India's Clampdown on Generic Drugs Imperils World's Poor, Say Advocates
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WASHINGTON, D.C., Mar 23 (OneWorld) - Indian lawmakers adopted a new patent law Tuesday that would ban domestic firms from making low-cost generic versions of patented drugs. Health campaigners warned that as a consequence, millions of people around the world would be denied access to cheap life-saving medicines.
The Lok Sabha, parliament's lower house, approved the legislation after the government agreed to demands from leftist allies and made several last-minute amendments to placate concerns that the new law would help multinational companies gain dominance and push up prices in the Indian market. International aid groups, however, said the law would restrict the ability of Indian companies to supply generic drugs to Africa and other poor regions. With respect to AIDS alone, the effect would be to threaten the survival of hundreds of thousands of current patients and millions more who had hoped the medicines would become more widely available, not less. ''The patent law will cut the lifeline to other countries,'' said Ellen 't Hoen, policy advocacy and research director at Doctors Without Borders' campaign for access to essential medicines. The measure was expected to become law later this week after being cleared by the upper house. It stemmed from India's membership of the World Trade Organization (WTO), which enhances the South Asian powerhouse's participation in global commerce but requires the country to tighten patent rules for its $5 billion pharmaceutical industry. It would replace a long standing policy of allowing local firms to make generic versions of Western drugs so long as these involved modified production processes. This approach helped to foster a strong drug manufacturing industry in India for more than three decades and turned the country into a leading supplier of inexpensive pharmaceuticals to the rest of the world. India exports two-thirds of its pharmaceutical output to developing countries, according to the World Health Organization. Generic competition fueled by Indian drugs has been largely responsible for reducing the prices of antiretroviral drugs used to treat AIDS, in some cases by as much as 98 percent. ''We are deeply disturbed and concerned that you are failing to listen to the voices of your people who have entrusted you with their welfare, not to mention the poor in the developing world who rely on affordable medicine from India,'' Hoen of Paris-based Doctors Without Borders and representatives from other aid groups said in a letter to Sonia Gandhi, leader of the governing Congress Party. The new measure empowers the government to override a patent on a medicine if such a large number of people need it and cannot afford it that this constitutes a national emergency. Despite having some 5.1 million people infected with the AIDS-causing HIV virus--the second largest number after South Africa--the disease is not seen as a national emergency and Indian companies will therefore no longer be allowed to copy new inventions in AIDS treatment, said Doctors Without Borders, also known by its French initials MSF. In the case of AIDS, Indian modifications have revolutionized treatment. Western cocktails of up to three separate drugs have been combined into one pill, for example, reducing costs and making it easier for poor people to keep up with treatment under difficult circumstances. Of the 700,000 people receiving antiretroviral treatment in developing countries, half rely on Indian generics. MSF said it treats 25,000 people in 27 countries and roughly 70 percent of these patients use Indian-made drugs. Before generic drugs became widely available in 2001, similar treatments cost more than $10,000 per patient per year--40 times more than the $250 average price of such treatment in MSF programs today. Groups voicing concern about the supply of cheap drugs have run the gamut from international aid agencies like ActionAid and Oxfam and health campaigners like Health GAP (Global Access Project) to regional organizations like Washington-based Africa Action, a group more accustomed to working on U.S. policy toward the continent. Brazil, Canada, China, Singapore, and South Africa are among other countries producing generic drugs. India is the biggest producer, however, and its companies make not only the finished tablet forms of drugs. They also make generic versions of the raw ingredients and chemicals used in the drugs' manufacture. Many of these they actually export to global pharmaceutical companies to produce their brand-name versions. India's new law is supposed to bring it in line with a WTO agreement called TRIPS, for ''trade related aspects of intellectual property rights.'' Since 2003, TRIPS has contained a waiver that allows ''compulsory licenses'' to be issued to override specific patent restrictions. With these, countries that suffer a serious health crisis but are unable to produce drugs at home can import generics from other nations. Some governments have been reluctant to enforce the licenses, however, for fear of jeopardizing the supply of aid and investment from wealthy nations. Major pharmaceutical companies can decide to issue voluntary licenses, bypassing the TRIPS system and making it easier for their drugs to be produced generically. In 2001, 39 major drug companies tried to prosecute the South African government for passing a law which they said violated TRIPS regulations by easing rules for producing and importing generics. Following immense pressure from the South African government, the European Parliament, and an international petition, the global firms backed down. At least one of them, GlaxoSmithKline, subsequently granted a voluntary license to a major South African generics producer. |
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