76. India welcomes the entry into force of the Protocol Amending the TRIPS Agreement in January this year, which is the first amendment to a multilateral treaty since the WTO Agreement came into force in 1995. India attaches high importance to the Doha Declaration on TRIPS and Public Health, the Paragraph 6 System as established under the 2003 Waiver Decision, and the Protocol Amending the TRIPS Agreement. India was one of the first countries that notified its acceptance of the Protocol in March 2007, and we would like to congratulate Members who have deposited their instrument of acceptance after the special meeting of the TRIPS Council in January. India has always been of the view that the Doha Declaration on TRIPS and Public Health constituted a major landmark in the history of the WTO because it recognized the primacy of public health needs and the preparedness of organizations to address the problem of access to medicines faced by the poor in developing countries. The 2003 Waiver Decision was expected to address public health problems faced by Members with insufficient or no manufacturing capacities in the pharmaceutical sector. It may have sounded prophetic at that time, when India voiced certain apprehensions in the General Council meeting of August 2003, and I quote "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 the System successful, a sincere collective effort was required on the part of all Members and the entire pharmaceutical industry."
77. Regrettably, we have been proven right. The export of HIV/AIDS medicines by the Canadian pharmaceutical company Apotex to Rwanda in September 2008 has been the first and only use of the System so far. The Trilateral Study by WTO, WHO and WIPO on Promoting Access to Medicines and Medical Technologies and Innovation: Intersection between Public Health, Intellectual Property and Trade of 2013 highlights some of the issues that need to be addressed for any meaningful utilisation of the System. We need to consider those issues carefully so that this measure does not remain confined only to paper.
78. The UN Secretary-General High Level Panel on Access to Medicines, in its report released in September 2016, also recognised that the Paragraph 6 System is complex and cumbersome. It recommended that WTO Members revise the System in order to find a solution that enables a swift and expeditious export of pharmaceutical products produced under compulsory licence. WTO Members should, as necessary, adopt a waiver and permanent revision of the TRIPS Agreement to enable this reform. During an event held on the side lines of the TRIPS Council meeting in November 2016, several participants also highlighted that the System was not workable in its current form, and that it was too complex, cumbersome and administratively unwieldly for use, and that it was commercially non-viable for companies to supply medicines under it. We urge Members to constructively engage on the question of improving the Paragraph 6 System for making it more workable and more effective so that it can benefit Members with insufficient or no manufacturing capacity in the pharmaceutical sector.
79. To come to a specific question, some Members who notify their acceptance have not incorporated the System into national law. We encourage these Members to take the necessary steps to incorporate the System into their national laws. We also encourage Members who are yet to notify their acceptance of the 2005 Protocol to do so by the end of the year. However, I am informed that as many as 46 Members are yet to accept the Protocol, and it may not be possible for all of them to notify their acceptance in time. We therefore support the extension of the deadline for accepting the Protocol by a further period of two years.
