Actions Developing in Countries Actions Developing in Countries Accessing the WTO SystemAccessing the WTO System

Vung Tau, 20-21 February 2006Vung Tau, 20-21 February 2006

““US – BrazilUS – BrazilCompulsory licensingCompulsory licensing

IPR or health?IPR or health?

Health of course, but …Health of course, but …

1999 US in conflict with several 1999 US in conflict with several developing countriesdeveloping countries

Dispute with Brazil referred to DSU (case Dispute with Brazil referred to DSU (case DS 199)DS 199) USA defending investments in R&D – Brazil USA defending investments in R&D – Brazil

protecting the right to health servicesprotecting the right to health services

IPR & medicinesIPR & medicines

Developing new chemical entities Developing new chemical entities expensive and time consumingexpensive and time consuming 10 – 12 years10 – 12 years Several 100 millions $Several 100 millions $

Easy to copyEasy to copy

Patent protection required Patent protection required TRIPS Art 27 (problem/solution)TRIPS Art 27 (problem/solution)

NewNew Inventive stepInventive step Industrial applicationIndustrial application

20 + 5 years protection20 + 5 years protection

Generic competitionGeneric competition

Generic race to the marketGeneric race to the market

Fair useFair use For private purposesFor private purposes

For experimental purposesFor experimental purposes

EU ./. Canada (dispute DS 114)EU ./. Canada (dispute DS 114) Experiments for registration purposesExperiments for registration purposes Experiments for stock-piling purposesExperiments for stock-piling purposes

Rules of interpretation used by the panelRules of interpretation used by the panel

Monopoly pricingMonopoly pricing

ConsequenceConsequence monopoly pricing during patent monopoly pricing during patent

protection. protection. Exorbitant treatment costsExorbitant treatment costs

Solution for the developed - but Solution for the developed - but not the developing worldnot the developing world

Compulsory licensingCompulsory licensing

Compulsory licensing an old Compulsory licensing an old conceptconcept Paris ConventionParis Convention Local production requirementLocal production requirement

Not much usedNot much used Exception Canada/GBException Canada/GB

No US legislationNo US legislation

Article 30 – 31 TRIPSArticle 30 – 31 TRIPS a cumbersome procedure a cumbersome procedure

Article 30 - Exceptions to Rights ConferredArticle 30 - Exceptions to Rights Conferred Members may provide limited exceptionsMembers may provide limited exceptions

not unreasonably prejudice the legitimate interests of the patent owner, not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.taking account of the legitimate interests of third parties.

Article 31 - Other Use Without AuthorizationArticle 31 - Other Use Without Authorization (b) prior efforts to obtain authorization on reasonable commercial terms. (b) prior efforts to obtain authorization on reasonable commercial terms.

Waived in case of national emergency or other circumstances of Waived in case of national emergency or other circumstances of extreme urgency; …extreme urgency; …

(f) any such use shall be authorized predominantly for the supply of the (f) any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use; …domestic market of the Member authorizing such use; …

(h) the right holder shall be paid adequate remuneration; … (h) the right holder shall be paid adequate remuneration; …

(k) anti-competitive practices;(k) anti-competitive practices;

Local production requirement Local production requirement hurdle for LDCshurdle for LDCs

HIV/AIDS and other epidemic diseasesHIV/AIDS and other epidemic diseases

LDCs have no production capacityLDCs have no production capacity

2001 DOHA Declaration2001 DOHA Declaration §6.§6. We recognize that WTO Members with We recognize that WTO Members with

insufficient or no manufacturing capacities in the insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in pharmaceutical sector could face difficulties in making effective use of compulsory licensing making effective use of compulsory licensing under the TRIPS Agreement. We instruct the under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution Council for TRIPS to find an expeditious solution to this problem and to report to the General to this problem and to report to the General Council before the end of 2002.Council before the end of 2002.

SolutionsSolutions

2003 August 30 Agreement2003 August 30 Agreement Problematic discussionProblematic discussion

Clinton foundation and MSFClinton foundation and MSF

2005 December 6 revision of TRIPS2005 December 6 revision of TRIPS First revision of a WTO AgreementFirst revision of a WTO Agreement

Still a cumbersome procedureStill a cumbersome procedure

Undertakings from developed nations not to abuse the Undertakings from developed nations not to abuse the systemsystem

Need to get national trade diversion rules in orderNeed to get national trade diversion rules in order