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
nineteenth annual review in October 2022. The General Council took note of
the report of the Council for TRIPS (document IP/C/94) at its meeting on 19-20 December 2022 (document
_WT/GC/M/202, paragraph 12.6).
3. The present report covers the
period from October 2022. At its meeting of 30-31 October 2023,
the Council undertook the 20th 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 organized by the Secretariat in response to
requests by Members to assist them in making the System work effectively in
practice.
[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.