IP/C/82  
 
27 November  2018 
(18-7471) Page: 1/8 
Council for Trade -Related Aspects of  
Intellectual Property Rights    
 
ANNUAL REVIEW OF THE  SPECIAL COMPULSORY LICENSING SYSTEM  
REPORT TO THE GENERA L 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 shall annually rep ort on its op eration to the General  Council.  
2.  The Council for TRIPS undertook the fourteenth annual review in Octo ber 201 7. The 
General  Council took note of the report of the Council for TRIPS (IP/C/7 9) at its meeting on 
30 November  2017 (WT/GC/M/1 70, parag raph 8.9). 
3.  The present report covers the period since October  2017. At its meeting of 8-9 November  2018, 
the Council undertook the f ifteenth 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 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 acceptance s of the Protocol.  Section 3 summarizes views express ed by Members with respect to 
possible next steps to ensure that the System works effectively in practice  and action taken by the 
Secretariat . 
1  INFORMATION ON IMPLE MENTATION AND USE OF  THE SYSTEM ESTABLIS HED UNDER 
THE DECISION  
5.  Since the last annual review, no Member has notified the Council for TRIPS of an amendment to 
its legislation implementing the System into its domestic law. An overview of all notified 
implementing laws and regulations, including hyperlinks to the legal texts, is available on a  dedicat ed 
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 
regularly updates a page on the WTO website to ensure the public availability of notifications made 
under the System .5 
                                                
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 Review of the Special Compulsory Licensing System.  For the purposes of the 2003 Decision, this 
review is deem ed 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  
5 http://www.wto.org/english/tratop_e/trips_e/public_health_e.htm  IP/C/82  
 
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  7.  In line with the deliberations of the Council for TRIPS  following the entry into forc e of the 
amended Agreement ,6 the Secretariat has further bolstered its technical assistance, in cooperation 
with multilateral partners, relating to the effective use of the System.7 This work builds on t he 2013 
WHO-WIPO -WTO study on "Promoting Access to Medical Technologies and Innovation – 
Intersections Between Public Health, Intellectual Property and Trade" which set s out explanatory 
background material on the implementation and use of the System.8 Updated background 
information9 and a Guide to Notifications, including a set of model notifications , to further facilitate 
the use of the System10 have been made available on the WTO's webp age dedicated to public health . 
Focused technical assistance materials have also been developed to enable interested Members 
effectively to assess the operational context of the System  and to support their effective use of it . 
2  AMENDMENT TO THE TRI PS AGREEMENT  
8.  In accordance with paragraph 3 of Article X of the WTO Agreement, t he 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 fourte enth annual review in 2017, the 
Russian  Federation, Congo, Madagascar, Gabon, the Plurinational State of Bolivia, the 
Kyrgyz  Republic, Guinea, Côte d'Ivoire and Paraguay  have accepted the Protocol.  
10.  Information on the status of acceptances of the Protocol c an be found on a dedicated webpage 
which is regularly updated by the WTO Secretariat.11 
11.  As of 15 September 201 8, the amended TRIPS Agreement applie d to 126 Members . The 
following 38 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. Antigua & Barbuda  
4. Armenia  
5. Barbados  
6. Burundi  
7. Cabo Verde  
8. Cameroon  
9. Chad 
10. Cuba 
11. Democratic Republic of the Congo  
12. Djibouti  
13. Ecuador  
                                                
6 See minutes of the TRIPS Council meeting of 30 January 2017 (document IP/C/M/84).  
7 See 2017 WTO Secretariat Report  on Technical Cooperation in the TRIPS Area  (document IP/C/W/634, 
para.1); the news item reporting on the Annual Workshop on Trade and Publi c Health organized by the WTO in 
2017 ( https://www.wto.org/english/news_e/news17_e/heal_06nov17_e.htm ) and the Regional Workshop on 
Trade and Public Health With a Special Focus on Compulsory Licences for Export of Medicines for Countries from 
the Latin American Region held in Brazil from 21 -23 November 2017 (see  Section 3  below ). 
8 See pages 177 to 180 and Annex II of the study, available at the three organizations' respective 
websites: https://www.wto.org/english/res_e/publications_e/who -wipo-wto_2013_e.htm  
http://www.wipo.int/edocs/pubdocs/en/global_challenges/628/wipo_pub_628.pdf   
http://www .who.int/phi/promoting_access_medical_innovation/en/ .  
9 https://www.wto.org/english/tratop_e/trips_e/pharmpatent_e.htm .  
10 http://www.wto.org/english/tratop_e/trips_e/par6_modelnotifs_e.htm .  
11 http://www.wto.org/english/tratop_e/trips_e/amendment_e.htm .  IP/C/82  
 
