IP/C/90  
 
26 October 2021 
(21-8109) Page: 1/9 
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 Co mpulsory 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 seventeenth annual review in October 20 20. The 
General  Council took note of the report of the Council for TRIPS ( document IP/C/86 and Corr.1 ) at 
its meeting on  16-18 December 20 20 (docum ent WT/GC/M/ 188, paragraph 13.6). 
3.  The present report covers the period from October  2020. At its meeting of 13-14 October 2021, 
the Council undertook the eighteenth annual review. Annex  1 and Appendix  1 to this report record 
the review and the stat ements 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 
acceptance s of the Protocol.  Section 3  summarizes considerations given to the functioning of the 
System to address the COVID -19 pandemic in TRIPS Council discussions during the reporting period. 
It also provides an overview of capacity -building activities  organized by the Secretariat  in response 
to requests by Members t o 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 U nited Kingdom  has notified the Council  for TRIPS  of 
amendments that have been  made to the retained EU implementing Regulation  (EC) No 816/2006 .4 
While not changing the substantive provisions, t he Patents (Amendment) (EU Exit) Regulations have 
removed some of the EU -specific provisions.5 No other 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.6 
6.  During the period covered by the present report,  the Plurinational State of Bolivia, and 
Antigua  and Barbuda, notified the Council for TRIPS of their respective intention s to use the System 
 
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 Corr.1)  continues to constitute the legal basis, including as regards 
the Annual R eview 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 Regulation (EC) No 816/2006, document IP/N/1/EEC/P/5.  
5 See document IP/N/1/GBR/P/11.  
6 http://www.wto.org/english/tratop _e/trips_e/par6laws_e.htm  IP/C/90  
 
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  as an importing Member pursuant to paragraph 1(b) of the Annex to the amended 
TRIPS  Agreement.7 The Plurinational State of Bolivia has also notified the Council for TRIPS of its 
specific needs to import COVID -19 vaccines under the System in line with paragraph 2(a) of the 
Annex to the amended TRIPS Agreemen t.8 No notifications by exporting Members pursuant to 
paragraph 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 regularly updates a page on the WTO 
website to ens ure the public availability of notifications made under the System .9  
7.  Members seeking to use the System are encouraged to submit their notifications using the 
e-TRIPS Submission System,10 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.11 The 
accessibility of notifications, once circulated, has been further enhanced through their inclusion on 
the related publicly a ccessible e -TRIPS Gateway, currently available in beta version.12 
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 thirds of the WTO Mem bers 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 seventeenth annual review in 20 20, The Gambia and 
Antigua and Barbuda  have accepted the Protocol.  
10.  Also, on 1  January 2021, the United Kingdom confirmed its continued acceptance of the Protocol 
amending the TRIPS Agreement.13 
11.  Information on the status of acceptances of the Protocol can be found on a dedicated webpage 
which is regularly updated  by the WTO Secretariat.14 
12.  As of 1 September 20 21, the amended TRIPS Agreement applie d to 133 Members . The following 
31 WTO Members were yet to accept the Protocol and continue d 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. Ecuador  
10. Eswatini  
11. Ghana  
12. Guatemala  
 
7 See documents IP/N/8/BOL/1 and IP/N/8/ATG/1.  
8 See document IP/N/9/BOL/1.  
9 http://www.wto.org/english/tratop_e/trips_e/public_health_e.htm  
10 https://www.wto.org/english/tratop_e/trips_e/etrips_e.htm   
11 https://www.wto.org/english/tratop_e/trips_ e/par6_modelnotifs_e.htm . 
12 https://e -trips.wto.org . 
13 See document WT/Let/1500.  
14 http://www.wto.org/english/tratop_e/trips_e/amendment_e.htm .  IP/C/90  
 
