IP/C/72  
 
9 November 2015  
(15-5906)  Page: 1/17  
Council for Trade-Related Aspects of  
Intellectual Property Rights   
 
 ANNUAL REVIEW OF THE DECISION ON THE IMPLEMENTATION 
OF PARAGRAPH 6 OF THE DOHA DECLARATION ON 
THE TRIPS AGREEMENT AND PUBLIC HEALTH 
REPORT TO THE GENERAL COUNCIL 
 
1.  Paragraph 8 of the Decision on the Implementa tion of Paragraph 6 of the Doha Declaration on 
the TRIPS Agreement and Public Health of 30 Augu st 2003 (the "2003 Decision") provides that the 
Council for TRIPS shall review annually the functioning of the System set out in the Decision with a 
view to ensuring its effective operation and shall annually report on its operation to the 
General Council.  This review is d eemed to fulfil the review requirements of Article IX:4 of the WTO 
Agreement. 
2.  The Council for TRIPS undertook the eleventh  annual review in October 2014. The General 
Council took note of the report of the Council for TRIPS (IP/C/69) at its meeting on 10-11 December 2014 (WT/GC/M/155, paragraph 11.15). The present report covers the period since 
October 2014. 
3.  At its meeting of 15-16 October 2015, the Council undertook the twelfth annual review. 
Annex 1 and Appendix 1 to this report record the review and the statements made by delegations. The paragraphs below set out factual informatio n regarding the implementation and use of the 
2003 Decision and the acceptance of the Protocol Amending the TRIPS Agreement. 
1  INFORMATION ON IMPLEMENTATION AND USE OF THE SYSTEM ESTABLISHED UNDER 
THE DECISION 
4.  Since the last annual review, New Zealand and Australia have notified legislation implementing 
the System into domestic law to the Council for TRIPS.
1 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 at http://www.wto.org/english/trat op_e/trips_e/par6laws_e.htm . 
5.  During the period covered by the present re port, no notifications by importing or exporting 
Members pursuant to paragraphs 1(b), 2(a) and 2(c) of the 2003 Decision have been made to the Council for TRIPS. As foreseen in the 2003 Decision, the Secretariat regularly updates a page on 
the WTO website dedicated to this Decision, notably to  ensure the public availability of notifications 
made pursuant to it ( http://www.wto.org/english/tratop _e/trips_e/public_health_e.htm ). 
6.  A trilateral study on "Promoting Access to Medical Technologies and Innovation – Intersections 
Between Public Health, Intellectual Property an d Trade", launched by the WHO, WIPO and WTO 
Secretariats in February 2013, offers explanatory background material on the implementation and 
use of the System.2 In addition, a set of model notifications has been provided for illustrative 
                                               
1 WTO Documents IP/N/1/NZL/P/5 and IP/N/1/AUS/P/11 and 12. 
2 See pages 177 to 180 and Annex II of the study, av ailable 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  IP/C/72 
 
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  purposes on the WTO's webpage dedicated to public health in order to further facilitate the use of 
the System.3 
2  DECISION ON THE AMENDMENT TO THE TRIPS AGREEMENT 7.  As called for in paragraph 11 of the 2003 Decision, the General Council adopted a Protocol 
Amending the TRIPS Agreement, by a Decision of 6 December 2005 (WT/L/641). The Protocol is 
open for acceptance by Members until 31 December 2015 or such later date as may be decided by the Ministerial Conference (WT/L/899). In accordan ce with Article X:3 of the WTO Agreement, the 
Protocol will enter into force upon accept ance by two thirds of the WTO Members. 
8.  In February 2015, Director-General Azevêdo addressed letters to all WTO Members, 
encouraging those who were yet to accept the Protocol to urgently complete their domestic procedures so that the TRIPS amendment could enter into force by the 10
th Ministerial Conference, 
and asking other WTO Members to provide practical advice and assistance based on their own 
experience with the process of acceptance. He emph asized that securing the entry into force of the 
TRIPS amendment was not only a priority for the WTO, but represented a concrete contribution 
that WTO Members could make to global efforts to strengthen the legal framework for access to 
medicines. Permanently incorporating the Paragraph 6 System into the TRIPS Agreement would thus respond to the many calls for its timely implementation and entry into force that emanated 
from the multilateral system, including from the UN General Assembly, ECOSOC, the WHO and 
UNAIDS. 
9.  On 20 February 2015, Director-General Azevêd o updated the General Council on the status of 
acceptances and called upon Members that were yet to accept the TRIPS amendment to complete 
their domestic procedures. He recalled that the entry into force of the Paragraph 6 System 
provided the necessary legal certainty that would strengthen the future potential to facilitate exports of much-needed medicines.
4 At the same meeting, the General Council also agreed to the 
circulation of an Aide Mémoire as a formal WTO do cument that set out the expected benefits of the 
Paragraph 6 System and provided a model instrument of acceptance.5 
10.  Based on an initiative taken by the Chair of  the Council for TRIPS, H.E. Ambassador Al-Otaibi 
from Saudi Arabia, the Council, at its meeting on 9-10 June 2015, had a constructive discussion 
under the agenda item on "Technical Cooperation" of possible ways and means to enhance cooperation among Members with a view to facilitating the completion of domestic acceptance procedures.
6 This initiative built on the Council's past work that had recognized the need for 
technical assistance concerning the acceptance process and as part of which support had already 
been provided to Members. 
11.  As of 15 October 2015, the following Members have notified their acceptance: 
 United States, 17 December 2005, WT/Let/506; 
 Switzerland, 13 September 2006, WT/Let/547; 
 El Salvador,  19 September 2006, WT/Let/548; 
 Republic of Korea, 24 January 2007, WT/Let/558; 
 Norway, 5 February 2007, WT/Let/563; 
 India, 26 March 2007, WT/Let/572; 
 Philippines, 30 March 2007, WT/Let/573; 
                                               
3 http://www.wto.org/english/tratop_e/trips_e/par6_modelnotifs_e.htm .  
4 See minutes of the General Council meeting of 23 February 2015, WT/GC/M/156, para.3.5. 
5 Document WT/GC/W/696 of 20 February 2015. 
6 See minutes of the TRIPS Council meeting of 9- 10 June 2015, IP/C/M/79, paras.9.1 to 9.8 and 
IP/C/M/79/Add.1. IP/C/72 
 
