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.