Ambassador Mero (United Republic of Tanzania)

États-Unis d'Amérique

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

198. The United States fully associates ourselves with the delegation and the intervention from Switzerland. We also want to thank the Secretariat for the update regarding the status of acceptances of the 2005 Protocol Amending the TRIPS Agreement. 199. The United States strongly supports the Paragraph 6 System as established under the 2003 waiver decision and the 2005 Protocol. 200. The United States congratulates the significant number of countries who have formally accepted the amendment since last year's review. This is a significant achievement. We encourage other Members to notify their acceptance of the amendment so that it can enter into force. 201. Finally, again, we want to welcome the Secretariat's efforts, I think Chinese Taipei also referred to it, and draw delegations' attention to the WTO TRIPS webpage where Members can find an "Illustrative guide to notifying under the Paragraph 6 System." This is quite a helpful document. We have taken a look at it. It is easy and it is very understandable so we commend the Secretariat's work in this regard and join Chinese Taipei in that respect. 202. There are multiple avenues available for promoting access to medicines. The Paragraph 6 System is of course important, but it is not alone. As raised through the Public Health Workshop held at the WTO the week of 17 October as referenced by the European Union, there are many mechanisms that governments can use to promote access. Such improvements are the building blocks for a sustainable healthcare system. These include, as cited in the October Workshop: • strong and effective procurement systems and processes; • supply chain management, including reliable data regarding actual demand; • improvements in notification systems and coordination with producers; • strong and efficient regulatory control of assured quality of medicines; • eliminating retail mark-ups through more efficient distribution and dispensing systems; • advance policies that combat substandard and spurious, falsely labelled, falsified; or • counterfeit (SSFFC) medicinal products that displace innovative and generic drugs; and • eliminating taxes and tariffs. 203. For example, taxes or tariffs may be levied - often in a non-transparent manner - on imported medicines and the increased expense associated with those levies is then passed directly to healthcare institutions and patients. For example, in a review of tariffs as applied and bound on medicinal products, we see ranges of 25% to 40% on tariffs at the border with respect to pharmaceutical products. We see applied levels of 10% or 7.5% but that is not the end of the analysis. We see an additional 13% by some Members added as other duties and taxes creating an applied rate of 21% on pharmaceuticals. 204. We continue to believe that the access to medicines issue is multidimensional. Making lifesaving medicines available requires transparency and a commitment to address measures that unduly delay patients from getting the treatments they need.

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