NEW DELHI, Nov. 15 — The good news for the world's poorest countries is that they emerged from this week's global trade talks in Doha, Qatar, with the right to make low- cost generic knock-offs of medicines patented by multinational pharmaceutical corporations.
The bad news is that many of these nations, home to millions of people afflicted with AIDS and other epidemic diseases, do not have factories capable of producing these medicines. Nor does the deal reached this week explicitly allow them to import such drugs from the handful of developing countries that have thriving generic drug industries, like India and Brazil.
While the declaration accepted this week by the more than 140 countries participating in the talks recognized in principle that the 1994 world treaty on intellectual property should be interpreted "to promote access to medicines for all," it did not give the most disadvantaged nations the tools to do so.
Indeed, the declaration explicitly acknowledged this problem, and called for further negotiations to come up with a solution by the end of next year for countries "with insufficient or no manufacturing capacities in the pharmaceutical sector."
"This is the core of the issue," said Yasuhiro Suzuki, an executive director with the World Health Organization in Geneva.
The question that negotiators grappled with was how to make vital drugs affordable for the poorest people on earth — and it remains incompletely unanswered.
News of the agreement in Doha has only begun to reach the major Indian drug manufacturers, who hope to begin selling their products in countries like Rwanda and Gambia that completely lack a pharmaceutical industry. Wednesday was Diwali, a national holiday in India, and newspapers did not publish today.
But drug makers in India who have seen the two-page declaration called it a step in the right direction that nonetheless falls far short of opening up new markets for them in Africa, Asia and Latin America.
"The benefits of this Doha declaration will be more for domestic sales than for export sales," said Nichal Israni, president of the 450-member Indian Drug Manufacturers Association, based in Bombay.
Under current Indian law, which recognizes patents on ways to make drugs but not the drugs themselves, manufacturers are able to produce and sell medicines here at a tiny fraction of the prices charged in the United States. In some cases, though, the generic makers have been blocked from selling their wares in other developing countries that have Western-style patent laws.
The new declaration means that Indian companies will probably be able to go on making and selling copycat drugs even after 2005, the deadline for India to bring its patent laws into accordance with the 1994 treaty on intellectual property, which recognizes 20-year patents on most inventions, including drugs.
Under the new agreement, countries will have the right to issue what are known as "compulsory licenses," which effectively require a patent-holding company to share its invention with a rival. The agreement gives countries "the freedom to determine the grounds upon which such licenses are granted," particularly for public health crises like AIDS, tuberculosis, malaria and other epidemics.
Bimal Raizada, senior vice president of Ranbaxy Laboratories Ltd., India's largest pharmaceutical company, with $502 million in sales last year, sounded distinctly underwhelmed by the outcome of the Doha talks. He called the agreement "a limited opportunity which will be country-specific."
Like others in India's drug industry, he pointed to the American debate over whether to issue a compulsory license for Cipro, Bayer's treatment for anthrax, as a demonstration that even wealthy Americans sometimes have to worry about a drug's availability and price. Mr. Raizada noted that Bayer's steeply discounted price to the United States of 95 cents a tablet for Cipro was still much higher than the cost of the Indian version — 17 cents a pill.
Mr. Raizada and others predicted today that multinational drug companies would fiercely resist any move to allow generic drug makers like Ranbaxy and Cipla in India to export copycat drugs. "They have to protect these prices and fight for them," Mr. Raizada said.
Mr. Suzuki, the W.H.O. executive director for health technology and pharamaceuticals, who attended the Doha talks this week, said the drug giants saw enticing growth potential in emerging markets like India, Brazil and China, and they did not want generic manufacturers to rob them of the chance for profit.
"If they can't establish markets in these countries, there will be no future potential for expansion," he said.
Trade experts say the big pharmaceutical companies have formidable influence on the issue of drug exports. "Oh, yes, they're powerful," said Veena Jha, the coordinator on trade issues for the United Nations Conference on Trade and Development. "Most of the resistance has come from companies in the United States, Switzerland and some European Union countries."
Even if poor countries prevail and cross-border trade in copycat generic drugs is allowed, though, the market for many such medicines, especially the antiviral "cocktails" for AIDS patients, is likely to be restricted by an obstacle that may be just as daunting as patent-related import restrictions.
Even the rock-bottom prices charged by generic manufacturers like Aurobindo of India are still far out of reach for most people in African nations ravaged by AIDS, said Venkat Kamalakar, Aurobindo's general manager for international operations.
According to Doctors Without Borders, Aurobindo offers some of the world's lowest prices, yet Mr. Kamalakar said they were not low enough to solve the problem of access.
"Where is the money for poor countries to buy these medicines?" he asked. "Who will finance all this?"
Copyright 2001 The New York Times Company