IP/C/79  
 
25 October 2017 
(17-5793) Page: 1/12 
Council for Trade -Related Aspects of  
Intellectual Property Rights  
    
 
   ANNUAL REVIEW OF THE  SPECIAL COMPULSORY L ICENSING 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 Implem entation 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 Syst em (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 report on its operation to the General  Council.  
2.  The Council for TRIPS undert ook the thirteenth annual review in November 2016. The General 
Council took note of the report of the Council for TRIPS (IP/C/76) at its meeting on 
7 December  2016 (WT/GC/M/165, paragraph 9.16).  
3.  The present report covers the period since October  2016. At i ts meeting of 
19-20 October  2017, the Council undertook the fourteenth annual review. Annex  1 and Appendix  1 
to this report record the review and the statements made by delegations.  
4.  Sections 1 and 2 below set out factual information regarding the implement ation and use of 
the System, as well as the entry into force of the Amendment to the TRIPS Agreement and 
the status of acceptances of the Protocol. Section 3 summarizes views expressed by Members with 
respect to possible next steps to ensure that the Syste m works effectively in practice.  
1  INFORMATION ON IMPLE MENTATION AND USE OF  THE SYSTEM ESTABLISH ED 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 i ts 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 
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 wa s adopted on 6 December 2005 (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 y et to accept it, the General Council Decision of 
30 August 2003 (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 re view 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/79  
 
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  7.  The 2013 WHO -WIPO -WTO study on "Promoting Access to Medical Technologies and Innovation 
– Intersections Between Public Health, Intellectual Property and Trade" offers explanatory 
background mater ial on the implementation and use of the System.6 Updated background 
information7 and a set of model notifications to further facilitate the use of the System8 are also 
available on the WTO's webpage dedicated to public health.  
2  AMENDMENT TO THE TRI PS AGREE MENT  
8.  In accordance with Article X:3 of the WTO Agreement, the Protocol entered into force 
on 23 January 2017, upon acceptance by two thirds of the WTO Members who had accepted it on 
or before that date.  
9.  Members took note of the entry force of the amended T RIPS Agreement at an extraordinary 
meeting of the Council for TRIPS held on 30 January 2017.9 They welcomed the first ever 
amendment to the WTO agreements as a significant step forward for WTO Members, since it 
provided legal certainty to access affordable  medicines. Members noted that the entry into force 
demonstrated that the WTO was not only about trade liberalization, but could respond to essential 
needs beyond trade policy. It was also recalled that the System was part of the broader picture 
which incl uded other important aspects that impacted on access to affordable medicines.  
10.  In accordance with the provisions of paragraph 3 of Article X of the WTO Agreement, for each 
other Member the Protocol takes effect upon acceptance by it. Since the entry into fo rce of 
the amended TRIPS Agreement, Oman, Sierra Leone, Fiji, Saint Vincent  and the Grenadines, 
Malawi, as well as the Russian Federation  have accepted the Protocol.  
11.  As of 30 September 2017,  the amended TRIPS Agreement thus applies to 11 8 Members. 
Informat ion on the status of acceptances of the Protocol can be found on a dedicated webpage 
which is regularly updated by the WTO Secretariat.10 
12.  At the Council's meetings in November 2016, as well as in March , June and October  2017, 
the respective Chairs of the Co uncil for TRIPS updated Members on the state of play of 
acceptances that had been submitted and 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 pos sible.  
13.  As of 30 September 2017,  the following Members were yet to accept the amendment:  
 Afghanistan  
 Angola  
 Antigua & Barbuda  
 Armenia  
 Barbados  
 Bolivia, Plurinational State of  
 Burundi  
 Cabo Verde  
 Cameroon  
 Chad 
 Congo  
                                                
6 See pages 177 to 180 and Annex II of the study, ava ilable 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/PAMTI_WHO -WIPO -WTO.pdf  
7 https://www.wto.org/english/tratop_e/trips_e/pharmpatent_e.htm .  
8 http://www.wto.org/english/tratop_e/trips_e /par6_modelnotifs_e.htm .  
9 For the minutes, see documents IP/C/M/84 and IP/C/M/84/Add.1.  
10 http://www.wto.org/english/tratop_e/trips_e/amendment_e.htm .  IP/C/79  
 
