WORLD TRADE  
ORGANIZATION  IP/C/49 
12 November 2008 
 (08-5476) 
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 fourth annual review took place in Oct ober 2007 and the General Council took note of 
the Council for TRIPS' report (IP/C/46) at its  meeting on 18 December 2007 (WT/GC/M/112, 
paragraph 185).  This report c overs the period since October 2007. 
3. At its meeting of 28 October 2008, the Council t ook 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 and the acceptance of the Protocol 
Amending the TRIPS Agreement. 
1. Information on implementation and use of the system established under the Decision 
4. On 22 August 2008, the delegation of Switzer land notified the Council for TRIPS of the 
consolidated version of its Fede ral Law on Patents for Inventions (IP/N/1/CHE/P/9), which entered 
into force on 1 July 2008.  Article 40 d implements the system established under the 2003 
Decision into Swiss law. 
5. The delegation of Canada informed the C ouncil at its meeting on 13 March 2008 that the 
statutory review of the Canadian Access to Medi cines Regime (CAMR) had been completed in May 
2007, as required by the Patent Act.  A report on the results had been submitted to Parliament in 
December 2007.  It concluded that, while future amendments remained possible, changes were not 
warranted at this time since CAMR had come in to force in May 2005 and more time and evidence 
was needed (IP/C/M/56, paragraphs 108-109). 
6. As regards the use of the system by Rwanda to import a fixed-dose combination medicine for 
the treatment of HIV infection from Canada (see the report on the annual review in 2007, IP/C/46, 
paragraphs 4-5), the delegation of  Canada reported to the Council' s meeting on 17 June 2008 that the 
Canadian generic drug company Apotex had been awarded a tender from the Rwandan Government 
to supply the HIV/AIDS drug "Apo-TriAvir" under CAMR.  A pre-export inspection was conducted 
by Health Canada as part of anti-diversion measu res required under CAMR to confirm the existence 
of distinguishing characters on the products, product containers and product la bels.  Furthermore, IP/C/49 
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  drugs exported under CAMR had to meet the same safety, efficacy and quality standards as those 
approved for sale in Canada.  An expert advisory committee was in the process of being established to 
review the list of medicines eligible for export (IP /C/M/57, paragraphs 127-128).  The delegation of 
Canada informed the Council on 23 October 2008 that the first shipment of the generic medicine 
produced under Canada's Access to Medicines Regime took place on 24 September 2008 and that a 
second shipment was scheduled for 2009 (IP/C/W/526). 
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 Secretar iat has established and regularly updates a page 
on the WTO website dedicated to this Decision, notably to ensure the public availability of 
notifications made pursuant to it (http://www.wt o.org/English/tratop_e /public_health_e.htm). 
2. Decision on the Amendment to the TRIPS Agreement 
9. 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 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. 
10. As of 30 September 2008, 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; 
• China, People's Republic of, 28 November 2007, WT/Let/607;  IP/C/49 
 Page 3 
 
 
  • 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; and  
• Jordan, 6 August 2008,WT/Let/630. 
Information on the status of acceptances of the Prot ocol is periodically up dated in revisions of 
document IP/C/W/490. 
 
                                                      
 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 (TRI PS), 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 Representative                 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/49 
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  ANNEX 
 
EXCERPT FROM THE MINUTES OF THE COUNCIL'S MEETING OF  
28 OCTOBER 2008 TO BE CIRCULATED AS IP/C/M/58
1 
  
H. 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(08)/102).  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 the circ ulation of the draft cover note, Canada had 
provided a communication to the Council informing it th at the first shipment of the generic medicine 
produced under Canada's Access to Medicines Regime (CAMR) had taken place on 24 September 
2008 (IP/C/W/526).  The final version of the co ver note for the Council's report would be updated 
accordingly.   
4. 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, since the Council's meeting in June, Jordan 
had notified its acceptance of the Protocol on 6 August 2008 (document WT/Let/630).  The 
Secretariat had circulated an update to the note on th e 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.3).  He said that 
the Secretariat would continue to update it periodically. 
5. The Chairman recalled that the Protocol woul d enter into force for the Members that had 
accepted it upon acceptance of the Protocol by two thirds of the Members.  It was open for acceptance 
by Members until 31 December 2009 or such later date as may be decided by the Ministerial 
Conference.  He encouraged Members to ensure that the necessary measures were being taken in 
capitals to allow the consideration of the acceptance in a timely fashion. 
6. The representative of Canada
 informed the Council that, following Rwanda's notification to 
the Council in July 2007 regarding its inten tion to import drugs under CAMR, the Canadian 
pharmaceutical company Apotex had been awarded a tender from the Rwandan Government to export 
the triple combination HIV/AIDS drug "ApoTriav ir" in May 2008.  This had occurred after the 
Commissioner of Patents had granted Apotex the fi rst ever compulsory licence under the terms of the 
Decision, as implemented by CAMR.  On 24 Septem ber 2008, Apotex had sent its first shipment of 
lower-cost HIV/AIDS drugs produced under CAMR to  Rwanda.  The representative of Canada said 
that his Government recognized the devastating impa ct of HIV/AIDS and was engaged in a long-term, 
comprehensive approach to fighting the disease.  The first shipment of ApoTriavir was a key 
                                                      
