H.E. Ambassador Dr. Walter Werner

Japan

6   ANNUAL REVIEW OF THE SPECIAL COMPULSORY LICENSING SYSTEM (PARAGRAPH 7 OF THE ANNEX TO THE AMENDED TRIPS AGREEMENT AND PARAGRAPH 8 OF THE DECISION ON THE IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH)

119.   The delegation of Japan would like to express our gratitude to the Secretariat for preparing a draft report so we can review the Special Compulsory Licensing System. We welcome this work, hoping that it will encourage all remaining Members to notify their acceptance of the Protocol. 120.   This delegation would like to reiterate the importance of access to medicines, which needs to be discussed in a broader context, taking into account not only the Special Compulsory Licensing System, but also various other relevant measures and factors, such as procurement and tariffs. Japan supports the Paragraph 6 System as established under the 2003 Waiver Decision and the 2005 Protocol Amending the TRIPS Agreement. The very objective of the System is to support WTO Members in obtaining greater access to medicines, specifically Members that have either insufficient or no pharmaceutical manufacturing capacity. Compulsory licenses are, whether granted under the System or not, just one of the potential means that can be utilized for this objective under an exceptional circumstance and, therefore, the System should not be considered as the only solution, but rather as just an option we could consider. 121.   In addition, this delegation would like to mention that voluntary efforts to streamline access to medicines have been increasing. For example, in September WIPO and IFPMA collaboratively launched a new medicinal patent information database, Pat-INFORMED, to help procurement agencies better understand the global patent status of medicines. We believe such a voluntary and collaborative effort will be one of the possible ways forward to respond to better access to medicines.

The Council took note of the statements made.
The Council agreed on the draft cover note to the Report and to attach the record of the discussion to it.

17.   The Chair recalled that, in the past, the Special Compulsory Licensing System had been conducted pursuant to paragraph 6 of the 2003 Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health. Since the entry into force of the Protocol Amending the TRIPS Agreement on 23 January 2017, the review also responded to the requirements that had now been incorporated into the amended TRIPS Agreement.
18.   Paragraph 7 of the Annex to the amended TRIPS Agreement and paragraph 8 of the 2003 Waiver Decision required the Council to review the functioning of the System annually, with a view to ensuring its effective operation. They also required the Council to report annually on the System's operation to the General Council. In the case of the Waiver Decision, the review was also deemed to fulfil the requirements of Article IX:4 of the WTO Agreement.
19.   The Chair informed Members about the status of acceptances of the Protocol Amending the TRIPS Agreement. The current period for accepting the Protocol ran until 31 December 2019. Since the last meeting in June 2018, Paraguay had deposited its instrument of acceptance with the Director-General on 4 July. The amended TRIPS Agreement was binding for 126 WTO Members. In other words, 38 Members were yet to accept the Protocol Amending the TRIPS Agreement. He encouraged those Members to complete their domestic procedures as soon as possible.
20.   When the TRIPS Amendment had entered into force in January last year, Members had noted that it would be useful to consider how to make this new procurement tool worked effectively in practice. He encouraged Members to engage in a constructive discussion, which could also build on earlier reviews. Members might find two documents particularly helpful to facilitate their considerations. The first was the Council's annual review of 2016 (circulated in document IP/C/76); and the second was the Secretariat's 2016 report on technical cooperation activities (circulated in document IP/C/W/618). Annex II of that report summarized key issues that delegations might wish to consider supporting the practical use of the System.
21.   The representatives of Brazil, India, Japan, Canada, the United States of America and Switzerland took the floor.
22.   The Council took note of the statements made.
23.   The Chair turned to the Report to the General Council. A draft cover note had been prepared by the Secretariat (circulated in document JOB/IP/32). It was modelled on previous years' reports and contained factual information on the implementation and use of the System. Under the section on the Amendment to the TRIPS Agreement, it also included a list of Members who were yet to accept the Protocol Amending the TRIPS Agreement. As for past reports, an extract from the Council's minutes on this agenda item would be attached to the cover note.
24.   The Council agreed on the draft cover note to the Report and to attach the record of the discussion to it.

IP/C/M/90, IP/C/M/90/Add.1