IP/C/86 
 
11 November 2020  
(20-8079) Page: 1/16 
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 sixteenth annual review in October 201 9. The 
General  Council took note of the report of the Council for TRIPS ( document IP/C/84) at its meeting 
on 9-10 December 201 9 (document WT/GC/M/ 181, paragraph 17.9). 
3.  The present report covers the period from October  2019. At its meeting of 15-16 October 2020, 
the Council undertook the seventeenth 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  cover s resources  to support the review of the functioning of 
the System  and provides an overview of capacity building activities  organized by the Secretariat  in 
response to requests by Member s to assist them in making the System  work effectively in practice.  
1  INFORMATION ON IMPLEMENTATION AND USE OF THE SYSTEM  ESTABLISHED 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  dedicated 
page on the WTO website.4 
6.  During the period covered by the present report, no notifications by importing or exporting 
Member s 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 p ublic 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 Protoc ol. 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 th e 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 . 
5 http://www.wto.org/english/tratop_e/trips_e/public_health_e.htm . IP/C/86 
 
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  7.  Member s seeking to use the System  are encouraged to submit their notifications using the 
e-TRIPS Submission System ,6 which is an online tool for WTO Member s 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 . Member s may also consult a 
Guide to no tifications, including a set of model notifications, on the WTO 's webpage.7 The 
accessibility of notifications, once circulated, has been further enhanced through their inclusion on 
the related publicly accessible e -TRIPS Gateway, currently available in b eta version.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 thirds of the WTO Member s 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 sixteenth annual review in 201 9, Barbados, Burundi 
and Niger 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 Secretariat.9 
11.  As of 1 September 20 20, the amended TRIPS Agreement applie d to 131 Member s. The following 
33 WTO Member s 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. Cabo Verde  
6. Cameroon  
7. Chad 
8. Democratic Republic of the Congo  
9. Djibouti  
10. Ecuador  
11. Eswatini  
12. The Gambia10 
13. Ghana  
14. Guatemala  
15. Guinea -Bissau  
16. Guyana  
17. Haiti 
18. Jamaica  
19. Kazakhstan  
 
6 https://www.wto.org/english/tratop_e/trips_e/etrips_e.htm . 
7 https://www.wto.org/english/tratop_e/trips_e/p ar6_modelnotifs_e.htm . 
8 https://e -trips.wto.org . 
9 http://www.wto.org/ english/tratop_e/trips_e/amendment_e.htm . 
10 Since the adoption of this report by the Council for TRIPS at its meeting of 15 -16 October  2020, 
The Gambia has deposited its instrument of acceptance on 20 October 2020 ( document WT/Let/1475).  
 IP/C/86 
 
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  20. Kuwait , the State of  
21. Liberia  
22. Maldives  
23. Mauritania  
24. Mozambique  
25. Namibia  
26. Solomon Islands  
27. Suriname  
28. Tonga  
29. Tunisia  
30. Vanuatu  
31. Venezuela, Bolivarian Republic of  
32. Yemen  
33. Zimbabwe  
12.  At the Council 's meetings in February  and Ju ly 2020, the successive Chairs of the Council for 
TRIPS updated Member s 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 poss ible. In addition, the TRIPS  Council Chair, by means 
of a letter of 18 September 2020, invited Member s concerned to proceed with the acceptance of the 
Protocol as this represented a significant contribution to further 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 Member s until 31 December 20 21 or 
such later date as may be decided by the Ministerial Conference ( document WT/L/ 1081). 
3  MAKING THE SYSTEM  WORK  
14.  TRIPS Council Chairs have repeatedly r eferred delegations to the Council 's 2016 report on the 
annual review of the System  (document IP/C/76), as well as to the  WTO Secretariat 's 2016 annual 
report on its technical cooperation activities ( document IP/C/W/618)  which provide useful 
information resources for future considerations  to make the System  work in practice  and, in 
particular, to prepare for  the annual review of the System .11 
15.  Echoing the former TRIPS C ouncil 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 ",12 Member s 
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 tha t were considering implementing the 
System  in domestic law.  
16.  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 .13 
 
11 See minutes of the TRIPS Council meetings of 30 January 2017 (document IP/C/M/84, para.9); 13 June 
2017 (document IP/C/M/86, para.38); 19 -20 October 2017 (document IP/C/M/87, para.21); 5 -6 June 2018 
(document IP/C/M/89, para.59); 8 -9 November 2018 (document IP/C/M/91, pa ra. 20); 6 June 2019 (document 
IP/C/M/92, para.93); and 17 -18 October 2019 (document IP/C/M/93, para. 25). 
12 See minutes of the TRIPS Council meeting of 30 January 2017 (document IP/C/M/84, para.9).  
13 See 2019 WTO Secretariat Report on Technical Cooperatio n in the TRIPS Area (document IP/C/W/658) 
and the news item reporting on the Annual Workshop on Trade and Public Health organized by the WTO in 2019 
(https://www.wto.org/english /news_e/news19_e/heal_15nov19_e.htm ). IP/C/86 
 