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   Israel, 10 August 2007, WT/Let/582; 
 Japan, 31 August 2007, WT/Let/592; 
 Australia, 12 September 2007, WT/Let/593; 
 Singapore, 28 September 2007, WT/Let/594; 
 Hong Kong, China, 27 November 2007, WT/Let/606; 
 China, People's Republic of, 28 November 2007, WT/Let/607; 
 European Communities7, 30 November 2007, WT/Let/608; 
 Mauritius, 16 April 2008, WT/Let/619; 
 Egypt, 18 April 2008, WT/Let/617;  
 Mexico, 23 May 2008, WT/Let/620;  
 Jordan, 6 August 2008,WT/Let/630; 
 Brazil, 13 November 2008, WT/Let/636; 
 Morocco, 2 December 2008, WT/Let/638; 
 Albania, 28 January 2009, WT/Let/639; 
 Macao, China, 16 June 2009, WT/Let/645; 
 Canada, 16 June 2009, WT/Let/646; 
 Bahrain, Kingdom of, 4 August 2009, WT/Let/652; 
 Colombia, 7 August 2009, WT/Let/650; 
 Zambia, 10 August 2009, WT/Let/651; 
 Nicaragua, 25 January 2010, WT/Let/663; 
 Pakistan, 8 February 2010, WT/Let/664;  
 Former Yugoslav Republic of Macedonia, 16 March 2010, WT/Let/671; 
                                               
7 The text of the instrument of acceptance reads as follows: 
 
"THE PRESIDENT OF THE COUNCIL OF THE EUROPEAN UNION, 
 
HAVING regard to the Treaty establishing the Europe an Community, and in particular Article 133(5) in 
conjunction with the first sentence of the first subparagraph of Article 300(2) and the second subparagraph of Article 300(3) thereof, 
 
NOTIFIES by these presents the acceptance, by th e European Community, of the Protocol amending 
the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), done at Geneva on 6 December 2005, 
 
CONFIRMS, in accordance with Article 300(7) of the Treaty establishing the European Community, that the Protocol will be binding on the Member States of the European Union. 
 
The Secretary-General/High Represen tative                The President of the Council 
        o f  t h e  E u r o p e a n  U n i o n "  IP/C/72 
 
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   Uganda, 12 July 2010, WT/Let/678; 
 Mongolia, 17 September 2010, WT/Let/684; 
 Croatia, 6 December 2010, WT/Let/747; 
 Senegal, 18 January 2011, WT/Let/753; 
 Bangladesh, 15 March 2011, WT/Let/758; 
 Argentina, 20 October 2011, WT/Let/830; 
 Indonesia, 20 October 2011, WT/Let/831; 
 New Zealand, 21 October 2011, WT/Let/832; 
 Cambodia, 1 November 2011,WT/Let/833; 
 Panama, 24 November 2011, WT/Let/837;  
 Costa Rica, 8 December 2011; WT/Let/838; 
 Rwanda, 12 December 2011, WT/Let/839; 
 Honduras, 16 December 2011, WT/Let/843; 
 Togo, 13 March 2012, WT/Let/848; 
 Saudi Arabia, Kingdom of, 29 May 2012, WT/Let/855; 
 Chinese Taipei, 31 July 2012, WT/Let/870;  
 Dominican Republic, 23 May 2013, WT/Let/884; 
 Chile, 26 July 2013, WT/Let/888; 
 Montenegro, 9 September 2013, WT/Let/893; 
 Trinidad and Tobago, 19 September 2013, WT/Let/894; 
 Central African Republic, 13 January 2014, WT/Let/920; 
 Turkey, 14 May 2014, WT/Let/949; 
 Botswana, 18 June 2014, WT/Let/953; 
 Uruguay, 31 July 2014, WT/Let/984; 
 Brunei Darussalam, 10 April 2015, WT/Let/1037; 
 Moldova, 7 July 2015, WT/Let/1048; 
 Kenya, 21 July 2015, WT/Let/1052; 
 Saint Kitts and Nevis, 27 July 2015, WT/Let/1055; 
 Sri Lanka, 9 September 2015, WT/Let/1080; 
 Lao People's Democratic Republic, 29 September 2015, WT/Let/1084; and IP/C/72 
 
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   Iceland, 12 October 2015, WT/Let/1088. 
12.  Information on the status of acceptances of the Protocol can be found on a dedicated 
webpage which is regularly updated by the WTO Secretariat.8 
13.  Given the present status of acceptances, and the indications that a number of Members are 
actively pursuing their respective domestic proced ures in order to accept the Protocol, the Council 
for TRIPS submits the attached proposal to the General Council for a decision to extend the period for acceptances of the Protocol. A draft of such a proposal for consideration by the Council is 
contained in Annex 2 of this document. 
                                               
8 http://www.wto.org/english/tratop_e/trips_e/amendment_e.htm . Revisions of document IP/C/W/490 
will no longer be circulated. IP/C/72 
 
