IP/C/97  
 
9 November 2023 
(23-7567) Page: 1/6 
Council for Trade -Related Aspects of   
Intellectual Property Rights    
 
  
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 p aragraph 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") respectively2 provide that the Council for TRIPS shall review annually 
the functioning  of the Special Compulsory Licensing System ("the System")3 established under 
Article 31 bis 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 20 22. 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 deleg ations.  
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  INFORMATION ON IMPLEMENTATION AND USE OF THE SYSTEM  
5.  Since the last annual review,  no Member  has notified an amendment to its legislation 
implementing the System into its domestic law. A compilation of notified implementing laws and 
regulations, including hyperlinks to the legal texts, is available on a  dedicated page on the WTO 
website .4 
6.  During the period covered by the present report, no notifications by importing or exporting 
Members pursuant to paragraphs 1(b), 2(a) and 2(c) of the Annex to the amended TRIPS Agreement 
and the 2003 Decision respectively have been made to the Council for TRIPS. 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. F or 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.  
4 http://www.wto.org/english/tratop_e/trips_e/par6laws_e.htm . IP/C/97  
 
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  regularly updates a page on the WTO website to ensure the public availability of notifications made 
under the System.5  
7.  Members seeking to use the System are encouraged to submit their notifications using the 
e-TRIPS Submission System6, which is an online tool for WTO Members to submit notifications, 
review materials and reports related to the TRIPS Agreement. Access credentials to use the e -TRIPS 
Submission System are available upon request to e-TRIPS@wto.org . Members may also consult a 
Guide to notifications, including a set of model notifications, on the WTO's webpage.7 The 
accessibility of notifications, once circulated, has been further enha nced through their inclusion on 
the related publicly accessible e -TRIPS Gateway.8 
2  AMENDMENT TO THE TRIPS AGREEMENT  
8.  In accordance with paragraph 3 of Article X of the WTO Agreement, the Protocol entered into 
force on  23 January 2017, by which date two thir ds of the WTO Members had accepted it.  
9.  Pursuant to paragraph 3 of Article X of the WTO Agreement, the Protocol takes effect for each 
other Member upon its acceptance. Since the nineteenth annual review in 20 22, Namibia has  
accepted the Protocol.  
10.  Informatio n on the status of acceptances of the Protocol can be found on a dedicated webpage 
which is regularly updated by the WTO Secretariat.9 
11.  As of 1 September 202 3, the amended TRIPS Agreement applied to 13 7 Members. The following 
27 WTO Members were yet to acc ept the Protocol and continued to operate on the basis of the 
2003 Decision:  
1. Afghanistan  
2. Angola  
3. Armenia  
4. Cabo Verde  
5. Cameroon  
6. Chad 
7. Democratic Republic of the Congo  
8. Djibouti  
9. Ghana  
10. Guatemala  
11. Guinea -Bissau  
12. Guyana  
13. Haiti 
14. Jamaica  
 
5 http://ww w.wto.org/english/tratop_e/trips_e/public_health_e.htm . 
6 https://www.wto.org/english/tratop_e/trips_e/etrips_e.htm . 
7 https://www.wto.org/english/tratop_e/trips_e/par6_modelnotifs_e.htm . 
8 https://e -trips.wto.org . 
9 http://www.wto.org/english/tratop_e/trips_e/amendment_e.htm .  IP/C/97  
 
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  15. Kazakhstan  
16. Kuwait, the State of  
17. Liberia  
18. Mauritania  
19. Mozambique  
20. Solomon Islands  
21. Suriname  
22. Tonga  
23. Tunisia  
24. Vanuatu  
25. Venezuela, Bolivarian Republic of  
26. Yemen  
27. Zimbabwe  
12.  At the Council's formal meetings in March , June, and October  2023, the successive Chairs of 
the Council for TRIPS updated Members on the state of play of acceptances. They also encouraged 
delegations that were yet to accept the  TRIPS amendment to take the necessary steps so that the 
domestic procedures could be completed as soon as possible.  
13.  The Protocol is currently open for accepta nce by these  Members until 31 December 2023 or 
such later date as may be decided by the Ministerial Conference ( document WT/L/1122 ). Despite 
indications that a number of Members are actively pursuing their domestic procedures in order to 
accept the Protocol, not all Members concerned are expected to complete those procedures by this 
deadline. The Council for TRIPS therefore submits the  attached proposal to the General Council for 
a decision to extend the period for acceptances of the Protocol. A draft of such a proposal for 
consideration by the Council is contained in Annex 2 of this document.  
3  MAKING THE SYSTEM WORK  
14.  Echoing the former TRIPS Council Chair's note of the importance "to look into how to make this 
new procurement tool work effectively so that it delivers concrete results in practice"10, Members 
have called for awareness raising and capacity -building for p otential users of the System, targeting, 
in particular, procurement officers in charge of buying medicines and representatives from IP offices, 
as well as the provision of legislative assistance to countries that were considering implementing the 
System in  domestic law.  
15.  In line with these deliberations of the Council for TRIPS following the entry into force of the 
amended Agreement in January 2017, the Secretariat has continued to provide technical assistance, 
in cooperation with multilateral partners, rela ting to the effective use of the System.11 Relevant 
capacity -building activities included a module dedicated to the System at the annual Trade and 
Health Workshop, organized by the WTO Secretariat from 28 November to 2 December 2022 in close 
collaboration with WHO and WIPO .12 
 
