RESTRICTED  WORLD TRADE  
ORGANIZATION  IP/C/M/60 
28 September 2009 
 (09-4545) 
Council for the Trade-Related Aspects 
of Intellectual Property Rights  
 
 
 
MINUTES OF MEETING 
 
Held in the Centre William Rappard 8-9 June 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 8-9 June 2009. 
 
Subjects discussed
 Page nos.  
 
A. NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT .........................................................2  
B. REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION ..............................................................2  
C. REVIEW OF THE PROVISIONS OF ARTICLE 27.3( B)......................................................................3  
D. RELATIONSHIP BETWEEN THE TRIPS  AGREEMENT AND THE CONVENTION ON 
BIOLOGICAL DIVERSITY .............................................................................................................3  
E. PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE ...................................................3  
F. NON-VIOLATION AND SITUATION COMPLAINTS .......................................................................12  
G. REVIEW OF IMPLEMENTATION OF THE TRIPS  AGREEMENT UNDER ARTICLE 71.1..................13  
H. REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON 
GEOGRAPHICAL INDICATIONS UNDER ARTICLE 24.2 ...............................................................13  
I. TECHNICAL COOPERATION AND CAPACITY -BUILDING ............................................................13  
J. LETTER FROM THE CHAIR OF THE GENERAL COUNCIL CONCERNING WAYS TO 
IMPROVE THE TIMELINESS AND COMPLETENESS OF NOTIFICATIONS AND OTHER 
INFORMATION FLOWS ...............................................................................................................19  
K. INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO ..............................19  
L. OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS ...............19  
M. OTHER BUSINESS ......................................................................................................................21  
 
 IP/C/M/60 
Page 2  
 
  A. N
OTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT  
1. The Chairperson  said that, since its meeting in March 2009, the Council had received a 
notification of laws and regulations from Tonga, a ne wly acceded Member.  It was being circulated in 
document IP/N/1/TON/1 and rela ted law series documents.   
2. The Council had also received a number of supplem ents and updates to earlier notifications of 
laws and regulations notified under Article 63.2 of the Agreem ent.  Singapore had provided a 
consolidated notification detailing all amendments to its IP legislation from 2000 to 2008;  Germany 
had notified a notice in respect of the patent centres  authorized to receive applications for patents, 
utility models, trademarks and designs;  Norway  had notified its new Act on Customs Duties and 
Movement of Goods;  and the United States had no tified its Prioritizing Resources and Organization 
for Intellectual Property Act of 2008.  These notificati ons were being circulated in the IP/N/1/- series 
of documents. 
3. She urged those Members whose initial notifi cations remained incomplete to submit the 
outstanding material without delay and reminded other Members of their obligation to notify any 
subsequent amendments of their la ws and regulations without delay 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 TRIPS and Public Health  and who had not yet notified such changes to 
the Council to do so. 
4. As regards notifications of contact points under Article 69, since the Council's meeting in 
March 2009, an update to a contact  point notified earlier had been received from Singapore.  This 
notification was being circulated in an addendum to document IP/N/3/Rev.10. 
5. The Council took note  of the information provided. 
B. REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION  
(i) Follow-up to the review of legislation of Ukraine 
 
