A Precautionary Approach to Compulsory Licensing of Medicines: Tempering Data Exclusivity as an Obstacle to Access
(3) Intellectual Property Quarterly 241-255, 2014
25 Pages Posted: 2 Oct 2015 Last revised: 17 Oct 2015
Date Written: 2014
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.
Keywords: Precautionary approach; Stewardship; TRIPS; Compulsory licensing; Data exclusivity; Access to medicines
JEL Classification: K11
Suggested Citation: Suggested Citation