10 See minutes of the TRIPS Council meeting of 30 January 2017 (document IP/C/M/84 , para.9).  
11 See 2022 WTO Secretariat Report on Technical Cooperation in the TRIPS Area (document 
IP/C/R/TC/WTO -OMC/3 ). 
12 See the news item reporting on the Trade and Health Workshop, available at: WTO | 2022 News 
items - Workshop on Trade and Public Health focuses on pandemic preparedness and respons e. IP/C/97  
 
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  16.  The capacity -building activities are based on the second edition of the WHO -WIPO -WTO study 
on "Promoting Access to Medical Technologies and Innovation – Intersections Between Public Health, 
Intellectual Property and Trade" which was la unched on 29 July 2020 . It sets out explanatory 
background material on the implementation and use of the System.13 Updated background 
information is also available on the WTO's webpage dedicated to public health.14 This is 
complemented by the Updated extra ct: integrated health, trade and IP approach to respond to the 
COVID -19 pandemic, published by the WHO, WIPO and WTO Secretariats in October 2021.15 In 
addition, focused technical assistance materials have been developed to enable interested Members 
effect ively to assess the operational context of the System and to support their effective use of it.  
_______________  
 
 
 
13 See pages 241 to 244 and Annex III of the study, available at the three organizations' respective 
websites: https://www.wto.org/ english/res_e/publications_e/who -wipo-wto_2020_e.htm . 
https://www.wipo.int/publications/en/details.jsp?id=4511 . 
https://www.who.int/publications/i/item/9789240008267 .  
14 https://www.wto.org/english/tratop_e/trips_e/pharmpatent_e.htm . 
15 who-wipo-wto_2021_e.pdf . IP/C/97  
 
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  ANNEX 1  
[EXCERPT FROM THE MINUTES OF THE COUNCIL'S MEETING OF 30-31 OCTOBER 202 3  
TO BE CIRCULATED AS IP/C/M/109 ] 
_______________  
 
 
7 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 PU BLIC HEALTH)  
1.  The Chair  recalled that 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, this 
review was also deemed to fulfil the requirements of Article IX:4 of the WTO Agreement.  
2.  The Chair updated Members on the status of acceptances of the TRIPS Protocol. The current 
period for accepting it ran until 31 December 2023. 13 7 Members had accepted the amended TRIPS 
Agreement. 2 7 Members were yet to accept the Protocol Amending the TRIPS Agreement. She 
encouraged those Members to complete their domestic procedures and deposit their instrument of 
acceptance with the WTO Director -General as soon as possible.  
3.  When the TRIPS Amendment  had entered into force in January 2017, Members had noted that it 
would be useful to consider how to make this new procurement tool work effectively in practice. The 
Chair  therefore encouraged Members to engage in a constructive discussion which could als o build 
on earlier reviews, as recorded for instance in the Council 's Annual Review  Report  of 2016 (circulated 
in document IP/C/76 ), as well as the Secretariat 's 2016 Report on Technical Cooperation Activities 
(circulated in document IP/C/W/618 ). 
4.  No statements  were made.  
 
5.  The Chair  turned to the Council 's report to the General Council. A draft report had been prepared 
by the Secretariat (circulated in document JOB/IP/ 68). It was modelled on previous years ' reports 
and contained factual inform ation 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 with past reports, an extract from the 
Council's minutes on this agenda item would be attached to the report in Annex 1 and Appendix 1.  
6.  The Council also had to decide whether to extend the period for acceptance of the Protocol which 
currently ran until the end of 2023. Since there were 27 Members that had yet to accept the Protocol, 
the Chair suggested that the Council once again extend the period for acceptance for another two 
years – until 31 December 2025. A draft decision for the General Council was included in Annex 2 
of the Draft Report.  
7.  The Council agreed  to adopt the draft report and to attach the record of the discussion to it  and 
to submit, for the General Council's adoption, a decision to extend until 31 December 2025 the 
period for the acceptance by Members of the Protocol Amending the TRIPS Agreement . 
_______________  
 
 
 IP/C/97  
 
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  APPENDIX 1  
[EXCERPT FROM THE ADDENDUM TO THE MINUTES, CONTAINING THE STATEMENTS MADE 
DURING THE COUNCIL'S MEETING HELD ON 30-31 OCTOBER 202 3, TO BE CIRCULATED AS 
IP/C/M/109/ADD .1] 
AGENDA ITEM 7: 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)  
1.  No statements were made  under this agenda item . 
__________