6. The Chairperson  recalled that, at its meeting in Ma rch 2009, the Council had initiated the 
review of the legislation of Ukraine, a newly acced ed Member.  As foreshadowed at that meeting, 
Switzerland had since then posed one follow-up ques tion, which had been circulated in document 
IP/C/W/528/Add.1.  Ukraine's response to this  question had been circulated in document 
IP/C/W/530/Add.1. 
7. The representative of Switzerland  thanked Ukraine for the res ponse to his follow-up question 
and said that he had no further questions. 
8. The Chairperson  suggested that the review of the legislation of Ukraine 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. 
9. The Council took note  of the statements made and so agreed . 
(ii) Follow-up to reviews already undertaken 
 10. 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 six reviews that still 
remained on the Council's agenda.  These reviews c oncerned Cuba, Fiji, Grenada, Saint Kitts and 
Nevis, Saint Vincent and the Grenadines and Suriname.  IP/C/M/60 
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  11. Furthermore, a number of questions had been  raised with regard to the implementing 
legislation of certain other Members whose revi ews had already been deleted from the Council's 
agenda on the understanding that any delegation should feel free to revert to any matter stemming 
from the reviews at any time.  These Members were Dominica, Gabon, Ghana and Guyana. 
12. She recalled that the Chair had informed the Counc il at its last meeting that Saint Vincent and 
the Grenadines had, just prior to the meeting, provid ed responses to all of the questions posed to it in 
its review.  These responses had been circulated in document IP/Q/VCT/1.  In order to provide 
Members more time to study them, the Council had ag reed to revert to this review at the present 
meeting.  Since there were no further questions, sh e suggested that the review 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. 
13. The Council so agreed . 
14. The Chairperson  urged the other delegations concerned to  provide the outstanding material as 
soon as possible, so as to allow the Council to complete these reviews. 
15. The Council took note  of the statements made and agreed  to revert to the matter at its next 
meeting. 
(iii) Arrangements for the review of national implementing legislation of Tonga 
16. The Chairperson  recalled that, at its meeting in June 2008, the Council had agreed that it 
would take up the review of the TRIPS implemen ting legislation of Tonga, a newly acceded Member, 
at its first meeting in 2009.  Since then, the Council had agreed to postpone the review until its 
meeting scheduled for 27-28 October 2009 and set the ta rget dates for the submission of questions and 
responses for that review at the present meeting.  The Council had now received Tonga's notification 
of its TRIPS implementing laws  and regulations, which was be ing circulated in document 
IP/N/1/TON/1 and related law series documents.  In  accordance with the st andard procedures for 
reviews of legislation, she proposed that the Counc il set the following target dates for the submission 
of questions and answers in this review: 
- Questions should normally be submitted to Tonga , with a copy to the Secretariat, ten weeks 
before the meeting in which the review takes place;  accordingly, she suggested setting the 
target date on 17 August. 
- Responses to questions posed within that d eadline should normally be submitted four weeks 
before the meeting;  accordi ngly, she suggested setting the target date on 28 September. 
17. The Council so agreed . 
C. REVIEW OF THE PROVISIONS OF ARTICLE 27.3( B) 
D. RELATIONSHIP BETWEEN THE TRIPS  AGREEMENT AND THE CONVENTION ON BIOLOGICAL 
DIVERSITY  
E. PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE  
18. 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 IP/C/M/60 
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  suggested that the Council continue its past prac tice of discussing these three agenda items together 
on the basis of the contributions by Members. 
19. The representative of India
 said that inadequacy of the TRIPS Agreement to combat biopiracy 
and misappropriation of genetic resources and trad itional knowledge needed no elaboration.  The 
TRIPS Agreement was inconsistent with intellectua l property-related obliga tions of the CBD which 
predated the TRIPS Agreement and had 191 par ties.  The contradiction between the TRIPS 
Agreement and the CBD was one of the factors lead ing to an imbalance in the TRIPS Agreement.  
The geographical spread and socio-economic profil e of the co-sponsors of the disclosure proposal 
made it clear that a Doha outcome could not be co mplete without satisfactorily addressing this issue 
of immense importance to a vast majority of the WT O membership.  He said that the steep rise in bio-
prospecting for natural remedies and other pur poses that was taking place worldwide could have 
undesirable consequences in the ab sence of internationally acceptable legal regulations, and therefore 
the issue should be adressed with urgency and priority.   
20. He said that after a great deal of detailed technical work at the TRIPS Council, the disclosure 
proposal contained in document IP/C/W/474 had b een submitted in 2006.  Subsequently, document 
TN/C/W/52, which contained key parameters the pr oponents wished to see reflected in a Ministerial 
decision on three TRIPS issues, had been submitted in  July 2008.  This document was balanced since 
it was an outcome of constructive engagement, fl exibilities and accommodation of interests of about 
110 Members which included develope d and developing countries, and most LDCs.  While nearly 
three quarters of the WTO membership supported document TN/C/W/52, only a few countries had disagreement with the proposed approach.  He noted that some of the proponents of document 
TN/C/W/52 were countries which had the largest pharmaceutical companies and filed the highest 
number of patents.  Document TN/C/W/52 was an  agreement among the 110 Members that the three 
TRIPS issues must be dealt with in tandem based on the key parameters mentioned therein.  He strongly supported the proposed approach on procedur e and the substantive elements of GI extension 
and GI register as mentioned in that document, and said that it provided a sound basis for the way 
ahead on these issues.  He expressed his delegation's disappointment at the lack of progress on the 
TRIPS/CBD issue despite exhaustive technical work of nine years and overw helming support of the 
majority of the WTO membership.  He said that the proponents of the disclosure proposal had consistently demonstrated the spirit of compromi se and constructive engage ment which had resulted 
in document TN/C/W/52.  While most Members agreed that work on all areas on the Doha  Programme must progress apace, it was ironical that there had been no progress on the TRIPS/CBD 
issue, which his delegation saw as a critical  developmental deliverable from the Round. 
21. He appreciated the three rounds of consu ltations on the issues of TRIPS/CBD and GI 
extension held by the Directo r-General since the TRIPS Council' s meeting in March 2009, which 
served the mandate contained in paragraph 39 of the Hong Kong Mini sterial Declaration, calling for 
intensification of consultations by the Director General "by appointing Chairpersons of concerned 
WTO bodies as his Friends and/or by holding dedicated consultations".  He said that the chairmanship 
of the Director-General and the participation of Ambassadors could provide meaningful and 
constructive engagement among Members.  Howeve r, he noted that it was important that the 
momentum generated must not slacken if the process were to deliver on its objectives of providing a 
basis for Ministers to take an in formed decisions on two important implementation-related issues.  He 
said that there was no other proposal that coul d squarely address the issues of biopiracy and 
misappropriation of genetic resources and traditiona l knowledge, erroneously gr anted patents and the 
promotion of transparency and traceability.  The da tabase proposal claimed to address only part of the 
problem, i.e. the problem relating to erroneously grante d patents.  He recalled that, at the last meeting 
of the TRIPS Council, his delegation had informed  the Council that India had created a Traditional 
Knowledge Digital Library (TKDL), which would act as a bridge between ancient texts in different 
local languages and patent examiners at the globa l level.  While India was taking initiatives to 
improve prior art searches, he indicated that it was only complementary to, but not in lieu of, a  IP/C/M/60 
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  mandatory disclosure requirement.  He said that it was nearly impossible to have an exhaustive 
database of genetic resources and tr aditional knowledge, particularly when a major part of traditional 
knowledge was oral.  Considering the enormity of  genetic resources and tr aditional knowledge, it 
would be impossible even to map them globally.  Th ere was also the issue of capacities to create such 
databases by developing countries, which were home  to about 80 per cent of genetic resources and 
traditional knowledge.  He said that there were disadvantages of databases without an accompanying 
mandatory disclosure requirement, because database s might result in attracting undesirable attention 
towards genetic resources and traditional know ledge and might actually become a tool for 
misappropriation and further aggravate the problem.  It was therefore important to establish an international enforceable mechanis m, such as the disclosure requirement even for databases, to serve 
their objectives. 
22. The representative of Brazil
 supported negotiations on the draft modalities for the three 
TRIPS-related issues as proposed in document TN /C/W/52.  He said that 108 Members, over 
two-thirds of the WTO membership, had made a signi ficant effort to approximate their positions and 
to put forward a balanced and reasonable proposal.  He expressed his delegation's disappointment that 
a few Members retained their positions without showing any willingness to bring their positions 
closer to what had been proposed by the large majority of the WTO membership.  He reiterated that 
the disclosure requirement would promote a mutu ally supportive implementation of the TRIPS 
Agreement and the CBD.  The disclosure requireme nt would provide mega-diverse developing and 
developed countries with information with regard to the invention that was derived from or was 
developed with genetic resources a nd/or traditional knowledge.  It would enable developing countries 
to benefit from the sustainable exploitation of thei r biodiversity and to make conservation of genetic 
resources a commercially attractive activity.  He said that the disclosure requirement was a major development component of the Doha Round and an  agreement on the disclosure requirement would 
respond to a major demand of developing countr ies within the Doha Development Round.   
23. He said that, during the Uruguay Round, deve loping countries had made a great concession 
by accepting the TRIPS Agreement and therefore it was now necessary to amend the TRIPS 
Agreement to respond to the demand of devel oping countries.  The TRIPS Agreement required 
developing countries to protect innovations, tec hnologies and cultural products, the production of 
which was virtually monopolized by developed countries.  Genetic resources and traditional 
knowledge were, to a large extent, the only intang ible asset held by developing countries.  The 
disclosure requirement would increase the legitimacy of  patent systems and widen the participation of 
developing countries in the system by enabling them  to protect and benefit from the intangible asset 
held by themselves.   He said that the disclosure re quirement would also increase the efficiency of the 
patent system.  Under the patent system, an invent or enjoyed patent protection for his invention, and 
in return he should disclose his invention to the society.  The disclosure requirement was in harmony with the objective of the patent system because it stre ngthened the patent system's capacity to disclose 
relevant information to the society and patent exam iners.  In other words, the disclosure requirement 
could help to avoid the granting of erroneous patents and misappr opriation of genetic resources and 
traditional knowledge.  He said that many countr ies, both developing and developed countries, had 
adopted or were in the process of adopting their ow n legislation on the disclosure requirement.  The 
industry needed an international legal framework that would provide predictability and encourage 
investment in the biotechnology field.  The only wa y for bringing about such an international legal 
framework was to introduce the di sclosure requirement into the TRIPS Agreement and set out a 
commonly agreed international standard on the disclosure requirement.   
24. The representative of Egypt, speaking on behalf of the African Group
, said that the protection 
of biological resources, traditional knowledge and folklore was of prime concern to the African 
Group.  In view of the importance of this issue,  the African Group continued to support engagement 
in full negotiations on the relationship between the TRIPS Agreement and the CBD, which was a 
critical part of the implementation-related issues  and concerns as contained in the Doha Work IP/C/M/60 
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  Programme.  Nevertheless, there was a continui ng lack of engagement from certain quarters 
presenting an argument that a case had not been ma de to commence text-based negotiations.  He 
reiterated that this issue had significant developmen tal impact 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 latter.   
25. He said that technical discussions on this issue had been ongoing for the past nine years, 
during which the African Group had made several subm issions with the aim of clarifying the issue so 
that an effective and consistent framework could be established to enable the WTO Members to meet 
their obligations under both the TRIPS Agreement and the CBD.  The essence  of Members' efforts 
was that the TRIPS Agreement should be amended in  order to provide that Members shall require a 
patent applicant for a patent relating to biological  materials or associated traditional knowledge to 
disclose the source and country of origin of the biological resource and the associated traditional knowledge used in his invention.  Furthermore, th e patent applicant shall also provide evidence of 
prior informed consent and of fair and equitable be nefit sharing under relevant national regimes.  He 
reaffirmed that there was a solid case supported by  a majority of the WTO membership to commence 
text-based negotiations as presented in document IP/C/W/474.   
26. He said that the African Group was grateful for the engagement of the Director-General in 
resuming his mandated consultative process on the i ssues of TRIPS/CBD and GI extension, and he 
looked forward to his continuing consultations towards a possible outcome.  He requested that all Members engage constructively th erein and note the important deve lopment concerns over some of 
the issues discussed.  He said that, over the y ears, Members had all witnessed numerous cases of 
biopiracy, where traditional knowledge and genetic  material of African countries and other 
developing countries was taken out of their countries and then patented.  It had proven very difficult 
and costly for the poor communities in their countries  to fight for their rights.  The amendment of the 
TRIPS Agreement to include the disclosure requireme nt, prior informed consent and benefit sharing 
was important for these communities to protect their traditional knowledge.  The amendment would 
ensure that the outcome of the Doha Deve lopment Round was truly a development round. 
27. The representative of Ecuador
 reiterated his delegation's commitment to legal instruments 
which would ensure the recognition of countries' sovereign rights over biodiversity and indigenous 
and local communities' collective rights over traditi onal knowledge.  He welcomed the consultations 
conducted by the Director-General according to th e Hong-Kong Ministerial Declaration, and said that 
constructive dialogue among Members would facilitate  the conclusion of the Round and help to reach 
agreement on the TRIPS issues.  He reiterated th e development dimension of the Doha Round.   
28. The representative of Cuba  said that her delegation was encouraged by the recent 
consultations led by the Director-General wh ich, among other things, addressed the disclosure 
requirement in connection with the examination of the relationship between the TRIPS Agreement 
and the CBD.  These consultations helped to narrow the gaps and to clarify pending technical issues 
although the proposal to amend the TRIPS Agreemen t, which was officially submitted in 2006, had 
already been extensively discussed.  In addition, for many years before the submission of the 
proposal, the disclosure requirement was examined in other international forums, such as the CBD 
and WIPO.  The proposal, co-sponsored by her de legation from the outset, was supported by more 
than half of WTO Members and certain important groups such as the LDCs, the African Group and the ACP Group. 
29. The submission of the draft modalities for TRIPS-related issues in July 2008, which included 
the mandatory disclosure in the framework of the TRIPS Agreement and the CBD, had given an 
impetus to this issue.  In the light of the above, she sincerely hoped that the consultations would continue and that advantage would be taken of th is impetus, although she was aware that technical 
fine-tuning alone would not lead to success in th ese negotiations.  What was needed above all was  IP/C/M/60 
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  political will.  The issue, although discussed in ot her forums, continued to be a problem and an 
amendment to the TRIPS Agreement would be one way of contributing to a solution. 
30. The representative of Peru  associated his delegation with the statements made by India, 
Brazil, Egypt, Ecuador and Cuba.  He said that  his delegation had subm itted 11 working papers 
together with other delegations concerning the relationship between the TRIPS Agreement and the 
CBD and the protection of traditional knowledge and fo lklore since 2003.  It had also submitted four 
papers by itself, including a concrete case study of  biopiracy and legal and practical arguments on the 
need to include the disclosure requirement in pate nt systems.  He said that a multilateral mandatory 
disclosure requirement would be the most efficient way to address the international problem of misappropriation of genetic resources and traditiona l knowledge, for it would allow mega-biodiverse 
developing countries to track down the supplying count ry by requiring patent applicants to disclose 
the supplying country as well as the evidence of co mpliance with prior informed consent and benefit 
sharing.  Document TN/C/W/52, co-sponsored by  over 110 Members, represented a step towards 
achieving the objective.  He said that the disclos ure requirement would make it possible to recognize 
the rights of Members, local communities and indigenous peoples over their genetic resources.   
31. Only by taking action against biopiracy would Me mbers be able to establish a balanced patent 
system and intellectual property systems in general.   Intellectual property systems were based on the 
promotion of innovation and Members should resolve to improve the systems to the benefit of all, in 
particular the local and indigenous communities in  the poorest rural areas of developing countries. 
32. The representative of China
 welcomed the discussion on the relationship between the TRIPS 
Agreement and the CBD as an important item on the agenda of the Council and fully supported the 
statements made by the previous speakers.  He  said that it was a critical issue for developing 
countries, and should be an integral part of th e Doha Work Programme.  He said that all WTO 
Members shared the objective of preventing biopiracy and erroneously granted patents but that there 
was a divergence of views on how to achieve the objective.  Some Members asserted that it was 
effective to set up national access and benefit-shar ing systems and databases on genetic resources to 
eliminate biopiracy.  Those methods might help, to some extent, but were still not sufficient to solve 
the problem of biopiracy.  Most Members, including China, firmly believed that the disclosure requirement in patent applications  would substantially contribute to fully implementing three main 
principles of the CBD.   
33. Accordingly, the effective approach was to introduce the principles of the CBD into the 
TRIPS Agreement, which would provide an intern ational legal framework and enhance the mutual 
supportiveness between the TRIPS Agreement and the CBD .  He noted that over two-thirds of  the 
WTO membership had co-sponsored the draft moda lities text contained in document TN/C/W/52, 
which requested the inclusion of the TRIPS/CBD issu e, as well as the issues of GI extension and GI 
registration as part of the horizontal process.  He said  that this emerging convergence proved that the 
three TRIPS issues were mature both politically an d technically, and therefore merited substantial 
text-based negotiations in the horizontal process, toge ther with the issues of agriculture and NAMA.  
He welcomed the consultations on the TRIPS/CBD is sue under the leadership of  the Director-General 
as the chair of the TNC.  He said that, over the p ast three months, with the active involvement of 
Ambassadors, these consultations had brought positive discussions.  However, he was disappointed at 
the unwillingness of some Members to participate in a meaningful way and at the lack of progress.  
He said that China would continue to engage in constructive discussions and make its contributions.  
34. The representative of Pakistan
 supported the statements made by the previous speakers and 
said that the disclosure requirement was important for developing countries.  A multilateral system 
was needed to protect traditional knowledge and folklore because individual databases were not 
possible due to capacity constraints and jurisdictio nal validity later on.  Any delay in having the 
disclosure requirement was causing serious economic concerns to Members, unlike some imaginary IP/C/M/60 
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  losses in some areas, such as non-violation and situa tion complaints.  He urged Members to engage 
seriously in order to find an optimum solution for the three TRIPS issues.  
35. The representative of Nigeria
 associated his delegation with the statement made by Egypt on 
behalf of the African Group.  He welcomed the cons ultations under the Director-General on the issues 
of TRIPS/CBD and GI extension according to  paragraph 39 of the Hong Kong Ministerial 
Declaration.  He said that the overwhelming support for these issues from over 110 Members 
indicated that these issues deserved to be part of  the Single Undertaking.  He said that the TRIPS 
Agreement did not include a mandatory di sclosure requirement which would prevent 
misappropriation of genetic resources and traditiona l knowledge.  He also indicated that text-based 
negotiations on the issues of TRIPS/CBD and GI exte nsion should be undertaken as soon as possible.   
36. The representative of Angola  supported the statement made by Egypt on behalf of the African 
Group.  He welcomed the consultations led by the Director-General and asked  for more inclusiveness 
in the consultative process in order to allow Members to express their concerns.      
37. The representative of New Zealand  shared the objective of preventing misappropriation of 
biological resources.  He said that his delegation had been pleased to participate in the Director-
General's consultations on the TRIPS/CBD issue in a constructive spirit.  He said that the 
consultations had been very useful in allowing Memb ers, on a without prejudice basis, to gain a better 
understanding of this complex issue and possible ways  forward.  He said that the consultations were 
still at a very early stage, and his delegation looked  forward to continuing to participate with other 
Members to discuss technical issues which had an important development dimension.   
38. He said that his delegation considered that the WTO was not necessarily the best forum - and 
certainly it was not the only way - to address these issues.  The focus on the TRIPS Agreement's 
interaction with the CBD was very narrow in sco pe, which effectively narrowed discussions to 
biological resources.  He said that New Zealand ha d a highly diverse environment rich in unique 
biological resources, as well as a significant indige nous community with which it had a partnership 
arrangement codified in the Treaty of Waitangi, which dated back over 150 years.  While New 
Zealand shared the objective of preventing misappropr iation of biological resources, it had very real 
concerns over misappropriation of  traditional knowledge and trad itional cultural expressions, and 
believed a CBD-focused outcome might not necessar ily address these concerns.  He said that his 
delegation shared the commitment to address these issu es.  While it agreed with Pakistan that these 
issues needed to be addressed in a multilateral way, it could not agree that they should be addressed in 
the narrow or restrictive way which would be the inevitable result of a CBD-focused outcome.  
Therefore, he retained a strong preference for these discussions to take place within the WIPO 
Intergovernmental Committee on Intellectual Propert y and Genetic Resources, Traditional Knowledge 
and Folklore (IGC) rather than in the WTO.  Th is process was undertaking very important work to 
build understanding of the nature of the problem s of misappropriation, and had the benefit of 
addressing a much broader scope than was possible with in the WTO or the CBD.  This sort of holistic 
approach, drawing together work across a broad rang e of issues, also had the benefit of promoting 
coherence across various international forums which were discussing related issues.  He further said 
that any solution must take account of the need fo r Members to have the policy space they needed to 
meet their unique national circumstances.  A one-size-fits-all solution imposed from a narrow 
multilateral discussion would not work.  He looked forward to further engagement at the 14th WIPO 
IGC in June 2009.   
39. He acknowledged that Brazil, India and a large number of developing countries had concerns 
over the relationship between the TRIPS Agreement and the CBD, and would like to continue to 
engage in discussions within the TRIPS Council to better understand these concerns and how to 
address these concerns.  He said that the current  approach was not moving Members forward, and 
hoped that the Director-General's consultations on the TRIPS/CBD issue could progress.  He  IP/C/M/60 
 Page 9 
 
