RESTRICTED  WORLD TRADE  
ORGANIZATION  IP/C/M/47 
3 June 2005 
 (05-2292) 
Council for Trade-Related Aspects 
of Intellectual Property Rights  
 
 
 
MINUTES OF MEETING 
 
Held in the Centre William Rappard  
on 8-9 and 31 March 2005  
 
Chairperson:  Mr. Tony Miller (Hong Kong, China) 
 
The present document contains the record of  the discussion which took place during the 
TRIPS Council meeting held on 8-9 and 31 March 2005. 
Subjects discussed  Page nos.  
A. NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT .........................................................2  
B. FOLLOW -UP TO 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. REVIEW OF IMPLEMENTATION OF THE TRIPS  AGREEMENT UNDER ARTICLE 71.1..................20  
G. REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON 
GEOGRAPHICAL INDICATIONS UNDER ARTICLE 24.2 ...............................................................20  
H. DECISION ON THE IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION 
ON THE TRIPS  AGREEMENT AND PUBLIC HEALTH ..................................................................20  
I. FOLLOW -UP TO THE SECOND ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE 
DECISION ON THE IMPLEMENTATION OF ARTICLE 66.2  OF THE TRIPS  AGREEMENT ...............43  
J. TECHNICAL COOPERATION AND  CAPACITY -BUILDING ............................................................44  
K. REQUEST FROM MALDIVES FOR AN EXTENSION OF THE TRANSITION PERIOD UNDER 
ARTICLE 66.1  OF THE TRIPS  AGREEMENT ...............................................................................44  
L. NON-VIOLATION AND SITUATION COMPLAINTS .......................................................................45  
M. SPECIAL AND DIFFERENTIAL TREATMENT PROPOSALS REFERRED TO THE COUNCIL ..............47  
N. INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO ..............................47  
O. OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS ...............49  
P. OTHER BUSINESS ......................................................................................................................49  
Q. ELECTION OF CHAIRPERSON .....................................................................................................51  
 IP/C/M/47 
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 A. N
OTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT  
1. The Chairman  informed the Council that, since its me eting in December 2004, it had received 
a number of supplements and updates to earlier notif ications of laws and regulations. Albania had 
updated the notification of its laws  and regulations that was circulated in 2001;  the Czech Republic 
had notified a law relating to border measures and certain amendments to its intellectual property 
legislation;  Japan had provided an updated text  of its Seeds and Seedlings Laws;  and Jamaica had 
notified amendments to its copyright legislation a nd industrial property fees and a law concerning its 
accession to the Nairobi Treaty on the Protection of  the Olympic Symbol.  These notifications were 
being circulated in the IP/N/1/- series of documents.  He urged those Members whose initial notifications remained incomplete to submit the outstanding material without delay, and reminded 
other Members of their obligation to notify any sub sequent amendments of th eir laws and regulations 
without delay after their entry into force. 
2. As regards notifications of contact points under Article 69, he said that, since the Council's 
meeting in December, updates to contact points notif ied earlier had been received from Albania, the 
Slovak Republic and the United States.  These no tifications had been circulated in document 
IP/N/3/Rev.8/Add.2.  There were now 121 Members who had notified contact points under Article 69. 
3. The Council took note
 of the information provided. 
B. FOLLOW -UP TO REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION  
4. The Chairman  said that the Secretariat had update d its informal note that listed the 
outstanding material required to complete the reviews that the Council had already undertaken 
(JOB(05)/27).  The table attached to the note lis ted 14 Members whose reviews had been initiated at 
the Council's meeting since April 2001 but which remained on the Council's agenda.  The table 
referred to submissions, including both responses an d follow-up questions, received by 2 March 2005.  
As requested by the Council at its last meeting, the Secretariat had written to these Members, drawing 
their attention to the outstanding material  required to complete the pending reviews. 
5. Since the Council's last meeting, Armenia ha d provided responses to the last outstanding 
questions posed to it (IP/C/W/422/Add.1).  The Chai rman suggested that the regular review of the 
legislation of Armenia be deleted from the agen da, it being understood that any delegation could 
revert to any matter stemming fro m this review at any time. 
6. The Council so agreed . 
7. The Chairman  turned to the remaining 13 Members, na mely Congo;  Cuba;  Egypt;  Fiji;  the 
Former Yugoslav Republic of Macedonia;  Grenada;  Ma uritius;  Qatar;  Saint Kitts and Nevis;  Saint 
Vincent and the Grenadines;  Suriname;  Swaziland;  and Zimbabwe. 
8. The representative of Egypt  said that she was coordinating with her capital and hoped to be 
able to provide further information in the near future. 
9. The representative of Zimbabwe  said that his delegation would provide the outstanding 
responses in the near future. 
10. The Chairman  said that the Secretariat note also listed five Members whose reviews 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 revi ew at any time.  In that connection, certain 
questions had been raised with regard to the impl ementing legislation of those countries.  Since the  IP/C/M/47 
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 circulation of the note, Argentina had provided r esponses to all of the remaining follow-up questions 
posed to it by Switzerland (IP/Q/ARG/1/Add.2). 
11. The representative of Switzerland  thanked the delegation of Argentina for its responses and 
said that he would send them back to the capital for further study. 
12. The Chairman  urged the delegations concerned to pr ovide the outstanding material as soon as 
possible, so as to allow the Council to complete the follow-up to those reviews.  He suggested that the 
Council revert to this matter at its next meeting. 
13. The Council took note  of the statements and agreed  to proceed as suggested by the Chair. 
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 FOLKLORE1 
14. The Chairman  recalled that, at the end of the discussion of the three agenda items at the 
Council's December meeting, he had observed that th ere had been useful discussions, and that there 
were several constructive contributions, including suggestions and counter suggestions for a more 
structured discussion on some of the issues and a pproaches.  Since then, he had continued his 
consultations on how future work on these items s hould be organized.  His impression was that there 
was a wide view that the discussions presently ta king place were both fruitful and constructive and 
were enabling all points of view to be put forward and explored.  Thus, he did not see any need to 
propose any new way to organize work on these matte rs, and suggested that Members continue to 
discuss the three agenda items together on the basis of contributions by Members. 
15. He recalled that, at its meeting in Septem ber 2004, the Council had received a submission 
from Bolivia, Brazil, Cuba, Ecuador, India, Pakist an, Peru, Thailand and Venezuela on "Elements of 
the Obligation to Disclose the Source and Country of Origin of Biological Resource and/or Traditional Knowledge Used in an Invention" (IP /C/W/429/Rev.1 and add.1).  Since the Council's 
meeting in December, Colombia and the Dominican Re public had requested that they be added to the 
list of sponsors of the submission (IP/C/W/429/Re v.1/Add.2 and 3).  In addition, three new 
documents had been presented at the December me eting, one from Switzerland (IP/C/W/433), another 
from the United States (IP/C/W/434), and the third from Bolivia, Brazil, Cuba, Ecuador, India, Pakistan, Peru, Thailand and Venezuela (IP/C/W/438).   At that meeting, some delegations had said 
that they intended to comment on these submissions at the present meeting.  Since the December 
meeting, the Council had received the following ne w communications:  one from Peru (subsequently 
circulated as IP/C/W/441);  another from Brazil on behalf of Bolivia, Brazil, Colombia, Cuba, the 
Dominican Republic, Ecuador, India, Peru and Tha iland (subsequently circulated as IP/C/W/442); and 
a third from India on behalf of Brazil and India (IP/C/W/443). 
16. The representative of Peru
, introducing document IP/C/W/441, said that his delegation was 
committed to the discussion of the disclosure issu e in the WTO, which, in its view, was the 
appropriate forum for this.  He said that it wa s time for Members to stop "forum shopping" and 
commit themselves to finding concrete solutions to the problems of misappropriation of genetic 
resources and biopiracy.  He reiterated that due prior ity should be given to the disclosure issue within 
                                                      
1 As requested by the delegations of Peru, Turkey and India and agreed by the Council, the record also 
reflects the statements made by these delegations duri ng an informal meeting on TRIPS matters that the 
Chairman of the Council held, acting as a Friend  of the Director-General, on 8 March 2005. IP/C/M/47 
Page 4  
 
 the rubric of outstanding implementation issues as it had reached sufficient maturity to enable 
concrete negotiations to begin in order to arrive at a favourable solution for developing countries by 
the end of the current round.  His delegation wished this issue to be included in the negotiations for 
the Ministerial Conference in Hong Kong, China, as the current round could not otherwise be called a 
development round. 
17. The objective of the Peruvian submission was to present the problems faced by a developing 
country in the fight against biopiracy and to illustra te the efforts necessary to be made in the absence 
of a universal and legally-binding obligation to disclo se origin of genetic resources related to a patent.  
As the Council was already aware, Law 28216 of 1 May 2004 had established the National 
Commission for the Protection of Access to Peruvian Biological Diversity and to the Collective 
Knowledge of the Indigenous Peoples (hereinafter the National Anti-biopiracy Commission).  This 
Commission was chaired and coordinated by the Na tional Institute for the Defence of Competition 
and Intellectual Property Protec tion (INDECOPI) and was made up of the representatives of the 
Ministry of Foreign Relations, Ministry of Foreign Trade and Tourism (MINCETUR), National 
Environmental Council (CONAM), Commission for th e Promotion of Exports (PROMPEX), National 
Institute for Natural Resources (INRENA), National In stitute for Agricultural Research and Extension 
(INIEA), International Potato Centre (CIP), Nati onal Centre for Intercultural Health (CENSI), 
National Commission of Andean, Amazonian an d Afro-Peruvian Peoples (CONAPA), National 
Assembly of Governors (ANR), Peruvian Envi ronmental Law Society (SPDA) (representing the 
NGOs), and the Peruvian Institute for Natural Pr oducts (IPPN) (representing business associations). 
18. The National Anti-Biopiracy Commission had the task of developing actions to identify, 
prevent and avoid acts of biopiracy with an aim to prot ect the interests of the Peruvian State.  Its main 
functions were to establish and maintain a register  of biological resources and traditional knowledge;  
provide protection against acts of biopiracy;  identi fy and follow up patent applications made or 
patents granted abroad that relate to Peruvian biological resources or collective knowledge of the 
indigenous peoples of Peru;  make technical eval uations of the above-men tioned applications and 
patent grants;  issue reports on the cases studied;  lodge objections or institute actions for annulment 
concerning the above-mentioned patent  applications or patent grants ;  establish information channels 
with the main intellectual property offices around the world;  and draw up proposals for the defence of 
Peru's interests in different forums. 
19. The National Anti-Biopiracy Commission had consid ered it desirable to share the experience 
acquired in this first stage of the search for po tential cases of biopiracy, in as much as this may 
contribute to an understanding of the problems faced by a country like Peru in the fight against 
biopiracy.  To that end, and in order to enri ch the ongoing debate within the TRIPS Council 
concerning the disclosure requirement, the results of  a search effected on the websites of the main 
patent offices in the world, namely, the United Stat es, Europe and Japan, were presented in respect of 
six priority resources of Peruvian origin, together  with a summary of the patent documents found 
wherein the inventions claimed related to tho se resources, and which might involve the use of 
traditional knowledge of the indigenous peoples of  Peru.  The products presented in the submission 
were: hercampuri, camu-camu, yacón, caigua, sacha inchi and chancapiedra .  However, these six 
products were just a sample of more than fifty products of vegetal and an imal origin, which the 
National Anti-Biopiracy Commission had already started to investigate since their medicinal properties were being analysed and tested in several countries. 
20. This document was the fruit of the efforts carried out by the National Anti-Biopiracy 
Commission to identify possible cases of biopiracy as the subject-matter of a more rigorous and detailed analysis and of possible administrative or judi cial proceedings.  It was no more than the first 
step in the long and complex process starting with the search for potential cases of biopiracy and 
ending with the institution of actions against pendi ng patent applications or patents obtained or 
developed from the use of a biological resource or  traditional knowledge without the prior informed  IP/C/M/47 
 Page 5 
 