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/49 
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  achievement with regard to access to  medicines in developing countries.  He hoped that this would 
lead to a better understanding of how CAMR could be  used to effectively ad vance this humanitarian 
objective.  While CAMR received continuing support,  he noted that it was only one part of the 
Government's broader response to improving access to medicines in developing countries.  His 
delegation also supported a number of other initiatives to provide medicines and vaccines to countries 
in need.  For example, CAN$450 million had been pledged over the next three years to the Global 
Fund to Fight AIDS, Tuberculosis and Malaria, which facilitated the purchase and delivery of life-
saving medicines to developing countries.  Domestic legislation had also been amended to facilitate 
the transfer of essential medicines to developi ng countries through the Donations of Medicine 
Eligibility Program.  With respect to the draf t report to the General Council (JOB08/102), his 
delegation agreed with the contents and suggested  removing the square brackets currently found in 
paragraph 6 of the draft report. 
7. The representative of India  welcomed the first shipment of HIV/AIDS drugs to Rwanda 
which was a key achievement in the use of the sy stem established under the Decision.  He proposed 
that the Secretariat prepare a compilation of docum ents concerning national implementing legislation 
adopted by WTO Members with a view to facilitati ng the use of the system by those Members with 
insufficient or no manufacturing capacities in the pharmaceutical sector. 
8. The representative of Ecuador  expressed his satisfaction with the first export of medicines 
based on the system established under the Decision.  He  paid tribute to the Canadian Government for 
having taken measures to facilitate the export of  medicines which enabled developing and least 
developed countries with no or limited manufact uring capacities to deal with public health 
emergencies.  However, his dele gation considered the procedures for such exports set up by the 
system as too complex and bureaucratic, seriously reducing the chances to meet the objectives of the 
Decision, i.e. to enhance access to medicines and to protect public health.  This was witnessed by the 
procedures in Canada, which took some three years to achieve the supply of medicines to Rwanda.  
His delegation appealed to Members with manufac turing capacities to implement the system in a 
flexible manner into their national law and to en sure the availability of simple and operational 
procedures.  He informed the Council that his Government was drawing up a programme on access to 
medicines and intended to make full use of the flexib ilities contained in the system, as well as of other 
flexibilities in the TRIPS Agreement, to address the public health needs of its population. 
9. The representative of the European Communities  said that his delegation attached great 
importance to the system established under the Decisi on.  He welcomed the fact that, following the 
notification by Rwanda on its intention to use th e system and Canada's decision to authorize the 
manufacture and export of the drugs concerned under compulsory licence, the first shipment of the 
drugs had left Canada in Sept ember 2008.  The shipment of sev en million doses to Rwanda would 
help save the lives of several thousan d patients.  This was an important step which demonstrated that 
the system worked when it was used.  He recalled that his delegation had adopted Regulation 
816/2006 implementing the Decision in 2006.  This allowed European companies to produce generic 
drugs under compulsory licence for export to countri es facing public health problems.  His delegation 
stood ready to respond to requests from developing countries in need of medicines.  He also encouraged those WTO Members who had not yet accepted the Protocol Amending the TRIPS Agreement to do so as soon as possible.  It was im portant for Members to confirm their commitment 
to this process so that the Protocol c ould enter into force as soon as possible. 
10. The representative of China
 said that the supply of medicines by a generic manufacturer from 
Canada based on the system established under th e Decision set a good example.  His delegation 
attached great importance to the issue of TRIPS and public health.  It had ratified the Protocol 
Amending the TRIPS Agreement in 2007 and had launc hed the process of amending relevant national 
laws and regulations to implement the Protocol in 2008.  The results would be notified to the Council 
after completion of this process.  His delegation welcomed the notification of national implementing IP/C/49 
Page 6  
 
  legislation by some Members.  He encouraged  those Members who had already amended their 
national laws to make presentations to the Counc il with a view to setting out their implementing 
measures, as well as any problems they had enc ountered and the way in which those had been 
addressed.  This information was important for many developing country Members potentially facing some technical difficulties in amending their national laws and regulations. 
11. The representative of Switzerland
 welcomed the first use of th e system established under the 
Decision by a developing country and commended Rwa nda for doing so.  As referred to in the draft 
report, his delegation had notified the Council of the entry into force of its revised Federal Law on 
Patents for Inventions on 1 July 2008.  Its Article 40 d provided for the possibility of granting a 
compulsory licence for export purposes in accordance with the draft Article 31 bis of the TRIPS 
Agreement.  Through the implementation of the sy stem into national law, his delegation had made 
available its manufacturing capacities in the pharmaceu tical sector to developing and least developed 
countries facing a situation which was intended to be addressed by the system and enabling them to 
make use of the new flexibility introduced in the TRIPS Agreement.  For more detailed information, 
he referred Members to the revised law as notifie d to the Council (IP/N/1/CHE/P/9).  As regards 
China's proposal to invite Members to present thei r implementing legislation to the Council, he said 
that his delegation stood ready to do so in a future meeting.  He supported India's proposal to compile national legislation implementing the system which could serve as a reference tool for Members intending to make use of the system. 
12. He said that his delegation was concerned about  the status of acceptances of the Protocol 
Amending the TRIPS Agreement.  The Secretariat' s revised note showed that only 18 Members had 
accepted it so far whereas more than 100 acceptances  were needed for the amendment of the TRIPS 
Agreement to enter into force.  He encouraged WTO Members who had not yet ratified the Protocol 
to expedite national procedures so that the amendment could enter into force by the end of 2009.  This 
would also provide a safe legal basis in the TRI PS Agreement for those Members who had already put 
in place implementing legislation or were in the process of doing so. 
13. The Chairman
 proposed that the Council agree to the cover note to the report, as contained in 
JOB(08)/102 and updated concerning  Canada's latest communication, and also that the Council 
minutes containing the record of the discussion be attached to it. 
14. The Council took note  of the statements made and agreed  to proceed as suggested by the 
Chair. 
__________