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Unpublished Paper
WHEN PATENT RIGHTS AND PUBLIC HEALTH COLLIDE: GOING BEYOND COMPULSORY LICENSING TO SOLVE THE DOHA PARAGRAPH 6 PROBLEM
ExpressO (2011)
  • Marcela I Shirsat, American University Washington College of Law
Abstract

It has been almost ten years since the Doha Ministerial Conference’s Declaration on Public Health, however, since that time the developing nation’s access to medicines has not changed. Towards the end of 2001, the Doha Declaration on Public Health (“Doha Declaration”) was meant to alleviate the dissatisfaction with aspects of the TRIPS regime by reaffirming the flexibility of TRIPS member states in circumventing patent rights for better access to essential medicines. However, it raised a concern under paragraph 6 that certain members had either insufficient or no manufacturing capacities in the pharmaceutical sector and therefore could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. Therefore, the Council for TRIPS set out to find an expeditious solution to this issue. After creating an interim waiver in 2003, the Council decided to turn the waiver into a permanent amendment of TRIPS in 2005, known as Article 31bis. Nevertheless, as of December 2010 only 32 of the 151 members have ratified the change, far less than the two-thirds needed, and an extension for 2011 was issued. With all the negotiations and talks held over a viable solution the fact of the matter is nothing has really changed. In ten years the problems facing developing nation’s is more than just access. In the recent years these countries have had to deal with the transitioning period of other developing nations, like India, thereby affecting their present availability of medicines, the fear of retaliation from the developed world for threatening to use a compulsory license, as was the case for Thailand, not to mention the complicated procedures involved in just trying to navigate through the WTO’s compulsory license regime. Lastly, there is the further constricting of their rights, as reaffirmed in the Doha Declaration, by bilateral and regional trade agreement issues known as TRIPS plus. Therefore, this article will look at the current issues facing developing nation’s access to medicines and reevaluate the current solution. In addition, the innovative interpretation of TRIPS under Article 30 and several policy recommendations will be discussed as possible alternatives for solving the paragraph 6 dilemma.

Keywords
  • Doha Declaration,
  • Paragraph 6,
  • Article 30,
  • Artice 31(f)
Disciplines
Publication Date
January 14, 2011
Citation Information
Marcela I Shirsat. "WHEN PATENT RIGHTS AND PUBLIC HEALTH COLLIDE: GOING BEYOND COMPULSORY LICENSING TO SOLVE THE DOHA PARAGRAPH 6 PROBLEM" ExpressO (2011)
Available at: http://works.bepress.com/marcela_shirsat/1/