 
 consent of the country of origin of the resource or of the indigenous people owning rights in the 
knowledge, and without providing for any type of comp ensation to that country or indigenous people.   
21. He hoped that this document would help serve the purpose of:  (a) ascertaining how a mega-
diverse country makes a serious attempt to address this phenomenon through its institutions;  
(b) understanding to some extent the methodology and standards used in the search for such patents, 
thereby helping other countries or regions which might  wish to initiate similar efforts;  (c) gaining 
knowledge of the large number of inventions referri ng to resources of Peruvian origin that might 
reflect cases of biopiracy (either because such res ources have been obtained illegally, or because they 
involve the unauthorized use, without compensation, of traditional knowledge);  and (d) demonstrating that a systematic and methodical search and analysis of "problem" patents can be 
undertaken. 
22. He stressed that no assertion was being made that all the pending patent applications or patent 
grants mentioned in the attached report did not d eserve protection.  What was presented was merely a 
set of pending patent applications or patent gr ants which had as their subject matter inventions 
apparently obtained or developed using biological  resources of Peruvian origin and/or traditional 
knowledge of the indigenous peoples of Peru, for wh ich it was necessary to check whether the rights 
of Peru as the country of origin of the resources and of the indigenous peoples of Peru as the owners 
of rights in the knowledge had been respected.   
23. He said that Peru had had to make significan t efforts, both in terms of human and material 
resources, in order to fight against biopiracy.  Th is was why it was necessary to require the disclosure 
of origin in patent applications to fight bi opiracy.  Upon the conclusion of the Uruguay Round, 
countries had made a commitment to implement new standards for the promotion and protection of 
intellectual property rights.  Since then, Peru, like many other developing countries, had made enormous efforts to fight against piracy and enforc e intellectual property rights in its territory.  He 
said that the time had come to take a concrete decision to include the disclosure issue in the 
negotiations on implementation issues in order to pr esent results by July 2005 and the next Ministerial 
Conference in order to find a solution by the end of the Development Round.  He said that Peru 
considered the TRIPS Council, and the WTO in genera l, to be the appropriate forum to discuss this 
issue, because of the legally-binding nature of its ag reements.  He shared India's view with respect to 
the necessity to hold dedicated consultations on the issues related to disclosure of origin. 
24. The representative of Brazil
 introduced the submission made by Bolivia, Brazil, Colombia, 
the Dominican Republic, Ecuador, India, Peru and Thailand on the "Elements of the Obligation to 
Disclose Evidence of Benefit Sharing under the Relevant National Regi me" (IP/C/W/442).  He 
recalled the previous submissions made by the pr oponents from the TRIPS Council meeting of March 
2004 onwards, including the Checklist, which he sa id had been generally accepted as the basis for 
pursuing discussions on this issue.  The new submission addressed and elaborated the third and final set of issues mentioned in the Checklist, namely the disclosure of evidence of benefit-sharing under 
the relevant national regime and should be read t ogether with the earlier su bmissions, as the elements 
treated therein were closely interlinked. 
25. He said that the first section of the new document sought to explain what was meant by 
evidence of benefit-sharing under the relevant na tional regime.  The disclosure requirement was 
aimed at ensuring not only that there was benefit-sharing per se , but that such benefit-sharing took 
place in a fair and equitable manner, taking into account  the circumstances of each particular case.  It 
had been argued that there might be no straightfo rward way of determining the fair and equitable 
sharing of benefits.  There were a number of factor s that could be used to make this determination 
such as, in the case where there had been sufficient prior informed  consent, that the shaping of 
benefits or an arrangement for future sharing of be nefits was premised upon mutually agreed terms in 
the context of Article 15(7) of the CBD.  Also, cons ideration should be given to whether there was a IP/C/M/47 
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 reporting obligation on issues relating to patenting or commercialization, especially where future 
benefit-sharing was contemplated. 
26. Some had argued that a disclosure requirement for benefit-sharing, as well as related 
disclosure requirements for country of origin and prior informed consent, could not per se  transfer 
benefits and that national level me chanisms for benefit-sharing must be established.  He said that the 
disclosure proposal was not intended as a replacement for national access and benefit-sharing regimes 
but as supplementary measures and necessary incentives for patent applicants to comply with the 
prevalent laws and practices of the countries of origin of the genetic resources and/or associated traditional knowledge.  Thus, bio-prospectors, rese archers and other prospective patent applicants 
who wished to access genetic resources and associat ed traditional knowledge in a fully lawful manner 
had nothing to fear from the proposed disclosure re quirements as these would do little other than to 
ask applicants to supply information to the effect  that the resources and knowledge had been accessed 
lawfully in the countries of origin.  There was no reason why such requirements should be found cumbersome by well-meaning patent applicants. 
27. He emphasized that "biopiracy" was a global problem, more often than not involving the 
acquisition of material in one country and the s eeking of a patent over that material, or over 
inventions deriving from or involving that material , in another country.  Therefore, to effectively 
tackle the problem, it would not be sufficient to re ly solely on measures and regimes adopted at the 
national level in the countries of origin of the ge netic resources and an in ternational framework of 
protection was needed.  The ability of patent offices  and other authorities in a national jurisdiction to 
curb biopiracy by imposing a disclosure requireme nt would be limited unless similar actions were 
also taken by patent offices in other jurisdictions .  Disclosure of evidence of benefit-sharing, as well 
as the disclosure of the country of origin and of evidence of prior informed consent, would enhance 
the credibility of the patent system by contributin g to the realization of the stated objectives and 
principles of the TRIPS Agreement itself, as enshrined in Articles 7 and 8. 
28. Questions had been asked about when the patent  applicants would be expected to introduce 
evidence of benefit-sharing.  Some had pointed out that benefit-sharing can only take place after the 
grant of a patent and the commercialization of the re levant technology.  This did not raise a problem 
with respect to furnishing the evidence of benefit- sharing.  In many cases, the very fact of gaining 
access to genetic resources might trigger a certain leve l of benefit-sharing.  When real benefits could 
only arise from the patenting and commercialization of  the invention, it was still envisaged that the 
patent applicant would be required to provide eviden ce of benefit-sharing.  The applicant could do so 
by submitting evidence of the existence of an arra ngement for the fair and equitable sharing of 
benefits arising out of the utiliza tion of the genetic resources, an a rrangement that would have been 
entered into in accordance with the national la ws and practices of the country of origin. 
29. If there was no national regime in the country of origin, then a similar approach to that taken 
for prior informed consent, as sp ecified in document IP/C/W/438, would apply.  The applicant would 
merely have to indicate in the relevant declara tion that there had been no national access and benefit-
sharing regime in the country of origin, but that, in  any case, benefit-sharing had or would take place 
through an arrangement established with the authori ties in charge of the location where the resources 
were accessed. 
30. The final section of the new document addressed the question of the legal effects of non-
compliance with the requirement to  disclose evidence of benefit-sh aring.  As in the case of the 
obligation to disclose evidence of prior informed consent, the nature of the legal effects of non-
compliance with disclosure of benefit-sharing woul d depend on whether it is at pre- or post-grant 
stage.  At the pre-grant stage, if no evidence of benefit-sharing was furnished as required before the 
examination or grant of the patent, then the legal e ffect could be that the application is not processed 
any further until the necessary evidence is submitte d.  This could be accompanied by penalties and  IP/C/M/47 
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 time-limits within which the proper declaration a nd evidence must be provided.  Where failure to 
disclose evidence of benefit-sharing was discovered after the grant of the patent, the legal effects could include revocation of the patent, particularly wh ere it was determined that there was a fraudulent 
intention behind the failure to provide evidence of benef it-sharing.  It could also include full or partial 
transfer of rights to the invention as a means to promoting fair and equitable benefit-sharing or 
criminal and/or civil penalties, including the possibi lity of punitive damages, where it was determined 
that the patent holder had, in fact, provided be nefits but had not provided the evidence in the 
application. 
31. Speaking on behalf of his delegation, he said that  Brazil shared the concerns raised by Peru 
and had faced similar problems.  In recent times, a number of similar cases involving resources and/or 
knowledge which had been taken from the Brazilian Amazon had been  also brought to the attention of 
the authorities.  Those were apparent cases of misa ppropriation involving attempts to take out patent 
rights over resources and/or traditional knowledge of the Amazon and the indigenous peoples residing 
in this region, involving a number of important  biological materials that are well-known to the 
Brazilian population.  There had been an attempt to steal the name of a well-known fruit and to have it 
registered as a trademark in the big markets of the North.  There was also a very recent case involving 
the extraction of a substance from the skin of a frog from the Amazon and apparently there had been 
attempts to take out patent rights over the extracted substances and also involving traditional 
knowledge used by indigenous peoples in Brazil.  These cases were being investigated by the 
Brazilian authorities.   
32. It was clear that the current intellectual pr operty system was inadequate to address the 
biopiracy problems faced by developing countries. The system was inequitable, since it facilitated the 
actions of powerful, industrial interests, but there were no safeguards to protect the rights of 
developing countries and their indigenous communities.   This imbalance would be rectified with an 
amendment to the TRIPS Agreement, including the disclosure of origin obligation.  Like the delegation of Peru, Brazil called upon WTO Members to  engage constructively in the light of the 
mandate given by the Ministers and to re frain from engaging in "forum shopping". 
33. The representative of India
 said that the paper presented by the delegation of Peru responded 
to the view of some Members that national expe riences could help them in working towards an 
outcome on the issue of disclosure.  He said that  further substantive discussions on the issue of 
disclosure were necessary.  The Peruvian experi ence of establishing the National Anti-Biopiracy 
Commission showed that national efforts were not  enough to prevent bi opiracy and that an 
international mandatory obligation to introduce discl osure requirements in patent applications was 
necessary.  He supported the statement made by Br azil, in its presentation of document IP/C/W/442 
co-sponsored also by India, confirming the existenc e of biopiracy and looked forward to the views of 
Members on the contents of the submission. 
34. Introducing document IP/C/W/443 on behalf of Brazil and India, he recalled that the United 
States had submitted document IP/C/W/434 during th e last TRIPS Council meeting in which it had 
said that it viewed with utmost caution any proposals that would add uncertainties to patent rights, or 
undermine the role of the delicately balanced patent system.  He said that the disclosure requirements 
in the joint proposal by India and other Members had, on the other hand, introduced certainty for 
researchers and bio-prospectors. It  would ensure the legitimacy of the patent system and preserve and 
strengthen its balance.  Document IP/C/W/434 had argued that new patent disclosure requirements 
would not work to guarantee that prior informed consent was obtained, and suggested an approach 
based on national level contractual arrangements.  The co-sponsors of IP/C/W/443 were in agreement 
with the United States that national level laws were  an important component in order to address the 
relevant goals, but have said that these were not e nough.  Just as national level patent regimes alone 
did not suffice and TRIPS Agreement had been intr oduced in the WTO to address that insufficiency, IP/C/M/47 
Page 8  
 