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   Côte d'Ivoire  
 Cuba 
 Democratic Republic of t he Congo  
 Djibouti  
 Ecuador  
 Gabon  
 The Gambia  
 Georgia  
 Ghana  
 Guatemala  
 Guinea  
 Guinea -Bissau  
 Guyana  
 Haiti 
 Jamaica  
 Kazakhstan  
 Kuwait, the State of  
 Kyrgyz Republic  
 Liberia  
 Madagascar  
 Maldives  
 Mauritania  
 Mozambique  
 Namibia  
 Niger  
 Paraguay  
 Solomon Islands  
 Suriname  
 Swaziland  
 Tonga  
 Tunisia  
 Vanuatu  
 Venezuela, Bolivarian Republic of  
 Yemen  
 Zimbabwe  
14.  The Protocol is currently open for acceptance by these Members until 31 December 2017 or 
such later date as may be decided by the Ministerial Conference (WT/L/965). However, d espite 
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 fo r TRIPS therefore submits 
the attached proposal to the General Council for a decision to extend the period for acceptances IP/C/79  
 
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  of the Protocol. A draft of such a proposal for consideration by the Council is contained in Annex 2 
of this document.  
3  NEXT STEPS  
15.  At the meeting on 30 January 2017, the then Chair of the TRIPS Council, Ambassador Mero 
(United Republic of Tanzania), noted the importance "to look into how to make this new 
procurement tool work effectively so that it delivers concrete results in practice".  He referred 
delegations to the Council’s report on the annual review of the System (IP/C/76), as well as to 
the WTO Secretariat’s annual report on its technical cooperation activities (IP/C/W/618) which 
provide useful information resources for future cons iderations.11 
16.  This was echoed by Members. The need to intensify work to ensure that the System was 
effectively used a s a practical procurement tool for medicines  was emphasized. This included 
awareness raising and capacity building for potential users of th e System, targeting, in particular, 
procurement officers 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 . The n eed for a mechanism that ensured the effective coordination among 
the providers of technical assistance was also raised. Furthermore, the importance for Members to 
share their experiences with respect to the implementation and use of the System was noted 
in order to better understand its potential, but also the challenges that could arise when using it.  
17.  As a first step to address the suggestions made by Members, the WTO Secretariat provided 
an overview of the notification requirements that applied under the  System at the Council’s 
meeting in March.12 
 
_______________  
 
                                                
11 See minutes of the meet ing in document IP/C/M/84, para.9.  
12 The presentation of the Secretariat is recorded in the minutes of the meeting held on 1 -2 March, see 
document IP/C/M/85/Add.1, paras. 145 to 179.  IP/C/79  
 