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  ANNEX 1  
 
 EXCERPT FROM THE MINUTES OF THE COUNCIL'S MEETING OF 15-16 OCTOBER 2015 
(TO BE CIRCULATED AS IP/C/M/80) 
7  REVIEW UNDER PARAGRAPH 8 OF THE DECISION ON THE IMPLEMENTATION OF 
PARAGRAPH 6 OF THE DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH 
1.  The Chairman recalled that paragraph 8 of th e waiver Decision provided that the Council for 
TRIPS shall review annually the functioning of the system set out in the Decision with a view to 
ensuring its effective operation and shall annually report on its operation to the General Council. Furthermore, the paragraph provided that this review shall be deemed to fulfil the review 
requirements of Article IX:4 of the WTO Agreement. 
2.  He said that the records of the Council's earlier reviews continued to provide a unique and 
valuable resource for understanding this important measure. This included the records of the 
reviews in 2010 and 2011 when the Council had held a more structured debate on the basis of lists 
of topics for the discussion that had been agreed in advance. These earlier records and lists of 
topics might also inform discussions at the present review. If Members felt that any questions 
posed at earlier reviews regarding the Paragraph 6 System itself or possible alternatives to it were 
not adequately addressed at those reviews, they sh ould feel free to revert to any such questions. 
3.  The Secretariat had prepared a draft cover note for the Council's report modelled on previous 
years' reports (circulated as JOB/IP/13). He suggested that the Council take up the preparation of 
its report to the General Council after it had exhausted its discussion. The cover note of the report 
contained a list of Members that had notified thei r acceptance of the Protocol Amending the TRIPS 
Agreement (WT/L/641). The following Members ha d deposited their instruments of acceptance 
since the Council's last meeting in June: Moldova on 7 July, Kenya on 21 July, Saint Kitts and 
Nevis on 27 July, Sri Lanka on 9 September, Lao People's Democratic Republic on 29 September, and Iceland on 12 October. 
4.  The Chairman further recalled that the Protoc ol had been originally open for acceptance by 
Members until 1 December 2007. Upon proposals by the TRIPS Council, the General Council had 
four times extended this period for further two- year periods. At present, the period ran until 31 
December 2015. The TRIPS amendment would enter in to force once two thirds of the membership 
had accepted it. For this to happen, another 21 in struments of acceptance needed to be deposited 
with the Director General. He strongly encourag ed those Members, especially developing country 
M e m b e r s ,  w h o  w e r e  y e t  t o  c o m p l e t e  t h e i r  d o m e s t i c  p r o c e d u r e s  t o  d o  a s  s o o n  a s  p o s s i b l e .  I f  
needed, the Secretariat could assist Members concerned regarding the steps that were required in 
order to accept the Protocol.  
5.  The representative of the WTO Secretariat took the floor.  
6.  The Chairman noted that the vast majority of Members that had already deposited their 
instrument of acceptance had done so before adopting implementing legislation, if at all, which 
was not required by the amendment. 
7.  He reported that, at the informal meeting on 14 October 2015, some delegations had reiterated 
the proposal that a workshop open to all stakeh olders be jointly organized by the WTO, WHO and 
WIPO as part of their trilateral cooperation. Wh ile other delegations had indicated their readiness, 
in principle, to consider such a proposal, they had asked for more information regarding the issues 
to be covered by such a workshop. He encouraged the proponents to explore the proposal in their 
direct contacts with other delegations. 
8.  The representatives of Canada; India; Australia; Cuba; Chinese Taipei; Egypt; Brazil; 
Indonesia; Thailand; Chile; the European Union; New Zealand; Ecuador; Switzerland; Japan; the 
United States; Bangladesh on behalf of the LDC Group; South Africa; and Uganda took the floor. IP/C/72 
 
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  9.  The Council took note of the statements made. 
10.  Turning to the draft cover note for the Co uncil's report (circulated as JOB/IP/139), the 
Chairman said that, in accordance with the way that the Council had prepared its reports in the 
previous years, the part of the minutes of the meeting that reflected the discussions held under 
this agenda item might be attached to the cover note.  He also suggested that the report be 
updated in order to take account of the instruments of acceptance that had been deposited since the circulation of the initial draft report. 
11.  He said that the Protocol had originally been open for acceptance by Members until 1 
December 2007. At present, the period ended on 31 December 2015. Given the proximity of this date, the Council might wish to consider again submitting a proposal to the General Council for a decision to extend the period for the acceptance of  the Protocol. For this purpose, a draft decision 
that could be submitted to the General Council for adoption had been included in Annex 2 to the 
draft report. As the draft proposal for a decision by the General Council did not yet contain a new deadline for the extended period for acceptances, he suggested that the Council propose to extend 
the period by a further two years until 31 December 2017. 
12.  In conclusion, the Chairman proposed that the Council agree on forwarding to the General 
Council the proposal for a decision to extend the period of acceptance by Members of the Protocol 
Amending the TRIPS Agreement until 31 December 2017. The last paragraph of the draft decision 
by the General Council contained in Annex 2 to the draft report should be complemented by 
inserting this date. He also proposed that the Council agree on the cover note to the report contained in JOB/IP/13, with the update concerni ng the instruments of acceptance that had been 
deposited by Sri Lanka, Lao People's Democratic Republic and Iceland since the circulation of the 
draft cover note, and also that the Council minutes containing the record of the discussion be attached to it. 
13.  The Council so agreed. 
 
_______________ 
 
 IP/C/72 
 
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  ANNEX 2 
  
  
WT/L/..  
 
 
(15-0000)  Page: ../..  
    
AMENDMENT OF THE TRIPS AGREEMENT – FIFTH EXTENSION OF THE PERIOD FOR THE 
ACCEPTANCE BY MEMBERS OF THE PROTOCOL AMENDING 
THE TRIPS AGREEMENT 
DRAFT DECISION OF [DATE] 
 
 The General Council, 
  Conducting  the functions of the Ministerial Conference in the interval between meetings  
pursuant to paragraph 2 of Article IV of the Marrakesh Agreement establishing the World Trade 
Organization (the "WTO Agreement");  
 Having regard to paragraph 2 of the Decision of the General Council of 6 December 2005 
on the Amendment of the TRIPS Agreement (the "TRIPS Amendment Decision") and paragraph 3 
of the Protocol Amending the TRIPS Agreement (the "Protocol")
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 26 November 2013 (the "2013 
Extension Decision")
2, extended the period for acceptances of the Protocol by Members for the 
fourth time until 31 December 2015 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 shall take effect and enter into force in accordance with the provisions of paragraph 3 of Article X of the WTO Agreement; 
 
 Noting  that acceptance of the Protocol by two thirds of the Members in accordance with 
paragraph 3 of Article X of the WTO Agreement is taking 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/70); 
 
 Decides  as follows: 
  The period for acceptances by Members of the Protocol Amending the TRIPS Agreement 
referred to in paragraph 2 of the TRIPS Amendm ent Decision and paragraph 3 of the Protocol, 
and extended by the 2013 Extension Decision, sh all be further extended until 31 December 2017 
or such later date as may be decided by the Ministerial Conference. 
 
