WORLD TRADE  
ORGANIZATION  IP/C/53 
4 December 2009 
 (09-6208) 
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 Implementati on of Paragraph 6 of the Doha Declaration on 
the TRIPS Agreement and Public Health of 30 August 2003 (the "2003 Decision") provides that the 
Council for TRIPS shall review annually the functioni ng 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 deemed to fulfil the review requirements of Article IX:4 of the WTO 
Agreement. 
2. The fifth annual review took place in Octobe r 2008 and the General Council took note of the 
report of the Council for TRIPS (IP/C/49 and Corr.1) at its meeting on 18 December 2008 
(WT/GC/M/117, paragraph 84).  The present re port covers the period since October 2008. 
3. At its meeting of 27-28 October 2009, the Council took up the annual review.  Annex 1 to this 
report records the statements made in the review.  The paragraphs below set out factual information 
regarding the implementation and use of the 2003 Decision, discussions on the operation of the 
system and the acceptance of the Protocol Amending the TRIPS Agreement. 
1. Information on implementation and use of the system established under the Decision 
 
4. In February 2009, the delegation of the Phili ppines notified the Council for TRIPS of the 
Republic Act No. 9502, also known as the "Univer sally Accessible Cheaper and Quality Medicines 
Act of 2008", and of Joint Administrative Order No. 2008-01 providing for the Implementing Rules 
and Regulations of Republic Act No. 9502 (IP/N/1 /PHL/I/10).  The Republic Act No. 9502 became 
effective on 4 July 2008. Its Section 93-A and Rule 13 of the Joint Administrative Order No. 2008-01 
implement the system established under the 2003 Deci sion into the domestic law of the Philippines.   
5. On 15 April 2009, the delegation of Singapore no tified the Council for TRIPS of amendments 
to its intellectual property legislation during the period from 2000 to 2008 (IP/N/1/SGP/4).  The 
consolidated notification under Article 63.2 TRIPS refers, among others, to the Patents (Amendment) 
Act 2008 which entered into force on 1 December 2008.   Amendments to Sections 2, 56, 60, 62 and 
66 of the Patents Act implement the system estab lished under the 2003 Decision into Singapore law.  
6. As regards the use of the system by Rwanda to import a fixed-dose combination medicine for 
the treatment of HIV infection manufactured by  the Canadian drug company Apotex (see annual 
review in 2007, IP/C/46, paragra phs 4-5) and following up on reports regarding the first shipment of 
the generic medicine produced under Canada's Ac cess to Medicines Regime on 24 September 2008 
(see annual review in 2008, IP/C/ 49, paragraph 6), the delegation of  Canada informed the Council at IP/C/53 
Page 2  
 
  its meeting on 27-28 October 2009 that the second sh ipment of 7.6 million tablets of the generic 
medicine to Rwanda took place on 17 September 2009.  
7. No notifications have been made  to the Council for TRIPS of the intention to use the system 
as an importer pursuant to paragraph 1(b) of the Decision. 
8. As foreseen in the 2003 Decision, the Secr etariat regularly updates a page on the WTO 
website dedicated to this Decision, notably to ensu re the public availability of notifications made 
pursuant to it (http://www.wto.org/English/tratop_e/public_health_e.htm). 
2. Discussion on the operation of the system established under the Decision 
9. At the Council's meeting on 3 March 2009, the delegation of India raised under "Other 
business" the issue of the effective operation of th e system (IP/C/M/59, para graphs 192-210).  Taking 
into account that the system had only been used  once since 2003, it suggested that the legal, 
procedural, commercial or other obstacles to the operation of the system be discussed and 
recommendations for its effective implementation be  submitted to the Council for consideration as 
part of the system's annual review at its meeting in October.  Given that the matter was raised under 
"Other business", the Council limited itself to  taking note of the statements made.  
3. Decision on the Amendment to the TRIPS Agreement 
10. As called for in paragraph 11 of the 2003 Deci sion, 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 2009 or such later date as may be decided by the 
Ministerial Conference (WT/L/711).  In accordance with Article X:3 of the WTO Agreement, the 
Protocol will enter into force upon acceptance by two thirds of the WTO Members. 
11. As of 30 September 2009, 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; 
• 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;  IP/C/53 
 Page 3 
 
