India to stop producing generic antiretrovirals

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News of the impending revocation an amendment to India ’s Patent Law of 1970 that allows that country’s production of most of the world’s generic antiretrovirals is cause for concern for the worldwide HIV/AIDS community.

While India is not alone in the production of these drugs, they do produce the bulk of the generics available in the world market. A decrease in production would mean a substantial increase in the cost of these medications, some as much as 98 percent.

Paul Zeitz, M.D., of the Global AIDS Alliance, points to the admission of India to the World Trade Organization (WTO) as the cause for the change and specifically to trade-related aspects of intellectual property rights (TRIPS.)

“India has to come into compliance with TRIPS in order to maintain their standing with the WTO,” asserts Zeitz.

India has been a WTO member since 1994. While some view the impending production halt of generic antiretrovirals as being India ’s choice, others feel that the government of the sub-continent is surrendering to economic pressures from other WTO members.

Dr. Zeitz and his wife, Mindy, have served in Africa battling AIDS there. Their five sons include one son, Cletus, who they adopted while in Africa .

“There will be little or no effect in the U.S. ,” states Zeitz. “The impact will be much greater abroad.”
William Schaffner, M.D., Professor and Chair of Preventive Medicine for Vanderbilt University Medical Center , concurs with Zeitz, saying, “ Africa will undoubtedly feel the greatest effect. All the inroads we have made as to diagnosis and treatment in that part of the world will be for naught if we lose the ability to effectively treat patients there due to skyrocketing medication costs.”

Dr. Schaffner also says that there may be a time in the future when the lack of control of HIV/AIDS in Africa could affect western countries. His point that we are a mobile world is well taken.

Mark Hubbard, local HIV/AIDS activist, agrees.

“This will have little or no impact on the price of treatment in the U.S. Only one antiviral will go generic in the US anytime soon. That drug is AZT, now marketed as Retrovir, which is expected in the next year. Its price will be determined by our market,” says Hubbard.

Hubbard is quick to note that past actions on the part of activists prevented enforcement of patent infringements in certain environments. Should this situation result in similar circumstances, activists could once again play a lead role in keep these medications accessible.