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

See all articles by Phoebe Li

Phoebe Li

University of Sussex Law School

Pheh-Hoon Lim

Auckland University of Technology

Date Written: 2014

Abstract

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

Li, Phoebe and Lim, Pheh-Hoon, A Precautionary Approach to Compulsory Licensing of Medicines: Tempering Data Exclusivity as an Obstacle to Access (2014). (3) Intellectual Property Quarterly 241-255, 2014, Available at SSRN: https://ssrn.com/abstract=2667863

Phoebe Li (Contact Author)

University of Sussex Law School ( email )

Falmer
Brighton BN1 9QN
United Kingdom

HOME PAGE: http://www.sussex.ac.uk/profiles/305243

Pheh-Hoon Lim

Auckland University of Technology ( email )

AUT City Campus
Private Bag 92006
Auckland, 1142
New Zealand

Do you have a job opening that you would like to promote on SSRN?

Paper statistics

Downloads
80
Abstract Views
555
rank
375,026
PlumX Metrics