 
  • China, People's Republic of, 28 November 2007, WT/Let/607; 
• European Communities1, 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, 4 August 2009, WT/Let/652; 
• Colombia, 7 August 2009, WT/Let/650; and 
• Zambia, 10 August 2009, WT/Let/651. 
Information on the status of acceptances of the Prot ocol is periodically up dated in revisions of 
document IP/C/W/490. 
12. Given the present status of acceptances, the C ouncil for TRIPS submits the attached proposal 
to the General Council for a decision to exte nd the period for acceptances of the Protocol. 
 
                                                      
 1 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 Europ ean 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 the 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 Tr eaty establishing the European Community, that the 
Protocol will be binding on the Member States of the European Union. 
 
The Secretary-General/High Representa tive  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/53 
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  ANNEX 
 
EXCERPT FROM THE MINUTES OF THE COUNCIL'S MEETING OF  
27-28 OCTOBER 2009 TO BE CIRCULATED AS IP/C/M/61
1 
  
G. R
EVIEW 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 Chairperson  recalled that paragraph 8 of the wa iver Decision provided that the Council 
for TRIPS should review annually the functioning of th e system set out in the Decision with a view to 
ensuring its effective operation and should annuall y report on its operation to the General Council.  
Furthermore, the paragraph provided that this review should be deemed to fulfil the review 
requirements of Article IX:4 of the WTO Agreement.   
2. She said that the Secretariat had circulated a draft cover note for the Council's report modelled 
on previous years reports (JOB(09)/128).  It cont ained factual information on the implementation and 
use of the system established under the Decision,  on discussions regarding its operation and on the 
acceptance of the Protocol Amending the TRIPS Agre ement.   She proposed that, in accordance with 
the way that the Council prepared its reports in th e previous years, the part of the minutes of the 
meeting reflecting the discussions held under this ag enda item be attached to the cover note as an 
annex.   
3. As regards the status of acceptances of the Protocol Amending the TRIPS Agreement that 
was done at Geneva on 6 December 2005, she said that the following Members had notified their 
acceptance of the Protocol since the Council's meeti ng in June:  Macao, China on 16 June;  Canada on 
16 June;  Bahrain on 4 August;  Colombia on 7 August;  and Zambia on 10 August (documents 
WT/Let/645, 646, 652, 650 and 651, respectively).  She recalled that 26 notifications of acceptance of 
the Protocol, including from the European Commun ities, had been received.  The Protocol would 
enter into force for the Members concerned upon accep tance of the Protocol by two thirds of the 
Members.  She said that the Secretariat had circ ulated an update to the note on the status of 
acceptances of the Protocol that the Council request ed it to prepare at its meeting in October 2006 
(IP/C/W/490/Rev.5) and that the Secretariat would continue to update it periodically. 
4. The Chairperson recalled that the Protocol w as originally open for acceptance by Members 
until 1 December 2007 and upon a proposal by the TR IPS Council, the General Council had extended 
this period until 31 December 2009.  Given the proxim ity of this date, she suggested that the Council 
may 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 on the extension of the 
period for the acceptance that could be submitte d to the General Council for adoption had been 
included in Annex 2 to the draft report.  As regards the deadline for the extended period, she 
suggested that the Council consider proposing an ex tension by a further two years until 31 December 
2011. 
5. The representative of Egypt, speaking on behalf of the African Group,  said that the African 
Group fully supported the Council for TRIPS subm itting a proposal to the General Council for a 
decision to extend the period for acceptance of the Protocol until 31 December 2011.  The amendment 
of the TRIPS Agreement was premised on the need to ensure the continued access to medicines and 
reflected the concern that Members had with rega rd to the Agreement's functioning in the area of 
public health.  The African Group continued to ur ge Members to accept the Protocol and to notify 
                                                      