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  17.  Relevant c apacity building activities included  a module dedicated to the System  at the Trade 
and Health Workshop that the WTO organizes annually in Geneva.  An online wo rkshop  organized for 
capital -based experts from Vanuatu discussed the acceptance of the TRIPS Amendment, as well as 
the implementation and use of the Special Compulsory Licensing System . The capacity building 
activities  are based on the second edition of t he 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 
implementation and use of the System .14 Updated background information is  also available on the 
WTO's webpage dedicated to public health.15 In addition, f ocused technical assistance materials have 
been developed to enable interested Member s effectively to assess the operational context of the 
System  and to support their effective use of it.  
_______________  
 
14 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 . 
15 https://www.wto.org/english/tratop_e/trips_e/pharmpatent_e.htm . IP/C/86 
 
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  ANNEX 1  
 [EXCERPT FROM THE MINUTES OF THE COUNCIL 'S MEETING OF 15-16 OCTOBER 20 20 TO 
BE CIRCULATED AS DOCUMENT IP/C/M/ 96] 
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, in the past, the review had been conducted pursuant to 
Paragraph  6 System 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 the TRIPS  Agreement  on 23 January 2017, the review also responded to the require ments 
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 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 Agr eement.  
3.  During the Chair 's consultations in September concerning  Member s' preferences for approach ing 
the annual review , a number of Member s had suggested that the discussion focus on concrete 
problems with the application of the System , rather than an abs tract consideration of issues. Some 
had referred to procedural complexities of the System  that needed to be discussed so that the 
System  could ensure access to medicines  as intended. Others had cautioned that this  agenda  item 
should not be "another COVID -19 item ". One concrete proposal that had gathered broad support 
was the suggestion that the Secretariat give a presentation on how to use the Special Compulsory 
Licensing System  (as opposed to how to accept the Amendment), so as to refresh delegations ' 
memo ry and provide background to the discussion.   
4.  The Chair suggested that she would  proceed by first inform ing Member s about the status of 
acceptances of the Protocol Amending the TRIPS Agreement , and then give the floor to the 
Secretariat to provide a presentation on how to use the Special Compulsory Licensing System  to 
remind everyone  about  the detail . The floor would  then be open to delegations for an exchange of 
views about the functioning of the System, and finally, the Council would consider its Report to the 
General Council.  
5.  The Chair updated Member s 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 t hus binding 
for 131 WTO Member s. In other words, 3 3 Member s were yet to accept the Protocol Amending the 
TRIPS Agreement . She encouraged those Member s to complete their domestic procedures as soon 
as possible.  
6.  When the TRIPS Amendment had entered into forc e in January 2017, Member s had noted that it 
would be useful to consider how to make this new procurement tool work effectively in practice. The 
Chair  therefore encouraged Member s to engage in a constructive discussion which could also build 
on earlier rev iews. As previous Chairs and she herself had indicated on past  occasions, Member s 
might find two documents particularly helpful to facilitate their considerations. The first document 
was the Council 's Annual Review of 2016 (circulated in document IP/C/76); and the second 
document 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 to support the practical use of the System . 
7.  The representatives of the WTO Secretariat , Chad (on behalf of the LDC Group), Ukraine , 
South  Africa , India, China , Tanzania  (on behalf of the A frican  Group) , Japan , Australia , the 
United  States of America , Canada , Chile,  and Switzerland  took the floor.  
8.  The Council took note  of the statements made.  IP/C/86 
 
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  9.  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/3 8). 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 Member s 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 .  
10.  The Council  agreed  to adopt the draft report and to attach the record of the discussion to it . 
_______________  
 
