WORLD TRADE  
ORGANIZATION  IP/C/46 
1 November 2007 
 (07-4741) 
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 third annual review took place in Octobe r 2006 and the General Council took note of the 
Council for TRIPS' report (IP/C/42) at its m eeting on 14-15 December 2006 (WT/GC/M/106, 
paragraph 165).  This report c overs the period since October 2006. 
3. At its meeting of 23-24 October 2007, 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 of the 2003 Decision and the acceptance of the Protocol Amending the TRIPS Agreement. 
Information on implementation and use of the system established under the Decision 
 
4. On 17 July 2007, the delegation of Rwanda notif ied the Council for TRIPS of its intention to 
import a fixed-dose combination medicine for the treatment of HIV infection from Canada under the 
system established by the 2003 Decision (IP/N/9/RWA/1).  Under paragraph 2(a) of the 2003 Decision, it notified the name and expected qu antities of the product needed.  It also informed 
the Council of its decision to rely on paragraph 7 of the Doha Declaration (WT/MIN(01)/DEC/2) and 
the Council for TRIPS Decision on the Extension of the Transition Period under Article 66.1 of the 
TRIPS Agreement for Least-Developed Country Memb ers for Certain Obligations with respect to 
Pharmaceutical Products (IP/C/25) in order to susp end the enforcement of any related patent rights. 
5. On 4 October 2007, the delegation of Canada notified the Council for TRIPS that it had 
authorized the manufacturing and export of the pha rmaceutical product concerned to meet Rwanda's 
needs (IP/N/10/CAN/1).  Under paragraph 2(c) of the 2003 Decision, it notified the grant of a 
compulsory licence, including the conditions attached to it, and provided information on the details of 
the licence.  Pursuant to paragraph 2(b)(iii) of the 2003 Decision, it also notified the address of the 
website where the licensee is to post information on the quantities and the distinguishing features of 
the product manufactured under the compulsory licence prior to shipment. 
6. No notifications have been made to the Counc il for TRIPS of the intention to use of the 
system as an importer pursuant to paragraph 1(b) of the Decision. IP/C/46 
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  7. As foreseen in the 2003 Decision, the Secretariat has established a page on the WTO website 
dedicated to this Decision, notably to ensure the pub lic availability of notifications made pursuant to it 
(http://www.wto.org/English/tratop_e/trips_e/public_health_e.htm). 
Decision on the Amendment to the TRIPS Agreement 
8. 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 1 December 2007 or  such later date as may be decided by the 
Ministerial Conference.  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. 
9. As of 30 September 2007, 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, and 
• Singapore, 28 September 2007, WT/Let/594. 
Information on the status of acceptances of the Prot ocol is periodically up dated in revisions of 
document IP/C/W/490. 
10. Given the present status of acceptances, the Counc il for TRIPS submits the attached proposal 
to the General Council for a decision to exte nd the period for acceptances of the Protocol. 
  IP/C/46 
 Page 3 
 
 
  ANNEX 
 
EXCERPT FROM THE MINUTES OF THE COUNCIL'S MEETING OF  
23-24 OCTOBER 2007 TO BE CIRCULATED AS IP/C/M/551 
 
 
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 Chairman  recalled that paragraph 8 of the waiv er Decision provided that the Council for 
TRIPS should review annually the functioning of the 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. He said that the Secretariat had prepared a draft cover note for the Council's report modelled 
on that of last year's report (JOB(07)/150).  The draft cover page contained factual information on the 
implementation and use of the system established under the Decision and on the acceptance of the 
Protocol Amending the TRIPS Agreement.  He pr oposed that, in accordance with the way that the 
Council prepared its report last year, the part of the minutes of the meeting reflecting the discussions held under this agenda item be  attached to the cover note. 
3. He informed delegations that, since its me eting in June, the Council had received from 
Rwanda a notification under paragraph 2(a)  of the Decision of 30 August 2003 on the 
"Implementation of Paragraph 6 of  the Doha Declaration on the TRIPS Agreement and Public Health" 
(IP/N/9/RWA/1).  The Council had also recei ved a related notification from Canada under 
paragraph 2(c) of the same Decision (IP/N/10/CAN/1). 
4. As regards the status of acceptances of the Protocol Amending the TRIPS Agreement that 
was done at Geneva on 6 Decembe r 2005, he said that the following Members had notified their 
acceptance of the Protocol since the Council's me eting in June:  Israel on 10 August, Japan on 
31 August, Australia on 12 Septembe r, and Singapore on 28 Septembe r (documents WT/Let/582, 592, 
593 and 594, respectively).  He recalled that the United States, Switzerland, El Salvador, Korea, 
Norway, India and the Philippines had notified th eir acceptance already earlier.  Therefore, 11 
Members had accepted the Protocol so far, whic h would enter into force for these Members upon 
acceptance of the Protocol by two thirds of the Member s.   He said that the Secretariat had circulated 
an update to the note on the status of acceptances of the Protocol that the Council had requested it to 
prepare at its meeting in October 2006 (IP/C/W/490/Rev. 1) and that the Secretariat would continue to 
update it periodically. 
5. The Chairman recalled that the Protocol  was open for acceptance by Members until 
1 December 2007 or such later date as may be d ecided by the Ministerial Conference.  Given the 
proximity of this date, he suggested that the Counc il may wish to consider submitting a proposal to 
the General Council for a decision to extend the peri od for the acceptance of the Protocol.  For this 
purpose, a draft decision on the extension of the pe riod for the acceptance that could be submitted to 
the General Council had been included in Annex 2 to the draft report.  As regards the deadline for the 
extended period for acceptances, he suggested that th e Council consider proposing an extension of the 
period by a further two years until 31 December 2009. 
                                                     
