Ambassador Mero (United Republic of Tanzania)

Brésil

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

155. The Paragraph 6 System represents the recognition of the importance of international solutions for public health emergencies. In the Doha Declaration, Members of the WTO recognize that countries with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licences under the TRIPS Agreement. The System that implements the Decision has only been used once in 13 years. According to the Report of the UN Secretary General's High-Level Panel on Access to Medicines, "some note that multilateral health financing has removed the need for resource constraint countries to use it. Others argue that it is too complex to be used. The only time the mechanism was used it proved to be complex and cumbersome and serious questions remain as to its effectiveness. More than ten years after WTO Members agreed to transform the temporary waiver into an amendment of the TRIPS Agreement, the amendment is yet to be accepted by two-thirds of the WTO Members. At a time of increased political commitments to enhance local pharmaceutical production in developing countries, attention should be paid to incorporating an efficient easy-to-use compulsory licensing provision into domestic legislation". 156. We would like to highlight the importance of this periodic review of the implementation of the Paragraph 6 Mechanism which will become even more necessary after the entry into force of the TRIPS Amendment. We were glad to be co-sponsors of the South Centre initiative to host a side event to the TRIPS Council on the subject. We had the opportunity to hear from representatives from industry, government, non-governmental organizations and academia their assessment of the System. We will continue to contribute constructively to discussions on the improvement of the System.

The Council so agreed.

25. The Chairman said that Paragraph 8 of the Decision required the Council to review the functioning of the System annually, with a view to ensuring its effective operation. The Council was also required to report annually on its operation to the General Council. This review was deemed to fulfil the requirements of Article IX:4 of the WTO Agreement.

26. He suggested that the Council start with an exchange of views between Members about the functioning of the System. He encouraged Members to engage in a constructive discussion which could usefully build on the records of earlier reviews which continued to provide a unique and valuable resource for understanding this important measure. The reviews in 2010 and 2011 had taken the form of a structured debate on the basis of lists of topics for the discussion that had been agreed in advance. The General Council's Aide Mémoire circulated on 20 February 2015 (WT/GC/W/696) was also a useful resource; it set out the expected benefits of the Paragraph 6 System and provided a model instrument of acceptance.

27. After that discussion, the Council could then consider the report to the General Council. A draft cover note modelled on previous years' reports had been circulated as JOB/IP/18.

28. The Chairman updated the Council on the status of acceptances of the Protocol Amending the TRIPS Amendment (WT/L/641). The current period for accepting the Protocol ran until 31 December 2017. Fifteen instruments of acceptance had been deposited in 2016, including instruments from Papua New Guinea, Peru, and Belize since the Council's meeting in June 2016. All Members that had notified their acceptance were listed in the cover note of the draft report prepared by the WTO Secretariat, as well as the dedicated WTO webpage that was regularly updated. Only five more instruments of acceptance were needed to trigger entry into force.

29. He strongly encouraged those Members who were yet to complete their acceptance procedures to do as soon as possible. His call upon these Members echoed the multiple efforts Director General Azevêdo and his predecessors had made since 2015 to secure the entry into force of the Protocol. The Director-General in his contacts regularly emphasized that this was not only a priority for the WTO, but represented a concrete contribution that WTO Members could make to global efforts to strengthen the legal framework for access to medicines. Providing the necessary legal certainty for the export of much needed medicines through the permanent incorporation of the Paragraph 6 System into the TRIPS Agreement would, in particular, also respond to many calls for its timely implementation and entry into force that emanated from the multilateral system, including most recently the Political Declaration on HIV and AIDS that had been adopted by the UN General Assembly in June 2016.

30. He invited the WTO Secretariat to update the Council on the Paragraph 6 System, including on capacity building and on the process of acceptance.

31. The representative of the Secretariat took the floor.

32. The representatives of India, Brazil, Canada, Bangladesh, South Africa, the European Union, Australia, Japan, Chinese Taipei, Switzerland, the United States and Panama took the floor.

33. The Council took note of the statements made.

34. Turning to the Council's report to the General Council, the Chairman said that the Secretariat had prepared a draft cover note for the report which was modelled on previous years' reports and had been circulated as JOB/IP/18. It contained factual information on the implementation and use of the System, and the status of acceptances of the amendment Protocol. As for past reports, an extract from the Council's minutes on this agenda item might be attached to the cover note.

35. The Chairman proposed that the Council agree on the cover note to the report contained in JOB/IP/18 and also that the Council minutes containing the record of the discussion be attached to it.

36. The Council so agreed.

IP/C/M/83, IP/C/M/83/Add.1