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  ANNEX 1  
 
 EXCERPT FROM THE MIN UTES OF THE COUNCIL' S MEETING OF 19 -20 OCTOBER 2017  
(TO BE CIRCULATED AS  IP/C/M/87)  
6  ANNUAL REVIEW OF THE  SPECIAL COMPULSORY L ICENSING SYSTEM  (PARAGRAPH  7 
OF THE AN NEX TO THE AMENDED T RIPS AGREEMENT AND P ARAGRAPH 8 OF 
THE DECISION ON THE IMPL EMENTATION OF PARAGR APH 6 OF THE DOHA 
DECLARATION ON THE T RIPS AGREEMENT AND P UBLIC HEALTH ) 
1.  The Chairperson  said that paragraph 7 of the Annex to the amended TRIPS Agreement and 
paragraph 8 of the 2003 Waiver Decision required the Council to review the functioning of 
the special compulsory licensing system ( the "System ") annually, with a view to ensuring its 
effective operation. The Council was also required 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 have 
fulfilled the requirements of Article  IX:4 of the WTO Agreement.  
2.  She invited Members to exchange views on the functioning of the System. T wo documents 
could serve as background for the discussion: (i) the TRIPS Coun cil's report on its annual review in 
2016 (IP/C/76); and (ii) the Secretariat's 2016 r eport on its technical cooperation in the TRIPS 
area (IP/C/W/618). Annex II of the latter doc ument summarized the discussions on the practical 
use of the Paragraph 6 System.  
3.  Turning to the Council's report to the General Council, the Chairperson noted that a  draft cover 
note, modelled on previous reports, had been prepar ed by the Secretariat (JOB/ IP/27). 
It contain ed factual information on the implementation and use of the System. The draft would 
need to be updated to reflect the recent acceptance of the Protocol by the Russian Federation. 
The minutes of the discussion under this agenda  would also have to be attached  as Annex 1  and 
Appendix 1 . 
4.  Additionally , the Council would  need to decide on Annex 2, which referred to the Protocol 
Amending the TRIPS Agreement . She recalled that  the Protocol was currently open for acceptance 
by Members until 31 Dece mber 2017 . There we re 46 Members that ha d not yet accepted 
the Protocol . As it was unlikely that all of them would  do so before the end of 2017, the Council 
needed  to consider the way forward. Previous consultations  had indicate d that most Members 
would li ke to see a further extensio n of the period for acceptance.  A draft decision to that effect, 
for adoption by the General Council, ha d been included as Annex 2 to the draft report. The  draft 
decision did not yet contain a deadline. At a recent  informal meeting of the TRIPS Council , one  
delegation had raised the possibi lity of an indefinite extension. However, most delegations had  
preferred a fixed deadline, either a  two year or a four year extension . She suggested focusing 
the discussion on the se two  options  and that the Council decide on the  one with greater support.  
5.  The representatives of India; the United States ; Barbados ; the European Union ; Haiti, on behalf 
of the LDC Group ; Brazil ; Canada ; South Africa ; Switzerland ; Japan ; Thailand ; the Republic of 
Korea; the Russian Federation ; Australia ; China ; Costa Rica ; and Nigeria, on behalf of the African 
Group  took the floor.  
6.  The Council took note  of the statements made.  
7.  The Chairperson  proposed that the Council agree on forwarding to the General Council the 
proposal for a decision to extend the period for acceptance by Members of the Protocol Amending 
the TRIPS Agreement until 31 December 2019 . The last paragraph of the draft decision by the 
General Council contained in Annex 2 to the draft re port should be compl emented by inserting this 
date. She also proposed that the Council agree on the cover note to the report contained in 
JOB/IP/27, with updates concerning an instrument of acceptance that had been deposited since 
the circulation of the draft cover note, and also that the Council minutes containing the record of 
the discussion be attached to it as Annex 1  and Appendix 1 . 
8.  The Council so agreed . 
 
_______________  IP/C/79  
 
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  ANNEX 2  
  
  
  WT/L/..  
 
 
(17-0000)  Page: ../..  
    
AMENDMENT OF THE TRI PS AGREEMENT – SIXTH E XTENSION OF THE PERI OD FOR 
THE ACCEPTANCE BY MEMBER S OF THE PROTOCOL AM ENDING  
THE TRIPS AGREEMENT  
DRAFT DECISION OF [D ATE] 
 
 The General  Council,  
 
 Conducting  the functions of the Ministerial  Conference in the interval between meetings  
pursuant to paragrap h 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  Amend ment Decision") and paragraph  3 
of the Protocol Amending the TRIPS  Agreement (the  "Protocol")1, 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 30  November  2015 
(the "2015  Extension Decision")2, extended the period for acceptances of the Protocol by Members 
for the  fifth time until 31  December  2017 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 a ccepted 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 Agreem ent;  
 
 Noting also  that a number of Members are yet to accept the Protocol and that 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/ 78); 
 
 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 2015  Extension  Decision, shall be further extended until 31  December  2019 
or such later date as may be decided by the Ministerial  Conference.  
 
