RESTRICTED  WORLD TRADE  
ORGANIZATION  IP/C/M/61 
12 February 2010 
 (10-0792) 
Council for Trade-Related Aspects 
of Intellectual Property Rights  
 
 
 
MINUTES OF MEETING 
 
Held in the Centre William Rappard  on 27-28 October and 6 November 2009  
 
Chairperson:  Ambassador Karen Tan (Singapore) 
 
  The present document contains the record of the discussion which took place during the 
TRIPS Council meeting held on 27 -28 October and 6 November 2009. 
 
Subjects discussed
 Page nos.  
 
A. NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT .........................................................2  
B. REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION ..............................................................2  
C. TRANSITIONAL REVIEW UNDER SECTION 18 OF THE PROTOCOL ON THE ACCESSION OF THE 
PEOPLE 'S REPUBLIC OF CHINA ....................................................................................................4  
D. REVIEW OF THE PROVISIONS OF ARTICLE 27.3( B)....................................................................13  
E. RELATIONSHIP BETWEEN THE TRIPS  AGREEMENT AND THE CONVENTION ON BIOLOGICAL 
DIVERSITY ............................................................................................................................... ..13 
F. PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE .................................................13  
G. REVIEW UNDER PARAGRAPH  8 OF THE DECISION ON THE IMPLEMENTATION OF 
PARAGRAPH  6 OF THE DOHA DECLARATION ON THE TRIPS  AGREEMENT AND PUBLIC 
HEALTH ............................................................................................................................... ......22  
H. NON-VIOLATION AND SITUATION COMPLAINTS ......................................................................28  
I. REVIEW OF THE IMPLEMENTATION OF THE AGREEMENT UNDER ARTICLE 71.1 ......................31  
J. REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON GEOGRAPHICAL 
INDICATIONS UNDER ARTICLE 24.2 ..........................................................................................31  
K. SEVENTH ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE DECISION ON THE 
IMPLEMENTATION OF ARTICLE 66.2  OF THE TRIPS  AGREEMENT ............................................31  
L. TECHNICAL COOPERATION AND CAPACITY BUILDING .............................................................34  
M. LETTER FROM THE CHAIR OF THE GENERAL COUNCIL CONCERNING WAYS TO IMPROVE THE 
TIMELINESS AND COMPLETENESS OF NOTIFICATIONS AND OTHER INFORMATION FLOWS .....40  
N. INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO...............................44  
O. OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS ...............44  
P. ANNUAL REPORT ......................................................................................................................46  
Q. OTHER BUSINESS ......................................................................................................................47 IP/C/M/61 
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  A. N
OTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT  
1. The Chairperson  said that, since its meeting in June 2009, the Council had received a number 
of supplements and updates to ear lier notifications of laws and re gulations notified under Article 63.2 
of the Agreement.  Nicaragua had notified a d ecree approving its accession to the Trademark Law 
Treaty, which had entered into force with respect  to it on 22 September 2009;  Chile had notified 
various main dedicated intellectual property laws and regulations and othe r laws;  the European 
Communities1 had notified three regulations, one on the de finition, description, presentation, labelling 
and the protection of geographical indications of sp irit drinks, another on the common organization of 
the market in wine, and a third laying down certain  detailed rules for the implementation of the latter 
regulation as regards protected designations of orig in and geographical indica tions, traditional terms, 
labelling and presentation of certain wine sector pr oducts;  and Tunisia ha d notified a law amending 
and supplementing its law on literary and artistic property.  These notifications were being circulated 
in the IP/N/1/- series of documents. 
2. She urged those Members whose initial notifi cations remained incomplete to submit the 
outstanding material without delay.  She also re minded other Members of their obligation to notify 
any subsequent amendments of their laws and regulations without de lay after their entry into force.  In 
particular, she reminded those Members who had made  any changes to their laws and/or regulations 
to implement the Decision on the TRIPS Agreement and Public Health and who had not yet notified 
such changes to the Council to do so. 
3. As regards notifications of contact points unde r Article 69 for the exchange of information 
and cooperation on trade in infringing goods, she said that, since the Council's meeting in June, an 
update to a contact point notified earlier had been re ceived from Pakistan.  This notification was being 
circulated in an addendum to document IP/N/3/Rev.10. 
4. The Council took note  of the information provided. 
B. REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION  
(i) Review of legislation of Tonga 
5. The Chairperson  recalled that, at its meeting in Marc h 2009, the Council had agreed to review 
the legislation of Tonga, a newly acceded Member, at  the present meeting.  Tonga's notification of its 
TRIPS laws and regulations had been circulated in document IP/N/1/TON/1, and the texts of the 
notified laws in the relevant law series of docum ents.  Tonga had received questions from the United 
States and Japan, which had been circulated in documents IP/C/W/531 and 532, respectively.  Its 
responses to the questions from the United States and Japan had been circulated in documents 
IP/C/W/533 and 534, respectively. 
6. The representative of Tonga  said that, during Tonga's accession process, Tonga had made an 
extensive presentation on its legislation and committed  to an action plan to put in place the necessary 
legislation to make its intellectual property system  fully compliant with the TRIPS Agreement.  The 
main instruments of this system included the followi ng:  (a) the Industrial Property Act 1994 and later 
amendments which provided protection for patent s and trademarks, and the amendments which 
ensured the compliance with WTO commitments a nd TRIPS-plus provisions including compulsory 
                                                      
1 On 1 December 2009, the Tr eaty of Lisbon amending the Treaty on European Union and the Treaty 
establishing the European Community  (done at Lisbon, 13 December 2007) entered into force.  On 
29 November 2009, the WTO received a Verbal Note (WT/L/779) from the Council of the Eu ropean Union and 
the Commission of the European Communities stating that, by virtue of the Treaty of Lisbon , as of 
1 December 2009, the European Union replaces and succeeds the European Community.  IP/C/M/61 
 Page 3 
 
 
  licensing, parallel importing and da ta exclusivity;  (b) the Copyright Act 2002 which had been in 
force since July 2002 and included comprehensive provisions on copyright;  (c) the Protection of 
Geographical Indications Act 2002 wh ich had entered into force in September 2002 and provided for 
a system of protection of geographical indications that was uncomplicated and complied with international obligations in the fiel d of intellectual property;  draft re gulations were currently with the 
Crown Law and needed to be redrafted according to  drafting protocols and drafting instructions;  
(d) the Protection of Layout-Designs (Topography) of  Integrated Circuits Act 2002 which provided 
protection for original layout-designs or topography of  integrated circuits and had been in force since 
September 2002;  (e) the Protection against Unfair  Competition Act 2002 which had been in force 
since September 2002;  this Act provided protec tion against acts or practices deemed as unfair 
competition under agreements and the said Act;  a nd (f) regarding civil judicial procedures and 
remedies, the Supreme Court Rules 2007 made pur suant to section 6 of the Supreme Court Act 
(Cap. 10) which governed judicial proceedings and prescribed modalities for civil proceedings in the 
superior courts. 
7. He said that, despite the efforts and the pr ogress achieved so far in bringing Tonga's 
intellectual property regime into full complianc e with the TRIPS Agreement and international 
standards, some intellectual property laws were still outstanding due to domestic events which had 
shifted priority to other more pressing legislative requirements.  Two bills were awaiting adoption.  
One was the Enforcement and Bord er Measures Bill providing remedies for infringements of rights 
under existing intellectual property laws.  This w as essential to ensure full compliance with the 
minimum standard set out in the TRIPS Agreement.  The other was the Plant Variety Protection Bill 
seeking to protect plant varieties, which had been drafted with the technical support of UPOV.  The 
Bill would go through a process of public consultati on before being discussed at the next session of 
Tonga's legislative assembly. 
8. He said that Tonga would continue its efforts to  bring its intellectual property regime into full 
compliance
 with WTO rules.  He expressed his gra titude to WTO Members who had provided 
technical support at various levels, especially Austra lia and New Zealand.  He also thanked Japan and 
the United States for their questions. 
9. The representative of Japan  appreciated Tonga's commitment to the review of its national 
implementing legislation and its great efforts to resp ond to his delegation's questions.  He said that the 
updates on the provisions contained in the proposed  Industrial Property Amendment Bill 2009 seemed 
very relevant.  While he did not have any follow-up questions, he wished to reserve the right to revert 
to the issue if necessary, for instance dependi ng on the outcome of the said amendment process.  
10. The Chairperson  proposed that the review of the legislation of Tonga be deleted from the 
agenda, it being understood that an y delegation should feel free to re vert to any matter stemming from 
it at any time. 
11. The Council took note  of the statements made and so agreed . 
(ii) Follow-up to reviews already undertaken 
12. The Chairperson  said that, as regards the reviews of national implementing legislation that 
had been initiated at the Council's meetings sinc e April 2001, there were five reviews that still 
remained on the Council's agenda.  These reviews con cerned Cuba;  Fiji;  Grenada;  Saint Kitts and 
Nevis;  and Suriname.  She urged the delegations concerned to provide the outstanding material as 
soon as possible, so as to allow the Council to complete the follow-up to these reviews. 
13. The Council took note  of the information provided and agreed  to revert to the matter at its 
next meeting. IP/C/M/61 
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  C. T
RANSITIONAL REVIEW UNDER SECTION 18 OF THE PROTOCOL ON THE ACCESSION OF THE 
PEOPLE 'S REPUBLIC OF CHINA  
14. The Chairperson  recalled that section 18 of China's Protocol on Accession required the TRIPS 
Council to review the implementation by China of  the TRIPS Agreement each year for eight years 
and report the results of such review promptly to  the General Council.  She further recalled that 
section 18 required China to provide relevant info rmation, including information specified in 
Annex 1A, to the TRIPS Council in advance of th e review.  She informed the Council that the 
information submitted by China pursuant to that  requirement, dated 21 October 2009, had been 
circulated as document IP/C/W/542.  Questions a nd comments in connection with the transitional 
review had been submitted by Japan, the Un ited States and the European Communities 
(documents IP/C/W/537, 538 and 540, respectively). 
15. The representative of the European Communities  said that his delegation welcomed the 
progress in the area of intellectual property rights ma de by China since last year and took note of the 
many ongoing initiatives of which he underline in pa rticular The Action Plan for IP protection for 
2009;  the implementation of the National IP Strategy ;  the entry into force of the new patent law 
which took place in October 2009;  the revision of th e trademark law;  and the announced revision of 
the copyright law.  However, despite these positive de velopments and China's real efforts to address 
problems, his delegation remained concerned by the high level of counterfeiting and piracy in China.  
Although European customs seizures of counterfe it products coming from China had seen a certain 
decrease, China remained the main source of infri nging goods with 54 per cent of infringing articles 
seized at EC borders coming from there.  Euro pean companies continued to face serious IPR 
problems in China, particularly the lack of proper access to the judicial or administrative enforcement 
systems because of cumbersome notarization and legalization require ments which are unknown 
anywhere else in the world. 
16. In addition, criminal prosecution remained in effective, sanctions against infringers were 
insufficient to deter them, and administrative enfo rcement procedures were subject to discretion in 
many areas without any possibility of controlling why action was or was not taken.  Civil procedures 
against infringing activities also remained expensive,  time-consuming, and difficult to obtain.  This 
situation was reflected in the last EC intellectua l property rights survey which had been published 
recently. 
17. The EC was also concerned about certain offici al statements and internal notices in China 
which linked the financial crisis with a lowering of effective IP enforcement, as his delegation did not 
see a logical connection between the two concepts.  To encourage China to actively pursue its efforts 
towards an effective IPR enforcement system, hi s delegation was committed to continue working 
bilaterally with China, particularly through the world's largest technical cooperation programme on 
intellectual property, IPR2. 
18. The European Communities' cooperation with Ch ina was based on a structured dialogue on 
intellectual property as well as the EU-China inte llectual property working group which included 
participation of industry and which had held its sixth session in Beijing in September 2009.  The EU 
and China had also recently agreed on a cust oms action plan specifically dedicated to IPR 
enforcement.  Finally, he said, the European O ffice for Community Trademarks and Designs and its 
Chinese partners had concluded two memoranda of  understanding promoting the cooperation in the 
fields of trademarks and designs.  He hoped that this cooperative approach with China would lead to 
concrete and tangible results in further im proving the IPR situation in this country. 
19. His delegation had submitted thirty questions c overing a wide range of IPR issues, including 
patents, technology transfer, the protection of co nfidential data, trademarks, copyrights, including 
online piracy, plant variety protection and compet ition rules.  It had also asked questions on  IP/C/M/61 
 Page 5 
 
 
  enforcement, including the involvement of right holders in legal proceedings, on customs measures 
and on these notarization and legalization requirement s.  He looked forward to receiving the answers 
to these questions from China. 
20. The representative of the United States  said that for her delegation the transitional review 
mechanism continued to be a usef ul mechanism that helped to pr ovide additional transparency for 
China's trade regime and allowed Members to better understand and assess China's progress in 
implementing and complying with its WTO obligati ons.  Turning to his delegation's submission 
before the Council, she noted that the United States appreciated the importance China attached to the 
protection of intellectual property rights and th e active steps that it had taken to improve IPR 
enforcement and protection, including a vigorous enforcement campaign during last year's Olympics 
as well as notable prosecutions of large software piracy operations. 
21. At the same time, the United States remained concerned about several aspects of China's 
regime for the protection and enforcement of intelle ctual property rights, in particular about reports 
that Chinese officials, especially at the provincial and local level, had been urging a more lenient 
enforcement of IPR laws in light of the global fi nancial crisis.  Her dele gation believed that the 
current situation called for a strengthened approach to IPR protection and enforcement in China, in 
order to grow and sustain a more robust and innovative economy in the longer term.  It was critically 
important that China and other WTO Members main tained regimes that respected all intellectual 
property rights regardless of national origin.  While  she understood the importance that China placed 
on promoting its domestic industries through indigenous innovation po lices, her delegation 
encouraged China to ensure that  these polices did not undermine the rights of non-Chinese owners of 
intellectual property rights or otherwise ran afoul of WTO rules.  The United States also continued to 
see evidence of unacceptable levels of IPR infringement , particularly in the numbers of Chinese goods 
seized at US borders.  Mid-year statistics for 2008 sh owed that China remained the source of the vast 
majority of infringing goods seized at US borders, accounting for 81 per cent of seizures by value, and 
it was troubling that the seizure of Chinese goods had been increasing, not d ecreasing, each year since 
China had joined the WTO in 2001. 
22. Exports of counterfeit and pira ted goods, however, were only part of the problem.  United 
States industries continued to report high rates of in fringement within China.  More work was needed 
to address growing challenges involving internet co unterfeiting and piracy in China, such as offering 
infringing products for sale to businesses and consumer s or deep linking to infringing files.  At the 
same time, the problem of physical counterfeiting an d piracy in China continued and was widespread 
as illustrated by the continuing operation of larg e wholesale and retail markets for counterfeit and 
pirated goods in a number of jurisdictions in Chin a.  The range of industry sectors affected by 
infringement within China was quite broad, in cluding, among many others, pharmaceuticals, 
electronics, batteries, auto parts, industrial equipm ent, toys, and musical instruments.  The United 
States was further concerned because many of the counterfeit products made in China continued to 
pose a direct threat to the health and safety of c onsumers not only in China, but in the United States 
and elsewhere around the world. 
23. In conclusion, her delegation looked forward to receiving China's responses to its questions, 
and to continuing to engage bilaterally with China on a wide range of IPR issues.  The United States 
appreciated the cooperative spirit in which the tw o countries had intensified IPR discussions under the 
Joint Commission on Commerce and Trade and other b ilateral mechanisms, and continued to believe 
that deeper multilateral and bilateral dialogue and cooperation would provide an important path to 
progress. 
24. The representative of Japan  said that his delegation appreciat ed China's efforts to address the 
intellectual property problem in China, including deve loping its patent, trademark and copyright laws.  
However, counterfeiting remained a big problem as a large number of Japanese companies continued IP/C/M/61 
Page 6  
 
  to face counterfeit problems in China.  One problem was that the equipment of former counterfeiters 
could easily be reused to produce counterfeit goods , because the equipment w as not destroyed after 
seizure of the goods and enforcement in China th erefore remained ineffective.  His delegation 
therefore requested that China enhance the seizure,  forfeiture and destruction not only of infringing 
goods but also of materials and implements predom inantly used in infringement.  Furthermore, his 
delegation requested China to provide sufficiently  deterrent measures by enhancing administrative 
action against counterfeiting, as Japa nese companies were bearing a high burden of investigation costs 
in administrative actions.  Japan also requested  the Chinese Government to upgrade its rules and 
regulations to better address the current situation, and to establish an adequate system to enhance 
copyright protection and enforcement.  In this cont ext his delegation welcomed that more expeditious 
and effective judicial reviews would be conducted by the Intellectual Property Tribunal referred to in 
the Regulation regarding Allocation of Judicial Re views of Administrative Decisions on Intellectual 
Property Cases including Patents and Trademarks , issued on 22 June 2009 by China's Supreme 
People's Court.  Japan looked forward to China's efforts to enhance intellectual property right protection in general and take further steps to provide effective enforcement against any act or 
infringement of intellectual property rights in China. 
25. The representative of China
 said that while his delegation welc omed the continuous interest in 
China's IPR situation and had listened carefully to the questions posed by the three Members, he was 
disappointed that the interventions this year did not  differ very much from the ones in the past seven 
years, apart from the figures cited.  His delegation had already stated at past debates that it had strong doubts about the credibility of these figures and their ability to reflect the real situation.  In particular, 
the recent interventions by other developing count ry Members regarding the confusion of generic 
medicines and counterfeit medicines in some c ountries, and customs officials without enough IP 
expertise and without sufficient support by their IP experts cast further doubt on the reliability of 
customs figures.  His delegation remained ready to  further discuss these issues both bilaterally and 
multilaterally. 
26. He also rejected some Members' assertions that China was trying to lower protection for IP 
because of the financial crisis.  He said that he ha d never heard anything like the statements or notices 
the European Communities had refe rred to, neither from his superiors nor from provincial capitals, 
and he questioned by what intelligence any internal notices may have been obtained by Members.  His 
delegation requested that the European Communiti es substantiate this assertion by sharing any 
documents, if that was not against their rules. 
27. During the past twenty years China had done a lo t to improve its IP protection, not purely in 
response to external pressures, but as a natural response to China's intern al needs, in which IP 
protection figured as essential and extremely important for building an innovative society.  At the same time, China remained open to  listen and help other Members to resolve any problems they might 
have in China.  Regarding assertions that comp anies had serious problems regarding expensive and 
time-consuming civil procedures, he encouraged  Members to share more detailed substantial 
information about these concerns with his delegation,  so that the issue could be addressed through the 
bilateral and multilateral channels.  However, his delegation could not  respond to assertions that were 
not substantiated. 
28. Another representative of China said that he woul d respond to the questions and concerns that 
had been raised under the TRIPS Transitional Review  Mechanism.  Regarding revisions to laws and 
regulations in the field of intellectual property ri ghts in China, law enforcement measures and related 
statistics, he encouraged Members to refer to the information submitted by China under Annex 1A.  
As for the information not cove red by Annex 1A, he referred Me mbers to updates on the website 
http://www.gov.cn/
 and the websites of the relevant governme nt authorities.  His remaining responses 
to Members' questions and c oncerns would be grouped under the following four headings:   IP/C/M/61 
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  Part I:  Patents and related questions;  Part II:  Trademarks and ge ographical indications;  
Part III:  Copyrights and related ques tions;  and Part IV:  Enforcement.  
Part I:  Patents and related questions: 
 
29. Regarding the examination and approval of assigni ng a patent or a patent application right to 
a foreign country, the relevant procedures were provi ded for in Article 10 of China's Patent Law on 
technology export, which had been formulated in acc ordance with the requirements of the Regulations 
on Technology Import and Export Administration of the People's Republic of China.  He said that the 
present revision would cause no substantive change in these procedures as the revisions were confined 
to wording, aimed at achieving a more accurate expression of the provision. 
30. Regarding the confidentiality examination on filin g a patent application in a foreign country, 
he said that the revised Detailed Implementation Rules of the Patent Law and the Guidelines for 
Examination would specify the meaning of "the i nvention or utility model completed in China".  
According to Article 20(4), if a patent application for an invention or a utility model was filed in a 
foreign country in violation of th e provision of paragraph 1 of this Article, no patent would be granted 
if a patent application was subsequently filed in  China.  The provision provided a ground for rejecting 
a patent application or declaring a patent invalid.  Regarding compulsory licences, the revised Article 48(1) should be interprete d as imposing stricter conditions on the granting of a compulsory 
licence than before the revision, and would theref ore reduce the possibility of issuing a compulsory 
licence.  He said that the EC's understanding in this  regard was not correct, as there was no stipulation 
for a so-called automatic compulsory licence in China' s Patent Law.  The "public interest request", as 
was mentioned in Article 49 of China's Patent Law,  was in conformity with the meaning of "in cases 
of public non-commercial use" mentioned in Article 31 of the TRIPS Agreement. 
31. The counterplea system concerning existing tec hnology had been established under Article 62 
of the revised Patent Law.  It meant that, in a pa tent infringement dispute, if the accused infringer had 
evidence to prove that the technology or design he exploited was an existing technology or design, no 
patent infringement would be found.  An accu sed infringer could therefore settle a burdensome 
dispute over patent rights without having to launc h a counterplea or initiating a complex invalidation 
procedure.  The patent right assessment report system  for the utility model or  design patent had been 
established in the second paragraph of Article 61 of the revised Patent Law.  According to this system, 
the People's Court or the patent administrative aut hority could require the patentee or the interested 
parties to present a patent assessme nt report in an infringement di spute involving a utility model or 
design patent.  Such a report would assess whether the patent right met the s ubstantive conditions for 
granting the patent right, which would effectively prevent the right holder from abusing his rights. 
32. With regard to the extension of the term of protection of patent rights, China's Patent Law 
stipulated the term of patent right protection for inve ntions to be twenty years, and the term of patent 
right protection for utility models and designs to be  ten years.  The patent rights terminated upon the 
expiration of its term and there was no extension of the term of protection for drugs and plant 
products. 
33. As to the term of protection for test data, he said that Article 35 of the Provisions for 
Implementation of the PRC Law for Drug Control stipul ated that "the State protects experimental data 
and other data that is self-obtained, undisclosed  and submitted by the manufacturer or seller who 
obtains the licence of manufacturing or selling the drug containing the new type of chemical 
composition.  Nobody should put such undisclosed e xperimental data and ot her data into improper 
commercial use."  Within a period of six years from the day when the manufacturer or seller obtained 
a licence for manufacturing or selling the drug containing a new chemical composition, the drug supervision and administration authorities would not grant a licence for manufacturing or selling that drug to other applicants who applied for the licence by using the same data without the consent of the IP/C/M/61 
Page 8  
 
  applicant who had obtained a licence.  This did not apply in cases where the other applicants had 
submitted their own self-obtained data. 
Part II:  Trademarks and Geographical Indications 
 
