102. This update to previous reports to the TRIPS Council will focus on activities to support acceptance of the Protocol Amending the TRIPS Agreement, and related technical assistance.
103. At the request of the Members concerned, we are providing technical assistance concerning both the process for entry into force of the amendment, and the implementation and use of the Paragraph 6 System which enables the grant of special compulsory licenses for export of pharmaceuticals. This theme also forms part of almost all of our TRIPS related technical assistance, at the national, regional and international levels, including annual flagship activities such as the advanced course for government officials, the WIPO-WTO colloquium, and the workshop on IP and public health.
104. We have had feedback from a number of Members that acceptance of the Protocol is awaiting domestic procedures, in particular concerning national legislation to implement the System. As you have noted, Mr Chair, these two processes have been considered by many Members to be distinct – acceptance of the Protocol is a confirmation that other Members are legally entitled to make use of this additional flexibility if they so wish; and the optional act of separately introducing this System into national legislation is a distinct choice to be taken. Actual practice bears this out. On the basis of information available to us (including some Members that are yet to notify implementing legislation), an informal review of acceptances of the Protocol indicate that a significant proportion of Members, across a wide spectrum, have accepted the TRIPS amendment without having introduced domestic implementing legislation. Some then went on subsequently to develop domestic implementing legislation, while others have not taken any steps to implement it domestically. In at least one instance, a Member initially planned to notify acceptance only after introducing domestic implementing legislation, and then later decided to accept the protocol without any domestic legislation, on the understanding that such legislation was not a prerequisite for accepting the amendment. At the request of the Council, the Secretariat has developed and made available on a dedicated webpage a simple model for acceptance, with associated information, and we stand ready to work with any delegation wishing to advance this process.
105. Since the last annual review of the System, and as reported to previous sessions of the Council, the Secretariat has launched a study, prepared with counterparts in WHO and WIPO and intended essentially as a resource for technical assistance, entitled "Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade". This report consolidates and makes available the technical assistance resources provided by the three Organizations in the course of their technical cooperation relating to health, IP and trade.
106. The study notes how access to essential medicines and the lack of research to address neglected diseases have been a major policy concern for many years. The publication responds to the needs expressed by health policy‑makers for a systematic understanding both of the innovation processes that lead to new technologies and of the ways in which these technologies are disseminated in health systems. The study captures a broad range of experience and data in dealing with the interplay between IP, trade rules and the dynamics of access to, and innovation in, medical technologies.
107. The study informs ongoing technical cooperation activities undertaken by the three organizations concerning the interplay between health, IP and trade, including activities that specifically address the Paragraph 6 System. Based on many years of field experience in technical cooperation, the study has been prepared to serve the needs of policy‑makers who seek a comprehensive presentation of the full range of issues, as well as lawmakers, government officials, delegates to international organizations, non‑governmental organizations and researchers.
108. The study provides information to support technical assistance relating to TRIPS and public health, describing how the Paragraph 6 System was designed as an additional flexibility to enhance access to medicines by removing a potential barrier for countries that need to import medicines. In particular, the study outlines the background, context, and scope of use of the System (pages 177ff), giving an overview of the ongoing policy discussions. It notes that while the reasons for the limited use of the Paragraph 6 System are still under consideration, it could be more widely used in the future, for example, in the case of a pandemic or some other health security event where effective treatments may be patented in all major supplier countries following the introduction of the product patent regime since 2005.
109. The study describes the particular procurement scenario that the System is designed to address, and reviews some of the issues that have been discussed here and in other fora regarding whether the System has been used as expected, noting that its operational context is still being mapped.
110. Finally, Annex II provides specific practical information on the operation of the System, its context and scope and use, and domestic implementation, as a means of technical assistance to Members considering the possible use of the System. It provides references to the model forms for notifications under the System that have been made available on the WTO website, again as a technical assistance resource for the benefit of Members considering making use of the System.