Ambassador Mero (United Republic of Tanzania)

Sudáfrica

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

166. The Doha Declaration stresses that TRIPS can and should be interpreted and implemented to support the right to health and promote access to medicines for all. The Sustainable Development Goal target of achieving universal health coverage by 2030, requires strong government and international leadership to effectively implement access to essential medicines. 167. South Africa notes that the number of notifications required for the entry into force of the Protocol Amending the TRIPS Agreement is now fewer than ever. We would encourage all Members who have not yet done so to deposit their notifications in order for the Protocol to enter into force. This will mark a significant landmark toward the realization of access to essential medicines. 168. As the sources of generic drugs are substantially depleted over time, the most effective method by which a country with insufficient or no manufacturing capacity may obtain certain medicines at competitive prices is through the use of the Paragraph 6 System. In addition, the Paragraph 6 System may prove to be increasingly important for HIV/AIDS patients who need to shift to second-line or third-line treatments. Studies indicate that at least 22% of people on treatment would have to switch over to second-line treatment within a five-year period. Second and third-line treatments are substantially more expensive, costing up to four to eleven times as much as first-line treatments. For these treatments and other widely patent protected treatments, the Paragraph 6 System may prove to be an important mechanism for obtaining a bulk of the medicine at a competitive price. 169. Having said this, it is indeed not the end of the story since the Paragraph 6 System has been reviewed since 2004. During this time a rich debate has emerged between Members regarding their experiences of the use of the System. This review mechanism continues to provide Members with an opportunity to exchange their views and to devise ways to make the System more effective. As already mentioned by India and Brazil, the side event hosted this afternoon (of which South Africa is a co-sponsor), clearly outlined many criticisms associated with the Paragraph 6 System including the length of time it takes to use it. Procedural and other substantive complexities make it difficult to effectively use the System, while many developing countries face severe political pressures when they consider using it. Raising these criticisms is not an attempt to undermine the System, but is indeed an attempt to fully understand the challenges that countries face when they want to use it. 170. The review should not be an opportunity for delegations to repeat longstanding arguments. Our focus should be to ensure that the System does not remain a flexibility that is consigned to a piece of paper, but to move forward to a substantive review of the System and its functioning, including through the more systematic collection and sharing of information. The world has changed since the System was first introduced. Many more factors now influence its operation, including the introduction of many so-called access initiatives that are likely to limit the need to use the System; the steady increase in the number of voluntary licences that can make its use redundant; while developments under RTAs may further erode the actual use of the System. 171. In concluding, we further note that the Report of the United Nations Secretary-General's High Level Panel on Access to Medicines, recommends that WTO Members should revise the Paragraph 6 decision in order to find a solution that enables a swift and expedient export of pharmaceutical products produced under special compulsory license. South Africa looks forward to hear other Members' views in this respect and remains available for any further discussion on the points raised in the High-Level Panel Report.

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