ANNUAL
REVIEW OF THE special compulsory licensing system
Report to the General Council
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 shall annually report on its operation to the
General Council.
2. The Council for TRIPS undertook the thirteenth annual review in
November 2016. The General Council took note of the report of the Council for
TRIPS (IP/C/76) at its meeting on 7 December 2016 (WT/GC/M/165,
paragraph 9.16).
3. The present report covers the period since October 2016. At its
meeting of 19‑20 October 2017, the Council undertook the fourteenth
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 regarding 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 summarizes views expressed by Members with respect to
possible next steps to ensure that the System works effectively in practice.
[1] The Protocol which was adopted on 6 December 2005 (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
(WT/L/540 and 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.