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

H.E. Ambassador Xolelwa Mlumbi-Peter
7 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)
259.   My delegation would like to first thank the Chair, for your consultations held to prepare the review under agenda item 7. 260.   I would like to join other delegates to thank also the Secretariat for their technical assistance throughout the previous year and for the very useful, clear and concise overview of the functioning of the 31bis System and how beneficiary Members may make use of it. We hope the Secretariat will make the presentation available on the WTO's dedicated webpage, together with the other helpful information and the Guide to Notifications facilitating the use of the System. 261.   The presentation of the Secretariat showed that the use of the 31bis System by beneficiary countries is straightforward. In contrast, in their interventions India and South Africa called the System complex, cumbersome and not practical, citing as evidence that the System has been used only once so far. We disagree. 262.   The Secretariat recalled in its presentation that the purpose of adopting the System in 2003 was to extend the TRIPS flexibility of Article 31 of the TRIPS Agreement to eligible beneficiary Members without relevant manufacturing capacity in the pharmaceutical sector. It has not been conceived for frequent use. The System applies to eligible beneficiary countries, in a specific case scenario and under particular circumstances. There are many instances, where the reasons for a lack of access to needed medicines in potential beneficiary countries are not related to patent protection. And it is misleading to imply that the many casualties that today still – and tragically enough - result from insufficient and untimely access to medicines would be the result of IP or perceived deficiencies in the system provided by Article 31bis. 263.   By making the so-called Paragraph 6 System on patents and public health permanent in their decision of 6 December 2005 and amending the TRIPS Agreement formally by adding Article 31bis in its Part II Section 5, Members have ensured transparency, clarity and legal certainty. 264.   Should eligible beneficiary Members meet with concrete problems when actually making use of the System, then it is the Council's duty to examine these specific difficulties in its Annual Reviews and look into how they can be addressed best in a practical manner. So far, we have not heard of such practical problems. 265.   We call on those 33 Members who have not yet accepted the Protocol Amending the TRIPS Agreement to do so now without further delay. 266.   We were pleased, in this respect, to hear from the distinguished delegate from Chad on behalf of the LDC Group that they will undertake additional efforts to encourage their Members to accept the Protocol before the expiry of the extended deadline, and that he considered the 31bis System to be very useful from the perspective of a beneficiary country group.
30. The Chair recalled that, in the past, the review had been conducted pursuant to Paragraph 6 System 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.
31. 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, this review was also deemed to fulfil the requirements of Article IX:4 of the WTO Agreement.
32. During the Chair's consultations in September concerning Members' preferences for approaching the annual review, a number of Members had suggested that the discussion focus on concrete problems with the application of the System, rather than an abstract consideration of issues. Some had referred to procedural complexities of the System that needed to be discussed so that the System could ensure access to medicines as intended. Others had cautioned that this agenda item should not be "another COVID-19 item". One concrete proposal that had gathered broad support was the suggestion that the Secretariat give a presentation on how to use the Special Compulsory Licensing System (as opposed to how to accept the Amendment), so as to refresh delegations' memory and provide background to the discussion.
33. The Chair suggested that she would proceed by first informing Members about the status of acceptances of the Protocol Amending the TRIPS Agreement, and then give the floor to the Secretariat to provide a presentation on how to use the Special Compulsory Licensing System to remind everyone about the detail. The floor would then be open to delegations for an exchange of views about the functioning of the System, and finally, the Council would consider its Report to the General Council.
34. The Chair updated Members on the status of acceptances of the TRIPS Protocol. The current period for accepting it ran until 31 December 2021. The amended TRIPS Agreement was thus binding for 131 WTO Members. In other words, 33 Members were yet to accept the Protocol Amending the TRIPS Agreement. She encouraged those Members to complete their domestic procedures as soon as possible.
35. When the TRIPS Amendment had 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. The Chair therefore encouraged Members to engage in a constructive discussion which could also build on earlier reviews. As previous Chairs and she herself had indicated on past occasions, Members might find two documents particularly helpful to facilitate their considerations. The first document was the Council's Annual Review of 2016 (circulated in document IP/C/76); and the second document was the Secretariat's 2016 Report on Technical Cooperation Activities (circulated in document IP/C/W/618). Annex II of that report summarized key issues that delegations might wish to consider to support the practical use of the System.
36. The representatives of the WTO Secretariat, Chad (on behalf of the LDC Group), Ukraine, South Africa, India, China, Tanzania (on behalf of the African Group), Japan, Australia, the United States of America, Canada, Chile, Switzerland and the European Union took the floor.
37. The Council took note of the statements made.
38. The Chair turned to the Council's report to the General Council. A draft report had been prepared by the Secretariat (circulated in document JOB/IP/38). It was modelled on previous years' reports and contained factual information on the implementation and use of the System. Under the section on the Amendment to the TRIPS Agreement, it also included a list of Members who were yet to accept the Protocol Amending the TRIPS Agreement. As with past reports, an extract from the Council's minutes on this agenda item would be attached to the report in Annex 1 and Appendix 1.
39. The Council agreed to adopt the draft report and to attach the record of the discussion to it.
IP/C/M/96, IP/C/M/96/Add.1