 
                                               
1 WT/L/641. 
2 WT/L/899. IP/C/72 
 
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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 2015 
(TO BE CIRCULATED AS IP/C/M/80/ADD.1) 
7  REVIEW UNDER PARAGRAPH 8 OF THE DECISION ON THE IMPLEMENTATION OF 
PARAGRAPH 6 OF THE DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH 
7.1  Secretariat  
 1.  We have engaged in dialogue with a num ber of Members about this matter following the 
Director General's introduction of this issue in the General Council in February and following 
Ambassador Al-Otaibi's communication to Members as Chair of this Council in May.  
2.  Our feedback has been very much about practical matters concerning the instrument of 
acceptance of the Protocol Amending the TRIPS Agreement. The key message that comes up in 
many conversations is this: there is concern that before accepting the Protocol, the assumption 
has often been that it is necessary to introduce domestic implementing legislation, in other words to implement this new TRIPS flexibility before accepting the amendment. Without questioning or 
analysing individual Members' constitutional arrangements, the wide experience among the 
membership is that this is not the case. Indeed , as a rough estimate almost fifty members have 
lodged their acceptances without having first passed any legislation implementing the System. Why is this? It is because this is a new flexibility, not a new obligation. It is an optional measure 
for WTO Members to use if they wish to so as to advance their public health interests.  
3.  The Protocol as such, and the amendment of the Agreement, create no obligation to implement 
this flexibility in domestic law, just as is the current situation under the interim waiver, which 
applies at the moment – that has not obliged Members to avail themselves of that waiver. It would 
remain entirely a matter of choice for individual Members to implement or not to implement, even 
when the waiver is converted into a permanent amendment of the TRIPS Agreement. From that 
point of view it is important to understand, that it is a flexibility – it is an additional flexibility, and 
not a mandatory standard.  
4.  In that sense the TRIPS amendment is different in character from the Agreement itself, which 
does require positive implementation in domestic law. Therefore if a Member does accept the 
Protocol, it does not assume any legal obligation to have in place or to put in place implementing 
legislation. Effectively, the step of accepting the Protocol means that a Member is confirming its agreement that other Members are entitled to use th e System if they so wish. Of course, it is an 
important step to accept the Protocol, but essentially because it will mainly give other Members 
legal certainty and confidence to use the System. If they do choose to use the new flexibility to 
obtain affordable medicines, their access to medicines by these means will thus be on a legal 
parity with any other health-related flexibility in the TRIPS Agreement. Therefore, it is clear that 
many Members - in fact the overwhelming majority of acceptances of the Protocol from a wide range of legal, economic, geographic backgrounds - have accepted the Protocol without first putting implementing legislation in place. I have mentioned this at length, because this is a 
recurrent issue that does come up in a more informal dialogue with Members. We hope that this 
clarifies at least one practical obstacle to acceptance of the Protocol.  
5.  The other constraint that has been mentioned has been simply the process of getting an 
instrument of acceptance signed and lodged. From that point of view, we would draw Members' 
attention to what is available on the website – a resource providing background on how to accept the Protocol and including a Model Instrument of Acceptance, as well as that map and other details 
t h a t  y o u  h a v e  s e e n  e a r l i e r .  A n d  j u s t  t o  c l a r i f y  – the Model Instrument of Acceptance is a very 
simple document. It refers to the Protocol Amending the TRIPS Agreement, it refers to the process of acceptance in general terms and has in effect one very brief operational paragraph stating that the signatory (who does have to be a sufficiently senior in the administration) hereby formally 
declares that the Member concerned accepts the Pr otocol and expresses consent to be bound by it. 
That is the full operative paragraph, it is nothing more than that. Being bound by it is effectively IP/C/72 
 
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  saying: other Members may wish to avail themselves of this option, rather than binding any 
Member to make use of it itself, or implement it.  
6.  We have had very constructive conversation s with a wide spectrum of delegations on this 
matter. The Director General has flagged that this would be a highly desirable outcome in the 
context of the Nairobi Ministerial, for a whole host of reasons, of course, and we look forward to 
working with Members, interested delegations in a practical way to help them take this process forward. 
7.2  Canada   
 7.  I am happy to take the floor on behalf of Canada on this major issue. Canada would like to urge all Members having not done it as yet to deposit their instruments of acceptance. We consider 
the Protocol on access to medicines which Canada has been the first country to implement. As a 
major tool permitting access to medicines for developing and LDCs.  
7.3  India  
 
8.  India attaches high importance to the Doha Declaration on the TRIPS Agreement and Public Health, the Paragraph 6 System as established under the 2003 Decision and the 2005 Protocol 
Amending the TRIPS Agreement.  
9.  India notified its acceptance of the Protocol  in March 2007. We would like to congratulate 
Members who have deposited their Instrument of A cceptance of the Protocol since the last TRIPS 
meeting held in June 2015. However, in spite of the fourth extension of the period of acceptance 
until 31 December 2015, only 60 Members including the EU have accepted the Protocol so far. The 
fact that it is still a long way to go for it to enter into force and that acceptance by two thirds of the membership is required is not a positive signal.  
10.  While we reiterate the concern that the Paragraph 6 System was only used once so far and 
the System is too complex and administratively unwi eldy for further use, we have always been of 
the view that the Doha Declaration on the TRIPS Agreement and Public Health constituted a major 
landmark in the short history of the WTO, because it recognised the primacy of public health needs 
and the preparedness of the Organization to take up the problems faced by the poor and developing countries.  
11.  Along with several other Members, India has worked relentlessly on the Doha Declaration and 
the Decision. The Decision established the framework for special compulsory licences which is an 
additional flexibility aimed at enabling exports of  medicines to WTO Members with insufficient or 
no manufacturing capacity in the pharmaceutical sector.  
12.  The TRIPS Council has been reviewing the Paragraph 6 mechanism for the last several years. 
Our delegation feels that the review mechanism has become ritualistic in nature and it will not serve any purpose if we go on repeating the similar questions and get similar replies. The 
implementation of the Paragraph 6 mechanism in volves several stakeholders and our discussions 
would not be effective if we restrict the discussion to this level.  
13.  At the TRIPS Council meeting in October 2014, we have also proposed a multi-stakeholder 
symposium. I proposed it again during yesterday's informal meeting, and the membership 
accepted in principle and asked me to provide more information on this suggestion. I am providing 
more information now.  
14.  Discussion in the symposium with relevant stakeholders including international organisations, 
public health experts, industry experts, civi l society organisations and WTO Members would be 
extremely useful to explore the issue in depth.  The symposium could discuss the implementation 
of the Paragraph 6 System so far, the challenges and opportunities involved as well as ways of 
improving the System to make it effective and me aningful. In this regard India proposes that a 
technical symposium be held in March 2016 under the trilateral cooperation of WHO, WIPO and WTO. The symposium could be aimed to increase our understanding of the System, the challenges 
in its implementation so far and suggestions on the way forward. It would be an experience 
sharing and exploratory basis with various views on the System being discussed and debated. We IP/C/72 
 
