Ambassador Mothusi Palai (Botswana)

United States of America

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

167. The United States strongly supports the Paragraph 6 System as established under the 2003 waiver decision and the 2005 Protocol. The United States was the first WTO Member to accept the amendment in 2005. We also welcome the latest General Council decision of 26 November 2013 which extended the deadline for acceptance of the amendment to 31 December 2015. We also welcome and congratulate Botswana, the Central African Republic, Turkey and Uruguay who have formally accepted the amendment this year. We welcome and encourage the Secretariat's efforts with respect to depositing instruments of acceptance of the Amendment as well. We join Uganda in encouraging other Members to notify their acceptance of the Amendment so that it can enter into force. Finally, we wanted to highlight the Secretariat's good efforts in this regard, and draw delegates' attention to the WTO TRIPS webpage where Members can find a link to an illustrative guide to notifying under the Paragraph 6 System which we find to be quite helpful. As we have explained, there are multiple avenues available for promoting access to medicines, the Paragraph 6 System is important of course, but it is not alone. 168. There are many mechanisms to overcome barriers, and such barriers of course include tariffs and non-tariff barriers. Measures including those that are discriminatory, non-transparent or otherwise trade-restrictive have the potential to hinder access to pharmaceuticals and medical devices and potentially result in reduced access to healthcare due to higher healthcare costs. For example, taxes or tariffs may be levied often in a non-transparent manner on imported medicines and the increased expense associated with those levies is then passed directly to health-care institutions and to patients. Moreover unreasonable regulatory approval delays and non-transparent reimbursement policies can create uncertainty or ambiguity about when a new drug or medical product can enter into the market and thereby discourage the development and marketing of such new drugs and other medical products. The criteria, rational and operation of such measures are often non-transparent and not fully disclosed, contributing to this uncertainty. Appropriate mechanisms for transparency, procedural and due process protections and opportunities for public engagement are important in the context of health care systems. We continue to believe that the access to medicines issue is multidimensional; making life-saving medicines available requires transparency and a commitment to address measures that unduly delay patients from getting the treatments they need. 169. Finally, to the extent that a delegation has requested a TRIPS Council decision today on a workshop, as this is a new proposal and on which we have received no advance notice, including at yesterday's informal meeting, we will need to revert this request, if it is a request, back to capital.

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