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PM urged not to introduce data exclusivity

Special Correspondent

Repealing clinical trials will force drug companies to perform unethical studies

NEW DELHI: The Washington-based non-profit agency, Global AIDS Alliance, has urged Prime Minister Manmohan Singh to ensure that amendments are not made to the Indian Drugs and Cosmetics Act to introduce data exclusivity provisions as this will seriously affect India's ability to provide generic drugs to millions of people in developing countries.

In a letter sent to Dr. Singh, the Alliance has expressed concern that such amendments will have adverse effects on the global availability of affordable essential medicines meant to treat HIV/AIDS, hypertension, diabetes, asthma and many other diseases. "Without Indian generic drugs, millions of people in developing countries will die as a result of lack of access to affordable medicines,'' it says.

The broad based alliance, which has Bishop Desmond Tutu on its board of directors, argues that 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. It maintains that generic companies will be forced to repeat time-consuming and expensive studies to receive regulatory approval.

Essential medications will be prohibitively expensive without the competition from generic companies and generic drugs will take years to bring to market under data exclusivity laws, it has stressed.

The Alliance has stated in the letter that repeating clinical trials will 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 will be denied access to the newest treatments available to those who can afford brand name drugs,'' it has said.

In addition, it has pointed out that the TRIPS agreement does not require India to implement data exclusivity provisions. Article 39.3 simply requires that members protect "undisclosed test or other data... against unfair commercial use.''

It notes that World Health Organization's Commission on Intellectual Property Rights, Innovation, and Public Health recently reinforced the view that TRIPS does not require data exclusivity.

Underlining the need to avoid amending the Drugs and Cosmetics Act, the alliance says the Commerce Ministry of Commerce has already publicly stated its opposition to the implementation of data exclusivity provisions.

"We hope that the Ministry of Health and Family Welfare and the Ministry of Chemicals and Fertilizers will follow suit and oppose a data exclusivity amendment to the Drug and Cosmetic Act,'' it says.

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