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  request that the Council for TRIPS agree to hold this technical symposium and direct the 
Secretariat to draw the broad contours of the symposium based on the suggestions of various 
Members.  
15.  It is also requested that the Chair continues to hold informal consultations with interested 
Members in this regard in the coming months.  
16.  With regard to the proposal for the extension of the period for acceptance of the Protocol for a 
further period of two years up to 31 of Decemb er 2017, we support the proposal. I conclude by 
encouraging Members who are yet to accept the Protocol Amending the TRIPS Agreement to 
accept the Protocol and notify their acceptance on a priority basis.  
7.4  Australia   
 
17.  May I begin by thanking the Secretariat for what was a very clear explanation of a simple 
process for acceptance. Certainly Australia's experience bears out the simplicity of the process, but also, as the Secretariat noted, the fact that there is no need for implementation necessarily 
attached to the acceptance. In our case there was an eight year gap between our acceptance in 
2007 and our implementing, domestic implementation  arrangements, which we notified this year 
and which are referred to in my intervention under item 2.   
18.  Australia adds its voice in support of desiring to see the TRIPS Protocol enter into force. We 
believe that this outcome will reinforce the WTO's potential to deliver practical, development-orientated outcomes. And like Canada and India before us, we commend Members from every region and at every stage of development that  have already accepted this Instrument. In 
particular, we welcome recent acceptances this year of the Protocol by Members in the Asia-
Pacific, including Brunei Darussalam, and as the Chair has mentioned, most recently: Lao PDR and Sri Lanka.  
19.  Australia is very encouraged by interventions that have been made at the TRIPS Council 
earlier this year that indicated that other Members are preparing to take this important step and we look forward to seeing the number of 21 that was mentioned reduce further.  
20.  Now mindful that a number of Members are acti vely pursuing acceptance and noting what the 
Chair has referred to as the proposal that has been informally discussed for an extension of the period of time for acceptance, Australia adds its voice in support of an extension period and we are flexible about the time-period of this extension.  
7.5  Cuba  
 21.  Cuba would wish to support in full the propos al presented by the delegation of India regarding 
the organization of the technical symposium next year under trilateral cooperation. We hope 
M e m b e r s  w i l l  b e  a b l e  t o  s u p p o r t  t h i s  p r o p o s a l .  I n  t h i s  r e g a r d  w e  e n c o u r a g e  a l l  t o  s h o w  a  constructive spirit. All delegations should see this technical workshop as an excellent opportunity 
to discuss the implementation of the System. This  would furthermore help Members that have not 
as yet accepted the Protocol.  
7.6  Chinese Taipei   
 
22.  We wish to thank the Secretariat for their excellent work regarding the implementation of 
Paragraph 6 of the Doha Declaration on the TRIP S Agreement and Public Health. My delegation 
attaches great importance to the Paragraph 6 System , particularly in the view of the 2003 Decision 
and the 2005 Protocol.  
23.  We have ratified the Protocol on 31 July 2012. We also wish to congratulate Sri Lanka and the 
other seven Members which have accepted the TRIPS amendment this year. We welcome the 
efforts of the Secretariat in order to obtain more acceptances of the amendmen t. In this regard we 
wish to call the delegates' attention to the TRIPS webpage, where Members will be able to find the 
link taking them to a manual on notifications as contemplated by Paragraph 6 which we also consider very useful.  IP/C/72 
 
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  24.  Many developing countries and many LDCs suffer from public health problems. We wish to 
highlight that this Agreement does not prevent Me mbers and should not prevent them from taking 
measures protect public health, particularly in terms of facilitating access to medicines for all. We encourage Members to notify their acceptance of the amendment in order to allow it to come into 
force.  
7.7  Egypt   
 
