Ambassador Alfredo Suescum (Panama)

Inde

6 REVIEW UNDER PARAGRAPH 8 OF THE DECISION ON THE IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH

72. India attaches high importance to the Doha Declaration on the TRIPS Agreement and Public Health, the Paragraph 6 System and the Protocol Amending the TRIPS Agreement of December 2005. We see from JOB/IP/9 that although 47 Members have accepted the Protocol, we are still far away way from the two thirds mark required for its entry into force, i.e. 106 Members. 73. 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 sensitivity of this organization to the problems faced by the poor in the less developed countries. 74. Along with several other Members, India worked relentlessly for the Decision of 30/08/2003 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 General Council meeting of August 2003. India sounded a word of caution and expressed 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. 75. 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 in the context of the Paragraph 6 mechanism 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 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. 76. 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 Paragraph 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 stakeholders, including patients, legal experts and civil society organisations. It is therefore pertinent that the Council organizes 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. 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.

The Council so agreed.

6.1. The Chairman suggested that, in light of the consultations he had held on the preparations for the tenth annual review under paragraph 8 of the Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, the Council follow the standard format in the present review. Accordingly, after introducing the item and any relevant recent developments, the floor would be opened to delegations for comments. This was how the Council had conducted most of the reviews, including the previous review, although in 2010 and 2011, the Council had had in place more elaborated procedures that had been agreed in advance, including a set of topics and questions to guide the discussion.

6.2. He said that 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 could also inform discussions at the present review. He had therefore encouraged delegations to consult this material, recorded in the minutes of previous reviews, and consider whether there was any issues they would wish to follow up.

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

6.4. The Secretariat had circulated a draft cover note for the Council's report modelled on previous years' reports (JOB/IP/9). It contained factual information on the implementation and use of the System established under the Decision and on the status of acceptances of the Protocol Amending the TRIPS Agreement. In accordance with the way that the Council had prepared its report in previous years, the part of the minutes of the meeting that reflected the discussions held under the agenda item could be attached to the cover note.

6.5. Paragraph 8 of the cover note contained a list of Members that had notified their acceptance of the Protocol. The Chairman said that Chile and Montenegro, on 26 July and 9 September 2013 respectively, had deposited their instruments of acceptance since the Council's last meeting in June. In addition, since the circulation of the draft report, Trinidad and Tobago had also accepted the Protocol (WT/Let/894). Paragraph 8 would need to be updated accordingly.

6.6. The Chairman clarified a frequently asked question on how the acceptance of the Protocol related to the implementation of the Paragraph 6 System in a Member’s domestic legal framework. He said that these were two entirely separate acts, in other words, the Protocol could be accepted independently from adopting domestic implementing legislation. By accepting the Protocol, a Member in essence 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 those additional flexibilities, the adoption of appropriate domestic legislative measures could be required. He emphasized that, since these two processes were entirely separate, a Member could choose to deposit an instrument of acceptance of the Protocol without the need to wait for any domestic implementation. In fact, a number of 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 the United States, India, Canada, China, Australia, Japan, the European Union, Cuba, Switzerland, Chile and El Salvador, as well as of the WTO Secretariat and the WIPO Secretariat took the floor under this agenda item. The statements will be reproduced in an addendum to the present record.

6.8. The Council took note of the statements made.

6.9. Turning to the report to the General Council on the annual review of the Paragraph 6 System, the Chairman said that the Secretariat had circulated a draft cover note for the Council's report modelled on previous years' reports (JOB/IP/9). It contained factual information on the implementation and use of the System established under the Decision and 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 reflected the discussions held under the agenda item could be attached to the cover note.

6.10. As regards paragraph 8 of the cover note to the report, he recalled that Trinidad and Tobago had also recently accepted the Protocol. This paragraph would be updated accordingly.

6.11. The Protocol had originally been open for acceptance by Members until 1 December 2007. Upon proposals by the TRIPS Council, the General Council had three times extended that period for further two-year periods. The period for acceptance was currently due to expire on 31 December 2013. Given the proximity of this date, the Chairman suggested that the Council consider again submitting a proposal to the General Council for a decision to extend the period for the acceptance of the Protocol. For that purpose, a draft decision that could be submitted to the General Council for adoption was included in Annex 2 to the draft report. It did not yet contain a new deadline for the extended period for acceptances. In the light of the consultations he had held on this matter, he suggested that the Council propose to extend the period by a further two years until 31 December 2015.

6.12. The Chairman proposed that the Council agree on forwarding to the General Council the proposal for a decision to extend the period of acceptance by Members of the Protocol Amending the TRIPS Agreement until 31 December 2015. He suggested that the last paragraph of the draft decision by the General Council contained in Annex 2 to the draft report be complemented by inserting this date. He also proposed that the Council agree on the cover note to the report contained in JOB/IP/9, with the update to paragraph 8 concerning Trinidad and Tobago, and also that the Council minutes containing the record of the discussion be attached to it.

6.13. The Council so agreed.

IP/C/M/74, IP/C/M/74/Add.1