 
  reiterated that the linkage bei ng drawn between the TRIPS/CBD issue and unrelated issues did not 
help progress, particularly given the difficulty th at the proponents of other issues seemed to be 
experiencing in the Director-General's process.  He said that the linkage was a factor in constraining 
New Zealand's position on the TRIPS/CBD issue.  
40. The representative of Norway  said that her delegation did not see any conflict between the 
TRIPS Agreement and the CBD, and that the two treaties could and should be implemented in a 
mutually supportive manner.  Nevertheless, she said that the relationship between the two instruments 
would be enhanced by introducing a mandatory ob ligation in the TRIPS Agreement to disclose the 
origin of genetic resources and tr aditional knowledge in patent applica tions.  She recalled that Norway 
had introduced a proposal for such an amendment in June 2006, and believed the proposal would 
support the aims of the CBD and woul d be useful in ensuring that pate nts were not granted contrary to 
the fundamental principles of patent law. 
41. The representative of the United States  said that the Council had continued to engage in a 
useful and constructive exchange of views based on a sharing of national experiences and by posing 
and responding to questions among Members.  This manner of working should continue to be the 
basis for the Council's work on these issues.  Sh e acknowledged that some Members had advocated 
commencing negotiations on the basis of a proposed text to amend the TRIPS Agreement.  However, 
she reiterated that her delegation did not sup port amending the TRIPS Agreement to address the 
concerns of the demandeurs and did not think that doing so would be the most effective way of 
addressing these concerns.    
42. She said that Members should fo cus on the shared objectives that had been revealed.  She 
agreed that prior informed consen t and equitable benefit sharing for the use of genetic resources and 
related traditional knowledge and a voiding erroneously granted patents were important issues.  Where 
Members continued to diverge was on the premis e that the disclosure requirement would be an 
effective means of achieving these objectives.  At a f undamental 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 frameworks designed specifically to 
accomplish these objectives.   
43. Bringing the patent system into the equation di d not make sense if there was an absence of a 
well functioning prior informed consent in access a nd benefit-sharing regimes.  She said that her 
delegation continued to puzzle over how new patent requirements, incl uding the possibility of denial 
of patents or revocation of patents in some ci rcumstances would help accomplish the legitimate and 
important shared objectives.  The most effective way to ensure the sharing of benefits was to bring 
about the generation of benefits in the first place.  Benefits would be genera ted when useful and good 
products were developed and comme rcialized.  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 prior in formed consent and access and benefit sharing 
systems were in place, Members could have co nfidence that the common objectives could be 
achieved.  She said that the agenda of the Council limited Members' discussion and consideration of 
the three issues in tandem at this point.  She object ed strongly to any discussion in this context of 
other TRIPS-related issues.  She said that the fact that some Members deemed it as expeditious to address these issues together did not overcome he r delegation's vigorous opposition to their being 
considered as a package.  She said that these issues must continue  to be considered under specific 
individual merits and within the specific bodies and consultation mechanisms designated in previous 
ministerial guidance.   
44. The representative of Canada
 reiterated that the most meaningful way to advance the 
discussion on the TRIPS/CBD issue in the WTO was to  engage in fact-based technical discussions of 
the various proposals, and that time and considerati on should be given to a full scoping of the issue IP/C/M/60 
Page 10  
 
  before proceeding further with particular focus on those who had best practices to share or had 
experienced problems.  He encouraged Members to c onsider other mechanisms to protect biodiversity 
and prevent misappropriation of genetic resources,  such as developing broader, more globally 
accessible and functional prior art databases, using mutually agreed terms and material transfer agreements, licensing, code of conduc t and other contracts.  He said that his delegation had not been 
shown that there was a contradiction between the TRIPS Agreement and the CBD, and therefore 
remained unconvinced of the need for the amendmen t of the TRIPS Agreement.   While his delegation 
could not agree to negotiations on this issue, it w ould continue to engage constructively in ongoing 
discussions on the TRIPS/CBD issue.  He highlighted that other international forums had established 
expertise and capacity in this area, such as th e CBD and WIPO, which were undertaking significant 
technical discussions.  Canada was committed to acc elerating the work of the WIPO IGC as per its 
mandate and to achieve concrete outcomes.  He ag reed with New Zealand that WIPO was the better 
forum to discuss these issues and looked forward to working with other Members at the upcoming 
July meeting of the WIPO IGC.  He shared New Zealand's concern over the linkage of three TRIPS 
issues.  He also stressed that Canada would conti nue to be fully engaged in the consultative process 
led by the Director-General on the TRIPS/CBD issue.  
45. The representative of Japan
 reiterated that biopiracy should be discussed through making 
distinction between the issues of erroneously gran ted patents and that of CBD compliance.  He 
recalled that his delegation had subm itted a proposal on databases for patent examination in order to 
avoid erroneously granted patents in the TRIPS Council as well as in WIPO, which had obtained the 
support of numerous countries.  He said that the case had not been made that a mandatory disclosure 
requirement would effectively monitor possible CBD violations.  He noted that it would be 
problematic to introduce the disclosure requirement in  terms of patent appli cants' burden and the legal 
stability of patent rights.  Since the profit gained by utilizing patent systems was the source of benefit sharing, he expressed concern over an adverse effect  of the disclosure requirement on the provider of 
genetic resources.  He said that the best way to re ach a practical solution would be to deepen fact-
based analysis of biopiracy and then discuss opt imal solutions.  He informed the Council that 
technical discussions on the issue of the CBD comp liance would be undertaken in the CBD prior to 
the 10
th Session of the Conference of Parties (COP10)  in 2010, and that dedicated and technical 
discussions were also underway in the WIPO IGC.   He said that Members should take into 
consideration the results of these discussions.  
46. The representative of Argentina  did not support the artificial linkage between three TRIPS 
issues and did not support the proposal of amendm ent of the TRIPS Agreement. She said that 
misappropriation of generic resources and traditiona l knowledge was a serious problem and Members 
should discuss the TRIPS/CBD issue without forgetting that substantial work was being carried out in 
WIPO and the CBD.   
47. The representative of Switzerland  said that document TN/C/W/52 proposed modality 
language for a Ministerial decision on the basis of which text-based negotiations  could take place with 
a view to finding mutually agreeable solutions for outstanding issues in the Doha Round.  The 
proposal of a disclosure requirement for genetic  resources and traditional knowledge in patent 
applications and GI extension were two implementation-related issues deriving from the Doha 
Declaration which Members had agreed to resolve as outstanding matters.  The GI register issue was a 
negotiation built into the TRIPS Agreement and alread y agreed to in the Uruguay Round.  He said 
that more than two-thirds of the WTO membership  had formally supported taking three TRIPS issues 
forward to a substantive solution in the Doha De velopment Round.  He welcomed the resumption of 
consultations by the Director-General on the two implementation issues and said that useful work had 
been undertaken in three consultations and more wo rk remained to be done.  Meaningful progress on 
these three issues, substantively and/or procedurally, needed to be made in parallel to each other and 
in parallel to other fields of the negotiations.  IP/C/M/60 
 Page 11 
 
 
  48. The representative of Korea  said that the TRIPS Agreement was not a proper tool to address 
the objectives of the CBD, namely the prevention of erroneously granted pate nts, equitable benefit 
sharing and protection of biodiversity.  The solution should be sought for outside patent systems.  His 
delegation was not convinced that the introduction of disclosure requirements into existing patent 
systems was an effective solution to prevent err oneously granted patents as it did not understand how 
the disclosure requirement could help to examine the inventive step and novelty of an invention.  The 
origin of source only indicated whom the benefits accruing from an invention should be shared with, 
and did not indicate whether the invention involved an inventive step or had novelty.  He said that 
Members should not lump together IPR-related laws with civil or criminal laws which could address 
the act of stealing of genetic material.  He reiterated that the amendment of the TRIPS Agreement was 
not needed to address the CBD objectives.  He also doubted whether the disclosure requirement was 
an effective and useful way to prevent erroneously granted patents.  He said that patent authorities 
should search for prior arts as a step of the ex amining process to determine whether a claimed 
invention was original or not.  In this process, au thenticated national or international databases would 
be a useful tool to reduce the burden of patent ex aminers, while the informat ion provided by patent 
applicants might mislead the examiner.   
49. He expressed his concern over ongoing consulta tions chaired by the Director-General.  He 
said that although consultations could be done in a small group setting in order to facilitate 
discussions, what the small group had discussed should be  shared with the wider membership.  In this 
regard, he requested that the results  of the Director-General's consulta tions be reported to the Council.  
He also expressed his delegation's willingness to engage in discussions according to the mandate 
established in the Council.   
50. The representative of the European Communities  said that two-thirds of the WTO 
membership had proposed specific modalities language  for the three TRIPS issues under the Doha 
Development Agenda, and that his delegation was co mmitted to this common platform reflected in 
document TN/C/W/52.  His delegation attached gr eat importance to these three issues and supported 
the parallel treatment with the view to a decision and modality.  He welcomed the Director-General's 
consultations on the issues of GI extension and TRIPS/CBD, and hoped that the consultations would 
be pursued in an intensive manner.  He said that his delegation had taken a constructive stand on the 
disclosure requirement and expressed readiness to meet developing countries' concerns, while 
preserving the balance of rights and obligations of th e patent system.  The disclosure requirement as 
set out in document TN/C/W/52 could be helpful for patent examiners to establish novelty through 
making more focused searches and thus to contribut e to prevent misappropriation of genetic resources 
and associated traditional knowledge.  Meanwhile, his delegation saw the merits in other approaches 
such as the database proposal in document IP/C/W /472.  However, such databases would not be 
sufficient to meet the objectives pursued in doc ument TN/C/W/52 and would not have the same 
effectiveness as the mandatory disclosure requirement.  In conclusion, he said that a broad consensus 
for decisions and modalities could only be found  if the TRIPS issues were part of them. 
51. The representative of Australia  rejected the artificial parallelism between the three TRIPS 
issues and reiterated that these issues should be dealt with separately and on their own merits.  He said 
that Australia shared the common objectives on th e TRIPS/CBD issue, including the objectives of 
facilitating access to genetic resources with prior informed consent and on mutually agreed terms, 
equitable sharing of the benefits arising from the utilization of genetic resources, and respecting and 
preserving traditional knowledge.  Nevertheless, there was little evident agreement on the best 
mechanism to achieve these objectives and on the a ppropriate forum to conduct discussions.  There 
was disagreement on the adequacy, sufficiency and n ecessity of the patent disclosure requirement.   
52. Australia's national experience had indicated that  effective regimes for prior informed consent 
and access and benefit shari ng could be implemented outside the pa tent system, such as legislation on 
permission and contracts.  He said that the Aust ralian Government had re newed its commitment to IP/C/M/60 
Page 12  
 
  looking into indigenous policy both domestically and internationally, which was reflected in the 
Government's decision to support the UN Declaration on the rights of indigenous people.  He said that 
his delegation had fully supported continuing fact-based discussions concerning the best mechanisms 
for achieving the shared objectives in various foru ms and had participated constructively in the 
Director-General's consultations without prejud ice to the discussions on the patent disclosure 
requirement.  He said that there was lack of de tailed discussion on the impact of a mandatory 
disclosure requirement on the patent system and th e scope of the proposed disclosure requirement.  
Therefore, there was need for detailed technical c onsideration of all options in appropriate forums. 
53. The representative of Chinese Taipei
 said that the TRIPS Council had a mandate to discuss 
the relationship between the TRIPS Agreement and the CBD.  While some Members thought that it 
was critical to amend the TRIPS Agreement to address the problem of misappropriation, others 
thought that the need for an amendment had not b een demonstrated.  He said that his delegation had 
actively participated in the discussions on this i ssue over the past years, but it had not taken sides 
because this issue was complicated in  terms of the implications of the amendment for the owners of 
genetic resources and traditional knowledge, inve ntors and researchers, and intellectual property 
administration authorities.  He said that all Me mbers recognized that misappropriation was unlawful 
and even immoral, and that they should find a ba lanced approach to avoid overburdening researchers 
and patent examiners.  He said that the database proposal made by Japan might be a way to avoid 
erroneously granted patents.  He sa id that, given the complexity of this issue, his delegation had not 
come to a conclusion about the necessity of am ending the TRIPS Agreement to address the objective 
of fair and equitable benefit sharing.  His delega tion wished to continue the discussion either in the 
Council or in consultations mandate d by paragraph 39 of the Hong Kong Ministerial Declaration.    
54. The representative of Chile  said that his delegation rejected the artificial parallelism within 
document W/52, although it was partic ipating constructively in the c onsultations being conducted by 
the Director-General.  During those consultations he  had indicated that Chile supported the objectives 
of the CBD as well as those of avoiding bio-piracy and the misappropriation of genetic resources.  He 
believed that the discussion was very useful in cl earing certain doubts and helping to understand the 
problems of the proponents and indeed had no objection in principle to amending the TRIPS Agreement.  However, as pointed out by New Zeala nd, the fact that this topic was grouped together 
with unrelated topics had complicated matters and made  it more difficult to achieve greater flexibility.  
It was thus misleading to say that there was a group that opposed document W/52.  There were 
nuances, and the opposition concerned certain aspects,  as indeed there were considerable nuances 
within this group of countries. 
55. The representative of Brazil
 said that the WIPO mandate could not supersede the Doha 
mandate and that Members could not simply outs ource the Doha Developmen t Round and refer it to 
WIPO.  He said that, although there was a thema tic proximity between the activities of WIPO IGC 
and the WTO TRIPS Council, WIPO and the WTO ha d different mandates in terms of nature and 
scope.  While WIPO attempted to accomplish a co mprehensive international instrument for the 
protection of genetic resources, traditional knowledge and folklore, WTO Members had a mandate to 
examine the relationship between the TRIPS Agreement and the CBD.   
56. The Council took note  of the statements made under these three agenda items and agreed  to 
revert to them at its next meeting.   
F. NON-VIOLATION AND SITUATION COMPLAINTS  
57. 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 to make 
recommendations to the next session of the Minister ial Conference.  It was agreed that, in the  IP/C/M/60 
 Page 13 
 