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  14. Eswatini  
15. The Gambia  
16. Georgia12 
17. Ghana  
18. Guatemala  
19. Guinea -Bissau  
20. Guyana  
21. Haiti 
22. Jamaica  
23. Kazakhstan  
24. Kuwait , the State of  
25. Liberia  
26. Maldives  
27. Mauritania  
28. Mozambique  
29. Namibia  
30. Niger  
31. Solomon Islands  
32. Suriname  
33. Tonga  
34. Tunisia  
35. Vanuatu  
36. Venezuela, Bolivarian Republic of  
37. Yemen  
38. Zimbabwe  
12.  At the Council's meetings in October 2017, as well as in February and June 2018, the  respective 
Chairs of the Council for TRIPS updated Members on the state of play of acceptances that had been 
submitted. 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.  In 
addition, the TRIPS Counci l Chair, by means of a letter of  10 August 2018, invited Members 
concerned to proceed with the acceptance of the Protocol as this represented a significant 
contribution to furt her strengthening the legal foundation for the effective exercise of this additional 
public health flexibility in the TRIPS Agreement.  
13.  The Protocol is currently open for acceptance by these Members until 31 December 201 9 or 
such later date as may be decide d by the Ministerial Conference (WT/L/ 1024).   
3  NEXT STEPS  
14.  TRIPS Council Chairs have repeatedly r eferred delegations to the Council’s 2016 report on the 
annual review of the System (IP/C/76), as well as to the  WTO Secretariat’s 2016 annual report on 
                                                
12 Since the ad option of this report by the Council for TRIPS at its meeting of 8 -9 November 2018, Georgia 
has deposited its instrument of acceptance on 21 November 2018 ( WT/Let/1420 ). IP/C/82  
 
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  its technical cooperation activities (IP/C/W/618)  which provide useful information resources for 
future considerations  and, in particular, to prepare for  the annual review of the System .13 
15.  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" ,14 Members 
have called for awareness raising and capacity building for potential users of the System, targeting, 
in particular, procurement office rs in charge of buying medicines  and representatives from IP offices, 
as well as the provision of l egislative assistance to countries that were considering implementing the 
System in domestic law . 
16.  In response, the WTO Secretariat organiz ed a Regional Works hop on Trade and Public Health 
with a special focus on compulsory licences for export of medicines  for countries from the 
Latin American region  in Brazil from 21 to 23 November 2017. This activity complements the module 
dedicated to the System at the Trade  and Health Workshop that the WTO organizes  annually  in 
Geneva. Noting  the positive evaluation of the activity , the WTO Secretariat is exploring the possibility 
of convening similar workshops in other regions.  
 
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13 See minutes of the  TRIPS Council  meeting s of 30 January 2017 ( document IP/C/M/84, pa ra.9); 13 June 
2017 (document IP/C/M/86, para.38) ; 19-20 October 2017 (document IP/C/M/87, para.21); and 5 -6 June 2018 
(document IP/C/M/89, para.59) . 
14 See minutes of the TRIPS Council meeting of 30 January 2017 (document IP/C/M/84, para.9).  IP/C/82  
 