_______________  
                                                
1 WT/L/641.  
2 WT/L/965.  IP/C/79  
 
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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 19 -20 OCTOBER 2017  
(TO BE CIRCULATED AS IP/C /M/87/ADD.1)  
6  ANNUAL REVIEW OF THE  SPECIAL COMPULSORY L ICENSING SYSTEM  (PARAGRAPH  7 
OF THE ANNEX TO THE AMENDED TRIPS AGREEM ENT AND PARAGRAPH 8 OF THE 
DECISION ON THE IMPL EMENTATION OF PARAGR APH 6 OF THE D OHA DECLARATION ON 
THE TRIPS AGREEMENT AND PUBLIC HEALTH ) 
6.1 India  
1.  India welcomes the entry into force of the Protocol Amending the TRIPS Agreement in January 
this year, which is  the first amendment to a  multilateral treaty since the WTO Agreement came 
into force in 1995. India attaches high importance to the Doha Declaration on  TRIPS and  Public 
Health, the Paragraph 6 System as established under the 2003 Waiver Decision, and the Protocol  
Amending the TRIPS Agreement . India was one of the first countries t hat notified its acceptance of 
the Protocol in March 2007, and we would like to congratulate Members who have deposited their 
instrument of acceptance after the special meeting of the TRIPS Council in January. India has 
always been of the view that the Doh a Declaration on TRIPS and Public Health constituted a major 
landmark in the history of the WTO because it recognized the prima cy of public health needs and 
the preparedness of organizations to address the problem of access to medicine s faced by the poor 
in developing countries. The 2003 Waiver Decision was expected to address public health problems 
faced by Members with insufficient or no manufacturing capacities in the pharmaceutical sector. 
It may have sounded prophetic at that time, when India voiced ce rtain apprehensions in the 
General Council  meeting of August 2003, and I quote "the results accruing from this mechanism 
should not be negated by the creation of cumbersome systems that would lead to huge delays in 
getting medicine s across at reasonable co st to those that needed them or discourage Members 
from using the System for the benefit of the people. In order to make the System successful , 
a sincere collective effort was required on the part of all Members and the entire  pharmaceutical 
industry. " 
2.  Regrettably, we have been proven right. The export of HIV /AIDS medicine s by the Canadian 
pharmaceutical company Apotex to Rwanda in September 2008 has been the first and only use of 
the System so far. The Trilateral Study by WTO, WHO and WIPO on Promoting Acc ess to Medicines 
and Medical Technologies and Innovation: Intersection between Public Health, Intellectual Property 
and Trade of 2013 highlights some of the issues that need to be addressed for any meaningful 
utilisation of the System. We need to consider those issues carefully so that this measure does not 
remain confined only to paper.  
3.  The UN Secretary -General  High Level Panel on Access to Medicines , in its report released in 
September 2016 , also recognised that the Paragraph 6 System is complex and cumbe rsome. 
It recommended that WTO Members revise the System  in order to find a solution that enables 
a swift and expedi tious export of pharmaceutical products produced under compulsory licence. 
WTO Members should, as necessary, adopt a waiver and permanent re vision of the TRIPS 
Agreement to enable this reform. During an event held on the side lines of the TRIPS Council 
meeting in November 2016, several participants also highlighted that the System was not 
workable in its current form, and  that it was too compl ex, cumbersome and administratively 
unwieldly for use, and that it wa s commercially non -viable for companies to supply medicine s 
under it . We urge Members to constructively engage on the question of improving the Paragraph 6 
System for making it more worka ble and more effective so that it can benefit Members with 
insufficient or no manufacturing capacit y in the pharmaceutical sector.  
4.  To come to a specific question, some Members who notify their acceptance have not 
incorporated the System  into national law . We encourage these Members to take  the necessary 
steps to incorporate the System into their national law s. We also encourage Members who are yet 
to notify their acceptance of the 2005 Protocol to do so by the end of the year. However, I am 
informed that as  many as 46 Members are yet to accept the Protocol, and it may not be possible IP/C/79  
 
