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

Ambassador Mero (United Republic of Tanzania)
World Trade Organization
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
131. We have observed a steady rise in the rate of acceptances of the Protocol Amending the TRIPS Agreement in the course of this year. As you have noted, Mr Chair, to date already 15 Members have accepted the Protocol in this year alone. It is worth observing that if it were not for the very welcome fact of new Members acceding to the WTO in this period, the Protocol would have already entered into force some time ago earlier this year. 132. We are providing technical assistance on request to Members who are in the process of accepting the Protocol – and a number of Members have told us that they are at the final stages of their domestic processes. We are at the disposal of any delegation or Member who would need practical support in the acceptance process. As a very general observation, it often takes Members by surprise how straightforward and simple the process is. It is not a difficult procedure and we have the necessary model instruments of acceptance to facilitate the process. 133. The other aspect of the report concerns technical assistance for implementation. Document IP/C/W/618 is the regular annual report of the Secretariat's technical assistance activities in the area of TRIPS in general. We will be introducing that report briefly under that separate item later in this meeting. However, as for previous annual reviews of the Paragraph 6 System, because this has been a matter of particular focus and particular attention for technical assistance, we give a more focused update under this agenda item. 134. In general, TRIPS flexibilities with specific reference to public health have long formed a consistent element of our technical assistance activities. A strong impetus in this direction was given by the Doha Declaration on the TRIPS Agreement and Public Health; this flows through to the practical level of technical assistance in the TRIPS area. 135. This element of TRIPS implementation is also extensively covered in the Trilateral Study published jointly by WHO, WIPO and the WTO in 2013, which includes specific material on flexibilities for health and in particular the System of compulsory licences for export of medicines (also known as the "Paragraph 6" System). 136. This mechanism has also been a focus of an annual series of Workshops dealing with TRIPS and Public Health since 2005. These Workshops were conceived as cross-cutting programmes directed at a blend of health, trade and IP officials. As this series evolved over the years, it maintained coverage of the key issues concerning medicines, innovation and access to medicines from a TRIPS perspective, especially the use of TRIPS flexibilities. In addition, because of the demand received from Members, it provided an increasing focus on public health policy within a wider range of disciplines, including the human rights dimension. 137. Specifically looking at the use of TRIPS flexibilities and the implementation of the Paragraph 6 System of compulsory licensing for export, these capacity-building Workshops have evolved in line with progress in the domestic implementation of the System in many Members. In recent years, many more Members have introduced export provisions into their laws to facilitate the System as a tool for export. Accordingly, more recently, the Workshops have turned from looking at legislative implementation towards a more detailed look at how to make effective use of this additional procurement tool in practice so that affordable medicines do reach patients. 138. The most recent session of these series of Workshops, the WTO Workshop on Trade and Public Health, was held here in Geneva in October. The Workshop included updated capacity-building material on making effective use of special compulsory licences for export as a procurement tool for medicines. This material was tailored exactly for the mix of public health, trade and intellectual property officials that took part in the Workshop. The feedback and practical guidance provided by those officials will, as ever, guide us in updating and improving our technical assistance activities and programmes to enhance its practical relevance. 139. Some of the general points that we have made in the Workshop are touched upon in an annex to the Secretariat report (IP/C/W/618). This notes as an important recent development that the significant increase in pharmaceutical exporting countries that are putting in place the necessary legislation to use the System for export. This has gone literally from one Member, at the time of the first use of the System, to over 52 today. By informal estimates, the System now covers about 80% of current global medicines export capacity. It also mentions that the practical context of the System is such that it applies when the best option for access to a medicine is production especially for export under a compulsory licence in a foreign country. It need not apply for instance when lower cost medicines are available by other means through regular generic production, voluntary licensing, or when some of the production under regular compulsory licences could be exported. For example, if a compulsory licence is applied to serve a relatively large home market this production could, in principle, also be used to serve also a smaller export market. 140. A key element in the use of the System concerns notifying expected demands for medicines. It was noted that this could be done early in the procurement process, so as to open up a wider range of potential suppliers and potentially enable the pooling of demand by different Members with similar needs. Notification under the System could also be used at this early stage to identify all possible sources of supply so as to ensure the most competitive and sustainable range of options for access to medicines. 141. The important point of economies of scale has been considered and discussed. The need for economies of scale was foreseen in the design of the System and would clearly be a factor when the needs of relatively small populations are concerned. On that note, it was observed that the System makes it clear that an export compulsory licence can serve the needs of multiple Members. When countries do share the same needs and the same constraints, for example, in the same region, this could be an opportunity to pool demand so as to use the System more effectively. This would be especially effective if their regulatory requirements were similar or compatible, for example, through the WHO prequalification programme. 142. Discussion has also covered how the System could be used as part of efforts to build local production capacity, especially when this would enable one country's production to serve several countries in the same region, enabling economies of scale and thus lower cost, and to support more sustainable production of medicines. 143. The Workshop on Trade and Public Health also considered the human rights dimension of access to medicines with a participation of a range of international organizations, including the Office of the United Nations High Commissioner for Human Rights. The Secretariat of the UN Secretary General's High-Level Panel on Access to Medicines presented the Panel Report which will be the subject of a separate agenda item in this session of the Council. We would like to record our warm gratitude to our colleagues from across the multilateral system for their invaluable contributions to this essential capacity-building dialogue. 144. Participating experts in the procurement field and other related fields explored a range of practical questions in the course of the Workshop discussion on the use of the System. They mentioned the need for awareness-raising of the practical possibilities of use of this mechanism within domestic agencies and other programmes responsible for medicines procurement. More generally, they also looked at the practicalities of situating the System as an integral part of procedures for access to medicines, including procurement processes and other processes such as needs identification, procurement policies and the regulation of medicines for safety and efficacy. Other points raised by the experts included the possible choices for effective implementation of the System at the domestic and regional levels and, in particular, how to make the System more streamlined in its practical use in those countries that are most likely to be producers and exporters under the System. Further points discussed concerned the information needs of potential importing countries about potential sources of supply and how to facilitate the forecasting of expected needs which in turn would enable early notification under the System and more capacity to aggregate demand of similar needs. 145. A final point that has come up in a range of our activities concerning this matter is a question of economic viability, or commercial sustainability, given the significance recognized in the System of boosting economies of scale, how to use the System for greater predictability for potential suppliers, and the pooling and aggregation of demand so as to ensure that its use is commercially sustainable for producers seeking to export under this System. 146. We look forward to continuing cooperation with multilateral partners on our capacity building work in this area and again warmly thank our colleagues for their invaluable contributions to this work.
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