Minutes - TRIPS Council - View details of the intervention/statement

Ambassador Mothusi Palai (Botswana)
World Trade Organization
187. As in the past, we are taking the opportunity to update Members on the work done by the Secretariat in the field of technical cooperation dealing specifically with the Paragraph 6 System, but also more broadly concerning intellectual property and public health, in view of the way in which technical cooperation in this field is undertaken. 188. The three partner organizations, the Secretariats of the WHO, WIPO and the WTO, have continued their trilateral cooperation in the field of intellectual property, trade and public health with a view to fostering a better understanding of the linkage between those three policy domains and to enhance the mutually supportive implementation of policies in those areas. This means that we increasingly work together to coordinate, design and carry out capacity building activities in this area. This work is undertaken on the foundation of the trilateral study which has already been referred to by delegations. 189. The study, "Promoting Access to Medical Technologies and Innovation", was launched last year as a shared platform for technical assistance and capacity building for policy makers in those areas of policy spanning the intersections of public health, trade and intellectual property. It includes specific material on the background and implementation of the Paragraph 6 System of special export licences for medicines. The System has been continuously addressed at almost all of our major technical cooperation activities in the past period under the review. In particular, it was covered by the 11th Joint WIPO-WTO Colloquium for Teachers of Intellectual Property and the 6th Joint WIPO-WTO Advanced Course on Intellectual Property for government officials; it was covered in more detail in the 9th Annual Workshop on Intellectual Property and Public Health organized by the WTO itself. 190. This workshop was held in December 2013, in close collaboration with our colleagues in WHO and WIPO. The goal was to draw together each organization's particular expertise in a complementary manner and to put into practice the comprehensive coordinated approach outlined in the trilateral study. The workshop was accordingly a direct follow-up to the study and followed its content in practice. The study itself often served as starting point for the presentation and discussions at the workshop. Further, as with past workshops, the emphasis was on hearing a diversity of views, practical experience, and policy perspectives. This workshop covered a wide range of issues, including the intellectual property and TRIPS issues specifically relating to the Paragraph 6 System, but also other areas of intellectual property law and the provisions and the flexibilities within the TRIPS Agreement. The breadth of stakeholders taking part as experts and speakers included a range of officials from the three partner organizations, but also experts from elsewhere in the international system and the United Nations system, as well as representatives of industry, the philanthropic sector and civil society organizations, with a view to providing a rounded view of the issues at the crossroads between intellectual property and public health. 191. Building on the series of joint policy symposia that the three organizations have held, the most recent hosted by WIPO in July last year on medical innovation and changing business models, the three organizations will be convening the fourth in this series of trilateral technical symposia on 5 November 2014. It will focus on "Innovation and Access to Medical Technologies - Challenges and Opportunities for Middle-Income Countries". The idea is to focus on the concept of middle income countries. The chief economists of WIPO and WTO will be joined by the Director of Health Systems Governance from WHO for a discussion on the policy significance of middle income countries in general in relation to innovation and access issues. The following session will turn to the innovation dimension, concerning how to measure the innovative capacity in the medical sector in middle income countries and looking at the factors that are behind the success in innovation in those countries, as well as at overall trends. Discussions will then turn to the challenge of ensuring access to medical technologies and the kind of policies, initiatives, measures that have been explored in those areas by middle income countries. The emphasis as in the past is to draw on practical experience, a breadth of perspectives from those working in the field who can bring to the Geneva policy community a broader understanding of their practical activities and programmes, as well as on the policies and the initiatives in middle income countries. 192. The series of workshops on Intellectual Property and Public Health has proceeded for 10 years and has been progressively broadening in scope from a specific focus on TRIPS and intellectual property issues to address the broader trade and health aspects as well. The eleventh workshop in this series will be held in Geneva from 24-28 November, once again in close collaboration with the Secretariats of the WHO and WIPO. It will closely track the trilateral study as a foundation for inclusive, comprehensive and holistic capacity building in this area. 193. Intellectual property, TRIPS and public health, as well as the Paragraph 6 System, have also been regular items at other training activities such as regional and advanced trade policy courses, the Geneva Week programme for non-resident delegations, as well as a number of national workshops. The WTO Secretariat has also offered ad hoc advice to Members upon request. This information has included specific advice on the Paragraph 6 System, including the process for acceptance of the Protocol of Amendment of the TRIPS Agreement. Here, we have been able to assist along the lines of previous discussions in the TRIPS Council identifying the specific steps that are needed for acceptance of the Protocol. A number of Members have taken the step of accepting the Protocol without any domestic implementing legislation. It is clearly not a prerequisite for acceptance to pass domestic legislation: the instrument of acceptance of the protocol entirely focuses on signalling legal agreement that other Members are entitled to use the System if they so wish. We see different experiences in terms of accepting the TRIPS amendment on the one hand, and practical steps to implement the System in domestic law on the other hand, with Members treating these generally as distinct steps. This distinction has been usefully clarified in conversation with a number of Members. This agenda item also has links to the first agenda item, on notifications under the TRIPS Agreement: there has been significant amount of legislative activity among Members to implement, but we are aware that not all of this legislation has been notified. Up to date notification of such implementing legislation is one element that could help inform our work on the System. 194. Finally, concerning the acceptance process, as directed at a previous session of the TRIPS Council, the Secretariat has prepared a model notification of acceptance: this is available online, and we can share a copy with any interested delegation. The key point is that this is a very straightforward and simple document, and the procedure is not complex. The instrument of acceptance simply has to be executed by someone with the requisite authority in the government, such as the minister for foreign affairs.
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