 
  meantime, Members would not initiate such complain ts under the TRIPS Agreement.  She said that, 
as requested by the Council at its meeting in March 2009, she had held consulta tions on the matter.  In 
these consultations, a number of delegations had expressed their views on the action that the Council 
should take with a view to making a recommendation on the matter prior to the Seventh Session of the 
Ministerial Conference that was to be held in Geneva from 30 November to 2 December 2009.  One 
delegation had said that the General Council had yet to  decide whether this item would be included in 
the agenda of the next Ministerial Conference, whic h was to be a regular session of the Conference.  
Another Member took the view that a recommendation would be required only if the Council made any recommendations that contained some specific suggestions on the scope and modalities for such 
complaints, and that no recommendation was require d if the Council wished that the moratorium 
should expire. 
58. Continuing, she said that, in case the Council were to make any recommendations, a number 
of delegations were of the view that the Council should follow the proposal in document IP/C/W/385, 
originally introduced by Peru and co-sponsored by a number of developing countries, and recommend to the Seventh Ministerial Conference that violations  of the type identified in Article XXIII.1(b) and 
(c) of GATT 1994 be determined ina pplicable to the TRIPS Agreement.   Some other delegations were 
in favour of letting, at the end of the present exte nsion of the moratorium, non-violation and situation 
complaints become available under the TRIPS Agr eement, without subjecting them to any specific 
guidance as to their scope and modalities over and above  those already envisaged by the DSU, that is 
the general safeguards provided in Article 26 of the DSU.  Reference was also made to the possibility 
of a further extension of the moratorium to allo w the Council more time to consider the scope and 
modalities of non-violation and situation complaints in the area of TRIPS. 
59. In the light of this situation, she suggested th at she continue her consultations on the matter. 
60. The Council so agreed
. 
G. REVIEW OF IMPLEMENTATION OF THE TRIPS  AGREEMENT UNDER ARTICLE 71.1 
61. No statements were made  under this agenda item. 
62. The Council agreed  to revert to the matter at its next meeting. 
H. REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON GEOGRAPHICAL 
INDICATIONS UNDER ARTICLE 24.2 
63. 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.   
64. The Council agreed
 to revert to the matter at its next meeting. 
I. TECHNICAL COOPERATION AND CAPACITY -BUILDING  
65. The Chairperson  recalled that the Council had traditiona lly undertaken its annual review of 
technical cooperation each autumn.  She therefore s uggested that the Council hold its annual review 
of technical cooperation at its next meeting schedul ed for 27-28 October.  Accordingly, she suggested 
that the Council invite developed country Members to supply information on their activities pursuant 
to Article 67 of the TRIPS Agreement.  Other Members who also made available technical IP/C/M/60 
Page 14  
 
  cooperation were encouraged to share information on these activities if they so wished.  She also 
suggested that the Council invite those intergovernment al organizations that had observer status in the 
TRIPS Council to provide information on their activ ities of relevance and that the WTO Secretariat 
also be instructed to report on its activities.  She proposed that the Council request that this 
information be made available by 2 October in or der to allow its timely circulation before the 
meeting. 
66. The Council so agreed
. 
67. The representative of Angola  stressed the necessity of discussing LDC priority needs for 
technical and financial cooperation at the national level, in order to share information on the 
implementation of the TRIPS Agreement, on the syst em of notifications and on the main constraints 
preventing the full implementation of provisions such as the 2003 General Council decision on the 
Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health.  
Such discussions could be followed by regional work shops for LDCs to share best practices, and a 
workshop in Geneva to address concerns of all LDCs. 
68. The representative of Tanzania, speaking on behalf of LDC Group , supported the statement of 
Angola stressing the importance of needs assessment s for the LDCs.  He said that some LDCs had 
already benefited from technical assistance to assess their priority needs for technical and financial 
cooperation from the WTO and other partners.  Af ter regional and Geneva workshops, which should 
not be end results, a programme of assistance for LDCs should be establis hed to ensure that they were 
assisted according to their needs. 
69. The representative of Bangladesh  associated his delegation with the statement made by 
Tanzania and said that, in order to integrate them  in the multilateral trading system, LDCs needed a 
level-playing field in the form of special and differential treatment.  Technical assistance was one of the means to plug the inherent supply-side limitati ons of LDCs.  As LDCs were the poorest Members 
of the WTO by definition, they deserved the utmost attention in regard to technical cooperation.  He 
urged the developed country Members to fulfil thei r obligation to provide technical and financial 
cooperation to LDCs pursuant to TRIPS Article 67 to facilitate the implementation of the Agreement.  
Technical cooperation included appropriate assistance in preparation of laws and regulations on the 
protection and enforcement of intellectual propert y rights as well as the prevention of their abuse, 
commensurate with the level of the development of LDCs.  It also included assistance towards establishing and strengthening of domestic offices and agencies, including training of personnel.  
Technical cooperation should not be contingent  on the level of compliance with the TRIPS 
Agreement.  LDCs needed adequate policy space an d flexibilities to promote their social goals.  In 
order to take advantage of the extension of the tr ansition period granted to LDCs until 1 July 2013, 
LDCs needed assistance with resp ect to needs assessments in accord ance with Article 67  of the 
Agreement and paragraph 3 of the TRIPS Counc il decision of 29 November 2005 in document 
IP/C/40.  Concluding, he expressed his interest in  any updates from developed country Members on 
their technical cooperation towards LDCs in general and Bangladesh in particular as per Article 67 of 
the TRIPS Agreement. 
70. 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 th e following principles:  (i) be development-
oriented, demand-driven and transparent, taking in to account the priorities and the special needs of 
developing countries, especially LDCs, as well as the di fferent levels of development of Members;  
(ii) promote a development-oriented  intellectual property culture;  (iii) place particular emphasis on  IP/C/M/60 
 Page 15 
 
 
  the needs of small and medium-sized enterprises (SMEs) and institutions dealing with scientific 
research and cultural industries;  (iv) promote measur es that will help countries deal with intellectual 
property-related anti-competitive practices, by pr oviding technical cooperation to developing 
countries, especially LDCs, at their request, in or der to better understand the interface between IPRs 
and competition policy;  (v) further develop infrast ructure and other facilities with a view to making 
national intellectual property institutions more effici ent and promote fair balance between intellectual 
property protection and the public interest;  (vi)  strengthen national capacity for protection of 
domestic creations, innovations a nd inventions and support developm ent of national scientific and 
technological infrastructure;  and (vii) mainstream de velopment considerations.  This list was, by no 
means, exhaustive but contained what the Afri can Group deemed to be the essence of the ongoing 
efforts to bring balance in the intellectual prope rty debate and should, at a minimum, ensure 
widespread endorsement.  He called Members' at tention to these essential principles and to the 
necessity of providing qualitative assessments of their technical assistance and capacity-building 
efforts accordingly. 
71. The representative of Uganda  said that, in response to the TRIPS Council decision on the 
Extension of the Transition Period under Article 66:1 for LDC Members, Uganda had identified in 
2007 its priority needs for technical and financial cooperation necessary for the implementation of the 
TRIPS Agreement.  This had been followed by the development of a comprehensive programme 
referred to as the Uganda Trade and Intellectua l Property Programme (UTIP) in 2008.  This 
programme had been circulated to developed country Members in the same year.  Uganda was glad to 
note that some countries had responded positively to  it.  Currently, Uganda was implementing two 
activities under its cluster 1, namely th e development of intellectual property  policy and legislative 
review, with funding from the European Communiti es under the BizClim and TradeCom projects, for 
which Uganda was grateful.   
72. However, Uganda was concerned at the slow speed at which it was receiving technical and 
capacity building in this area.  Only two activitie s were currently being funded under cluster 1.  
Uganda had identified four major clusters.  Given this speed, it was apparent that it would not be 
possible for Uganda to implement the TRIPS Agreem ent in the time-frame given by the WTO.  The 
Diagnostic Trade Integration Study (DTIS) would be updated in 2009 and so me activities identified 
under the UTIP would be incorporated into the revised  version.  However, this did not guarantee that 
these activities would be fully funded within the time period expected since the disbursement of funds 
under the Enhanced Integrated Framework (ElF) had also been very slow.  She therefore requested 
that developed country Members examine the progra mme which had been presented and help Uganda 
implement it in good time and in a coordinated manner. 
73. The representative of Brazil  recalled its proposal, circulated in document IP/C/W/513 in 
June 2008, that the WIPO Development Agenda pr inciples be taken as a framework for technical 
cooperation and capacity-building activities carried out  under TRIPS Article 67.  The ongoing debate 
in the TRIPS Council on how to achieve compliance w ith obligations under that Article would greatly 
benefit from the contribution of the intense and broad discussions going on in WIPO on the 
implementation of the Development Agenda.  At  the third session of the WIPO Committee on 
Development and Intellectual Propert y, held from 27 April to 1 May 2009, nine projects had been 
presented, referring to the implementation of "Cluster  A" of the Agenda.  This cluster, containing 
14 recommendations, dealt with technical assistance and capacity building.  It stated that technical 
assistance should be demand-driven, transparent, neutral, accountable and take into account the 
special needs of developing countries, in particul ar least-developed countries.  Such principles should 
not be taken for granted.  He urged the Council to approve them. 
74. The representative of Switzerland  said that he was convinced about the importance of the 
TRIPS Agreement for the WTO and of the consistent  implementation of the TRIPS obligations at the 
national level, which was the responsibility of each individual Member.  He acknowledged the IP/C/M/60 
Page 16  
 