 national level contractual arrange ments could only suffice if they were obligatory and enforceable 
across borders.  
35. He said that there was a significant international dimension of mutual supportiveness of the 
CBD and the TRIPS Agreement. On the one hand, Article 5 of the CBD envisaged international 
cooperation with competent international organizati ons.  On the other hand, the WTO was competent 
with regard to international minimum standards for patents based on biological resources and/or 
traditional knowledge and thus, with regard to cr oss-border biopiracy and misappropriation.  It was 
argued in IP/C/W/434 that the act of patenting per se did not constitute misappropriation.  The co-
sponsors of document IP/C/W/443 agreed and had said that what constituted a misappropriation was 
the act of applying for a patent or patenting an i nvention using biological r esources and/or traditional 
knowledge without obtaining prior informal consent and sharing benefits.  The disclosure proposal 
remedied such form of misappropriation.  The document had also argued that the disclosure requirement per se  could not transfer benefits, since it would merely convey the information required 
but would have no mechanism to transfer benefits.  However, the proposed disclosure of the use of 
biological material or traditional knowledge and evidence of prior informed consent and benefit-
sharing arrangements, coupled with the national level regimes on prior informed consent and ABS 
would ensure the transfer of benefits.  
36. Further, IP/C/W/434 argued that benefits from an  invention would be di minished if patents 
were not issued, or revoked, and yet inventions were commercialized.  However, this phenomenon 
was not limited to patents related to biological materi al and could happen to any invention.  As in any 
other case, other legal means would have to be used to rectify the damage, such as parallel 
importation 
37. He said that the submission from the United States had argued that the disclosure 
requirements would be ineffective in preventing erro neously granted patents, and did little to ascertain 
inventorship, novelty or inventive step.  However,  the disclosure requirement would ensure that 
information is disclosed on whether biological r esources and/or traditional kn owledge had been used; 
(a) to form part of the claimed invention, (b) in  developing the invention, (c) as its necessary pre-
requisite, (d) in facilitating the invention, or (e) as its necessary background material or information.  
Such information would be relevant in determin ing prior art, non-obviousness and inventorship or 
entitlement to a patent.  IP/C/W/434 accepted this prem ise when it refers to the benefits of organized 
searchable databases. 
38. He recalled that document IP/C/W/434 had ra ised concerns on administrative burdens and 
costs and on the capacity of patent examiners to de termine the validity of prior informed consent or 
adequate benefit-sharing.  The issue of admini strative burdens and costs had been addressed in 
document IP/C/W/429/Rev. l.  In terms of implementation for the US system, the proposed disclosure requirement would not be burdensome at all, as it could be covered under the existing requirement of 
information material to patentability.  What wo uld need to be included was evidence of prior 
informed consent and benefit-sharing arrangements.  The proposal did not require patent examiners to 
determine the validity of these arrange ments in order to grant a patent. 
39. Furthermore, IP/C/W/434 had proposed an altern ative mechanism outside the patent system.  
But a fragmented nation-to-nation system would not achieve the objectives and would imply high 
transaction costs.  National-level requirements could do little to address the transnational character of 
biopiracy.  Organized searchable databases were useful to determine prior art but were 
complementary to and could not substitute for the disclosure requirement.  He said that the 
explanations contained in the paper presented by hi s delegation should persua de all Members of the 
benefits of the disclosure requirement and the c onclusion that there was no further alternative.   IP/C/M/47 
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 40. Speaking on behalf of India, he referred to th e earlier papers that had been co-sponsored by 
his delegation, and said that they sought to address the mandate contained in paragraph 12 and 19 of 
the Doha Ministerial Declaration and the realizati on of a key development dimension, guided by the 
principles and objectives of the TRIPS Agreement as set out in Articles 7 and 8, and responded to the 
need for an outcome as part of the conclusion of the work programme set out in the Doha Ministerial 
Declaration.  
41. The representative of Cuba  associated her delegation with  document IP/C/W/442.  The 
document was explicit and developed the viewpoints of  the competent authorities in Cuba with regard 
to the need to modify the TRIPS Agreement.  The amendment was necessary to achieve a balance 
between patent holders worldwide and the holders  of traditional knowledge associated to genetic 
resources.  It was necessary to make patent rules compatible with the TRIPS Agreement and the CBD, 
based on multilateral reciprocity, so that the inte rests of both groups of holders were adequately 
balanced. 
42. The representative of the United States  recalled that the United States saw no conflict 
between the TRIPS Agreement and the CBD.  Both ag reements could be implemented in a mutually 
supportive manner and there was no need for an ame ndment to the TRIPS Agreement.  The CBD did 
not require patent disclosure requirements;  it only called upon parties to condition access to genetic 
resources on prior informed consent and to encourage the equitable sharing of benefits arising upon 
mutually agreed terms. 
43. The most effective means to achieve the objec tives of authorized access to genetic resources 
and the equitable sharing of benefits was through tailored national solutions.  New patent disclosure 
requirements would add uncertainties into the patent system and open a new avenue for litigation and 
dispute.  This would undermine the role of the patent system in promoting innovation and 
technological development and the economic incen tives that patents provide and any potential 
benefit-sharing that would be derived therefrom. 
44. She believed that there was a growing recognitio n that the new patent disclosure requirements 
were not enough to guarantee that prior informed consent had been obtained and that benefits were 
shared in a fair and equitable way.  It was obtaining authorized access and not the disclosure of origin in a patent application that manifested prior inform ed consent.  Fair and e quitable benefit-sharing was 
accomplished upon an agreement by entities.  The c ontract-based system was easily adaptable to a 
country's particular legal system  and provided the flexibility to protect traditional knowledge and 
genetic resources without undermining the economic  development incentives of strong intellectual 
property protection.  The proposed patent discl osure requirements would not be effective in 
preventing erroneously granted patents. 
45. Responding to the Peruvian submission, she said  that Peru had cited a number of pending 
published patent applications but, since the pate ntability of the claimed inventions had not been 
determined, it would be improper to comment on those.   It was not clear whether the mere filing of a 
patent application could amount to an act of misa ppropriation.  Peru had also discussed the patent 
applications relating to Maca  during the introduction of its paper.   Her delegation had reviewed the 
data base of US patents and located some patents related to  Maca , citing literature dating to the 1960's 
and all the patents had disclosed the country of orig in as Peru.  Apparently, the inventors had created 
new, useful and non-obvious inventions from the genetic  material that fully met the patenting criteria 
under US patent law, for example patents pertai ning to chemically active isolates, chemical 
compounds and compositions and not the plant itself.  This did not appear to be an example of 
misappropriation.  Her delegation had also  reviewed the patents related to the Chancapiedra  that Peru 
had referred to in its paper.  Th ey covered novel compositions useful in cosmetics, and that met the 
statutory requirements for patentability.  They listed more than thirty species of plants from which the IP/C/M/47 
Page 10  
 
