Enabling Access to Clinical Trial Data: When is Unfair Use Fair?

Abstract

This inquiry is prompted by the unprecedented policy of the European Medicines Agency that enables the disclosure of clinical trial reports submitted for drug marketing authorization, effective as of January 1, 2015. It addresses the question whether such practice is in compliance with the international standard of clinical data protection under Article 39.3 of the TRIPS Agreement. Most scholarly and policy debate regarding this provision analyzes whether it precludes the referential use of data to facilitate the approval of a generic drug. Rather than focusing on a particular use, this Article seeks to identify the principle underlying the protection obligation by which the legitimacy of “use X” can be evaluated. In doing so, it interprets the provision from literal, historical and teleological perspectives, and it analyzes a peculiar overlap between three legal regimes: unfair competition, trade secret, and sui generis data protection.

The proposed principle allows avoidance of situations where, due to the ambiguous notion of unfair commercial use, the protection of data under the TRIPS Agreement can be stretched indefinitely. With regard to data disclosure for experimental use, it is argued that the protection obligation under 39.3 TRIPS does not justify monopoly type protection of clinical trial data, neither does it require the reservation of experimental use exclusively for the data originator, even if such use can have commercial benefits for competitors.

Keywords: pharmaceutical innovation, clinical research, data protection, data disclosure, European Medicines Agency

JEL Classification: O34, I18, K23, K33