Actas - Consejo de los ADPIC - Ver detalles de la intervención/declaración

Ambassador Mero (United Republic of Tanzania)
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
187. I would like to add the thanks from my delegation to my neighbour who has just intervened and to the Director-General and to yourself and the WTO Secretariat for all your efforts to secure the necessary number of acceptances of the Protocol during this year. We certainly commend those 15 WTO Members who have completed their acceptance procedure so far this year. 188. We also thank the WTO Secretariat for holding its 12th Workshop on Trade and Public Health, as noted in its annual report in document IP/C/W/618, as a capacity-building Workshop to raise awareness about the System and to help Members make effective use of it. 189. Switzerland was among the first WTO Members to put in place the necessary legislation to enable the System at the national level and use of the mechanism for export. According to information available from the WTO Secretariat, more than 52 WTO Members have done so by today covering about 80% of current medicines export capacity. This was done on the basis of the waiver solutions agreed in 2003, and in spite of the fact that the TRIPS Amendment has not yet entered into force. This demonstrates the commitment and the support of WTO Members for the use of the Paragraph 6 System. In the Paragraph 6 Review in the TRIPS Council, Members have confirmed this political support and encouragement for use of the System. 190. I would like to refer to two points that have been mentioned by preceding speakers. One was the complexity and cumbersomeness of the System that was claimed. However, in our recollection, in past reviews in this Council of the Paragraph 6 System, we have not heard, at least not from potential beneficiary Members, of cases where the System needed to be used, but was not used or dropped because it was too complex, or that the process of making it proved to be not workable at any specific stage of the System. 191. When we look at the System it seems quite straightforward. The WTO Secretariat is assisting Members who may want to use the Paragraph 6 System very helpfully through all the information and the special dedicated website on the WTO site. Notifications certainly should not pose a problem. 192. Concerns were raised with regard to the need of having to mark medicines that are produced under special compulsory licence. Switzerland has argued in earlier reviews that such special marking of medicines is in the very interest of the potential beneficiary country because it will ensure that the medicines produced under such a special licence reach the people who need these medicines. 193. Also, the requirement for the generic producer under such a licence to put up a website has been described as cumbersome. However, I believe hosting a website for a generic manufacture capable of actually assisting under this System should not pose an unsurmountable hurdle nowadays. 194. Having said this, compulsory licences are as such not an easy and quick-fix solution to address the broader problem of sustainable access to affordable medicines – whether in developing countries or any other WTO Member. Implementing a compulsory licence, and again I refer to normal or special compulsory licences even once granted, pose their own challenges. A generic manufacturer needs to be found who is ready, willing and available to produce the medicine needed and the quantities needed within a short time-period at an affordable and competitive price and at the required quality and safety standards. This demonstrates that a compulsory licence is never a quick-fix solution and this cannot be remedied by the Paragraph 6 System or by revising it for that matter. 195. Also, the fact that the System has only been used once so far was taken as evidence that the System is not workable. However, I believe it is important to note, as stated by the EU, that the Paragraph 6 System does not have result in the grant of an export licence. One of its key benefits is to give all WTO Members, including those without manufacturing capacity in the pharmaceutical market, the negotiation leverage when they need to address a specific public health problem and to negotiate with potential manufacturers the price and any delivery conditions for receiving the needed medicine. That was the very basis of the mandate that Ministers gave the TRIPS Council in the Doha Declaration on the TRIPS Agreement and Public Health. Their intention was to ensure that this policy flexibility that was identified and confirmed in the Doha Declaration would be available to all WTO Members equally. 196. The case of Canada-Rwanda was the first one and was not an easy one. Always when you do a thing for the first time, you learn lessons. Therefore, we do believe that the Paragraph 6 Review, within this Council, is extremely beneficial for Members to exchange and share experiences made, raise concerns so that all can learn for any next use of the Paragraph 6 System. 197. We have also heard that in many cases the Paragraph 6 System might not have been needed since medicine was available from a country or manufacturer in a country where this medicine was still available off patent. It has also been mentioned in that context that in the future this might be less often the case. In my delegation's view, this only raises the importance of the Paragraph 6 System in the future. Therefore, we very much welcome the discussions in this Council under the Paragraph 6 Review so that we can learn how to make this System and its application in practice more useful to potential beneficiary countries.
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