 
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/46 
Page 4  
 
  6. The representative of Canada
 said that the draft report accurately reflected Rwanda's 
notification to the Council of its intention to im port 260,000 packs of triple combination HIV/AIDS 
therapy manufactured by the Canadian company Apotex .  On 4 September, Apotex had filed the first 
compulsory licence application under Canada's Acc ess to Medicines Regime and, on 19 September, 
the Commissioner of Patents had granted an author ization to Apotex to manufacture and export the 
triple therapy drug to Rwanda.  His delegation w as pleased to be the first country to issue a 
compulsory licence under the system set out in th e Decision.  The licence was valid for two years 
from the date of the grant.  Apotex could seek a renewal for a further two years if the authorized 
quantity of the drug was not exported during the initial period.  He referred to his delegation's 
notification for further details (IP/N/10/CAN/1) a nd hoped that Rwanda's no tification would inspire 
other countries to follow.  Canada's officials were pr epared to explain to other interested parties how 
best to take advantage of the regime. 
7. He noted that his delegation had been among the first to introduce legislation to implement 
the Decision.  Based on the automatic review me chanism built into domestic legislation, public 
comments had been sought on a consultation paper and a parliamentary committee had held public 
hearings.  The review was now completed and the Government was working on finalizing the ensuing 
report.   He hoped to be in a position to shar e more details at the Council's next meeting. 
8. He noted that Canada's Access to Medicines Regime was only one part of the Government's 
broader response to addressing public health problems  in the developing world.  For example, the 
budget for 2007 had introduced a new tax incentive to encourage pharmaceutical manufacturers to donate greater amounts of needed medicines to deve loping and least-developed countries.  In addition, 
an HIV/AIDS vaccine initiative was currently being funded in collaboration with the Gates 
Foundation. 
9. Turning to the proposal for a decision to extend the period for the acceptance of the Protocol, 
he said that his delegation supported the extensi on of the deadline until 31 December 2009.  He 
encouraged all WTO Members to complete their inte rnal procedures before that date.  He reminded 
delegations that the waiver remained in place in th e meantime and that Canada's Access to Medicines 
Regime would continue to function fully. 
10. The representative of Uganda, speaking on behalf of the African Group,
 said that the African 
Group fully endorsed the Chairman's proposal that  the draft report be s ubmitted to the General 
Council and the deadline for the acc eptance of the Protocol be extended for another two years to 
31 December 2009.  This would allow WTO Member s to complete their internal ratification 
procedures.  The African Group was working very cl osely with capitals to get the necessary approval 
for the acceptance of the Protocol and expected that  most of its members would be depositing their 
instruments of acceptance sooner rather than later so  that the required acceptance of the Protocol by 
two thirds of the membership could be reached  and the TRIPS amendment enter into force. 
11. He thanked the delegation of Ca nada for its support for the extension of the deadline and  
endorsed the African Group's support for Canada's st atement according to which the waiver remained 
in place until the procedures regarding the acceptance of  the Protocol were completed.  He also noted 
that the African Group would continue to monitor the domestic processes in those members that had 
not filed their intention to use the system. 
12. The representative of Rwanda  recalled that, pursuant to the 30 August 2003 Decision on the 
Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, 
his delegation had notified the Council for TRIPS of its  intention to import a fixed dosed antiretroviral 
drug.  It was the first country without manufactur ing capacities to initiate the process of using the 
waiver to the TRIPS Agreement.  Since Canada had issued a compulsory licence to a domestic 
company in order for it to start producing the generi c version of the medicine, the process was moving  IP/C/46 
 Page 5 
 