1 The paragraph numbering of this excerpt will not  correspond with that of the minutes of the 
TRIPS Council meeting but has been included for the convenience of users.  IP/C/53 
 Page 5 
 
 
  such acceptance.  At the same time, he noted that  the system established under the Decision had not 
been used as often as had been expected.  Th e African Group therefore supported conducting an 
analysis as to the reasons for this and possible means of addressing any difficulties and impediments. 
6. The representative of Switzerland  said that his delegation was prepared to join consensus to 
further extend the period for acceptance by Members of the Protocol with a view to permanently 
inserting the system established under the Decision in the TRIPS Agreement.  However, he was 
concerned by the fact that four years had passed  since the General Council's Decision in December 
2005 and only less than one third of the Members had notified their acceptance of the Protocol.  He 
reminded delegations of the urgent  calls at the time of negotiating the amendment which was meant to 
address a major concern of developing count ries without manufacturing capacity in the 
pharmaceutical sector when facing a public health pr oblem.  Given the efforts deployed to adopt the 
Protocol, it was disappointing that only a small number of Members had accepted it so far.  His delegation had done so in 2006 and had also implemen ted the system at the national level through the 
revised Patent Act in force since July 2008 (IP/N/1 /CHE/P/9).  Manufacturing capacities in the Swiss 
pharmaceutical sector were thus made available to  Members who found themselves in a situation 
addressed by the system.  It was, however, unfortuna te that the implementing legislation continued to 
be based on a waiver decision adopted by the Gene ral Council, and not on a permanent amendment of 
the TRIPS Agreement.  His delegation therefore encouraged those Members which had not yet accepted the Protocol to do so expeditiously so as to allow its entry into force before the expiry of the 
once more extended period for acceptance.  He remain ed convinced that the system was workable and 
should be used by Members efficiently.   
7. The representative of Canada
 recalled that his delegation had announced the first shipment to 
Rwanda of a lower cost generic medicine to treat HIV/AIDS, manufactured by the Canadian pharmaceutical company Apotex Inc., at the Council's  meeting in October 2008.  He confirmed that 
the second shipment of HIV/AIDS medication comp rising 7.6 million tablets to Rwanda had taken 
place on 17 September 2009, thus completing the terms of the compulsory licence.  These shipments 
demonstrated that the system established under the Decision, while only being one aspect of a broader 
international strategy, could help coun tries to accede life-saving medicines. 
8. He was pleased to inform the Council that hi s delegation had deposited its instrument of 
acceptance of the Protocol with the WTO on 16 June  2009.  He encouraged Members who had not yet 
accepted the Protocol to do so.  His delegation supp orted the proposed extension of the deadline to 
accept the Protocol.  The Decision and the Protocol that transformed the waivers into a permanent 
amendment of the TRIPS Agreement would send an important signal that trade and intellectual 
property rights were supportive of facilitating acces s to medicines in developing countries.   
9. The representative of th e European Communities
 recalled that Regulation (EC) No 816/2006 
had been adopted in 2006 to implement the Decision .  This allowed European companies to produce 
generic drugs under compulsory licences for export to  countries facing public health problems.  His 
delegation would welcome any request from developing countries in view of the use the system.  In 
November 2007, the European Communities had also accepted the Protocol.  Given the present status 
of acceptances, he encouraged those Members who ha d not yet accepted the Protocol to do so as soon 
as possible.  It was important for Members to conf irm their commitment to this process, so that the 
Protocol could enter into force as soon as possible.   Concurring with the Swiss delegation, he noted 
the contradiction between the urgency felt in 2003 to put the system into place and the still limited 
number of acceptances.  He supported the extension of the period for the acceptance of the Protocol 
until the end of 2011. 
10. Supporting the statement made by Egypt, the representative of Kenya  welcomed the proposal 
that the period for acceptance of the Protocol be  extended until 31 December 2011.  His delegation IP/C/53 
Page 6  
 