 IP/C/86 
 
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  APPENDIX 1  
[EXCERPT FROM THE ADDENDUM TO THE MINUTES, CONTAINING THE STATEMENTS MADE 
DURING THE COUNCIL 'S MEETING HELD ON 15-16 OCTOBER  2020, TO BE CIRCULATED AS 
DOCUMENT IP/C/M/ 96/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 IMPL EMENTATION OF PARAGRAPH 6 OF THE DOHA 
DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH ) 
7.1  WTO Secretariat  
1.  Thank you very much for providing the Secretariat with an opportunity to make a presentation 
on how to use the Special Compulsory Licensing Sys tem.1  
2.  To start with it is useful to put the System  into context. Where does it come from? Back in 2001 , 
the Doha Declaration on  the TRIPS  Agreement  and Public Health identified the problem of Members 
with insufficient or no manufacturing capacity  in the pharmaceutical sector  to make effective use of 
compulsory licensing. This can be found in  Paragraph 6 of the Doha  Declaration, which also explains 
why many people still refer to the  mechanism as the  “Paragraph 6 System ”.  
3.  The problem identified by the Doha Declaration is about securing adequate supply of affordable 
generics from  third country sources where the needed products are patent -protected.  The difficulty 
does not lie  on the importing Member 's side because that Member can issue compulsory lic ences for 
local production and import under  Article 31 TRIPS. It is located on the exporting Member 's side 
because of  the restrictive condition in Article 31(f) which requires compulsory licen ces to be used 
predominantly to supply the domestic market. Unde r a normal compulsory licen ce, only the 
non-predominant part can be exported . This was considered to be potentially a problem and explains  
why the System  puts in place two distinctive derogations from Article 31(f) , as well as  a derogation 
from the calculation of remuneration to be paid to the right holder  under Article 31(h) . 
4.  Let's now look at when to use the System  [slide 2 ]. There is place for use of the System  when 
there is insufficient or no local manufacturing capacity  in the importing Member  to produce the 
needed medicines and this Member  therefore  needs to rely on imports from a generic  supplier  in 
another Member . In the exporting Member , the product needed is covere d by a patent  and the 
export of the non -predominant share of the production which would be possible under a normal 
compulsory licence  does not satisfy  the need of the importer. Hence, there would be  a need to 
authorize the generic manufacture exclusively f or export. This is typically the scenario in which  the 
System  could  be used.  
5.  The following are i nstances in which  the System  would not be used . This is the case when the 
potential  import ing Memb er has manufacturing capacity to produce what is needed in ter ms of 
medicines or pharmaceutical products. On the exporting Member 's side,  the System would not  be 
used if there is no patent on the products needed by the importer  and there would therefore no 
compulsory licence be required to manufacture for export . The same applies if there is a patent, but  
the standard compulsory license in the exporting Member  would be  sufficient to satisfy the needs of 
the importing country by exporting the non -predominant share of the production. Finally,  the System 
would  not be used in  situations where anti -competitive practices have been determined by judicial 
or administrative processes . Under  Article 31(k) , this would lift  the restrictive condition in 31(f).  
6.  What does  the System  cover?  [slide 3 ] On the 'disease side ', it covers public health problems 
affecting developing countries and LDCs , especially those resulting from HIV/AIDS, tuberculosis and 
malaria , but not limited to those. It also refers to other epidemics. On the 'product side ', the System  
covers all pharmac eutical products, including active ingredients and diagnostic kits which are 
patented or manufactured under patented processes.  
 
1 The PowerPoint presentation is available in Room Docu ment RD/IP/ 40. Reference s to the relevant 
slides are added in brackets.  IP/C/86 
 
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  7.  Who can use the System ? [slide 4 ] LDCs automatically qualify as importers under the System . 
Other Member s will have to notify th e intention to use the System as importers. We should bear in 
mind that developed countries opted out of using the System  as importers. There is  also a group of 
11 high -income developing countries which voluntarily agreed to use the System  only in 
circumst ances of extreme urgency. And we should also note that this is different from a standard 
compulsory license under Article 31  which can be used by all WTO Member s for local production or 
import of all health and other technologies.  
8.  On the exporting Member 's side, any WTO Member  is entitled to export under the System  as 
soon as it has export capacities . Usually , this would require implementation of this form of 
compulsory licence within domestic law , which most WTO Member s with establ ished capacit y to 
export medicines  have done. The data for world -wide pharmaceutical exports in 2014 for 122 
countries  confirm that  the share of the total exports covered by WTO Member s with implementing 
legislation  amount ed to more than 85% of the total pharmaceutical exports [ slide 5 ]. It can thus be 
safely assumed that the legislative framework enabling Members with manufacturing capacities to 
engage in exports under the System is in place.  
9.  We now come to the key question of this presentation , i.e. h ow to use th e System  [slide 6 ]? The 
use consists of four easy steps. The first two are notifications by the importing Member  and the 
exporting Member . In addition, the product which is manufactured under the System  needs to be 
clearly identified as such through labelling or marking of those products for the purpose of avoiding 
trade diversion to high income countries so that they will stay in the country that needs the product. 
And finally , the licensee  is required to post the details of the shipment(s) on a website  to ensure  
transparency about what is shipped, the quantity of the shipped product  and the distinguishing 
features applied to it, and  the destination .  
10.  Let’s first look at the notifications in more detail  [slide 7 ]. For LDC Member s, the n otification  
would provide information about its  specific needs, including the n ames and expected quantities of  
the neede d products  and, if the product is patent -protected in the importing LDC Member , the 
intention to grant  a compulsory license  or the actual grant of a licence . Alternatively , reference can 
be made to the extended transition period  in the pharmaceutical sector which exempts LDCs from 
the obligation to protect such patents .  
11.  Among the  points which merit being kept in mind is that the notification merely sign als the need 
of the LDC and does not mean a commitment to procure medicines under this System . In other 
words, if the LDC Member  finds a more affordable  source from which to procure the  medicines it 
needs, i t does  not have to continue the use of the System . There is n o need to notify the name of 
the supplier , nor the expected time frame of supply and use  of the medicines. This is an important 
point, because notifying the name of the supplier would  unnecessari ly limit the range of potential ly 
interested candidates who could otherwise  engage in supply of the medicines. So , keeping it open 
to a wide range of potential suppliers is important. Joint notifications can be made by importing 
Member s or a regional organ ization on behalf of its Member s with their consent . Finally, this  
notification  is not needed when pharmaceutical products  are imported from another Member  under  
the RTA derogation in Article 31 bis(3). 
12.  To illustrate how this would like in practice , let’s take the  hypothetical example of Aradia, an 
LDC [slide 8 ]. Its Ministry of Health, in cooperation with an International procurement programme, 
determined that it need s 15 million doses of 'panaceavir '. It also exercised rights not to protect 
pharmace utical patents until 2033. All its notification under the System  therefore needs to say  is 
that "Aradia needs to import 15 million doses of panaceavir ." 
13.  For Members that are not LDCs, two notifications would be required to use the System [ slide 
9]. The first notification is about  its intention to use the System  as an importer . It can be made any 
time, also together with the notification of its specific needs . This notification is  not needed if the 
importing Member  is an LDC  or if the  import takes place from another Member  under the  RTA 
derogation in Article 31 bis(3). Again, making the notification does not imply a commitment to 
procure medicines under the System . It is just the first step and the Member  remains  free to get the 
medicines from a different source.  
14.  The second notification is about the importer’s specific needs . This  has to be made each time 
the System  is used by a Member  for a particular medical need [slide 10 ]. It is almost identical to the IP/C/86 
 
