WORLD TRADE  
ORGANIZATION  IP/C/37 
3 November 2005 
 
 (05-5173) 
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 (WT/L/540  and Corr.1) provides that the Council for TRIPS 
shall review annually the functioning of the system se t out in the Decision with a view to ensuring its 
effective operation and shall annually report on its op eration to the General Council.  This review is 
deemed to fulfil the review requirements of Article IX:4 of the WTO Agreement. 
2. The first annual review took place in December 2004 (IP/C/33).  This report covers the period 
since then. 
3. At its meeting of 25-26 October 2005, the Counc il took up the annual review.  The annex to 
this report records the statements made in the review.  The paragraphs below set out factual 
information regarding the implementation of the D ecision and the work pursuant to its paragraph 11 
on the amendment to the TRIPS Agreement. 
1. Information on Implementation and Use of  the System Established Under the Decision 
4. As foreseen in the 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/public_health_e.htm).   To date, there have been no notifications 
made to the Council for TRIPS of the use of the syst em pursuant to paragraphs 1(b), 2(a) and 2(c) of 
the Decision. 
5. The delegation of Canada informed the TRIPS Council at its meeting of 14-15 June 2005 that, 
on 14 May 2004, it had passed legislation amending its  Patent Act and Food an d Drug Act to facilitate 
the export of low-cost pharmaceutical products to co untries in need.  This legislation had come into 
force on 14 May 2005.  Further details of Canada 's implementation can be found in the minutes of 
that meeting (IP/C/M/48, paragraphs 112-120), in Ca nada's notifications pursuant to Article 63.2 of 
the TRIPS Agreement (IP/N/1/CAN/1/Add.2 and IP/N/1/CAN/P/5 to P/7), and in the communication from Canada entitled "Canada's Im plementation of the August 30
th Decision on TRIPS and Public 
Health" (IP/C/W/464). 
6. The delegation of India informed the TRIPS C ouncil at its meeting of 14-15 June 2005 that 
India's Patent Act had been amended in April 2005 to further clarify its legislation to ensure that drugs 
made locally continued to be available at affordable  prices to all citizens in India and other developing 
countries, particularly least-developed countries, in c onformity with the Decision.  Further details of 
India's implementation can be found in the minutes of  that meeting (IP/C/M/48,  paragraph 121) and in 
India's notifications pursuant to Article 63.2 of the TRIPS Agreement (IP/N/1/IND/P/2 to P/5). IP/C/37 
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 7. The delegation of Korea informed the TRIPS Council at its meeting of 14-15 June 2005 that 
Korea had revised its patent law to make it possible to grant compulsory licences for export to eligible 
Members, while also introducing safeguard measures as required by the Decision.  The revised patent 
law had been promulgated on 31 May 2005 and woul d enter into force on 1 December 2005.  The 
Government was in the process of reviewing the rele vant regulations to implement the revised patent 
law (IP/C/M/48, paragraphs 122-123). 
8. The delegations of the European Communiti es, Switzerland and the People's Republic of 
China informed the TRIPS Council at its recent m eetings of preparatory work with respect to 
amendments to their legislation to give effect to the provisions of the Decision. 
9. At the TRIPS Council's meeting of 14-15 June 2005, the delegation of Norway recalled that it 
had put in place a fully operational system in its domestic legislation which had entered into force on 
1 June 2004 (IP/C/M/48, paragra ph 126).  Details of Norway's implementation can be found in the 
document IP/C/W/427, as well as in its notification pursuant to Article 63.2 of the TRIPS Agreement 
(IP/N/1/NOR/1 and 2). 
2. Work on the Preparation of an Amendment to the TRIPS Agreement 
10. The Council continued its work pursuant to paragraph 11 of the "Decision on the 
Implementation of Paragraph 6 of the Doha Declaration on the TRI PS Agreement and Public Health" 
(WT/L/540 and Corr.1) on the preparation of an amendment to the TRIPS Agreement to replace the 
provisions of the waiver Decision. 
11. At its meeting in March 2005, the Council ha d before it communications from the African 
Group entitled "Legal Arguments to Support the A frican Group Proposal on the Implementation of 
Paragraph 11 of the 30 August 2003 Decision" (IP/C/W/440 and Corr.1);  from the delegation of 
Barbados, on behalf of the Gr oup of Commonwealth Developing C ountries, containing a "Report on 
the Workshop on the WTO Decision on Access to Medi cines at Affordable Prices for Countries with 
no or Insufficient Manufacturing Capacities", that wa s organized by the Commonwealth Secretariat in 
cooperation with the ACP Geneva Office and the Ag ency for International Trade Information and 
Cooperation (AITIC) in Geneva from 12 to 14 October 2004 (IP/C/W/439);  and from the United 
States entitled "Comments on Implementation of the August 30, 2003 Agreemen t (Solution) on the 
TRIPS Agreement and Public Hea lth" (IP/C/W/444).  The delegation of Rwanda submitted, on behalf 
of the African Group, a communication on the TR IPS Agreement and public health, containing a 
statement made at the TRIPS Council meeting of 31 March 2005 (IP/C/W/455). 
12. On 9 March 2005, the Council agreed to suspe nd its meeting so as to allow the Chair to 
continue his consultations with a view to mee ting the March 2005 time-frame agreed by the TRIPS 
Council in June 2004.  At the request of some delegations, the Chair reconvened the meeting on 
31 March to provide an opportunity for delegations to make statements on TRIPS and public health.  
The Council agreed that the Chair continue his cons ultations in the period until the General Council 
meeting of 26 May with a view to enabling the Gene ral Council to take action at that time (IPC/M/47, 
paragraph 217).  At that meeting, the Chair of the TRIPS Council reported to the General Council that 
the question of the preparation of an amendment c ontinued to be actively under consideration in the 
TRIPS Council but some more time was necessary befo re the Council was to be in position to make a 
recommendation (WT/GC/M/95, paragraph 104).  IP/C/37 
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 13. At its meeting of 14-15 June 2005, the TRIPS Council agreed that the Chair continue his 
consultations on the preparation of an amendment to the TRIPS Agreement with a view to agreeing 
on a recommendation as soon as possible (IP/C/M/48, paragraph 156).  The Chair informed the General Council of these arrangements at its meetin g of 27 July 2005 (WT/GC/M/97, paragraph 2).  
He reported again to the General Council on hi s further consultations at its meeting of 
19 October 2005 (WT/GC/M/98). IP/C/37 
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ANNEX 
 
