Numerous civic society groups are concerned about the impact of implementation strategy of Trade-Related aspects of Intellectual Property rights (TRIPS) in India. A petition is being presented to the PM of India to analyze these concerns.

The petition is also presented below. To sign the petition, readers may click here.

Dear Prime Minister,
The global HIV/AIDS Community is thankful to India for the health and hope that the Indian generic pharmaceutical industry gives to those people living with HIV/AIDS around the world. We would like to express our concern that some law and policy changes in India may have adverse effects on the global availability of affordable quality essential HIV/AIDS medicines and new inventions such as women-controlled prevention methods (microbicides).

Through this letter, we would like to communicate our concern particularly about the amendments in the Indian Drugs and Cosmetic Act. The implementation of data exclusivity provisions as an amendment to the Drug and Cosmetic Act would seriously affect India's ability to provide drugs to millions of people around the world living with diseases such as HIV/AIDS, hypertension, diabetes, asthma, and many more.

There are actions that can be taken that will allow for maximum availability of generic drugs while being TRIPS compliant. Without Indian generic drugs, millions of people in developing countries will die as a result of lack of access to affordable medicines.

Data exclusivity provisions, if added to the Drugs and Cosmetic Act, will prevent generic companies from using data on existing drugs to gain regulatory approval for generic versions. Generic companies would be forced to repeat time-consuming and expensive studies to receive regulatory approval. Essential medications would be prohibitively expensive without the competition from generic companies and generic drugs would take years to bring to market under data exclusivity laws. Repeating clinical trials would force drug companies to perform unethical studies that withhold medicines known to be effective from the control group. The people of India and the developing world would be denied access to the newest treatments available to those who can afford brand name drugs.

Current Trade-Related aspects of Intellectual Property rights (TRIPs) regulations do not include data exclusivity clauses. India is not obligated to impose data exclusivity laws. Article 39.3 simply requires that members protect "undisclosed test or other data against unfair commercial use." The World Health Organization's Commission on Intellectual Property Rights, Innovation, and Public Health recently reinforced the view that TRIPS does not require data exclusivity:

"Article 39.3, unlike the case of patents, does not require the provision of specific forms of rights. It does not create property rights, nor a right to prevent others from relying on the data for marketing approval of the same product by a third party or from using the data except when unfair (dishonest) commercial practices are involved."

All WTO members also agreed in the Doha Declaration of 2001, "that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all." As a member of the WTO, India has an obligation to protect the rights of the citizens of the world in the face of the HIV/AIDS pandemic.

On behalf of the millions of people around the world currently taking generic drugs made in India, we sincerely thank you. And we urge you to keep these life-saving medicines available and affordable to all those in need for the future by not adopting a new amendment that includes data exclusivity provisions in the Drugs and Cosmetic Act.

We would welcome an opportunity to meet with you in person to share our concerns and suggestions.