  was in the process of accepting the Protocol.  Inte rnal procedures had taken some time, but he hoped 
that the Protocol could be accepted w ithin the extended period for acceptance.  
11. The representative of Tanzania, speaking on behalf of the LDC Group
, said that many LDCs 
suffered from the difficulties of insufficient or non-manufacturing capacities in the pharmaceutical 
sector which rendered the effective use of compulso ry licensing difficult.  The Decision constituted a 
major hope for LDCs, as well as for other Members.  The fact that the majority had not yet accepted 
the Protocol could be indicative of some barriers  to the implementation of the system established 
under the Decision, causing delay to the expeditious  access to medicines in LDCs and other Members 
in need.  The annual review of the system was em bedded in the Decision and would provide a useful 
tool for its re-examination.  He urged the Chair to undertake consultations with all the interested 
Members, including LDCs, aimed at identifying any difficulties encountered with the use of the 
system and to make suggestions to solve those problems.  The findings and the recommendations of 
such consultations could be submitted to  the Council for further consideration. 
12. The delegation of Mexico  said that the lack of acceptan ces sent a negative systemic message 
with regard to the amendment of the TRIPS Agr eement and, beyond this, any other WTO agreement.  
There was a need to ensure legal certainty.  He  therefore urged those Members who had  not yet 
ratified the Protocol to do so.  The example of e xport of generic medicines from Canada to Rwanda 
demonstrated that the system functioned and could be used effectively.  The acceptance of the Protocol could be done independent ly and should not be prejudged by  the analysis of its operation as 
requested by some delegations.  
13. The delegation of India
 said that it attached high importance to the Doha Declaration on the 
TRIPS Agreement and Public Health, the system est ablished under the Decision and the Protocol.  His 
delegation had notified its acceptance of the Protoc ol in March 2007.  However, in spite of the 
extended period for acceptance agreed in Dece mber 2007, only 26 Members had accepted the 
Protocol so far.  The fact that there was still a lo ng way to go for it to en ter into force, as acceptance 
by two thirds of the membership was required, w as not a positive signal.  There was no choice but to 
extend the period for acceptance by another two years, and at the same time urge Members to 
complete acceptance formalities as soon as possible.   
14. His delegation had always been of the view that the Doha Declaration constituted a major 
landmark in the short history of the WTO because it had recognized the primacy of public health 
needs and the preparedness of the Organization to take up the problems faced by the poor in 
developing countries.  Along with several other Me mbers, India had worked relentlessly on the Doha 
Declaration and the Decision.  The Decision was e xpected to address the public health problems faced 
by Members with insufficient or no manufacturing ca pacities in the pharmaceutical sector.  However, 
already at the General Council meeting in August 2003, his delegation had expressed concerns that 
"the results accruing from this mechanism would not be negated by the creation of cumbersome 
systems that would lead to huge delays in getting medicines across at reasonable cost to those that 
needed them or discourage Members from using the syst em for the benefit of the people.  In order to 
make this system successful, a sincere collective ef fort was required on the part of all Members and 
the entire pharmaceutical industry."  He regretted that his delegation had been proven right.  The 
export of HIV/AIDS medicines by the Canadian pharmaceutical company Apotex to Rwanda in 
September 2008 had been the first use of the system.  Canada had to be complemented on its effort to 
supply the medicines and to operationalize the system .  However, it had taken about three years to 
supply the medicine.  It was therefore time for re flection on the obstacles to the use of the system 
which was supposed to be an expeditious solution to  the problem with respect  to access to medicines 
in countries with insufficient or no manufacturing capacity.  Experience showed that it had been far 
from expeditious.  Even a perfunctory examinati on of the list of the 26 Members which had accepted 
the Protocol so far revealed that there were hard ly any of the anticipated beneficiaries which had 
completed the process of acceptance.  Countries w ith insufficient or no manufacturing capacities were  IP/C/53 
 Page 7 
 