25.  We would like first to asso ciate ourselves with India and Cuba. Many questions spring to mind, 
including the administrative and regulatory complexity of the System, lack of appreciation of business methods in supplying markets and associated overhead costs, as well as constraining requirements.  
26.  These questions need to be addressed. Egyp t strongly supports the proposal to organize a 
workshop to address these questions and others of relevance, and include in this workshop participants from all stakeholders. Therefore we urge those Members that seem to be reluctant to 
join consensus on the convening of this workshop with the participation of all stakeholders to 
reconsider their position in view of the direct relevance for access to medicines and ultimately for human rights involved in this problem.  
7.8  Brazil   
 27.  We welcome the information about the acceptan ce of the Protocol by Moldova, Kenya, Saint 
Kitts and Nevis, Sri Lanka, Lao PDR and Iceland. We congratulate these countries and urge those 
that have not yet accepted it, to take the necessary measures to do so at an early stage. As 
mentioned, taking these steps is even more urgent when we consider that the overwhelming majority of Members that are still to accept the Protocol are comprised by developing countries, 
potentially beneficiaries of this instrument.  
28.  We thank the Director of the IP Division for his detailed explanation on the details for the 
acceptance of the Protocol. We hope the efforts of  the Secretariat led by the Director General bear 
the expected fruit soon, so that we reach the 21 needed instruments of acceptance soon. Thus, 
the beneficiaries of this mechanism can start enjoying the flexibilities of the System.  
29.  On the proposal for a multi-stakeholder technical symposium on Paragraph 6 of the Doha 
Declaration on the TRIPS Agreement and Public Heal th, we would like to thank the delegation of 
India for this timely initiative. We believe it is a timely initiative for one simple reason, namely: 
that the Paragraph 6 has not been used in practice except on one occasion. We believe that this would suffice to make it necessary or at least timely, to bring other stakeholders to discuss the 
reasons for this, well, lack of knowledge about the benefits of the System. Yesterday during our 
informal meeting, we heard some delegations requesting something on paper. I don’t know if all of us have a document that was prepared by India, but I believe, regardless of the details that can be 
discussed further during the time till we prepare the conference, that the contours of this multi-
stakeholder event would benefit those countries that need more information in order to consider the possibility of using the System. So we fully su pport the initiative and we hope we can agree to 
hold it on a date that is fore seen here in this document.  
7.9  Indonesia   
 30.  First of all we would like to thank the Secretariat for the presentation on the notification of the 
Paragraph 6 System.  Access to medicines still remains a problem for most developing countries 
and LDCs. A WHO report said that with growing recent numbers of trade in medicines, developing countries and LDCs only contribute to 70% of all imports and 6% of all exports. The situation will 
affect the health profile of the population which will subsequently hamper the productivity of their 
people which is significant for their development. Therefore, the unanimously adopted 2005 General Council Decision to amend the TRIPS Agreement to give legal certainty to the implementation of the Paragraph 6 System was a great breakthrough to help developing countries 
and LDCs obtain greater access to affordable medicines when needed. We would like to 
congratulate Brunei, Lao PDR, Sri Lanka, Moldov a, Kenya, Iceland and other Members that have 
accepted the Protocol this year. Yet, we still n eed more Members to submit their instruments of 
acceptance before this noble objective can be implemented. In this light, while calling on Members 
to expedite their ratification process, Indonesia wo uld like to lend its support for the extension of IP/C/72 
 
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  the period of acceptance by the Members of the Protocol Amending the TRIPS Agreement. On this 
opportunity, we would also like to support the proposal of India that a technical symposium be held on the Paragraph 6 System of the Doha Declaration on the TRIPS Agreement and Public Health. 
7.10  Thailand   
 31.  Regarding Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, 
Thailand is currently accelerating the internal process for accepting the Protocol Amending the 
TRIPS Agreement and aims to accept the Protocol, possibly by the tenth Ministerial Conference. 
7.11  Chile   
 
32.  Our delegation has been attentive to the efforts of the Director General and those undertaken 
by delegations regarding the Paragraph 6 System. As we see it, it is very important to extend the period for acceptance as proposed in Job/IP/13. We  would also like to voice our concern that this 
very important amendment has not yet received a sufficient number of ratifications so as to enter 
into force. Given the potential of this measure to save thousands of lives on a daily basis, we would like to extend our appeal to all the remaining countries to ratify this draft amendment and 
thank all those who have taken this initiative. Finally, we would like to thank India for their 
proposal. We see the proposed symposium as an important element, and it could make it possible for those countries that have not been able to ratify so far to avail themselves of the necessary information so that they can ratify very swiftly.  
7.12  European Union   
 33.  The European Union agrees with DG Azevêdo th at the entry into force of the Protocol will be 
an important signal that will ensure a legally secure, predictable, effective and sustainable solution 
for those countries wishing to use the TRIPS flexibilities to get affordable medicines. Therefore, the European Commission will continue to encourage and assist the remaining WTO Members to accept 
the Protocol so that it can enter into force, if possible by the time of the next Ministerial 
Conference, if not, as soon as possible thereafter. Commissioner Malmström herself has included this in her briefing and each time she is meeting with countries concerned she is stressing the importance of this, as was requested by DG Azevêdo. On the idea of a symposium, and noting that 
there are different positions held here, we wonder whether it would not be possible to have a more 
Member-driven approach and to have the kind of events in the margins of this Council that have been taking place for a number of years regarding issues that we consider very valuable like the 
debate on IP and innovation. If the intention is to provide information and assistance to the 
countries who need it in this process, we believe it is perfectly possible to do it as a Member-driven approach and have these informative sessions organized in the margins of a TRIPS Council 
meeting. 
7.13  New Zealand   
 34.  Since the last annual review, New Zealand has notified its legislation implementing the system 
established under this Decision. We would like to congratulate Members who have accepted the 
Amendment this year. As others have mentioned, we would like to encourage Members who have not completed domestic procedures to take the relevant steps to deposit instruments to accept the 
Amendment before MC10 given the humanitaria n objectives of the Amendment and the 
development dimension as well. We hope that th e TRIPS Amendment can enter into force at the 
tenth Ministerial Conference; that would be a highly-desirable outcome.  
7.14  Ecuador   
 35.  We would like to thank those delegations who have accepted the Protocol and also add our voice to the request made by India to have this technical symposium or workshop. This ought to 
make it possible for countries to be more knowledgeable regarding a number of items and ratify 
the Protocol so that it could come into force.  IP/C/72 
 