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  ANNEX 1  
 
 [EXCERPT FROM THE MI NUTES OF THE COUNCIL 'S MEETING OF 8-9 NOVEMBER  
CIRCULATED AS IP/C/M /90] 
6  ANNUAL REVIEW OF THE  SPECIAL COMPULSORY LICENSING SYSTEM (PA RAGRAPH 7 
OF THE ANNEX TO THE AMENDED TRIPS AGREEM ENT AND PARAGRAPH 8 OF THE 
DECISION ON THE IMPL EMENTAT ION OF PARAGRAPH 6 O F THE DOHA DECLARATI ON ON 
THE TRIPS AGREEMENT AND PUBLIC HEALTH)  
1.  The Chair recalled that, in the past, the Special Compulsory Licensing System had been 
conducted pursuant to paragraph 6 of the 2003 Decision on the Implementation of Para graph 6 of 
the Doha Declaration on the TRIPS Agreement and Public Health. Since the entry into force of the 
Protocol Amending the TRIPS Agreement on 23 January 2017, the review also responded to the 
requirements that had now been incorporated into the amen ded TRIPS Agreement.  
2.  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 requi red the Council to report annually on the System's 
operation to the General Council. In the case of the Waiver Decision, the review was also deemed 
to fulfil the requirements of Article IX:4 of the WTO Agreement.  
3.  The Chair  informed Members about the status  of acceptances of the Protocol Amending the 
TRIPS  Agreement.1 The current period for accepting the Protocol ran until 31 December 2019. Since 
the last meeting in June 2018, Paraguay had deposited its instrument of acceptance with the 
Director -General on 4  July. The amended TRIPS Agreement was  binding for 126 WTO Members. In 
other words, 3 8 Members were yet to accept the Protocol Amending the TRIPS Agreement. He 
encouraged those Members to complete their domestic procedures as soon as possible.  
4.  When the TRI PS Amendment had entered into force in January last year, Members had noted 
that it would be useful to consider how to make this new procurement tool worked effectively in 
practice. He encouraged Members to engage in a constructive discussion, which could also build on 
earlier reviews. Members might find two documents particularly helpful to facilitate their 
considerations. The first was the Council's annual review of 2016 (circulated in document IP/C/76); 
and the second was the Secretariat's 2016 report on  technical cooperation activities (circulated in 
document IP/C/W/618). Annex II of that report summarized key issues that delegations might wish 
to consider supporting the practical use of the System.  
5.  The representatives of Brazil , India, Japan , Canada , the United States of America  and Switzerland  
took the floor.  
6.  The Council took note  of the statements made.  
7.  The Chair turned to the Report to the General Council. A draft cover note had been prepared by 
the Secretariat (circulated in document JOB/IP/32). It w as 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 for past reports, an extract from the Council's 
minutes on this agenda item would be attached to the cover note.  
8.  The Council agreed  on the draft cover note to the Report and to attach the record of the discussion 
to it. 
 
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1 Document WT/ L/641.  IP/C/82  
 
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  APPENDIX 1  
[EXCERPT FROM THE AD DENDUM TO THE MINUTE S, CONTAINING THE ST ATEMENTS MADE 
DURING THE COUNCIL'S  MEETING HELD ON 8-9 NOVEMBER 2018, TO BE CIRCULATED AS 
IP/C/M/90 /ADD.1]  
6  ANNUAL REVIEW OF THE  SPECIAL COMPULSORY LICENSING SYSTEM (PA RAGRAPH 7 
OF THE ANNEX TO THE AMENDED TRIPS AGREEMENT  AND PARAGRAPH 8 OF THE 
DECISION ON THE IMPL EMENTATION OF PARAGR APH 6 OF THE DOHA DE CLARATION ON 
THE TRIPS AGREEMENT  AND PUBLIC HEALTH)  
6.1  Brazil  
1.  The entry into force of the Protocol Amending TRIPS was an im portant signal for the multilateral 
trading system that the protection of IP can go hand in hand with measures to ensure access to 
medicines. The Protocol provides a legally secure and predictable option for those countries wishing 
to use the TRIPS flexibi lities to get affordable medicines. We would like to highlight the importance 
of this periodic review of the implementation of the System , which became even more necessary 
after the Protocol entered into force.  
2.  While we reiterate our concern that the Special Compulsory Licensing System was used only once 
so far, it would be important to reflect on ways to improve it. According to reports provided by 
participants in the single case of use of the System, it is considered too complex and administratively 
unwieldy. In 2017, Brazil, India and South Africa organized a side event to the TRIPS Council in 
order to receive  the assessment of the System from representatives of industry, government, 
non-governmental organizations and academia. Future discussions in the Council could benefit from 
additional information that can be provided by stakeholders other than Member  States . 
3.  We believe it is important that this Organization continues to provide techn ical support to Member 
States , including through the provision of legal assistance, awareness -raising activities and 
capacity -building. This will ensure that the System becomes a practical option for the procurement 
of medicines in countries without indust rial capacity, allowing that the fruits of the IP system are 
enjoyed in an inclusive way. The regional event held last year in Brasília for Latin American countries 
was considered a great success by participants and we will continue to support those action s by the 
Organization, including through the provision of experts from Brazil. We also support that the 
Secretariat continues its efforts to reach out to those Members not yet parties to the Protocol. 
Member States  could also act through the periodic Trade  Policy Review mechanism.  
4.  We have always been of the view that the Doha Declaration on the TRIPS Agreement  and Public 
Health constitutes a major landmark in the history of the WTO, because it recognized the primacy 
of public health needs and the preparedne ss of the Organization to take up the problems faced by 
the poor and developing countries. The recent agreement on the United Nations' Sustainable 
Development Goals clearly reinforce s that agenda, as it s Goal number 3 mandates the global 
community  to ensur e healthy lives and promote well -being for all at all ages. To attain the goals of 
reducing child mortality and end the epidemics of AIDS, tuberculosis, malaria and neglected tropical 
diseases, access to medicines is a fundamental part of that. The global community needs to act 
together through a multitude of ways, including through the Special Compulsory Licensing System 
before us.  
6.2  India  
5.  India attaches high importance to the Doha Declaration on the TRIPS Agreement and Public 
Health, the Paragraph 6 System as established under the 2003 Waiver Decision and the Protocol 
Amending the TRIPS Agreement . India is one of the first countries that notified its acceptance of the 
Protocol in March 2007.  
6.  India has always been of the view that the Doha Declaration on TRI PS and Public Health 
constituted a major landmark in the history of the WTO because it recognized the primacy of public 
health needs and the preparedness of the Organization to address the problems in access to 
medicines faced by the poor in developing cou ntries. The 2003 Waiver Decision was expected to 
address the public health concerns  faced by Members with insufficient or no manufacturing capacities IP/C/82  
 
