H.E. Ambassador Dr. Walter Werner

Brazil

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)

111.   The entry into force of the Protocol Amending TRIPS was an important signal for the multilateral trading system that the protection of IP can go hand in hand with measures to ensure access to medicines. The Protocol provides a legally secure and predictable option for those countries wishing to use the TRIPS flexibilities to get affordable medicines. We would like to highlight the importance of this periodic review of the implementation of the System, which became even more necessary after the Protocol entered into force. 112.   While we reiterate our concern that the Special Compulsory Licensing System was used only once so far, it would be important to reflect on ways to improve it. According to reports provided by participants in the single case of use of the System, it is considered too complex and administratively unwieldy. In 2017, Brazil, India and South Africa organized a side event to the TRIPS Council in order to receive the assessment of the System from representatives of industry, Government, non-governmental organizations and academia. Future discussions in the Council could benefit from additional information that can be provided by stakeholders other than Members. 113.   We believe it is important that this Organization continues to provide technical support to Members, including through the provision of legal assistance, awareness-raising activities and capacity building. This will ensure that the System becomes a practical option for the procurement of medicines in countries without industrial capacity, allowing that the fruits of the IP system are enjoyed in an inclusive way. The regional event held last year in Brasília for Latin American countries was considered a great success by participants and we will continue to support those actions by the Organization, including through the provision of experts from Brazil. We also support that the Secretariat continues its efforts to reach out to those Members not yet parties to the Protocol. Members could also act through the periodic Trade Policy Review mechanism. 114.   We have always been of the view that the Doha Declaration on the TRIPS Agreement and Public Health constitutes a major landmark in the 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 and developing countries. The recent agreement on the United Nations' Sustainable Development Goals clearly reinforces that agenda, as its Goal number 3 mandates the global community to ensure healthy lives and promote well-being for all at all ages. To attain the goals of reducing child mortality and end the epidemics of AIDS, tuberculosis, malaria and neglected tropical diseases, access to medicines is a fundamental part of that. The global community needs to act together through a multitude of ways, including through the Special Compulsory Licensing System before us.

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