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  for all of them to notify their acceptance in time . We therefore support the extension of 
the deadline for accepting the Protocol by a further period of two years.  
6.2 United St ates 
5.  The United States welcomed the entry into force of the Protocol Amending 
the TRIPS  Agreement in January of this year. We also welcome the Secretariat's draft report, and 
its work throughout the year to encourage all remaining Members to notify their a cceptance of 
the Protocol. We congratulate the Members that have accepted the Protocol since the entry into 
force of the amended TRIPS Agreement, namely Oman, Sierra Leone, Fiji, S aint Vincent  and 
the Grenadines and Malawi.  
6.  While the entry into force of th e 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. 
We continue to encourage Members to focus efforts to address other salient barrie rs to access 
while also recogniz ing the important roles that intellectual property and international trade 
liberalisation play in incentivising drug development and expanding access to medicines around 
the world. For example, the WHO has identified numerous considerations including pricing and 
procurement policies, taxes, mark -ups and tariffs and other national policies that ultimately result 
in higher costs for co nsumers and for health systems.  
7.  While we remain disappointed that such a large number of Members have yet to no tify their 
acceptance of the Protocol, and urge as many of the remaining to do so before the end of the year, 
we can support the proposal to extend the period of acceptance for two years.  
6.3 Barbados  
8.  Barbados wishes to take the floor to support a further extension of two years for 
the acceptance of th e Protocol Amending the TRIPS Agreement. Barbados is a small developing 
country, and as such , we face  many challeng es, including resource and technical limitations. 
An extension will allow Barbados to continue  the necessary process on this important issue.  
6.4 European Union  
9.  The European Union can support the first part of the Indian intervention, praising 
the amendment of the TRIPS Agreement, and we can also support the extension for two years.  
6.5 Haiti ( on behalf of the LDC Group ) 
10.  Access to medicines remains an important subject for the group of LDC s, and we attach 
a large amount of attention and importance to the facilitating of access to medicines for vulnerable 
countries. As you know, a number of Members o f the Group, for one reason or another, have not 
yet accepted the Protocol. Taking into account the approaching deadline , the LDC Group is not 
sure that all of its Members will have the time to accept the Protocol before 31 Decem ber of this 
year. T he LDC G roup therefore  seeks a four year extension to allow Members concerned sufficient 
time to accept th e Protocol. However , the LDC Group would be ready to show flexibility should 
there be a consensus around a two year extension.  
6.6 Brazil  
11.  The Protocol Amendin g the TRIPS Agreement entered into force last January. We see this as 
a landmark development for the multilateral trading system, showing that trade rules can and 
must contribute to addressing people's needs in poorer countries. It enhanced the legitimacy of 
the WTO and sent a strong message about the capacity of the international community to reach 
consensus decisions. We support that this Organization continues to work towards ensuring that 
the System becomes a practical option for the procurement of medi cines in countries without 
industrial capacity. This is provided in paragraph 16 of document JOB/IP/27. During the session of 
the TRIPS Council held last January, we suggested some potential actions that could be taken by 
the WTO to assist Members , namely (i) legislative  assistance to enable the incorporation of 
the Protocol into Members ' national legislation; (ii) awareness -raising activities ; and (iii) capacity 
building activities.  IP/C/79  
 
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  12.  We are very happy to note that the WTO  Secretariat  has responded according ly, and is taking 
concrete steps to assist Members in such an important issue. Brazil is very appreciative of this and 
will do its best to continue supporting tho se actions by the Organization.  
13.  The document prepared by the Secretariat also lists 47 countri es that are yet to accept 
the Amendment. In spite of active efforts by the WTO  Secretariat  and WTO Members, it is not 
expected that all those countries complete their domestic procedures before the end of this year. 
It is thus advisable to ensure that appr opriate time be granted to enable those Members to finalise 
the necessary legal actions for accepting  the Protocol. While, in our view, ideally there should be 
no fixed deadline for the acceptance of the Protocol, we have heard some Members stating 
a preference for a two year extension. In order to advance the issue, Brazil is in the position of 
joining the consensus of two years for such an extension.  
6.7 Canada  
14.  Canada would once again like to recognize the recent entry into force of the Protocol 
amending the TRIPS Agreement, and would like to acknowledge the leadership of Director -General 
Azevêdo as well as the dedication of the Secretariat in reaching this important milestone. 
The entry into force of the Amendment is important, not only because this is th e first time one of 
the original WTO Agreements  has been amended, but, more importantly, because WTO Members 
now enjoy the certainty that the system of compulsory licensing envisaged in the Doha Declaration 
on the TRIPS Agreement and Public Health is a per manent and integral feature of the TRIPS 
Agreement. In our view the TRIPS Amendment facilitates meeting one of the key objectives of 
the Declaration, namely promoting access to affordable medicines for developing and least -
developed countries. The Amendmen t provides countries with another important tool to improve 
access to affordable medicine. As the only country to have exported medicine s under the System , 
pursuant to the temporary waiver, Canada has always been a strong proponent of 
the Amendment.  
15.  In lig ht of this, Canada would support an extension of the deadline for acceptance of 
the Agreement. We see value in a time -limited extension that will create a specific time point for 
countries to aim for as they complete their domestic procedures. Canada can s upport a further two 
year extension, but we are flexible with respect to the number of years that garners consensus in 
this body.  
6.8 South Africa  
16.  South Africa welcomes the entry into force of the Protocol Amending the TRIPS Agreement as 
an important miles tone in achieving the flexibilities inherent to the interpretation of the TRIPS 
Agreement. We also note that various Members have still not notified their acceptance  of 
the Protocol, and we encourage Members that have not done so, to do so as soon as possi ble. 
In respect of the time -period for the extension, this delegation is willing to suppo rt a fixed period 
of two years.  
6.9 Switzerland  
17.  Switzerland welcomed the entry into force of the revised TRIP S Agreement, incorporating 
the Paragraph  6 solution. While  the Para graph  6 mechanism could already be used since 2003 
through the waiver decisi on, inserting the new Art icle 31bis into the TRIPS Agreement  clearly  adds 
transparency, clarity and legal certainty. It is also a positive signal illustrating that the WTO  and its 
Members are willing and able to recognise relevant public policy challenges and find appropriate 
solutions to them. Switzerland ratified the amendment back in 2006 as the second WTO Member. 
We implemented the special compulsory licensing system in  our national legislation in 2008.  
18.  Article 31bis of the TRIPS Agreement addresses the particular situation of developing 
countries with insufficient or no manufacturing capacity in the pharmaceutical sector. It removes 
a potential legal barrier for countri es without a relevant pharmaceutical manufacturing industry to 
use the instrument of a compulsory license that may have occurred otherwise under Art icle 31(f) 
of the TRIPS Agreement. The new  System was used when Rwanda imported medicines under 
the Paragraph 6 mechanism from Apotex in Canada.  IP/C/79  
 
