151. India attaches high importance to the Doha Declaration on the TRIPS Agreement and Public Health, the Paragraph 6 System as established under the 2003 waiver decision and the Protocol. The Paragraph 6 System is also the first ever proposed amendment to the WTO Agreement in the form of the 2005 Protocol Amending the TRIPS Agreement. India had notified its acceptance of the Protocol in March 2007. We would like to congratulate Uruguay, Botswana, Turkey and the Central African Republic for depositing their instruments of acceptance of the Protocol during the last year. However, in spite of the fourth extension of the period for acceptance until 31 December 2015, only 53 Members have accepted the Protocol so far. The fact that there is still a long way to go for it to enter into force, as acceptance by two thirds of the membership is required, is not a positive signal. Therefore, we urge other Members to notify their acceptance of the 2005 Protocol Amending the TRIPS Agreement for it to enter into force. We would like to appreciate the Secretariats of WTO and WIPO for providing technical assistance for the process of entry into force of the amendment, and also for the implementation and use of the Paragraph 6 System.
152. India has always been of the view that the Doha Declaration on the TRIPS Agreement 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 preparedness of the Organization to take up the problems faced by the poor in developing countries. Along with several other Members, India had worked relentlessly on the Doha Declaration and the Decision. The Decision was expected to address the 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. 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. The export of HIV/AIDS medicines by the Canadian pharmaceutical company Apotex to Rwanda in September 2008 was the first and only use of the system so far.
153. The trilateral study by WTO, WHO and WIPO on "Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade" (2013) has summarised the diverse observations of the WTO Members on whether the Paragraph 6 System is fulfilling its intended objectives into six points as follows:
i. "By 2012, the System was only used once, and it took three years before the shipments in question proceeded. The System is too complex and administratively unwieldy for further use, and a multi-stakeholder workshop is needed in order to discuss the operation of the System. It is essential to clarify whether constraints on its use were built into the System, thus necessitating its reform, or whether such constraints were a consequence of how individual countries chose to implement it.
ii. Potential users of the System may be deterred by concerns about political or trade ramifications associated with the use of compulsory licensing.
iii. The Canada's Access to Medicines Regime (CAMR) was successfully utilized, and only a very small portion of the three-year time period was taken up with procedures associated with the System. Much of the time that elapsed between the regulatory review of the medicine in question and the actual shipments was attributable to other factors.
iv. The limited use of the System is not an appropriate measure of its success, as no delegation demonstrated evidence of obstacles to its use when such use was required. A single case demonstrated that the System could work when necessary, and that it could play a supportive role in the wider effort to improve access to essential medicines, given that alternative ways of procuring the needed medicines are often available.
v. The System is not a panacea to solve all public health related problems. Rather, it is part of a broader picture which includes other important aspects that have an impact on innovation and access, such as infrastructure, tariffs, innovative financing mechanisms, partnerships and cooperation (including at the regional level), and regulatory frameworks.
vi. Implementation of full patent protection for pharmaceutical products in India, coupled with the approaching expiry of transition periods in LDCs, could make it more difficult in the future to procure generic versions of new medicines. Under such circumstances, the Paragraph 6 System might assume a greater significance."
154. The TRIPS Council has been reviewing the mechanism for the last several years. My delegation feels that the review mechanism has become ritualistic in nature and will not serve any purpose if we go on repeating similar questions and get similar replies as summarized by the trilateral study done by the WTO, WIPO & WHO. The implementation of the Paragraph 6 System involves several stake holders and our discussions would not be effective if we restrict the discussion to this level.
155. It is pertinent to mention here that the WTO, WHO and WIPO are holding a technical symposium on "Innovation and access to medical technologies: challenges and opportunities for middle income countries" on 5 November 2014 at the WTO in Geneva. As part of the trilateral cooperation between the WHO, WIPO and the WTO on innovation and access to medicines, we request these Organizations to organize a dedicated workshop involving all stakeholders to expand the scope of the discussion on the question of making effective use of the Paragraph 6 System, including alternatives to it.