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  notification requirement for LDC Member s with one difference, i.e. the importing non -LDC Member  
also has to notify  that it has  establish ed that it has  insufficient or no manufacturing capacities in the 
pharmaceutical sector and how this has been established . The other notes are similar to those set 
out regarding  LDC notification requirements.  
15.  How would this look like in practice  [slide 11 ]? In the hypothetical case for illustration purposes , 
Sanatos is a developing countr y. Its Ministry of Health procurement programme determ ined that it 
needs 30 million doses of 'elixivir'. The country has insufficien t manufacturing capacities  in the local 
pharma ceutic al industry . In this case all the notification need s to say  is that  "Sanatos intend s to use 
the System  set out in Article 3 1bis of the TRI PS Agreement and the Annex and the Appendix to it, 
as an importi ng Member " and "Sanatos needs to import 30 million doses of elixivir . Sanatos has 
found that its manufacturing capacity in the pharmaceutical sector is insu fficient to meet its needs 
for this product, on the basis of 'Pharma Sanatos 2016 ', the most recent report on the 
pharmaceutical sector prepared by the Ministry of Industry ".  
16.  Optional ly, if no patent is in force,  the notification could also indicate that  "elixivir is not patent 
protected in the territory of Sanatos ". If a patent is in force, the notification would need to confirm 
that "Sanatos intends to authorize use of the subject matter of the patent or patents in force for 
elixivir without the consent of the patent owner in accordance with the provisions in Article  31 and 
Article 31 bis of the TRIPS Agreement ". 
17.  Let’s now turn to the n otification requirements for an exporting Member  [slide 12 ]. It needs to 
notify the grant of a compulsory license and conditions attached to it. What exactly does it need to 
notify? The notification has to include the name and address of licensee ; product and quantities for 
which the compulsory licence  has been granted; importing Member (s); duration of compulsory 
license; website address with information on quantities being supplied and distinguishing features 
applied to the product manufactured for export; and , on an optional basis, other licensing conditions  
and patent numbers.  
18.  It is important to note that in the not ification that has to be made by any exporting Member  for 
every compulsory licence issued under the System , information about details can be replaced by a 
copy of  the compulsory license  attached to the notification . The notification has to be submitted pri or 
to export. Specific labelling/marking requirements apply to formulated products, active ingredients 
and finished products using such active ingredients. Before the shipment begins,  the licensee may 
post information about the shipment on its own website or on a dedicated WTO website. This 
notification is not required if export takes place under  the RTA derogation (Art.31 bis(3)). 
19.  Finally, h ow to notify [slide 13 ]? The preferred option would be the use of  the e -TRIPS 
Notification and Submission System . The links in the presentation are active in the room document 
and can be accessed by Member s.  
20.  The e -TRIPS platform facilitates entry of each of the three notifications. We would encourage 
Member s to use th is facility . Other means of making notifications  by email, by fax, or by mail  remain 
also available . For Member s wishing to use those options, a Guide to Notifications , including model 
notifications , is available on the WTO webpage . The link s are also provided on this slide .  
21.  The notifications will be c irculated by the Secretariat  to the TRIPS  Council as a formal document 
and can be accessed  either on e -TRIPS or the TRIPS and Public Health webpage, which l inks to the 
relevant notification s on Documents Online .  
22.  Please note that none of these notification s require approval by a WTO body ; that the general 
TRIPS requirements for compulsory license  in Art icle 31 continue to apply such as  the requirement 
to first seek a voluntary license by the right holder  in normal circumstances; and , as the System  is 
about intellectual property, that it does not address any procedural issues relating to, for example, 
procurement of medicines and regulat ory approval . 
23.  For those who are interested in more detail, slide 14  provides  a list of resources which includes 
very recent material like Annex 3 to the Second Edition of the Trilateral Study . This  Annex  addresses  
the operation of the Special Compulsory Li cense System . Also, the Guide to the TRIPS Agreement 
has a module on TRIPS and Public Health , including  a specific section on using the Special 
Compulsory License System .  IP/C/86 
 