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  in the pharmaceutical sector. It may have sounded prophetic at that time when India voiced certain 
apprehe nsions in the G eneral Council  meeting of August 2003 by stating : "the results accruing from 
this mechanism should not be negated by the creation of cumbersome systems that would lead to 
huge delays in getting medicines across at reasonable cost to those th at needed them or discourage 
Members from using the System for the benefit of the people. In order to  make this S ystem 
successful, a sincere collective effort is required on the part of all Members and the entire 
pharmaceutical industry". Regrettably, we h ave been proven right. The export of HIV/AIDS 
medicines by the Canadian pharmaceutical company Apotex to Rwanda in September  2008 has been 
the first and only use of the System so far.  
7.  The UNSG High Level Panel on Access to Medicines, in its report released  in September 2016, 
also recognized that the Para graph  6 System is complex and cumbersome.  
8.  My delegation urge s Members to constructively engage on improving the Paragraph 6 System 
for making it more workable and effective, so that it can benefit Members w ith insufficient or no 
manufacturing capacities in the pharmaceutical sector.   
6.3  Japan  
9.  This delegation would like to express our gratitude to the Secretariat for preparing a draft report 
so we can review the Special Compulsory Licensing System. We welcome t his work, hoping that it 
will encourage all remaining Members to notify their acceptance of the Protocol.  
10.  This delegation would like t o reiterate the importance of access to m edicine s, which needs to 
be discussed in a broader context, taking into account not only the Special Compulsory Licensing 
System , but also various other relevant measures and factors , such as procurement and tariffs. 
Japan supports the Paragraph 6 System as established under the 2003 Waiver Decision and the 
2005 Protocol Amending the TRIPS Agreement . The very objective of the System is to support WTO 
Members in obtaining greater access to medicines, specifically Members that have either insufficient 
or no pharmaceutical manufacturing capacity. Compulsory licenses are, whether granted u nder the 
System or not, just one of the potential means that can be utilized for this objective under an 
exceptional circumstance and, therefore, the System should not be considered as the only solution, 
but rather as just an option we could consider.  
11.  In addition, this delegation would like to mention that voluntary efforts to streamline access to 
medicine s have been increasing. For example, in September WIPO and IFPMA collaboratively 
launched a new medicinal patent information database, Pat -INFORMED, to he lp procurement 
agencies better understand the global patent status of medicines. We believe such a voluntary and 
collaborative effort will be one of the possible ways  forward to respond to better a ccess to medicine s. 
6.4  Canada  
12.  The Government of Canada conside rs access to medicines to be a key priority in our ongoing 
efforts to promote global health and prosperity. Canada recognizes that improving access to 
medicines needs to be achieved through the promotion of health equity, stronger health systems, 
and unive rsal health coverage. Indeed, Canada's international development priorities and significant 
investments in strengthening health systems and the health and rights of women and children are 
contributing to improved access in this regard.  
13.  Canada is a global l eader in supporting partnerships such as the Global Fund to Fight AIDS, 
Tuberculosis and Malaria; the Global Drug Facility ; and Gavi, the Vaccine Alliance, which strengthens 
health systems and provides targeted programming to increase access to medicines a nd vaccines.  
14.  In September 2016, Canada hosted the Fifth Replenishment Conference of the Global Fund and 
pledge d CAD 804 million , which is roughly USD 613 million for 2017-2019. Canada is also the sixth 
largest donor to Gavi having pledge d CAD 520 million for 2016 -2020.  
15.  Canada's Access to Medicines Regime (CAMR), which implements paragraph 6 of the Doha 
Declaration on the TRIPS Agreement  and Public Health, is another measure Canada uses to promote 
access to medicines. Canada continues to believe that CAMR is a useful and effective tool to enhance 
access to medicines in the specific circumstances the System was designed to address.  In 2015, IP/C/82  
 
