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What is TRIPs Plus and Data Exclusivity?

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What is TRIPs Plus and Data Exclusivity?
posted Aug 19, 2017 by Deepika Jain

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TRIPs Plus are higher level of protection norms demanded by the developed countries that are not prescribed by the WTO’s TRIPs regime. Although they are named as ‘TRIPS-Plus,’ they are not formally related to TRIPs. Rather, the term is used to indicate that these requirements go beyond the minimum standards imposed by TRIPs. Many developing countries who are members of FTAs are under pressure to enact these tougher conditions in their patent laws.

The developing countries have concerns over the higher level of protection demanded by the developed world. They fear that once such levels of protection are given multilaterally, it will reduce competition and may led to price rise of medicines, affecting health security in poor countries.

An example for advanced norms under TRIPs Plus is the protection demanded by developed countries for data exclusivity.

What is Data Exclusivity?

Data exclusivity is the protection of clinical test data submitted to a regulatory agency to prove safety, quality and efficacy of a new drug, and preventing the generic drug manufacturers from relying on this data in their own applications. Such a data exclusivity will stop generic drug manufactures of developing countries from using these data while applying for licenses. The demand for protecting exclusive data that have high commercial value is a major demand from the developed world which doesn’t usually come under TRIPs.

answer Aug 21, 2017 by Sunita