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  13. Guinea -Bissau  
14. Guyana  
15. Haiti 
16. Jamaica  
17. Kazakhstan  
18. Kuwait , the State of  
19. Liberia  
20. Maldives  
21. Mauritania  
22. Mozambique  
23. Namibia  
24. Solomon Islands  
25. Suriname  
26. Tonga  
27. Tunisia  
28. Vanuatu  
29. Venezuela, Bolivarian Republic of  
30. Yemen  
31. Zimbabwe  
13.  At the Council 's meetings in March  and Ju ne 2021, 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.  
14.  The Protocol is currently open for acceptance by these Members until 31 December 20 21 or 
such later date as may be decided by the Ministerial Conference ( document WT/L/ 1081). Despite 
indications that a number of Members are actively pursuing their respective domestic procedures in 
order to accept the Protocol, not all Members concerned are expected to complete their respective 
domestic 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 con tained in Annex 2 of this document.  
3  MAKING THE SYSTEM WORK  
15.  Members have discussed the role and the importance of the System to respond to a global 
health crisis in the context of the COVID -19 pandemic  as part of the considerations of the proposed 
Waiver fr om Certain Provisions of the TRIPS Agreement for the Prevention, Containment and 
Treatment of COVID -19.15  
16.  In its communication of 4 June 2021, the E uropean Union has submitted to the Council for 
TRIPS a Draft General Council Declaration on the TRIPS Agreement and Public Health in the 
Circumstances of a Pandemic EU proposal.16 Its objective is to clarify and facilitate the use of 
compulsory licensing provisions in the T RIPS Agreement, including as contained in Article 31 bis.  
 
15 See revised decision text, Communication from the African Group, the Plurinational State of Bolivia, 
Egypt, Eswatini, Fiji, India, Indonesia, Kenya, the LDC Group, Maldives, Mozambique, Mongolia, Namibia, 
Pakistan, South Africa, Vanuatu, the Bolivarian Republic of Venezuela and Zimbabwe, document 
IP/C/W/669/Rev.1 and addenda.  
16 See document IP/C/W/681.  IP/C/90  
 
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  17.  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 ",17 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.  
18.  In line with the se 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, relating to the effective use of the System.18 Relevant 
capacity -building activities included  a module dedicat ed to the System at the  virtual Course on Trade 
and Public Health with Special Focus on COVID -19, organized by the WTO Secretariat in 
May-June 2021 in close collaboration with WHO and WIPO .19 
19.  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 launched on 29 July 2020. It  sets out explanatory 
background material on the implementa tion and use of the System.20 Updated background 
information is  also available on the WTO 's webpage dedicated to public health.21 In addition, f ocused 
technical 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.  
_______________  
 
 
 
17 See minutes of t he TRIPS Council meeting of 30 January 2017 (document IP/C/M/84, para.9).  
18 See 20 20 WTO Secretariat Report on Technical Cooperation in the TRIPS Area (document 
IP/C/R/TC/WTO -OMC/1 ). 
19 See the news item reporting on  the Workshop , available at : 
https://www.wto.org/english/news_e/news21_e/tech_15sep21_e.htm . 
20 See pages 241 to 244 and Annex II I 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/publ ications/en/details.jsp?id=4511   
https://www.who.int/publications/i/item/9789240008267 .  
21 https://www.wto.org/english/tratop_e/trips_e/pharmpatent_e.htm . IP/C/90  
 
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  ANNEX 1  
[EXCERPT FROM THE MINUTES OF THE COUNCIL 'S MEETING OF 13-14 OCTOBER 20 21  
TO BE CIRCULATED AS IP/C/M/ 103] 
_______________  
 