34. With respect to the length of trademark exam ination, he said that following the annual 
increase in registered trademarks the number of trad emarks examined this year by China's trademark 
authorities had reached one million on 15 Septembe r 2009.  China had adopted various means to 
improve the efficiency of trademark examination.  In 2009, the time length of trademark examination 
was shortened from 30 months to 19 months. 
35. In 2008, the State Administration of Industry and Commerce (SAIC) had received 
17,518 trademark oppositions, of which 10,993 were concluded.  He said that, at present, the delay for 
rulings on trademark oppositions was about 30 months.  As for the cases of re-examining rejected 
trademark applications, cases that had been submitted in  June 2009 were now being heard so that the 
time from lodging an opposition to the substantive handling of the case was four months.  With regard to cases of re-examining trademark oppositions, cance lling re-examinations, or trademark disputes, 
cases filed at the end of 2006 were now being h eard, so that the time from lodging a trademark 
opposition to the substantive handling of such a cas e was 34 months.  According to the rules and 
practices of the Trademark Review and Adjudication Board, the time from the initiation of substantive 
handling to the ruling on a case was six months. 
36. Regarding joint examination of trademarks, in addition to the application for international 
registration of marks under the Madrid Agreement, the SAIC
 applied the principle of "one trademark, 
one class" to trademark registrations, and conduc ted a classification examination of trademarks. 
37. Regarding well-known trademarks, in the pro cess of determining well-known trademarks, the 
SAIC treated trademark owners from China and othe r countries equally and without discrimination.  
He said that local governments formulated the measures of determining and protecting famous 
trademarks based upon local conditions at the provi ncial level.  Therefore, there was no unified 
national standard for determining famous trademarks and the level of protection for famous brands 
varied from region to region.  As regarded the issue of "export brands", he said that the implementation of the programmes on expor t brands had already been stopped. 
38. Regarding geographical indications, he said that the Chinese Government attached 
importance to their protection and had established its own geographic indication protection system 
based on China's national conditions and economic development level.  The relevant authorities were 
actively working to improve the effectiveness of GI protection and China was seeking to strengthen 
cooperation with other Members in this regard. 
39. With regard to GIs for agricultural products, he said that agricultural authorities would not 
accept GIs for agricultural products that had alr eady been registered with the quality control 
authorities.  Grounds for opposition to an application included the qualifications of the applicant, the 
scope of regional protection, the pr oduct name and the technical standa rds for quality control.  Once a 
GI for an agricultural product had obtained prot ection from the agricultural authorities, the 
registration certificate was effective for a long term and needed no renewal if the registration conditions remained unchanged.  The registration information on th e agricultural product was open to 
the public in the GI registration process.  Furt her information was available at the website 
http://www.aqsc.gov.cn./
  The Ministry of Agriculture was further considering the formulation of 
Management Measures for the Registration and Protection of GIs of Agricultural Products from 
Foreign Countries in the People's Republic of China.  IP/C/M/61 
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  Part III:  Copyrights and related questions 
 
40. He said that the question of how to pay rem uneration for the broadcas ting of audio products 
between the time when the Copyright Law was pu t into effect in 2001 and the time when the 
Measures for Paying the Remuneration for the Broad casting of Audio Products at Radio Stations and 
Television Stations would come in to force would be addressed in t hose measures, which were still in 
the process of formulation. 
41. Regarding the obligations of users of works a nd audio-visual products, it was stipulated in 
Article 27 of the Copyright Collective Management Re gulations that "Unless it is otherwise agreed in 
the licensing contract, the user should, when paying the royalties to the copyright collective 
management organization for the work or the audi o-visual product he uses, provide the name, the 
name or the title of the right holder and the means,  amount, time and other information about its usage 
of the work or the audio-visual product."  Article 43 stipulated that in case of a violation of Article 27, where a user refused to provide or falsified info rmation about the use, the copyright administrative 
department under the State Council would order the u ser to correct the information and the copyright 
collective management organization could disconti nue the performance of the licensing contract.  
These stipulations showed that the user had a legal obligation to provide this information, and that 
failure to do so was sanctioned not only by the administrative authority's order to make the 
appropriate corrections, but also the possible discon tinuation of the licensing contract by the copyright 
collective management organization. 
42. With respect to the current revision of the Co pyright Law, he said that this revision was 
related to the WTO Dispute Settlement Body, and th at China was actively working in this regard. 
Part IV:  Enforcement 
 
43. With regard to the pendency period of administ rative cases concerning patents, trademarks or 
other intellectual property rights, the Administrative Litigation Law stipulated that period to be three 
months in the first instance, and two months at the appeals stage.  He said that compared with other 
countries, Chinese courts were relatively efficient in this area. 
44. With regard to the familiarity of judges with intellectual property law, most Chinese courts at 
or above the intermediate level had established special IP tribunals as early as the late 1990s and a 
number of judges familiar with intellectual property rights had already been given their posts.  For 
instance, after the promulgation of the Provisions of the Supreme People's Court on the Jurisdiction 
over Administrative Cases Concerning Patent, Tradem arks and other Authorized and Recognized IP 
Rights, the Beijing First Intermediate People's Court had posted six judges and eight judicial assistants to its IP tribunal. 
45. With regard to the coordination between civil tribunals and intellectual property tribunals, in 
situations where the IP issues involved in a case unde r judicial review and in a civil case were the 
same and both cases were pending, if the trial of th e civil tort case depended on the outcome of the 
judicial review, the civil tribunal could decide to suspend the trial of the civil case. 
46. With regard to case initiation standards for crim inal IP investigations, the Supreme People's 
Court and the Supreme People's Procuratorate had pr omulgated two Interpretati ons on Several Issues 
Concerning the Application of Law to Criminal IP C ases in 2004 and 2007, respectively.  The Public 
Security Bureaus (PSB) of China dealt with crim inal IP cases in accordance with these regulations. 
47. With regard to the effectiveness of IP enforc ement in China, he said that the information 
provided by China in Annex 1 of China's submissi on had demonstrated the effectiveness of such IP/C/M/61 
Page 10  
 
  enforcement.  Furthermore, in the dispute DS362 China – IPRs , the panel had not found the thresholds 
in the Chinese Criminal law to be  inconsistent with WTO rules. 
48. He said that after the Supreme People's Court and the Supreme People's Procuratorate had 
jointly promulgated the Judicial Interpretation on IP-related Criminal Cases at the end of 2004, the 
number of IP-related criminal cases accepted and h eard by courts had increased considerably.  In 
2007, 3326 IP-related criminal cases of first instan ce had been settled in local courts throughout the 
country.  These decisions had been binding upon 5388 persons, out of whic h 5386 were convicted.  
Among the settled cases, 1657 persons had been co nvicted of IP infringement in 996 cases, 1040 
persons had been convicted of producing and ma rketing fake or substandard commodities in 
610 cases, and 2667
 persons had been convicted of il legal business operations in 1707 cases. 
49. With regard to the calculation methods for the cr iminal thresholds, he said that in accordance 
with the relevant provisions in the Interpretation on Several Issues Concerni ng the Application of Law 
to Criminal IP Cases jointly promulgated by the Supreme People's Court and the Supreme People's Procuratorate in December 2004, "sales revenues" an d "value of the goods" should apply to different 
criminal IP cases.  The concept of "sales revenues"  applied to Article 214 of the Criminal Law and 
was prescribed in the Interpretation in that regard, while the concept of "value of the goods" applied to 
Articles 213, 215, 216 and 217 of the Criminal Law.  In accordance with Article 12 of the 
Interpretation, the calculation of "value of the goods " did not exclude infringing products at the stages 
of "production, storage and transportation". 
50. With regard to the export of counterfeit and pirated goods, he said that the TRIPS Agreement 
did not oblige Members to apply border measures with respect to exports and that, therefore, these IP 
enforcement actions of Chinese customs should not fa ll under the transitional review mechanism.  In 
addition, IP infringement and international trade of  counterfeit and pirated goods were not issues of 
one particular Members, but a problem facing all WTO Members.  He emphasized that China had always paid special attention to its customs c ooperation regarding IP protection with the United 
States, the European Communities, as well as with other Members, and had ta ken various measures in 
this regard.  These included strengthening law enfo rcement regarding counterfeit and pirated goods 
exports, enhancing cooperati on with foreign customs in law enforcement, as well as IP education of 
domestic manufacturers and exporters. 
51. With regard to the commercial production and sal e of optical disks containing pirated movies 
and music, the Copyright Law specifically stipulated "legal liability and enfo rcement measures" for IP 
infringement in Articles 46 to 52 of its Chapter V. All of these provisions we re consistent with the 
current international rules for copyright.  Right holders, who learnt of any commercial production and 
sale of optical disks containing pirated movies and music or other relevant activities, could seek remedies through the legal channels. 
52. The representative of Cuba
 said that his delegation recognized the long and systematic work 
China had carried out in order to progressively in crease the level of IP protection.  As China had 
mentioned, protecting intellectual property rights was part of its national system in order to achieve 
scientific results for national development.  Th ese results were perceptible and measurable in a 
country where intellectual property had been prot ected for only about 30 years.  His delegation 
believed that such results should be compared to the situation in developed countries that had gone 
through different stages following the imperatives of th eir own development.  Even so, 120 years after 
such systems of IP protection had been drawn up in developed countries, in spite of all the measures 
taken against piracy, these countries had not yet been  able to eliminate piracy and counterfeiting. 
53. The representative of the European Communities  thanked the Chinese delegate for his 
answers, although he said that not all of his delegatio n's questions had been answered.  He said that, 
while his delegation acknowledged the progress made by China, the reason why the statements by  IP/C/M/61 
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  Members were not very different from statements at  previous sessions was that many of the problems 
remained the same.  With regard to the customs st atistics, he said that these were accurate and that 
93 per cent of counterfeit medicines intercepte d at EC borders were suspected trademark 
infringements, indicating that these were pure fa ke medicines that could actually kill people. 
54. As to the issue of lowering standards of protection for IPR in the context of the economic 
crisis, he referred the Chinese delegation to the statement of the vice-president of the Supreme Court 
of December 2008 and to the administrative notice at lo cal level which had been issued in this regard.  
He noted that other delegations ha d also referred to this issue. 
55. In respect to the efficiency of the Chin ese courts he said that, while his delegation 
acknowledged the positive aspects, the problem was not so much the delay, but the lack of 
justification why a case was or was not accepted by a c ourt.  In Chinese the issue was referred to as 
LI-AN. 
56. With respect to the answers provided by China,  he said that his delegation appreciated their 
comprehensiveness, but a few issues had not been addressed.  These included question 32 on 
notarization and legalization of the powers of attorn ey and of evidence, which was a big problem in 
terms of access to justice.  Also, question 16 on  the relationship between intellectual property and 
standards, and the reduction of patent rights when  technology was included in a standard, had not 
been answered.  Question 27, on plant variety protection and the absence of a certain form of 
protection, as well as question 30 on the issue that right holders were not informed about the follow 
up to their cases, had also not been answered either. 
57. The representative of Canada  said that her delegation appreciated China's continued 
engagement in a dialogue on IP issues at the WT O and at other international fora, such as the 
Heiligendamm process.  This provided opportunities to share best practices and other experiences 
between the respective intellectua l property agencies and experts, such as on the ongoing challenges 
that Canadian companies were facing in China.   Canada acknowledged the progress and achievements 
in reforming China's IP regime but noted that there were still areas of concern.  Her delegation 
remained concerned about the range of patent, tr ademark and copyright infringement cases occurring.  
The rights of Canadian and Chinese innovators alike were damaged by individuals or organizations 
who were able to exploit loopholes in the existing Chinese regulations and legal processes.  Canadians 
hoped the ever deepening investments in innovation technology development would be backed up and 
supported by a growing legal and enforcement infr astructure under Chinese IP laws.  Her delegation 
encouraged the Chinese Central Government to work  closely with local governments and to continue 
strengthening IP protection across China.  Fina lly, Canada commended China's commitment to IPR 
training, especially in the area of traditional protec tion in local courts, and looked forward to further 
progress on this front. 
58. The representative of China  said that, with respect to the so-called financial crisis related IP 
issue, China's determination to further improve its IP situation ran from its highest leaders down to the 
field handlers and would not be affected by inappr opriate factors, including the financial crisis.  
However, as one could never rule out isolated cases of such remarks, his delegation would verify any 
information that the European Communities could share. 
59. He said that, while the credibility of figures and statistics could be discussed forever, the point 
was that counterfeiting and piracy was a global issue that existed not merely because infringing products were produced somewhere, but also because there were markets, trans-shipments, importers 
and consumers of such products.  While China ma inly combated the infringements by producers, 
retailers and wholesalers, his de legation hoped that something could also be done about the 
consumers.  With regard to the issue of whether the results of China's efforts were concrete and 
tangible, he said that the results of China's civ il and administrative enforcement procedures were well IP/C/M/61 
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  illustrated by the information provide d under Annex 1A of section 18.  He said that this dual system 
was something specific to China not comparable to most other Members.  China also had criminal 
procedures in place that had been upheld by a dispute settlement panel, as well as bilateral and 
multilateral mechanisms which could go through these i ssues and try to improve them to make results 
more concrete and tangible. 
60. Regarding the EC comments regarding unanswere d questions, he said that his delegation had 
only received the EC communication one week before  the meeting.  The communication consisted of 
nine pages of 35 questions which touched on areas relating to various ministries, regional 
governments and also the judicial system.  It had b een extremely difficult for his delegation to collect 
this information, translate the questions from E nglish into Chinese and the answers from Chinese into 
English, and complete the requirements of their inte rnal system for verification and approval, and he 
apologized for this.  There were, however, also some  questions that his delegation had found difficult 
to answer, since they had been based on pure assumptions that had not been substantiated.  For 
example, paragraph 11 of the EC submission had stated that it had been felt in many cases that the information required for document verification ha d gone beyond the scope necessary for approval or 
authorization.  Without any substantiating info rmation regarding the cases and the information 
required, it was extremely difficult for governments to verify and answer such questions. 
61. Another example in this regard were the ques tions in paragraph 21 which related to various 
retail and wholesale markets in Beijing City.  Th e European Communities ha d asked:  "can China 
indicate which action it intends to take to definite ly clean out the markets from counterfeit products."  
As a non-native English speaker, he had looked up the dictionary definition of the formulation "clean 
out", which had indicated that it had a very strong meaning along the lines of "to deprive of any", so 
that there should be no more incidents like that.  He said that while any Member could commit itself 
to clean out any counterfeit products from its reta il or wholesale markets, it was something that was 
realistically impossible for anyone.  In the same way that a doctor could not guarantee that a child 
would never cough again after treatment, or a policeman could not guarantee the end of illegal 
parking after issuing a parking ticket, in the same way the laws were there to prevent IP infringements 
from happening, but it was impossible to guarantee their complete end.  What could be done, 
however, if the European Communities could share information regarding specific cases with his 
delegation, was that China could address them on a case-by-case basis.  In the remaining questions in paragraph 21, the European Communities had simply re quested China's agreement to the view that its 
police needed to be involved and that infringements needed to  be addressed, and so forth.  
Theoretically speaking, of course, China and all Members could agree to these kinds of assumptions, 
because they were theoretically co rrect.  But in practice, as illustrated by the information provided 
under Annex 1A, these actions had already been take n.  If the European Communities wanted China 
to revise its onerous formality requirement for enfo rcement, it would help to specify how onerous and 
expensive they really were.  He expressed doubts whether, compared to Europe, anything could be 
expensive in China.  China appreciated Members' in terest in its IP system and looked forward to 
further dynamic and meaningful interaction w ith them both bilaterally and multilaterally. 
62. The representative of the European Communities
 said he was disappointed about China's 
response regarding the lack of clarity of questions.  Any lawyer could answer a question by at least one other question, but the point was to answer the questions in this review mechanism.  Since these 
questions had all been discussed bilaterally between  the EU and China in their IP dialogues and 
working groups, he could not accept the argument that  China did not know what these questions were 
about.  His delegation was worried to hear that it was impossible to clean out a market of counterfeit 
goods, because that was what the TRIPS Agreement said Members should do.  The comparison with the doctor and policeman regarding future action was irrelevant since nobody asked China to commit 
that there would be no more counterfeiting ever, but  his delegation would first like to see that there 
was no more counterfeiting as of the present day.  It was understandable that there would be 
enforcement issues on the scale of an entire country , and that was not a problem.  But here, as  IP/C/M/61 
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  specified in its question, the European Commun ities was referring specifically to the Beijing Silk 
Market, the largest counterfeit market of the wo rld in downtown Beijing next to the diplomats' 
quarter, which was a six-floor building full of counterfeits .  So this was not an issue of pockets of lack 
of enforcement, but a specific case which had been  highlighted for years as a high priority.  With 
respect to the term "clean out", he said that while  he sympathized with not being of English mother 
tongue, the formulation "clean out" could easily be  replaced by "emptied of counterfeit goods", or 
"close the markets" since the market in question was exclusively relying on counterfeit goods. 
63. The Chair  thanked China for the information it had provided, as well as other Members for 
their contributions.  Turning to the Council's reporting obligation to the General Council, she 
suggested that the Council follow th e same procedure as in the past years, namely that the Chair, 
acting on her own responsibility, would again prepare a factual report.  The content of the cover page 
to the report would be similar to that of the repor t submitted by the Council in 2008 and the part of the 
minutes reflecting the discussions held under this agenda item would be attached. 
64. The Council took note  of the statements made and agreed  to proceed as suggested by the 
Chair. 
D. REVIEW OF THE PROVISIONS OF ARTICLE 27.3( B) 
E. RELATIONSHIP BETWEEN THE TRIPS  AGREEMENT AND THE CONVENTION ON BIOLOGICAL 
DIVERSITY  
F. PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE  
65. The Chairperson  recalled that, at its meeting in March 2006, the Council had agreed to 
maintain its present method of work on these matte rs, and to keep this method under review to assess 
whether any change might prove appropriate in the light of developments.  Accordingly, she 
suggested that the Council continue its past prac tice of discussing these three agenda items together 
on the basis of the contributions by Members. 
66. She said that, in paragraph 44 of the Hong Kong Ministerial Declaration, Ministers had taken 
note of the work undertaken by the Council for TRIPS pursuant to paragraph 19 of the Doha 
Ministerial Declaration and had agreed that this work should continue on that basis and the progress 
made in the Council for TRIPS to that date.  Furthe rmore, they had instructed the General Council to 
report on its work in this regard to  their next Session.  She noted th at the draft Annual Report that had 
been circulated in advance of this meeting covered the Council's work in this regard.  Therefore, she 
suggested that Members revert to the issue of how the Council should report on its work to the General Council under item P on "Annual Report". 
67. The representative of India
 said that, in the course of several  years of discussions on the issue 
of the relationship between the TRIPS Agreement and the CBD, his delegation had highlighted the 
inadequacy of the TRIPS Agreement to combat bi opiracy and misappropriation of genetic resources 
and traditional knowledge.  This was one of the majo r shortcomings of the TRIPS Agreement.  The 
CBD, signed by 191 countries, contained several intellectual property rights related obligations, 
including obliging countries to cooperate to ensure  that patents and other intellectual property rights 
did not run counter to the objectives of the CBD.  Despite the fact that the CBD had been signed 
several years before the TRIPS Agreement had entered into force, the TRIPS Agreement was 
oblivious to the intellectual property provisions of th e CBD so far.  This contradiction obstructed the 
proper implementation of the CBD and caused an imba lance in the TRIPS Agreement.  The steep rise 
in bioprospecting for natural remedies and other pu rposes and patent applica tions based on genetic 
resources and associated traditional knowledge could have undesirable conse quences in the absence 
of internationally acceptable legal regulations.  The issue therefore must be dealt with urgently and IP/C/M/61 
Page 14  
 
  with priority.  He said that, after a great deal of  technical work, the disclosure proposal contained in 
document IP/C/W/474 had been submitted in 2006.  The geographical spread and the socio-economic 
profile of the co-sponsors of the disclosure proposal made it clear that the Doha development outcome 
could not be completed without satisfactorily address ing this issue of immense importance to a vast 
majority of the WTO membership.  Subsequent ly, document TN/C/W/52 had been submitted in 
July 2008, containing key parameters that the pr oponents wished to see reflected in a Ministerial 
Decision on three TRIPS-related issues, namely, TR IPS/CBD, GI register and GI extension.  
Document TN/C/W/52 made for a balanced pr oposal which was the result of constructive 
engagement, flexibilities and accommodation of interest s of some 110 Members, including developed 
and developing countries and most LDCs.  Docume nt TN/C/W/52 provided a sound basis for the way 
ahead on these issues.  Significantly, there was agreement among some 108 Members that the three 
TRIPS issues must be dealt with in tandem base d on the key parameters me ntioned.  His delegation 
strongly supported such an approach to procedure as well as the elements of the GI extension and GI 
register as mentioned in document TN/C/W/52. 
68. He was appreciative of the consultations held  by the Director-General since March 2009 on 
the issues of TRIPS/CBD and GI extension as outstanding implementation-related issues.  He said 
that these consultations served the mandate containe d in paragraph 39 of the Hong Kong Ministerial 
Declaration which called for intensification of consultations by the Director-General.  The 
Chairmanship of the Director-General and particip ation of Ambassadors had provided meaningful and 
constructive engagement among Members involved in the exercise.  The consultations had provided 
an opportunity for detailed technical discussions without getting trapped in theological issues.  
However, he said that it was important that th e momentum generated should not slacken on this 
important issue where there was a clear acceptance of shared objectives to combat misappropriation 
and biopiracy while also adhering to the concepts of prior informed consent and equitable benefit 
sharing.  He said that document TN/C/W/52 was perhaps the only proposal on the table which could squarely address the issues of biopiracy and mi sappropriation of genetic resources and traditional 
knowledge, erroneous pate nts and promote transparency and traceability. 
69. The representative of Colombia
 said that his country was one that was megabiodiverse i.e. 
rich in biological resources.  These resources and the associated traditional knowledge were viable 
and high-potential alternatives for resolving national and international problems in areas such as 
health, food security, indigenous and rural production, and envir onment.  Traditional knowledge 
associated with biodiversity was a fundamental pa rt of wealth and depended largely on these 
resources.  When biological resources and associated  traditional knowledge were used for profit, it 
was important to ensure that this was done in accordance with the intenti ons of the communities who 
owned them, and that the resulting profits were properly shared.  This meant that it was essential to ensure close linkage between the regulation of access and the regulation of use.  There had been much 
discussion in the Council about the best mechanism for avoiding misappropriation of such resources 
and associated knowledge.  For a variety of reasons  that had been discussed time and again, he said 
that his delegation, along with many other deve loping country Members, considered that current 
mechanisms for protection against biopiracy, such as national legislation, contracts and databases, 
were insufficient or unsuitable.  In Colombia's view , the WTO needed to tackle the issue of revision 
of international patent law so as to halt misappropr iation of biodiversity.  He reiterated that it was 
important for the TRIPS Agreement to contribu te to achieving the objectives of the CBD by 
maintaining mutual support, synergies and the inte grity of both instruments.  Hence, Colombia 
supported the disclosure proposal contained in docu ment IP/C/W/474 circulated in 2006 which had 
the backing of a large group of Members.  He said that, during the period 2006-2008, Members had taken a constructive and enthusiastic  part in the technical discussions  held on the subject and provided 
abundant information and explanations for the reaso ning behind their proposal.  His delegation was 
discouraged by the fact that so me Members lacked the decisive ness to adopt a common stance to 
address an interest that was largel y shared by the membership as a whole.  Some Members had even 
concluded free trade agreements with Colombia that  contained obligations relating to disclosure of  IP/C/M/61 
 Page 15 
 