  importance of technical and financial cooperation in  order to assist least-developed country Members 
in taking the necessary steps to implement the Ag reement.  The WTO membership had confirmed its 
commitment to this task in the Council's decisi on in IP/C/40 of 29 November 2005 when extending 
LDC's transition period from 2006 to 2013. 
75. The decision called for assessments by LDCs of their individual priority needs to implement 
the Agreement in order to provide a useful basi s for addressing this task.  He commended Sierra 
Leone and Uganda for having subm itted such priority needs assessme nts to the Council, acting as 
pioneers for other LDC Members to follow.  He th anked the WTO Secretariat for having organized 
informal meetings for Uganda a nd Sierra Leone with developed c ountry Members to consider how 
their identified priority needs could best be met, thus facilitating initial bilateral contacts to look at 
potential contributions by developed country partne rs.  In those informal meetings and at the 
Council's earlier discussions, Switzerland had pointed out the importance of considering a number of 
questions of a broader nature, such as the coordina tion of technical cooperation provided in order to 
avoid duplication and to ensure coherence and sustainability of assistance granted by individual 
donors and/or organizations competent in the field.   
76. In order to promote a coordinated, efficient a nd expeditious response to the identified priority 
needs by LDCs, the role of existing multilateral mechan isms or frameworks that could come into play 
for addressing these needs merited further consideration.  In this respect, his delegation had earlier referred to the EIF and the Aid for Trade initiative.   A preliminary look at the action matrixes 
established in the context of the EIF indicated that  LDCs had not submitted a nd listed priority needs 
in the field of intellectual property and TRIPS.   
77. In order to make relevant information availa ble to the Council and to its LDC Members, he 
proposed that the Council request the Secretariat to contact the EIF Secretariat and the coordinator of 
Aid for Trade with a view to gathering and presentin g information to the Council's meeting in October 
on how these existing multilateral mechanisms and the expertise and funds available for trade-related 
technical assistance could be made use of to assist  and help implement LDC priority needs assessment 
submitted to the Council under Article 67 of the TRIPS Ag reement.  He said that he was quite flexible 
as to the format and exact timing the Secretariat might choose for this, as long as the goal could be 
reached and that as many interested delegations as possible could be reached with that information.  
The presentation of this information could be comb ined with the workshops requested earlier by 
Angola and Tanzania.  In this context, it would al so be useful to address possible collaboration with 
other competent international organizations, such as WIPO, ARIPO or OAPI, which could partner in 
providing assistance to LDC Members.  In the Council 's decision in IP/C/40, the WTO Secretariat had 
been requested to seek to enhance its cooperation with  relevant international or ganizations in order to 
assist LDC Members.  He also recalled the provi sions on technical assistance in the WTO-WIPO 
cooperation agreement.   
78. He believed that such informa tion would be useful for the WTO membership, particularly its 
LDC Members, in clarifying whether and how exis ting international coordination mechanisms and 
available expertise could be made use for the pur poses of responding in an effective and expeditious 
manner to LDC priority needs assessments and na tional technical cooperation programmes in the 
TRIPS area, in addition to and beyond any assistance by  individual donors.  Concrete results in this 
process were of vital importance in view of the end date of the extension of the transitional period of 
1 July 2013. 
79. The representative of Cuba
, supporting  the statement made by Brazil, said that she was in 
favour of establishing a link between the recommendati ons in "Cluster A" of the WIPO Development 
Agenda and the technical assistance and capacity-bu ilding work by the WTO, for which the proposal 
in document IP/C/W/513 was a good working basis.  IP/C/M/60 
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  80. The representative of Argentina  said that Argentina was one of the countries that had 
promoted the WIPO Development Agenda and sh e welcomed Brazil's document IP/C/W/513.  She 
believed that the principles of the WIPO Developmen t Agenda were also applicable to this forum. 
81. The representative of the United States  emphasized the US interest in engaging with 
developing and LDC Members to support their effo rts to implement the provisions of the TRIPS 
Agreement.  She recognized Brazil's continuing interest in the issue of technical cooperation.  The US 
report on its technical cooperation activities provide d a detailed overview of its efforts to work 
together with its trading partners to provide assistance and her delegation would update it for the 
Council's next meeting.  Referring to Brazil's submission relating to the WIPO Committee on 
Development and Intellectual Property and the recomme ndations that it had been asked to implement, 
she said that the United States had been highly invol ved in the Committee and would continue to do 
so in order to contribute to its continued success.  To date, the Committee had only had a few 
meetings and was still in its formative stages.   The Committee was working with the WIPO 
Secretariat to establish proper and necessary steps to implement each of the adopted 
recommendations, including programme and budgetary  issues related to implementation.  Those 
recommendations expressly concerned the work of WIPO, and many of them did not make sense 
outside that context, since they concerned the co re mission, responsibilities, capabilities and resources 
of WIPO.  It would be inappropriate  to consider outside that context how they should apply to WIPO's 
activities, particularly since the Committee was at the nascent stages of addressing its task of 
implementation. 
82. The representative of India  recognized the importance of t echnical cooperation and capacity 
building and supported Brazil's comments on the li nkages between the work in the WTO and in 
WIPO as reflected in the proposal in IP/C/W/513.  There was a clear link between the work in the 
TRIPS Council and the thirteen proposals on te chnical assistance and capacity building issues 
contained in "Cluster A" of the Development Agen da 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.  Clause 3 provided a relevant guiding framework for 
discussions in the TRIPS Council.  As stated by Egypt, technical assistance activities should be 
demand-driven, transparent, neutral and accountable  and take into account the special needs of 
developing countries, in particular LDCs.  This  would facilitate effective compliance with the 
obligations under Article 67 and ma ke the implementation fully deve lopment-oriented and contribute 
to balanced implementation of the TRIPS Agreemen t in light of the objectives and principles laid 
down in its Articles 7 and 8. 
83. The representative of New Zealand  welcomed the Swiss proposal to host a workshop on 
mechanisms available to support LD Cs' implementation of the TRIPS Ag reement.  It would be useful 
for LDCs and also for the broader membership, includ ing his delegation, to have a better sense of the  
facilities available to help assist TRIPS implemen tation and how these could be accessed.  He was 
open to suggestions regarding format, but would en courage the Secretariat to consider a means to 
ensure that relevant organizations could be involved, and perhaps gi ve presentations to the 
membership, as well as facilitate informal discussion between interested Members.  The Secretariat 
could consider a format similar to the Article 66. 2 workshop which it organized in the margins of the 
Council's meeting in October 2008.   
84. The representative of Norway,  supporting Switzerland's proposal, said that gathering such 
information would be useful also for his delegati on.  As regards format, she supported New Zealand's 
idea of a workshop. 
85. The representative of Canada  endorsed the proposal put forwar d by Switzerland and, in terms 
of format, he favoured the approach of the Article  66.2 workshop in October 2008, which had been 
helpful.  With respect to the intervention by Brazil, specifically on document IP/C/W/513, he said that IP/C/M/60 
Page 18  
 
  his position continued to be reflected  in the intervention that his delegation had made at the Council's 
meeting in March 2009 and reflected in paragr aph 96 of the minutes of that meeting. 
86. The representatives of the European Communities
 thanked Sierra Leone and Uganda for their 
individual submissions on their priority needs for tec hnical and financial coopera tion in order to assist 
them take the necessary steps to implement the Agreement.  From the outset, his delegation had 
indicated that it would be ready to look into them  in a positive spirit.  Regarding the submission by 
Uganda, his delegation had agreed to support a numbe r of intellectual property activities identified by 
Uganda.  As mentioned by Uganda, two intellectual pr operty projects had already been launched.  His 
delegation was also working with Sierra Leone on its request for technical and financial cooperation 
and he hoped to be able to provide the same kind of assistance and support to it.  His delegation stood 
ready to consider any new submission of priori ty needs by other LDC Members.  His delegation 
supported the suggestion made by Switzerland to ma ke relevant informatio n on existing expertise 
available to the Council. 
87. The representative of Japan  underlined the importance of improving technical assistance for 
the sustainable development of developing Member s, in particular from the perspectives of the 
promotion of innovation and development of local industry through the creation of its own brands, 
and the promotion of foreign direct investment.  In  addition to the conventi onal funds for developing 
country Members in the Asia-Pacific region, Jap an had set a new WIPO fund trust of CHF 110 
millions as a voluntary contribution to Africa and LDCs.  Utilizing these funds, his delegation was 
committed to various cooperative activities to improve  IP systems through various channels, including 
IP training.  An event to launch this fund was organized by WIPO on 26-27 May 2009 in Pretoria, 
South Africa, in cooperation with the Intellectual Pr operty Registration Office of South Africa and the 
Japan Patent Office, under the theme of experi ence in successfully linking IP and business.  
Intellectual property policy makers from 43 African countries participated.  The seminar had been 
successful in providing an opportunity to reflect upon an environment for the effective use and management of IP assets.  Good practices introduced  at the seminar had not been only those of 
developed countries but also those of many developi ng countries.  This sort of sharing of experience 
was very meaningful for learning how to effectiv ely link IP with development.  The fund trust 
programme continued to support the human res ources development programme for government 
officials, intellectual property policy makers and e xperts.  His delegation in tended to continue to 
provide technical assistance.  Through such efforts, it wished to contribute to the capacity building of 
developing countries in the field of intellectual prope rty.  Finally, he supported Switzerland's proposal 
to coordinate various assistance mechanisms in the framework of the Council's next meeting. 
88. The representative of Nepal
 supported the statements made by Tanzania and Bangladesh, and 
the idea of organizing a workshop on needs assessment. 
89. The representative of China  recognized the importance of te chnical cooperation and capacity 
building in the area of TRIPS, especially in the f ace of the present financial crisis.  Referring to 
Brazil's proposal in document IP/C/W/513, he said that "Cluster A" and the principles of the 
Development Agenda could provide a relevant guiding framework for discussions in the Council.   
90. The Chairperson  requested the Secretariat to follow up  with the LDC Group on the request to 
organize a workshop on needs assessment and to wo rk out the specific details.  As regards the 
proposal from Switzerland, she requested the Secretariat to contact the EIF Secretariat as well as the coordinator for Aid for Trade to work out the deta ils and contents as well as the format of their 
contributions.  Noting suggestions th at this be done as soon as possible, she believed that the October 
meeting provided a good timeframe. 
91. The Council took note
 of the statements made.  IP/C/M/60 
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  J. LETTER FROM THE CHAIR OF THE GENERAL COUNCIL CONCERNING WAYS TO IMPROVE THE 
TIMELINESS AND COMPLETENESS OF NOTIFICATIONS AND OTHER INFORMATION FLOWS  
92. The Chairperson  recalled that, at its last meeting, her predecessor had informed the Council of 
a letter he had just received from the Chair of the General Council recalling that the informal meeting 
of the Trade Policy Review Body held on 9 Febr uary 2009 had initiated a process of monitoring 
recent trade developments associated with the current  global financial and economic crisis.  At that 
meeting, the Chair of the Trade Policy Review Body ha d noted that if this exercise were to be carried 
out successfully and were to be useful to the WT O membership, the availability of comprehensive, 
accurate and timely information would be crucial.  In his letter, the General Council Chair invited the 
Chair of the TRIPS Council to consult with Members on ways to improve the timeliness and 
completeness of notifications and other information flows on trade measures falling within the areas 
of responsibility of the Council and requested that the Chair of the Council inform the Chair of the 
Trade Policy Review Body of the results of such consultations. 
93. She said that, as requested by the TRIPS Council, she had consulted on the matter.  In the 
light of her consultations, she suggested that, in or der to facilitate its consideration of the issue of 
improving the timeliness and completeness of notifica tions and other information flows in the area of 
its responsibility, the Council invite the Secretaria t to prepare a factual background note summarizing 
the relevant procedures and providing references to th e relevant 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 impr ove the transparency and user-friendliness of the 
notification system, for example by making notifications more easily accessible on the WTO 
webpage. 
94. The Council so agreed
. 
K. INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO 
95. The Chairperson  informed the Council that, at its meeting on 20 March 2009, the Dispute 
Settlement Body had adopted the Panel report on China – Measures Affecting the Protection and 
Enforcement of Intellectual Property Rights , a complaint by the United States.  This information 
could be found in document IP/D/26/Add.1.   
96. Regarding the status of acceptances of the Prot ocol Amending the TRIPS Agreement that was 
done in Geneva on 6 December 2005, she said that , since the Council's meeting in March, no new 
instruments of acceptance had been deposited.  The list of Members that had accepted the Protocol 
was contained in document IP/C/W/490/Rev.4, wh ich the Secretariat would continue to update 
periodically.  She recalled that the Protocol was open for acceptance by Members until 
31 December 2009 or such later date as might be  decided by the Ministerial Conference.  She 
encouraged those Members that had not yet notified their acceptance of the Protocol to ensure that 
necessary measures were being taken in their capitals to allow the consideration of the acceptance in a 
timely fashion. 
97. The Council took note  of the information provided. 
L. OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS  
98. The Chairperson  recalled that the list with 17 pending requests for observer status in the 
TRIPS Council by other intergovernmental organizations was contained in document 
IP/C/W/52/Rev.11.  The Council had discussed these pe nding requests at its previous meetings, but 
had been unable to reach consensus on any of them.  At its last meeting, the Council had requested the 
Chair to continue the consultations on the request for observer status from the CBD Secretariat.  She IP/C/M/60 
Page 20  
 
