Heeding urgent appeals from African countries hit hard by AIDS, the World Trade Organization in Geneva agreed Saturday to allow poor countries to import cheap generic copies of patented drugs. Member nations had approved the idea in principle Thursday night but kept haggling over an accompanying statement meant to address some pharmaceutical companies' concerns that their patents would be exploited. The deal creates a loophole in WTO law that allows poorer developing countries to override patents on expensive drugs and either make or order cheaper copies from generic manufacturers. Patent holders would receive a small payment. Until now, governments could only override patents as long as they ordered the drugs from domestic producers. But most of the countries that urgently need the drugs have no domestic pharmaceutical industry.
The deal calls for measures to prevent generic drugs being smuggled back into rich-country markets, including special packaging or differently colored tablets. Developed countries would agree not to use the provision, and wealthier developing countries would use the measure only in "situations of national emergency or other circumstances of extreme emergency."
WTO delegates and some AIDS advocates praised the decision. World Health Organization director-general Jong-Wook Lee called the move "a good step forward. Based on this, we can work further, so every person who needs medicines can have access to them at an affordable price." South African ambassador to the WTO Faizel Ismail, one of the deal's negotiators, said his country plans to start using the law to import needed drugs and also pressure patent holders to reduce their drug prices for poor nations.
But many U.S. AIDS activists say the agreement is too cumbersome, carries too many protections for the pharmaceutical industry, and will still prevent most developing nations from gaining access to the medications by forcing poor countries to go through a lengthy application process for waivers on each drug. Tim Kingston, communications associate for the San Francisco-based Global Exchange, told Advocate.com that WTO delegates from the United States, Canada, the European Union, or Switzerland can challenge a patent waiver application. He also said generic firms making or selling cheap versions of patented medicines will not be allowed to make any profit on their sale, while the patented versions can still be sold with considerable profit margins.
"In the time it would take a generic company to comply with all the conditions set out by the U.S., a patent would likely expire anyway," said Asia Russell of Health Global Access Project in a press release. "The Bush administration lied when it promised to let countries prioritize public health and access to medicines for all at the Doha Ministerial two years ago. The current solution is designed to placate U.S. drug companies and guarantee ever-expanding market share, not to increase access to affordable generic medicines for people dying of treatable diseases."