 active ingredients might be derived and that were available from sources throughout the world.  They 
had not identified any examples of misappropriation or biopiracy.  
46. She recalled that while some delegations ha d recognized that cont ract-based access and 
benefit-sharing systems were essential, others had continued to argue that patent disclosure 
requirements were needed to improve complian ce with such mechanisms.  The United States 
disagreed with such a policy approach as it was burdensome for the patent system and did not 
effectively meet the stated goals.  Effective enfo rcement regimes for access and benefit-sharing would 
be part of civil and criminal codes and might include existing established mechanisms to enforce 
contracts. 
47. She was pleased that the Indian delegation agr eed that patenting in itself did not constitute 
misappropriation.  Patents could, in combination w ith an effective access and benefit-sharing regime, 
be a valuable tool to generate benefits that could later be shared.  If new patent disclosure 
requirements were adopted and non-compliance was discovered that would invalidate a patent, any 
benefits from that invention would be greatly diminished.  
48. Patent laws were designed to promote the progr ess of the useful arts by awarding intellectual 
property rights. They were not designed to regula te all matters relating to those inventions.  
Restrictions were placed on the use of certain inve ntions to ensure safety and efficacy, for example 
the health regulations governing pharmaceutical s, environmental regulations on emissions from 
automotive engines, or to protect domestic and national security, such as the regulations on firearms.  These restrictions were implemented and enforced outside the patent system.  The patent system did not condone violation of these other laws and in th e same manner, the patent system did not condone 
misappropriation of genetic resour ces and violation of a country's access and benefit-sharing 
requirements.  Just as health, saf ety and environmental regulations applied in their own spheres, a 
contract-based administrative access and benefit-sh aring system could effectively and adequately 
achieve domestic policy goals related to the conser vation and sustainable use of genetic resources.  
Criminal and civil liability for failure to comp ly with an access and benefit-sharing system 
requirement could be included in a country's laws .  She said that Members should fully examine 
national experiences with respect to access and benef it-sharing systems currently in place in order to 
better understand the perceive d shortcomings of such existing syst ems.  The Council might also want 
to consider the work of the IGC on Intellectual Property, Genetic Resources and Folklore at the 
WIPO. 
49. The representative of Ecuador
 said that the delegation of Peru had, in its presentation of 
document IP/C/W/441, explained clearly the difficulties faced due to the lack of international rules 
and provided elements on the importance of protect ing genetic resources and traditional knowledge.  
There was a need to amend the TRIPS Agreement to include the disclosure of origin and source in the 
requirements for patentability.  He said that document IP/C/W/442, presented by Brazil and co-
sponsored by his delegation, put forward concepts to  demonstrate the validity of the arguments on the 
relationship between the TRIPS Agreement and the CBD.  His delegation had always expressed their 
position in favour of the obligation to disclose the source and origin of genetic resources.  He said that it was important to take into account the arguments that had been presented in document IP/C/W/443.  
The issues presented in this document did not burden the intellectual property system and responded to the need for a balance in the TRIPS Agreement.  Instead of creating uncertainty or undermining the 
international patent system, the incorporation of  the disclosure requirement would enhance legal 
certainty and predictability and strengthen the legitim acy of the patent grant.  It was important to 
agree on this minimum set of international rul es to strengthen the intellectual property system. 
50. The representative of Indonesia
 supported the document that had been introduced by Brazil 
(IP/C/W/442).  This submission was a constructive c ontribution in the efforts to find a satisfactory 
solution, as mandated by the Ministers in the Doha Declaration.  One  of the core objectives of the  IP/C/M/47 
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 TRIPS agreement was to achieve a balance between rights and obligations and to ensure that the 
agreement is conducive to social and economic welfare.  Indonesia  implemented the TRIPS 
Agreement believing that its various provisions, would safeguard in totality the objectives and 
principles.  However, as proved by the issue of access to medicines and recognized by the Members 
through the TRIPS and Public Health Declarati on, the TRIPS Agreement had not fully met the 
objectives and principles which were enshrined in Ar ticles 7 and 8.  The lack of recognition under the 
TRIPS Agreement of the disclosure issue undermined the objectives and principles of the Agreement.  
Moreover, whilst the rights of new inventions were  protected, many developing countries continued to 
lose out as resources and knowledge passed down form generations were exploited in these 
inventions. 
51. He noted that some Members thought that the TRIPS Agreement did not present an obstacle 
to address the disclosure issue at the national context.   He shared the view that the ability of patent 
offices and other authorities in a national jurisdicti on to enforce prior informed consent and benefit-
sharing mechanism in one jurisdiction, did not lead to  similar actions in respect to patent applications 
in other countries.  He agreed with the need to establish an international framework for disclosure and 
prior informed consent, as well as for access and benefit-sharing of genetic resources and traditional 
knowledge.  The mandate on this issue clearly re quired the TRIPS Council to find a satisfactory 
solution.  A balanced outcome of the negotiations was needed to ensure that issues of real concern for 
developing countries were addressed in this round. 
52. The representative of New Zealand  welcomed the deepening of the debate on this aspect of 
the work of the TRIPS Council.  Her delegati on had not yet made definitive decisions about 
disclosure in the national context, but had previously  stated that disclosure in some form might assist 
or support CBD objectives.  She agreed that there might be potential for measures such as disclosure 
of the source of genetic resources and associated tr aditional knowledge to further the objectives in the 
TRIPS Agreement as enunciated in Articles 7, 8 and 27.  Additionally, such disclosure might bolster 
the TRIPS Agreement by providing more informa tion to enable better decisions on the existing 
criteria for patentability.   
53. She said that the two recently submitted papers  acknowledged the primary role of national 
systems in ensuring prior informed consent in relation to access and benefit-sharing.  The answers to 
problems of non-compliance with prior informed con sent and benefit sharing were not to be found in 
the intellectual property system, but should be addressed primarily through national ABS systems, which had been comprehensively implemented only in a few countries.  Without national systems 
being in place, the intellectual property system coul d not even play a supportive role.  Any suggestion 
that an applicant should provide evidence of benef it-sharing through the intellectual property system 
where there had been no such requirement in the country of origin of the genetic resources, as 
suggested in paragraph 11 of  docum ent IP/C/W/442, went too far.   
54. There was also a need to be realistic about the likely compensatory outcomes from this kind 
of disclosure that had been proposed, given that th e majority of genetic-resource based research was 
non-commercial and even where bio-discovery was undertaken with commercial objectives in mind, 
the hit rate was very low.  Her delegation was a little concerned that both sides seem to over-estimate 
the likely "green gold" at the end of the rainbow , and the potential benefits from patenting of 
inventions based on genetic resources.  She was interested in following up on a Canadian proposal 
made at the last meeting and hearing further fro m proponents about how the disclosure system would 
work in practice, and how it might have been applied in some frequently cited examples of 
misappropriation.  
55. The representative of Australia
 noted the large amount of work that had been generated on 
this issue not only in the TRIPS Council, but also in the WIPO.  She said that there was no conflict 
between the TRIPS Agreement and the CBD and that the two agreements could be implemented in a IP/C/M/47 
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 mutually supportive manner.  Her delegation consider ed all the contributions as useful and that no 
particular document was the basis for the ongoing wo rk.  She said that the relationship between the 
problem of biopiracy and the solution proposed in documents such as IP/C/W/442 was still unclear.  She agreed that the equitable sharing of benefits  from the use of genetic resources and/or traditional 
knowledge was important and that the patent system  was not the only solution to this problem.  She 
was concerned about the possible effects of denyin g or invalidating patent protection because of a 
lack of a benefit-sharing arrangement.  This might  have the effect of undercutting the objectives of 
any benefit-sharing arrangement, if as a result of su ch action there was no way to capture the benefits 
of the innovation.  She was also concerned about co sts since this was not a simple notification system 
and would impose additional burdens on patent applicants and patent authorities.  Paragraph 5 of 
document IP/C/W/429 stated that patent challe nges involved high costs in terms of time and 
resources.  She questioned how this system could be implemented while avoiding substantial costs, 
particularly with regard to the effects of no n-compliance outlined in paragraph 14 of the new 
document relating to patent challenges. 
56. The representative of Thailand
 said that his delegation attached great importance to the 
disclosure issue, as well as to GIs and the other implementation related issues.  Contractual 
arrangements, as had been proposed in the previous meetings of the TRIPS Council, could not, in his 
view, solve the problem of biopiracy, nor did they  safeguard genetic resour ces from being exploited 
outside the country of origin.  The recent submissions  explained in detail the disclosure issue.  He said 
that the disclosure issue should not be dealt with onl y in the WTO, but also in other fora such as the 
WIPO and UNCTAD.  The exercise at the WTO was to find a solution to this problem, as mandated 
by the Ministers at Doha. 
57. The representative from China  supported the submissions contained in documents 
IP/C/W/442 and IP/C/W/443.  The proposals had prov ided specific suggestions on how to implement 
the obligation of submitting evidence of benefit-sharing and this w ould push forward the negotiations 
in order to build a reasonable international system  on biotechnology.  It was necessary to amend the 
TRIPS Agreement and other relevant international rules in accordance with the CBD.  Each Member 
should prepare its laws to protect traditional knowledge and biodiversity .  Regarding the United States 
proposal contained in document IP/C/W/434, he ac knowledged that, to some extent, the contractual 
system was reasonable.  However, it might lead to unfair results since developed countries might take 
advantage of their strong position on technology to  force developing countries to accept an unfair 
contract.   
58. The representative of the European Communities  said that the Peruvian contribution on 
national experiences was very useful to better unders tand the issue.  He said that, at the December 
meeting, his delegation had indicated that it w ould submit a proposal to WIPO on "Disclosure of 
Origin or Source of Genetic Resources and A ssociated Traditional Knowledge in Patent 
Applications".  This proposal had been sent to WI PO in the context of the invitation of the WIPO 
Director-General to submit proposals before 15 De cember in order to prepare a contribution to the 
Secretariat of the Convention on Biological Diversity.  The objective of the EC proposal was to formulate a way forward that should ensure an effective, balanced a nd realistic system for disclosure 
in patent applications.  The outline of the EU pr oposal was as follows:  (1) a mandatory requirement 
should be introduced to disclose the country of or igin or source of genetic resources in patent 
applications;  (2) the requirement should apply to all international, region al and national patent 
applications at the earliest stage possible;  (3) the applicant should declare the country of origin or, if 
unknown, the source of the specific genetic resource  to which the inventor had had physical access 
and which was still known to him;  (4) the invention must be directly based on the specific genetic 
resources;  (5) there could also be a requirement on the applicant to declare the specific source of 
traditional knowledge associated with  genetic res ources, if he was aware that the invention was 
directly based on such traditional knowledge and, in this context, a further in-depth discussion of the 
concept of "traditional knowledge" was necessary;  (6 ) if the patent applicant failed or refused to  IP/C/M/47 
 Page 13 
 
