TRIPS, Doha and generic antiretroviral drugs in India

India, historically, has supplied a significant amount of the generic antiretroviral drugs available to treat HIV/AIDS in developing nations.  The TRIPS agreement and TRIPS-plus, however, threaten this affordable supply of life-sustaining drugs.

An interesting commentary in The Lancet (March 18, 2011) from Anand Grover and Brian Citro of the Lawyers Collective HIV/AIDS Unit in Mumbai suggests that if health is a universal right, then TRIPS is actually getting in the way of achieving that mission by preventing Indian drug manufacturers from producing generic antiretroviral drugs. The authors say that approximately 89% of the antiretroviral drugs in developing countries are generic versions that come from Indian manufacturers, purchased by donor funds.

Until recently, patent protection did not exist in India, which allowed the country to produce generic drugs at very low prices until 2005. While TRIPS requires the recognition of post-2005 patent rights, the Doha Declaration affords countries some “flexibility” in their interpretation of the TRIPS agreement. This seems to allow for some interpretation of TRIPS as it might pertain to public health and be particularly important for developing countries.

First, Doha allows countries to issue compulsory licenses, or licenses to produce products protected by patent law without permission from the company or person who has ownership of that patent.

Second, it allows countries to determine when public health is threatened and declare an emergency in order to address the issue. This flexibility would allow India to continue to combat HIV/AIDS through the production of generic drugs. It is interesting that the “emergencies” listed as examples in the Doha Declaration are long-term health issues, like HIV/AIDS, which could not really be capped with a time limit.

Finally, the Doha Declaration allows for patent exhaustion, which means the patent owner loses protection after the first use or sale of its product.

While it seems like these three provisions would help India, the article correctly suggests that there are other international agreements that might interfere with the use of these flexibilities. One such agreement is TRIPS-plus, which takes the TRIPS agreement to another level. TRIPS-plus reinforces the patent period in which the patent owner has exclusive rights and forces companies to prove scientifically that their generic drug is as safe as the patent equivalent through clinical trials. It also allows patent holders to keep their data confidential for a period of time.

While the Doha Declaration tried to even the playing field by introducing flexibilities, both TRIPS and TRIPS-plus are stifling competition. This leads to a reduction in the supply of generic, affordable, live-prolonging medications in developing nations, as well as a significants loss of jobs and revenue in India.



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