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  7.15  Switzerland   
 36.  We would first like to congratulate Brunei Da russalam, Iceland, Kenya,  Lao PDR, Moldova, Sri 
Lanka, and St. Kitts and Nevis for notifying the WT O of their acceptance of the Protocol Amending 
the TRIPS Agreement.  
37.  Switzerland seizes the opportunity to encourage Members who have not yet notified their 
acceptance to undertake the necessary steps and proceed so that the required acceptance by two 
thirds of WTO Members may be met and that the Protocol can enter into force. The Paragraph 6 
system is a significant mechanism. Its goal is to put those WTO Members on a level playing field with the other WTO Members that do not have manufacturing capacity in the pharmaceutical sector. It enables those Members to make use of the flexibility offered by Article 31 TRIPS, thereby 
filling the shortfall of this article. 
38.  As the Director General stressed in his letter to the WTO Members last February, acceptance 
of the Protocol is a concrete contribution that WTO Members can make to global efforts to 
strengthen the legal framework for access to medicines. We would also like to remind that the 
procedure of acceptance of the Protocol is straightforward, as was just explained by the Secretariat. The WTO Secretariat's website provides helpful information on the procedure in 
general and the few formalities that apply.  
39.  My delegation thus calls on all those WTO Members who have not yet done so, to proceed 
with their acceptance of the Protocol without further delay.  
40.  As for the proposal for a multi-stakeholder symposium, taken up by a number of delegations, 
in order to discuss the workability of the Paragraph 6 mechanism and associating therefore a 
broad range of WTO external stakeholders, we cons ider this premature. We have not heard from 
potential beneficiary Members whether at all they face specific obstacles, and if so, which ones, 
when wishing to make use of the Paragraph 6 mechanism. Before having heard about such 
concerns and problems from beneficiary WTO Members, we see neither the need nor the merits of considering including external stakeholders to th e Council’s discussion. Experience sharing should 
in the first place be deepened in this Council. 
7.16  Japan   
 41.  Firstly, this delegation would like to reit erate that Japan attaches great importance to the 
issue of access to medicines, which needs to be discussed in a broader context, taking into account 
not only the Paragraph 6 System but also various other relevant measures and factors, such as procurement and tariffs to name a few. Japan supports the Paragraph 6 System as established 
under the 2003 waiver decision and the 2005 Protocol Amending the TRIPS Agreement. At the 
same time, however, we would like  to recall that the very objective of the System is merely, but 
importantly, to enable those WTO Members that have either insufficient or no pharmaceutical 
manufacturing capacity to make use of compulsory licenses as a policy tool under the TRIPS 
Agreement, just like other WTO Members with pharmaceutical manufacturing capacity, for the purpose of promoting access to medicines. Compulsory licenses are, whether granted under the Paragraph 6 System or not, just one of the potential policy tools that can be utilized for this 
purpose and therefore, the Paragraph 6 System shou ld not be considered as the only solution, but 
rather as just an option we could consider. 
42.  Secondly, the delegation of Japan would like to congratulate Republic of Moldova, Kenya, 
Saint Kitts and Nevis, Sri Lanka, Lao People’s Democratic Republic and Iceland for depositing their 
instruments of acceptance of the Protocol most recently. To our disappointment, however, the list 
of Members has not yet reached the necessary number for the Protocol to enter into force and we 
are looking into the fifth extension of the deadline for the acceptance of the Protocol. We would 
like to call upon all Members that have not yet done so to deposit their instruments of acceptance of the Protocol as soon as possible and urge su ch Members to inform the Council their intended 
timeline for doing so, just like the distinguished dele gate of Thailand did so earlier in this meeting. 
43.  Lastly, with respect to the proposal at yesterday's informal meeting on holding a multi-
stakeholder technical symposium on this subject, we are open to consider the proposal provided 
its objective is made clear in written form. At the same time, this delegation believes that we IP/C/72 
 
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  should take full advantage of this annual review to fully understand and identify challenges that 
Members might be facing in utilizing the Paragraph 6 System. 
7.17  United States of America   
 
44.  Thank you for this update regarding the stat us of notifications of acceptance of the 2005 
Protocol Amending the TRIPS Agreement. Since th e last annual review, New Zealand and Australia 
have notified legislation implementing the Sy stem. The United States strongly supports the 
Paragraph 6 System as established under the 2003 waiver decision, the 2005 Protocol, and the 
2013 General Council decision to extend the deadline to 31 December 2015 for acceptance of the Amendment. 
45.  The United States congratulates those Members identified by the Chairman -- Brunei 
Darussalam, Moldova, Kenya, and Saint Kitts and Nevis, Sri Lanka, Lao PDR, and Iceland – which 
formally accepted the Amendment since the last review. We welcome and encourage the Secretariat's efforts with respect to depositing instruments of acceptance of the Amendment as 
well and encourage other Members to notify their acceptance of the Amendment so that it can 
enter into force. 
46.  With respect to the present status of a cceptances, and the indications that a number of 
Members, including the delegation of Thailand, which so indicated today, are actively pursuing 
domestic efforts in order to accept the Amendment, the United States supports the draft TRIPS Council proposal to the General Council for a decision to extend the period for acceptances of the Protocol.  
47.  We would also encourage those delegations th at have expressed criticism of the Paragraph 6 
System under this agenda item to consider furthe r the impact of their interventions on our shared 
efforts to encourage Members to accept this important Amendment. We urge caution regarding 
suggestions that its use indicates flaws in the System. We do not share this view. We also think 
Members should take full advantage of meetings of this Council. If Members have information to share that is relevant to acceptances of the Amen dment, it should be presented at our meetings, 
including the presently, and not held for some future  date at some future event.  The time is now 
to deliver on a decade-old promise on public health. 
48.  As we have explained, there are multiple avenues available for promoting access to 
medicines. The Paragraph 6 System is important, but it is not alone. Appropriate mechanisms for 
transparency, procedural and due process protecti ons, and opportunities for public engagement 
are important in the context of health care systems. Measures, including those that are 
discriminatory, non-transparent or otherwise trade-restrictive, have the potential to hinder access 
to pharmaceuticals and medical devices, and potentially result in reduced access to healthcare due 
to higher healthcare costs.  
49.  We continue to believe that the access to medicines issue is multidimensional. Making 
life-saving medicine available requires transpar ency and a commitment to address measures that 
unduly delay patients from getting the treatments they need. For example, we continue to have a great interest in hearing from other delegations regarding their efforts related to trade to facilitate such access. For instance, what measures have been taken by those Members identified in the 
2012 staff working paper entitled, "More Trade for Better Health? International Trade and Tariffs 
on Health Products" as maintaining the highest ta riffs, bound and applied, on medicines, medical 
inputs and medical devices? We recall the Urugua y Round pharmaceutical zero-for-zero agreement 
including the United States and other WTO Members. Are other WTO Members preparing to do the 
same? 
50.  Finally, while we are not in a position to accept the proposal due to a lack of information on 
this suggestion, we support the suggestion made by the EU. We also confirm our support for the 
proposal to extend the period of acceptan ce of the amendment for another two years. IP/C/72 
 