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  19.  The P aragraph  6 solution has been criticised earlier by some delegations and certain civil 
society actors as being complex and burdensome. My delegation disagrees with this view.  We have 
not heard in the Council 's past Paragraph  6 reviews from potential beneficiary Members about 
hurdles that they would have faced when wishing to make use of the mechanism. The WTO 
Secretariat has provid ed on its website an illustrative guide on  how to use the P aragraph  6 
mechanism efficie ntly, and we believe it  demonstrates how straightforward this use can be . 
20.  Claims that the System is not working simply because it has been used only once so far are 
jumping to conclusions. A more likely explanation is that other modalities , instruments  or 
mechanisms are just as , if not more relevant and efficient to facilitate access to pharmaceutical 
products, and are being made use of more regularly . In our view, it is wrong to consider 
the Paragraph  6 solution  and the new Article 31bis as a silver bullet  to the access to medicines 
issue. We should avoid raising overstated expectations of what the TRIPS Agreement  can 
contribute.  
21.  Article 31bis is a special compulsory license. Compulsory licenses are a flexibility foreseen in 
the TRIPS Agreement. They may be  used, provided a number of circumstances are present and 
conditions are fulfilled. However, my delegation considers compulsory licences , whether under 
Article 31 or Art icle 31bis of the TRIPS Agreement, neither an efficient nor a simple tool to use to 
gain quick access to essential medicines. Compulsory licensing may overcome a patent -related 
barrier. However, most of the time, other barriers are present, as well. Lack of infrastructure, of 
diagnostics and health  care personnel, insufficient provider or pa tient knowledge may come into 
play and prevent access . Insufficient or inexistent public health care, mark -ups by intermediaries 
or customs duties imposed by governments also impact on affordability.  
22.  Pharmaceutical companies, whether R&D originators or gen eric manufacturers, need financial 
incentives to invest in the manufacturing of relevant medical products, i.e. a fair return on their 
investment. Even the production of medical products under a compulsory license costs money and 
so does getting the releva nt marketing authorisation by regulatory agencies.  
23.  Many countries face challenges related to access to medical products. It is important to 
address these challenges in a holistic and sustainable manner.  Switzerland has been a long -time 
supporter of strengt hening health systems and sustainable financing, including t hrough domestic 
resources. Our G overnment sees this as one of the primary avenues to facilitate access to medical 
products.  
24.  Instead of advocating the use of compulsory licenses, which are by natur e contentious in their 
approach, this delegation strongly believes in the promotion of initiatives and approaches that 
incentivise research and development, add transparency, bring potential partners together to 
make use of synergies and, by the same token , improve access to affordable medical products for 
people in low - and middle -income countries.  
25.  We believe that building on voluntary and inclusive efforts , such as  the Medicines Patent Pool, 
the Global Fund 's e-procurement platform , WIPO Re:SEARCH , produc t development partnerships, 
such as DNDi , or the recent patent information transparency partnership Pat -INFORMED  launched  
by WIPO and the private sector , are the way forward and correspond to the collaborative spirit of 
the 2030 Agenda for Sustainable Deve lopment.  
26.  Switzerland has no comments on the draft report apart from expressing our gratitude to 
the Secretariat for preparing it.  
27.  As concerns the further extension of the period of acceptance, my delegation has, as others, 
a preference for a fixed deadline . This corresponds with the  WTO as a rule s-based o rganisation  
guided by procedures and dead lines. However, Switzerland is flexible whether this extension shall 
be for another two or four  years and will, in this r egard, join Members' consensus.  
6.10 Japan  
28.  The delegation of Japan welcomes the entry into force of the Protocol Amending the TRIPS 
Agreement and would like to express its sincere appreciation for the efforts by the Chair and 
the Secretariat.  IP/C/79  
 
