Actions Developing in Countries Accessing the WTO System Vung Tau, February 2006 “US – Brazil Compulsory licensing

IPR or health?  Health of course, but …  1999 US in conflict with several developing countries  Dispute with Brazil referred to DSU (case DS 199)  USA defending investments in R&D – Brazil protecting the right to health services

IPR & medicines  Developing new chemical entities expensive and time consuming  10 – 12 years  Several 100 millions $  Easy to copy  Patent protection required  TRIPS Art 27 (problem/solution)  New  Inventive step  Industrial application  years protection

Generic competition  Generic race to the market  Fair use  For private purposes  For experimental purposes  EU./. Canada (dispute DS 114)  Experiments for registration purposes  Experiments for stock-piling purposes  Rules of interpretation used by the panel

Monopoly pricing  Consequence  monopoly pricing during patent protection.  Exorbitant treatment costs  Solution for the developed - but not the developing world

Compulsory licensing  Compulsory licensing an old concept  Paris Convention  Local production requirement  Not much used  Exception Canada/GB  No US legislation

Article 30 – 31 TRIPS a cumbersome procedure  Article 30 - Exceptions to Rights Conferred  Members may provide limited exceptions  not unreasonably prejudice the legitimate interests of the patent owner,  taking account of the legitimate interests of third parties.  Article 31 - Other Use Without Authorization  (b) prior efforts to obtain authorization on reasonable commercial terms.  Waived in case of national emergency or other circumstances of extreme urgency; …  (f) any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use; …  (h) the right holder shall be paid adequate remuneration; …  (k) anti-competitive practices;

Local production requirement hurdle for LDCs  HIV/AIDS and other epidemic diseases  LDCs have no production capacity  2001 DOHA Declaration  §6.We recognize that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002.

Solutions  2003 August 30 Agreement  Problematic discussion  Clinton foundation and MSF  2005 December 6 revision of TRIPS  First revision of a WTO Agreement  Still a cumbersome procedure  Undertakings from developed nations not to abuse the system  Need to get national trade diversion rules in order