 
 declare the required information, and despite bei ng given the opportunity to remedy that omission 
continued to do so, then the app lication should not be further processed;  (7) if the information 
provided was incorrect or incomplete, effective, proportionate and dissuasive sanctions should be 
envisaged outside the field of patent law;  (8) a si mple notification procedure should be introduced to 
be followed by the patent offices every time they r eceived a declaration and it would be adequate to 
identify in particular the Clearing House Mechan ism of the CBD as the central body to which the 
patent offices should send the available information. 
59. Commenting on document IP/C/W/438, he said that  a disclosure of origin requirement was 
sufficient at this stage.  There were serious prob lems with the introduction of a system where patent 
applicants should provide evidence of prior info rmed consent since it would impose an unreasonable 
burden on them.  He sought clarification on the role th at patent offices should play in such a system.  
In the view of his delegation, the request to verify  whether patent applicants complied with legal rules 
related to the material used in their invention w ould overburden patent offices and create problems of 
legal interpretation. 
60. With regard to the question of how furnishi ng evidence of prior informed consent would 
facilitate achieving the objectives of the CBD and en sure a harmonious relationship between the CBD 
and the TRIPS Agreement, and whether contract ual arrangements could suffice to achieve the 
objectives of the CBD, his delegation took the view that the implementation of the CBD required a 
combination of legislative and/or regulatory appro aches, setting the general rules, and of contractual 
approaches.  Regarding the question of how the evidence of prior informed consent should be 
provided, he felt there was some incoherence betw een "requiring, as a condition for acquiring patent 
rights, that applicants furnish evidence of prior informed consent" (paragraph 8) and "requiring 
applicants to provide information known to them or which they should reasonably know" (paragraph 
9) and sought a clarification of this point. 
61. As to the nature of the obligation that should satisfy the requirement of prior informed 
consent, the developing country paper said that the declaration indicating that prior informed consent 
was obtained from the relevant national authoritie s would be accompanied, for example, by a 
certificate or duly certified contract between the ap plicant and the national authorities of the country 
of origin.  The creation of an internationally recogn ised certificate of origin could certainly be a good 
idea, but was not relevant at this stage.  In this  respect, he would like to draw the attention of the 
Council to the recommendation adopted by the 3rd meeting of the CBD Ad Hoc Open-Ended Working 
Group on ABS that had been held in Bangkok on 14- 18 February 2005, which had called for further 
studies and pilot projects as well as for views on the creation of a certificate of origin/source/legal 
provenance, scheduled to be discussed at th e next ABS meeting in March 2006 in Spain. 
62. As to what the obligation should be if there was no national regime in the country of origin, 
he said that in many countries such national regime s did not exist or, where they did, they were not 
fully operational.  In these countries, certificates of evidence could not be delivered.  This was one of 
the reasons why his delegation thought it was prem ature to consider a requirement to provide 
evidence of prior informed consent.   As regards the legal effect of not providing evidence of prior 
informed consent, his delegation was not in favour of sanctions that would include the revocation of 
the patent.   
63. The representative of Turkey  said that all implementation issues had an equal footing.  He 
shared the concerns voiced by Peru, India, Br azil and other developing countries and wanted to 
further discuss this issue in order to find an appr opriate solution to the global biopiracy problem since 
the international system was in sufficient to tackle this probl em.  A new mechanism should be 
included in the TRIPS Agreement in order to s upport the objectives and the adequate implementation 
of the CBD.  His delegation was in favour of a pa tent system that would take into account the 
principles of prior informed consent and benefit-shari ng in patent applications, so as to better protect IP/C/M/47 
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 genetic resources and traditional knowledge.  His coun try was trying to reflect these principles in its 
legislation and supported the proposals made by  Brazil and India on the disclosure issue. 
64. The representative of Norway
 said that Norway was in the process of reviewing its policy and 
hoped to promote the objectives of the CBD through th e international patent system.  Her delegation 
saw nothing in the TRIPS Agreement that prevented a Member from requiring patent applicants to 
disclose the source or origin of biological material s.  For reasons of transparency, a provision that 
required or enabled Members to oblige a patent a pplicant to provide such information could be 
considered as it would enhance the support of the provisions of the CBD, particularly on equitable 
sharing of benefits and prior informed consent.   
65. She recalled that Norway had amended its pate nt act in order to take into account the 
provisions of the CBD.  Under the new provisions, pa tent applications concerning biological material 
should include information regarding the country of origin of the material.  Also, should the national 
legislation of the providing country so require, in formation about whether prior informed consent had 
been given, should be submitted.  These provisions did not apply to international patent applications.  
The duty to provide information was without prejudi ce to the processing of the patent applications.  
Nevertheless, a failure to provide correct information was liable to a penalty, under the general civil 
penal code.  Her delegation viewed positively the recent proposal made by the European Communities 
to the WIPO.  The interface between intellectual pr operty rights and biologi cal diversity was being 
discussed in a number of international fora.  In a ddition to the discussion in the TRIPS Council, her 
delegation continued to consider the discu ssions at the WIPO to be important.  
66. The representative of Canada  associated his delegation with th e points made and the questions 
raised by the delegations of New Zealand and Au stralia.  He saw no conflict between the TRIPS 
Agreement and the CBD and said that each should be implemented in a mutually supportive manner.  
He said he was not convinced that patent law was th e best means to ensure prior informed consent and 
access and benefit-sharing, or that an amendment to  the TRIPS Agreement was the best way forward.  
However, he recognized the mandate in paragraphs  12 and 19 of the Doha Declaration and the July 
2004 Framework.   
67. He appreciated the exchange of views between the delegations of Peru and the United States, 
which had been based on real life situations and r ecalled that Canada had encouraged the proponents 
to elaborate on how their approach would have a ddressed real life situations.  Such a diagnostic 
approach would help the Council and Members, who had not yet come to a firm view on these issues, to find the best way forward to prevent biopiracy.  Recognizing that the submission of the EC had 
been to WIPO, he said that that forum continued to provide the best opportunity to resolve the 
questions on the relationship between intellectual property, genetic resour ces, traditional knowledge 
and folklore. 
68. The representative of Kenya
 associated his delegation with the papers that had been circulated 
by Brazil and other delegations.  In his view th ere was a need to review and amend the TRIPS 
Agreement to prevent biopiracy, to ensure that ever y patent applicant disclosed the country of origin 
of any traditional knowledge involved in the inventi on, obtained prior informed consent and based 
access to genetic resources on a fair and equitable sharing of benefits.  He  supported the position of 
the European Communities regardi ng the need for a mandatory requirement for disclosure.  His 
delegation was of the view that a combination of  national and multilateral approaches would be the 
most appropriate means to tackle the problem. 
69. The representative of Japan  said that there was no conflict between the TRIPS Agreement and 
the CBD and that they should coexist in a mutually  supportive manner.  He said that the discussion on 
what should be disclosed in a patent application sh ould be based on the requirements of the patent 
system per se .  The disclosure issue should be discussed main ly at the IGC of the WIPO because of its  IP/C/M/47 
 Page 15 
 
 
 expertise and because its Director-General had shown his strong support to that forum.  His delegation 
shared many views with the United States, as stated in their paper as it proposed to make some impact 
on biopiracy without putting additional burden on to the patent system. 
70. The representative of Peru  said that his country faced similar problems as described by Brazil 
with respect to genetic resources from the Amazon re gion, with regard to some products on which the 
National Anti-Biopiracy Commission was currently carrying out research.  He said that document 
IP/C/W/442 closed the circle that had started with the presentation of the checklist and the 
development of each of the issues.  He believe d that IP/C/W/443 contained the majority of the 
concerns that Peru and other deve loping countries had with regard to the contract-based approach.  He 
was concerned that the contractual approach was st ill being considered as a possible solution to the 
problems faced by developing countries.  He th anked all those who had made comments on the 
Peruvian paper, especially the delegations of Ca nada, New Zealand and Australia, who had promoted 
the presentation of real life cases.   
71. Responding to some of the comments made by th e delegation of the United States, he said 
that it had not been said that the presentation of a patent application constituted proof of 
misappropriation or biopiracy.  He clarified that the six examples that had been included in the paper 
were illustrative.  The National Anti-Biopiracy Commission had identified approximately fifty products but this did not mean that misappropriation or biopiracy had in fact taken place in all these 
patent applications.  This was the first part of th e work to be carried out by the Commission where all 
the possible applications containing Peruvian genetic  resources would be identified.  In a second 
phase, they would identify the applications where the Peruvian National Authorities considered that 
there could have been misappropriation in order to pr esent the case to revoke such patent applications.  
The United States delegation had mentioned the case of Maca  and Peru had avoided presenting it, 
since some patents granted were already in the phase of revocation.  A similar process might be 
carried out with a product known as Chancapiedra , which had cosmetic uses. 
72. He said that the delegations of the United States and Japan had stated that the disclosure issue 
should be discussed at the WIPO.  The WIPO had a ddressed this issue in the Committees dealing with 
patents and in the IGC.  The IGC's mandate concluded this year with the last meeting to be held in 
July 2005 and there was no clarity on the conti nuation of its work.  The IGC had no negotiating 
mandate and could not address the problems faced by  the TRIPS Council on the need to include a 
universal, legally binding requirement to disclose or igin.  While the patent committees dealt with this 
issue, they had a limited scope.  For example, Peru was not a party to any of the patent treaties of the 
WIPO.  Therefore, the TRIPS Council was the appropria te forum to deal with the disclosure issue.  
He hoped that the decision to carry out dedicated in formal consultations would allow the work with to 
be continued the objective of reaching a consensus, e ither in July or by the Ministerial Conference in 
Hong Kong, China on a work plan which would allow a satisfactory solution by the end of the round. 
73. He said that even though Peru had an obligation to disclose origin in its national legislation, it 
was very difficult to implement since the Peruvian patent system granted only five or ten patents per 
year and could not be compared to those of the United States, Europe or Japan.  Consequently, a 
country like Peru had to search, not in its own pa tent system, where there was an obligation to 
disclose origin, but in those countries where the majo rity of patent applications were presented and 
where the large corporations could carry out research and development using foreign genetic 
resources.  He repeated that this did not mean that  all the genetic resources originating in Peru were 
misappropriated, or that all the patent applications  involved biopiracy.  He explained that if the 
obligation to disclose origin in the patent appli cation was properly implemented with an universal, 
legally binding requirement, it would be much easier for countries like Peru to search for specific cases, without having to go thro ugh expensive legal procedures, un like the current situation with 
respect to patents involving the use of Maca  where, were it not for international support and NGOs, 
the Peruvian government would have found it impo ssible to present the cases on revocation of patents IP/C/M/47 
Page 16  
 