 
  origin or the source of genetic resources.  His dele gation would continue to pl ead in favour of fair 
treatment of the protection of biodiversity and associated traditional knowledge. 
70. The representative of Argentina  said that her delegation did not support the artificial 
parallelism between the three TRIPS-related issues as proposed in document TN/C/W/52.  She said 
that while misappropriation of genetic resources a nd traditional knowledge wa s a serious problem, her 
delegation did not support the pr oposal of amendment of the TRIPS Agreement as contained in 
document TN/C/W/52.  She said that Member s should continue to have discussions on the 
TRIPS/CBD issue without denying the important work  being carried out at WIPO.  She informed the 
Council of the new mandate given to the relevant WIPO body at the WIPO General Assemblies in 
2009, and hoped that this would yield important results in the future. 
71. The representative of Egypt , speaking on behalf of the African Group, said that the protection 
of biological resources, traditional knowledge a nd folklore was a prime development concern of 
African countries.  In view of the importance of this issue to Africa, the Group continued to support engagement in full negotiations on the TRIPS/ CBD issue which was a critical part of the 
implementation-related issues and c oncerns as contained in the Doha Work Programme.  The African 
Group believed that there was a continuing lack of e ngagement from certain Members.  He reiterated 
that this was an issue of significant development im pact on developing countries, particularly African 
countries, and not tackling it within the context of the Doha Development Agenda would detract from 
the developmental grounding of the Agenda.  He said that technical discussions on this issue had been 
ongoing for the past nine years.  During this period,  Members had made several  submissions with the 
aim of clarifying the issues and establishing an e ffective and consistent framework to enable WTO 
Members to meet their obligations under both th e TRIPS Agreement and the CBD.  The essence of 
Members' efforts was that the TRIPS Agreement shoul d be amended in order to  provide that Members 
should require an applicant for a patent relating to biological materials or associated traditional 
knowledge, to disclose the source and country of or igin of the biological resource and associated 
traditional knowledge used in the invention.  Furthe rmore, the applicant should also provide evidence 
of prior informed consent and of fair and equitabl e benefit sharing under rele vant national regimes.  
He reaffirmed that there was a solid case suppor ted by a majority of the WTO membership for 
commencing text-based negotiations as presen ted by the Disclosure Group contained in 
document IP/C/W/474.  More recently, Members had witnessed, and were grateful for, the 
engagement of the Director-General in con tinuing his mandated consultative process on the 
TRIPS/CBD issue.  He looked forward to continui ng this consultation towards a possible outcome and 
specifically requested that all Members engage  constructively therein and note the important 
development concerns in some of the issues discussed. 
72. He said that, over the years, Members had all witnessed numerous cases of biopiracy where 
the traditional knowledge and genetic  material belonging to African countries and other developing 
countries had been taken out of their countries and th en patented erroneously.  It had proven very 
difficult and costly for poor communities in these c ountries to fight for their rights.  Therefore, the 
amendment of the TRIPS Agreement to include th e disclosure requirement, including prior informed 
consent and benefit sharing, was important fo r these communities to protect their traditional 
knowledge and would ensure that the outcome of D oha was truly a developmental one.  He said that 
the African Group had proceeded to tackle this issu e at all possible and relevant multilateral forums 
within its own specific mandates and focus.  Most importantly, the Group had been at the forefront of 
efforts to establish international binding rules on the protection of genetic resources, traditional 
knowledge and folklore at the WIPO.  He said th at the mandate of the WIPO Intergovernmental 
Committee on Genetic Resources, Traditional Knowledge  and Folklore (IGC) had been renewed, and 
that the African Group had shown the utmost flexibility  despite the insistence of a few member States 
against the development of international binding le gal instruments.  He hoped that such a show of 
flexibility would be reciprocated in future sessions of the IGC.  Ultimately, delays in addressing the 
issue at the WIPO forum impinged further on Member s' efforts within the WTO to produce a concrete IP/C/M/61 
Page 16  
 
  and viable outcome concomitant w ith the development needs of th e African Group and the developing 
world at large.  He said that the outcome of the negotiations on the TRIPS/CBD issue should lead to a 
mandatory requirement for patent applicants to disclose the origin of biological materials and 
traditional knowledge used in their inventions, evid ence of prior informed consent and benefit-sharing 
arrangements with the country of origin and relevant communities. 
73. The representative of El Salvador
 recognized the efforts undertak en by the Director-General 
to hold consultations since March 2009.  Although  her delegation had not participated in these 
consultations, the Director-General had kept it in formed through his report to the General Council.  
She said that while her delegation did not oppose the disclosure proposal, it was unable to support the proposed parallelism as each issue should be examin ed on its own merit.  She informed the Council 
that El Salvador was party to the CBD and had b een undertaking efforts within its national patent 
legislation, as well as in drawing up an inventory of  its biological resources.  Finally, she said that the 
consultations carried out by the Director-General had not yet led to formal decisions, and that any 
formal decision should be taken in the Council. 
74. The representative of Peru
 said that his delegation was in agreement with India, Egypt and 
Colombia and that since 2003 his delegation ha d presented 11 documents together with other 
delegations on the TRIPS/CBD issue.  His dele gation had individually pr esented four documents 
providing concrete cases of biopiracy, together with the launch of a website against biopiracy so as to 
protect the interest of the State with respect to biol ogical materials originating in Peru.  He said that 
Members should focus on the disclosure of gene tic resources and trad itional knowledge, prior 
informed consent and benefit sharing in order to fu lfil the objectives of the CBD, avoid biopiracy, and 
ensure coherence between the TRIPS Agreement a nd the CBD.  He said that intellectual property 
systems had been perceived as an important tool of economic, social and cultural development.  It was 
the need to improve the intellectual property system  in order to increase the value of the resources of 
developing countries that led Peru to sponsor documen t TN/C/W/52.  He said that Peru had not tried 
to prevent its resources being accessed but rather ha d tried to ensure sustainable development for all 
Peruvians, in particular for indigenous peoples.  His delegation respected intellectual property in 
conformity with international norms.  Fighting ag ainst biopiracy would achieve a balance between 
indigenous people and inte llectual property owners. 
75. The representative of Brazil  supported the draft modalities for the three TRIPS-related issues 
as proposed in document TN/C/W/52.  He said th at, as the proponents of this document, Brazil 
together with more than 100 Members, believed that  the TRIPS-related issues must be dealt with in 
parallel, which was the most effective way of expediting work on these issues.  It was time for 
Members to start work on the draft modalities pr oposed in document TN/C/W/52.  The earlier 
Members began, the better would be the prospect s for progress towards an overall conclusion of the 
Doha Round.  His delegation appreci ated the consultations held by the Director-General pursuant to 
paragraph 39 of the Hong Kong Ministerial Declaration.   The last round of such consultations held at 
the beginning of October 2009 had been positive.  The decision of the Director-General to take on the 
responsibility of chairing these consultations had show n the key role that the TRIPS-related issues 
enjoyed within the wider context of the Doha R ound.  He said that the misappropriation of genetic 
resources and associated traditional knowledge, also re ferred to as biopiracy, was a serious and grave 
international problem facing megabiodiverse coun tries.  This problem required commensurate 
international responses to be provided within th e legal framework of international intellectual 
property systems.  The introduction of an amendment to the TRIPS Agreement requiring patent 
applicants to disclose the name of the country providing genetic resources and associated traditional 
knowledge was the best and only way of providing an effective response to the interconnected product 
of misappropriation and biopiracy. 
76. The representative of Angola  reiterated the LDC position on the TRIPS/CBD issue which had 
been adopted by the LDC Trade Ministers' Meeting held in Dar Es Salaam.  He recalled that the  IP/C/M/61 
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  Ministers of the LDCs had urged for an agreement to amend the TRIPS Agreement to include a 
mandatory requirement for the disclosure of th e country providing genetic resources, and/or 
associated traditional knowledge for which a definition would be agreed in patent applications, and to 
include a requirement that patent applications would not be processed without completion of the 
disclosure requirement.  The Ministers had also re quested an agreement to define prior informed 
consent and access and benefit sharing. 
77. He then commended the effort made by the Director-General in conducting the series of 
consultations so far in accordance with paragraph 39 of the Hong Kong Ministerial Declaration.  He 
hoped that an agreement would be achieved as soon as possible, taking account of the strong desire of 
the majority of Members, including deve loped and developing countries and LDCs. 
78. The representative of Tanzania  hoped that the interest of the LDC Group, which was shared 
by India, the African Group and many other Members, would be seriously taken into account. 
79. The representative of China  welcomed the discussion on the relationship between the TRIPS 
Agreement and the CBD and the protection of tradit ional knowledge and folklore as important items 
on the agenda of the Council.  These were primary concerns for a great number of developing 
countries and should be an integral part of the Wo rk Programme according to the Doha mandate.  In 
the light of the recent positive developments in WI PO with regard to the renewed IGC mandate for 
negotiation on the protection of genetic resourc es, cultural expression and folklore, he said that 
discussion and negotiations needed to catch  up within the framework of the WTO. 
80. He said that, as one of the co-sponsors of doc ument TN/C/W/52, China would like to stress 
that it was a common aspiration of at least 108 WT O Members that the TRI PS/CBD, GI extension as 
well as GI register should be negotiated in parallel.  In this regard, he than ked the Director-General 
for organizing informal consultations on the TRIP S issues.  After several rounds of questions and 
answers, more and more issues had been clarified, wh ich was beneficial for Members' future efforts in 
achieving concrete outcomes on these three issues.  Therefore, he urged text-based negotiations on the 
issues of TRIPS/CBD, GI register and GI extension as soon as possible. 
81. The representative of Cuba  said that her delegation supporte d the amendment of the TRIPS 
Agreement with a view to introducing disclosure of source and country of origin of biological 
resources, evidence of prior informed consent and fair benefit sharing.  After more than eight years of 
negotiations on this issue, a significant group of Members had realized that the amendment was 
essential for trade in biological di versity and was a means of avoiding erroneous granting of patents 
and biopiracy.  She said that other TRIPS-related issues had sufficient merits to be addressed 
alongside this issue.  However, she said that, without prejudice to the views just expressed, her 
delegation shared the view that geographical indica tions must be protected equally for all categories 
of products as stipulated in Cuban laws, and th at her delegation did not support the system of 
registration proposed by the European Communitie s under which, among other things, participation 
would not be voluntary.  Consequently, her de legation could not support document TN/C/W/52. 
82. The representative of Indonesia  said that, as a co-sponsor of document TN/C/W/52, his 
delegation supported the statements made by India,  Colombia, Egypt, Peru, Brazil, Angola and those 
who advanced the case for the TRIPS/CBD issue.  He  indicated his delegation's great interest in a 
swift and comprehensive solution, which should e ffectively address the problems of misappropriation 
and biopiracy.  He said that misappropriation and biopiracy denied the right of developing countries 
to their own genetic resources, traditional knowledg e and folklore and traditional expressions.  He 
was disappointed with the lack of progress made since July 2008 when two thirds of the WTO 
membership had tabled document TN/C/W/52 while  welcoming the consulta tions conducted by the 
Director-General.  He said that technical discussi ons in the past nine years had gone forward and 
therefore it was high time to start multilateral negotiations on the issues of TRIPS/CBD and IP/C/M/61 
Page 18  
 
  GI extension.  He stressed the need to ame nd the TRIPS Agreement to address the issues of 
misappropriation and biopiracy and to make the D oha Round deliver on its development dimension. 
83. The representative of Australia
 said that, as a megadiverse country with a strong living 
indigenous cultural heritage, Australia was co mmitted to finding a solution to the problem of 
misappropriation of genetic resources and associated  traditional knowledge and was actively engaged 
in discussions on this issue in various forums.  Ho wever, her delegation was not convinced that the 
solution as proposed in document TN/C/W/52 was the b est approach to address this issue.  Australia 
considered that WIPO was a more appropriate foru m to deal with issues surrounding the protection of 
traditional knowledge and folklore.  Australia wa s constructively engaged in the WIPO IGC and 
welcomed the recent renewal of the IGC mandate, wh ich would enable it to continue its work on 
traditional knowledge and folklore and include an outcome-oriented accelerated work programme 
towards a possible negotiation of an international instrument.  Her delega tion joined Argentina, 
El Salvador and others in rejecting the artificia l parallelism that some Members were promoting in 
relation to the issues of TRIPS/CBD, GI register and GI extension, particularly through the draft 
modalities as contained in document TN/C/W/52.  In her view, these issues should be dealt with 
separately and on their own merits.  The linking of the TRIPS/CBD issue with the GI issues was 
likely to hold back the process. 
84. The representative of New Zealand  said that his delegation's stake in this issue was well 
known.  While very few patents originated from Ne w Zealand his delegation had a systemic interest 
in the stability of the system as it had a si gnificant indigenous interest in preventing the 
misappropriation of New Zealand's genetic res ources and traditional knowledge.  There were a 
number of examples of the misappropriation.  He said that New Zealand had a particular domestic 
context due to requirements stemming from a treaty between the government and indigenous tribes in 
New Zealand, and rules regarding the ownership and management of biological resources and traditional knowledge.  He further informed that  the domestic situation was still evolving and New 
Zealand's interests were much wider than e rroneous patents and misa ppropriation of genetic 
resources.  One of his delegation's concerns was that a narrow WTO response would detract from 
broad issues associated with the protection of tr aditional knowledge and biological resources.  
Therefore, the issue of misappropriation could no t be resolved through the intellectual property 
system.  For that reason, his delegation had always  been a strong proponent for developing solutions 
within the WIPO IGC, which was now able to l ook at all the related issues in a holistic and a 
coordinated way.  New Zealand played an active and constructive role in the IGC.  His delegation's 
preference for this path was not a way of deflec ting or avoiding the issue.  He welcomed the 
agreement on a new IGC mandate at the recent WIPO General Assemblies and said that the new mandate contained the promise of concrete outcomes on this and othe r broader related issues.  He 
looked forward to inputting into the process.  Finally , he said that the parallelism meant that Members 
would not be able to consider the TRIPS/CBD i ssue on its own merits and it would underline why 
WIPO provided the best opportunity for a solution. 
85. The representative of Korea
 expressed his delegation's willingn ess to engage in constructive 
discussions on these issues according to the mandate established in the Council.  He said that an 
attempt to address other TRIPS issues under other mandates as a package was not helpful in finding a consultative solution.  Each issue should be discussed  on its own merits.  Korea was still of the view 
that the TRIPS Agreement was not an appropriate tool to address the objectives of the CBD, namely 
the prevention of misappropriation of genetic reso urces and the protection of biodiversity.  He 
reiterated that patentability resulted from novelt y of inventions.  Misa ppropriation of genetic 
resources should be addressed under contract law and criminal law domestically, and under the CBD 
internationally.  The existence of an artificial  link between the TRIPS Agreement and the CBD might 
discourage activities without providing a solution to the problem.  He said that effective national 
regimes should be implemented through contract-based approaches and the prevention of 
misappropriation should be addressed outside the patent system.  His delegation doubted the  IP/C/M/61 
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  usefulness of disclosure requirements to avoid err oneous granting of patents, because the information 
on prior art provided by patent applicants might risk misleading examiners.  On the other hand, 
authenticated national or international databases w ould be more useful in providing more reliable 
information than that disclosed by the patent applicant and would reduce the burden of patent examiners to guarantee that the right decisions were made by them. 
86. The representative of Norway
 said that the provisions of the TRIPS Agreement and the 
provisions of the CBD were mutually supportive, and that there was no conflict between these two 
instruments.  Nevertheless, the relationship be tween the TRIPS Agreement and the CBD would be 
enhanced by introducing a mandatory obligation in the TRIPS Agreement to disclose the origin of 
genetic resources and traditional knowledge in patent  applications.  For this reason, Norway had 
introduced a proposal for such an amendment in J une 2006.  Norway believed this proposal would 
support the aims of the CBD as well as being useful in ensuring that patents we re not granted contrary 
to the fundamental principles of patent laws. 
87. The representative of the European Communities  said that his delegation remained committed 
to a specific modality language for the three TRIPS-related issues and other issues of the DDA and, in 
particular, to the common platform reflected in docum ent TN/C/W/52.  He fully supported the parallel 
treatment of the three TRIPS issues and welcomed th e consultations on the issues of GI extension and 
TRIPS/CBD.  He hoped that this process could be pursued in an intensive manner, which was much 
needed after many years of negotiations.  Regard ing the disclosure requirement, he said that his 
delegation remained open to an am endment of the TRIPS Agreement to introduce such a requirement 
while preserving the balance of rights and obligations of  patent systems.  He said that the disclosure 
requirement as set out in document TN/C/W/52 could be  helpful particularly for patent examiners in 
helping them establish novelty more accurately and therefore prevent misappropriation of genetic 
resources and associated traditional knowledge.  On th e other hand, he said that even if there were 
some merits in the contract-based approach as set  out in document IP/C/W/472, such an approach 
would not be sufficient to meet the objectives pur sued in document TN/C/W/52 and would not have 
the same effectiveness as a mandatory disclosure requi rement.  He said that a broad consensus for a 
decision on the DDA modalities could only be found if th ese three TRIPS issues were part of it, which 
was supported by two thirds of the WTO membership .  Nevertheless, his delegation remained open to 
discussion and prepared to engage construc tively with other Members on this issue. 
88. The representative of the United States  said that the TRIPS Council had continued to engage 
in a useful and constructive exchange of view s on these issues based on the sharing of national 
experiences and the posing of and responding to qu estions among Members.  This way of working 
could and should continue to be the basis for the TRIPS Council's work  on these issues.  Her 
delegation acknowledged that some Members had a dvocated commencing negotiations on the basis of 
a proposed text to amend the TRIPS Agreement.  She reiterated that her delegation did not support 
amending the TRIPS Agreement to address the concer ns of the demandeurs and did not think that 
doing so would be the most effective way of ad dressing these concerns.  The United States continued 
to believe that Members should focus on the shared  objectives that had been revealed through their 
work.  She agreed on the importance of prior inform ed consent and equitable benefit sharing for the 
use of genetic resources and relate d traditional knowledge and of a voidance of erroneously granted 
patents.  Nevertheless she said that where Members continued to diverge was on the premise that this 
disclosure requirement would be an effective m eans of achieving these objectives.  She therefore 
could not support the initiation of negotiations towards a preordained outcome that would not 
accomplish shared objectives.  At a fundamental level, she said that the most critical element in ensuring appropriate prior informed consent and access and benefit sharing was the development and 
strengthening of national regimes and legal fra meworks designed specifically to accomplish these 
objectives.  Bringing the patent system into the equa tion simply did not make sense, particularly in the 
absence of well functioning prior informed consent and access and benefit-sharing regimes.  She said 
that her delegation continued to puzzle over how ne w patent requirements including the possibility of IP/C/M/61 
Page 20  
 
  denial of patents or revocation of patents in so me circumstances would help accomplish the legitimate 
and important objectives that Members shared.  The mo st effective way to ensure the effective sharing 
of benefits was to bring about the generation of be nefits in the first place.  Benefits would be 
generated when useful and good prod ucts were developed and commerc ialized.  The existence of an 
incentive through the patent system was a critical element in encouraging such development and 
commercialization.  When this happened and when meaningful national systems were in place, then 
Members could have confidence in the common objectives they had identified. 
89. She agreed with Argentina, El Salvador, Austra lia, New Zealand and others that the agenda of 
the Council limited Members' discussion to consider ation of the three agenda items in tandem.  
Therefore she objected strongly to any discussion of other TRIPS-related issues.  The fact that some 
Members deemed it expedient to address these i ssues together in document TN/C/W/52 did not 
overcome other Members' vigorous opposition to their being considered as a package.  These issues 
must continue to be considered on their specifi c individual merits and within specific bodies and 
consultation mechanisms designated in the previous Ministerial guidance.  Finally, she said that her 
delegation would continue to rema in actively engaged in the Council's examination of these issues 
and that, along with Australia and others, it also supported the renewed mandate of the WIPO IGC, 
where technical experts continued to examine these issues. 
90. The representative of Pakistan
 reiterated her delegation's s upport for the disclosure proposal, 
and associated itself with the statements by Braz il, China, India, the European Communities, the 
African Group, the LDC Group and other Members. 
91. The representative of Switzerland  associated his delegation with the statements made by India 
and the European Communities.  He supported the modalities language as proposed in document 
TN/C/W/52 for the three TRIPS issues.  He also we lcomed the Director-Gener al's consultations under 
the mandate of paragraph 39 of the Hong Kong Minist erial Declaration, in which his delegation was 
actively engaged.  He hoped that this work would be  further intensified.  He believed that such work 
was meaningful since it was a relevant component of the overall outcome of the Doha Round, which 
was expected to report to the forthcoming Ministerial Conference. 
92. He welcomed the renewed mandate of the WI PO IGC while considering it to be much 
broader and thus a different mandate than the one Members had under paragraph 39 of the Hong 
Kong Ministerial Declaration.  He said that his delegation could not agree with some Members' 
comments on parallel treatment of the three TRIPS issu es.  He said that there were some procedural 
and substantive links between the three TRIPS issu es and these links had been taken into account by 
more than two-thirds of the WTO membership when coming up with document TN/C/W/52. 
93. The representative of Japan  reiterated that the issues of e rroneously granted patents and CBD- 
compliance should be dealt with separately.  Me mbers could deepen discussions on the issue of 
erroneously granted patents by examining his dele gation's proposal on databases.  He said that the 
case had not yet been made that misconduct could be effectively monitored through a mandatory 
disclosure requirement, while certain concerns, su ch as the undue burden on patent applications, 
would be triggered by the introduction of such a mandatory requirement.  He said that technical 
discussions on access and benefit sharing had been conducted from a broader perspective within the 
framework of other forums, such as WIPO.  He said that the WIPO IGC would intensify its dedicated deliberations under the renewed mandate.  Therefore,  those technical discussions  should be duly taken 
note of.  Hence, it was not appropriate to prejudge the amendment of the TRIPS Agreement.  Finally, 
he said that the three TRIPS-related issues were di fferent in substance and each of them should be 
dealt with individually on their own merits. 
94. The representative of Canada
 said that the TRIPS Agreement and the CBD were mutually 
supportive and therefore there was no need to ame nd the TRIPS Agreement.  His delegation agreed  IP/C/M/61 
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  with others who had stated that attempts to link th e three TRIPS-related issues and to include them as 
part of the Single Undertaking were simply unjust.   He said that the WIPO IGC remained the best 
forum for technical discussions of intellectual property-related genetic resources and traditional 
knowledge.  To this end, Canada looked forward to working with other WIPO member States at the 
next IGC meeting in December under its newly renewed mandate. 
95. The representative of Chinese Taipei  said that many Members agreed there was no conflict 
between the TRIPS Agreement and the CBD, and that  Members shared the objectives of avoiding 
erroneously granted patents and misappropriation of genetic res ources and traditional knowledge.  
Nevertheless Members had divergent views on how  to achieve the aforementioned objectives, 
especially whether the TRIPS Agreement should be  amended to include a mandatory disclosure 
requirement.  He said that his delegation did not agr ee with the artificial linkage between the issue of 
TRIPS/CBD and other issues because each issue shoul d be evaluated on its own merits.  He expressed 
his delegation's concern about the lack of clarity  in document TN/C/W/52.  He recalled that his 
delegation had raised a number of questions about  the proposed Article 29bis contained in document 
IP/C/W/474;  likewise, the proposal contained in document TN/C/W/52 was of concern for his 
delegation.  He questioned whether it was a cons tructive approach for Members to negotiate a 
mandatory disclosure requirement before discussing the definition of "associated traditional knowledge", and the trigger of the disclosure obligat ion.  He said that as some proposals on the table 
might have an impact on the effectiveness and efficiency of the patent system, more clarity was needed to avoid unnecessarily increasing the burden on pa tent applicants and examiners and to avoid 
uncertainty with respect to issued patents.  He emphasized the need for continuing technical 
discussions.  He said that further discussion and sharing of national experience on prior informed 
consent and access and benefit sharing was important .  In his delegation's view, national systems and 
the proposed disclosure requirement were not mutually  exclusive.  Members should be encouraged to 
share their experiences in the Council.  Finally, he sa id that, due to the complexity of the issue, his 
delegation had not yet come to a conclusion abou t the necessity of amending the TRIPS Agreement. 
96. The representative of Guatemala
 said that the recent decision by the WIPO General Assembly 
to renew the mandate of the WIPO IGC was positive,  and represented well the level of ambition that 
they wished to reach in the three areas, namely, traditional knowledge, traditional culture 
expressions/folklore and genetic resources.  She said that an international legal instrument was under 
consideration by WIPO covering these three areas.  However, the IGC had laid down the principle 
that its work supplemented the work carried out in other forums and was thus without prejudice to the 
work carried out in the WTO.  As there had be en considerable discussion of misappropriation of 
genetic resources and the disclosure proposal c ontained in document IP/C/W/474 in the TRIPS 
Council for a long period, the issues should be resolved  soon.  She said that the consultations led by 
the Director-General had shown that the discussion on the TRIPS/CBD issue had reached a high level of maturity.  Developing countries had great interests in  this subject, and it should therefore be part of 
the outcome of the Doha Round.  However, she said th at a case had not been made for the issue of GI 
extension, which deserved ongoing technical discussions and clarifications as to its implications.  She 
said that there was an undue linkage between the three TRIPS-related issues as indicated by El 
Salvador, Argentina and New Zealand.  She sai d that an artificial parallelism between three 
TRIPS-related issues, which had different mandat es and different levels of maturity, was not 
acceptable. 
97. The representative of Ecuador
 supported the Disclosure Group's proposal as a means to fully 
comply with the Doha mandate and acknowledged the existing paralle lism between the TRIPS issues 
under discussion.  He reiterated the importance of en suring the legitimate use of  biological materials 
and traditional knowledge and of ensuring the r ecognition of countries' collective rights over 
traditional knowledge at national and international levels.  He said that  there was a need to amend the 
TRIPS Agreement in order to fulfil the objectives an d principles provided for in Articles 7 and 8 of 
that Agreement and to establish an adequate and effective coordination between the TRIPS IP/C/M/61 
Page 22  
 
