H.E. Ambassador Lundeg Purevsuren

India

6 ANNUAL REVIEW OF THE SPECIAL COMPULSORY LICENSING SYSTEM (PARAGRAPH 7 OF THE ANNEX TO THE AMENDED TRIPS AGREEMENT AND PARAGRAPH 8 OF THE DECISION ON THE IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH)

139.   India attaches high importance to the Doha Declaration on the TRIPS Agreement and Public Health, the Paragraph 6 System as established under the 2003 Waiver Decision and the Protocol Amending the TRIPS Agreement. India is one of the first few countries that notified its acceptance of the Protocol in March 2007. 140.   India has always been of the view that the Doha Declaration on TRIPS and Public Health constituted a major landmark in the history of the WTO because it recognized the primacy of public health needs and the preparedness of the Organization to address the problems in access to medicines faced by the poor in developing countries. The 2003 Waiver Decision was expected to address the public health problems faced by Members with insufficient or no manufacturing capacities in the pharmaceutical sector. It may have sounded prophetic at that time when India voiced certain apprehensions in the GC meeting of August 2003 by stating: "the results accruing from this mechanism should not be negated by the creation of cumbersome systems that would lead to huge delays in getting medicines across at reasonable cost to those that needed them or discourage Members from using the system for the benefit of the people. In order to make this system successful, a sincere collective effort is required on the part of all Members and the entire pharmaceutical industry". Regrettably, we have been proven right. The export of HIV/AIDS medicines by the Canadian pharmaceutical company Apotex to Rwanda in September 2008 has been the first and only use of the system so far. 141.   The United Nations Secretary-General’s High-Level Panel on Access to Medicines, in its report released in September 2016, also recognized that the Paragraph 6 System is complex and cumbersome. 142.   My delegation urges Members to constructively engage on improving the Paragraph 6 System for making it more workable and effective, so that it can benefit Members with insufficient or no manufacturing capacities in the pharmaceutical sector.

The Council took note of the statements made and so agreed.

21.   The Chair recalled that the review of the Special Compulsory Licensing System had been conducted pursuant to paragraph 6 of the 2003 Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health. Since the entry into force of the Protocol Amending the TRIPS Agreement on 23 January 2017, the review also responded to the requirements that had now been incorporated into the amended TRIPS Agreement.
22.   Paragraph 7 of the Annex to the amended TRIPS Agreement and paragraph 8 of the 2003 Waiver Decision required the Council to review the functioning of the System annually, with a view to ensuring its effective operation. They also required the Council to report annually on the System's operation to the General Council. In the case of the Waiver Decision, the review was also deemed to fulfil the requirements of Article IX:4 of the WTO Agreement.
23.   He suggested that: (i) he would brief the Council on the status of acceptances of the Protocol Amending the TRIPS Agreement; (ii) he would offer the floor to delegations for an exchange of views about the functioning of the System; and (iii) the Council would consider the draft report to the General Council.
24.   He noted that the current period for accepting the Protocol Amending the TRIPS Agreement ran until 31 December 2019. To date, the amended TRIPS Agreement was binding for 128 WTO Members. In other words, 36 Members were yet to accept the Protocol Amending the TRIPS Agreement. He encouraged those Members to complete their domestic procedures as soon as possible.
25.   When the TRIPS Amendment entered into force in January 2017, Members had noted that it would be useful to consider how to make this new procurement tool work effectively in practice. He encouraged delegations to engage in a constructive discussion, which could also build on earlier reviews. As previous Chairs and he himself had indicated on past occasions, delegations might find two documents particularly helpful to facilitate their considerations: (i) the Council's Annual Review of 2016, circulated as IP/C/76; and (ii) the Secretariat's 2016 Report on Technical Cooperation Activities, circulated as IP/C/W/618. Annex II of that report summarized key issues that delegations might wish to consider supporting the practical use of the System. He invited delegations to exchange views about the functioning of the System.
26.   The representatives of India; Brazil; South Africa; Canada; the United States of America; Japan; and Zimbabwe took the floor.
27.   The Chair noted that a draft report had been prepared by the Secretariat. It was modelled on previous years' reports and had been circulated as JOB/IP/34. It contained factual information on the implementation and use of the System. It also included a list of Members who were yet to accept the Protocol Amending the TRIPS Agreement. As with previous reports, an extract from the Council's minutes on this agenda item would be attached to the report in Annex 1.
28.   The Council also had to decide whether to extend the period for acceptance of the Protocol, which currently ran until the end of 2019. Since 36 Members had yet to accept the Protocol, he suggested that the Council once again extend the period for acceptance for another two years, until 31 December 2021. A draft decision for the General Council had been included in Annex 2 of the Draft Report. He invited delegations to comment on the draft report and, to clearly indicate whether they agreed to the 2-year extension of the period of acceptance.
29.   The representatives of Barbados and India took the floor.
30.   The Chair proposed that the Council agree to: (i) adopt the draft report, on the understanding that the record of today’s discussion would be attached to it as Annex 1; and (ii) to submit, for the General Council’s adoption, a decision to extend until 31 December 2021 the period for the acceptance by Members of the Protocol Amending the TRIPS Agreement.
31.   The Council took note of the statements made and so agreed.

IP/C/M/93, IP/C/M/93/Add.1