WORLD TRADE  
ORGANIZATION  IP/C/42 
2 November 2006 
 
 (06-5279) 
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 second annual review took place in Octobe r 2005 and the General Council took note of 
the Council for TRIPS' report (IP/C/37) at its meeting on 1-2 December 2005 (WT/GC/M/100, 
para. 95).  This report covers the period since October 2005. 
3. At its meeting of 25-26 October 2006, 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 2003  Decision, the work pursuant to its paragraph 11 
on the amendment to the TRIPS Agreement and the Decision on an Amendment to the 
TRIPS Agreement. 
Information on implementation and use of the system established under the Decision 
 
4. 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/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 the European Communities informed the TRIPS Council at its meeting 
of 14-15 June 2006 that it had adopted Regulatio n 816/2006 on compulsory licensing of patents 
relating to the manufacture of pharmaceutical produc ts for export to countries with public health 
problems.  The Regulation had been published in the Official Journal of the European Union 
on 9 June 2006 and would enter into force on 29 June 2006.   It said that this created the legal basis for 
the granting of compulsory licenses for export pur poses, in line with the WTO General Council 
Decisions of 30 August 2003 and 6 December 2005.  Further details of the European Communities' 
implementing legislation can be found in the minutes of that meeting (IP/C/M/51, paras. 5-6) and in 
the European Communities' notification pursuant to Article 63.2 of the TRIPS Agreement 
(IP/N/1/EEC/P/5). 
 IP/C/42 
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  Decision on the Amendment to the TRIPS Agreement 
6. Pursuant to paragraph 11 of the 2003 Decisi on, in autumn 2005 the Council continued its 
work on the amendment to the TRIPS Agreement to re place the provisions of the waiver Decision.  At 
the meeting of the Council for TRIPS on 6 December 2005, the Council agreed to submit, in accordance with Article X:1 of the WTO Agreement,  a proposal for a decision on an amendment to 
the TRIPS Agreement (IP/C/41) to the General C ouncil, attached to which was a proposal for a 
Protocol Amending the TRIPS Agreement.  Along w ith the draft decision, the Council also approved 
the forwarding of the text of a "Chairman's statemen t" (JOB(05)/319 and Corr.1), as well as the text of 
a "Chairman's statement concerning paragraph 4 of Article 31 bis of the proposed amendment to the 
TRIPS Agreement" (JOB(05)/320), both to be made  by the Chair of the General Council prior to the 
adoption by the General Council of the proposal. 
7. At the meeting of the General Council on 6 D ecember, the Chair of the Council for TRIPS 
informed Members of the recommendation of the Council for TRIPS for action by the General Council.  The Chair of the General Council made the statement forwarded by the Council for 
TRIPS in document JOB(05)/320 and then read out the Chairman's statement forwarded by the 
Council for TRIPS in document JOB (05)/319 and Corr.1.  The Chair then proposed that the 
General Council take note of the statements and, in the light of the Chairman's statement, adopt the 
draft Decision in document IP/C/41 (subsequently circulated in document WT/L/641).  The General Council so agreed.  It also agreed th at the statements made after the adoption of 
the 2003 Decision were to be considered as reaffirmed by the Members concerned. 
8. Pursuant to paragraphs 1 and 2 of the Ge neral Council's Decision of 6 December 2005 
(WT/L/641), the Protocol Amending the TRIPS Agre ement attached to it has been submitted to 
Members and is open for acceptance until 1 December 2007 or such later date as may be decided by 
the Ministerial Conference.  In accordance with Artic le X:3 of the WTO Agreement, the Protocol will 
enter into force upon acceptance by two thirds of the WTO Members. 
9. The following Members have notified the acceptance of the Protocol Amending the 
TRIPS Agreement: 
• United States, 17 December 2005, WT/Let/506, 
• Switzerland, 13 September 2006, WT/Let/547, and 
• El Salvador, 19 September 2006, WT/Let/548.  IP/C/42 
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  ANNEX 
 