 
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 reca lled that, in the past, the review had been conducted pursuant to Paragraph 6 
of the 2003 Decision on the Implementation of Paragraph 6 of the Doha Declaration on the 
TRIPS  Agreement and Public Health. Since the entry into force of the Protocol Amending th e 
TRIPS  Agreement on 23 January 2017, the review also responded to the requirements that had now 
been incorporated into the amended TRIPS Agreement.  
2. Paragraph 7 of the Annex to the amended TRIPS Agreement and paragraph 8 of the 2003 
Waiver Decision require d 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 re view was also deemed 
to fulfil the requirements of Article IX:4 of the WTO Agreement . 
3. The Chair updated Members on the status of acceptances of the TRIPS Protocol. The current 
period for accepting it ran until 31 December 2021. The amended TRIPS Agreement was binding for 
133 WTO Members. In other words, 31 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.  
4. 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. 
He therefore encouraged Members to engage i n a constructive discussion which could also build on 
earlier reviews , as recorded for instance in the Council 's Annual Review of 2016 (circulated in 
document IP/C/76) , as well as  the Secretariat 's 2016 Report on Technical Cooperation Activities 
(circulate d in document IP/C/W/618).  
5. The Chair also noted that during his small -group consultations on the waiver proposal and the 
proposal from the European Union , a detailed discussion on the TRIPS requirements for using 
Article  31bis and the Annex  had taken  place, including on areas for possible improvement. He added 
that t he topics identified there could also usefully inform Members ' discussion.  
6. The Chair turned to the Council 's report to the General Council. A draft report had been 
prepared by the Secretar iat (circulated in document JOB/IP/ 48). It was modelled on previous years ' 
reports and contained factual information 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 . 
7. The Council also had to decide whether to extend th e period for acceptance of the Protocol 
which currently ran until the end of 2021. Since there were 31 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 2023. A draft decision for the General Council was included 
in Annex 2 of the Draft Report.  
8. The representatives of Australia , Chile, Brazil , the European Union , Zimbabwe , Namibia , the 
United States  of America , Switzerland , the United Kingdom , Japan  and Argentina  took the floor.   
9. The Council took note  of the statements made.  IP/C/90  
 
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  10. 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 2023 the 
period for the acceptance by Members of the Protocol Amending the TRIPS Agreemen t. 
_______________  
  IP/C/90  
 
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  ANNEX 2  
  
  
  WT/L/..  
 
 
(21-0000)  Page: ../..  
    
AMENDMENT OF THE TRIPS AGREEMENT – EIGH TH EXTENSION OF THE PERIOD FOR 
THE ACCEPTANCE BY MEMBERS OF THE PROTOCOL AMENDING  
THE TRIPS AGREEMENT  
DRAFT DECISION OF [DATE]  
 The General  Council,  
 
 Conducting  the functions of the Ministerial  Conference in the interval between meetings  
pursuant to paragraph  2 of Article  IV of the Marrakesh Agreement establishing the World Trade 
Organization (the  "WTO Agreement "); 
 
 Having regard to paragraph  2 of the Decision of the General  Council of 6  December  2005 on 
the Amendment of the TRIPS  Agreement (the  "TRIPS  Amendment  Decision ") and paragraph  3 of the 
Protocol Amending the TRIPS  Agreement (the  "Protocol ")22, which provide that the Protocol shall be 
open for acceptance by Members until 1  December  2007 or such later date as may be decided by 
the Ministerial  Conference;  
 
 Recalling that the General Council, by its decision of 10 December  2019 
(the "2019 Extension Decision ")23, extended the peri od for acceptances of the Protocol by Members 
for the seventh time until 31  December  2021 or such later date as may be decided by 
the Ministerial  Conference;  
 
 Recalling also that, pursuant to paragraph  3 of the TRIPS  Amendment  Decision and 
paragraph  4 of the Protocol, the Protocol took effect and entered into force on 23  January  2017 upon 
acceptance by two thirds of Members who had accepted it on or before that date in  accordance with 
the provisions of paragraph  3 of Article  X of the WTO  Agreement;  
 
 Noting that the Protocol takes effect for each other Member upon acceptance by it pursuant 
to paragraph 3 of Article X of the WTO Agreement;  
 
 Noting also  that a number of Members are yet to accept the Protocol and t hat this is taking 
them longer than initially foreseen;  
 
 Having considered the proposal to further extend the period for acceptances of the  Protocol 
submitted by the Council for TRIPS (IP/C/ 89); 
 
 Decides  as follows:  
 The period for acceptances by Members  of the Protocol Amending the TRIPS Agreement 
referred to in paragraph  2 of the TRIPS  Amendment  Decision and paragraph  3 of the Protocol, 
and extended by the 201 9 Extension  Decision, shall be further extended until 31  December  2023 
or such later date as ma y be decided by the Ministerial  Conference.  
 
