World Trade Organization Agrees on Deal To Allow Developing Countries To Import Generic Drugs
The World Trade Organization on Saturday, after several days of "nonstop" negotiations, unanimously agreed on a deal to allow developing countries to import generic versions of patented medicines from countries that produce the generic drugs, such as India or Brazil, without violating patent rights, the New York Times reports. Public health advocates, who have been asking for such an agreement for years, believe that the extent of health epidemics such as AIDS, tuberculosis and malaria in developing nations outweighs the "commercial considerations" of allowing poorer nations to import generic treatments, the Times reports (Becker, New York Times, 8/31). WTO talks on generic drug access for poor nations had been stalled since Dec. 31, 2002, when members missed a deadline to reach an agreement. In February, U.S. negotiators refused to sign a deal under the Doha declaration to allow developing nations to override patent protections to produce or import generic versions of drugs to combat public health epidemics unless wording was included to specify which diseases constitute a public health epidemic. However, the United States in June made a concession by dropping its demand that the agreement apply only to a specified list of diseases. On Wednesday, the United States, Brazil, India, Kenya and South Africa agreed to a compromise that would leave intact the text discussed in December but add a three-page "chairman's statement," delineating how the patent concessions could be used. The policy agreed to on Saturday allows a country to issue a "compulsory license" to import generic drugs if it confirms that it "has insufficient or no manufacturing capacities in the pharmaceutical sector for the product(s) in question." The statement says that the system "should be used in the good faith to protect public health and ... not be an instrument to pursue industrial or commercial policy objectives." In addition, the chairman's statement says that "all reasonable measures," such as the use of special packaging and different drug coloring, should be made to prevent the reimportation of generic drugs into wealthy countries (Kaiser Daily HIV/AIDS Report, 8/29).
Final approval of the policy stalled last week when several countries asked to make statements before the WTO General Council. Such statements can be used to express reservations or to announce limits that countries will place on their adherence to an accord, the AP/Philadelphia Inquirer reports (Koppel, AP/Philadelphia Inquirer, 8/30). Some countries said that the deal would create new complications in generic drug access, such as requiring developing countries to justify their drug programs to the WTO and potentially giving Western countries veto power, according to the Washington Post. In addition, some negotiators expressed concern about language in the statement that countries would not use the program as an "instrument to pursue industrial or commercial policy objectives," saying it could be broadly interpreted to prevent middle-income countries from obtaining generic drugs (Gillis/Barbaro, Washington Post, 8/30). Representatives of some developing countries said that the packaging and pill coloring requirements could increase the price of the drugs or could make it more difficult to obtain them (AP/Philadelphia Inquirer, 8/30). Several trade representatives said that the United States "exert[ed] heavy pressure behind the scenes" to gain approval of the compromise, the New York Times reports (Becker, New York Times, 8/30). The final agreement came after several African representatives noted in a joint statement that nearly 2.2 million Africans have died from AIDS-related causes and other diseases since progress on the issue stalled in December (New York Daily News, 8/31).
"This is a historic agreement for the WTO," WTO Director-General Supachai Panitchpakdi said, adding, "The final piece of the jigsaw has fallen into place, allowing poorer countries to make full use of the flexibilities in the WTO's intellectual property rules in order to deal with the diseases that ravage their people" (Washington Post, 8/31). "All people of good will and good conscience will be very happy today with the decision that the WTO members have made," Kenyan Ambassador Amina Chawahir Mohamed said, adding, "It's especially good news for the people of Africa who desperately need access to affordable medicine" (New York Daily News, 8/31). Several advocacy groups said that the chairman's statement "essentially doom[s] the accord" by placing too many restrictions and imposing too much bureaucracy on the drug importation program, according to the New York Times. "Today's deal was designed to offer comfort to the U.S. and the Western pharmaceutical industry," Ellen 't Hoen of Doctors Without Borders said, adding, "Unfortunately it offers little comfort for poor patients. Global patent rules will continue to drive up the price of medicines" (New York Times, 8/31). World Health Organization Director-General Dr. Jong-Wook Lee on Monday at the start of the WHO's Africa regional meeting welcomed the agreement but warned that it will fail unless countries are able to improve the infrastructure of their health care systems, Reuters reports. "I want to be optimistic ... it is a good, positive development. There are many conditions attached to it, but we can solve them one by one," Lee said (Harding, Reuters, 9/1). Pascal Lamy, trade commissioner for the European Union, also highlighted the need for improved health care infrastructure, saying that the deal has "solved about 10% of the problem of access to medicines by developing countries" (Miller, Wall Street Journal, 9/2). According to a statement from the Pharmaceutical Research and Manufacturers of America, a drug industry trade group, "[N]ow that this issue has been resolved, governments and the public health community can concentrate on the immense practical problems of delivering needed medicines to patients in the world's poorest countries" (New York Times, 8/31).