The India-European Union (EU) Free Trade Agreement (FTA) is still in the pipeline, and most aspects of the agreement are still not in the public domain. The agreement, likely to be concluded sometime this year, is highly controversial as it aims to include a data exclusivity law which could delay the market entry of various generic drugs. This in turn could lead to a number of lifesaving drugs becoming inaccessible and unaffordable to Indians as well as citizens of various third world nations to which India exports. Though the Indian Government has recently clarified that it will not compromise the interests of the common man, it will be interesting to see if the EU can arm-twist India into strengthening its Intellectual Property Rights (IPR) regime. While the EU’s stand may seem unjustified to most Indians, this article endeavors to throw light on the arguments of both sides.

A Free Trade Agreement (FTA) is a trade treaty between two or more countries. Usually, these agreements are between two or more countries to eliminate tariffs on substantially all trade between them.1 The European Union (EU)-India FTA is one such agreement, but is still in its nascent stage. Efforts are being made to conclude the FTA in the near future; however, talks have been hit by certain roadblocks and hence there is no definite date as to when it will be completed. A critical stipulation in the draft of the India-EU FTA may have drastic consequences on the accessibility and affordability of medicines in India, and it is this controversial clause that is hampering the negotiations between these two major trading blocs. The EU is unyielding on the inclusion of the data exclusivity law, a strict provision, which could potentially delay market entry of all generic medicines. A generic drug2 is a drug which is produced and distributed without patent protection. The manufacturer of the generic drugs saves on the cost of Research and Development (R&D) and creates a drug identical to the innovator drug which has patent protection and is thus able to sell the drugs at a lower cost. When generic products become available, the market competition often leads to substantially lower prices for both the original brand name product and the generic forms. ‘Data Exclusivity’ refers to a practice whereby, for a fixed period of time, drug regulatory authorities do not allow the test data of the innovator company to be used to register an equivalent generic version of that medicine.3 This is to ensure that top multinational pharmaceutical giants who spend time, money and huge investment on R&D to assess the efficacy, quality and safety of the new product through clinical trials are able to reap the financial benefits of their newly developed product. If such a data exclusivity law is introduced in India, the Drug Controller of India (DCI), which is a regulatory authority, will be barred from relying on test data, submitted by pharmaceutical giants, in granting marketing approval to generic medicines. Instead, it will ask the generic drug manufacturers to undertake its own clinical trials and submit test data to the controller of drugs to assess the quality, efficacy and safety of the generic version of the drugs. Since clinical trial is a very complex and time-consuming process and demands huge investment in R&D, the generic companies usually lack the financial infrastructural capabilities to undertake such a task; and even if they undertake such a task, it will lead to significant increase in the price of such generic drugs because generic companies by using test data of innovator companies save significant expenditure cost which is reflected in their affordable pricing system and thus paves the way for easy accessibility of lifesaving drugs to common people. In the course of this paper, the pros and cons of data exclusivity shall be analyzed while simultaneously looking at India’s responsibilities under the Trade Related Aspects of Intellectual Property Rights (TRIPS) and also the impact on the Indian municipal law.

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