 in foreign countries.  He concluded by saying that  the development round had to take into account the 
fact that developing countries were burdened with all these costs.  While the obligation to disclose 
origin would probably imply a cost, it was smaller th an the costs that countries like Peru had had to 
face in creating the National Anti-Biopiracy Commissi on, carrying out searches, etc.  He said that the 
questions posed had allowed him to further clar ify how the National Anti-Biopiracy worked, the 
problems it faced and the difficulties that might be  avoided with the incl usion of a mandatory 
requirement of the disclosure of origin through an amendment of the TRIPS Agreement. 
74. The representative of Switzerland
 recalled several oral interventions of his delegation, and the 
three communications to the TRIPS Council contained in documents IP/C/W/400, IP/C/W/423 and IP/C/W/433 on the proposal that had been submitt ed to the Working Group on the reform of the 
Patent Cooperation Treaty of the WIPO.  These proposal s would enable the contracting parties of the 
PCT to require patent applicants to disclose the source of genetic resources and traditional knowledge 
in patent applications.   
75. He supported the proposal of Canada that th e discussion under paragr aph 19 should be aimed 
at a more fact-based approach and that the discu ssions could benefit from national experiences with 
respect to access and benefit-sharing systems.  The Council had gained a better understanding of the 
challenges and shortcomings that might occur in  practice from the paper and the explanations 
submitted by the Peruvian delegati on.  His delegation was of the view that the process should be 
Member-driven and encouraged other Member s to come up with such information. 
76. With regard to the communications IP/C/W /429/Rev.1 and IP/C/W/438, which had been 
submitted by Brazil, India and various  other delegations, his delegation had four questions.  First, how 
did these delegations define the term "country of or igin"?  Second, what was the reason that these 
communications only referred to the country of origin?  He highlighted that Article 15 of the CBD in the context of access and benefit-sharing did not refe r to the country of origin, but referred to the 
contracting party providing genetic resources.  In the view of his delegation the wording "country of 
origin" excluded the International Treaty of FAO,  since it was not based on a bilateral, country-by-
country approach but established a multilateral syst em of access and benefit-sharing. The same 
problem applied to the proposals that had been subm itted by the EC and the US.  The third question 
was how did these delegations define the terms "biopiracy" and "misappropriation"?  He said that having a clear understanding of these terms and the unde rlying concepts was a crucial prerequisite for 
the discussions in the TRIPS Council.  The fourth question was how would the proposals of these delegations be reflected in WIPO's PCT and PLT? 
77. Responding to the United States' submission (IP/C/W /434), he said that with respect to prior 
informed consent and benefit-sharing, his delega tion had stated in its communication of June 2003 
(IP/C/W/400/Rev.1), that the task of verifying whet her the national system of prior informed consent 
had been adhered to and if the benefits had been shar ed could best be carried out by the parties to the 
contracts on access and benefit-sharing.  He propo sed to explicitly enable the national patent 
legislation to require the declaration of the sour ce of genetic resources and genetic knowledge and to 
establish a list of government agencies which coul d be informed by the office receiving a patent 
application containing such a declaration.  These tw o measures would allow the parties to the contract 
on access and benefit-sharing to verify whether the other contracting party had complied with its 
obligations arising under that c ontract and would simplify the enforcement of these contractual 
obligations.  IP/C/M/47 
 Page 17 
 
 
 78. He asked how a purely national approach w ould address problems arising from transboundary 
access and benefit-sharing in cases where genetic resources and traditional knowledge were being 
used outside the scope of national solutions.  Further it was not clear how a purely contractual 
approach would address cases where no contract on  access and benefit-sharing had been concluded 
between the provider and the user of genetic resources and traditional knowledge.  He was also 
interested in receiving further information from th e European Communities and its member States on 
the specific PCT and PLT provisions which would need to be changed in implementing their 
proposal.  
79. The representative of the Philippines  said that his country had also faced situations which 
could be characterized as unfair or inequitable exploitation of biological and genetic resources or 
traditional knowledge.  He supported the objective of  the proponents in seeking a solution through the 
disclosure requirement, which could indeed provi de the basis for a multilateral solution to the 
problems associated with biopiracy.  The requirement  of providing evidence of benefit-sharing was  
most commercially and economically meaningful in the context of the WTO and the TRIPS Agreement.  If the premise of the supposed link between intellectual property rights and trade was 
accepted, presumably through the importation and utili zation by the prospective patent applicant of 
biological resources and traditional knowledge in to his home country and their international 
marketing, then disciplines requiring evidence of be nefit-sharing would potentially offer the most 
trade-related of the three requirements that the prop onents had suggested.   National schemes, such as 
contractual arrangements, had not proven to be ade quate in ensuring benefit-sharing. A requirement 
for patent applicants to disclose evidence of benef it-sharing and prior informed consent could be seen 
as an alternative to national access and benefit-sh aring schemes.  However, national benefit-sharing 
schemes in themselves should be strengthened, in partic ular to ensure that the internal allocation of 
benefit-sharing reaches those peoples or parties th at were actually the source of the genetic or 
biological resource or traditional knowledge. 
80. He said that the suggested international framewo rk contained in document IP/C/W/442 might 
be pursued in parallel in various forums to truly attain an effective international protection.  He 
encouraged the proponents to look more closely at the aspect relating to the legal effects of not 
providing evidence of fair and equitable benefit-shar ing under the relevant national regime.  The issue 
of how to enhance the existing mechanisms for benefit-sharing in relation to commercialization 
outside the patent system should be pursued in order to obtain a fully effective international 
framework of protection, although this was outside th e jurisdiction of the TRIPS Council.  It was also 
critical to look at how adequate compensation could be ensured, particularly where the patent had 
already been granted.   
81. The representative of Malaysia
 said that there was a number of Members interested in a 
system of protection of genetic resources and trad itional knowledge that was effective and benefited 
both the patent applicants and the owners of such resources or knowledge. She looked for further 
clarification of how this system would work in a practical and operational manner.  She said that 
IP/C/W/442 stated that there should be evidence of  fair and equitable benefit-sharing based on 
national law.  This requirement would not be cu mbersome, as the applicants had simply to supply 
information of full compliance with the laws of the country of origin.  However, it was not clear who 
determined whether the requirements had been met by  the applicant, whether it should be the patent 
office or the national authority of the country of origin.  If it was the patent authority or even the 
courts of the country where the patent office was lo cated, how would such authorities be able to judge 
adherence to laws outside their own jurisdiction?  It was not clear if the patent authorities would be 
able to conduct this task with due diligence and co mmitment.  Certification systems of compliance at 
the national or international levels had been men tioned, but it was not clear what would happen in 
cases where the beneficiaries had not been clearly  identified or where the source or origin was 
unknown.  She sought clarification on whether a pa tent application could still continue even if 
benefit-sharing could not take place due to these reasons.  IP/C/M/47 
Page 18  
 
 82. The representative from Brazil
 recalled that his delegation, together with the Indian 
delegation, had tabled a document containing a comme ntary on the issues raised by the United States 
in document IP/C/W/434.  He said that they were willing and open to consid er any additional issues 
that the United States would like to raise on the resp onses contained in their submission.  He said that 
his delegation was ready to engage on the issue of  the role of patent offices and definitions. These 
were important technical matters that had to  be addressed in the course of negotiations 
83. He responded to the argument that had been made  on the suggestion that disclosure of origin 
was not feasible and should not be included in th e TRIPS Agreement because it would not solve all of 
the problems that developing countries were facing.   He emphasized that the disclosure requirement 
was not intended as a stand alone mechanism but co uld make an important contribution in addressing 
the concerns that had been raised by developing co untries.  The international patent system and the 
TRIPS Agreement would be improved by such an obligation as it would provide for a more cost-
effective system to pursue appropriate actions in  response to cases of biopiracy and misappropriation. 
84. In response to the point that there was no reference in the CBD to disclosure of origin, he 
pointed out that an article of the CBD did state that the parties to that convention should take 
measures to ensure that intellectual property rights were supportive of and di d not run counter to its 
objectives.  The TRIPS Agreement was an internatio nal intellectual property agreement administered 
by the WTO and that was the reason why the group of  developing countries had come to this forum to 
present their proposals and it had a role to play to  ensure that the objectives of the CBD were not 
undermined. 
85. With respect to the issue of th e absence of national regimes, he said that the submissions did 
state that, for cases where national access and benefit- sharing regimes were not available in the 
country of origin, patent applicants would merely ha ve to make such a declaration.  He pointed out 
that the CBD was an international agreement and th at prior informed consent and benefit-sharing, as 
embodied in the CBD, were to be respected even in  cases where specific AB S regimes might not have 
been set up in the countries of origin.  Responding to the point made with respect to the burden on 
patent offices and patent applicants, he said that  this argument was not relevant since the TRIPS 
Agreement had created a significant burden, partic ularly on developing countries and impoverished 
peoples and consumers of t echnology in general.   
86. With respect to arguments on appropriate forum,  he reiterated that there was a mandate from 
the Ministers to address this issu e and encouraged all delegations to engage constructively in the 
discussion and refrain from engaging in "forum shopping ".  He said that the TRIPS Council had also 
been charged with taking into account the developmen t dimension in its future work.  It was up to 
WIPO Member States to ensure that their interests were properly taken care of in the work of that 
organization, not only in the context of the PCT and the PLT, but also the SPLT.  He pointed out that the discussion in the TRIPS Council had, in fact, moved work forward on the disclosure issue and the relationship of the TRIPS Agreement and the CBD.  These discussions had allowed the proponents to 
present the technical points that would have to be co nsidered in the course of the negotiations for an 
amendment of the TRIPS Agreement.   
87. The representative of India
 said that he disagreed with the statement of the US delegation that 
there was a growing recognition that the disclosure requirement was not an adequate solution.  The 
discussions that had taken place had shown a growing realization that disclosure requirements were an 
integral component of the eventual recommenda tion that the TRIPS Council had to make under 
paragraph 19 of the Doha Ministerial Declaration.  The US delegation also said that it appeared there 
was a growing recognition in favour of the nationa l contract-based approach whereas, in his view, 
there was a diminishing recognition of the stand-al one contract based approach being an adequate 
solution to the issue of the relationship between the TRIPS Agreement and the CBD.  IP/C/M/47 
 Page 19 
 
