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
147. India attaches high importance to the Doha Declaration on Public Health, the Paragraph 6 System as established under the 2003 waiver decision and the 2005 Protocol Amending the TRIPS Agreement. India had notified its acceptance of the Protocol in March 2007. We would like to congratulate Papua New Guinea, Peru and Belize who have deposited their instruments of acceptance of the Protocol since the last TRIPS Council meeting held in June 2016. So far, over 64% of WTO Members have submitted their instruments of acceptance for the TRIPS Protocol and five more Members have to submit their instruments of acceptance for entry into force of the 2005 Protocol Amending the TRIPS Agreement. 148. We have always been of the view that the Doha Declaration on TRIPS and Public Health constituted a major landmark in the short history of the WTO because it recognized the primacy of public health needs and the preparedness of the Organization to take up the problems faced by the poor in developing countries. Along with several other Members, India had worked relentlessly on the Doha Declaration and the Decision. The Decision established a framework for special compulsory licences, which is an additional flexibility aimed at enabling exports of medicines to WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector. However, the export of HIV/AIDS medicines by the Canadian pharmaceutical company Apotex to Rwanda in September 2008 has been the first and only use of the System so far. 149. The side event which was held today to discuss the challenges and problems associated with this Paragraph 6 Mechanism and the comments by experts has broadened our understanding on aspects related to the Paragraph 6 System, especially as regards its implementation so far, the challenges and opportunities involved, as well as the ways of improving the System to make it effective and meaningful. 150. Ms. Yuanqiong Hu from Medicines Sans Frontiers said that her organization had requested the HIV/AIDS medicines from Canada to supply Rwanda, but it had taken three years for the whole process to deliver because there were delays associated with regulatory approval, as well as discussions with patent holders which took a lot of time. At the same time, the HIV/AIDS medicines were available and supplied by Indian generic companies before Rwanda accorded supplies from the Canadian company Apotex. 151. The representative from Canada who spoke at the side event confirmed that the regulatory approval had taken close to six months, as compared to one year under the normal procedure, to ensure the quality, safety and efficacy of the drugs. The company had made losses and had supplied the tablets at a very cheap rate. He was also informed by some companies that they would never venture into providing medicines under this special compulsory licensing scheme. 152. Mr. Denis Broun, the representative of CIPLA, shared the experiences of a generic producer to manufacture under the System. There was no way to achieve economies of scale because of the limited quantities of medicines to be procured by the importing countries. He also noted requirements like special labelling and markings and the need for the generic company to host a special website and to pay remuneration to the patent holder. According to him, there was so much red tape built into the System that it was difficult for the Paragraph 6 Mechanism to achieve its intended purpose. Unless the procedures were simplified, his company would never use the System. 153. Ms. Suerie Moon, Director of Research, Global Health Centre, Graduate Institute of International and Development Studies opined that this was not a good System. It should be renegotiated before it entered into force as it was not workable. She also said that patenting in exporting countries like India was on the rise. In her view, the Paragraph 6 System needed to be made more workable for it to be used by countries. 154. Based on the experts opinion at the side event held today, we reiterate our concern that the Paragraph 6 System is too complex, cumbersome and administratively unwieldy for further use. I conclude by quoting the recommendation on the special compulsory license mechanism by the UN Secretary General's High-Level Panel on Access to Medicines in its report released in September. The recommendation was also endorsed by many experts at the side event. Recognizing the Paragraph 6 System as complex and cumbersome, the UNSG High-Level Panel on Access to Medicines has recommended 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 compulsory licence. WTO Members should, as necessary, adopt a waiver and permanent revision of the TRIPS Agreement to enable this reform."
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