  Agreement and the CBD.  He welcomed the consulta tions on the TRIPS/CBD issue carried out by the 
Director-General under the mandate contained in the Hong Kong Ministerial Declaration.  He 
emphasized the urgency of these issues and said th at negotiations towards an amendment of the 
TRIPS Agreement should constitute a central part  of the Doha Round's development dimension, 
should reflect the parallelism in the intellectual prope rty negotiations and be intimately linked to the 
Single Undertaking. 
98. The representative of the Dominican Republic
 thanked the Director-General for conducting 
horizontal consultations on the issues of GI extensio n and TRIPS/CBD in order to achieve a text to be 
included in a Ministerial decision as part of the Single Undertaking.  She said that more than 
100 Members had shown their interest in these issues .  Therefore the consultations should continue on 
the basis of document TN/C/W/52, which had been supported by a majority of the WTO membership. 
99. The Council took note  of the statements made under these three agenda items and agreed  to 
revert to them at its next meeting. 
G. REVIEW UNDER PARAGRAPH  8 OF THE DECISION ON THE IMPLEMENTATION OF PARAGRAPH  6 
OF THE DOHA DECLARATION ON THE TRIPS  AGREEMENT AND PUBLIC HEALTH  
100. The Chairperson  recalled that paragraph 8 of the wa iver Decision provided that the Council 
for TRIPS should review annually the functioning of th e 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. 
101. She said that the Secretariat had circulated a draft cover note for the Council's report modelled 
on previous years reports (JOB(09)/128).  It cont ained factual information on the implementation and 
use of the system established under the Decision,  on discussions regarding its operation and on the 
acceptance of the Protocol Amending the TRIPS Agre ement.  She proposed that, in accordance with 
the way that the Council prepared its reports in th e previous years, the part of the minutes of the 
meeting reflecting the discussions held under this ag enda item be attached to the cover note as an 
annex. 
102. As regards the status of acceptances of the Protocol Amending the TRIPS Agreement that 
was done at Geneva on 6 December 2005, she said that the following Members had notified their acceptance of the Protocol since the Council's meeti ng in June:  Macao, China on 16 June;  Canada on 
16 June;  Bahrain on 4 August;  Colombia  on 7 August;  and Zambia on 10 August 
(documents WT/Let/645, 646, 652, 65 0 and 651, respectively).  She recalled that 26 notifications of 
acceptance of the Protocol, including from the Eu ropean Communities, had been received.  The 
Protocol would enter into force for the Member s concerned upon acceptance of the Protocol by two 
thirds of the Members.  She said that the Secretariat had circulated an update to the note on the status 
of acceptances of the Protocol that the Council re quested it to prepare at its meeting in October 2006 
(IP/C/W/490/Rev.5) and that the Secretariat would continue to update it periodically. 
103. The Chairperson recalled that the Protocol w as originally open for acceptance by Members 
until 1 December 2007 and upon a proposal by the TR IPS Council, the General Council had extended 
this period until 31 December 2009.  Given the proxim ity of this date, she suggested that the Council 
may wish to consider again submitting a proposal to  the General Council for a decision to extend the 
period for the acceptance of the Protocol.  For this  purpose, a draft decision on the extension of the 
period for the acceptance that could be submitte d to the General Council for adoption had been 
included in Annex 2 to the draft report.  As regards the deadline for the extended period, she 
suggested that the Council consider proposing an extension by a further two years until 31 December 2011.  IP/C/M/61 
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  104. The representative of Egypt, speaking on behalf of the African Group , said that the African 
Group fully supported the Council for TRIPS subm itting a proposal to the General Council for a 
decision to extend the period for acceptance of the Protocol until 31 December 2011.  The amendment 
of the TRIPS Agreement was premised on the need to ensure the continued access to medicines and 
reflected the concern that Members had with rega rd to the Agreement's functioning in the area of 
public health.  The African Group continued to ur ge Members to accept the Protocol and to notify 
such acceptance.  At the same time, he noted that  the system established under the Decision had not 
been used as often as had been expected.  Th e African Group therefore supported conducting an 
analysis as to the reasons for this and possible means of addressing any difficulties and impediments. 
105. The representative of Switzerland  said that his delegation was prepared to join consensus to 
further extend the period for acceptance by Members of the Protocol with a view to permanently 
inserting the system established under the Decision in the TRIPS Agreement.  However, he was 
concerned by the fact that four years had passed since the General Council's Decision in December 2005 and only less than one third of th e Members had notified their acceptance of the 
Protocol.  He reminded de legations of the urgent calls at the time of negotiating the amendment which 
was meant to address a major concern of devel oping countries without manufacturing capacity in the 
pharmaceutical sector when facing a public health pr oblem.  Given the efforts deployed to adopt the 
Protocol, it was disappointing that only a small number of Members had accepted it so far.  His delegation had done so in 2006 and had also implemen ted the system at the national level through the 
revised Patent Act in force since July 2008 (IP/N/1 /CHE/P/9).  Manufacturing capacities in the Swiss 
pharmaceutical sector were thus made available to  Members who found themselves in a situation 
addressed by the system.  It was, however, unfortuna te that the implementing legislation continued to 
be based on a waiver decision adopted by the Gene ral Council, and not on a permanent amendment of 
the TRIPS Agreement.  His delegation therefore encouraged those Members which had not yet accepted the Protocol to do so expeditiously so as to allow its entry into force before the expiry of the 
once more extended period for acceptance.  He remain ed convinced that the system was workable and 
should be used by Members efficiently. 
106. The representative of Canada
 recalled that his delegation had announced the first shipment to 
Rwanda of a lower cost generic medicine to treat HIV/AIDS, manufactured by the Canadian pharmaceutical company Apotex Inc., at the Council's  meeting in October 2008.  He confirmed that 
the second shipment of HIV/AIDS medication comp rising 7.6 million tablets to Rwanda had taken 
place on 17 September 2009, thus completing the terms of the compulsory licence.  These shipments 
demonstrated that the system established under the Decision, while only being one aspect of a broader 
international strategy, could help coun tries to accede life-saving medicines. 
107. He was pleased to inform the Council that hi s delegation had deposited its instrument of 
acceptance of the Protocol with the WTO on 16 June  2009.  He encouraged Members who had not yet 
accepted the Protocol to do so.  His delegation supp orted the proposed extension of the deadline to 
accept the Protocol.  The Decision and the Protocol that transformed the waivers into a permanent 
amendment of the TRIPS Agreement would send an important signal that trade and intellectual property rights were supportive of facilitating access to medicines in developing countries. 
108. The representative of th e European Communities
 recalled that Regulation (EC) No 816/2006 
had been adopted in 2006 to implement the Decision .  This allowed European companies to produce 
generic drugs under compulsory licences for export to  countries facing public health problems.  His 
delegation would welcome any request from developing countries in view of the use of the system.  In 
November 2007, the European Communities had also accepted the Protocol.  Given the present status 
of acceptances, he encouraged those Members who ha d not yet accepted the Protocol to do so as soon 
as possible.  It was important for Members to conf irm their commitment to this process, so that the 
Protocol could enter into force as soon as possible.   Concurring with the Swiss delegation, he noted 
the contradiction between the urgency felt in 2003 to put the system into place and the still limited IP/C/M/61 
Page 24  
 
  number of acceptances.  He supported the extension of the period for the acceptance of the Protocol 
until the end of 2011. 
109. Supporting the statement made by Egypt, the representative of Kenya
 welcomed the proposal 
that the period for acceptance of the Protocol be  extended until 31 December 2011.  His delegation 
was in the process of accepting the Protocol.  Inte rnal procedures had taken some time, but he hoped 
that the Protocol could be accepted w ithin the extended period for acceptance. 
110. The representative of Tanzania, speaking on behalf of the LDC Group , said that many LDCs 
suffered from the difficulties of insufficient or non-manufacturing capacities in the pharmaceutical 
sector which rendered the effective use of compulso ry licensing difficult.  The Decision constituted a 
major hope for LDCs, as well as for other Members.  The fact that the majority had not yet accepted 
the Protocol could be indicative of some barriers  to the implementation of the system established 
under the Decision, causing delay to the expeditious  access to medicines in LDCs and other Members 
in need.  The annual review of the system was em bedded in the Decision and would provide a useful 
tool for its re-examination.  He urged the Chair to undertake consultations with all the interested 
Members, including LDCs, aimed at identifying any difficulties encountered with the use of the 
system and to make suggestions to solve those problems.  The findings and the recommendations of 
such consultations could be submitted to  the Council for further consideration. 
111. The representative of Mexico  said that the lack of acceptances sent a negative systemic 
message with regard to the amendment of the TR IPS Agreement and, beyond this, any other WTO 
agreement.  There was a need to ensure legal certainty.  He therefore urged those Members who had 
not yet ratified the Protocol to do so.  The exampl e of export of generic medicines from Canada to 
Rwanda demonstrated that the system functioned an d could be used effectively.  The acceptance of 
the Protocol could be done independently and should  not be prejudged by the analysis of its operation 
as requested by some delegations. 
112. The representative of India  said that it attached high importance to the Doha Declaration on 
the TRIPS Agreement and Public Health, the system established under the Decision and the Protocol.  
His delegation had notified its acceptance of the Prot ocol in March 2007.  However, in spite of the 
extended period for acceptance agreed in Dece mber 2007, only 26 Members had accepted the 
Protocol so far.  The fact that there was still a lo ng way to go for it to en ter into force, as acceptance 
by two thirds of the membership was required, w as not a positive signal.  There was no choice but to 
extend the period for acceptance by another two years, and at the same time urge Members to complete acceptance formalities as soon as possible. 
113. His delegation had always been of the view that the Doha Declaration constituted a major 
landmark in the short history of the WTO because it had recognized the primacy of public health 
needs and the preparedness of the Organization to take up the problems faced by the poor in 
developing countries.  Along with several other Me mbers, India had worked relentlessly on the Doha 
Declaration and the Decision.  The Decision was e xpected to address the public health problems faced 
by Members with insufficient or no manufacturing ca pacities in the pharmaceutical sector.  However, 
already at the General Council meeting in August 2003, his delegation had expressed concerns that 
"the results accruing from this mechanism would not be negated by the creation of cumbersome 
systems that would lead to huge delays in getting medicines across at reasonable cost to those that 
needed them or discourage Members from using the syst em for the benefit of the people.  In order to 
make this system successful, a sincere collective ef fort was required on the part of all Members and 
the entire pharmaceutical industry."  He regretted that his delegation had been proven right.  The 
export of HIV/AIDS medicines by the Canadian pharmaceutical company Apotex to Rwanda in 
September 2008 had been the first use of the system.  Canada had to be complimented on its effort to 
supply the medicines and to operationalize the system .  However, it had taken about three years to 
supply the medicine.  It was therefore time for re flection on the obstacles to the use of the system  IP/C/M/61 
 Page 25 
 
 
  which was supposed to be an expeditious solution to  the problem with respect  to access to medicines 
in countries with insufficient or no manufacturing capacity.  Experience showed that it had been far 
from expeditious.  Even a perfunctory examinati on of the list of the 26 Members which had accepted 
the Protocol so far revealed that there were hard ly any of the anticipated beneficiaries which had 
completed the process of acceptance.  Countries w ith insufficient or no manufacturing capacities were 
missing from this list.  He wondered whether this w as merely due to reasons of domestic procedures 
or whether it represented some kind of apathy towards the system. 
114. Paragraph 8 of the Decision instructed the TR IPS Council to review annually the functioning 
of the system with a view to ensuring its effectiv e operation and to annually report on its operation to 
the General Council.  During the fifth annual review  at the Council's meeting in October 2008, factual 
information regarding the implementation and use of  the system and the acceptance of the Protocol 
had been circulated.  There had been limited discu ssion on why the paragraph 6 system had been used 
only once in the last six years.  He supported the suggestion by Egypt and Tanzania that the Chair hold informal consultations with interested Members on obstacles, if any, to the effective operation of 
the system.  The recommendations emerging from such  discussions could then be considered by the 
Council for further action. 
115. The representative of the United States
 recalled its strong support for the system established 
under the Decision as one element in what had to be a multi-faceted international approach to improve 
responses to serious health crises in developing co untries.  At the Hong Kong Ministerial Conference, 
it had become the first Member to formally accept this solution as a permanent part of the TRIPS 
Agreement.  It was important to note, however, that the number of compulsory licences issued should 
not be the mark of success or failure of the ame ndment.  Rather than being a reflection of the 
practicability of the system, its limited use in dicated the increased access to pharmaceuticals by 
countries with little or no pharmaceutical manufacturi ng capacity.  Her delegation would continue to 
carry forward as a foremost contributor of pharmac eutical vaccine and diagnostic aid to countries in 
need.  This was demonstrated notably by the US Pr esident's Global Health Initiative, which aimed to 
raise 63 billion dollars over the next six years to focus on broad global health challenges, as well as 
President Obama's decision to make 10 per cent of  the US H1N1 vaccine supply available to the 
World Health Organization for use in developi ng countries.  Her delegation was thus joining 
Australia, Brazil, Switzerland, New Zealand, Italy,  France, Norway, Germany, Japan and the United 
Kingdom, which had either donated vaccines or fund ed their purchase.  She supported the extension 
of the period for acceptance of the Protocol un til 2011 and hoped to see the amendment enter into 
force as soon as possible. 
116. The representative of Ecuador  supported the proposed extension of the period for acceptance 
of the Protocol.  However, the fact that the system had only been used once so far and that only 26 of 
the 153 WTO Members had ratified it raised questions  regarding its effectiveness.  This called for a 
thorough examination of the system and what need ed to be done to improve its functioning.  
Flexibilities available to developing countries with in the framework of the TRIPS Agreement to 
address public health problems needed to be looked at .  He supported the proposal by Egypt to carry 
out a review of the system.  Questions that needed  to be taken up included why the system had not 
functioned as it was meant to, wh at aspects of public health in developing countries should be 
considered, and whether the low number of acceptances of the Protocol was a reflection of the fact 
that the objective had not been met, indicating that  the mechanism was not functioning effectively.  
Based on the periodic review of the system, the Chair should start a study of its effectiveness to 
address the needs of developing countries. 
117. The representative of Norway  said that her delegation had ratif ied the Protocol in February 
2007.  She echoed other delegations in urging Members who had not yet done so to ratify the Protocol 
as soon as possible.  She supported the extension of the period for acceptance until 
31 December 2011, but hoped that the Pr otocol would enter into force earlier. IP/C/M/61 
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  118. The representative of Pakistan
 supported the proposed extension of the period for acceptance 
until 31 December 2011.  His delegation had complete d its domestic legislative procedures to accept 
the Protocol.  The instrument of acceptance would be  submitted to the WTO Secretariat in due course.  
He supported the statements made by Egypt, Tanzania , India and Ecuador, suggesting that a review of 
the system be undertaken in order to check if ther e were any issues with respect to its functioning.  
Consultations in an informal setting would help achieving the shared objective of enhancing access to 
medicines in developing countries. 
119. The representative of Japan  reiterated the importance which his delegation attached to the 
issue of public health, especially where it affected  developing Members.  The Protocol should come 
into effect as early as possible.  It was regrettable that only a limited number of Members had notified 
their acceptance so far.  There was therefore no c hoice but to further extend the period for acceptance 
for another two years.  He urged Members that ha d not yet accepted the Protocol to redouble their 
efforts to complete their domestic procedures a nd to notify their acceptance as expeditiously as 
possible. 
120. The representative of Australia  welcomed the supply of HIV/AI DS medicines from Canada to 
Rwanda under the system.  This demonstrated its effectiveness.  As noted by the delegation of the 
United States, measures could be taken outside of the system too.  The donation of the H1N1 vaccine 
by Australia and other countries to the global supply for the benefit of developing countries 
constituted but one example.  She encouraged othe r Members who had not yet done so to accept the 
Protocol as soon as possible.  Her delegation suppor ted the extension of the period for acceptance of 
the Protocol until 31 December 2011. 
121. The representative of Brazil  supported the interventions by Eg ypt, Tanzania, India, Ecuador 
and Pakistan, suggesting that the functioning of the system established under the Decision be 
reviewed, as there was a pressing need for rendering it  more effective and operational.  Paragraph 6 of 
the Doha Declaration and the system established thereby were milestones in the history of the implementation of the TRIPS Agreement.  Paragr aph 6 provided a much needed and long awaited 
response for the specific situation of countries with limited or no manufacturing capacities.  His 
delegation had actively participated in the negotia tions that had led to the adoption of the Doha 
Declaration.  On 13 November 2008, it had accepted  the Protocol.  He strongly believed in the 
message delivered by the Doha Declaration, accord ing to which intellectual property protection could 
not and should not supersede more fundamental values, such as the protection of life through the access to life-saving drugs in developing countries.   He supported the proposal that the Council hold 
consultations with developing countries and other Members interested in the system to identify 
obstacles that were preventing developing countries from making full use of it. 
122. The representative of China
 said that his delegation had notifie d its acceptance of the Protocol 
on 28 November 2007.  Public health was an import ant issue to his delegation, as well as to many 
other developing countries and LDCs.  The ship ment of HIV/AIDS medicines from Canada to 
Rwanda was the first case to test the functioning of the system established under the Decision.  It 
deserved thorough examination, as it had already rev ealed some hurdles with respect to the lengthy 
process leading to the shipment.  The annual revi ew provided an important platform for future 
discussions.  He supported the request by Egypt, Tanzania and India that the TRIPS Council hold 
informal consultations on how to improve the f unctioning of the system.  He also proposed the 
organization of a workshop specifically dedicated to  the experience made in the case of supply of 
generic medicines from Canada to Rwanda under the system be considered. 
123. The representative of Venezuela  noted that most of the Members who had accepted the 
Protocol were developed countries and that preci sely those Members were asking for the acceptance 
of the Protocol by other Members.  He wondered wh ether this was not contradicting the objective of  IP/C/M/61 
 Page 27 
 
 
  the system whose aim was to support developing coun tries.  He supported the proposal by Ecuador to 
examine the functioning of the system, in particular  whether it met the needs of developing countries. 
124. The representative of El Salvador  said that her delegation, who had already accepted the 
Protocol Amending the TRIPS Agreement in 2006, supported the extension of the period for its 
acceptance until 31 December 2011. 
125. The representative of Angola  supported the statements made by Egypt and Tanzania, 
suggesting that consultations be launched in order to identify the obstacles preventing Members from 
accepting the Protocol.  The system had been ne gotiated by developing countries, but mostly 
developed countries had accepted the amendment of the TRIPS Agreement.  There was a lack of 
information which needed to be addressed by th e TRIPS Council and through technical assistance.  
This could help setting up local manufacturing capac ities to produce anti-malaria medicines instead of 
importing them, ensuring thus transfer of technol ogy.  This would make many more Members accept 
the Protocol as a means to reduce imports of costly  medicines.  As part of its capacity building 
activities, the WTO Secretariat should look at how best to sensitize Member s to the benefits of 
accepting the TRIPS amendment, including by setting up local production facilities to reduce the costs 
arising from the import of medicines. 
126. The Chairperson  proposed that the Council agree on forwarding to the General Council the 
proposal for a decision to extend the period for acce ptance of the Protocol until 31 December 2011.  
She suggested that the last paragraph of the draft decision by the Gene ral Council contained in 
Annex 2 to the draft report (JOB(09)/128) be comple mented by inserting this date.  She also proposed 
that the Council agree to the cover note to the report contained in JOB(09)/128 and also that the 
Council minutes containing the record of the discussion be attached to it. 
127. The Council so agreed . 
128. The Chairperson  reverted to the suggestion made by Egypt and Tanzania, supported by 
certain other delegations, that she hold consultati ons with interested delegations to examine the 
experiences regarding the use of the system, including obstacles, if any, to its effective operation.  She 
asked whether such informal consulta tions were acceptable to Members. 
129. The representative of the United States  said that the request for consultations and the way it 
was framed were assuming that there were barriers to the implementation of the system.  This was 
contradicted by the effective implementation that ha d been described by Canada and the shipment of 
medicines to Rwanda.  While it was important to c ontinually evaluate practical experiences with its 
implementation, the system provided for an annual review which should serve to discuss practical 
experiences with respect to its implementation. 
130. The representative of Egypt  said that the system had been used only once in four years.  
Given the nature and gravity of the problem to be addressed, there were legitimate concerns about the 
limited use of the system so far.  In addition to  the agenda item on the annual review of the system, 
the Chair could therefore usefully explor e the issues with interested delegations. 
131. The representative of India  said that there was a prima facie case given that the system had 
been used only once in six years.  This had not b een the expectation when the system was negotiated 
in 2003.  While there were legitimate concerns , his delegation did not attempt to prejudge the 
outcome of informal consultations by the Chair.  T hose were merely requested to explore if there were 
obstacles, and, if so, what kind of obstacles.  It sh ould also be borne in mind that this was a request 
made by the LDC Group and the African Group which accounted for a large number of the 
anticipated beneficiaries of the system.  He felt that  informal consultations would be useful and, as the IP/C/M/61 
Page 28  
 