EXCERPT FROM THE MINUTES OF THE COUNCIL'S MEETING OF  
25-26 OCTOBER 2005 TO BE CIRCULATED AS IP/C/M/49
1 
   H. 
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 the Decisi on on the Implementation of Paragraph 6 
of the Doha Declaration on the TRIPS Agreement a nd Public Health 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. The representative of Canada  recalled that, at the last TRIPS Council meeting, a Canadian 
expert had outlined Canada's legisl ation and regulations that implem ented the Decision.  Canada was 
distributing a paper that provided a written explan ation of some aspects of the legislation and 
regulations (IP/C/W/464).  This paper outlined sever al issues, such as eligible importers, eligible 
pharmaceutical products, the application process, th e "good faith clause" which implemented aspects 
of the Chairman's statement, anti-diversion measur es, royalties and aspects of termination.  He said 
that the Canadian system was flexible, as the list of eligible products had rece ntly been updated to add 
a fixed-dose combination antiretroviral medication u sed in the treatment of HIV/AIDS.  A special 
review stream had been put in place by the Minister  of Health to expedite  the approval of products 
that came under this system and that had not prev iously been approved for use in Canada.  He drew 
attention, in particular, to the part of the paper th at outlined how a country c ould take advantage of the 
Canadian system.  His delegation was committed to making the system work and would be prepared 
to provide any further information, clarification or  explanation of the Canadian system, including to 
those who wished to take advantage of it. 
3. The representative of the European Communities  informed the TRIPS Council that his 
delegation expected the Council of the European Unio n and the European Parliament to reach soon an 
agreement on the draft regulation proposed by th e European Commission.  This would allow the 
adoption of legislation implementing the Decision prior to the Hong Kong Ministerial Conference. 
4. The representative of Argentina  said that legislation adopted by Members to implement the 
Decision should not prejudice the interpretation and application of the Decision at the national level 
by other Members.  She said that no precedents shou ld be set in the way in which the Decision would 
be required to be implemented.  She recalled that the freedom of WTO Members in Article 1.1 of the 
TRIPS Agreement to determine the appropriate met hod of implementing the provisions of the TRIPS 
Agreement, which included the Doha Declarati on on TRIPS and Public Health and the Decision, 
remained in effect. 
 
                                                      
1 The paragraph numbering of this excerpt will not co rrespond with that of the minutes of the TRIPS 
Council meeting but has been included for the convenience of users.  IP/C/37 
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 5. Turning to the TRIPS Council's report to the Ge neral Council foreseen in paragraph 8 of the 
Decision, the Chairman  said that, in anticipation of this, th e Secretariat had prepared a draft cover 
note to this report modelled on that of last year's  report, which had been circulated as JOB(05)/255.  
The draft cover page contained factual informa tion on the implementation and use of the system 
established under the Decision and on the work on th e preparation of an amendment to the TRIPS 
Agreement pursuant to paragraph 11 of the Decision.  He said that his intention was to attach to the 
cover note the part of the minutes of the meeting reflecting the discussions held under this agenda 
item.  This format would follow the way that the Council prepared its report last year. 
6. The Council so agreed . 
 
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