Ambassador Mothusi Palai (Botswana)

Switzerland

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

181. I would like to react to some of the criticism that we have heard in the discussion in the Council this morning on the Paragraph 6 System. Some Members have said that the System has not fulfilled its objective of addressing the access to medicines problem of potential beneficiary countries. It is important to recall in this context that the mandate in the Doha Declaration on the TRIPS Agreement and Public Health as well as the solution eventually found was not, and could not have been, to solve the access to medicines problem for countries without manufacturing capacity. The mandate was merely - but importantly - to put all WTO Members on a level playing field with regard to the use of compulsory licences as a policy tool provided under the TRIPS Agreement. The Paragraph 6 System has achieved this objective, as is evidenced by the Rwanda-Canada case. 182. This is not to say that my delegation considers the grant of a compulsory licence as a good or even easy-to-use tool to be applied and implemented to facilitate access to medicines in a specific situation of a health need. In practice, the grant and implementation of a compulsory licence may pose a number of problems and challenges which can render it burdensome and inefficient as a tool, not allowing for the quick access to medicines required. But this may be true for any compulsory licence, whether granted under the Paragraph 6 System or not. 183. Having said this, what the Paragraph 6 System did achieve is that it allows all WTO Members to make use of this policy tool. The mere possibility of doing so may be the biggest benefit of the System, as it improves a Member's negotiating position vis-à-vis manufacturers in the case of a public health situation where a particular medicine is required and still under patent protection. This may be one of the very reasons why, in practice, the Paragraph 6 System has not been used more often. 184. Regarding the criticism that the mechanism is burdensome and complicated, in our annual reviews since 2003, we have not heard from potential beneficiary countries any specific and real case evidence of problems they have encountered when they wanted to make use of the System. In this context it is also recalled that the safeguards under the Paragraph 6 System are mainly geared to avoid diversion of medicines produced under a special compulsory licence. They shall make sure that these medicines actually reach the beneficiary country rather than being diverted for commercial purposes to other, more affluent markets. 185. My delegation does therefore not agree with others who said that our annual review has become ritualistic, nor do we see any merit of inviting external stakeholders to the Council's discussion before we have heard from potential beneficiary Members what difficulties they may have encountered when they actually had wanted to make use of the Paragraph 6 System.

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