 
  missing from this list.  He wondered whether this w as merely due to reasons of domestic procedures 
or whether it represented some kind of apathy towards the system.   
15. Paragraph 8 of the Decision instructed the TR IPS Council to review annually the functioning 
of the system with a view to ensuring its effectiv e operation and to annually report on its operation to 
the General Council.  During the fifth annual review  at the Council's meeting in October 2008, factual 
information regarding the implementation and use of  the system and the acceptance of the Protocol 
had been circulated.  There had been limited discu ssion on why the paragraph 6 system had been used 
only once in the last six years.  He supported the suggestion by Egypt and Tanzania that the Chair hold informal consultations with interested Members on obstacles, if any, to the effective operation of 
the system.  The recommendations emerging from such  discussions could then be considered by the 
Council for further action. 
16. The delegation of the United States
 recalled its strong support for the system established 
under the Decision as one element in what had to be a multi-faceted international approach to improve 
responses to serious health crises in developing co untries.  At the Hong Kong Ministerial Conference, 
it had become the first Member to formally accept this solution as a permanent part of the TRIPS 
Agreement.  It was important to note, however, that the number of compulsory licences issued should 
not be the mark of success or failure of the ame ndment.  Rather than being a reflection of the 
practicability of the system, its limited use in dicated the increased access to pharmaceuticals by 
countries with little or no pharmaceutical manufacturi ng capacity.  Her delegation would continue to 
carry forward as a foremost contributor of pharmac eutical vaccine and diagnostic aid to countries in 
need.  This was demonstrated notably by the US Pr esident's Global Health Initiative, which aimed to 
raise 63 billion dollars over the next six years to fo cus on broad global health challenges, as well as 
President Obama's decision to make 10 per cent of  the US H1N1 vaccine supply available to the 
World Health Organization for use in developi ng countries.  Her delegation was thus joining 
Australia, Brazil, Switzerland, New Zealand, Italy,  France, Norway, Germany, Japan and the United 
Kingdom, which had either donated vaccines or fund ed their purchase.  She supported the extension 
of the period for acceptance of the Protocol un til 2011 and hoped to see the amendment enter into 
force as soon as possible. 
17. The representative of Ecuador  supported the proposed extension of the period for acceptance 
of the Protocol.  However, the fact that the system had only been used once so far and that only 26 of 
the 153 WTO Members had ratified it raised questions  regarding its effectiveness.  This called for a 
thorough examination of the system and what need ed to be done to improve its functioning.  
Flexibilities available to developing countries with in the framework of the TRIPS Agreement to 
address public health problems needed to be looked at .  He supported the proposal by Egypt to carry 
out a review of the system.  Questions that needed  to be taken up included why the system had not 
functioned as it was meant to, wh at aspects of public health in developing countries should be 
considered, and whether the low number of acceptances of the Protocol was a reflection of the fact 
that the objective had not been met, indicating that  the mechanism was not functioning effectively.  
Based on the periodic review of the system, the Chair should start a study of its effectiveness to address the needs of developing countries. 
18. The representative of Norway
 said that her delegation had ratif ied the Protocol in February 
2007.  She echoed other delegations in urging Members who had not yet done so to ratify the Protocol 
as soon as possible.  She supported the extension of the period for acceptance until 
31 December 2011, but hoped that the Pr otocol would enter into force earlier. 
19. The representative of Pakistan  supported the proposed extension of the period for acceptance 
until 31 December 2011.  His delegation had complete d its domestic legislative procedures to accept 
the Protocol.  The instrument of acceptance would be  submitted to the WTO Secretariat in due course.  
He supported the statements made by Egypt, Tanzania , India and Ecuador, suggesting that a review of IP/C/53 
Page 8  
 
