Data Exclusivity

One of the most contentious issues in India today in the struggle for access to affordable medicines is whether India is required to introduce data exclusivity into its laws. Under intense pressure from the US government and the multinational pharmaceutical lobby, the Indian government is preparing to amend its laws to introduce data exclusivity.

Most experts agree that India is not required under the Agreement on Trade Related Aspects of Intellectual Property (TRIPS) to introduce a data exclusivity provision into its laws. The World Health Organization [Click here to download attachments] , the Commission on Intellectual Property Rights [Click here to download attachments], Innovation and Public Health , and other expert bodies recommend that developing countries reject data exclusivity, as data exclusivity would result in a delay of affordable generic medicines from entering the market.

The Lawyers Collective HIV/AIDS Unit, through the Affordable Medicines and Treatment Campaign, has been at the forefront of the struggle against the introduction of data exclusivity in India. Our efforts have included educating the general public about the dangers of data exclusivity, advocating before numerous government officials and parliamentarians, and making various written submissions[Click here to download attachments] to government.

Our Allies in the fight against Data Exclusivity :-

• Proposed Amendment to the Drug and Cosmetics Act,and the issue of Data Exclusivity by Jan Swasthya Abhiyan (JSA) [Click here to download attachments]
• Letter from INP+ to the Prime Minister expressing concerns on Data Exclusivity

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