 
  ahead.  He said that the steps al ready undertaken provided evidence th at the instrument negotiated by 
WTO Members for public health purposes could work. 
13. The representative of China  welcomed Rwanda's effort to use the flexibilities in the system 
set up by the Decision, as well as the notifications  submitted by Rwanda and Canada.  This was a 
useful attempt to test the effectiveness of the syst em.  It would be helpful for other Members to learn 
from the experience made in this regard.  He said th at China attached great importance to the Protocol 
and was approaching the final stage of the process for its acceptance.  While he believed that China 
would be able to notify its acceptance before the orig inal deadline, he could also support the extension 
of the deadline for another two years. 
14. He welcomed notifications by Members who had already amended national legislation in 
order to implement the system.  He encouraged them to make presentations on their implementing 
legislation, including on how any problems had b een addressed, since many developing country 
Members were facing technical problems in amending their relevant national la ws and regulations and 
in understanding the national legisla tions of other Members.  In this  regard, he welcomed Canada's 
introduction to the review mechanism of its national legislation and was looking forward to the report 
by Canada on its outcome at the Council's next meeting. 
15. The representative of the European Communities  welcomed the notification by Rwanda of its 
intention to use the system set up by the Decision and the positive and quick answer by Canada authorizing the manufacture and export of the drugs c oncerned to meet Rwanda's needs.  This was an 
important step which demonstrated that the system  was working.  He encouraged other countries in 
need to use it.  His delegation had adopted a Regulation in 2006 which implemented the system, 
allowing European companies to produce ge neric drugs under compulsory licence.   
16. As the required threshold for the entry into force of the Protocol would not be reached by 
1
 December 2007, his delegation supported the extensi on of the deadline for another two-year period.  
He informed the Council that the European Par liament's assent to the TRIPS amendment was 
imminent, which would enable his delegation to proceed to the notification of the acceptance of the 
Protocol after the final approval by the European  Communities' Council of Ministers.  Other WTO 
Members which had not accepted the Protocol should do so as soon as possible to confirm their commitment to the process. 
17. The representative of Norway
 said that his delegation was ready to go along with the proposal 
to extend the period for acceptance.  He encour aged WTO Members that had not notified their 
acceptance to maximize their efforts to m eet the original December 2007 deadline. 
18. The representative of Switzerland  supported the draft report, as well as the Chairman's 
proposal to extend the deadline for acceptance of the Prot ocol for another two years.  He regretted that 
this had become necessary, despite the urgency a ttached by many delegations to the transposition of 
the waiver into an amendment of  the TRIPS Agreement in 2005.  His delegation had hoped that the 
amendment could have entered into force within the initial period for acceptance set by the General 
Council. He encouraged Members which had not yet acc epted the Protocol to complete their internal 
procedures so that the amendment could enter into force before the expiry of the extended period for 
acceptance. 
19. He welcomed the notifications by Rwanda a nd Canada and was looking forward to having 
further news on how the system was put in operatio n.  His delegation had notified its acceptance in 
2006.  In June 2007, the Parliament had approve d national implementing legislation which was 
expected to enter into force early in 2008.  It introduced the possibility of granting a compulsory 
licence for export purposes in accordan ce with the terms and conditions of the draft amendment of 
Article 31 bis of the TRIPS Agreement and its Annex. IP/C/46 
Page 6  
 
  20. 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 until 
31 December 2009.  He suggested that paragraph 10 of the draft report to the General Council be 
modified to read as follows:  "G iven the present status of acceptan ces, the Council for TRIPS submits 
the attached proposal to the General Council for a decision to extend the period for acceptances of the 
Protocol."  He proposed that, with these modifica tions, the Council agree to the cover note to the 
report contained in JOB(07)/150 and also that the Council minutes containing the record of the 
discussion be attached to it. 
21. The Council so agreed . 
 
_______________ 
 
  IP/C/46 
 Page 7 
 
 
  ANNEX 2 
 
 
 WORLD TRADE  
ORGANIZATION   
 
 (07-0000) 
General Council  
  
AMENDMENT OF THE TRIPS AGREEMENT – EXTENSION OF THE PERIOD FOR THE 
ACCEPTANCE BY MEMBERS OF THE PROTOCOL AMENDING THE TRIPS 
AGREEMENT 
 
Draft Decision of [date] 
  
 The General Council;   Conducting, pursuant to paragraph 2 of Article IV of  the WTO Agreement, the functions of 
the Ministerial Conference in the interval betw een meetings of the Ministerial Conference; 
 
 Having regard to paragraph 2 of the Decision of th e General Council of 6 December 2005 on 
the Amendment of the TRIPS Agreement (the "Decisi on") and paragraph 3 of the Protocol Amending 
the TRIPS Agreement (the "Protocol")
2, which provide that the Protocol shall be open for acceptance 
by Members until 1 December 2007 or such later da te as may be decided by the Ministerial 
Conference; 
  Recalling that, pursuant to paragraph 3 of the De cision and paragraph 4 of the Protocol, 
the Protocol shall take effect and enter into for ce in accordance with the provi sions of paragraph 3 of 
Article X of the Marrakesh Agreement establishing the World Trade Organization (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 extend the period for acceptances of the Protocol 
submitted by the Council for TRIPS (IP/C/...); 
  Decides  as follows: 
 
The period for acceptances by Members of th e Protocol Amending the TRIPS Agreement 
referred to in paragraph 2 of the Decision and para graph 3 of the Protocol shall be extended until 31 
December 2009 or such later date as may be decided by the Ministerial Conference.  
__________  
 
                                                     
 
2 WT/L/641.