  delegation of the United States had mentioned, experiences could also be shared during such 
consultations. 
132. The representative of Ecuador
 concurred with the statements  made by Egypt and India.  
Taking up questions addressing the concerns expr essed with respect to experience with the 
functioning of the system would neither have a ne gative connotation nor prejudge the outcome of the 
discussion.  He supported the proposal that the Ch air hold informal consultations with interested 
Members in order to discuss the issues raised. 
133. In support of the statements made by Egypt,  India and Ecuador, the representative of China  
said that a single case of use of the system within six years could not be characterized as effective functioning.  Without wanting to draw any immediat e conclusion from that experience, his delegation 
merely requested that informal consultations be  initiated, as had been done on many other occasions 
by the Council, as well as by other WTO bodies.  Informal consultations would provide a good 
opportunity for an open-minded exchange of views and experiences without imposing any obligations 
on Members. 
134. The representative of the United States
 said that her delegati on could go along with the 
organization of one round of informal consultations by  the Chair, provided that this was not going to 
be looked at in any prejudiced way, either positive or  negative.  This would allow Members to discuss 
the implementation of the system and their experien ces.  Her delegation expected, however, that there 
be no outcome document other than, possibly, the re porting to the Council of what had been discussed 
in the informal consultations. 
135. In the light of the di scussion, the Chairperson  suggested that she hold informal consultations 
on the operation of the paragraph 6 system befo re the Council's next formal meeting without 
prejudging the outcome.  A single round of informal  discussions with interested delegations would 
provide a platform to share experiences and to lo ok at concerns in an informal setting.  Members 
should inform the Chair or the Secretariat of thei r interest to participate in the consultations. 
136. The Council so agreed . 
H. NON-VIOLATION AND SITUATION COMPLAINTS  
137. The Chairperson  recalled that paragraph 45 of the Hong Kong Ministerial Declaration 
directed the TRIPS Council to continue its examina tion of the scope and modalities for complaints of 
the types provided for under subparagraphs 1(b)  and 1(c) of Article XXIII of GATT 1994 and make 
recommendations to the next session of the Minister ial Conference.  It was agreed that, in the 
meantime, Members would not initiate such  complaints under the TRIPS Agreement. 
138. At its meeting on 20 October 2009, the Ge neral Council had taken note of its Chair's 
statement on his consultations on the prepara tion of the Seventh Session of the Ministerial 
Conference, as contained in document JOB(09)/144.  She had stated, inter alia , that the consultations 
held on TRIPS non-violation and e-commerce by, respectively, the Chair of the TRIPS Council and DDG Singh had indicated a consensus on placing th ese issues on the Provisional Agenda for the 
Ministerial Conference.  The Provisional Agenda had been circulated on 23 October in document 
WT/MIN(09)/W/2 and it specifically referred to these two issues as items for possible action. 
139. Given that this was its last formal meeting before the Ministerial Conference, the TRIPS 
Council should consider whether it could agree on any recommendation on TRIPS non-violation.  She 
said that, as requested by the Council, she had con tinued her consultations on this matter.  Most 
delegations that had spoken on this issue had indicat ed that their preference remained to determine 
non-violation complaints inapplicable to TRIPS but th at they were willing to compromise by agreeing  IP/C/M/61 
 Page 29 
 
 
  that, first, the Council recommend the further exte nsion of the moratorium, second, the extension 
would be until the next Ministerial Conference and, third, the Ministers' decision would use language 
that would follow as closely as possible the language used in the Hong Kong Ministerial Declaration.  
However, some other delegations were of the view  that the moratorium should expire but they had 
shown flexibility in being ready to explore the matter. 
140. The representative of Japan  believed that the TRIPS Council s hould continue its examination 
of the scope and modalities of non-violation comp laints and, therefore,  supported the further 
extension of the moratorium. 
141. The representative of Egypt, speaking on behalf of the African Group , said that violations of 
the type identified in Article XXIII.1:  (b) and (c) of GATT 1994 should be determined inapplicable 
to the TRIPS Agreement, thus establishing the pred ictability essential to the efficient functioning of 
the TRIPS Agreement, particularly the rights and obli gations therein.  However, without prejudice to 
this position, the African Group could accept the renewal of the moratorium as suggested. 
142. The representative of India  recalled that the position of his delegation was that non-violation 
and situation complaints should be determined inapplicable to the TRIPS Agreement.  However, in 
the spirit of compromise and in an effort to have a smooth Ministerial Conference, it could agree with 
the emerging consensus that the moratorium be co ntinued until the next Ministerial Conference, 
following the Hong Kong language as closely as possible.  
143. The representative of the United States  continued to be of the view that it was entirely 
appropriate that non-violation and situation complaints be applicable to the TRIPS Agreement and 
that the moratorium expire at the next Ministeria l Conference.  In the past, Members had agreed to 
extend the moratorium in order to allow Members to submit proposals on scope and modalities.  This 
had been a significant concession on the part of  the United States.  Her delegation had shown 
considerable flexibility in joining consensus to place this issue on the agenda for the upcoming 
Ministerial Conference.  Unfortunately, this flexibilit y had not been reciprocated in another important 
area of work for the Ministerial Conference.  Under the circumstances, her delegation had to continue 
to stand firm on its position regarding the expiry of the moratorium.  
144. The representative of Ecuador  said that it was not possible to extrapolate rules that had been 
originally envisaged for trade in goods as cont ained in GATT 1994 and apply them to intellectual 
property as regulated by the TRIPS Agreement.  He said that non-violation complaints had no basis in 
the multilateral system and hence were not applicab le to the TRIPS Agreement.  However, in a 
constructive spirit, he was prepared to consider the Chair's suggestion. 
145. The representative of China  was of the view that non-violati on and situation complaints were 
not applicable to the TRIPS Agreement.  However,  to demonstrate his flexibility, he wished to 
support the extension of the moratorium.  He said that there was an intere sting interpretation of 
paragraph 45 of the Hong Kong Ministerial Declar ation according to which, in the absence of any 
agreement, the moratorium would expire.  He wondered how this interp retation could be in 
conformity with paragraph 45, in which Minist ers had clearly instructed the TRIPS Council to 
examine the issue and make recommendations to their next session.  
146. The representative of Pakistan  said that, while he could accept the extension of the 
moratorium until the next Ministerial Conference,  his position was that non-violation and situation 
complaints were not relevant in the context of th e TRIPS Agreement.  He appreciated the flexibility 
shown by the United States.  Nevertheless, in his view, the establishment of a linkage with electronic 
commerce was not helpful.  IP/C/M/61 
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  147. The representative of Venezuela
 said that his delegation shared the view of other delegations 
that non-violation and situation complaints were not applicable to the TRIPS Agreement.  His 
delegation was prepared to agree on the moratorium  and thanked other dele gations that had shown 
great sensitivity in accepting this moratorium.  
148. The representative of Switzerland  said that his position remained unchanged.  From the 
systemic point of view, the TRIPS Agreement was one  of the three main pillars of the WTO system 
and therefore the principle of non-violation should be  applicable also in the context of the TRIPS 
Agreement.  From a legal point of view, Article  64.2 and 3 made a clear and unambiguous reference 
to non-violation and situation complaints.  The fact  that Article 64 provided for a moratorium meant 
that, after expiration, such complaints would b ecome applicable under the TRIPS Agreement.  The 
purpose of the moratorium had been to allow the examination of the scope and modalities of 
non-violation and situation complaints in the TRI PS context with a view to making recommendations 
to the Ministerial Conference.  Although his delegation believed that the Dispute Settlement 
Understanding provided sufficient guidance in even t that a non-violation or situation complaint 
should occur in the TRIPS context, it had consente d to extending the moratorium three times.  
However, during the last four years no proposals or  submissions had been made by delegations on 
scope and modalities.  Therefore, his delegation was of  the view that the moratorium should expire at 
the forthcoming Ministerial Conference.  Throughout the discussion on this matter in the Council over 
the last 14 years, his delegation had confirmed its willingness to discuss with other Members, without prejudice to its substantive position.  It was r eady to further explore the matter, presupposing, 
however, that this had to apply similarly to th e moratorium discussion in this one and related 
discussions in other forums in the WTO.  He said that his delegation did not see itself in a position to 
agree on a recommendation in isolation in this C ouncil and requested that the Chair continue her 
consultations with Members and rele vant colleagues in other WTO bodies.  
149. The representative of Peru
, supporting the statements by India, Egypt, Ecuador and Pakistan, 
said non-violation and situation complaints were not necessary to protect the balance in the TRIPS 
Agreement, since Members were not obliged to appl y a higher level of protection.  Therefore, such 
complaints were not applicable in the context of TRIPS.  However, in the spirit of compromise, he 
was ready to agree to an extension of the mo ratorium until the next Ministerial Conference.  
150. The representatives of Argentina , Malaysia , the European Communities , Norway  and Kenya  
said that they considered that non-violation and situ ation complaints were inapplicable to TRIPS.  
However, in the spirit of compromise and to ensu re a smooth Ministerial Conference, they were 
willing to agree that the Council recomm end the extension of the moratorium.  
151. The Chairperson  proposed that the Council keep this agenda item open and that she continue 
her consultations.  She said that she hoped to be ab le to reconvene the Council, once the further work 
was sufficiently mature, with a view to the Council agreeing on a recommendation to the Ministerial 
Conference.  
152. The Council took note  of the statements and agreed  to proceed as suggested by the Chair.  
153. At the Council's reconvened meeting on 6 November, the Chairperson  recalled that, at its 
meeting of 27 and 28 October 2009, the Council had agreed to keep open the agenda item on 
non-violation and situation complaints and that she continue her consultations on the matter.  In the 
light of the consultations, she suggested that th e Council agree to recommend, pursuant to paragraph 
45 of the Hong Kong Ministerial Declaration, that the Seventh Session of the Ministerial Conference 
decide as follows:  
"We take note of the work done by th e Council for Trade-Related Aspects of 
Intellectual Property Rights pursuant to pa ragraph 11.1 of the Doha Decision on  IP/C/M/61 
 Page 31 
 
 
  Implementation-Related Issues and Concer ns and paragraph 45 of the Hong Kong 
Ministerial Declaration, and direct it to continue its examination of the scope and modalities for complaints of the types provide d for under subparagraphs 1(b) and 1(c) 
of Article XXIII of GATT 1994 and make recommendations to our next Session, 
which we have decided to hold in 2011.  It  is agreed that, in the meantime, Members 
will not initiate such complaints under the TRIPS Agreement." 
154. The Council so agreed
. 
I. REVIEW OF THE IMPLEMENTATION OF THE AGREEMENT UNDER ARTICLE 71.1 
155. No statements were made  under this agenda item.  
156. The Council agreed  to revert to the matter at its next meeting.  
J. REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON GEOGRAPHICAL 
INDICATIONS UNDER ARTICLE 24.2 
157. The Chairperson  recalled that Article 24.2 provided that the Council should keep under 
review the application of the provisions of the GI Section of the Agreement.  She urged those delegations that had not yet provi ded responses to the Checklist of Questions contained in document 
IP/C/13 and Add.1 to do so.  Also those Members that had already provided responses could provide 
updates to the extent there had been any significant changes on the way they provided protection to geographical indications.  
158. The Council agreed
 to revert to the matter at its next meeting. 
K. SEVENTH ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE DECISION ON THE 
IMPLEMENTATION OF ARTICLE 66.2  OF THE TRIPS  AGREEMENT  
159. The Chairperson  recalled that, at its meeting in Fe bruary 2003, the Council had adopted a 
decision on the "Implementation of Article 66.2 of  the TRIPS Agreement".  Paragraph 1 of the 
Decision provided that developed country Member s should submit reports a nnually on actions taken 
or planned in pursuance of their commitments under Artic le 66.2.  To this end, they were to provide 
new detailed reports every third year and, in the intervening years, provide updates to their most 
recent reports.  These reports were to be submitted prior to the last Council meeting scheduled for the 
year in question.  She said that the second set of  detailed annual reports under the Decision had been 
presented to the Council's meeting in October 2006.  At its meeting in June 2009, the Council had 
requested developed country Members to submit a th ird set of new detailed reports on actions they 
had taken or planned in pursuance of their co mmitments under Article 66.2 for the present meeting.  
160. The Council had received new detailed repor ts from the following developed country 
Members:  Japan, the United States, Australia, Switzerland, Norway, Canada and New Zealand  
(being circulated in document IP/C/W/536 and addenda).   
161. As regards the purpose and conduct of the revi ew of this information, she recalled that 
paragraph 2 of the Decision on the Implementation of Article 66.2 of the TRIPS Agreement explained 
that the annual review meetings should provide Me mbers with an opportunity to pose questions in 
relation to the information submitted and request add itional information;  discuss the effectiveness of 
the incentives provided in promoting and encouragin g technology transfer to least-developed country 
Members in order to enable them to create a sound and viable technological base;  and consider any 
points relating to the operation of the reporting procedure established by the Decision.  IP/C/M/61 
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  162. She said that, since some of the information had only been received very recently and most of 
it was available only in its original language, she intended to provide an opportunity at the next meeting for Members to make further comments on  the information submitted for the present meeting 
that they might not yet have been able to study, and on any further information that might be provided 
before the next meeting.  
163. Furthermore, she recalled that the Secretariat had organized in 2008, at the request of the 
delegation of Lesotho on behalf of the LDC Gr oup, a workshop on transfer of technology under 
Article 66.2 back-to-back with the Council's end-of-y ear meeting.  At that meeting, the representative 
of Lesotho had expressed his appreciation of the ev ent and requested that the Secretariat organize 
another workshop during the current year.  Pursuant to this request, the Secretariat had organized the 
day before the current meeting another workshop  that had brought together LDC and developed 
country experts to discuss transfer of technology under Article 66.2  
164. The representative of Tanzania, speaking on behalf of the LDC Group
, thanked the Secretariat 
for organizing the workshop that had been very  constructive and useful.  He expressed his 
appreciation to developed country Members that had already taken positive measures and requested 
that they seriously consider the exchanges at the workshop.  
165. At the LDC Trade Ministerial Meeting, held on 14-16 October, Ministers had urged 
developed country Members to effectively implemen t their obligations pursuant to Article 66.2 to 
provide incentives to enterprises and the institutions  within their territories to achieve effective 
technology transfer to LDCs.  Ministers had al so requested the establishment of a monitoring 
mechanism to review situations where enterprises  and institutions in de veloped country Members 
provided technology transfer to LDCs as a result of  the incentives and the effectiveness at creating a 
viable technological base in LDCs. 
166. The representative of Bangladesh  thanked those developed country Members who had 
submitted their reports on the implementation of Ar ticle 66.2 of the TRIPS Agreement and for the 
assistance provided to LDCs.  He recalled that the first workshop held in 2008 had been a very useful 
pathfinder.  At the workshop, fruitful discu ssions had taken place on the implementation of 
Article 66.2, which had allowed for a better understanding on how to improve the quality of 
information for the beneficiary LDCs.  He thanked the Secretariat for the preparation of the summary 
of projects and requested the Secretariat to organi ze a similar workshop in 2010 back-to-back with the 
Council's end-of-year meeting. 
167. Supporting the statement by Tanzania, he said th at technology transfer was vital to improve 
productive capacity in LDCs.  LDC Trade Minister s had highlighted the need for an effective 
implementation of the obligation on developed country Members to provide incentives to enterprises 
and institutions within their territories that achieve d effective technology transfer to LDCs, as well as 
for a monitoring mechanism to review and evaluate to what extent incentives had been given and how 
far they had resulted in technology transfer to LDCs. 
168. He said that (i) Article 66.2 was binding in nature, so far as providing of incentives was 
concerned and was not of best-endeavour type;  (ii)  reporting should be LDC-specific;  (iii) reports 
should focus on the provision of incentives to enterp rises and institutions and the resulting transfer of 
technology;  (iv) the specific budgets allocated should be mentioned in the reports;  (v) reports should 
list the specific products;  and (vi) reports s hould be organized per LDC, project and budget 
allocation. 
169. He continued by saying that six years had lapsed since the Council's Decision of 
February 2003 and it was time to agree on a common format for reporting.  Furthermore, there should 
be a common understanding among developed count ry Members and recipient LDCs about the  IP/C/M/61 
 Page 33 
 
 
  provision of incentives, as well as on the definition of  "transfer of technology" .  He wondered whether 
LDCs could be assured that each and every deve loped country Member had submitted all periodic 
reports on the actions taken or planned, as provided for in the TRIPS Council Decision of 
February 2003.  There was a basic difference between Articles 66.2 and 67 of the Agreement.  The first one dealt with the provision of incentives to transfer technology to LDCs for creating a viable 
and sound technological base and the second dealt w ith technical assistance to both LDCs and 
developing countries.  Most of the reports fell in to the second category, which was not the purpose of 
this annual review.  He urged deve loped country Members to report solely on Article 66.2, and not on 
Article 67.  His delegation looked forward to h earing from developed country Members about the 
progress and value-added achieve d since the 2008 reports. 
170. The representative of Switzerland
 thanked the WTO Secretaria t and participating Members 
for their contributions towards the workshop on  Article 66.2.  The cooperation between the 
stakeholders ensured openness and the positive spir it that would certainly assist in solving many 
issues and achieving more effective reporting of in centives for technology transfer to LDCs.  During 
the workshop, quality improvements geared at enhancing transparency, readability and 
comprehensibility of Article 66.2 reports were shown.   He said that his delegation was working on its 
reporting on incentives for technology transfer a nd encouraged LDC Members to focus on their 
national frameworks, so that more enterprises would d ecide to transfer the technology.  His delegation 
would gladly participate in and contribute to th e next workshop, when developed country Members 
would present their updated reports under Article 66.2.  
171. The representative of Egypt, speaking on behalf of the African Group , said that the African 
Group looked forward to the effective implemen tation of the obligation on developed country 
Members to provide incentives to enterprises and in stitutions within their territories, that could 
achieve effective technology transfer to LDCs, in  accordance with Article  66.2.  Indeed, this 
obligation on developed country Members flowed  directly from the objectives of the TRIPS 
Agreement enshrined in Article 7.  In pursuance of this goal, the African Group believed that the 
establishment of a monitoring mechanism to review  situations where enterprises and institutions 
within developed country Members had provided tec hnology transfer to LDCs was an effective means 
of quantifying the impact.  Ultimately, the results of such incentives and their effectiveness at creating 
a viable technological base in the LDCs should be  measured against this monitoring mechanism to 
establish whether or not the objectives of the TRI PS Agreement were being met.  The African Group 
sought an implementation of the TRIPS Agreem ent that promoted innovation in pertinent 
technologies for LDCs.  Finally, he called for the prov ision of financial and technical assistance to all 
LDCs for their needs assessments and to support their ability to develop capacities for implementing 
the TRIPS Agreement.  
172. The representative of the European Communities  said that his delegation was committed to 
the review and to the provision of incentives for tech nology transfer under Article 66.2 with a view to 
helping LDCs create a sound and viable technological base.  His delegation would submit its report in 
the coming days.  
173. He thanked the LDC Group for its initiativ e to hold a second workshop and the WTO 
Secretariat for organizing this successful event.  The workshop had allowed for fruitful exchanges of 
views between developed country and LDC Member s on the implementation of Article 66.2.  A 
number of issues had been highlighted and some pr actical suggestions had been made which were 
useful for the future.  His delegation stood ready to further discuss how to improve the reporting 
mechanism and was ready to par ticipate in a similar workshop.  
174. The representative of Angola  thanked delegations for thei r exhaustive reports on the 
implementation of Article 66.2.  He said that it w as important that, in the context of Article 66.2, 
developed country Members provide greater subsidies to their enterprises to promote clean IP/C/M/61 
Page 34  
 