  said that she had been in touch with some of the de legations most interested in this matter but that, 
unfortunately, she was not in a position to repor t any developments concerning this request. 
99. The representative of Egypt, speaking on behalf of the African Group
, noted that that there 
were 17 pending requests from international intergov ernmental organizations for observer status in 
the Council and deemed all of them to be equally re levant and important to its work.  For the African 
Group, the requests presented by African regional organizations, including the African Intellectual 
Property Organization (OAPI), the African Regiona l Industrial Property Organization (ARIPO), and 
the Conférence des Ministres de l'Agriculture de l' Afrique de l'Ouest et du Centre (CMA/AOC), were 
especially important. 
100. Furthermore,  the request submitted by the CBD Secretariat was particularly relevant because 
of the centrality of the TRIPS-CBD issue for the African Group.  The Group appreciated the positions 
taken by certain Members with regard to the ad mission of observers across WTO bodies, but in doing 
so, it particularly applauded the flexibility shown by some of t hose Members in their willingness to 
allow the CBD Secretaria t to be admitted as an ad hoc  attendee or ad hoc  invitee, to be extended on a 
meeting-by-meeting basis, pending the resolution of  the broader principle.  He called upon other 
Members to accept such an invitation in order not to create further obstacles for the Council's 
substantive debate.  He expressed support for furthe r consultations by the Chair in this regard.  
101. The representative of Brazil  reiterated his position that the CBD Secretariat should be 
accepted as an observer to the TRIPS Council.  Th e relationship between the TRIPS Agreement and 
the CBD was a permanent item on the Council's agenda, part of the Doha Round  mandate and also the 
object of a number of written communications and pr oposals circulated in the Council.  The fact that 
there were several pending requests for observer stat us by other internationa l organizations should not 
prevent the Council from granting observer status to th e CBD Secretariat.  In this regard, he thanked 
Egypt, speaking on behalf of the African Group, fo r the flexibility shown and said that, with the same 
spirit, his delegation was willing to be flexible in  considering the proposal made by Egypt that the 
CBD Secretariat be given an ad hoc  meeting-by-meeting invitation until the request for its permanent 
observer status was approved. 
102. The representative of the United States  said that her delegation could not join consensus on 
this issue. 
103. The representative of India  said that his delegation had raised the issue of observer status for 
the CBD Secretariat in several of the last Council meetings.  He appreciated the flexibility shown by 
Egypt, speaking on behalf of the African Group, th at, without prejudice to its position regarding the 
issue of permanent observer status, had signalled that it might be possible to make progress in this 
particular case based on the model used in th e Special Session of the Committee on Trade and 
Environment and the Negotiating Group on Trade Facilitation, namely, by inviting the CBD 
Secretariat as an ad hoc  invitee on a meeting-by-meeting basis.    
104. He felt that, among the organizations whose re quests for observership were pending, the CBD 
presented a special case due to its direct relevance to the issues being discussed in the TRIPS Council.  
Members had been engaged in the Council, and in  the Director-General's consultative process on 
TRIPS/CBD, in discussions that had a direct relati onship with the current work of the CBD.  The 
Council had three permanent agenda  items relevant to the CBD, including one on the "Relationship 
between the TRIPS Agreement and the Convention of Biological Diversity" and another on the 
"Protection of Traditional Knowledge and Folklore".   The CBD Secretariat was doing useful work on 
access and benefit-sharing regimes, technology transfer and cooperation, and on traditional 
knowledge, innovation and practices.  IP/C/M/60 
 Page 21 
 
 
  105. He said that the Ministers at Doha had recognized  in paragraph 30(ii) of  the Doha Declaration 
the importance of granting observer status to MEA secretariats.  Moreover, about 80 Members had co-
sponsored the disclosure proposal, which sought to  enhance mutual supportiveness between the 
TRIPS Agreement and the CBD.  The presence of the CBD Secretariat would help the WTO's 
coherence mandate.  The request by the CBD Secretariat should be decided positively and 
expeditiously.  Until then, an ad hoc  invitation should be extended on a meeting-by-meeting basis, as 
had been done in CTE SS and the Negotiating Group on Trade Facilitation.  He added that his 
delegation wished to be involved in future consultations on this matter. 
106. The representative of Ecuado r said it was important to grant permanent observer status to the 
CBD Secretariat, given that three items on the Coun cil's agenda had a direct relationship with the 
CBD.  His delegation expressed its interest to partic ipate in future consultations on this issue.  
107. The representative of China  said that, like most delegations, he believed that the CBD 
Secretariat had a direct interest in at least three agenda items of the Council.  The request for observer 
status received from the CBD Secretariat presente d a special case among the pending requests and 
should not be rejected for unfounded reasons.  He re quested the Chair to continue her consultations 
with relevant Members to find a soluti on as soon as possible, at least on an ad hoc  meeting-by-
meeting basis.   
108. The Chairperson  suggested that she continue her cons ultations on the request for observer 
status received from the CBD Secretariat.  She noted the interest expressed by India and Ecuador to be included in the consultations. She also suggested that the Council revert to this matter at its next 
meeting. 
109. The Council took note
 of the statements made and agreed  to proceed as suggested by the 
Chair. 
M. OTHER BUSINESS  
(i) Seventh annual review under paragraph 2 of  the decision on the "Implementation of 
Article 66.2 of the TRIPS Agreement" 
110. The Chairperson  recalled that paragraph 1 of the decision on the "Implementation of 
Article 66.2 of the TRIPS Agreement" provided that developed country Members shall submit 
annually reports on actions taken or  planned in pursuance of their commitments under Article 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.  Thes e reports were to be submitted prior to the last 
Council meeting scheduled for the year in question.   Paragraph 3 of the decision determined the 
information that had to be provided in these reports. 
111. She recalled that the first and second sets of detailed annual reports under the Decision were 
presented to the Council's end-of-year meetings in 2003 and 2006, and up dates to the Council's 
meetings in the intervening years.  Therefore, th is year developed country  Members should submit the 
third set of new detailed reports on actions taken or planned in pur suance of their commitments under 
Article 66.2 prior to the Council's end-of-year meet ing scheduled for 27-28 October.  As provided in 
paragraph 2 of the Decision, the Council would review these updates at that meeting. 
112. She suggested that developed country Members be requested to submit new detailed reports 
on actions they had taken or planned in pursu ance of their commitments under Article 66.2 by 
2 October, i.e.  about three weeks before the mee ting, in order to allow their timely circulation and 
review at the Council's meeting in October. IP/C/M/60 
Page 22  
 
  113. The Council so agreed
. 
(ii) Other reviews 
114. The Chairperson  said that, as already discussed under a previous agenda item, the Council 
was to take up at its October m eeting its annual review of technical  cooperation under Article 67.  The 
Council would also need to hold its sixth annual review under paragraph 8 of the Decision on the 
Implementation of Paragraph 6 of the Doha Declaration on TRIPS and Public Health, and report on its 
operation to the General Council.  Furthermore, the Council would have on its agenda the eight 
transitional review under Section 18 of the Protoc ol of the Accession of the People's Republic of 
China. 
(iii) Public health dimension of the TRIPS Agreement 
115. The Chairperson  recalled that the delegations of Braz il and India had indicated that they 
wished to raised under "Other Busi ness" the issue of the seizure of generic drug consignments at EC 
ports.   
116. The representative of Brazil  said that his delegation had, once more, asked for the floor 
together with India to bring the issue of seizures of generic drugs in transit through Europe to the 
Council's attention.  He expressed concern about th e seizure of a consignment of generic drugs in 
transit to Vanuatu at the Frankfurt airport.  The sei zure of goods in transit, on grounds that they might 
be violating IPRs conferred by a patent registered in  the country of transit, was a serious violation of 
WTO disciplines.  The decision to impede the tran sit of cargos of generic medicines violated the 
freedom of transit, a right enshrined in GATT Ar ticle V.  Only exceptional circumstances could 
warrant restrictions on that freedom.  Brazil was not  aware of any such circumstances in the concrete 
cases that it had brought to the Council's attention.   
117. Brazil's inquiries had led to the identification of more than a dozen seizures of consignments 
of generic drugs in transit through the Dutch territory in 2008.  The medicines were directed to at least 
seven different developing countries in South America and Africa.  On top of this came a new seizure 
on the German territory.  Contrary to EC assertions, the earlier case of the seizure of losartan was 
therefore not a "minor, exceptional and inconsequentia l" incident.  He recalled that trade in generic 
medicines was perfectly legal from the intellectual property point of view.  Generic medicines were 
not to be mistaken with counterfeit or pirated me dicines, nor were they substandard or illegal. 
118. In its response to Brazil and India at the Council's previous meeting, the European 
Communities had affirmed its commitment to "facilita ting access to medicines for countries in need".  
However, the dozen consignments of generic drugs  in transit through the Dutch territory and the 
recent seizure at the Frankfurt airport of a consig nment of amoxicillin seemed to be a move in the 
opposite direction.  The European Communities had also  claimed to be "one of the main promoters of 
the Doha Declaration and the TRIPS flexibilities".  Rather than TRIPS flexibilities, however, the 
European Communities was actively promoting TRI PS-plus standards in non-specialized multilateral 
agencies such as the World Health Organizati on (through the IMPACT initiative) and the World 
Customs Organization (within the SECURE Working Group), as well as in plurilateral contexts such 
as the Anti-Counterfeiting Trade Agreement (ACTA)  and in bilateral agreements (Economic 
Partnership Agreements). 
119. In an attempt to justify the seizure of generi c medicines in transit, the European Communities 
had claimed that its customs actions had "saved liv es in final destination countries – often developing 
countries".  In reality, the EC customs author ities' apprehensions had hampered the access of 
developing countries to affordable life-saving generi c medicines.  In none of the cases mentioned was 
there any issue with the quality of the drugs.  Th e EC customs authorities were only concerned about  IP/C/M/60 
 Page 23 
 
 
  enforcing EC patents.  Similarly, EC statistics a bout seizures of fake medicines could be questioned 
given the potential confusion by EC customs between  legitimate generic medicines and fake products.   
120. He said that the European Communities de fended the compatibility of EC Regulation 
No 1383/2003 with the WTO disciplines and, in par ticular, with the TRIPS Agreement, arguing that 
TRIPS was only a minimum-standards agreement a nd, for that reason, the Regulation, which 
authorized ex officio  seizure of goods in transit, was TRIPS-compliant.  According to his delegation, 
the mere seizure of any good in transit on grounds that  it might be violating IP rights registered in the 
country of transit was, in itself, a violati on of GATT Article V and other GATT obligations. 
121. As far as the TRIPS Agreement was concerned, a merely perfunctory examination would lead 
to the simple and straightforward conclusion that the Agreement did not allow the detention of goods 
in transit.  The seizure of goods in transit on grounds that they might be violating IP rights in the 
country of transit violated the principle of territori ality, a keystone of the international IP system.  
Furthermore, it ran counter the objectives and purposes of the TRIPS Agreement.  Article 7 stated that 
the "enforcement of intellectual property rights" must be done "in a manner conducive to social and 
economic welfare".  Article 8 upheld Members' rights to ''protect public health and nutrition". 
122. The case of losartan required further clarificati on. The European Communities argued that the 
consignment of losartan had been returned to I ndia because that was the free and autonomous will of 
the Indian manufacturer.  According to his delega tion's information, the Indian manufacturer was 
given only two options:  either to take the cargo back, or face the costs of litigation in the Netherlands.  
A third option – allowing the consignment to follow its  path to Brazil – was not given to the Indian 
manufacturer.   
123. He said that the seizures of in-transit medi cines by EC customs were a major source of 
concern for developing countries because they essentially  imperiled the public health dimension of the 
TRIPS Agreement.  He reiterated his request for cl arifying the following questions:  (a) how could EC 
customs' actions be reconciled with WTO discip lines;  (b) whether EC Regulation No 1383/2003 
required or justified such actions from the customs au thorities;  and (c) how would the EC ensure that 
such actions would not reoccur.  
124. In conclusion, he said that Brazil was fully co mmitted to intellectual property protection.  It 
was a founding Member of the Paris Convention, and Brazilian legislation provi ded fair and adequate 
protection to IP right holders.  Brazil also believe d that a functioning and effective international IP 
system could only be built on the solid basis of a fa ir balance between private and public interests.  
This was the very foundation of the TRIPS Agreemen t.  The protection of intellectual property could 
not supersede the protection of more fundamental values, such as life and the right to promote public 
health.   
125. The representative of India  said that when India and Brazil ha d raised the issue of seizure of 
generic drug consignments at EC ports at the Council' s last meeting, he had not foreseen the need to 
raise the issue again at the present meeting.  Taking into account the EC's confirmation of its 
commitment to the Doha Declaration on Public Health at that meeting, he had thought that the matter 
would get the attention it deserved and get resolved .  However, his delegati on had neither received a 
satisfactory response to its formal communication to  the European Communities in Brussels, nor had 
it seen any review of the relevant EC Regulation or actions by Customs authorities.  Seizures had 
continued with the latest one being at Frankfurt in  May.  His delegation was therefore compelled to 
raise the issue again.   
126. His delegation had received information that a shipment of a generic antibiotic, amoxicillin, 
manufactured in India and destined for a least-d eveloped country, the Republic of Vanuatu in the 
Pacific, was seized by customs officials on 5 May 20 09, while in transit through Frankfurt, Germany.  IP/C/M/60 
Page 24  
 
