Protection for Whom?

A new controversy in India relating to the World Trade Organisation’s Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement centres on implementation of Article 39.3 of the treaty. This clause requires WTO members to provide protection against unfair commercial use of undisclosed test and other data relating to pharmaceutical or agrochemical products using new chemical entities. These are data submitted by manufacturers to regulators for obtaining marketing approval. A condition laid down in Article 39.3 is that the generation of this data should involve “a considerable effort”.

As has become commonplace with many provisions of the TRIPS agreement, Article 39.3 has been subjected to varying interpretations. Most analysts in developing countries have argued that Article 39.3 only requires that there should be a transparent legal regime for providing protection against “unfair commercial use” of data from clinical trials that have been generated by the pharmaceutical companies and also to safety and efficacy data generated by the agrochemical companies. On the other hand, the industry associations in the US and the EU have argued that Article 39.3 commits WTO member-countries to provide “data exclusivity”. As the term suggests, data exclusivity means that the firms submitting data to the regulatory authorities would have exclusive rights over the same for a fixed period. During this period, the authorities would not be allowed to use this data to establish the bio-equivalence of a pharmaceutical and agrochemical product in case a second applicant seeks to market the same product.