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  7.2  Chad on behalf of the LDC Group  
24.  Chad is speaking on behalf of the LDC Group, wh ich thanks you for your report. We also thank 
the Secretariat for the update just provided to us.  
25.  As you recalled, it is true that the TRIPS Agreement and public health is a highly important 
matter for LDCs.  
26.  The entry into force of the amended TRIPS Agreem ent in January 2017 was a historic 
development, building integrally into the Agreement, as you reminded us, a valuable public health 
safeguard for the benefit of developing countries and particularly LDCs, which are extremely fragile 
and vulnerable.  
27.  The am endment provides for medicines to be produced under a special compulsory licence, for 
export to countries particularly reliant on overseas suppliers to meet the needs of their patients. As 
you know very well, the health needs in our countries, and especial ly in the least developed 
countries, are extraordinarily high.  
28.  It is therefore easy to see why this amend ment is important as we face this global health crisis 
caused by COVID -19. 
29.  The LDC Group understands the important role that the TRIPS Agreement and pu blic health 
play in relation to COVID -19. Indeed, we believe that the provisions of this amendment are highly 
relevant to the current global health crisis. The pandemic is an accelerator rather than a complication 
arising from the situation.  
30.  For this reaso n, the LDC Group is of the view that this issue is particularly important given the 
current pandemic. Focusing on access to medical supplies and saving human lives is therefore our 
overarching concern. We are currently facing difficulties due to the restri ctions on travel, market 
access and the movement of goods. We are struggling to access the tools necessary for tackling the 
pandemic, such as, inter alia, medicines, masks and ventilators.  
31.  This amendm ent, in our view, is highly valuable and useful in light  of the current situation. By 
way of conclusion, you reminded us that 33 Members, including LDC Members, are yet to accept this 
amendm ent. The LDC Group has therefore begun awareness -raising and mobilization activities to 
ensure that the Members of our Gro up accept the amendment by the deadline. We believe that these 
Members will do so and that it is simply a procedural matter. It is hoped that, by the deadline, this 
amendment  will be validated and accepted by those Members of the LDC Group that have not ye t 
done so.  
32.  Once again, this amendment  is highly useful and important for the LDC Group so that we are 
able to easily access medicines and pharmaceutical products. In light of this, it is clear that the 
matter is relevant to the pandemic.  
7.3  Ukraine  
33.  Ukraine expresses its gratitude to the WTO  Secretariat for preparing a draft report and the 
possibility of taking part  in the annual review of the Special Compulsory Licensing System . 
34.  Ukraine follows the discussions on this issue in the TRIPS Council and considers that exchanging 
information and e xperiences regarding  the implementation and use of the System  is very important 
and valuable, especially in the context of the COVID -19 crisis. Ukraine welcomes this work, hoping 
that it will ensure the effective operation of the System  and encourage all r emaining WTO Member s 
to notify their acceptance of the Protocol Amending the TRIPS Agreement . 
35.  Given the situation with the COVID -19 pandemic, it is extremely important for Ukraine to ensure 
greater access to affordable medical products by intellectual prop erty mechanisms, as provided in 
Article 31 of the TRIPS Agreement.  
36.  Ukraine would appreciate  hearing about the  experience of WTO Member s who have used or 
considered using the System , any updated information regarding its implementation into domestic IP/C/86 
 
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  legislative and regulatory framework , as well as thoughts concerning the System 's role to address 
the COVID -19 pandemic.  Such exchanges of views, as well as discussions in a broader context of  
the relationship of intellectual property and public health, will hel p to raise awareness of practical 
possibilities of using the System  or its alternatives and related TRIPS flexibilities both among WTO 
Member s as well as with interested agencies in charge of public health matters in their territories, 
and to adopt effecti ve measures necessary to protect public health.  
7.4  South Africa  
37.  The first question I have with respect to the Secretariat presentation refers to the definition of 
a 'pharmaceutical product ' as we find it in the Annex to the TRIPS Agreement. The last sentence of 
sub-paragraph  (a) says “it is understood  that active ingredients necessary for its manufacture and 
diagnostic kits needed for the use would be included ”. One interesting question that  always comes 
up is that this particular definition does not refer to vaccines. The question I have in context of our 
discussions around COVID -19 is whether or not we are talking about pharmaceutical products or 
products of pharmaceutical processes. This e ssentially would also include vaccines — it would be 
good if this point could be clarified .  
38.  The second question is in relation to Member s that have implemented regimes for exportation 
under this System . And just in terms of the statistics, you indicated th at 85% of the worldwide 
exports comes from Member s that have implemented the System  into their domestic law. Do we 
have statistics of who those Member s are , i.e. the world exporters, the WTO Member s with 
implementing legislation ?  
39.  The last question is in r espect of the use by LDCs in an RTA. If I go to the text of Article 31 bis 
and I look at paragraph 3, it says and confirms what the slide says . But it goes on to say that where 
a developing or a LDC Member  is party to an RTA within the meaning of Article XXIV of the GATT 
1994 and the Decision  of 28 November 1979  on Different ial and More Favourable Treatment  
Reciprocity  and Fuller Participation  of Developing Countries, the requirement then is that at least 
half of the current member ship is made up of countries presently on the United Nations list of least 
developing countries. This creates a more cumbersome requirement for Member s to benefit from a 
producer that may be situated within that RTA. To clarify that it is not just any RTA,  it is only RTAs 
where at least 50% of Member s are LDCs . According to my calculations , there are only two of these 
currently existing, and both of them are situated in Africa.  
40.  So as indicated I will proceed to read my prepared statement, and noting your i ntroduction, 
thanking you for the consultations that you have held. We are also appreciative of the Secretariat 's 
interventions including the excellent presentation.  
41.  The Doha Declaration on  the TRIPS  Agreement  and Public Health, and the Paragraph 6 System  
established under the 2003 waiver, and the Protocol Amending the TRIPS Agreement  through Article 
31bis, remains a fundamental achievement and a landmark worthy of admiration. Yet, the 
Paragraph  6 System  has st ood as a monument to good intentions —pristine and only invoked once 
during the entire time. There is a recognition that the use of the System  is overly cumbersome with 
too many conditionalities and procedural prescripts to be useful to Member s with insuffi cient or no 
manufacturing capacity in the pharmaceutical sector.  
42.  Having studied the recently updated trilateral study, it points out that concerns have been 
expressed that the System  is overly complex and not practical, and the potential use of the System  
may be deterred by concerns of political or trade ramifications associated with the use of compulsory 
licences. We agree that the System  cannot be a panacea against all eventualities. However, 
conditioning the use of the Paragraph 6 System  to time -consumi ng and overly burdensome 
procedures does not make for quick action irrespective of the level of development of a country.  
43.  Looking at the System  through the lens of COVID -19 quickly reveals of the cracks in its 
construction and application. The System  is based on developing countries notifying the WTO of the 
general intention to use the System , yet we see that there are many factors that might prevent a 
country from doing so and especially given the COVID -19 circumstances. As we indicated, we remain 
concern ed about the apparent procedural and legal difficulties that continue to exist under this 
System  and we stand ready to continue a discussion on many of these concerns that we have.  IP/C/86 
 