  Amoxicillin was an essential medicine used to tr eat a wide range of bacterial infections.  He 
understood that the consignment wort h approximately 28,000 Euros cons isted of 3,047,000 tablets of 
amoxicillin (250 mg), equivalent to 76,000 courses of treatment.  The seizures were made on grounds 
of alleged trademark violation,  although GlaxoSmithKline (GSK) had confirmed to the German 
authorities that GSK was the former patent holder for "Amoxil", a brand name for amoxicillin.  There 
seemed no valid reason for detaining these medicin es especially since the name "amoxicillin" was an 
international nonproprietary name (INN). 
127. At the Council's last meeting, and subsequently  in its formal communications to Brussels, 
India had asked the European Communities to provid e details of all drug consignments which had 
been seized by customs authorities and the grounds fo r such seizures.  It had not yet received such 
information from the European Communities.  Howeve r, in response to a request made by the Health 
Action International (Europe) under the Freedom of  Information Act, the Dutch Government had 
provided limited information.  The information show ed that the case of losartan exported from India 
to Brazil and seized at Amsterdam was just the tip of the iceberg.  There had been 17 seizures by the 
Dutch authorities in the year 2008 on the basis of EC Regulation No 1383/2003.  Of these, 16 
consignments originated in India and one in Chin a and they were bound for Brazil (1 consignment), 
Peru (5), Colombia (4), Ecuador (2), Mexico (2), Portugal (1), Spain (1) and Nigeria (1).  The drugs 
were for diseases such as cardiological ailments , AIDS, dementia and schizophrenia.  All 17 
consignments originated in developing countries and 15 of the 17 were destined for developing 
countries.   
128. His delegation had followed closely the diffe rent grounds mentioned by the European 
Communities for such seizures, which included c ounterfeits, fake drugs, s ubstandard, potentially 
dangerous products, patent vi olations, etc.  It had also made alle gations of drug trafficking after three 
months of the seizure of a particular consi gnment.  India took serious exception to such 
unsubstantiated allegations.  The fact that the dr ugs were subsequently released proved that the 
allegations were baseless .  Seizures had continued to take pl ace at EC ports.  The multitude of 
allegations and the spread across several EC ports implied an emerging pattern to disrupt and create 
barriers to legitimate trade of generic drugs and to challenge the Doha Declara tion on Public Health.  
The basic principle of transparency of procedures had also been violated by the inability of the EC to 
share and explain the specific course of action under EC regulations. 
129. The European Communities had sought to justify the action of customs authorities to control 
goods in transit suspected of infringing IPRs as a means to stop "traffic of potentially dangerous 
products, such as fake medicines, even when the ship ments were destined for any country".  It seemed 
that EC authorities assimilated products infringing IPRs  with potentially dangerous substances.  This 
was an untenable logic.  Moreover, the issue wa s about generic medicines, which were neither 
infringing IPRs nor "potentially dangerous".   
130. The European Communities had claimed that "EU customs actions in the past had saved lives 
in the final destination countries which were often developing countries".  He reminded the European 
Communities that the concept of "territoriality"  was a key stone in the edifice of the TRIPS 
Agreement and a widely understood and accepted principl e.  In his view, sovereign functions of the 
country of destination should be exercised by th e country itself and other countries might assist in 
enforcement of their law, only if requested.  The co untry of transit could not necessarily be expected 
to have a sound understanding of the IPR laws of the country of des tination or origin, nor would it 
have the authority to enforce them during transit.  It could also not be presumed that the sovereign 
countries, to which pharmaceutical goods were consi gned, were not responsible for ensuring health, 
safety and expectations of their consumers.  An information sharing mechanism was needed rather 
than action under the laws of the country in tran sit.  If there was a reason to doubt the quality of 
goods, enforcement action should follow from domestic  regulations in the importing country and not 
from WTO rules or those of a third country.    IP/C/M/60 
 Page 25 
 
 
  131. The seizures ran counter to the spirit of the TRIPS Agreement and the Resolution 2002/31 of 
the Commission on Human Rights on the right to enjo y the highest standards of physical and mental 
health.  He drew Members' attention to the report of the Special Rapporteur on the right of everyone 
to the enjoyment of the highest attainable standard  of physical and mental health which had been 
submitted to the 11th Session of the Human Rights Council, which read:  "The Special Rapporteur was 
concerned with reports of IP enforcement measures  that had resulted in multiple seizures at some 
ports of shipments of generic medicines heading to developing countries and LDCs." 
132. Widespread and repeated seizures had had an a dverse systemic impact on legitimate trade of 
generic medicines, South-South commerce, nationa l public health policies and the principle of 
universal access to medicines.  The importance of generic drugs to public health in developing 
countries and particularly in the LDCs was obvious.  Such barriers to legitimate trade of generic drugs 
would also seriously impair the efforts of civil society organizations enga ged in providing medicines 
and improving public health in the least-developed parts of the world. 
133. He said that trade of generic drugs was pe rfectly legitimate and desirable from the public 
health and access to medicine perspective.  It was ironical that while the WTO had taken steps to 
promote access to affordable medicines and remove  obstacles to the proper use of TRIPS flexibilities, 
some Members sought to negate the same by sei zing drug consignments in transit and creating 
barriers to legitimate trade.   
134. Since seizures had been recurring at different ports and on different grounds, it was clear that 
rather than just being a problem of implementing a law by Dutch Customs authorities, it was the EC Regulation No 1383/2003 itself that was problematic and could be misused, and had been misused, to 
create barriers to legitimate trade.  His delegati on therefore called upon the European Communities to 
urgently review the Regulation and the actions of the national authorities based on it.  They should be 
brought in conformity with the le tter and spirit of the TRIPS Agreement, the rules-based WTO system 
and the Doha Ministerial Declaration on the TRIPS Agreement and Public Health.   
135. His delegation attached the highest importance to the protection and enforcement of IPRs in 
accordance with the TRIPS Agreement.  However,  the Agreement could not be divorced from the 
objectives and principles set out in its Articles 7 and 8.  Enforcement of IPRs in disregard of these objectives and principles and efforts to enshrine ne w, maximalist TRIPS-plus enforcement provisions 
in other multilateral forums would seriously underm ine the delicate balance in the TRIPS Agreement 
and raise systemic issues, particularly for developing countries. 
136. The representative of China
 fully associated his delegation with the statements made by 
Brazil and India.  He shared their concerns on the serious implications of EC customs action, which 
disrupted the legitimate trade of generic drugs and undermined the effectiveness of the Doha 
Declaration on the TRIPS Agreement and Public H ealth.  Instead of being resolved following the 
repeated commitment from European Communities to the Doha Declarati on, the situation had actually 
deteriorated.  It seemed that more EC ports were  involved, more consignm ents were being seized, 
including one from China, and more exporting and importing Members were being affected.  Hence 
more patients in developing countries, particular ly those in LDCs, were being deprived of the 
opportunity to access essential and affordable medi cines.  From the perspective of developing 
countries, this was not an issue of commercial intere sts or legal consequences, but an issue of public 
health, or, to use the words continuously employed by developed countries, of human rights.  The Special Rapporteur of the Human Rights Council had also joined other developing country Members 
in requesting the European Communities to provide  detailed information on the seizures and on their 
grounds.  He had urged the European Communities to  review its relevant re gulations and actions on 
their conformity with the Doha Declaration and ta ke earnest actions to correct the situation.   IP/C/M/60 
Page 26  
 
