Ambassador Al-Otaibi (Kingdom of Saudi-Arabia) and Ambassador Alfredo Suescum (Panama)

Estados Unidos de América

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

130. Thank you for this update regarding the status of notifications of acceptance of the 2005 Protocol Amending the TRIPS Agreement. Since the last annual review, New Zealand and Australia have notified legislation implementing the System. The United States strongly supports the Paragraph 6 System as established under the 2003 waiver Decision, the 2005 Protocol, and the 2013 General Council Decision to extend the deadline to 31 December 2015 for acceptance of the Amendment. 131. The United States congratulates those Members identified by the Chairman -- Brunei Darussalam, Moldova, Kenya, and Saint Kitts and Nevis, Sri Lanka, Lao PDR, and Iceland – which formally accepted the Amendment since the last review. We welcome and encourage the Secretariat's efforts with respect to depositing instruments of acceptance of the Amendment as well and encourage other Members to notify their acceptance of the Amendment so that it can enter into force. 132. With respect to the present status of acceptances, and the indications that a number of Members, including the delegation of Thailand, which so indicated today, are actively pursuing domestic efforts in order to accept the Amendment, the United States supports the draft TRIPS Council proposal to the General Council for a Decision to extend the period for acceptances of the Protocol. 133. We would also encourage those delegations that have expressed criticism of the Paragraph 6 System under this agenda item to consider further the impact of their interventions on our shared efforts to encourage Members to accept this important Amendment. We urge caution regarding suggestions that its use indicates flaws in the System. We do not share this view. We also think Members should take full advantage of meetings of this Council. If Members have information to share that is relevant to acceptances of the Amendment, it should be presented at our meetings, including the presently, and not held for some future date at some future event. The time is now to deliver on a decade-old promise on public health. 134. As we have explained, there are multiple avenues available for promoting access to medicines. The Paragraph 6 System is important, but it is not alone. Appropriate mechanisms for transparency, procedural and due process protections, and opportunities for public engagement are important in the context of health care systems. 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. 135. We continue to believe that the access to medicines issue is multidimensional. Making life saving medicine available requires transparency and a commitment to address measures that unduly delay patients from getting the treatments they need. For example, we continue to have a great interest in hearing from other delegations regarding their efforts related to trade to facilitate such access. For instance, what measures have been taken by those Members identified in the 2012 staff working paper entitled, "More Trade for Better Health? International Trade and Tariffs on Health Products" as maintaining the highest tariffs, bound and applied, on medicines, medical inputs and medical devices? We recall the Uruguay Round pharmaceutical zero-for-zero agreement including the United States and other WTO Members. Are other WTO Members preparing to do the same? 136. Finally, while we are not in a position to accept the proposal due to a lack of information on this suggestion, we support the suggestion made by the EU. We also confirm our support for the proposal to extend the period of acceptance of the amendment for another two years.

The Council took note of the statements made.

7.1. The Chairman 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.

7.2. He said that the records of the Council's earlier reviews continued to provide a unique and valuable resource for understanding this important measure. This included the records of the reviews in 2010 and 2011 when the Council had held a more structured debate on the basis of lists of topics for the discussion that had been agreed in advance. These earlier records and lists of topics might also inform discussions at the present review. If Members felt that any questions posed at earlier reviews regarding the Paragraph 6 System itself or possible alternatives to it were not adequately addressed at those reviews, they should feel free to revert to any such questions.

7.3. The Secretariat had prepared a draft cover note for the Council's report modelled on previous years' reports (circulated as JOB/IP/13). He suggested that the Council take up the preparation of its report to the General Council after it had exhausted its discussion. The cover note of the report contained a list of Members that had notified their acceptance of the Protocol Amending the TRIPS Agreement (WT/L/641). The following Members had deposited their instruments of acceptance since the Council's last meeting in June: Moldova on 7 July, Kenya on 21 July, Saint Kitts and Nevis on 27 July, Sri Lanka on 9 September, Lao People's Democratic Republic on 29 September, and Iceland on 12 October.

7.4. The Chairman further recalled that the Protocol had been originally open for acceptance by Members until 1 December 2007. Upon proposals by the Council for TRIPS, the General Council had four times extended this period for further two-year periods. At present, the period ran until 31 December 2015. The TRIPS amendment would enter into force once two thirds of the membership had accepted it. For this to happen, another 21 instruments of acceptance needed to be deposited with the Director-General. He strongly encouraged those Members, especially developing country Members, who were yet to complete their domestic procedures to do as soon as possible. If needed, the Secretariat could assist Members concerned regarding the steps that were required in order to accept the Protocol.

7.5. The representative of the WTO Secretariat took the floor.

7.6. The Chairman noted that the vast majority of Members that had already deposited their instrument of acceptance had done so before adopting implementing legislation, if at all, which was not required by the amendment.

7.7. He reported that, at the informal meeting on 14 October 2015, some delegations had reiterated the proposal that a workshop open to all stakeholders be jointly organized by the WTO, WHO and WIPO as part of their trilateral cooperation. While other delegations had indicated their readiness, in principle, to consider such a proposal, they had asked for more information regarding the issues to be covered by such a workshop. He encouraged the proponents to explore the proposal in their direct contacts with other delegations.

7.8. The representatives of Canada, India, Australia, Cuba, Chinese Taipei, Egypt, Brazil, Indonesia, Thailand, Chile, the European Union, New Zealand, Ecuador, Switzerland, Japan, the United States, Bangladesh on behalf of the LDC Group, South Africa, and Uganda took the floor.

7.9. The Council took note of the statements made.

7.10. Turning to the draft cover note for the Council's report (circulated as JOB/IP/13), the Chairman said that, 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 this agenda item might be attached to the cover note. He also suggested that the report be updated in order to take account of the instruments of acceptance that had been deposited since the circulation of the initial draft report.

7.11. He said that the Protocol had originally been open for acceptance by Members until 1 December 2007. At present, the period ended on 31 December 2015. Given the proximity of this date, the Council might wish to consider again submitting a proposal to the General Council for a decision to extend the period for the acceptance of the Protocol. For this purpose, a draft decision that could be submitted to the General Council for adoption had been included in Annex 2 to the draft report. As the draft proposal for a decision by the General Council did not yet contain a new deadline for the extended period for acceptances, he suggested that the Council propose to extend the period by a further two years until 31 December 2017.

7.12. In conclusion, 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 2017. The last paragraph of the draft decision by the General Council contained in Annex 2 to the draft report should be complemented by inserting this date. He also proposed that the Council agree on the cover note to the report contained in JOB/IP/13, with the update concerning the instruments of acceptance that had been deposited by Sri Lanka, Lao People's Democratic Republic, and Iceland since the circulation of the draft cover note, and also that the Council minutes containing the record of the discussion be attached to it.

7.13. The Council so agreed.

IP/C/M/80, IP/C/M/80/Add.1