IP/C/ 94 
 
22 November 2022 
(22-8693) 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 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 ") respectively2 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 Gener al Council on its operation.  
2.  The Council for TRIPS undertook the eighteenth annual review in October 2021. The General 
Council took note of the report of the Council for TRIPS (document IP/C/90 ) at its meeting on 
22- 23 November 2021 (document WT/GC/M/194 , paragraph 6.5).  
3.  The present report covers the period from October 2021. A t its meeting of 12 -13 October 2022, 
the Council undertook the nineteenth 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 implementatio n 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 considerations given to the functioning of the 
System. It also provides an overview of capa city-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, the Russian Federation has notified amendments to its Civil Code, 
authorizing compulsory licensing of pharmaceutical products for export purposes to implement 
Article 31 bis of the TRIPS Agreement .4 No other Member has notified an amendment to its legislation 
implemen ting 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.5 
6.  During the period covered by the present report, no notifica tions 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 WTO 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 (documen ts 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 par agraph 1 (b) of the Annex to the amended TRIPS Agreement.  
4 Document IP/N/1/RUS/6 . 
5 http://www.wto.org/english/tratop_e/trips_e/par6laws_e.htm  IP/C/94 
 
- 2 - 
 
  regularly updates a page on the W TO website to ensure the public availability of notifications made 
under the System.6 
7.  Members seeking to use the System are encouraged to submit their notifications using the 
e- TRIPS Submission  System7, which is an online tool for WTO Members to submit notifications, 
review materials and reports related to the TRIPS Agreement. Access cred entials 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.8 The 
access ibility of notifications, once circulated, has been further enhanced through their inclusion on 
the related publicly accessible e -TRIPS Gateway, currently available in beta version.9 
2  AMENDMENT TO THE TRIPS AGREEMENT  
8.  In acc ordance with paragraph 3 of Artic le X of the WTO Agreement, the Protocol entered into 
force on 23 January 2017, by which date two thirds 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 eighteenth annual review in 2021, Ecuador, Eswatini 
and the Maldives have accepted the Protocol.  
10.  Information on the status of acceptances of the Protocol can be found on a dedicated webpage 
which is regularly updated by the WTO Secret ariat.10 
11.  As of 1 September 2022, the amended TRIPS Agreement applied to 136 Members. The following 
28 WTO Members were yet to accept 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  
 
6 http://www.wto.org/english/tratop_e/trips_e/public_health_e.htm  
7 https://www.wto.org/english/tratop_e/t rips_e/etrips_e.htm  
8 https://www.wto.org/english/tratop_e/trips_e/par6_modelnotifs_e.htm  
9 https://e -trips.wto.org  
10 http://www.wto.org/english/tratop_e/trips_e/amendment_e.htm  IP/C/94 
 
- 3 - 
 
  15. Kazakhstan  
16. Kuwait, the State of  
17. Liberia  
18. Mauritania  
19. Mozambique  
20. Namibia  
21. Solomon Islands  
22. Suriname  
23. Tonga  
24. Tunisia  
25. Vanuatu  
26. Venezuela, Bolivarian Republic of  
27. Yemen  
28. Zimbabwe  
12.  The Protocol is currently open for acceptance by these  Members until 31 December 2023 or 
such later date as may be decided by the Ministerial Conference ( document WT/L/1122) . 
3  MAKING THE SYSTEM WORK  
13.  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 "11, Members 
have called for awareness raising and capacity -building for potential 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.  
14.  In considerations under the agenda items on a Proposal for a waiver fro m certain provisions of 
the TRIPS Agreement for the prevention, containment and treatment of COVID -19 and a Draft 
General Council declaration on the TRIPS Agreement and Public Health in the circumstances of a 
pandemic at the Council 's meeting in October 20 21,12 some Members noted that TRIPS flexibilities, 
including Article 31 bis, were important tools, but offered only limited policy space to Members and 
were not designed to address a global pandemic. Other Members noted that it could be useful to 
look at any difficulties identified regarding the flexibilities, including the System, in order to see 
whether there was room for further clarifications to facilitate their use.  
15.  At the Council 's meeting in Ju ly 2022,13 the Chair recalled that some Members had made  efforts 
to use the System in the context of their pandemic response and that the annual review of the 
System could, therefore, be guided by the issues that Members had already identified in the past as 
well as the more recent experiences of Members that h ad made initial steps to use the System. He 
suggested that Members might also wish to consider discussing any measures taken to implement 
 
11 See minutes of the TRIPS Council meeting of 30 January 2017 (document IP/C/M/84 , para.9).  
12 See minutes of the TRIPS Council meeting of 13 -14 October; 5, 8 and 29 Novemb er; and 16 
December 2021 ( document IP/C/M/103/Add.1 , paras 286, 357, 378, 379 ). 
13 See minutes of the TRIPS Council meeting of 6 July 2022 (document IP/C/M/105 , paras 73 -74). IP/C/94 
 
- 4 - 
 
  and use the Special Compulsory Licensing System under Article 31 bis of the TRIPS Agreement into 
domestic law, includin g in the context of COVID -19. 
16.  In line with the 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 p artners, relating to the effective use of the System.14 Relevant 
capacity -building activities included the Advanced Course for Government Officials, the Advanced 
Trade Policy Course and the WIPO Sub -Regional Meeting on Intellectual Property, Public Health and 
COVID -19 for Selected Arab Countries.  
17.  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 an d Trade " which was launched on 29 July 2020. It sets out explanatory 
background material on the implementation and use of the System.15 Updated background 
information is also available on the WTO 's webpage dedicated to public health.16 In addition, focused  
techn ical assistance materials have been developed to enable interested Members effectively to 
assess the operational context of the System and to support their effective use of it.  
_______________  
 
 
 
14 See 2022 WTO Secretariat Report on Technical Cooperation in the TRIPS Area 
(document  IP/C/R/TC/WTO -OMC/3 ). 
15 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 . 
16 https://www.wto.org/english/tratop_e/trips_e/pharmpatent_e.htm  IP/C/94 
 
- 5 - 
 
  ANNEX 1  
[EXCERPT FROM THE MINUTES OF THE COUNCIL 'S MEETING OF 12 -13 OCTOBER 2022  
TO BE CIRCULATED AS DOCUMENT IP/C/M/106 ] 
_______________  
 
 
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.  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 f unctioning 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 fulfi l 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. 136 Members had accepted the amended TRIPS 
Agreement. 28 Members were yet to accept the Protocol Amending the TRIPS Agreement. He 
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 h ad 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. He 
therefore encouraged Members to engage in a constructive discussion which could also build o n 
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/ 62). It was modelled on previous years ' reports 
and contained factual information on the implementa tion 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  agreed  to adopt the draft report and to attach the record of the discussion to it.  
_______________  
 IP/C/94 
 
- 6 - 
 
  APPENDIX 1  
[EXCERPT FROM THE ADDENDUM TO THE MINUTES, CONTAINING THE STATEMENTS  
MADE DURING THE COUNCIL 'S MEETING HELD ON 12 -13 OCTOBER 2022,  
TO BE CIRCULATED AS DOCUMENT IP/C/M/106/ADD .1] 
AGENDA ITEM 7: ANNUAL REVIEW OF THE SPECIAL COMPULSORY LICENSING SYSTEM 
(PAR AGRAPH 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.  
__________