ANNUAL REVIEW OF THE SPECIAL COMPULSORY
LICENSING SYSTEM
REPORT TO THE GENERAL COUNCIL
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1. Paragraph 7 of the Annex to the
TRIPS Agreement as amended by the Protocol Amending the TRIPS Agreement
("the Protocol")[1] and paragraph 8 of the Decision on the
Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement
and Public Health of 30 August 2003 ("the 2003 Decision")
respectively[2] provide that the Council for TRIPS shall
review annually the functioning of the Special Compulsory Licensing System
("the System")[3] established under Article 31bis of the
amended TRIPS Agreement and the 2003 Decision with a view to ensuring its
effective operation. The Council is required to report annually to the General
Council on its operation.
2. The Council for TRIPS undertook the
21st annual review in November 2024. The General Council took
note of the report of the Council for TRIPS (document IP/C/101) at its meeting on 16‑17 December 2024 (document
WT/GC/M/215, paragraph 17.12).
3. The present report covers the
period from October 2024. At its meeting of 10‑11 November 2025, the
Council undertook the 22nd annual review. Annex 1 and Appendix 1
to this report record the review and the statements made by delegations.
4. Sections 1 and 2 below set out
factual information on the implementation and use of the System, as well
as the entry into force of the Amendment to the TRIPS Agreement and the status
of acceptances of the Protocol. Section 3 provides an overview of capacity-building
activities requested by Members and organized by the Secretariat.
[1] The Protocol which was adopted on 6 December 2005 (document
WT/L/641) entered into force on 23 January 2017 (see below under Section
2).
[2] Note that the TRIPS Agreement as amended on 23 January 2017 only
applies to WTO Members who have accepted the Protocol. For other Members who
are yet to accept it, the General Council Decision of 30 August 2003 (document WT/L/540
and WT/L/540/Corr.1)
continues to constitute the legal basis, including as regards the Annual Review
of the Special Compulsory Licensing System. For the purposes of the 2003
Decision, this review is deemed to fulfil the review requirements of Article
IX:4 of the WTO Agreement.
[3] See also the definition in paragraph 1 (b) of the Annex to the
amended TRIPS Agreement.