ismail says South Africa will not use America's tragedy as a bargaining chip during this weekend's negotiations. "We're fighting this on merit," he says. "It's about the need to protect and defend the right of ordinary people to get access to the medicines necessary to protect their lives. We're not interested in using the tragedies of other nations as a point of leverage."

Material from wire services was used in this report.