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  44.  I just wanted to point out that in the context of HIV/AIDS, South Africa being one of the most 
affected countries in the world and so too the African continent, it is estimated that between 1997 
and 2012, 12 million Africans died waiting for enough life -saving drugs to reach the continent. This 
is already during the time when  the Doha Declaration on the TRIPS  Agreement  and Public Health 
had been issued, the 2003 waiver had been  adopted and implemented on a provisional basis until it 
was finally subject to the Amendment  of the TRIPS Agreement —yet millions of people still died. 
What are we to make of a System  that allows a humanitarian crisis of this magnitude to continue 
without abatement? If this many people died in the genocide or an armed war or conflict t here would 
be immediate action. Yet many of these people did not die because they were killed by bullets or 
artillery shelling, they died because they could not access life -saving medicine in a timely manner. 
We ask, will we allow this to continue? I hope not. The WTO must be responsive to the needs of its 
Member s, chief amongst them must be counted the poorest and the most vulnerable.  
7.5 India  
45.  We thank the Secretariat for the comprehensive presentation on the use of the Special 
Compulsory Licensing Syste m. 
46.  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 . These provisions provide that the TRIPS Council shall review 
annually the functioning of the Special Compulsory Licensing System  with a view to ensuring its 
effective operation.  
47.  The impracticality and difficulty in using this System  should be self -evident in view of the fact 
that since 2007 thi s System  has been invoked only once, despite the existing lack of sufficient 
manufacturing capacities in many countries.  
48.  We note that while delivering the presentation, it was mentioned that the process to use this 
System  is fairly easy. However, when MSF  had actually attempted to use it to export HIV medicines 
from Canada to Rwanda, it had expressed some pertinent concerns and I quote, "that the mechanism 
is neither expeditious nor workable and it is so cumbersome and full of red tape that it acts as a 
major disincentive ". The onus, thus, lies on this Council to improve the procedures under this System  
so as to make it efficient and workable. We hope that Member s will engage constructively on this 
important issue.  
49.  Lastly, we congratulate Barbados, Burundi and Niger for accepting the Protocol since the 
sixteenth annual review in 2019 and encourage the 33 Member s who are yet to accept the Protocol, 
to do so expeditiously.  
7.6  China  
50.  China wants to thank the Secretariat for its presentation and the draft repor t. It is informative 
and very useful. China supports the discussion on flexibilities provided by the TRIPS Agreement and 
the Doha Declaration on  the TRIPS Agreement and Public Health , including how to make more 
effective use of the Special Compulsory Licensing System . 
7.7  Tanzania  on behalf of the African Group  
51.  The African Group would like to thank the Secretariat, in particular Mr Roger Kampf for the 
briefing  that he has provided under this important agenda  item. The briefing shares  the challenges  
that face potential use of this System  in terms of the bureaucratic  process es needed before importers 
or exporters engaged in the use of the System. This is an opportunity to reflect on the  importan ce 
on how to make  the System work eff ectively .  
52.  The African Group would like to express appreciation for the Secretariat 's continued good work 
under this important agenda item, which helps shed light on , among other  things,  ways of making 
the Para graph 6 System  work.  
53.  We welcome new developments which saw Burundi and Niger accept the Protocol Amending the 
TRIPS Agreement , and we also welcome the commitment of the delegation of Zimbabwe who at IP/C/86 
 
