On 10 October 2013, India delivered the following intervention at the WTO TRIPS Council’s annual review of the paragraph 6 system.
Para 6 MechanismMy delegation will like to thank the Secretariat for preparing a compilation of acceptances of the Protocol amending the TRIPS Agreement. India attaches high importance to the Doha Declaration on Public Health, the Para 6 system and the Protocol of Dec 2005 amending TRIPS. We see from JOB/IP/9 that although 47 Members have accepted the protocol agreed to in December 2011, we are still far away way from the 2/3rd mark i.e. 106 Members.
India has always been of the view that the Doha Declaration on TRIPS and Public Health constituted a major landmark in the short history of the WTO because it recognized the primacy of public health needs and the sensitivity of this organization to the problems faced by the poor in the less developed countries.
Along with several other Members, India worked relentlessly for the Decision of August 30, 2003 with the hope that it would genuinely and completely address the problems faced by WTO Members, with insufficient or no manufacturing capacities in the pharmaceutical sector to address their public health problems. It may have sounded prophetic at that time when India voiced certain apprehensions in the GC meeting of August 2003. India sounded a word of caution and while expressing hope that “the results accruing from this mechanism should not be negated by the creation of cumbersome systems that would lead to huge delays in getting medicines across at reasonable cost to those that needed them or discourage Members from using the system for the benefit of the people. In order to make this system successful, a sincere collective effort was required on the part of all Members and the entire pharmaceutical industry.” Regrettably, we have been proven right.
Chair, during the recently held negotiations to extend the TRIPS transition period for the LDCs, we found strong resistance from the developed country Members to provide an indefinite extension till the LDCs graduated to become developing countries. Since the ability of the LDCs to gain access to generic medicines would be directly and severely impaired with the implementation of the TRIPS Agreement, we cannot take seriously any prior or current rhetoric by these Members around Para 6 Mechanism and that these Members are committed to ensuring access to medicines. In fact the permanent exemption from the provisions of the TRIPS Agreement to all countries while they are classified as LDCs continues to be the most significant exception to ensure access to low-cost generic medicines in LDCs, though of course patent barriers in countries with capacity to manufacture generic medicines presents and will present a critical barrier that the Paragraph 6 mechanism was meant to help resolve.
Chair, let me also recall that our delegation during the last two Annual reviews in 2011 and 2012, had asked a few questions to some developed country members around the Para 6 mechanism. Regrettably these questions have still remained unanswered. Since the mechanism has been used only once for a single product, in favour of a single country and by a single country during the last several years and since the Members, especially those who would require this Mechanism in future, have several questions, it is necessary that the Council reviews the Mechanism comprehensively by taking into account the views of not only the Members but also all stake holders, including patients, legal experts and civil society organisations. It is therefore pertinent that the Council organises a dedicated workshop on the question of making effective use of compulsory licensing for export under the TRIPS Agreement, including alternatives to the paragraph 6 system involving all relevant stakeholders at the earliest. We are sure that an inclusive approach would help in a better review of the mechanism. Secondly Chair we also understand that a few Members have blocked the consensus required for holding such a workshop. In fact my delegation would urge them to reconsider their position on such a trivial issue to save the lives of thousands of people in the countries lacking manufacturing facilities and also lacking resources to import patented products.