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  29.   Regarding to the options of extension of the period  of acceptance of the Protocol, this 
delegation supports  a two-year extension.  
30.  In addition, the Japanese Government believes that the issue of access to medicines would be 
more effectively dealt with through a more comprehensive approach , based on the accumulat ed 
understanding and recommendations of previous discussions and reports. Accordingly, Japan has 
concerns about making any decisions, reports or discussions on the issue of access to medicines 
based on the UN  Secretary -General  High Level Panel report.  
6.11 Thailand  
31.  The entry into force of the Protocol Amending the TRIPS Agreement in January reflects that 
the WTO not only contributes to trade liberalization, but also responds to essential needs of 
Members beyond trade policy, particularly access to affordabl e medicines. We note that since 
the last Council for TRIPS in June, Malawi and the Russian Federation have accepted the Protocol. 
We would like to congratulate these Members and encoura ge others to do so.  
32.  Taking into account that the Protocol is currently open for acceptance until 
31 December  2017, and some Members are currently taking domestic procedures to accept 
the Protocol, which may require time beyond the deadline, we therefore can go along with 
the timeframe that meets the emerging consensus to exte nd the period of acceptance of 
the Protocol . Thailand  therefore  supports a two-year extension.  
6.12 Korea, Republic of  
33.  Korea also would like to join in welcoming the e ntry into force of the Protocol Amending 
the TRIPS Agreement, and at the same time encour ages the 46 Members who have yet to 
conclude their domestic procedures to do so as soon as possible. Korea supports the extension of 
the deadline for two years, even though we are flexible on the deadlines.  
6.13 Russian Federation  
34.  Thank you for the congrat ulations on acceptance of the Protocol. We welcome 
the Secretariat 's willingness to reflect this fact in the draft report . On the time period, we would 
definitely favo ur a two -year extension .  
6.14 Australia  
35.  Australia supports the TRIPS Protocol's entry in to force earlier this year. It reinforces 
the WTO's ability to deliver practical development -oriented outcomes. Australia commends 
Members from every region and at every stage of development that have accepted it. Australia 
supports an extension of the per iod for the acceptance by Members of the Protocol Amending 
the TRIPS Agreement. We support an extension of two years, but can be flexible on 
a longer  set period.  
6.15 China  
36.  China attaches  importance to TRIPS and public health  issues and formally accepted 
the Protocol in 2007. China supports the extension of the period for acceptance of the Protocol for 
two years, but is flexible  and could also accept  four years.  
6.16 Costa Rica  
37.  Thank you for organizing consultations around this subject which we found very u seful to 
prepare for this meeting. As others, we support the extension of  period for acceptance of  
the Protoc ol. We are flexible regarding  the time period . As we seem to see an emerging  consensus 
around two years, we will support it.  IP/C/79  
 
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  6.17 Nigeria  (on beha lf of the African Group ) 
38.  The African Group welcomes the entry into force of the Protocol Amending the TRIPS 
Agreem ent to incorporate the waiver  decision that was agreed by the General Council. We believe 
that it will provide a predictable flexibility that was enshrined in the Doha Ministerial Declaration on 
TRIPS and Public Health.  
39.  Regarding the extension of the period for the acceptance of the Protocol for those Members 
who have not yet accepted, of course, as I stated during our last consultations, the Af rican Group 
is in favour of two years. But listening to the LDC  Group  that ha s requested four years, 
the Africa n Group will want to see a balanced solution in this issue and we are flexible.  
40.  After the extension  of the period for acceptance,  the Secretariat  should continue to reach out 
to Members by informing the m of the need for them to accept  the Protocol . We also hope that 
the Secretariat will continue to provide technical assistance to those Members who are interested.  
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