Minutes - TRIPS Council - View details of the intervention/statement

Ambassador Mothusi Palai (Botswana)
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.
The Council took note of statements made and agreed on the draft cover note to the report. It also agreed that the record of the discussion be attached to it.
6.1. The Chairman recalled that the standard format for the review had been that, after an introduction and update on recent developments by the Chairman, the floor was opened to delegates for comments. In 2010 and 2011, the Council had held more structured debates. They had been conducted on the basis of a list of topics for the discussion that had been agreed in advance of the reviews. In light of the feedback previous Chairmen had received in their consultations prior to the subsequent reviews, the 2012 and 2013 reviews had again followed the standard format.

6.2. At his informal consultations in June 2014, he had encouraged delegations to consider how the Council should conduct the present review. In light of the feedback received, the Chairman suggested that the standard format be followed this year. The records of earlier reviews, including the exchange of questions and responses, continued to provide a unique and valuable resource for understanding this important measure and might inform Members' discussions at this review. If Members felt that any questions regarding the Paragraph 6 System itself or possible alternatives to it had not been adequately addressed at past reviews, they should feel free to revert to any such questions.

6.3. As regards the purpose of the review, he recalled that paragraph 8 of the waiver Decision provided that the Council for TRIPS shall review annually the functioning of the system set out in the Decision with a view to ensuring its effective operation and shall annually report on its operation to the General Council. Furthermore, the paragraph provided that this review shall be deemed to fulfil the review requirements of Article IX:4 of the WTO Agreement.

6.4. The Secretariat had prepared a draft cover note for the Council's report modelled on previous years' reports (circulated as JOB/IP/11). He suggested that the Council take up the preparation of its report to the General Council after it had exhausted its discussion. Paragraph 8 of the cover note contained a list of Members that had notified their acceptance of the Protocol. The following Members had deposited their instruments of acceptance since the Council's last meeting in June: Botswana on 18 June and Uruguay on 31 July.

6.5. He recalled that the Protocol had originally been open for acceptance by Members until 1 December 2007. Upon proposals by the TRIPS Council, the General Council had four times extended this period for further two-year periods. At present, the period extended until 31 December 2015. 53 instruments of acceptance, including from the European Union, had been deposited with the WTO Director-General. In order for the TRIPS amendment to enter into force, acceptance by two thirds of the membership was, however, required. He therefore strongly encouraged Members who had not yet completed their domestic procedures to do so as soon as possible.

6.6. He said that, regarding how accepting the Protocol related to the implementation of the Paragraph 6 System in a Member's domestic legal framework, these were two entirely separate acts; the Protocol could therefore be accepted independently from adopting domestic implementing legislation. By accepting the Protocol, a Member expressed its consent that other WTO Members were entitled to use the additional flexibility that the System provided. Should a WTO Member wish to take advantage itself of these additional flexibilities, it might need to domestically implement appropriate legislative measures. But since these two processes were entirely separate, a Member might choose to deposit an instrument of acceptance of the Protocol without the need to wait for any domestic implementation. Many instruments of acceptance that the WTO had received had been deposited before the Member in question had adopted any domestic implementing legislation.

6.7. The representatives of Chile; Uganda on behalf of the LDC Group; India; Brazil; Cuba; China; Chinese Taipei; the United States; Australia; Canada; Japan; the European Union; Switzerland; Egypt and the Secretariats of WTO; WIPO and WHO took the floor.

6.8. Referring to the draft cover note for the Council's report to the General Council (circulated as JOB/IP/11), the Chairman said that it contained factual information on the implementation and use of the system established under the Decision, as well as on the status of acceptances of the Protocol Amending the TRIPS Agreement. In accordance with the way that the Council had prepared its reports in the previous years, the part of the minutes of the meeting that would reflect the discussions held under this agenda item might be attached to the cover note.

6.9. The Council took note of statements made and agreed on the draft cover note to the report. It also agreed that the record of the discussion be attached to it.

IP/C/M/77, IP/C/M/77/Add.1