 
 88. He agreed that patents per se  did not constitute misappropriation, but said that the act of 
applying for a patent and the acts involving th e accrual of rights on patents without proper 
authorization did in fact constitute misappropriatio n, as stated in the submission IP/C/W/443.  The 
United States had also stated that there were a wi de variety of restrictions on the use of patented 
products and an example characterized as environm ental restrictions had been given but did not 
pertain to the obligations arising out of the CBD. 
89. With respect to criminal or civil liabilities, he said that it was not clear what would happen 
when the misappropriation involved transbounda ry activities and was happening outside the 
jurisdiction of the national enforcement authoriti es.  He concluded that it was clear from the 
discussion that national systems were important, but not  sufficient to resolve th e issue that was being 
discussed.   
90. He agreed that prior inform ed consent and access and benefit-sharing issues had to be 
responded to as a first step through a national level sy stem of requirements, but he believed that an 
international recognition of the need for resp ecting these prior informed consent and access and 
benefit-sharing requirements was essential to achieve the shared objective of mutual supportiveness of 
the CBD and the TRIPS Agreement.  The mu tual supportiveness of the CBD and the TRIPS 
Agreement would be achieved in part through the na tional regimes and other international treaties in 
other bodies, but the linkage with the TRIPS Agre ement for the achievement of these objectives had 
to be addressed in the WTO.   
91. In response to the point made by the Austra lian delegation that the disclosure requirement 
might undercut the objectives of the patent system , he believed that the TRIPS Agreement provided 
for a balance between rights and obligations that the society at large would benefit from.  With respect 
to the point on costs and burdens referred to para graph 5 of document IP/C/W/429/Rev.1, he said that 
these arose for those who had to use post-grant proceed ings to achieve what could have been achieved 
if there had been adequate knowledge through disclosur e of the origin of the biological material and 
associated traditional knowledge that was used in an invention.   
92. In response to the point made by the European Communities on th e role of patent offices in 
the disclosure requirement, he said that their role was to ensure that patent applications were complete 
and these did not add any burdens.  He said that a combination of national level regimes and the 
international recognition of the disclosure requireme nts was the minimum required to meet the shared 
objectives.  He said that the definitions sought to  be established by the Swiss delegation would be 
useful when the technical phase of undertaking th e amendment of the TRIPS Agreement took place. 
93. He referred the delegation of the Philippines to  the three papers submitted by his delegation 
and the cosponsors on the potential legal effects of the disclosure requirements and was ready to 
discuss any further concerns.  He said that he w ould revert to the technical comments from some 
delegations.  He proposed that in the forthcomi ng meetings of the TRIPS Council there should be a 
more technical discussion on the specifics of the amendment to the TRIPS Agreement. 
94. He said that the Doha Ministerial Declar ation had placed the needs and interests of 
developing countries at the heart of the work progr amme it had adopted.  Ministers had also strongly 
reaffirmed their commitment to the objective of su stainable development.  They were convinced that 
the aims of upholding and safeguarding an open a nd non-discriminatory multilateral trading system 
and protecting the environment and promoting sustai nable development could and must be mutually 
supportive.  This applied to all the agreements administered by the WTO, including the TRIPS 
Agreement. IP/C/M/47 
Page 20  
 
 95. The mandate of the negotiations in the D oha work programme tellingly started with 
implementation-related issues and c oncerns.  Paragraph 12 of the D oha Declaration highlighted the 
"utmost importance" attached to these concerns , a term not used anywhere else in the entire 
Declaration.  It then expressed determination to find appropriate solutions to these issues.  
Negotiations on outstanding implementation issues were  an integral part of the work programme.  
One needed to keep the outcome mandated in the Declaration and the process of organizing these 
negotiations in view when proceed ing to find appropriate solutions. 
96. There were half a dozen TRIPS outstanding impl ementation issues, most of which related to 
the relationship between the CBD and the TRIPS Agreement.  An outcome on this issue, therefore, was of utmost importance.  A number of delegations, including India, had suggested that one part of 
the solution was to require patent applicants to disclose the country and source or origin of any 
biological material and/or associated traditional kn owledge used in the inve ntion as well as evidence 
of prior informed consent and benefit-sharing that  may have been obtained in accessing the material 
and/or knowledge.  He believed th at the consultations should lead to a satisfactory outcome on this 
"disclosure issue".  He was sure that all Member s wished an outcome on this issue and thereby to 
fulfil the mandate given by Ministers.  It was clear to India that a satisfactory outcome on this issue 
was essential for the conclusion of the Doha work programme. 
97. The 1 August 2004 Decision by the General Council Decision, in particular the paragraph on 
"Implementation", had reminded Members that th ey had not yet progressed enough on issues that 
were at the heart of the work programme, including  implementation issues.  The Director-General had 
been requested by the General Council to continue his consultative process and to report to the TNC 
and the General Council no later than May 2005 in order to enable the General Council to take 
appropriate action by July 2005.  Efforts needed to be redoubled to find appropriate solutions as a 
priority.  He called upon the Chairman, in his capacity as a Friend of the DG, to structure a substantive, dedicated and inclusive consultation on  the disclosure issue.  The consultations should 
lead to a satisfactory outcome on this proposal. 
98. The Council took note
 of the statements made. 
F. REVIEW OF IMPLEMENTATION OF THE TRIPS  AGREEMENT UNDER ARTICLE 71.1 
99. No statements were made under this  agenda item.  The Council agreed  to revert to the matter 
at it's next meeting. 
G. REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON GEOGRAPHICAL 
INDICATIONS UNDER ARTICLE 24.2 
100. No statements were made under this  agenda item.  The Council agreed  to revert to the matter 
at it's next meeting. 
H. DECISION ON THE IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON THE 
TRIPS  AGREEMENT AND PUBLIC HEALTH  
101. The Chairman  recalled that, at its meeting in June 2004, the Council had agreed to continue 
its work pursuant to paragraph 11 of the Gene ral Council Decision on the "Implementation of 
Paragraph 6 of the Doha Declaration on the TRI PS Agreement and Public Health" (hereinafter 
referred to as "the Decision") on the preparation of an amendment to the TRIPS Agreement with a 
view to the TRIPS Council making a recommendation by the end of March 2005 so that the General 
Council could conclude its work on the amen dment at its first meeting thereafter.   IP/C/M/47 
 Page 21 
 
 
 102. He informed the Council that, as had been agreed at its meeting in December 2004, he had 
continued to consult with delega tions individually and in groups, as well as in open-ended format on 
the best way to proceed on this matter.  Howeve r, there seemed to remain significant differences 
among delegations in regard to the substantive co ntent of an amendment to replace the Decision, 
although there had been some signs of flexibility on the issue of the legal form.  
103. He drew attention to three new communicati ons;  one from the dele gation of Rwanda on 
behalf of the African Group providing arguments  to support the African Group proposal on the 
implementation of paragraph 11 of the Decision (IP/C/W/440, referring to an earlier proposal by the 
African Group circulated as document IP/C/W/437);  another from the delegation of Barbados on 
behalf of the Group of Commonwealth Developing Countries containing a "Report on the Workshop 
on the WTO Decision on Access to Medicines at Affordable Prices for Countries with No or 
Insufficient Manufacturing Capacities", that was or ganized by the Commonwealth Secretariat in 
Geneva from 12 to 14 October 2004 (IP/C/W/439);  and a third from the United States commenting on the implementation of the Decision (subsequently circulated as document IP/C/W/444). 
104. Introducing document IP/C/W/440, the representa tive of Nigeria, speaking on behalf of the 
African Group , recalled that, at the Council's meeting in December, the African Group had presented 
a proposal for the amendment of Article 31 of the TRIPS Agreement.  The proposed amendment was 
based on the waivers adopted in the Decision with modifications, but it did not include the Chairman's Statement either as part of the amendment text or as a footnote.  Some Members' concerns about and 
arguments against the proposed approach gave rise a num ber of issues.  In this respect, he noted that 
some Members had argued that there was no need to amend the text of the TRIPS Agreement and 
maintained that a footnote would be the most a ppropriate way to implemen t paragraph 11 of the 
Decision. 
105. He recalled that, in its note of 1 March 2004, the Legal Affairs Division had concluded that 
footnotes were considered by WTO panels and the WTO's Appellate Body as being integral parts of 
the articles to which they were attached.  In an addendum to this note, dated 12 May 2004, the 
Division had further concluded, that the legal effect  of a reference to another document, whether in 
the main body of the Agreement or in a footnot e, would obviously depend on the way the reference 
was written.  The same addendum also stated th at there was no reason emanating from the law and 
jurisprudence of the WTO to date that would pr event Members from using other options, including 
making additions to an article of the Agreement, mo difying the relevant paragraphs of Article 31 of 
TRIPS, or inserting an annex.   
106. Therefore, he considered that the proposal by  the African Group to add a new paragraph to 
Article 31 would stand on sound legal ground in the WTO law and jurisprudence as confirmed by the 
Secretariat.  This would be the most direct and straightforward approach, which left no doubts about 
the legal standing of the amendment.  As was clea r from the Secretariat's notes, while panels and the 
Appellate Body had generally interpreted footnotes as a substantive part of the text, the question of 
the status of footnotes vis-à-vis the text of an amendment had never been positively examined by a 
panel or the Appellate Body.  It would therefore be uncertain if a footnote could have the same 
substantive value as an embodiment into the text of the Agreement. 
107. Turning to the modifications to the Decision proposed by the African Group, he explained 
that those were based on the agreement that the "amendment would be based on the Decision, where 
appropriate".  The African Group proposal would modify the Decision as appropriate and, in 
particular, eliminate a number of provisions in the Decision, while main taining the fundamental 
elements and substance of the Decision.  First,  those provisions whose purpose had already been 
served or which would be redundant in the context of an amendment could be seen as self-eliminating 
elements.  This would include the Preamble, the la st part of paragraph 1( b), dealing with Members 
that voluntarily decided not to use the system or  to use it only in limited circumstances, as well as IP/C/M/47 
Page 22  
 
