Disease-Based Limitations on Compulsory Licenses Under Articles 31 and 31bis

Abstract

Compulsory licensure is one of the flexibilities retained under TRIPS to permit countries to support public health while granting pharmaceutical patents. The United States Government appears to take the position that compulsory licensure and other TRIPS flexibilities must be limited to certain infectious diseases, namely AIDS, tuberculosis, and malaria. These proposed limitations are not supported by the text of Articles 31 and 31bis of TRIPS or by the negotiating history of the Agreement. Introducing disease-based limitations would be unwise, as the developing world is undergoing a demographic transition, with increasing shares of its disease burden coming from non-infectious diseases. Public health calls for retaining TRIPS flexibilities in all categories of human need.

Keywords: compulsory license, TRIPS, pharmaceuticals, USTR, disease

JEL Classification: I18, K11, K33