Ambassador Mero (United Republic of Tanzania)

Union européenne

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

172. The European Union believes that the entry into force of the Protocol will be an important signal that will ensure a legally secure, predictable, effective and sustainable solution for those countries wishing to use the TRIPS flexibilities to get affordable medicines. 173. Therefore, the European Commission will continue to encourage and work with the remaining WTO Members so that they accept this Protocol and allow the amendment of the TRIPS Agreement to enter into force as soon as possible. 174. We have much appreciated a series of side events regarding this issue, including the one we assisted today. We are pleased to note that, as we pointed out a number of times, these events are extremely useful to have discussions about the issues that are addressed more formally here in the TRIPS Council. They are very valuable and allow good debates with people from the outside, with other stakeholders, and to hear different opinions. 175. We certainly appreciate clarifications that were presented today according to which the Paragraph 6 System is very much a last resort option which is most useful at the end of a long list of alternatives. Alternatives like the ones that were mentioned by my colleague of South Africa a few minutes ago, but also negotiating alternatives. 176. That takes us to another event that we consider extremely valuable for the debate, i.e. the Workshop that was organized by the Secretariat. We participated with pleasure and a lot of interest. The part of the Workshop that I assisted was very valuable. We saw presentations of issues that have not been raised today and that are rarely raised in this venue, including how countries use the Paragraph 6 System as a negotiating mechanism. This takes us back to the fact that it is a last resort mechanism. We heard experiences of officials saying how in the discussion process with a right holder the possible use of this mechanism was there as an additional strong negotiating tool and how in most cases, and increasingly so in recent years, this had led to a good agreement with the right holder without necessarily triggering the formal steps of the mechanism. 177. This being said, in Europe we have put in place legislation for this already in 2007. It has never been used so it is very difficult to assess. I see with some surprise how people are so certain that the System does not work based on only one case of use. In Europe, as far as we are aware because compulsory licences are managed at Member State level, there was never any attempt to use this System. We therefore wonder how people can state that it is burdensome and impossible to use. This debate is maybe a little bit more complex than it is sometimes presented and certainly proposals to review the Paragraph 6 System are way too premature at this stage.

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