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  their Trade Policy Review a couple of weeks back made a commitment to accept the Protocol 
Amending the TRIPS Agreement .  
54.  These are encouraging developments, particularly in Africa wh ere we have been 
disproportionately affected by the COVID -19 pandemic that has overstretched our financial 
resources and public health system s. It is, thus, important for Africa to have all the tools at our 
disposal to address the pandemic and build local pharmaceutical manufacturing capacities and 
address structural vulnerabilities that arise out of the over reliance on imports of pharmaceutical 
and medical consumables.  
55.  We would like to encourage Members that do not have ratified  the System  yet to do so  in the 
remaining time .  
7.8  Japan  
56.  This delegation would like to express our gratitude to the Secretariat for making a presentation 
and preparing a draft report so  that we can review the Special Compulsory Licensing System . We 
welcome this work, hoping that  it will encourage all remaining Member s to notify their acceptance 
of the Protocol.  
57.  This delegation would like to reiterate the importance of access to medicine 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 ve ry objective of the System  is to support WTO 
Member s in obtaining greater access to medicines , specifically Member s that have either insufficient 
or no pharmaceutical manufacturing capacity. Compulsory licenses are, whether granted under the 
System  or not,  just one of the potential means that can be utilized for this objective under an 
exceptional circumstance . Therefore, the System  should not be considered as the only solution, but 
rather as just an option we could consider.   
7.9  Australia  
58.  Australia thanks the Council for the Annual Review. As highlighted in the Review, Australia notes 
that the Secretariat has continued to provide technical assistance, in cooperation with other 
partners, to support the effective use of the Special Compulsory Licensing System . 
59.  The Review also notes a number of recent capacity building activities. We recognise that these 
activities are a useful way to  facilitate the implementation and understanding of the 
System .  Australia also commends the TRIPS Council for supporting transparency providing a guide 
to notifications for the Special Compulsory Licensing System  on the WTO website.    
60.  We welcome the joint  WTO-WHO-WIPO study on 'Promoting access to medical technologies and 
innovation ', and note that Annex III provides a helpful overview of the Special Compulsory Licensing 
System . We look forward to further efforts to promote transparency and understanding f or all TRIPS 
Member s.  
7.10  United States of America  
61.  The United States would like to thank the Secretariat for its presentation.  
62.  The United States welcomed the entry into force of the Protocol Amending the 
TRIPS  Agreement . We welcome the Secretariat 's draft Report and its work throughout the year to 
facilitate and encourage all Member s to notify their acceptance of the Protocol.  
63.  We also congratulate the additional Member s that have accepted the Protocol since the entry 
into force of the amended TRIPS Agreement.  
64.  While the entry into force of the amended TRIPS Agreement represented an important step in 
promoting our shared goal of facilitating access to medicines , it is only one piece of the puzzle . For 
example, the WHO has identified numer ous considerations, including pricing and procurement IP/C/86 
 
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  policies, taxes, markups and tariffs, and other national policies that ultimately result in higher costs 
for consumers and for health system s.  
65.  We encourage Member s to continue to focus efforts to addre ss other salient barriers to access 
while also recognizing the important role that intellectual property and international trade 
liberalization play in incentivizing drug development and expanding access to medicines  around the 
world.  
7.11  Canada  
66.  Canada c onsiders access to medicines  to be a key priority in our ongoing efforts to promote 
global health and prosperity.  
67.  Canada 's Access to Medicines  Regime (or CAMR), which implements Paragraph 6 of the 
Doha Declaration on the TRIPS Agreement and Public Health , is one such measure used in Canada 
to promote access to medicines . Canada  also recognizes  the 2017 entry into  force of the  Protocol 
Amending the TRIPS Agreement  which provides countries with an important tool to improve access 
to affordable medicines. As the only country to have exported a medicine pursuant to the temporary 
waiver, Canada has always been a strong proponent of the Amendment , and would be pleased t o 
share our experiences and lessons learned in implementing our own System  with any Member  who 
wishes to learn more.   
7.12  Chile  
68.  Our delegation would like to thank the Secretariat for the presentation on the use of the System, 
as well as the Annual Review . Chile congratulates all the Members  that have already ratified the 
Amendment and we commend th ose that have not done so to do it before the deadline. Chile is a 
strong promoter of this Amendment and is willing to share its experiences in how our country ratified 
the Amendment.  
69.  Our country is open to hearing more cases with empirical evidence in this area, as well as 
surrounding elements such as aspects of public procurement and pricing that could eventually have 
an effect on access to medicines. Our deleg ation is open to hearing concrete proposals on this issue.  
7.13  Switzerland  
70.  My delegation would like to first thank the Chair, for your consultations held to prepare t he 
review under agenda item 7.  
71.  I would like to join other delegates to thank also the Secretariat for their technical assistance 
throughout the previous year and for the very useful, clear and concise overview of the functioning 
of the 31 bis System and how beneficiary Members may make use of it . We hope the Secretariat will 
make the presentation available on the WTO’s dedicated webpage, together with the other helpful 
information and the Guide to Notifications facilitating the use of the System.  
72.  The presentation of the Secretariat showed that t he use of the 31 bis System by beneficiary 
countries is straightforward.  In contrast, in their interventions India and South Africa called the 
System complex, cumbersome and not practical, citing as evidence that the System has been used 
only once so far. W e disagree.  
73.  The Secretariat recalled in its presentation that the purpose of adopting the System in 2003 
was to extend the TRIPS flexibility of Article 31 of the TRIPS Agreement to eligible beneficiary 
Members without relevant manufacturing capacity in th e pharmaceutical sector. It has not been 
conceived for frequent use. The System applies to eligible beneficiary countries, in a specific case 
scenario and under particular circumstances. There are many instances, where the reasons for a 
lack of access to n eeded medicines in potential beneficiary countries are not related to patent 
protection. And it is misleading to imply that the many casualties that today still – and tragically 
enough - result from insufficient and untimely access to medicines would be th e result of IP or 
perceived deficiencies in the system provided by Art. 31 bis.  IP/C/86 
 