  the system be undertaken in order to check if ther e were any issues with respect to its functioning.  
Consultations in an informal setting would help achieving the shared objective of enhancing access to 
medicines in developing countries. 
20. The representative of Japan
 reiterated the importance which his delegation attached to the 
issue of public health, especially where it affected  developing Members.  The Protocol should come 
into effect as early as possible.  It was regrettable that only a limited number of Members had notified 
their acceptance so far.  There was therefore no c hoice but to further extend the period for acceptance 
for another two years.  He urged Members that ha d not yet accepted the Protocol to redouble their 
efforts to complete their domestic procedures a nd to notify their acceptance as expeditiously as 
possible. 
21. The representative of Australia  welcomed the supply of HIV/AI DS medicines from Canada to 
Rwanda under the system.  This demonstrated its effectiveness.  As noted by the delegation of the 
United States, measures could be taken outside of the system too.  The donation of the H1N1 vaccine 
by Australia and other countries to the global supply for the benefit of developing countries 
constituted but one example.  She encouraged othe r Members who had not yet done so to accept the 
Protocol as soon as possible.  Her delegation suppor ted the extension of the period for acceptance of 
the Protocol until 31 December 2011. 
22. The representative of Brazil  supported the interventions by Eg ypt, Tanzania, India, Ecuador 
and Pakistan, suggesting that the functioning of the system established under the Decision be 
reviewed, as there was a pressing need for rendering it  more effective and operational.  Paragraph 6 of 
the Doha Declaration and the system established thereby were milestones in the history of the 
implementation of the TRIPS Agreement.  Paragr aph 6 provided a much needed and long awaited 
response for the specific situation of countries with limited or no manufacturing capacities.  His delegation had actively participated in the negotia tions that had led to the adoption of the Doha 
Declaration.  On 13 November 2008, it had accepted the Protocol.  He strongly believed  in the message delivered by the Doha Declaration, accord ing to which intellectual property protection could 
not and should not supersede more fundamental values, such as the protection of life through the 
access to life-saving drugs in developing countries.   He supported the proposal that the Council hold 
consultations with developing countries and other Members interested in the system to identify 
obstacles that were preventing developing countries from making full use of it. 
23. The representative of China
 said that his delegation had notifie d its acceptance of the Protocol 
on 28 November 2007.  Public health was an import ant issue to his delegation, as well as to many 
other developing countries and LDCs.  The ship ment of HIV/AIDS medicines from Canada to 
Rwanda was the first case to test the functioning of the system established under the Decision.  It 
deserved thorough examination, as it had already rev ealed some hurdles with respect to the lengthy 
process leading to the shipment.  The annual revi ew provided an important platform for future 
discussions.  He supported the request by Egypt, Tanzania and India that the TRIPS Council hold 
informal consultations on how to improve the f unctioning of the system.  He also proposed the 
organization of a workshop specifically dedicated to  the experience made in the case of supply of 
generic medicines from Canada to Rwanda under the system be considered.  
24. The representative of Venezuela  noted that most of the Members who had accepted the 
Protocol were developed countries and that preci sely those Members were asking for the acceptance 
of the Protocol by other Members.  He wondered wh ether this was not contradicting the objective of 
the system whose aim was to support developing coun tries.  He supported the proposal by Ecuador to 
examine the functioning of the system, in particular  whether it met the needs of developing countries.  IP/C/53 
 Page 9 
 
 
  25. The representative of El Salvador  said that her delegation, who had already accepted the 
Protocol Amending the TRIPS Agreement in 2006, supported the extension of the period for its 
acceptance until 31 December 2011.   
26. The representative of Angola  supported the statements made by Egypt and Tanzania, 
suggesting that consultations be launched in order to identify the obstacles preventing Members from 
accepting the Protocol.  The system had been ne gotiated by developing countries, but mostly 
developed countries had accepted the amendment of the TRIPS Agreement.  There was a lack of 
information which needed to be addressed by th e TRIPS Council and through technical assistance.  
This could help setting up local manufacturing capac ities to produce anti-malaria medicines instead of 
importing them, ensuring thus transfer of technol ogy.  This would make many more Members accept 
the Protocol as a means to reduce imports of costly  medicines.  As part of its capacity building 
activities, the WTO Secretariat should look at how best to sensitize Member s to the benefits of 
accepting the TRIPS amendment, including by setting up local production facilities to reduce the costs 
arising from the import of medicines. 
27. The Chairperson  proposed that the Council agree on forwarding to the General Council the 
proposal for a decision to extend the period for acce ptance of the Protocol until 31 December 2011.  
She suggested that the last paragraph of the draft decision by the Gene ral Council contained in 
Annex 2 to the draft report (JOB(09)/128) be comple mented by inserting this date.  She also proposed 
that the Council agree to the cover note to the report contained in JOB(09)/128 and also that the 
Council minutes containing the record of the discussion be attached to it. 
28. The Council so agreed . 
29. The Chairperson  reverted to the suggestion made by Egypt and Tanzania, supported by 
certain other delegations, that she hold consultati ons with interested delegations to examine the 
experiences regarding the use of the system, including obstacles, if any, to its effective operation.  She 
asked whether such informal consulta tions were acceptable to Members. 
30. The representative of the United States  said that the request for consultations and the way it 
was framed were assuming that there were barriers to the implementation of the system.  This was 
contradicted by the effective implementation that ha d been described by Canada and the shipment of 
medicines to Rwanda.  While it was important to c ontinually evaluate practical experiences with its 
implementation, the system provided for an annual review which should serve to discuss practical 
experiences with respect to its implementation.   
31. The representative of Egypt  said that the system had been used only once in four years.  
Given the nature and gravity of the problem to be addressed, there were legitimate concerns about the 
limited use of the system so far.  In addition to  the agenda item on the annual review of the system, 
the Chair could therefore usefully explor e the issues with interested delegations. 
32. The representative of India  said that there was a prima facie case given that the system had 
been used only once in six years.  This had not b een the expectation when the system was negotiated 
in 2003.  While there were legitimate concerns , his delegation did not attempt to prejudge the 
outcome of informal consultations by the Chair.  T hose were merely requested to explore if there were 
obstacles, and, if so, what kind of obstacles.  It sh ould also be born in mind that this was a request 
made by the LDC Group and the African Group which accounted for a large number of the anticipated beneficiaries of the system.  He felt that  informal consultations wo uld be useful, and as the 
delegation of the United States had mentioned, experiences could also be shared during such 
consultations. IP/C/53 
Page 10  
 
