Finding flaws: the limitations of compulsory licensing for improving access to medicines--an international comparison.

Abstract

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. 2. The WTO's response to the Declaration on the TRIPS Agreement and Public Health The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) (7) requires all WTO Members to adopt minimum standards of intellectual property rights. In essence, TRIPS provides heightened standards for all member countries. Still, it does provide some flexibility for use of a patent without the patent holder's authorization, either through government use or through a compulsory licence issued to a third party, with payment of adequate remuneration to the patentee. (8) At the WTO's Fourth Ministerial Conference in Doha, Qatar in November 2001, WTO Members affirmed that the TRIPS Agreement should be interpreted in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all. (9) It was envisioned that patent exception provisions such as the compulsory licensing provisions contained in the TRIPS Agreement could be used by governments to facilitate access to essential medicines in a time of public health crisis or circumstance of national emergency by allowing for production of cheaper generic drugs. WTO Members further recognized in the Declaration (paragraph 6) that the TRIPS Agreement limited the effective use of compulsory licensing in those countries with insufficient or no manufacturing capacities in the pharmaceutical sector. Originally TRIPS Article 31(f) provided that compulsory licensing could only be used predominantly for the purposes of supply of the domestic market of the country in which the licence was issued. This posed a for those poorest countries which did not possess sufficient manufacturing capacity to produce their own generic pharmaceuticals and therefore needed to import medicines. In response, WTO Members committed to finding an expeditious solution to the Doha paragraph 6 problem by the end of 2002. (10) However, it was not until after much debate and almost two years later, in August 2003, that the WTO General Council finally reached a Decision on the Implementation of paragraph 6 of the Declaration on the TRIPS Agreement and public health (2003 WTO Decision). …

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