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  74.  By m aking the so -called Para graph  6 mechanism on patents and public health permanent in 
their decision of 6 December 2005 and amending the TRIPS Agreement formally by adding Ar ticle 
31bis in its Part II Section 5, Members have ensure d transparency, clarity and legal certainty.  
75.  Should eligible beneficiary Members meet with concrete problems when actually  making use of 
the System , then it  is the Council 's duty to examine these specific difficulties in its Annual Reviews 
and look into how they can be addressed best in a practical manner. So far, we have not heard of 
such practical problems . 
76.  We call on those 33 Members who have not yet accepted  the Protocol  Amending the TRIPS 
Agreement to do so now without further delay.  
77.  We were pleased, in this respect, to hear from the distinguished delegate from Chad on behalf 
of the LDC group that they will undertake additional efforts to encourage their Members to accept 
the Protocol before the expiry of the extended deadline, and that he considered the 31 bis System 
to be very useful from the perspective of a beneficiary country group . 
7.14 WTO Secretariat  
 
78.  We thank the Chair and delegations for their useful inputs into the debate. Let me  start with 
the questions which were posed by South Africa, which are very pertinent.  
79.  The first question concerned  the definition of pharmaceutical products and whether this included 
vaccines. This is, of course, a very pertinent question i n the current situation , as the pandemic is 
very much about access to vaccines if and when they become available. As usual , it is, however,  not 
for the Secretariat  to interpret relevant provisions . I would therefore  turn the question back to South 
Africa. Is there any serious concern about vaccine s not being included in the definit ion of a 
pharmaceutical product? Is there any argument being made saying that vaccines are indeed not 
considered to be pharm aceutical products? In relevant  WHO official documents , for example,  
vaccines  are generally included in the legal definition of a pharmaceutical product. Similarly, the 
WHO Good Manufacturing Practices  for Pharmaceuti cal Products ha s numerous references to  
vaccines. So , there are indications out there about what falls within the definition of a pharmaceutical 
product. But again the question is : is there really any concern about vaccines not being included ? 
80.  The second question  referred to the slide with the statistics  about Members with export capacity 
that have implementing legislation in place , seeking an explanation as to  how these statistics were  
put togethe r. These have been taken from  industry sources which have records on the export of 
pharmaceutical products on a country -by-country basis. I did compare this data with the 
implementing legislation that is compiled in a Staff Working Paper on the  key features of WTO 
Members’  implementin g legislation regarding the Paragraph 6 System .2 That led to the figures you 
see on the slide  concerned . While the data merit being updated,  newer figures can be expected to 
confirm the finding that the vast majority of Members with export capacities have  implementing 
legislation  in place .  
81.  The final point was about regional trade agreements and I apologise that the slide may  be a bit 
misleading , although  I did present  it orally in a more concise manner . As the delegate from South 
Africa has rightly noted , for RTAs to benefit from th e easier procedure  in Article 31bis to export 
medicines  to other members  within the RTA , they need to qualify as an RTA within  the meaning of 
Article XXIV  of the GATT 1994. The RTA  needs to be composed of 50% or more of least de veloped 
countries and also the Member s concerned need to share their health problems in question. However, 
I would rather see what has been  described as a cumbersome further condition  to use the System  
as an additional flexibility . It was built into the mechanism when it was adopted  to give additional 
flexibility to those who at the time were most suffering from the HIV/AIDS crisis. One can therefore  
also see that particular derogation from a positive a ngle.  
82.  To conclude, I just wanted to pick up on what our colleague from Chile said , i.e. that there is 
more need for empirical studies and evidence. Indeed , when it comes to  the question as to whether 
the procedures are  cumbersome and bureaucratic, it woul d actually be good to hear more about the 
problems and , in particular for least developed countries , the difficulties to submit  a one line  
 
2 Available at https://www.wto.org/english/res_e/reser_e/ersd201507_e.pdf . IP/C/86 
 
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  notification  identifying the products and the quantities needed. This call for empirical evidence or 
studies seems  therefore  pertinent and maybe something to be picked up in our  future work.  
__________