Finding Flaws: The Limitations of Compulsory Licensing for Improving Access to Medicines - an International Comparison‪.‬

1. Introduction In August 2003, the General Council of the World Trade Organization (WTO) unanimously adopted a Decision (1) ("2003 WTO Decision") to allow compulsory licensing of patented medicines for the purpose of exporting the generic versions to those countries with little or no pharmaceutical manufacturing capacity. This interim decision was lauded by many as a breakthrough in the efforts to improve access to medicines in developing countries. (2) However, as of August 2008, only a handful of WTO Members (3) have adopted domestic legislation, regulations or other instruments that in some way implement the 2003 WTO Decision. More concerning, only one export licence has been granted under the General Council 2003 WTO Decision, (4) and as of the time of writing, only one shipment of anti-retroviral drugs has been exported to Rwanda. (5) It has been argued that the underutilization of the 2003 WTO Decision illustrates the flawed nature of the WTO mechanism. (6) This paper does not attempt to confirm nor refute the claim that the Decision is unworkable, but rather examines the different domestic legislative amendments made by WTO Members in order to illustrate some aspects that both facilitate and hinder utilization of the General Council Decision. In particular, we focus on Rwanda's attempt to import under Canada's implementation of the 2003 WTO Decision and compare it to an Indian generic company's ongoing application for the grant of a compulsory licence under India's implementation of the 2003 WTO Decision. This is the only other example outside of Canada of an attempt to export compulsory licensed medicines under the 2003 WTO Decision. Finally, we offer some conclusions based on lessons learnt from these experiences.