  33. The representative of Ecuador
 concurred with the statements  made by Egypt and India.  
Taking up questions addressing the concerns expr essed with respect to experience with the 
functioning of the system would neither have a ne gative connotation nor prejudge the outcome of the 
discussion.  He supported the proposal that the Ch air hold informal consultations with interested 
Members in order to the issues raised. 
34. In support of the statements made by Egypt,  India and Ecuador, the representative of China  
said that a single case of use of the system within six years could not be characterized as effective functioning.  Without wanting to draw any immediat e conclusion from that experience, his delegation 
merely requested that informal consultation be in itiated, as had been done on many other occasions by 
the Council, as well as by other WTO bodies.  Informal consultations would provide a good 
opportunity for an open-minded exchange of views and experiences without imposing any obligations 
on Members. 
35. The representative of the United States
 said that her delegati on could go along with the 
organization of one round of informal consultations by  the Chair, provided that this was not going to 
be looked at in any prejudiced way, either positive or  negative.  This would allow Members to discuss 
the implementation of the system and their experien ces.  Her delegation expected, however, that there 
be no outcome document other than, possibly, the re porting to the Council of what had been discussed 
in the informal consultations.   
36. In the light of the di scussion, the Chairperson  suggested that she hold informal consultations 
on the operation of the paragraph 6 system befo re the Council's next formal meeting without 
prejudging the outcome.  A single round of informal  discussions with interested delegations would 
provide a platform to share experiences and to lo ok at concerns in an informal setting.  Members 
should inform the Chair or the Secretariat of their interest to participate in the consultations.   
37. The Council so agreed .  IP/C/53 
 Page 11 
 
 
  ANNEX 2 
 
 
 WORLD TRADE  
ORGANIZATION   
 
 (09-0000) 
General Council  
  
AMENDMENT OF THE TRIPS AGREEMENT – SECOND 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 "TRI PS 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 18 December 2007 (the "2007 
Extension Decision")
2, initially extended the period for acceptanc es of the Protocol by Members until 
31 December 2009 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 fo rce in accordance with the 
provisions of paragraph 3 of Article X of the WTO Agreement;  
 Noting  that acceptance of the Protocol by two th irds of the Members in accordance with 
paragraph 3 of Article X of the WTO Agreem ent is taking longer than initially foreseen; 
  Having considered the proposal to further extend the peri od for acceptances of the Protocol 
submitted by the Council for TRIPS (IP/C/..); 
                                                     
 
1 WT/L/641. 
2 WT/L/711. IP/C/53 
Page 12  
 
   
 Decides  as follows: 
 
The period for acceptances by Members of th e 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 2007 Extension Decision, sh all be further extended until 31 December 2011 
or such later date as may be decided by the Ministerial Conference.  
__________