  technology.  This had a cross-cutting importance, par ticularly in the light of the forthcoming meeting 
in Copenhagen.  It was also important to assist LDCs  with regard to infrastructure and the creation of 
local content.  He hoped that in October 2010, those two aspects would be reflected in the reports to 
satisfy the needs of LDCs  
175. The Chairperson
 thanked the Secretariat for organizi ng and the delegations concerned for 
their contributions at the workshop that, in the light of the comments made, had been very 
constructive.  She noted the request by Banglad esh for another workshop and trusted that the 
Secretariat would follow it up as appropriate.  Noting that the European Communities had indicated 
that it was submitting its report shortly, she urged those developed country Members that had not yet 
provided reports to do so.  She reiterated her inten tion to provide an opportunity, at the Council's next 
meeting, for Members to make further comments on the information submitted for this meeting that 
they had not yet been able to study.  
176. The Council took note  of the statements made.  
L. TECHNICAL COOPERATION AND CAPACITY BUILDING  
177. The Chairperson  recalled that the Council had agreed, at its meeting in June, to hold its 
annual review of technical cooperation at the present meeting.  In preparation for this annual review, 
developed country Members had once more been requ ested to update information on their technical 
and financial cooperation activities re levant to the implementation of  the TRIPS Agreement.  Other 
Members who had also made available technical c ooperation were encouraged to share information 
on these activities if they so wished.  In addition, intergovernmental organizations observers to the 
Council as well as the WTO Secretariat had b een invited to provide information. 
178. The Council had received information from th e following developed country Members:  
Japan, the United States, Australia, Switzerland, No rway, Canada and New Zealand (being circulated 
in document IP/C/W/539 and addenda ).  Updated information had b een received from the following 
intergovernmental organizations:  OECD, WIPO  and UNCTAD (being circulated in document 
IP/C/W/541, addenda and revisions).  In addition, the IMF had informed the Secretariat, by means of 
a communication dated 6 October 2009, that it provided  a wide range of technical assistance related to 
its mandate in core areas such as fiscal policy, monetary policy, the financial sector, and economic 
statistics but that it, however, had no technical assistance programmes related specifically to 
intellectual property or to the implementation of the TRIPS Agreement.  Updated information on the 
WTO Secretariat's technical cooperation activities in the TRIPS area could be found in document 
IP/C/W/535. 
179. She also recalled that paragraph 2 of the TRIPS Council's 2005 decision on the "Extension of 
the Transition Period under Article 66.1 for Least-D eveloped Country Members" provided that "with 
a view to facilitating targeted technical and financ ial cooperation programmes, all the least-developed 
country Members will provide to the Council for TR IPS, preferably by 1 January 2008, as much 
information as possible on their individual priority needs for technical and financial cooperation in 
order to assist them taking steps necessary to impl ement the TRIPS Agreement".  To that date, the 
Council had received such informati on from Sierra Leone and Uganda. 
180. She further recalled that, at the Council's mee ting in June, Angola and Tanzania on behalf of 
the LDC Group had requested the Secretariat to organize a workshop on LDC needs assessments, and 
a number of other Members had requested the Secretariat to contact the WTO Secretariat coordinator of Aid for Trade and the Integrated Framework Ex ecutive Secretariat to in form Council Members of 
the opportunities under these initiatives and advise LDCs  on the steps they would need to take in 
order to take advantage of these opportunities.  IP/C/M/61 
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  181. She said that, in response to the request from the LDC Group, the Secretariat was organizing 
a workshop on LDC priority needs for technical  and financial cooperation on 29 October 2009 
bringing together delegates and other official s from LDCs and donor countries, and from the WTO 
and WIPO Secretariats.  This was a technical-level workshop to promote practical dialogue and coordination on the needs assessment process.  Th e workshop followed up similar exercises held 
before, and was part of a concerted programme of  coordination and information sharing so as to 
enhance the alignment of available resources w ith the needs identified by LDCs.  Depending on 
feedback and guidance received from the concerned Members, it was envisaged that the Secretariat 
would organize follow-up activities in the coming year. 
182. As regards the request for information relating to activities of the Aid for Trade initiative and 
the Integrated Framework Executive Secretariat, Mr Hans-Peter Werner from the WTO Development 
Division coordinating the Aid for Trade initiative and Ms Sari Laaksonen, Depu ty Coordinator of the 
Integrated Framework Executive Secretariat, had agreed to brief the Council on these two initiatives.  
In preparation for this meeting, the Secretariat had also compiled information it had received on the 
respective roles of these two initiatives with r espect to the LDC need s assessment process and 
circulated it for the Council's information in a background note IP/C/W/544. 
183. Furthermore, she said that Brazil had ju st submitted an addendum to its earlier 
communication on "Technical Cooperation and Capacity Building:  'Cluster' A of the Development Agenda", circulated in document IP/C/W/513 (bei ng circulated in document IP/C/W/513/Add.1). 
184. The representative of the WTO Secretariat Development Division
 said that Aid for Trade 
aimed to help developing countries, particularly LD Cs, to build supply-side capacity and trade-related 
infrastructure.  As a result, they would benef it more from WTO Agreements, expand their trade and 
benefit more from the multilateral trading system.  Aid for Trade was part of the Official Development Assistance (ODA) – grant and c oncessional loans – targeted at trade-related 
programmes and projects.  It was a broad activity a nd not readily defined.  The idea had started in 
Hong Kong, China, at the Ministerial Conference in December 2005 and resulted in a Task Force 
which conducted its work throughout 2006.  He said that it was important to understand that Aid for 
Trade was not a new global development fund but more an integral part of normal, programmable 
ODA.  About 20 per cent of annual ODA was devoted to building supply-side capacities, particularly 
for low and middle income countries that engaged in international trade. 
185. Aid for Trade covered various areas:  (i) trad e policy and regulations , which could include 
aspects of intellectual property rights;  (ii) trade development, which mainly focused on investment 
promotion and institutional support for business and trad e in services;  (iii) trade-related infrastructure 
which covered physical infrastructure such as ports , roads, railways, bridges, water systems and 
electricity generation;  and (iv) other areas incl uding trade-related adjustme nt which included support 
for a loss of revenues due to trade reform. 
186. The Task Force had underscored the global acc ountability of Aid for Trade flows which were 
monitored by the OECD and included questionnaires wh ich were then sent to all beneficiaries.  The 
data on aid flows, and priority needs of LDCs and developing countries were then included in two 
publications published for the first and second Globa l Reviews on Aid for Trade called "Aid for Trade 
at a Glance".  The first publication was released in  November 2007.  The last went out in July 2009. 
187. He explained that Aid for Trade flows amounted to US$25.4 billion in 2007.  This figure was 
US$4.3 billion higher than during the baseline period of 2002-2005.  This was an increase which had 
not come at the expense of overseas development assi stance provided in other areas such as health or 
education.  The share of flows going to suppor t trade policy and regulation helped low income 
countries to develop trade strategies but represented only three per cent of the entire US$25 billion. IP/C/M/61 
Page 36  
 
  188. The OECD/WTO Doha Development Agenda Tr ade Capacity Building Database had tracked 
588 entries for trade-related IPR activities.  These had been provided by 15 different sources, including WTO Members, specifically Australia, th e European Communities and its member States, 
Japan, Korea and Norway, as well as internationa l organizations including APEC, Inter-American 
Development Bank, Islamic Development Bank, WI PO and WTO.  For example, the technical 
assistance programmes that the WTO conducted in th e area of intellectual property were included 
amongst the 588 entries.  In the past, assistance wi th trade-related intellectual property amounted to 
some US$12.1 million between 2002 and 2005 and had ri sen to US$27.4 million in 2007.  This figure 
needed to be treated with some  caution because it was hard to differentiate the actual amount of Aid 
for Trade that went to IPR-related activities.  The best approach was to act ually request information 
from the receiving country to see what kind of project had been implemented or what kind of 
technical assistance had been provided.  That said,  even though it was impossible to offer an accurate 
picture of the assistance offered and supportive IPR-re lated activities, it was clear that implementation 
of the TRIPS Agreement was an integral component of Aid for Trade, both at the practical level of 
projects on the ground and at the conceptual level of the coverage of the definition of Aid for Trade.  
Aid for Trade had come a long way since the 2005 Hong Kong Ministerial Conference, and would 
continue, given the 2009 to 2011 work programme. 
189. Finally, he underlined a few key points:  (i) pledges that had been made by governments to 
continue Aid for Trade flows would be maintained  and even improved, especially in light of the 
current economic crisis;  they would continue to be predictable, sustainable and effective;  (ii) work 
would continue on promoting mainstreaming trad e into national and regional economic planning 
frameworks;  (iii) the regional dimension of Aid for Trade was extremely important for the regional 
donors, including development ba nks, regional economic communities and bilateral donors, taking the 
lead in developing and realizing Aid for Trade pr ojects;  (iv) further work would be conducted on 
evaluation and monitoring mechanisms that tracked th e impact of Aid for Trade;  and (v) the private 
sector role had to be highlighted since it w as the private sector that engaged in trade. 
190. The representative of the Integrated  Framework Executive Secretariat
 said that the Integrated 
Framework (IF) was Aid for Trade in action for LDCs .  In other words, the IF was a mechanism that 
LDCs used to make Aid for Trade work for their pur poses.  Presently, the IF was often referred to as 
the Enhanced Integrated Framework (EIF).  Th is was because the programme, the IF, had been 
undergoing a process of improvement, or enhancement,  over the past couple of years.  The EIF was, 
however, not a new programme and the enhanced vers ion of the IF merely took over from where the 
IF left LDCs before the enhancement. 
191. The IF's overall objective was to support LDCs to further and better integrate into the global 
trading system.  The key IF principles were:  (i ) the IF was a process that aimed to support LDC 
governments in trade capacity building and integratin g trade issues into overall national development 
strategies;  (ii) the IF was a partnership compri sing of LDC governments, bilateral, regional and 
global development partne rs and the six IF core agencies (IMF, ITC, UNCTAD, UNDP, World Bank 
and the WTO);  and (iii) the IF was built on the prin ciples of country ownershi p, partnership, and no 
intervening external conditions. 
192. Experience with the IF so far showed that the trade development needs of the LDCs covered a 
wide area and typically included increasing macr oeconomic stability, developing trade policy and 
trade administration capacity, enhancing efficient management of import and export procedures to 
supply-side constraints, meeting international st andards, developing infrastructure, and developing 
export promotion capacity and developing targeted ec onomic sectors.  This, while extensive, was not 
a conclusive and exclusive list of trade developmen t needs – in the context of the IF, it was for the 
LDCs to define their own needs and the needs varied , to some degree, from one LDC to another.  The 
implementation of the TRIPS Agreement could therefore be an integral part of the IF, provided that 
LDCs made it a priority in their domestic IF processes.  IP/C/M/61 
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  193. The IF process consisted of the following f our phases:  (i) awareness-building on the 
importance of trade for development in the benefici ary LDC, and establishing/strengthening of the IF 
in-country governance structure;  (ii) preparing a Diagnostic Trade Integration Study (DTIS) or a 
DTIS update to identify constraints to overall comp etitiveness and sectors of greatest export potential.  
The DTIS included an Action Matrix – a list of trad e priorities – for better integration into the global 
trading system, as well as a write-up on the LDC's strategy for the IF implementation;  
(iii) mainstreaming – or integrating – trade into  the national development strategy – making trade 
really work for the country's development goals ;  and (iv) seeking financing from development 
partners and the EIF Trust Fund for prior ity actions requiring external funding. 
194. The DTIS exercise, the analytical part, was an  important component of the IF process.  A 
DTIS and its updates was a detailed analysis by th e LDC identifying the constraints to the overall 
competitiveness and sectors of greatest export poten tial.  The DTIS and its Action Matrix provided 
key inputs for mainstreaming, or integrating the trade priorities into the country's national 
development strategy, such as the Poverty Reduction Strategy Paper (PRSP).  The mainstreaming, in 
turn, would feed the trade priorities into the dialog ue between the LDCs and their donors.  This would 
facilitate the generation of the bulk of necessary funding for the priorities resulting from the DTIS 
process. 
195. The IF was by its nature a partnership.  The IF Focal Point, who was often a Director or a 
Vice-Minister at the Ministry of Trade, was, with funding available from the Enhanced IF Trust Fund, assisted by a National Implementation Unit.  At the national level, the IF Steering Committee was the forum for decision-making and coordination between  the various government entities expected to 
participate in the IF process, as well as the Privat e Sector and in some countries, the Civil Society 
entities.  The national players were supported by the IF donor Facilitator in-country and by the IF 
Executive Secretariat – based at the WTO, the Trust Fund Manager which was the UN Office for 
Project Services (UNOPS) and the IF Board.  The Board supervised the overall IF programme at the 
global level and consisted of representatives of the LDCs, donors and the IF core agencies. 
196. Finally, moving to the question of how LDCs' IPR priority needs could be addressed through 
the IF, she said that it all started at home.  To re ceive funding for IPR priorities through the IF – be it 
from the development partners present in the country  or from the global EIF Trust Fund – IPR issues 
needed to appear in the DTIS and IPR activities had to be prioritized in the DTIS Action Matrix.  For 
those LDCs that had already had their DTIS written and that were going to up date them, IPR issues 
should appear in the up-dated DTIS and Action Matr ix.  The IF built on country ownership and it was 
for the LDC government to decide which trade de velopment issues should be covered by the DTIS 
and which activities should be prioritized for funding by the Action Matrix.  Thus, for anyone seeking to promote taking on board the IPR needs, it was extrem ely important to make sure that the IPR sector 
be analysed by the DTIS or its up-date and that the findings be translated into priority actions.  To do 
this, the national IPR entities might wish to cons ider contacting the countries' IF Focal Point. 
197. The representative of Brazil
 recalled that document IP/C/W/ 513, circulated in June 2008, 
proposed that the WIPO Development Agenda prin ciples be adopted as a fra mework for technical 
cooperation and capacity-building activities carried out  under TRIPS Article 67.  The ongoing debate 
in the Council on how to achieve effective complia nce with obligations under that Article would 
greatly benefit from the contribution of the inte nse and broad discussions going on at WIPO on the 
implementation of its Development Agenda.  Cluster A of the WIPO  Development Agenda contained 
14 recommendations on technical assistance and capacity-building. 
198. At the Council's previous meeting, some delegations had expressed concern that the 
application of the WIPO Development Agenda frame work to capacity-building activities related to 
TRIPS obligations would be complicated.  He sai d that his understanding was that the Development 
Agenda recommendations were aimed at transparen t, accountable and demand-driven cooperation.  IP/C/M/61 
Page 38  
 
  They could easily be applied to South-South coope ration and there should be  no reason for them not 
to be applied to North-South capacity building in tech nical cooperation.  In this regard, he referred to 
the addendum to document IP/C/W/513/Add.1 which presented a project developed in Mozambique 
on sanitary controls related to pharmaceuticals.  Th is initiative respected all the principles enshrined 
in the WIPO Development Agenda.  He hoped that, by demonstrating how easily the WIPO 
Development Agenda recommendati ons could be followed, this  document could overcome the 
resistance of the few countries that opposed the adoption of document IP/C/W/513. 
199. The representative of Argentina
 said that her country was among those who had sponsored 
the WIPO Development Agenda and participated in the negotiations which had resulted in the 
adoption of the Agenda.  Argentina supported Br azil's document IP/C/W/513 and believed that the 
principles of the Development Agenda were  also applicable in the TRIPS Council. 
200. The representative of Ecuador  reiterated his delegation's s upport for document IP/C/W/513.  
The Council should take into consideration WIPO 's work in the framework of the Development 
Agenda and its principles since there was already im plementation in this cont ext and the information 
that was available could be useful to the Council.  There was clear provision in Articles 7 and 8 of the 
TRIPS Agreement on transfer of technology.  This  transfer should be part of and basis for the 
cooperation and capacity building.  In his view, the technical assistance programmes and capacity 
building, as agreed by the Members, should reflect  the results of the widely debated Development 
Agenda.  One example would be that some of th e projects promoted the relationship between small 
and micro enterprises and centres of higher education in developing countries.  Ecuador had actively 
participated in the negotiation of the Development Agenda and hoped to achie ve its implementation in 
the WTO. 
201. The representative of the United States  said that she recognized Brazil's continuing interest in 
technical cooperation.  The US report on its impl ementation of Article 67 provided a detailed account 
of its efforts to work together with its trading pa rtners to provide assistance.  Referring to Brazil's 
paper concerning the WIPO Committee on Deve lopment and Intellectual Property and the 
recommendations that this Committee had been tasked  to implement, she said that the United States 
had been highly involved in this Committee and its ne gotiations and would continue to be so in order 
to contribute to its continued success.  The Comm ittee had had only a few meetings so far and was 
working with the WIPO secretariat to establish the proper and necessary steps to be taken to 
implement each of the adopted recommendations .  These recommendations expressly concerned the 
work of WIPO.  Many did not make sense outside  that context as they concerned the core mission 
responsibilities, capabilities and resources of WIPO .  To presuppose, outside the working and 
functioning of the Committee, how those recomme ndations should apply to WIPO and its activities 
was highly inappropriate, particularly as the Co mmittee was at the nascent stages of addressing its 
task of implementation. 
202. The representative of Switzerland  expected the upcoming Workshop on LDC Priority Needs 
to be very beneficial for participants who could learn how developed country Members could 
cooperate with their LDC Member partners in implementing their priority needs assessments to 
enhance their IPR regimes to achieve TRIPS complian ce.  He said that the information contained in 
the Secretariat note IP/C/W/544 would be very u seful for the participants in the Workshop. 
203. The representative of India  said that he appreciated the efforts of Brazil to develop a model 
form for technical cooperation projects, and re called Brazil's proposal in IP/C/W/513 about the 
linkages between the work in the WTO and in WIPO .  The model form circulated by Brazil in the 
addendum to IP/C/W/513 would undoubtedly contribute to transparency of technical cooperation projects.  His delegation recognized the importanc e of technical cooperation and capacity building 
under the TRIPS Agreement from the viewpoint of de veloping countries.  Like Brazil, his delegation 
saw a clear link between the work in the TRIPS Council and the 14 proposals on technical assistance  IP/C/M/61 
 Page 39 
 
 
  and capacity-building contained in cluster A of the Development Agenda that had been adopted by the 
WIPO General Assembly in 2007.  Some of the recommendations referred to the TRIPS Agreement, 
and one to the agreement between WIPO and the WTO.  Cluster A provided a relevant guiding 
framework for discussions in the TRIPS Council. 
204. The representative of Egypt, speaking on behalf of the African Group , said that he believed 
that engaging in technical cooperation and cap acity-building activities was a core function and 
mandate in the TRIPS system.  Through effec tive technical cooperation and capacity-building 
activities, developing and least-developed countries c ould reap specific benefits and make full use of 
the TRIPS Agreement and its flexibilities.  The A frican Group believed that technical assistance and 
capacity-building activities should be premised on the following principles:  (i) be 
development-oriented, demand-driven and transpar ent, taking into account the priorities and the 
special needs of developing countries, especially LDCs , as well as the different  levels of development 
of Members;  (ii) promote a development-oriented intellectual property culture;  (iii) place particular 
emphasis on the needs of small and medium-sized enterprises (SMEs) and institutions dealing with 
scientific research and cultural industries;  (iv) promote measures that will help countries deal with 
intellectual property-related anti-competitive prac tices, by providing technical cooperation to 
developing countries, especially LDCs, at their re quest, in order to better understand the interface 
between IPRs and competition policy;  (v) further develop infrastructure and other facilities with a 
view to making national intellectual property instit utions more efficient and promote fair balance 
between intellectual property protection and the public  interest;  (vi) strengthen national capacity for 
protection of domestic creations, innovations and inventions and support development of national 
scientific and technological infrastructure;  and (vii)  mainstream development considerations.  This 
list was, by no means, exhaustive but contained wh at the African Group deemed to be the essence of 
the ongoing efforts to bring balance in the intell ectual property debate and should, at a minimum, 
ensure widespread endorsement.  He called Members'  attention to these essential principles and to the 
necessity of providing qualitative assessments of their technical assistance and capacity-building 
efforts accordingly.  In this regard, he welcom ed Brazil's submission in document IP/C/W/513. 
205. The representative of Bangladesh  said that, broadly speaking,  all technical cooperation under 
the DDA fell within either EIF or Aid for Trade.  He thanked developed country Members for their 
reports on technical cooperation, although time had not allowed his delegation to look at them in 
detail.  He was grateful to developed country Me mbers for their technical assistance to LDCs and 
developing countries in general and to Bangladesh in  particular.  Technical cooperation was a core 
principle of development dimension in the WTO.  As the poorest Members of the WTO, LDCs, as a 
group, deserved more technical cooperation than  other Members to address their supply side 
limitation, comply with the TRIPS Agreement and in tegrate into the multilateral trading system.  He 
said that he understood that LDCs had an obliga tion to implement the TRIPS Agreement.  The 
problem was not willingness but capacity constraints.  They were willing but not able to do so.  To 
match willingness with ability, they needed tec hnical assistance of the right kind and without 
constraint.  Technical assistance to LDCs should not  be conditional on the level of compliance with 
the TRIPS Agreement and LDCs needed policy space to  implement the Agreement step by step.  He 
recalled that developed country Members were committed to providing enhanced and targeted 
technical assistance under Article 67 to LDCs to ef fectively address the needs assessments mentioned 
in paragraph 2 of the TRIPS Council decision of 29 November 2005, and that technical cooperation 
was demand driven. 
206. He said that Bangladesh had already prepared its needs assessment report in compliance with 
the aforementioned Council Decision.  The report was going through a process of refining before 
submission to the WTO.  He sought in advance de veloped country Members' attention to the needs 
identified by Bangladesh.  It was also seeking assi stance from WIPO and other relevant international 
organizations under paragraph 4 of the Decision.  Finally, he referred to the recent LDC Ministerial 
Meeting in Dar Es Salaam, Tanzania, where Mi nisters had called upon WTO Members to provide IP/C/M/61 
Page 40  
 
  financial and technical assistance to LDCs for their needs assessment and to develop their capacity in 
implementing the TRIPS Agreement. 
207. The representative of Australia
 said that her delegation was co mmitted to assisting developing 
countries in the areas of technical cooperation pursu ant to Article 67.  Au stralia had submitted its 
report setting out technical cooperation activiti es conducted in a range of areas encompassing 
copyright and industrial property over the last ye ar.  On the Brazilian proposal to use the WIPO 
Development Agenda as a basis for technical c ooperation and capacity building, Australia's position 
was well known.  Australia supported the WIPO De velopment Agenda and was committed to its 
implementation.  However, as the United States and other Members had stated, the Development Agenda principles concerned WIPO activities incl uding its core mission, responsibilities, capabilities 
and resources.  Due to the different scope and purpos es of the principles, they could not be used as a 
basis for technical assistance a nd capacity building under Article 67.  She noted the principles and 
objectives of Articles 7 and 8 of the TRIPS Ag reement and remained committed to providing 
technical cooperation and capacity-building assistance. 
208. The representative of th e European Communities
 said that his delegation had indicated that it 
was ready to look in a positive spirit into the LDCs submissions on individual priority needs for 
technical assistance and financial cooperation and it would submit its report in the coming days.  So 
far only two LDCs, Uganda and Si erra Leone, had submitted their i ndividual needs.  His delegation 
had been in contact with these two countries on how to  assist them.  He confirmed that the European 
Communities had agreed to support a number of act ivities identified by Uganda and several of these 
activities had already been launched.  It had also been working with Sierra Leone and hoped to be 
able to provide shortly the same kind of assistance and support to it.  He stood ready to consider any 
new submissions of priority needs and encouraged  LDCs as well as other de veloped country Members 
to contribute to this important process.  Finall y, he welcomed the informal Workshop on the LDC 
needs assessment process in which his delegation would participate. 
209. The representative of Pakistan  said that, since TRIPS was a relatively new area in the 
international trading system for developing countri es and LDCs, he believed that it needed more 
attention.  Therefore, technical cooperation and capacity building in this area should be on a higher 
level, demand-driven, with utmost clarity, and fo cused.  In this regard, the proposal submitted by 
Brazil, which was based on the deliberations and discussions in the WIPO Committee on Development and Intellectual Property, was quite rele vant and should be a basis to further focus on 
technical cooperation and capacity building under TRIPS. 
210. The Chairperson
 urged those Members that had not ye t provided updated information on their 
technical cooperation activities to do so as soon as po ssible and assured Bangladesh that her intention 
was to provide Members an opportunity at the Coun cil's next meeting to make further comments on 
the information submitted for this meeting that they mi ght not yet have been able to study.  She also 
urged those LDC Members that had not yet provided information on their individual priority needs for 
technical and financial cooperation to do so. 
211. The Council took note  of the statements made. 
M. LETTER FROM THE CHAIR OF THE GENERAL COUNCIL CONCERNING WAYS TO IMPROVE THE 
TIMELINESS AND COMPLETENESS OF NOTIFICATIONS AND OTHER INFORMATION FLOWS  
212. The Chairperson  recalled that, at the Council's meeting in June 2009, she had reported on her 
consultations on a letter from the Chair of the General Council concerning ways to improve the 
timeliness and completeness of notifications and othe r information flows in the TRIPS Council's area 
of responsibility.  In order to fac ilitate its consideration of this i ssue, the TRIPS Council had requested 
that the Secretariat prepare a factual backgr ound note summarizing the relevant procedures and  IP/C/M/61 
 Page 41 
 