EXCERPT FROM THE MINUTES OF THE COUNCIL'S MEETING OF  
25-26 OCTOBER 2006 TO BE CIRCULATED AS IP/C/M/521 
 
 
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 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. He said that the Secretariat had prepared a draft cover note to the Council's report modelled 
on that of last year's report, which had been ci rculated as JOB(06)/244.  The draft cover page 
contained factual information on the implementa tion and use of the system established 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 proposed that the part of the minutes of the meeting reflecting the 
discussions held under this agenda item be attached to the cover note.  This format would follow the 
way that the Council prepared its report last year. 
3. As regards the status of acceptances of the Protocol Amending the TRIPS Agreement that 
was done at Geneva on 6 December 2005, he said th at Switzerland and El Salvador had notified, 
respectively, their acceptance of the Protocol on  13 and 19 September 2006 (documents WT/Let/547 
and 548).  He also recalled that the United Stat es had notified its acceptance on 17 December 2005.  
Therefore, to date, three Members had accepted the Protocol, which would enter into force for these 
Members upon acceptance of the Protocol by two thirds of the Members. 
4. The Chairman recalled that the Protocol  was open for acceptance by Members until 
1 December 2007 or such later date as may be decide d by the Ministerial Conference.  As this date 
was only a little over a year away, he encouraged Members to ensure that necessary measures were 
being taken in capitals to allow the consideration of  the acceptance in a timely fashion.  With a view 
to regularly updating the Council on the state of play  in regard to acceptances, he suggested that the 
Secretariat be requested to prepare a note setti ng out the status of acceptances, which would be 
updated for each meeting of the Council. 
5. The representative of El Salvador  considered that the Protocol represented a triumph in the 
WTO negotiations on public hea lth, which was unprecedented and highl y beneficial for developing 
countries and least-developed countries.  The Decision adopted in December 2005 would establish 
additional flexibilities under the TRIPS Agreement as it related to public health.  Countries with no or 
insufficient domestic manufacturing capacities would have the right to import patented medicines 
produced abroad by making use of compulsory li cences under the paragraph 6 system.  This already 
formed an integral part of her country's intellect ual property legislation.  The system would make it 
possible for a country with manufacturing and export capacities to authorize the use of a compulsory licence to permit the production of medicines for expor t to countries in need of such medicines which 
have no or insufficient supply capacity. 
                                                     
 
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/42 
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  6. The representative of Canada
 updated Members on the Canadian Access to Medicine Regime, 
which had come into effect on 14 May 2005.  He r delegation was committed to ensuring that the 
regime was effective, responsive, transparent and accessible to countries that had an interest in using 
it in their efforts to combat HIV/AIDS, tuberculos is, malaria and other epidemics.  In August 2006, 
Canada's Minister of Health had announced an immediate and comprehensive review of the Access to 
Medicine Regime in consultation with stakeholders .  The review had been built into the legislation 
because Canada was one of the first WTO Member s to implement the August 2003 Decision and had 
had to address many key legal and policy issues fo r the first time.  The review would provide an 
opportunity to identify ways in which a regime c ould better meet its human itarian objectives without 
derogating from international trade obligations and to compare the Canadian legislation with that of 
other WTO Members which had now implemented the Decision. 
7. She recalled that, under the Access to Medicine Regime, Canada had started with an initial 
list of drugs recognized by the WHO as being essen tial to the health needs of citizens around the 
world.  The list would minimize the discretion of Canada's Commissioner of Patents in deciding 
whether to issue a compulsory licence and could be  amended to reflect the evolving public health 
needs of developing and least-developed countries.  It had already been amended twice.  The first 
amendment was in response to a request from a non- governmental organization and a Canadian drug 
manufacturer to add a fixed-dose co mbination HIV/AIDS therapy.  It had passed Health Canada's 
regulatory review and was now listed on the WHO's pr equalification list.  Also at the request of a 
local manufacturer and a non-governmental or ganization, the second amendment had added 
Osteltamivir, an antiretroviral drug for the preven tion and treatment of the influenza virus.  The 
system was in place and the fixed-dose combination HI V/AIDS therapy was available.  All that would 
remain was for an eligible importing country to request it.   
8. To provide information on the regime, her government had developed a CD-Rom that 
explained the system, the procedures and the documentation.  The same information was also available at a special website created for th e Access to Medicines Regime (www.camr.gc.ca).  
Canada's experts stood to provide further information.   If potential users did not find the regime to be 
a feasible option, or did not consider it to be the right choice, her dele gation would welcome their 
feedback.  Her delegation would keep Members inform ed of the results of the domestic review, which 
was due to be completed by May 2007.    
9. The representative of Benin, speak ing on behalf of the African Group
, said that the 
implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health 
was of vital importance for the African Group, a nd particularly for the least developed countries 
belonging to that group.  The process under way fo r the amendment of the Agreement would enable 
countries having insufficient or no capacities for the production of medicines to benefit from 
flexibilities in the form of licences to be grante d by WTO Members possessing infrastructure for the 
production of medicines for export to countries la cking such capacities.  African countries would 
work with their trading partners to implement the Decision. 
10. The representative of Switzerland  agreed with the Chairman that Members should be 
encouraged to proceed swiftly to  the acceptance of the Protocol Amending the TRIPS Agreement. 
11. The representative of Kenya  said that his delegation was in the process of depositing its 
instrument of acceptance of the Protocol.  His delegation was seeking assistance from the 
Commonwealth Secretariat to implement the Decision. 
12. The representative of the European Communities  informed the Council that his delegation 
was in the process of accepting the Protocol.  IP/C/42 
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  13. The Council agreed on the draft cover note to the report and that the record of the discussion 
be attached to it, and that the Secretariat be requ ested to prepare a note on the status of acceptances of 
the Protocol Amending the TRIPS Agreement, wh ich would be updated for each meeting of the 
Council. 
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