  137. The representative of the European Communities
 said that he wished to take the opportunity 
to further explain and clarify the EC position on this issue.  The Europ ean Communities remained 
fully committed to ensuring access to  affordable medicines in developing countries.  His delegation's 
statement at the Council's last meeting enumerat ed a number of initiatives the European Communities 
had already taken in this respect. 
138. Customs action against counterfeit and dangerous medicines should not be at the expense of 
trade in genuine generic medicines.  In order to  limit the delays that customs controls might 
potentially cause, the EC Customs Regulation No 1 383/2003 therefore contained strict time-limits 
within which court proceedings had to be initiated.  Moreover, if goods  were detained on the basis of 
an unsubstantiated complaint,  the owner of the product could seek legal redress.   
139. Given that his delegation took this issue very seriously, it had been active in this matter and 
had met many stakeholders since the Council's meeting in March.  It had raised the awareness among 
the EC member States, informed the European Parliament and engaged in dialogues with the civil 
society.  Moreover, the Customs authorities of th e EC member States had been invited to pay 
particular attention when controlling generic medicin es in transit in order to avoid actions that would 
delay or cause unnecessary disruption to trade in genui ne generic medicines.  Last but not least, the 
European Communities was in permanent c ontact with the WTO Members concerned. 
140. He welcomed the important stat ement made by the EC pharmaceu tical industry clarifying that 
transiting generic medicines, even if infringing patent s in Europe, should not be detained if they were 
genuine generic medicines in the country of origin and destination.  Since any patent-related customs 
actions must be supported by right-holder acti on, this statement should allow genuine generic 
medicines to transit through the European Communities.   
141. His delegation had looked into the case at th e Frankfurt Airport mentioned by India and 
Brazil, the only case in 2009 that had been drawn to  its attention. It appeared that the customs 
procedures set out in the EC Customs Regulation had been respected.  On 5 May, the German 
Customs had controlled a shipment of antibiotics of  about 25,000 Euros from India and destined for 
Vanuatu.  The Customs had acted on the basis of a prior application for cust oms action lodged by the 
right holder.  This shipment was suspected of infri nging a trademark, not a patent.  Therefore, it did 
not involve the issue of generics, which was a pate nt matter in the present context.  On 7 May, the 
Customs informed the right holder of the intercepti on. The right holder received this information from 
the Customs authorities on 12 May.  On 20 May, the right holder informed the Customs authorities that there was no trademark infringement and that  the goods could be released.  On 26 May, the 
Customs informed the declarant that the goods were re leased for further destination.  On 28 May, the 
declarant, after fulfilling the customs formalities, tr ansported the goods towards their destination.   
142. This case had been solved swiftly under the EC  Customs Regulation.  Amongst the numerous 
customs actions undertaken in the European Comm unities on a daily basis, no further case had been 
reported since the beginning of the year.  With regard to the 17 cases mentioned by India and Brazil, 
which all referred to 2008 actions, hi s delegation was looking further into  all details.  It seemed that 
these cases included old cases that ha d already been discussed at the Council's meeting in March.  
They also included shipments that seemed to be  destined for EC member States and could not 
therefore be considered in transit in the EC territory. 
143. His delegation maintained that it was important to continue to allow Customs authorities to 
control goods in transit and ensure that measures c ould be taken against global trade in counterfeit 
products, and in particular fake medicines which mainly hit developing countries.  The European 
Communities did not confuse generic medicines, wh ich were legitimate quality  products, and fake 
medicines, which were often sub- standard products aiming at conf using the consumer about their 
quality.  Many dangerous goods, such as fake medici nes, were shipped to developing countries, often  IP/C/M/60 
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  through European ports and air ports.  In 2007, out of 76 million counterfeit and pirated goods stopped 
by the European customs, 40 per cent were goods in transit.  Compared to 2006, EC customs statistics 
for 2007 had revealed a significant increase in trad e of fake medicines (+51 per cent).  Although 
customs controls of this kind of goods were often di fficult, their role was crucial to prevent the flow 
of fake medicines in transit from reaching the pop ulations of the European Communities and other 
countries, in particular developing countries. 
144. It was likely that EC customs action had saved lives in final destination countries – often 
developing countries.  For example, the Belgia n Customs had recently stopped a consignment of 
600,000 fake anti-malaria pills coming from India and d estined for Togo.  Moreover, the flow of fake 
medicines often followed very complex and sophisticat ed routes, transiting through several territories, 
before reaching their final destination, which wa s not necessarily the one mentioned in the customs 
documents.  It was therefore important for the EC Cu stoms to control such shipments, also given the 
risk of re-entry into the EC territory.  
145. Responding to the assertion that the EC Customs Regulation violated WTO disciplines, he 
reaffirmed that the European Communities did not intend to hamper trade in genuine generic 
medicines or to create legal barriers to prevent m ovements of drugs to developing countries.  The EC 
Customs Regulation provided for customs to detain goods suspected of infringing certain IPRs, including patents, even when goods we re in transit.  Under the EC le gislation, customs did not make a 
final decision on whether goods were infringing IPRs .  The general procedure was to temporarily 
detain goods, if there was a suspicion of an infringeme nt and to contact the right holder.  It was then 
up to the right holder to pursue the matter through a court, under national provisions. 
146. It was accepted that the detention on grounds of suspicion of IPR infringement might cause 
some delay, but the role of customs in IPR borde r enforcement was recognized by the WTO, as well 
as by the World Customs Organization.  The EC Customs Regulation contained strict time-limits 
within which court proceedings had to be initiated.  The procedure was fully in accord ance with the 
relevant TRIPS provisions, in particular Article 55, which set out the time-limit of 10 working days 
for suspending the release of the goods, as well as the possible extension of a further 10 working days.   
147. Moreover, if goods were detained on the basis of  an unsubstantiated complaint, the owner of 
the products could seek legal redress.  The Cust oms Regulation was fully in line with WTO and 
TRIPS requirements, in terms of scope and coverage of customs in tervention.  The TRIPS Agreement 
foresaw that border enforcement measures might ap ply not only to imports of goods infringing any 
IPRs, including patents, but also to goods introdu ced into the customs territory or leaving that 
territory, including transit.  
148. He said that the European Communities was not alone in allowing for customs enforcement 
action on goods in transit when they infringed in tellectual property rights.  Notably, other WTO 
Members applied border measures for goods in tran sit suspected of infringement of intellectual 
property rights.  The EC Customs Regulation had no extra-territorial effect.  In conclusion, he 
confirmed that the European Communities would c ontinue monitoring the situation and remain 
attentive to any possible application of EC legi slation that could lead to undue hampering of 
legitimate trade, including that of generic medicine s, or to the creation of legal barriers to prevent 
movements of medicines to developing countries.  His delegation would maintain close contacts with 
interested parties and Members concerned and reply to the last letter received from the delegation of 
India. 
149. 
The representative of Cuba  thanked the delegations of Braz il and India for introducing this 
topic under "Other Business", and for the extensive in formation they had provided.  She said that her 
delegation rejected any measure that failed to recogni ze the right of a country to protect the health of 
its citizens.  The embargos, which were a barrier to  the transit of generic medicines, needed to be IP/C/M/60 
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  stopped.  In addition to Articles 7 and 8 of th e TRIPS Agreement, the Declaration on the TRIPS 
Agreement and Public Health established that the Agreement could and should be interpreted in a 
manner supportive of WTO Members' right to protect public health and, in particular, to promote 
access to medicines for all. 
150. The representative of Colombia
 said that his delegation was respectful of the IP system and 
fought against practices affecting the efforts and rights  of innovators and fake medicines.  However, 
he was concerned that measures to combat fake me dicines could end up affecting the free transit of 
generic drugs on the grounds that su ch products allegedly violated IPRs  in territories that were not the 
destinations of these goods.  The principle of territori ality with regard to patents was one of the basic 
pillars of the TRIPS Agreement and therefore, it had to be fully respected by all Members, 
particularly in circumstances that could affect pub lic health.  He trusted that the actions by the 
European Communities would take into account Memb ers' reasoning and arguments presented at the 
Council, so that results could be obtained that meet  the objectives and principles of Articles 7 and 8 of 
the Agreement.   
151. The representative of Ecuador  said that, like other developing countries, his delegation had 
been affected by the seizure of generic drugs in tr ansit in EC ports.  He reiterated concerns over these 
types of actions that were not only contrary to  GATT Article V and to Members' commitments under 
the TRIPS Agreement, but could also affect Member s' policies concerning public health.  He took 
note of the offer made by the European Communities to provide more informat ion on the other cases 
where generic drugs in transit were seized. 
152. Supporting the delegations of India a nd Brazil, the representative of Egypt  expressed concern 
about recent developments relating to IPR enforcem ent that negatively affected public health in 
developing countries, specifically the seizure of medici ne consignments in vari ous ports of transit of 
some Members.  Such developments had occurred in a manner that distorted the TRIPS Agreement 
and were symptomatic of a broader push for globa l enforcement provisions that went beyond TRIPS 
requirements and ran counter to developing count ries' interests.  More importantly, such 
developments also ran counter to developing count ry Members' interests, as well as to the spirit and 
the letter of the Doha Declaration on the TRI PS Agreement and Public Health and Members' 
commitments to ensure that the Agreement and IPR protection were part of the solution to the public 
health problems.  
153. He viewed the recent incidents affecting le gitimate generic medicines trade and their 
detention at certain ports of transit as part of a broader drive, including in intergovernmental 
organizations such as the World Customs Organi zation, the World Health Organization and the 
Universal Postal Union, to introduce IPR enforcem ent measures that could ran counter to the Doha 
Declaration on the TRIPS Agreement and Public Hea lth.  The recently published report of the Special 
Rapporteur on the right of everyone to the enjoymen t of the highest attainable standard of physical 
and mental health (Human Rights Council document H RC/11/12) raised concerns about the trends in 
IPR enforcement that had a detrimental effects on th e right to health.  This trend should not be 
allowed to continue.   
154. The representative of Argentina  said that she shared the concerns raised by Brazil and India 
relating to the seizure of cargoes of generic drugs in transit through the European Communities.  She 
believed that when authorities made decisions in such cases, they should had taken into account the 
need to facilitate access to medi cines for developing and least-dev eloped countries.  The seizures 
contradicted GATT Article V and were  not consistent either with the spirit of the TRIPS Agreement, 
with the flexibilities contained in it or with the D oha Declaration on the TRIPS Agreement and Public 
Health.    IP/C/M/60 
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  155. The representative of Venezuela  urged the European Communities to comply with the TRIPS 
Agreement, as requested by Brazil and India.  Th e economic crisis, which had not been caused by 
developing countries, highlighted the need for gene ric medicines for the poorest populations that often 
were also the most ill.  Development programmes were struggling as a result of EC actions.  The 
European Communities should stop trying to be the global police and comply with the principle of 
territoriality.  Moreover, in order to detain medici ne consignments, it was necessary to have evidence, 
a simple assumption was not sufficient. 
156. The representative of South Africa  supported the position taken by Brazil and India and 
expressed concern about the continued EC practice in  this particular matter.  South Africa fully 
complied with its obligations under the TRIPS Agreem ent and with any other international obligations 
it might have undertaken.  A distinction between legitimate and illicit trade in generic medicines 
should be made.  Insofar, as developing countries had the right to access to generic medicines, it was 
regrettable that the European Communities was interfering with these particular rights.  His delegation was also concerned that EC actions had systematically escalated over the last few months.  He called upon the European Communities to cease its unlawful be haviour and to bring it s domestic regulations 
in line with its WTO obligations. 
157. The representative of the United States
 said that, as many Members had experienced, the 
manufacture, distribution and sale of counterfeit trademark goods, including pharmaceuticals, had 
increased significantly over the last few years.  The results of counterfeiting could range from economic loss to the loss of life.  The prolifer ation of counterfeit pharmac euticals, in particular, 
caused serious concerns for consumer health and safety.   
158. The manufacture and distribution of counterfeit me dicine was a growing problem, particularly 
for countries that were most in need of safe a nd effective medicine.  Counterfeit pharmaceuticals 
included medicines which used the brand name or other likeness of another manufacture without 
authorization.  These products were potentially da ngerous because consumers were led to purchase 
the product and rely on the quality of the product associated with the mark employed.  Consumers in 
all countries had to be assured that the represen tation on the products they purchased accurately 
identified the products.  A product's reputation was founded in part on the assurance of quality that 
resulted from stringent regulatory reviews.  Authorit ies had to ensure that the products available to 
their consumers were safe and eff ective.  There was, however, no su ch assurance of the quality of a 
product when it was counterfeit and the potential con sequences of using that product might be severe 
and even deadly.   
159. Given that counterfeiting was a global problem , a cooperative approach was necessary to 
provide an effective response to the problem over the long term.  Authorities needed to be armed with the tools to identify counterfeit trademark pharmaceuti cals and to be able to stop them before they 
could be sold to consumers.  In this regard, enfo rcement of such IP rights was important at as well as 
inside borders.  Effective cooperation between the private sector and public authorities was the key 
element for success in combating counterfeiting, partic ularly with respect to identifying counterfeit 
products.  This cooperation contributed to the goal of promoting access to safe and legitimate 
medicines.   
160. It was also important for governments around the world to work together to stop the 
manufacturing and trafficking of counterfeit medicines and to allow them to effectively protect their 
citizens against the potentially serious adverse health consequences of counterfe it medicines.  In this 
spirit, it was important for countries to engage in a dialogue regardi ng domestic practices with the aim 
of promoting access to legitimate, safe and efficien t medicines, including both innovative and generic 
drugs, to those most in need.  It was also importa nt to bear in mind that trademark counterfeiting was 
a different form of unlawful activity from patent  infringement involving different rights, often 
different remedies and different consequences for consumers.  The United States looked forward to IP/C/M/60 
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  continuing a dialogue in the TRIPS Council on the ways that countries had put in place effective 
enforcement tools to combat the manufacture and trafficking of counterfeit trademark pharmaceuticals.   
161. The representative of India
 thanked the European Communities for responding to some of the 
points raised in various interventions.  The Eur opean Communities had indicated that its Regulation 
contained deadlines of 10 days plus an additiona l 10 days as enshrined in TRIPS Article 55.  He 
wondered whether it wished to use the letter of th e TRIPS Agreement to defeat the spirit of the 
Agreement and the Doha Declaration on the TRI PS Agreement and Public Health, and whether it 
intended to justify repeated measures that would create barriers to legitimate trade of generic drugs and undermined access to medicines by reference to th e deadlines in Article 55.  In his view, the EC 
measures were both against the letter and the spir its of the TRIPS Agreement, the GATT and the 
Doha Declaration.   
162. The Frankfurt case was about a trademark viol ation relating to amoxicillin, which was an 
international non-propriety name.  As regard s the 2007 figures it had cited, the European 
Communities had used the terms counterfeit and fake medicines interchangeably.  It also seemed to 
subsume standard, spurious and fake  generics under the broad term "count erfeit".  He was not sure if 
it used the definition of "counterfeit" as given in Article 51, footnote 14(a) or if it had a different 
TRIPS-plus definition for that term.  In his view , counterfeiting was an IP issue, whereas substandard 
and spurious medicines was a public health issue.  Not only in the WTO but in other international 
forums as well, some Members were trying to confuse the two issues as a part of their maximalist IP-enforcement agenda.  He doubted that customs aut horities had the capacity, or even the competence, 
to check whether a drug was substandard or not.  These matters were best left to drug regulatory 
authorities of the countries of origin and destination.   
163. His delegation did not support counterfeit medicines.  According to the EC 2007 figures, 
34 per cent of counterfeit drugs had originated in Indi a.  It was not clear whether this figure included 
the losartan consignment to Brazil, the HIV dr ugs consignment to Nigeria and the amoxicillin 
consignment to Vanuatu.  He requested the Europe an Communities to clarify this issue and asked 
about the origin of the remaining 66 per cent of counterfeit medicines.   
164. The representative of Brazil
 said that the European Communities was not the only delegation 
that confused generic, counterfeit and fake medi cines.  However, the EC assertion that it was 
legitimate to verify medicines on the basis of the law of the country of transit was particularly 
worrisome.  The EC Regulation allowed customs to seize medicines on the basis of whether there was 
an infringement in the country of transit, not the c ountry of origin or destination, and this would be 
the applicable law if one were to seek redress in co urt.  This practice would continue to prevent the 
legitimate transit of generic drugs.  He also urge d the European Communities to make sure that the 
principle of territoriality was respected.  Even t hough it said that it had done so, it only respected the 
principle of the EC territoriality when it controlled a shipment.   
165. The representative of the European Communities  reiterated his delegation's attachment to 
both the letter and the spirit of the Doha Declarati on on the TRIPS Agreement and Public Health.  He  
said that he had mentioned the time limits in the EC  Customs Regulation merely to show that all the 
safeguards were provided for in it.  As to the defi nitions of counterfeit medicines and fake medicines, 
his delegation had not confused these concepts.  C ounterfeit medicines had nothing to do with generic 
drugs and enforcement measures did not preclude th e legitimate trade in generics, provided that 
TRIPS obligations were respected.  Counterfeiting a pplied to fake or mislabelled drugs, that were 
drugs that did not contain the appropriate component s but sometimes were entirely ineffective or even 
dangerous substances.  This was a serious problem fo r all countries and in particular for developing 
countries.  His delegation had taken active part in a WHO working group on counterfeit medicines,  IP/C/M/60 
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  the IMPACT task force, and it fully supported th e definition of counterfeit medical products as 
proposed by the WHO.   
166. He reiterated that the European Communities t ook this issue very seriously,a nd understood 
the concerns of developing countries, in particular the countries of destination and the beneficiaries of 
the medicines in question.  The European Comm unities remained committed to facilitating access to 
medicines.  The targets of customs authorities were fake or counterfeit medici nes, not genuine generic 
products.  His delegation would contin ue monitoring the situation to ensure that the application of EC 
legislation would not hamper trade in genuine generi c medicines.  It stood ready for further bilateral 
discussions with interested delegations.  Referring to the US statement, he felt that it would be 
important to discuss further the issue of IPR enforc ement in the Council, as had been suggested by his 
delegation in the past. 
167. The Council took note  of the statements made.   
 
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