Doha Paragraph 6 Implementation Decision The Negotiations

The mandate to find an ‘expeditious’ solution to the problem countries with insignificant pharmaceutical manufacturing capacity might encounter in using compulsory licences under TRIPS led to series of negotiations on how to implement paragraph 6 of the Doha Declaration. The core issues that received preponderant consideration in negotiations were ‘scope of diseases’, eligible countries and the Article(s) of TRIPS that would be affected by the solution.103 Developing countries viewed limiting the solution to particular diseases as reneging on the Doha Declaration, which recognises public health problems ‘especially’ those resulting from ‘HIV/AIDS, tuberculosis, malaria and other epidemics’.104

What therefore eventually emerged in the decision implementing the paragraph 6 solution (the Implementation Decision) was a definition of public health problems that directly incorporates the scope covered by paragraph 1 of the Doha Declaration.105Paragraph 1 of the Doha Declaration is stated to cover all public health problems afflicting developing and least developed countries. It is submitted that any public health problem in any developing country

101

Epstein &Kieff, above n 51, 74.

102

See C M Ho, ‘Unveiling Competing Patent Perspectives’ (2009) 46 Houston Law Review 1047, 1082.

103

Abbott above n 60, 327.

104

See Communication from the African, Caribbean and Pacific Group of States (ACP), WTO Doc. IP/C/W401 (May 28, 2003).

105

Paragraph 1 of the WTO Implementation Decision on paragraph 6 of Doha Declaration on TRIPS and Public Health defines ‘Pharmaceutical Product’ as ‘any patented product … needed to address the public health problems as recognized in paragraph one of the Declaration’.

36 is within the wide ambit of the provision.

With respect to the eligible countries under the system, the US and EU’s interest in limiting the prospective exporting and importing countries seemed to have been borne out of a general desire to limit the use of the system.106 Thus, an initial proposal by the US sought to limit the eligible exporting countries to developing countries.107 The US also explored the possibility of basing entitlement to use the system on national income, on the ground that a country having sufficient financial capacity does not need to import cheap drugs.108 Developing countries, on the other hand, insisted that the criteria for eligibility should be based on insufficient or lack of manufacturing capacity in the pharmaceutical sector, as stated in paragraph 6 of the Doha Declaration.109 The US nonetheless maintained that the system was primarily meant to be for the benefit of African countries confronting HIV.110

It has been observed that the EU seems to have been principally concerned about protecting prices in developed countries from erosion by low priced imports through diversion of products manufactured under the system from the markets for which they are intended.111 To address this concern, the Decision imposes a number of stringent safeguards to prevent the diversion of products manufactured under the system.112 The Implementation Decision, as adopted, recognises insufficient or lack of manufacturing capacity as determining eligibility to use the system with least developed countries being presumed to lack such manufacturing capacity.

Another highly contentious part of the negotiations was the Article of the TRIPS Agreement that would be used to support the solution in the Implementation Decision.113 Developing countries, NGOs and the WHO desired a solution based on Article 30 of TRIPS as this would remove the need for a compulsory licence in the country exporting under the

106

Abbott above n 60, 327.

107

Second Communication from the US, WTO Doc. IP/C/W/358 (July 2002).

108

See USTR Press Release, US Announces Interim Plan to Help Poor Countries Fight HIV/AIDS and Other Health Crises in Absence of WTO Consensus (Dec. 20, 2002).

109

See South African Nonpaper, Substantive and Procedural Elements of a Report to the General Council Under Paragraph 6 of the Declaration on the TRIPS Agreement and Public Health, WTO Ref. Job(02)/156 (Nov. 4, 2002).

110

Tokyo Meeting Fails to Dislodge Impasse on TRIPS and Health, INSIDE US TRADE, Feb., 21, 2003.

111

See Abbott above n 60, 337.

112

Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health WTO Doc WT/L/540 (2 September) (Decision of 30 August 2003) para 2.

113

37 system.114Article 30 empowers members to provide limited exceptions to the exclusive rights conferred by patents to the extent that such exceptions do not unreasonably prejudice the normal exploitation of the patent.The pharmaceutical patent holders, however, viewed an Article 30 based approach as incapable of providing adequate safeguards against third party activity which would make it difficult to draw a dividing line between actions taken to meet the legitimate needs of importing countries and those taken predominantly for profit at the expense of the patentee’s rights.115

The African Group initially proposed using Articles 30 and 31 to provide a comprehensive solution to the problem116 but subsequently favoured an amendment or waiver of Article 31(f) of TRIPS.117 The Decision as adopted provides for a waiver of Article 31(f) but does make some allowance for the advocates of an Article 30 based solution by providing that it is without prejudice to the rights that members may otherwise have under the Agreement.