What is TRIPs Plus? What is Data Exclusivity?

World Trade Organization has emerged as the governing body for international trade since its inception in 1995. One of the important agreement of the WTO is the Trade Related Intellectual Property Rights (TRIPs), which deals about the protection of Intellectual Property Rights (IPRs) across countries.

TRIPs and the minimum standards

TRIPs Agreement stipulates minimum standards in the international rules governing patents, including that on pharmaceuticals or medicines. Member countries have to enact the necessary legal framework by including these minimum regulations. These standards include, amongst others, a minimum patent period of 20 years; provision for product patents; and the protection to pharmaceutical test data from ‘unfair commercial use’.

The developed countries are not happy about the TRIPs provisions. They demand higher protection to intellectual property rights including inventions, internationally. These higher levels of protection norms are named as TRIPs Plus. Since it is the developed countries who owns most of the technologies and patents, they are using various international forums to pressurize higher level of protection for intellectual property. Over the last few decades they are creating Free Trade Agreements to give higher level of protection to IPRs. Often these FTAs are outside the WTO framework and hence they can give higher level of protection to IPRs there.

What is TRIPS Plus?

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.

Data exclusivity and TRIPS Plus

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.

India’s stand on TRIPS Plus

India has consistently objected to put higher level of protection (TRIPs Plus) than provided by the TRIPs. The implication of TRIPs Plus on India is that it will restrict the operation of the countries’ generics drugs manufactures. Similarly, it will prevent India firms from obtaining high technology at affordable prices. All these will led to reduced exports from India.

India’s opposition to TRIPs Plus is reflected in the country’s FTA negotiation with countries like Japan and the EU who demand TRIPs Plus level of protection in their proposed CEPA (Comprehensive Economic Partnership Agreement).