E-DRUG: NEJM: Patents versus Patients? Antiretroviral Therapy in India
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[Unfortunately this article has no abstract and the complete article is too long for posting on e-drug. Extracts are provided below. The complete article can be accessed at the following URL.
http://content.nejm.org/cgi/content/extract/353/8/749
If you cannot access the web a copy can be sent directly to you. BS]
New England Journal of Medicine August 25, 2005 Number 8
Patents versus Patients? Antiretroviral Therapy in India
Diane V. Havlir, M.D., and Scott M. Hammer, M.D.
Legislation passed by the government of India rarely draws international attention, let alone global outrage. But in December 2004, to comply with the requirement of the World Trade Organization (which India had joined in 1995) that its member countries adhere to trade-related aspects of intellectual property rights (TRIPs), the president of India issued a patent-amendment ordinance requiring 20-year patents on all new medications. The ordinance went into effect January 1, 2005. Objections were voiced around the world by advocacy groups for patients with human immunodeficiency virus (HIV) infection, who characterized the proposed law as pitting patents against patients. As a result, in March 2005, the Indian Parliament passed a more lenient bill - but one that could still pose major obstacles for access to, and the development of, new generic drugs and that could stimulate lengthy litigation and increase the costs of new drugs substantially, thus threatening recent progress.
Over the past three years, a revolution in commitment, new funding, and price reductions for antiretroviral therapy has permitted expanded HIV-treatment programs to take root in many countries. The U.S. President's Emergency Plan for AIDS Relief (PEPFAR); the Global Fund to Fight AIDS, Tuberculosis and Malaria; the World Health Organization's 3 by 5 Initiative; the Elizabeth Glaser Pediatric AIDS Foundation; and Médecins sans Frontières, among others, have paved the way for large-scale access. The unmistakable benefits of the efforts of these groups have included a reduction in suffering and death, a substantial decrease in the transmission of HIV to infants, and improved medical care in resource-limited settings.
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The risks posed by the TRIPs legislation to HIV-infected persons in resource-limited countries cannot be ignored, but there are solutions to this apparent conundrum. The simple fact is that we need to have it both ways. We need to encourage quality-controlled manufacturing of generic versions of current and future antiretroviral agents, since this has proved to be the most efficient way to provide large-scale treatment at hugely discounted prices. At the same time, we need to provide incentives for major pharmaceutical companies to continue to develop antiretroviral drugs for the long-term benefit of HIV-infected people globally. Protection of intellectual-property rights and tiered pricing arrangements are key elements in maintaining this commitment.
Source Information
Dr. Havlir is a professor of medicine at the University of California, San Francisco, and chief of the HIV-AIDS Division at San Francisco General Hospital, San Francisco. Dr. Hammer is a professor of medicine at Columbia University College of Physicians and Surgeons and chief of the Division of Infectious Diseases at the Columbia University Medical Center, New York-Presbyterian Hospital, New York.
Nathan Ford
MSF, London
"Nathan Ford" <nathan.ford@london.msf.org>