A Precautionary Approach to Compulsory Licensing of Medicines : Tempering Data Exclusivity as an Obstacle to Access

This article takes up further on a framework developed for a precautionary approach which developing countries should adopt for granting compulsory licences in a national health emergency, and further explores an interpretation of the data exclusivity regime to temper the obstacle for access to medicines after a compulsory licence is granted. A precautionary approach to compulsory licensing is based on the proposal that a margin of safety is necessary when harm has crossed a significant threshold and scientific evidence has yet to be established. The authors propose that a precautionary approach, adopted in conjunction with a super-stewardship model, will allow for a coherent interpretation of the flexibilities under the TRIPS Agreement to help bridge the gap in the public health dilemma