 
  providing references to the rele vant decisions, as well as information on the use of these procedures 
by Members, and also to prepare suggestions for the Council's consideration at its next meeting on 
how to improve the transparency and user-friend liness of the notification system, for example by 
making notifications more easily accessible on th e WTO webpage.  This background note had been 
circulated to Members in document IP/C/W/543. 
213. The representative of the Secretariat  said that the background note on "Timeliness and 
Completeness of Notification and Other Information Flows" represented the combination of a great deal of hard work on the part of his colleagues in the Secretariat over many years in planning and 
managing a major documentation effort  and in undertaking the sheer hard work of processing, editing, 
checking, and distributing material submitted by Members in pursuance of the transparency 
mechanisms established by the Council under the TRI PS Agreement.  It also represented a massive 
amount of work on the part of the notifying Memb ers in compiling and submitting the information. 
214. To give a sense of the scale of this work, he said that the notification of laws and related 
measures had been a major undertaking, currently resulting in around 6,500 documents on line, each 
one containing unique and practically valuable info rmation and covering all aspects of IP law and its 
implementation and enforcement.  This, at a r ough estimate, amounted to over 150,000 pages of 
useful information about the laws and related measures of Members.  A good proportion of this 
material was still in paper form, in hard copy only, reflecting the limited use of information 
technology in the initial stages of the notification processes, which had begun almost 14 years previously. 
215. The Council's review of Members' laws had yielded some 800 additional documents, 
providing a detailed record of the dialogue in th e Council, which was in itself a unique multilateral 
process for establishing greater understanding about the IP  laws and policies of Members;  again, this 
material involved a huge amount of hard work on the part of delegations, capital-based officials and 
the Secretariat.  He added that, against this background of a major investment of resources and 
profusion of valuable data, it was ti mely to consider how best to manage the material and to use it for 
its intended purpose, namely to enhance understanding and to promote transparency. 
216. The current factual background note had been prep ared at the request of the TRIPS Council at 
its meeting in June, which request in turn ste mmed from the General Council Chair's letter to the 
TRIPS Council Chair inviting the latter to consult with Members on ways of improving the timeliness 
and completeness of notifications and other informati on flows.  Aiming to provide information to this 
end, the note firstly summarized the relevant pro cedures (with references to relevant decisions);  
secondly gave information on the use of these procedur es by Members;  and lastly offered suggestions 
as to how to improve the transparency and user-friendliness of the notification system. 
217. He explained that, to fulfil the first point (summarizing relevant procedures), the document 
provided a factual outline of the notification and related requirements, including the mechanisms 
within TRIPS itself and those mechanisms subseque ntly decided upon by the Council.  The document 
covered the two areas already mentioned – notifica tion of laws and the TRIPS Council review of 
these laws – and also set out the full range of  notification requirements and processes which had 
yielded valuable practical information in these sp ecialized fields, which included certain technical 
aspects of the protection of copyright and relate d rights, application of the national and MFN 
treatment principles, protection of state emblems, contact points in Members, and specific surveys undertaken by the Council itself in the context of various review processes. 
218. To fulfil the second element (information on the use of these procedures by Members), the 
document summarized the use of the notification system so far by Members.  In particular, Annex 2 of the document provided a table giving the date of the in itial notifications received, i.e. the first batch of 
laws received under the system, and the dates of any subsequent updates received.  These included IP/C/M/61 
Page 42  
 
  amendments to existing legislation as well as new it ems of legislation.  The document observed that 
the status of initial notifications was good:   overall 126 Members had notified implementing 
legislation in an initial notification and 99 Member s had responded to the checklist on enforcement 
which was established by the Council to enable notif ication of enforcement measures.  He said that 
Members' practices and experiences regarding update s or subsequent amendments to legislation had 
differed somewhat, as illustrated by Annex 2.  Some Members had been more active than others in 
updating their notifications. 
219. Turning to the third aspect of the Council' s request (suggestions on transparency and 
user-friendliness), he said that TRIPS Article 63.2 it self already recognized that steps should be taken 
to reduce the burden of notification procedures on Me mbers and this had in turn guided the Council's 
work in this area, including by the development of a cooperative relationship with WIPO, as had also 
been foreseen in the TRIPS Agreem ent.  The paper identified three specific areas in which to explore 
practical improvements with the aim of ensuring th at the operation of the system would promote the 
timeliness and comprehensiveness of information and would make it more user-friendly.  These three 
areas were the following:  firs tly, the submission and input of data;  secondly, the output and 
accessibility of information from the notifications;  and lastly, the practical management of data, 
including facilitating the existing practical linkage with WIPO. 
220. Regarding the input of information, he said th at, broadly speaking, it should be possible to 
make it easier for Members to prepare and submit re levant material;  as a pr actical matter, the Council 
should help to identify more efficient ways of prep aring and submitting texts, without prejudice to the 
existing rights and options available to Members.  He explained that, in practice, notified texts and 
materials were received in a wide range of formats,  some of which, perhaps unwittingly, could create 
some months of work for the Secretariat to edit, re vise and repackage the material in order to make it 
suitable for distribution through the WTO system.  Material was also received in a wide range of 
media, including from paper copies of official gazet tes through to data on USB data keys.  He added 
that any developing country Member seeking assistance in preparing material for notification could 
seek technical assistance as they required. 
221. He then turned to the output of information, i. e. how to make the information more practically 
accessible, more useful for its intended purpose and l ess burdensome to consult and to use in practice.  
He said that there were well over 120,000, possibl y 150,000 pages of material, some of it still only 
available in paper form.  Ways should be consider ed for practically enhancing on-line access to that 
material;  it should however be recognized that the existing forms of dissemination, including on 
paper, might still be more appropriate  for many potential users.  Furthe rmore, care had to be taken not 
to alter the status, character or content of the in formation.  A simple example of steps taken to 
improve access had been the process of scanning the backlog of legal texts, rendering them into 
digital form where previously they had only been available in paper form, and which had therefore 
been relatively difficult to acce ss for many potential users. 
222. Lastly, regarding the practical management of  information between the input and the output 
sides, he said that the aim would be to use inform ation technology to reduce delays, to facilitate the 
flow of information and to comply with the WIPO-WTO cooperation agreement to provide this 
information in a timely and practically useable fash ion.  He hoped that, in this way, resources could 
be freed up to pay more attention to the inform ation needs identified by the WTO's partners in 
technical cooperation work, especially the needs expressed by developing countries as the WTO was 
seeking to improve, tailor and focus its  development cooperation activities. 
223. A unique aspect of the notifications under th e TRIPS Agreement was that the Agreement 
itself foresaw cooperation with the WTO sister agen cy, WIPO, and indeed the two Organizations had 
signed a bilateral agreement in 1995, one key asp ect of which was cooperation on the administration 
and making available of notification of laws a nd regulations.  While th is cooperation had been  IP/C/M/61 
 Page 43 
 
 
  systematic and fruitful, the sheer bulk of material had at times put pressure on the WTO system.  
Advances in information technology now meant that it was timely to look at ways of improving the 
information flows and simplifying the sheer practical management of this information.  The fact that 
WIPO was currently overhauling its own legislativ e database made it especially timely to explore 
ways of improving this linkage and thus reduc ing the burden on users of the system and on WTO 
Members in particular. 
224. Finally, he wished to stress that any practical steps that might be taken to improve the 
management of this vast quantity of information would be undertaken within the existing framework 
of the TRIPS Agreement and the decisions already ta ken.  The systems that had been put in place 
were robust and well established, and had already been  used by the great majority of Members.  The 
task was simply to look at practical ways of managing the immense collection of data – around 
150,000 pages – so that the material did not pile up on the shelves and desks of those hoping to use it, as a literal physical burden on Members, but would be developed into a  workable and accessible 
information service within the existing framework already well defined by the TRIPS Agreement and 
the subsequent decisions of the Council, which ha d been reported and summarized in this document. 
225. The representative of WIPO
, providing an update on WIPO's pa rt of the relevant cooperation 
between the two Organizations, said that WIPO cu rrently offered a database accessible online to 
WTO and WIPO members and to the general public.  The database contained national IP laws and 
regulations and was available on the WIPO websit e under the name Collection of laws for online 
access (CLEA).  The bulk of the content of CLEA was sourced from notifications that the WIPO had received from WTO and which, in turn, came from WTO Members complying with Article 63.2 of 
TRIPS.  The Director-General of WIPO had la unched an initiative to develop and enhance CLEA 
which, in the near future, would be called the In tellectual Property Global Online Laws Database or 
"IP GOLD".  The first priority was to address the c ontent of the database with the objective of making 
it comprehensive;  currently, there were about 130 me mber States that were f eatured in the database 
and WIPO definitely wished to expand that to cove r all member States, with specific priority being 
given to developing and LDC member States.  WIPO wanted the content to be current and updated, 
and the presentation to be made in a rationalized manner and in such a way that it would be easily 
comprehensible to a wide audience.  Essentially, the presentation would be made in a hierarchical 
manner in terms of the rule-making system of a par ticular country, i.e. starting with any constitutional 
provisions that related to or protected intellectual property rights, moving on to legislation and then to 
regulations.  The contents of IP GOLD would also include the multilateral, plurilateral, and regional 
and bilateral treaties for that particular country  that were relevant to intellectual property. 
226. In the long term, the contents would also include  other information that interpreted, analyzed 
and elaborated the laws and treaties relating to intell ectual property.  Therefore, this was an ambitious 
and long-term project.  WIPO's current starting-po int was thus CLEA, which would soon become IP 
GOLD with a lot more information provided, not only to WTO and WIPO members but also to the 
general public.  A key part of this initiative was th e sourcing of its content.  The WTO notifications 
continued to be an important source for IP GOL D and every effort was being made between WTO 
and WIPO to strengthen the mechanism and the syst em by which WTO notifications were channelled 
as a source for the content of the database. 
227. In conclusion, she said that the WIPO particul arly welcomed the renewed calls from the WTO 
to its Members to comply more strictly with thei r notification obligations under Article 63.2 of the 
TRIPS Agreement, so that WIPO, as the recipient of these notified texts and regulations, would be 
able to work towards ensuring that IP GOLD would become a reliable source of information for laws 
and regulations and other releva nt information concerning intellectual property.  Further 
developments relating to IP GOLD would be dul y communicated to the TRIPS Council as and when 
the database itself was ready for public launching. IP/C/M/61 
Page 44  
 
  228. The representative of Switzerland
 thanked the Secretariat for the factual background note and 
expressed his appreciation for the work that had gone in to its preparation.  He considered it to be an 
excellent paper and one that would remain a reference paper for Members for years to come and which would help them in responding to their tr ansparency obligations under Article 63.2 of the 
TRIPS Agreement.  He supported the Secretariat's efforts to reorganize relevant pages on the WTO 
website and believed that a single access point to no tifications providing a clear overview and direct 
access to the various categories of notifications would add value to the current tools available on the website.  He also supported the dissemination of no tifications, making processes more transparent and 
further increase use of the information made available.   He supported the exploration of ways to better 
link WIPO and WTO databases, keeping in mind that  such linking up should not have a bearing on 
the rights and obligation of the members of these two Organizations, nor should it result in excessive 
cost. 
229. The representative of th e European Communities
 added his thanks to the Secretariat for the 
comprehensive note on the timeliness and completen ess of notifications and other information flows 
and expressed his appreciation of the summary of  the notification procedures, the provision of 
references to the relevant decisions and to the background documents, and the description of the way 
in which the relevant information was currently  made available.  He welcomed the initial 
considerations on ways in which the transparen cy and user-friendliness of the system could be 
improved.  For instance, a single transparency t ool-kit page allowing a single access point to the 
various notifications from Members was certainly a good idea for implementation.  There were other 
good ideas, like a wider use of descriptions of any new legislation or amendments, the clarification of 
the notification formats and enhanced cooperation with WIPO to streamline the administration of 
notifications.  He encouraged the Secretariat to pursu e this task and to report back on the state of play 
at the Council's next meeting. 
230. The Chairperson  thanked the two delegations that had spoken for their useful feedback and 
said she trusted that the Secretariat would take  these statements into account in developing its 
services.  Recognizing that delegations had had only a relatively short time to consider the Secretariat 
background note, she suggested that the Council revert to the matter at its next meeting, in order to 
allow delegations to make any further co mments they might have on this matter. 
231. The Council took note  of the statements made and so agreed . 
N. INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO 
232. The Chairperson  recalled that, under this agenda item, information had usually been provided 
in relation to new accessions to the WTO and developm ents in the area of dispute settlement, as well 
as about acceptances of the recent TRIPS Amendment.   She said that, on this occasion, she had no 
new developments to report in the first two ar eas, and that the new acceptances of the TRIPS 
amendment had already been mentioned under item G. 
O. OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS  
233. The Chairperson  said that the list of the 17 pending re quests for observer status in the TRIPS 
Council by other intergovernmental organizations we re contained in document IP/C/W/52/Rev.11.  
She recalled that the Council had discussed these pendi ng requests at its prev ious meetings, but had 
not been able to reach consensus on any of them.  She said that, as requested by the Council at its last 
meeting, she had continued her c onsultations with interested dele gations on the request for observer 
status from the CBD Secretariat but that, unfortuna tely, she was not in a position to report any new 
developments in their thinking concerning this request.  IP/C/M/61 
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  234. The representative of Brazil  said that the Secretariat of the Convention on Biological 
Diversity (CBD) should be accepted as an observer to the TRIPS Council.  The relationship between 
the TRIPS Agreement and the CBD was a permanent item on the Council's agenda.  It was also part 
of the Doha Round mandate and the object of a number of written communications and proposals.  
The fact that there were several pending requ ests for observer status from other international 
organizations should not prevent the Council from gran ting the observer status to the CBD Secretariat.  
Another possibility would be to consider a proposal that a CBD should be granted in ad hoc  invitation 
for each session of the Council. 
235. The representative of Egypt, speaking on behalf of the African Group , deemed all 17 pending 
requests to be equally relevant and important to  the Council's work.  For the African Group, the 
requests presented by African regional organizatio ns, including the African Intellectual Property 
Organization (OAPI), the African Regional Indu strial Property Organization (ARIPO) and the 
Conférence des Ministres de l'Agriculture de l'A frique de l'Ouest et du Centre (CMA/AOC) were 
especially important.  Furthermore, the request s ubmitted by the CBD Secretariat was particularly 
relevant due to the centrality of the TRIPS-CBD issue for the African Group.  He appreciated the 
positions taken and flexibility shown in this matter by certain Members.  He particularly applauded 
the efforts of some Members that strove to reach a constructive solution with regard to the admission 
of observers across WTO bodies and specifically with  regard to their willingness to allow the CBD 
Secretariat to be admitted as an ad hoc  attendee or ad hoc  invitee on a meeting-by-meeting basis 
pending the resolution of the broader principle.   He called upon other Members to accept such an 
invitation and engage in a constructive spirit in or der not to create further obstacles for the Council's 
substantive debate on this important issue. 
236. The representative of Ecuador  said that, given the on-going deliberations on TRIPS and CBD, 
the Council should grant the CBD Secret ariat an observer status on an ad hoc  meeting-by-meeting 
basis in order to overcome the concerns of certa in Members and to ensure its the presence of the 
Council's meetings. 
237. The representative of India , supporting the interventions made by Brazil, Ecuador and Egypt 
on behalf of the African Group, said that his delegati on had raised the issue of observer status for the 
CBD Secretariat over the Council's l ast several meetings.  Ministers had agreed in Marrakesh (April 
1994) to what was known as the "coherence mandate" of  the WTO.  It was recognized that the WTO 
system was only one part of a much broader set of international rights and obligations that bound 
WTO Members.  It was in furtherance of this mandate that there were some 140 international 
organizations that had observer status in WTO bodi es and the WTO also participated as observer in 
the work of several international organizations.  It was a two-way gainful engagement.  Separately, 
Ministers at Doha had recognized the importance of granting observer status to MEA Secretariats in 
paragraph 30(ii)of the Doha Ministerial Declarati on.  Being aware that there were several pending 
requests for observership, he felt that the CBD prese nted a special case due to its direct relevance to 
the issues being discussed in the Council, which ha d three permanent agenda items relevant to the 
CBD.  There were 108 Members who co-sponsored a proposal TN/C/W/52, which included the issue of the relationship between TRIPS and CBD.  Disc ussions in the Director-General's consultative 
process on outstanding implementation issues also included discussions on TRIPS-CBD disclosure proposal which sought to enhance mutual supporti veness between the TRIPS Agreement and CBD.  
The presence of the CBD Secretariat in the TRIPS Council meetings would also help the coherence 
mandate of the WTO.  The request by the CBD  Secretariat should be decided positively and 
expeditiously and, in the meantime, it should be extended an ad hoc  invitation, on a 
meeting-by-meeting basis, as was done in the Special Session of the Committee on Trade and Environment and the Negotiating Group on Trade Fac ilitation.  He expressed his appreciation to the 
flexibility shown by the Egyptian delegation on this ma tter.  Finally, he said that he would appreciate 
it if the Chair could continue her consultations on the matter. IP/C/M/61 
Page 46  
 
  238. The representative of Colombia
 endorsed what had been said about granting the CBD 
Secretariat observer status in the Council, including the intermediate solution that had been suggested 
as a compromise.  He expressed his hope that the Chair could make progress in her consultations. 
239. The representative of Peru  supported the statements by Brazil, Ecuador, Egypt, Colombia and 
India.  While for his delegation the 17 requests we re of equal importance, the request by the CBD 
Secretariat was particularly relevant due to the link between TRIPS and CBD.  He did not see any 
reasons for the CBD Secretariat not to  attend the Council's meetings on an ad hoc  basis, and called for 
flexibility and understanding from Members so that this could become reality. 
240. The representative of the United-States  said that she could not support the consensus. 
241. The representative of Indonesia , supporting the statements by Brazil, Ecuador, India, Egypt, 
Colombia and Peru, said that it was necessary to ac cept the CBD Secretariat as observer if the Council 
were to effectively and comprehensively discuss th e TRIPS and CBD issue.  Pending the resolution of 
this matter, he supported inviting it to the Council's meetings on an ad hoc  basis. 
242. The representative of China  supported the statements by India, Brazil, Ecuador, Peru, and 
others, taking into account the CBD Secretariat's di rect relevance with the Council's three permanent 
agenda items. 
243. The representative of Kenya , supporting the previous statements in favour of granting the 
CBD Secretariat observer status in the Council, said that also certain other organizations urgently 
needed such status.  Kenya was a member of AR IPO, whose Secretariat played a role in the 
implementation of the TRIPS Agreement.  It w ould no longer be necessary to spend time and money 
briefing the ARIPO Secretariat on the Council's work, if it could attend the meetings as an observer.  
He said that it would be helpful for further consu ltations, including bilatera l consultations, if those 
delegations unable to join consensus coul d explain the reasons behind their position. 
244. The Chairperson  suggested that, as requested, she continue her consultations on the request 
for observer status received from the CBD Secretariat.   She also suggested that the Council revert to 
this matter at its next meeting. 
245. The Council took note  of the statements made and agreed  to proceed as suggested by the 
Chair. 
P. ANNUAL REPORT  
246. The Chairperson  said that the draft Annual Report of the Council to the General Council had 
been circulated in document JOB(09)/148.  It still n eeded to be updated so as to reflect the discussions 
at the present meeting.  As she had mentioned unde r items D to F, paragraphs 7 and 8 of the draft 
report covered the Council's work pursuant to paragraph 44 of the Hong Kong Ministerial 
Declaration.  She recalled that, in paragraph 44 of  the Hong Kong Ministerial Declaration, Ministers 
had taken note of the work undertaken by the C ouncil for TRIPS pursuant to paragraph 19 of the 
Doha Ministerial Declaration and had agreed that this work shall continue on the basis of paragraph 19 of the Doha Ministerial Declaration and the progress made in the Council for TRIPS to 
that date.  Furthermore, they had instructed the Gene ral Council to report on its work in this regard to 
their next Session. 
247. She said that, prior to the formal meeting, sh e had held informal consultations on how the 
Council should report on its work pursuant to Doha paragraph 19.  In these consultations, it had been 
suggested that paragraphs 7 and 8 of the draft re port should mention the fact that in the Council's 
discussions references had also been made to a document entitled "Draft Modalities for TRIPS  IP/C/M/61 
 Page 47 
 
 
  Related Issues" circulated to the Trade Negotiations  Committee in July 2008.  In the light of these 
consultations, she suggested to complement the draf t by adding a new sentence in paragraph 8 of the 
draft report before the sentence starting "No ne w submissions...".  This sentence should read: 
In these discussions, some delegations referred to a communication from Albania, 
Brazil, China, Colombia, Croatia, Ecuador , the European Communities, Georgia, 
Iceland, India, Indonesia, the Kyrgyz Republic, Liechtenstein, the Former Yugoslav 
Republic of Macedonia, Moldova, Pakistan, Peru, Sri Lanka, Switzerland, Thailand, 
Turkey, the ACP Group and the African Group to the Trade Negotiations Committee on "Draft Modalities for TRIPS Related Issues"  circulated in July 2008 in document 
TN/C/W/52 and addenda 1-3. 
248. She suggested that the Secretariat be requested to update the draft with this  complement to 
reflect the discussions at the present meeting.  She fu rther suggested that the revised draft be faxed to 
Members who, given the proximity of the next General Council meeting scheduled for 17 November, 
would have three working days to comment on the updated parts of the draft report once it had been 
circulated by the Secretariat. 
249. The Council so agreed
.2 
250. At its reconvened meeting of 6 November, the Chairperson  suggested that the Council request 
the Secretariat to prepare an update to the Report that would cover the reconvened meeting, and that 
the Council adopt the report ad referendum, namely that Members would have two working days to 
comment on the draft report once the Secretariat had made it available to them and, if there were no major substantive comments on it, the report w ould be forwarded to the General Council. 
251. The Council so agreed
.3 
Q. OTHER BUSINESS  
(i) Dates of the Council's meetings in 2010 
252. The Chairperson  suggested that the Council agree on th e following dates for its meetings in 
2010:  Tuesday and Wednesday, 2 and 3 March;  Tuesday and Wednesday, 15 and 16 June;  and 
Tuesday and Wednesday, 26 and 27 October. 
253. The Council so agreed . 
(ii) Public health dimension of the TRIPS Agreement 
254. The representative of India  said that, at the Council's meeti ngs in March and June 2009, his 
delegation had already raised the serious impediment s to access to medicines created by drug seizures 
at EC ports and had provided deta ils of the 17 seizures by Dutch authorities in the year 2008 on the 
basis of EC Regulation 1383/2003.  All 17 consignm ents had originated in developing countries and 
15 of them had been destined for developing countries.  At the present meeting, he wished to update Members on the developments since the June meeting. 
255. As the European Communities had given assuranc es that they were putting in place systems 
to ensure that generic medicines would not be seized, India had believed that the Amsterdam seizures 
                                                     