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  7.18  Bangladesh, on behalf of the LDC Group   
51.  I am taking the floor on behalf of the LDC Group. The Paragraph 6 mechanism is a unique 
mechanism to serve the cause of public health an d the LDCs are grateful to the Members of the 
WTO for the Decisions taken in this regard. Ba ngladesh, as LDC coordinator had reminded and 
encouraged the LDC Members concerned to notify  their acceptance. However to find out the 
causes for non-ratification, we may hold formal or informal exchanges of ideas and experiences so that we can understand their causes for delay and we can help the countries if they need any 
technical support or any support for understanding and ratifying this amendment. 
7.19  South Africa   
52.  South Africa is a signatory to the TRIPS Ag reement and one of the countries that played an 
active role in ensuring that the TRIPS Agreement accommodates issues on public health. Hence 
South Africa would like to reaffirm its commitment to improve access to essential medicines in 
developing countries and preserving the spirit and principles contained in the TRIPS Agreement and the Doha Declaration. In this regard, South Africa is currently taking all the necessary steps in 
terms of its constitutional requirements to implement the Paragraph 6 System into its domestic 
legislative framework. South Africa will continue to participate in discussions that aim to improve the efficiency of the Paragraph 6 System. 
53.  Furthermore, South Africa supports all ende avors aimed at promoting and fostering a better 
understanding of the challenges associated with  the effective utilization of the Paragraph 6 
System, including through a dedicated workshop, as  proposed by India and other delegations, and 
wider stakeholder consultation to this end. This delegation wishes to further express its support for 
the extension of the period for acceptance of the Protocol Amending the TRIPS Agreement for a 
further two years. 
7.20  India   
54.  I apologise for taking the floor once again. I would like to restrict my comments to the 
proposal on the technical workshop or symposium. Firstly we would like to thank the delegations who have supported the idea of a technical work shop based on the information provided, but we 
are quite dismayed that a few delegations have opposed the idea of a workshop. The intention of 
India proposing this technical workshop was simple, we are aware of the working of the Paragraph 6 System. This item that has been discussed in the Council for TRIPS and Members 
have aired their views on its practical application and its working. The trilateral study too has 
discussed it and we felt that it is now time to discuss it in a larger setting with multiple 
stakeholders, including representatives from industry, civil society, from international organizations involved in these issues, from public  health experts on an exploratory informal basis 
without any bearing on any decisions. The proposal was just that – to take it forward in terms of a 
trilateral co-operation symposium with WHO, WIPO and WTO which is done every year on different issues. It would, in our opinion, increase Members' understanding on these issues without 
prejudice to the views that each Member has. A number of delegations have opposed this and we 
would like to address the concerns that they have raised and urge them to reconsider.  
55.  Firstly I would like to respond to the EU suggestion that it should be a Member-driven 
approach and could be held in the margins of th e Council and could be based on an information-
sharing basis where it is Member-driven. We do not necessarily disagree with this view, the timing 
of the technical symposium is immaterial, it could be when the next TRIPS Council is meeting or in the margins of the Council, but what is important is that a larger stakeholder involvement of 
different interests and different ideas including industry, civil society and experts would help to 
break this impasse we have seen for the past decade. It has been discussed in the TRIPS Council but it is not just an information-sharing exercise, it would be a sharing of experiences, sharing of 
challenges and sharing of different viewpoints. Wh ile we agree with the EU on holding it in the 
margins of the Council, we urge that this multi stakeholder technical symposium is important to get more views and understanding fo r all Members on this point.  
56.  The second opposition from Switzerland of being premature, we fail to understand when it 
would become mature, because the Paragraph 6 mechanism entered into force in 2003. Since 
then, we have been debating it in the TRIPS Council incessantly, we feel it has become ritualistic IP/C/72 
 
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  and we feel that it is the right mature time, as many delegations including Brazil have mentioned. 
Switzerland may find that it is premature. This opinion could be stated in the workshop, that it is premature to discuss it, but that should not be a bar to discuss it with other experts.  
57.  We thank Japan for making the point that they are open to consider if the objective is clear. I 
think we have made our objective very clear in the last meeting last year, and again at this 
meeting about the workshop being to tackle Para graph 6 and to see the challenges and problems 
being faced in the context of Paragraph 6. Of course Japan has differ ent views on a broader 
context in which this has to work, and it is free to air that during the symposium. There is no bar 
against Members bringing their opinions, to even suggest speakers; we don't have a list of speakers ourselves. I think that merely because there is a plethora of other ways to handle this doesn't bar a technical symposium on Paragraph 6, so I believe we have addressed to our limited 
ability Japan's objection.  
58.  The US has basically stated that we have different views on how Paragraph 6 should work and 
there are multiple avenues to promote access to  medicines. Nobody is making the point that 
holding this technical symposium would change that view. The US could continue to have that view 
and could place that particular view on the agenda  of the symposium, but it would be important to 
discuss that symposium so that we understand be tter how Paragraph 6 could work. The US also 
mentioned that they need more information; we fail to understand what other information we 
could provide. There are topics on the Council agenda for which we have no papers, but we are discussing them without any information. We should be more in a flexible mode of accepting. What we have proposed basically is that Members could come with various suggestions on the agenda, 
on the speakers, on the formats. The Chair could consult in informal mode how it could go, so it is 
Member-driven. I would urge Members who are opposi ng it to reconsider because this is purely a 
symposium on a technical basis, on an informal basis, which would not influence any decision in 
the TRIPS Council.  
7.21  Uganda   
59.  You recall that Uganda submitted its instrument of acceptance in 2010, so I would like to 
e n c o u r a g e  o t h e r s  t o  d o  s o  a s  w e l l .  W i t h  r e g a r d  t o  t h e  p r o p o s a l  b y  I n d i a ,  w e  w e l c o m e  t h e  
suggestion for a multi-stakeholder workshop to better understand, inter alia, why the System is not working well and what the concerns of Members are so as to be able to utilize this instrument. A technical symposium could offer us all an opportunity to find ways for the effective 
operationalization of this instrument. We have noted the different views expressed by Members, 
but we think that Members should not be afraid of an information and experience-sharing session, except of course if the instrument was never meant to be precise, effective and operational like is 
the case for so many S&D proposals currently under review in the CTDSS. 
__________