_______________  
 
 
22 WT/L/641.  
23 WT/L/10 81. 
IP/C/90  
 
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  APPENDIX 1  
[EXCERPT FROM THE ADDENDUM TO THE MINUTES, CONTAINING THE STATEMENTS MADE 
DURING THE COUNCIL 'S MEETING HELD ON 13-14 OCTOBER  2021, TO BE CIRCULATED AS 
IP/C/M/ 103/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 IMPLEMENTATI ON OF PARAGRAPH 6 OF THE DOHA 
DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH)  
7.1  Australia  
1.  Australia thanks the Secretariat for circulating the draft annual review of the Special Compulsory 
Licensing System. Australia recognizes th e sovereign right of a ll WTO Members to exercise their 
rights under the System, including in response to COVID -19. We encourage all remaining 
WTO Members to accept  the Protocol Amending the TRIPS Agreement and stand ready to provide 
assistance to Members that require advice or assistance with this process.  Given that not all Members 
have accept ed the Protocol, Australia supports the extension of the period for acceptance of the 
Protocol until 2023.  
2.  Australia thanks the Secretariat for its ongoing work to provide technical assistance to Members 
to support the effective use of the System and welcomes relevant capacity building activities 
dedicated to the System held over the past year. We also welcome further capacity building activities 
in line with the second edition  of the  WTO, WHO and WIPO Study on Promoting Access to Medical 
Technologies and Innovation. And we note that Annex 3 of the Study provides a helpful overview of 
the Special C ompulsory Licensing System. Consistent with past interventions, Australia reiterates its 
support for any efforts to streamline and improve the System, to ensure it  is user -friendly and can 
be quickly and effectively operationalized in times of crisis, including as neede d in response to 
COVID -19. 
7.2  Chile  
3.  The Chilean position on the topic is well -known to all . My delegation  can support th e proposed 
decision  to extend the period  for acceptance of the Protocol in order  to allow for additional 
acceptances .  
7.3  Brazil  
4.  My delegation would also like to show support for the proposed extension of the period for 
acceptance of the amendment of the TRIPS Agreement.  
7.4  European Union  
5.  We would like to thank the Secretariat for distributing the  draft report on the Special C ompulsor y 
Licensing System, as well as  for the continued technical assistance that it offers and provide s to 
Members on the use of the System. We also encourage all Members who have not yet done so to  
join the System.  Its importance has been clearly proven  in our discussions on the response to the 
COVID -19 pandemic and I am sure we will have further discussions going forward on this topic. 
Noting t hat not all Members  have joined the System yet, we also support the extensio n of the period 
for accepting the Protocol .  
7.5  Zimbabwe  
6.  My delegation joins others in supporting the extension of the deadline for acceptance of the 
Protocol  Amending the TRIPS Agreement .   IP/C/90  
 
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  7.6  Namibia  
7.  We take this opportunity to thank the Secretariat, and also join other Members who supported 
the extension of the period for acceptance of  the Protocol Amending the TRIPS Agreement.  
7.7  United States  of America  
8.  The United States welcomes the entry into force of the Protocol Amending the TRIPS Agreement . 
We also welcome  the Secretariat 's draft report and its work throughout the year to encourage all 
Members to notify their acceptance of the Protocol. We support the extension of the acceptance  
period.  
7.8  Switzerland  
9.  My delegation  joins previous statement s and support s the extension of the deadline until 2023.  
7.9  United Kingdom  
10.  The U nited Kingdom  would like to note that while it is still the case that some Members have 
not yet implemented the Special Compulsory Licensing System to be reviewed as set out in 
paragraph  7 of the Annex of the amended TRIPS Agreement . This is a vital capability available in 
the TRIPS Agreement. We therefore strongly encourage all Members to implement this amendment. 
As others, we also support the extension of the deadline as suggeste d. 
7.10  Japan  
11.  This delegation would like to express our gratitude to the Secretariat for preparing the draft 
report in order to allow us to  review the Special Compulsory  Licensing  System. We welcome this 
work hoping that it will encourage remaining Members to n otify the acceptance of the Protocol. We 
also support a two -year extension  of the period for acceptance . 
7.11  Argentina  
12.  We are grateful for the Secretariat 's report and wish to support the extended deadline  for 
accepting th e Protocol . 
__________