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  Canada amended the list of medications covered by CAMR to add three new antiretroviral drugs . 
Canada notified this A mendment to  the TRIPS Council in June 2016 . 
16.  Canada also recognizes the 2017 entry into force of the Protocol Amending the 
TRIPS  Agreement . The Amendment provides countries with another important tool to improve 
access to affordable medicines. As the only c ountry to have exported medicine pursuant to the 
temporary waiver, Canada has always been a strong proponent  of the A mendment, and would be 
pleased to share our experiences and lessons learned in implementing our own system with any 
Members who wish to lea rn more.  
17.  It is also important to recall that no single factor is responsible for preventing access to 
medicines. As the Doha Declaration emphasizes, the WTO is part of wider action required to improve 
access to medicines. This is why  Canada relies on a variety of measures to promote access to 
medicines. Our view is that only by addressing all of the factors affecting access to medicines can 
we end the tragedy of people suffering from treatable illnesses. To this end, Canada is open to  
discussing how best to promote access to medicines that considers all relevant factors and effective 
tools to promote access. Canada looks forward to learning more about the views of other Members 
on this issue, including with respect to Members' experien ces, challenges, and other considerations.  
6.5  United States of America  
18.  The United States thanks the Secretariat for the update regarding the status of notifications of 
acceptance of the 2005 Protocol Amending the TRIPS Agreement  contained in JOB/IP/32.  
19.  We con gratulate the Member s that have accepted the Protocol since last year's review.  
20.  We welcomed the entry into force of the Protocol Amending the TRIPS Agreement  in 
January  2017 and are pleased that the amended TRIPS Agreement  applies to 126 Members, as of 
September 2018.  
6.6  Switzerland  
21.  My delegation would like to first thank the Secretariat for  circulating the draft annual report;  
for the helpful, detailed information and the Guide to Notifications facilitating the use of the System 
offered on the ded icated WTO w eb page, as well as f or the technical assistance it has provided, 
throughout last year, relating to the functioning of the Special Compulsory Licensing System and its 
effective use.  
22.  Incorporating the System into the TRIPS Agreement  by way of adding Articl e 31bis and the 
Annex provides welcome d transparency, clarity and legal certainty. The System is there and ready 
for use by eligible beneficiary Members.  
23.  The Secretariat's draft annual report indicates that no notifications for the use of the System 
have been received in the year under review. No quick conclusions should be drawn from this fact 
with regard to the workability of the System. It has not been conceived for frequent use.  
24.  Its purpose is to extend the TRIPS flexibility of Article 31 of the TRIPS  Agreement  to eligible 
beneficiary Members without relevant manufacturing capacity in the pharmaceutical sector. The 
System applies to a certain number of WTO Members, in a specific case and under particular 
circumstances. There are many instances where th e lack of access to needed medicines in potential 
beneficiary countries is not related to patent protection. In such cases, recourse to the System will 
not and cannot provide a remedy.  
25.  Should eligible beneficiary Members m eet concrete problems w hen actuall y making use of the 
System, then it  would be  the Council's duty to examine these specific difficulties in its reviews and 
look into how they can be addressed best in a practical manner. Until we have heard in this Council 
of such concrete problems from eli gible beneficiary Members, it is not helpful for the Council's review 
of the System if some  delegat ions claim in the abstract that the System is not workable or should 
be amended.  
__________