Actas - Consejo de los ADPIC - Ver detalles de la intervención/declaración

Ambassador Alfredo Suescum (Panama)
World Trade Organization
102. This update to previous reports to the TRIPS Council will focus on activities to support acceptance of the Protocol Amending the TRIPS Agreement, and related technical assistance. 103. At the request of the Members concerned, we are providing technical assistance concerning both the process for entry into force of the amendment, and the implementation and use of the Paragraph 6 System which enables the grant of special compulsory licenses for export of pharmaceuticals. This theme also forms part of almost all of our TRIPS related technical assistance, at the national, regional and international levels, including annual flagship activities such as the advanced course for government officials, the WIPO-WTO colloquium, and the workshop on IP and public health. 104. We have had feedback from a number of Members that acceptance of the Protocol is awaiting domestic procedures, in particular concerning national legislation to implement the System. As you have noted, Mr Chair, these two processes have been considered by many Members to be distinct – acceptance of the Protocol is a confirmation that other Members are legally entitled to make use of this additional flexibility if they so wish; and the optional act of separately introducing this System into national legislation is a distinct choice to be taken. Actual practice bears this out. On the basis of information available to us (including some Members that are yet to notify implementing legislation), an informal review of acceptances of the Protocol indicate that a significant proportion of Members, across a wide spectrum, have accepted the TRIPS amendment without having introduced domestic implementing legislation. Some then went on subsequently to develop domestic implementing legislation, while others have not taken any steps to implement it domestically. In at least one instance, a Member initially planned to notify acceptance only after introducing domestic implementing legislation, and then later decided to accept the protocol without any domestic legislation, on the understanding that such legislation was not a prerequisite for accepting the amendment. At the request of the Council, the Secretariat has developed and made available on a dedicated webpage a simple model for acceptance, with associated information, and we stand ready to work with any delegation wishing to advance this process. 105. Since the last annual review of the System, and as reported to previous sessions of the Council, the Secretariat has launched a study, prepared with counterparts in WHO and WIPO and intended essentially as a resource for technical assistance, entitled "Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade". This report consolidates and makes available the technical assistance resources provided by the three Organizations in the course of their technical cooperation relating to health, IP and trade. 106. The study notes how access to essential medicines and the lack of research to address neglected diseases have been a major policy concern for many years. The publication responds to the needs expressed by health policy‑makers for a systematic understanding both of the innovation processes that lead to new technologies and of the ways in which these technologies are disseminated in health systems. The study captures a broad range of experience and data in dealing with the interplay between IP, trade rules and the dynamics of access to, and innovation in, medical technologies. 107. The study informs ongoing technical cooperation activities undertaken by the three organizations concerning the interplay between health, IP and trade, including activities that specifically address the Paragraph 6 System. Based on many years of field experience in technical cooperation, the study has been prepared to serve the needs of policy‑makers who seek a comprehensive presentation of the full range of issues, as well as lawmakers, government officials, delegates to international organizations, non‑governmental organizations and researchers. 108. The study provides information to support technical assistance relating to TRIPS and public health, describing how the Paragraph 6 System was designed as an additional flexibility to enhance access to medicines by removing a potential barrier for countries that need to import medicines. In particular, the study outlines the background, context, and scope of use of the System (pages 177ff), giving an overview of the ongoing policy discussions. It notes that while the reasons for the limited use of the Paragraph 6 System are still under consideration, it could be more widely used in the future, for example, in the case of a pandemic or some other health security event where effective treatments may be patented in all major supplier countries following the introduction of the product patent regime since 2005. 109. The study describes the particular procurement scenario that the System is designed to address, and reviews some of the issues that have been discussed here and in other fora regarding whether the System has been used as expected, noting that its operational context is still being mapped. 110. Finally, Annex II provides specific practical information on the operation of the System, its context and scope and use, and domestic implementation, as a means of technical assistance to Members considering the possible use of the System. It provides references to the model forms for notifications under the System that have been made available on the WTO website, again as a technical assistance resource for the benefit of Members considering making use of the System.
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