 
2 The Annual Report (2009) of the Council for TRIPS was subsequently circulated as 
document IP/C/52. 
3 An addendum to the Annual Report (2009) of the Council for TRIPS was subsequently circulated as 
document IP/C/52/Add.1. IP/C/M/61 
Page 48  
 
  would be the last.  However, in May a cons ignment of the generic antibiotic Amoxicillin, 
manufactured in India and destined for a least-d eveloped country, the Republic of Vanuatu in the 
Pacific, had been seized by custom s officials while in transit through Frankfurt, Germany.  He was 
alarmed to hear of yet another drug seizure.  India had been informed in a letter dated 
20 October 2009 that customs authorities at the Paris-Roissy airport had seized a shipment of 
1,740,000 tablets of Clopidogrel, an antiplatelet drug used to prevent strokes and heart attacks.  The 
consignment with a gross weight of 3,829 kg. had been in transit from Mumbai to Caracas, 
Venezuela, and the alleged ground for the seizure ha d been a patent violation.  He said that the 
European company involved was Sanofi Aventis and recalled that a shipment of the same generic 
drug had been seized in Amsterdam in October 2008 a nd had been released seven months later in May 
2009. 
256. Turning to India's efforts to find a satisfactory solution to the matter, he said that although his 
delegation had continued bilatera l efforts with the European Co mmunities at the level of senior 
officials, Ministers and through formal communicati ons, nothing concrete had been done.  Despite its 
inconsistency with provisions of GATT, the TRIPS Agreement and the spirit of the Doha Declaration 
on the TRIPS Agreement and Public Health, there we re still no signs of a review of the EC Customs 
Regulation 1383/2003.  The demand for review of the Regulation had been echoed by European and 
Dutch parliamentarians and civil society or ganizations engaged in public health work. 
257. He said that while the European Communities ha d informed India that an explanatory note 
had been issued to member States on the application of the EC Regulation 1383/2003 on 31 July 2009, his delegation found it hard to draw  comfort from this note after the recent Paris 
seizure.  This note merely shifted the blame for applying and interpreting their national laws to 
member States' national courts, while totally disr egarding the permissiveness of the EC Regulation 
itself.  Prior to 2003, EC regulations had only covered trademark and copyright infringements.  The 
EC Regulation 1383/2003 had expanded this scope to patents and other IPRs and to transit, thereby 
providing a basis for member States to apply IPRs extr aterritorially and to goods in transit, as shown 
by the drug seizures in question.  The European  Communities' explanatory note had repeated the 
timelines indicated in Article 55 of the TRIPS Agre ement (Duration of Suspension) which had hardly 
been followed by Customs authorities in the various cases of drug seizures in 2008.  However, in his 
view, elaborating on the timelines and procedures in the note was simply an e ffort to evade the real 
issue of the scope and applicability of the Regulation. 
258. He said that the European Communities' cl aim that drug seizures had stopped after 
December 2008 had proven hollow with the Frankfurt and Paris seizures, and his delegation saw no 
guarantee that there would be no further seizures of generic drug consignments as long as the EC 
Regulation 1383/2003 existed in its pr esent form.  The European Communities' attribution of part of 
the seizures to its operation MEDI-FAKE highlighted another root of the problem, namely dealing 
with sub-standard and spurious medicines through border measures and customs officials who could 
hardly be expected to be experts in public health  issues.  He said that underlying the drug seizures was 
also a deliberate confusion of the issue of spuri ous and sub-standard drugs with IP issues and he 
emphasized that the seizure cases involved legitimate generic medicines which were neither fake, nor 
counterfeit, nor pirated medicines.  Moreover, he said that the Frankfurt and Paris seizures happened 
long after operation MEDI-FAKE had been terminated. 
259. He noted that the Paragraph 6 System which ha d been intended as an expeditious solution for 
countries with insufficient or no manufacturing capacity had been used only once in six years of 
operation.  His delegation was conc erned about the hypothetical possibility that drugs which an LDC 
might have ordered from another country using the Paragraph 6 System would transit via the 
European Communities.  These drugs could well violate IPRs in the country of transit and, given the 
seizures of generics in the past, such consignmen ts produced under the Paragraph 6 System would in 
all probability also be seized.  Would this not constrain countries with no or insufficient  IP/C/M/61 
 Page 49 
 
 
  manufacturing capacities from using the TRIPS flex ibilities?  What assurances would Members have 
from the European Communiti es that such consignments would not be seized? 
260. He recalled that, at the Council's last meeti ng, the European Communities had stated its 
commitment to "facilitating access to affordable medicines for countries in need" and defined themselves as "one of the main promoters of th e Doha Declaration and the TRIPS flexibilities".  
However, actions on the ground contradicted these ex alted objectives.  His delegation was surprised 
by the irony that EC countries were on the one ha nd providing funds for public health programmes of 
developing countries, while on the other hand creating ba rriers to legitimate trade in generics and thus 
hampering access to medicines.  In his view, the EC  Regulation 1383/2003 prom oted this dichotomy. 
261. It was his delegation's view that the seizure of generic drugs also raised larger issues such as 
international humanitarian law and current trends in IP enforcement norms which required serious 
reflection. 
262. With respect to international humanitarian law, he said that the issue of generic drug seizure 
was not merely a trade issue but its implications for universal access to affordable and efficacious 
medicines were a larger humanitarian issue of immen se public interest that was closely related to the 
right to health.  The seizures, and the consequent de nial of access, ran counter not only to the spirit of 
the TRIPS Agreement but also to Resolution 2002/31 of the Commission on Human Rights on the right to enjoy the highest standards of physical and mental health.  In this context, he quoted the 
report of the Special Rapporteur submitted to the 11
th session of the Human Rights Council in 
June 2009 as saying "The Special Rapporteur is con cerned with reports of IP enforcement measures 
that have resulted in multiple seizures at some por ts of shipments of generic medicines heading to 
developing countries and LDCs."  He noted that, in response to the seizures, the WHO had also issued 
a strong statement in March 2009 saying that "recent events related to the handling of medicines in 
transit and the potential consequences for the suppl y of medicines in developing countries are of 
major concern to the organization".  The WHO had al so asserted that "Ensuring that the interests of 
trade and health are appropriately  managed also means that the flow of legitimate medicines, 
including generic medicines, is not impeded." 
263. Turning to the implications of TRIPS-plus en forcement norms, he said that, while the concept 
of minimum level of protection in TRIPS permitte d more extensive protection by Members, such 
higher levels of protection were clearly qualified by  Article 1.1.  More extensive protection could 
therefore only be granted "provided that such prot ection does not contravene the provisions of this 
Agreement".  Such higher levels of protection could disturb the balance of the Agreement that was 
elaborated in several parts of the Agreement such  as its preamble, which cautioned that TRIPS should 
"ensure that measures and procedures to enfor ce intellectual property rights do not themselves 
become barriers to legitimate trade", and Article 41.1, which said that enforcement procedures "shall 
be applied in such a manner as to avoid the creation of barriers to legitimate trade and to provide for 
safeguards against their abuse". 
264. He said that the transitional period under Article 65 of the Agreement had only been 
completed four years ago for developing countries and had not yet expired fo r LDCs, who were still 
in the process of making the necessary legislative chang es to bring their IP legislation in line with the 
Agreement.  Therefore, while developing countries including LDCs were still adjusting to TRIPS, a 
spiral of ever-increasing levels of protection w as reducing the flexibilities and the policy space that 
TRIPS had left open particularly for developing countries and LDCs.  Members also witnessed an 
orchestrated campaign for TRIPS- plus  enforcement norms in internati onal organizations such as the 
WHO, WIPO, WCO and UPU and others, some of which deliberately confused medicine quality 
issues with IPRs.  Furthermore, there was an insistence on TRIPS-plus  elements in FTAs and on top 
of this the ACTA agreement was being negotiated in secrecy and with the exclusion of a vast majority 
of countries, including developing countries and LDCs. IP/C/M/61 
Page 50  
 
  265. In conclusion, he said that India attached the highest importance to the protection and 
enforcement of IPRs in accordance with the TRIP S Agreement.  However, his delegation believed 
that the framework laid out by Article 1.1 and the objectives and principles stated in Articles 7 and 8 
of the Agreement provided that protection and enforcement of IPRs could not override the 
fundamental tenets of international humanitarian law,  the right of access to medicines and the balance 
of rights and obligations in the Agreement.  He  called upon the European Communities to urgently 
review the Regulation and to bring it into confor mity with WTO provisions including the GATT, the 
TRIPS Agreement and the letter and spirit of th e Doha Declaration on the TRIPS Agreement and 
Public Health. 
266. The representative of Brazil
 associated himself with the statement made by India and said that 
his delegation shared India's concern over the seizu re of generic medicines in transit from and to 
developing countries through the European Union, especially as one of those cases had involved a 
shipment of Losartan Potassium  bound for Brazil.  His delegation's pos ition on this issue had been set 
out repeatedly at the March and June 2009 sessions of the TRIPS Council and in other bodies within 
and outside the WTO.  Although some contacts had b een held with the European Commission, both in 
Brussels and in Geneva, no progress had so far r esulted from those "opportunities for dialogue" and 
there had been no indication that the EC Regulation 1383/2003 might be reviewed in such a way that seizures of legitimate generics in transit could no lo nger take place on intellectual property grounds.  
The fact that the possibility of  new seizures was still open remained a matter of grave concern for 
Brazil. 
267. The representative of China
 said that his delegation fully associated itself with the 
interventions by India and Brazil.  The different r eactions to this incident highlighted how developed 
and developing country Members were looking at TRI PS-related issues in different ways.  As India 
had pointed out, while for some developed countries these seizures of generic medicines might be 
purely an issue of commercial interest, for developi ng country Members they were more than merely 
a trade issue but were also a human issue of i mmense public interest.  As could be seen from the 
discussions at the Council's present meeting, these were  not the only examples that demonstrated how 
differently developed and devel oping Members viewed TRIPS-rela ted issues.  Members had had 
years of discussion on three important issues that were of concern to  developing Members had concerns on:  traditional knowledge, folklore and the CBD.  Yet Members could not even agree on 
inviting the CBD Secretariat to attend the Council's m eetings as an observer.  He added that, although 
the Paragraph 6 System, which after years of pa instaking negotiations had been labelled a huge 
concession by developed country Memb ers, had been used only once in six years, Members could not 
even agree to have informal cons ultations to look at what might be the problem behind this lack of 
use. 
268. He said that for developing country Memb ers, the TRIPS Agreement had been a huge 
concession.  Although China had not been there dur ing the Uruguay Round, it had accepted it because 
of the substantial compensation it had expected to r eceive from agreements on agriculture and textiles.  
But the benefits expected from agriculture were be ing offset by the large subsidies provided by 
developed country Members.  In textiles, China's in terests had been offset by the ten-year transition 
period and were further eroded now by  so-called preference erosion.  At the same time, the cost for 
developing Members to apply the TRIPS Agreemen t, according to an expert from the World Bank, 
had risen to six billion dollars this year.  In view  of this huge deficit, one had to ask whether the 
TRIPS Agreement was totally balan ced.  However, it was his impression that this was not enough for 
developed country Members w ho were still pushing a narrow-mi nded campaign for TRIPS-plus  
provisions everywhere, as had been pointed out by India.  Besides the examples mentioned by India, it was worth mentioning that some developed country  Members were even trying to impose TRIPS-plus  
standards on all WTO Members through disputes, and China had been a party to one of these disputes.  IP/C/M/61 
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  269. He said that for developed country Members to  keep turning a blind eye to developing 
country Member concerns while pushing for their TRIPS-plus  campaigns was not a way out of this 
situation.  While this might appeal to developed country Members as a way to achieve everything they 
wanted, to developing country Members this meant that the developmental objective which had been 
recognized in the TRIPS Agreement would remain a UFO that everyone had heard about but nobody 
had ever seen. 
270. The representative of Peru  said it was regrettable that the issue of seizures of medicines in 
transit had been on the table for months without a solution.  He shared the deep preoccupations 
expressed by Brazil and India regarding the conf iscation of generic drugs coming from India and 
China en route  to several developing countries.  These seizures on the basis of the EC 
Regulation 1383/2003 were clearly against the Doha Declaration that TRIPS should be applied in a 
manner that supported the rights of Members to protect  public health and, in particular, to promote 
access to medicines for all. 
271. In the case of Peru, he confirmed the seizures of two generic drugs en route from India to 
Peru.  The anti-psychotic drug Olanzapina and the Parkinson's disease-related dementia treatment 
drug Rivastigmina were both legitimate registered dr ugs in Peru and there had been no evidence that 
their production had violated any patent.  The seizur e of two consignments of these generic medicines 
from India destined for Peru had resulted in pa tients of the Peruvian Social Public Health 
Establishment (ESSALUD) not being able to comple te their treatment.  The seizures of these legal 
generic drugs clearly contravened Article 5 of GATT 1994, the releva nt articles of TRIPS, and the 
territoriality principle with regard to patents. 
272. In raising this issue, he was not only referring to the trade aspect, but also to the issue of 
access for the poorest people with low incomes in Pe ru and many developing countries to medicines 
that were indispensable for hea lth, as stated in the Doha Declaration on the TRIPS Agreement and 
Public Health, as well as in other humanitarian forums .  For Peru, this type of situation altered the 
delicate balance between IPRs and the obligations of  states to ensure public health.  He urged the 
European Communities to review its Customs Regula tion to ensure that it conformed with the letter 
and spirit of the WTO agreements as well as the Doha  Declaration and hoped that a speedy solution to 
this problem could be found through constructive dialogue. 
273. The representative of Ecuador  said that his delegation shared the concerns expressed by 
previous speakers.  Article 1.1 of the TRIPS Agreem ent allowed Members to provide higher levels of 
protection than required by the Agreement as l ong as that did not contravene any of its legal 
provisions.  In his view, this had happened with  the adoption of EC Regulation 1383/2003, as it 
affected the delicate balance of rights and obligat ions agreed upon by Members and violated the 
principle of territoriality.  The flexibility of Ar ticles 7 and 8 did not admit arguments opposing the 
marketing of legitimate medicines.  Article 41.1 est ablished that provisions on enforcement of IPRs 
had to avoid the creation of obstacles to legitimat e trade.  The requirement for safeguards against 
abuse was another commitment that seemed to have been contravened by the European Communities.  
Article 51 regulated the import of pirated and count erfeit goods and left it to Members to lay down 
procedures with regard to goods in transit.  In his view, the Doha Declaration on the TRIPS 
Agreement and Public Health had an interpre tative legal effect on the TRIPS Agreement by 
establishing the supremacy of public health over and above other concerns.  It therefore related to 
Article 51 and consequently to the permissive  EC Regulation which undermined the rights and 
obligations laid down in the Agreement. 
274. The current Regulation and the continuing actions by the European Communities laid down a 
precedent that endangered the provision of medicines and jeopardized the legitimate trade in generic 
medicines as well as public health in developing countries.  He said that, in order to prevent the 
undermining of the right to health and access to me dicines provided for in its constitution, Ecuador IP/C/M/61 
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  would make full use of all the flexibilities cont ained in the Agreement, including compulsory 
licensing. 
275. The representative of South Africa
 said that, in his view, this issue encapsulated the 
difficulties trade negotiators often faced in explaini ng what exactly was the value that they added to 
the lives of people in their respective countries, particul arly those on the African continent.  This issue 
was literally a question of life and death, as legitimat e affordable drugs destined for people who were 
in most need of them were being unfairly detained.  He said that India had explained in detail why it 
was important that the European Comm unities address this issue expeditiously. 
276. He said that South Africa had been the first A frican country to fully comply with the TRIPS 
Agreement already by 1997 and took the protecti on of intellectual property very seriously.  Any 
perception that mixed the issue of generic drugs and counterfeit drugs, however, had no basis in law 
or in fact, and he objected to such perceptions and related actions in the str ongest terms possible.  The 
European Commission President Baroso, Commissioner Ashton and Commissioner Michel had repeatedly stated their commitment to the principle of development a nd the alleviation of poverty and 
he believed this commitment to be sincere.  Howeve r, it was difficult to avoid the conclusion that the 
implementation of actions such as this particular EC Regulation undermined those statements and he 
therefore called upon the European Communities yet ag ain to address this issue as an urgent matter 
using all avenues available to them. 
277. The representative of Egypt, speaking on behalf of the African Group
, said that the African 
Group was concerned about recent customs seizures by a few Members that negatively affected public 
health in developing countries and shared the concer ns expressed by India and Brazil on this matter.  
Such developments ran counter to the letter an d spirit of the Doha Declaration on the TRIPS 
Agreement and Public Health as well as to Member s' commitment to ensure that TRIPS and IPR 
protection were part of the solution to the public  health problems and priorities of African and 
developing countries and affected consumers the world over. 
278. The African Group viewed these developments affe cting legitimate trade in generic medicines 
as part of a wider drive at intergovernmental organizations, such as the World Customs Organization 
and the World Health Organization, to introduce IP R enforcement measures that ran counter to the 
Doha Declaration.  He added that such action c ontravened norms of intern ational human rights law 
and ran counter to resolutions adopted at human  rights bodies, in particular those on access to 
medicines adopted at the Human Rights Council only a few weeks previously. 
279. The representatives of Argentina  and Chile  said that their delegations shared the concerns of 
Brazil, India, Peru and other developing countries w ith regard to the seizure of generic drugs in 
transit. 
280. The representative of the European Communities  said that he noted with interest that the 
Members that had put this issue on the agenda of this meeting were the same countries that had 
previously opposed a discussion on enforcement and pa rticularly on border measures in this Council. 
281. He said that the issue concerned a very limite d number of cases in one country where the 
customs authorities had detained, not seized, over a limited period of time medicines which were 
transiting from India to various countries.  It was important to note the difference between detention 
and seizure, with detention being a temporary meas ure after which the goods were returned to the 
owner, while seizure was a permanent measure.  In the cases in question, all medicines had been 
given back to their owners.  He also noted that no such incidents had been reported between 2004, 
when the EC Regulation 1383/2003 had entered into fo rce, and 2008.  This showed that, despite those 
voices that suspected a plot or a systematic polic y against generics behind these actions, the objective 
of the Customs Regulation was not to hamper legitim ate trade in generics.  He was happy that some  IP/C/M/61 
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  Members had reminded the Council of the Euro pean Communities' well-established policy of 
promoting access to medicines in developing countr ies including generic medicines, which was 
further evidenced by the European Communities'  commitment to the Doha Declaration, its 
contributions to the Global Fund on HIV/Aids , its Regulation 1816/2006 on the manufacture and 
export under compulsory licences of medicines fo r developing countries, a nd its Regulation 53/2003 
on tiered pricing mechanisms for the supply of cheaper medicines to developing countries. 
282. This policy had not changed and his delegation w as fully aware of the n eed to ensure that 
legitimate trade in generic medicines was not impeded.   At the same time, there was also a need to 
fight against fake medicines because those actually killed people, and to ensure that what was called 
transit really remained in transit because the Eur opean Union with its 27 customs administrations in 
one customs territory was confronted with a lot of trade diversion. 
283. With respect to the new case raised by India, he said that, as his delegation had not received 
advance notice of customs actions nor had on-line access to all customs administrations in Europe, he was obviously not in a position to verify allegations about a seizure in Paris that had been raised 
without any evidence or substantiati on.  He recalled, however, that the last case raised in the TRIPS 
Council regarding a seizure of generic medicines in transit seized in Germany and allegedly destined 
to Vanuatu had turned out not to be a case of transit at  all.  As the medicines had not been destined for 
Vanuatu, but for Denmark, this had turned out to be a case of import of medicines into the European 
Union so all the arguments had collapsed.  He said that regardless of whethe r information on this new 
case of seizures in Paris were to turn out to be as inaccurate as in the previous case of seizure in 
Frankfurt, his delegation recommended a more cauti ous approach.  He believed that the method of 
raising cases without any substantiation a couple of minutes before a meeting was neither useful nor 
fruitful because it did not permit a verification of the facts and therefore did not allow the Member in question to provide appropriate replies. 
284. He agreed with India's statem ent that customs officials were no experts in medicines or 
pharmacy and therefore could not verify whether a medicine was authentic, fake or a sub-standard 
medicine.  This was why customs officials were not  in charge of any such verification in the EU 
system.  On the contrary, the system was entirely b ased on the right holder's request which had to be 
approved by courts.  In other words, customs did not  seize, but only detained goods, in order to allow 
the right holder to verify the condition of the goods and only after such verification could the medicines be considered as a real generic or as a fake sub-standard medicine .  However, refusing to 
allow even such verification to take place was not  appropriate, as that would be like arguing that, 
because passports checked at airports were valid and authentic in 99 per cent of the cases, there 
should be no more passport controls at airports because controlling passports delayed travelling.  
While passport controls should be done in the most effective manner in order to keep delays to a 
minimum, abandoning the controls was not po ssible and could not be a consideration. 
285. While it might be difficult to achieve the objective of not hampering the trade in generic 
medicines while fighting fakes since statistics dem onstrated that there were more and more fakes 
coming, his delegation had taken initiatives with cust oms authorities and right holders to prevent this.  
Right holders had publicly committed themselves not to stop medicines in transit through Europe for 
reasons of patent infringement and this was ve ry visible on the EC website.  The European 
Communities had also insisted on the need to stric tly respect the deadlines provided by the Regulation 
and had reminded everyone of the European Comm unities' commitments with regard to access to 
medicines.  Furthermore, his delegation had kept  India and Brazil fully updated on this issue. 
286. The European Communities believed that these inte rventions had been useful since there had 
been no further incidents.  As he had already men tioned, the alleged German case had turned out not 
to be a case of transit after all.  If the above-men tioned initiatives did prove to be insufficient to 
address any problems, his delegation was fully prepar ed to address further real or perceived problems IP/C/M/61 
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  in the review process of the Regulation which was taking place in the coming months.  In the 
meantime, he believed that attention to these matte rs was being artificially maintained for political 
reasons. 
287. The representative of India
 said that the difference between seizures and detentions had been 
pointed out by the European Communities on several occasions, but that did not change the argument.  
Regarding the point that cases were raised at the l ast minute and in an unsubstantiated fashion, he said 
that his delegation could only raise these issues when  concrete information was available.  In the case 
of the Paris seizures, his delegation had received a copy of the airway bill and of a letter written by the French customs to India's Mission in Brussels on the previous afternoon at four o'clock, and he would 
share a copy of the document with the EC delegation after the meeting.  He said that the letter used 
the term "seizure", not detention, as it referred to the "seizure of 1.740 million tablets, counterfeits of 
a patent".  This illustrated the earlier point about ho w terms such as "counterfeit" were being used in a 
very expansive way, as it was difficult to understa nd what could be a "counterfeit" of a patent. 
288. With regard to raising barriers to legitimate trad e, he said that such barriers had certainly been 
raised as consignments of legitimate generic medici nes had not only been delayed but actually been 
blocked and sent back to the country of origin.  Thus this was not just a case where consignments 
reached their destinations after some delay, but there had been certain cases where they had never 
actually reached their destinations. 
289. With respect to the EC Regulation's review pr ocess, he said that India and Brazil had been 
invited by the European Communities to meet in Gene va to share details about the review process that 
was currently under way.  While he thanked the European Communities for this opportunity, it was 
his understanding that this review process was not a response to India's request, but a process which 
had started in September 2008 before the issue of drug seizures had been raised in the WTO.  India 
would be interested to know if the scope of th e review mentioned by the European Communities 
included the question of the Regulation's compatib ility with WTO provisions including GATS, TRIPS 
and the spirit of the Doha Declaration, or whethe r it was purely an internal exercise to examine 
compatibility with the European Commun ities' domestic resolutions and laws. 
290. The representative of the European Communities
 said in response that he was once again 
confronted with a document that his delegation had not seen.  He could hardly be expected to 
comment on a letter sent by the French customs to th e Indian Mission that allegedly used the English 
word "seizure", while it was unclear in which la nguage the letter had been  written and whether the 
word had been used appropriately.  As pointed ou t before, his delegation be lieved it would be more 
useful and less of a waste of everyone's time if su ch information could first be received in writing so 
that his delegation could verify and discuss it with the Indian delegation to see if it still would have 
concerns in that regard. 
291. With respect to the distinction between seizure and detention, he said that even though India 
might find this immaterial, the difference was that after a seizure goods were not given back to the 
importer.  In the case of Indian medicines, as India had acknowledged, the medicines had been given 
back and not been kept.  With respect to India' s claim that the consignments never reached their 
destination, he said that this was difficult to argue,  since the medicines had b een returned to India and 
nothing prevented the Indian manufacturer fro m sending them again through other channels. 
292. In response to India's questions on the Regulati on's review process, he said that the review 
process was comprehensive and would certainly ta ke into account the European Communities' 
commitment to access to medicines for developing countries.  IP/C/M/61 
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  293. The representative of Egypt  said that it did not matter whether there had been a seizure or 
detention since, ultimately, the drugs had not reached their destination. 
294. The Council took note  of the statements made. 
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