Ambassador Mothusi Palai (Botswana)

World Intellectual Property Organization (WIPO)

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

195. During the period from November 2013 to September 2014, WIPO provided legislative and policy advice on patents that referred to or included considerations regarding paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health as follows: At the request of eight Member States, the WIPO Secretariat prepared comments on draft laws which included reference to, or implemented, paragraph 6 of the Doha Declaration. In the framework of legislative assistance on patents, matters related to health policies, including paragraph 6 of the Doha Declaration, were also addressed in the context of two missions that were undertaken to capitals and two consultations that took place in WIPO headquarters in Geneva. Legislative implementation of patent law matters, including the international legal framework provided by the TRIPS Agreement, was addressed in the following seminars or meetings: i. WIPO Sub-Regional Workshop on Patent Law and Policy, Santiago, Chile, 3-4 December 2013; ii. WIPO National Workshop on Patent Policy and its Legislative Implementation, Santo Domingo, Dominican Republic, 29-30 April 2014; and iii. WIPO Regional Seminar on Issues of Patent Protection for Medicines, Bishkek, Kyrgyz Republic, 28-29 May 2014 WIPO staff participated in WTO Seminars, where the topic of patent-related flexibilities, including paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health has been dealt with, as follows: i. National Seminar on the WTO TRIPS Agreement, Addis Ababa, Ethiopia, 12-13 November 2013; ii. WTO National Workshop on the TRIPS Agreement, Naypyidaw, Myanmar, 20-21 November 2013; iii. WTO National Seminar on Public Policies concerning the TRIPS Agreement, El Salvador, San Salvador, 21-23 January 2014; iv. WTO Workshop on the TRIPS Agreement and IP related matters, Port Louis, Mauritius, 5-7 March 2014; v. WTO Annual Workshop on IP and Public Health, Geneva, 10-13 December 2013; and vi. WIPO-WTO Colloquium for Teachers of IP, Geneva, Switzerland, 16-27 June 2014. 196. WIPO's legislative assistance is consistently based on the multilateral legal framework. More recently, a number of national authorities in charge of drafting laws have sought advice from WIPO regarding how to use the available multilateral flexibilities so as to accommodate particular national interests that are specific to their countries. Since Paragraph 6 of the Doha Declaration is part of those flexibilities which are considered by several countries as part of their access-to-medicine policies, this issue is regularly covered by WIPO legislative and policy assistance. 197. The following is an update on WIPO Re:Search: • As reported to the TRIPS Council in October 2013, WIPO Re:Search is a platform launched by WIPO with the participation of the public and private sector. Its purpose is to catalyze more research for Neglected Tropical Diseases (NTDs), malaria, and TB through the sharing of IP assets between researchers in this field. NTDs, malaria and TB affect more than one billion people globally, and usually affect the most disadvantaged populations in developing countries. To generate more investment in innovation directed at these diseases, WIPO worked with public and private sector partners and created WIPO Re:Search in 2011. Its purpose is to create a new mechanism to facilitate the sharing of IP assets between public and private sector partners. For example, private sector companies have large libraries of pharmaceutical compounds and related information, but they are not generally investing substantially in NTD research. Yet, this information could be valuable to researchers that are focusing on these diseases. WIPO Re:Search was launched on 26 October 2011, with about 30 members, including pharmaceutical companies, research institutions and a range of public and private entities as members. • To date, WIPO Re:Search has more than tripled its membership, with 92 members currently. • Importantly, WIPO Re:Search has more than 17 members from the African continent, representing the public and private sectors, and academia. • 14 new Members, including a major private sector company, have joined since our report to the TRIPS Council in 2013. • Over 79 collaborations have been initiated, and more are in development. There were approximately 30 in October 2013. • Four scientists, from Egypt, South Africa, Nigeria, and Cameroon have completed research sabbaticals at WIPO Re:Search Members in Switzerland, India, and the United States. A fifth scientist, from Ghana, will return to the University of California, San Francisco, USA, to complete the second half of his sabbatical. This programme, funded by the Government of Australia, has become one of the most successful examples of capacity building and knowledge transfer facilitated by WIPO Re:Search. The programme is likely to be extended in 2015. • An additional example of technical assistance and capacity building provided by WIPO Re:Search is the upcoming Intellectual Property Management Workshop organized by WIPO with the financial support of the Government of Australia in November 2014. Fifteen scientists from a range of African countries will benefit from this programme, which is one of the 'supporting services' of WIPO Re:Search. The WIPO Re:Search website (http://www.wiporesearch.org/) provides further information.

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