WORLD TRADE  
ORGANIZATION  IP/C/33 
8 December 2004 
 (04-5393) 
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/54 0) 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 
deemed to fulfil the review requirements of Article IX:4 of the WTO Agreement. 
2. At its meeting of 1-2 December 2004, the Counc il took up the annual review pursuant to this 
paragraph.  The annex to this report records the st atements made in the review.  The paragraphs below 
set out factual information regarding the implementati on of the Decision and the work pursuant to its 
paragraph 11 on the amendment to the TRIPS Agreement. 
Information on use of the system established under the Decision 
 3. As foreseen in the Decision, the Secretaria t has established a page on the WTO website 
dedicated to this Decision, notably to ensure the publ ic availability of notifications made pursuant to it 
(http://www.wto.org/English/tratop_e/pub lic_health_e.htm).  To date th ere 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. 
4. The delegation of Norway informed the TRIPS Council at its meeting of 21 September 2004 
that it had taken steps to implement the Decision by  providing in its legisla tion for the production of 
patented medicines for export under compulsory licen ces with effect from 1 June 2004.  Details of 
Norway's implementation can be found in the docum ent IP/C/W/427 as well as in its notification 
under Article 63.2 TRIPS Agreement (IP/N/1/NOR/1 and 2). 
5. The delegation of Canada informed the TRIPS Council at its meeting of 16 June 2004 that, on 
14 May 2004, it had passed legislation amending its  Patent Act and Food a nd Drug Act to facilitate 
the export of low-cost pharmaceutical products to coun tries in need.  This legislation was to come into 
force with the promulgation of the supporting regulations.  
6. Some other delegations informed the TRIPS Coun cil at its recent meetings of preparatory 
work with respect to amendments to their legislation to give effect to the provisions of the Decision. IP/C/33 
Page 2 
 
 
Work on the preparation of an amendment to the TRIPS Agreement 
7. Paragraph 11 of the Decision provides that this Decision, including the waivers granted in it, 
shall terminate for each Member on the date on  which an amendment to the TRIPS Agreement 
replacing its provisions takes effect for that Member  and that the TRIPS Council shall initiate by the 
end of 2003 work on the preparation of such an am endment with a view to its adoption within six 
months (i.e. by June 2004), on the understanding that the amendment will be based, where 
appropriate, on this Decision and on the further understanding that it will not be part of the 
negotiations referred to in paragraph 45 of the D oha Ministerial Declaration (WT/MIN(01)/DEC/1).   
8. Accordingly, the TRIPS Council took up the matter at its last meeting in 2003 and again at its 
meetings in 2004.  In addition, the Chairs of th e Council have consulted ac tively with delegations.  
These consultations indicated that there remained si gnificant differences among delegations in regard 
to the substantive content and the legal form that an amendment to replace the paragraph 6 Decision 
should have, although many delegations emphasized th at they remained ready to consider alternative 
solutions.  At its meeting of 16 June 2004, the TR IPS Council agreed to c ontinue its work on the 
preparation of the amendment with a view to th e TRIPS Council making a recommendation by the 
end of March 2005 so that the General Council can conclude its work on th e amendment at its first 
meeting thereafter (IP/C/M/44).  The General Counci l was informed of this by the Chair of the TRIPS 
Council at the General Council meeting of 27-28 Ju ly 2004 (WT/GC/M/87).  At the TRIPS Council's 
meeting of 1-2 December 2004, the delegation of Ni geria presented, on behalf of the African Group, a 
proposal on the implementation of paragraph 11 of the Decision (IP/C/W/437).1 
_______________ 
 
                                                      
1 Made available as an advance copy, final document to be circulated.  IP/C/33 
 Page 3 
 
 
ANNEX 
 
Excerpt from the Minutes of the Council's meeting of 1-2 December 2004  
to be circulated as IP/C/M/462 
 
 
J. 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 Decision 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 annually 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  said that his country had pa ssed legislation relating to the 
Decision in May 2004.  The draft regulations to br ing Canada's legislation into effect had been  
published for public record and comment on 2 October 2004.  The 75-day period announced for 
comment would end soon, and he hoped that the regulations and the legislation would come into force 
some time in early 2005. 
3. The representative of Switzerland  said that it was important to hear about Members' national 
implementation of the paragraph 6 Decision.  In th is regard, he recalled that Canada and Norway had 
already announced that they had adopted implementing legislation as exporting countries and that the 
European Communities had provided information on  the preparation of similar legislation.  
Switzerland was preparing, in the context of th e revision of its Patent Law, a proposal on the 
implementation of the paragraph 6 solution.  Switz erland had been confident of initiating this work 
based on the WTO waiver Decision currently in pla ce, without waiting for the outcome of the efforts 
to incorporate it in the TRIPS Agreement, trustin g, however, that these efforts would leave the 
substance of that Decision intact.  All substant ive elements of the Decision would be faithfully 
reflected in this legislation, including effective an d deterrent measures to avoid such pharmaceuticals 
being diverted to other markets for commercial purposes. 
4. Switzerland had opted out of the paragraph 6 solu tion as an importing country, but intended 
to provide the possibility of co mpulsory licensing of patented pharmaceuticals for exportation 
purposes, in order to assist countries without, or with insufficient, manufacturing capacity that needed 
to address a public health problem such as HIV/AIDS , tuberculosis or malaria.  Rather than seeing 
compulsory licensing in the forefront as a solution to improve access to medicines in needy 
developing countries, he believed that negotiations w ith the right holders of patented pharmaceuticals 
needed in these countries promised  a swifter and a more suitable solution to affordable prices.  
Nevertheless, Switzerland had responded to the concerns of Members most interested in the 
paragraph 6 issue by joining the consensus on the paragr aph 6 Decision and was willing to follow suit 
at the national level.  The Swiss delegation was in terested in hearing about national implementation 
efforts also from those Members which had made th e case for the high degree of urgency for this 
solution throughout the negotiation pr ocess at the multilateral level. 
                                                      
2 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/33 
Page 4 
 
 
5. Turning to the TRIPS Council's report to the General Council foreseen in paragraph 8 of the 
Decision, the Chairman  said that, in anticipation of this, the Secretariat had prepared a draft cover 
note to this report which was available outside th e room.  The draft cover page contained factual 
information on the use of the system establishe d under the Decision and on the work on the 
preparation of an amendment to the TRIPS Agreement pursuant to paragraph 11 of the Decision.  He 
suggested that the Council agree on the contents of the draft cover note and that the part of the 
minutes of the meeting reflecting the discussion held under this agenda item be attached to it. 
6. The Council so agreed . 
__________