 paragraph 6(ii) on regional patent systems, para graph 8 on annual reviews, paragraph 9 on prejudice 
to other rights, and paragraph 11 on the amendment process.   
108. Second, provisions whose purpose was served by  other provisions of the TRIPS Agreement, 
such as those on enforcement and the already existing provisions of Artic le 31, were also proposed for 
elimination.  This category would comprise most of the provisions of paragraph 2 of the Decision, 
namely paragraph 2(a)(i) requiring the speci fication of the names and quantities needed, 
paragraph 2(a)(ii) relating to th e confirmation of lack of capacity  and the Annex to the Decision, 
paragraph 2(a)(iii) relating to the confirmation of intention to grant a compulsory licence, 
paragraph 2(b)(i) regarding the importation only of the amount necessary to meet the needs of the 
importing Member, paragraph 2(b)(iii) on the posti ng of information on the website, as well as 
paragraph 2(c) with respect to the notification to  the TRIPS Council of the grant of a licence.   
109. It was also proposed to eliminate paragraph 4 of  the Decision relating to re-exportation, since 
the patent holder would have sufficient ave nues to prevent re-exportation of the products 
manufactured under the system.  Therefore, paragr aph 4 would only complicate the implementation of 
the system without adding any value to it.  The most important component of preventing diversion 
would be in third countries.  This aspect would be adequately covered by Article 31(2)(d) of the 
African Group proposal, which incorporated elem ents of paragraph 5 of the Decision, with 
modifications to include the fundame ntal elements of paragraph 4.  
110. As to the Chairman's Statement, he said that it should not be part of the amendment as it was 
not part of the Decision.  Making it part of th e amendment text, including through a footnote, would 
elevate its legal status.  
111. Introducing document IP/C/W/439, the representa tive of Nigeria made a statement on behalf 
of the Chairman of the Geneva Group of Commonwealth Developing Countries  on the main findings 
and conclusions of the Workshop on the WTO Decision on Access to Medicines, held in Geneva from 
12 to 14 October 2004 and organized by the Comm onwealth Secretariat in cooperation with the 
Geneva ACP Office and the Agency for Internati onal Trade Information a nd Cooperation (AITIC).  
112. As regards quality, safety and effectiveness of  products produced under compulsory licences, 
the meeting had noted that a number of countries wh ich were important producers of pharmaceutical 
products would not require manufacturers to obtain ma rket authorizations for products that were 
produced only for exports.  The responsibility for the evaluation of generic medicines would therefore 
fall on the drug regulatory authorities of the importing countries.  However, a lack of qualified and 
trained human resources, as well as well-functioni ng laboratory facilities, would often make it 
difficult for regulatory authorities, particularly in countries with insufficient or no manufacturing 
capacities, to carry out independent evaluations th at were needed for the granting of marketing 
approvals of such products.  Moreover, according to  the WHO, nearly one third of such countries 
would have either no regulatory authority or on ly limited capacity to regulate the market for 
pharmaceutical products.   
113. In view of this situation, the meeting had considered the need for a country granting a 
compulsory licence to produce only for exports to  ensure that exports were permitted only after 
quality and safety evaluation of the product by its regulatory authority.  It was noted that some countries had recently initiated relevant legislatio n.  Where this could not be achieved through 
legislation, the exporting country should invariably impose conditions in the compulsory licence that 
exports could be made only after the product had been  evaluated by the drug regulatory authority, or, 
alternatively, allow the importing country to reque st the drug regulatory authority of the exporting 
country to make the necessary evaluations.  The meeting had also noted that it  might be possible for importing and exporting countries to agree on replyi ng on the WHO scheme for pre-qualification of  IP/C/M/47 
 Page 23 
 
 
 manufacturers and products, for the assurance of qu ality of products produced only for exports in 
accordance with the provisions of the WTO Decision.  
114. He reported that the workshop had also discussed  the feasibility and desirability of developing 
trade and production on a regional basis.  It was no ted that the flexibility to resort, where necessary, to 
compulsory licensing would only be available to developing countries which were members of 
regional economic groupings of which half the members were least-developed countries.  The 
development of a pharmaceutical i ndustry would require a number of critical resources.  Incentives 
would be necessary to encourage the development of such industry, which would require ensuring 
resource-sharing and industrial complementarity.  
115. As regards the desirability of developing regi onal patents, there had been consensus on the 
necessity for engaging in further discussions on the prac tical steps that would have to be taken for the 
development of trade and production on a regional basis.   It had been agreed that the secretariats of 
the regional economic groupings and the regional pa tent organizations shoul d be engaged.  The 
Commonwealth Secretariat, the Geneva Office of the ACP Secretariat and AITIC had indicated their willingness to consider providing technical assistan ce on request for further work in these areas. 
116. As regards the implementation issues, it had been  noted that one of the positive aspects of the 
Decision was the fall in prices of a number of pa tented products supplied to developing countries.  
Some evidence showed that there was greater willingn ess on the part of some patent holders to grant 
voluntary licences to firms wishing to produce generic drugs. 
117. The possible implications of the approach adopt ed in the free trade area agreements between 
some developed and developing countries had also b een discussed, especially with regard to rules 
relating to the protection of undisclosed test data  submitted by the innovator applicant to the drug 
regulatory authority for obtaining marketing approval  of its product.  Some concerns continued to 
prevail that these developments made it difficult for generic manufacturers to obtain approvals for 
their products during the period when such data was protected. 
118. He reported that the workshop had also noted that least-developed countries benefited from a 
transitional period until 1 January 2016 to change their national legislations in the pharmaceutical 
sector and bring them into conformity with their TRIPS obligations.  There had been a brief discussion on whether these countries would be able to effectively take advantage of the extended 
transitional period to develop pr oduction of generic versions. 
119. In concluding, he highlighted one of the importa nt findings of the Workshop, i.e. the need to 
pay greater attention to the regulatory aspects of production and trade in pharmaceutical products in 
further discussions on securing effective implementation of the Decision and work on making 
available pharmaceutical products that were needed in  developing countries at affordable prices.  The 
countries with no or insufficient manufacturin g capacities would no doubt be in need of 
pharmaceutical products for the treatment of diseas es like HIV/AIDS, malaria and tuberculosis at 
affordable prices.  However, it would have to be  ensured that products s upplied to them met the 
required quality and efficacy standards in the treatm ent of the ailments affecting people in these 
countries. 
120. Addressing many of these and other issues raised in the discussions required a greater degree 
of cooperation and coherence at th e national level between ministries of trade, industry and health, 
and between relevant internati onal organizations dealing with  health, trade and industrial 
development.  The Workshop had recommended that in  further work this aspect should be given due 
importance. IP/C/M/47 
Page 24  
 
 121. Introducing document IP/C/W/444, the representative of the United States
 noted that the 
purpose of the solution reached in August 2003 would have to be kept in mind when transforming it 
into an amendment to the TRIPS Agreement.  The Decision represented a comprehensive and 
balanced system which allowed those that lacked  the capacity to manufacture drugs to import the 
drugs they needed without drugs being diverted to other markets.  It met the objectives that Members 
were seeking and had garnered support from all WTO Members.  His delegation strongly supported 
the Decision and also encouraged and supported Members' effective and appropriate use of the 
solution.  His delegation also remained comm itted to expeditiously reaching consensus on an 
amendment to the TRIPS Agreement that fully refl ected the solution.  He said that the amendment 
would have to preserve the entire agreement reached  by consensus in August 2003, and, therefore, 
would have to include an express reference to both the Decision and the Chairman's Statement.  As 
was the case for many other delegations, he believed th at this should be a technical exercise and that 
substantive issues should not be re-opened.  Howe ver, the task of reaching an agreement for an 
amendment preserving all aspects of the Decision would be very difficult if Members sought to change its content. 
122. As regards the African Group proposal, he expr essed serious concerns about the suggested 
amendment to the TRIPS Agreement to implement th e Decision.  For example, the proposal did not 
make any reference to the Chairman's Statemen t, and omitted key safeguards from the Decision to 
ensure the proper functioning of the solution, such  as notification and diversion.  His delegation 
believed that any proposal would have to meet th e basic objective of formulating an amendment that 
preserved the consensus and delicate balance struck by  Members in August 2003.  It remained open as 
to how this technical exercise could be best and most expeditiously accomplished.  A footnote 
approach referring to both the Decision and the Chairman's Statement would be an easy and 
straightforward exercise and, therefore, an op timum solution.  But any other options for an 
amendment including both the Decision and the Chairm an's Statement could be considered, including 
a new section in Article 31 of the TRIPS Agreement itself. 
123. He recognized that some Members had expressed  concerns about the legal status of the 
Chairman's Statement being elevated.  He clarified th at his delegation did not seek to elevate the legal 
status of the Statement.  However, all aspects of  the Decision should be preserved, including the legal 
relationship between the Decision and the Chairman's Statement.  His delegation was open to discuss how best to describe the relationship between th e content of the Statement and the Decision.  
However, it was essential to preserve explicitly in th e amendment a reference to the Statement or the 
principles included therein.  The Statement had made the consensus solu tion possible by addressing 
and resolving questions concerning aspects of the Decision that were unclear or not addressed.  
Therefore, the Statement was an essential part of the consensus solution which had to be preserved.  
Eliminating the principles of the Statement would make it very difficult if not impossible to move forward. 
124. The representative of the European Communities
 confirmed that the EC remained fully 
committed to the amendment process and to the March 2005 deadline to complete work on the 
amendment.  His delegation, therefore, continued to believe that this process should remain a purely 
technical exercise without any re-opening of the discussion on substance.  The Decision was not perfect but reflected a compromise that had been difficult to reach.  Therefore, any attempt to 
renegotiate it would jeopardize the amendment pr ocess.  His delegation had the impression that 
certain Members were trying to obtain what they we re unable to achieve in August 2003.  It was, 
therefore, doubtful if those Members really wanted to complete work on the amendment expeditiously 
and even wanted an amendment at all.  To furt her the process and preserve its technical nature, he 
suggested that the Chairman, with  the possible assistance of the Secretariat, continue consultations 
and produce a text consisting of a technical adaptation of the Decision.  IP/C/M/47 
 Page 25 
 
 
 125. As regards the African Group proposal, he said th at it adopted a "pick-and-choose" approach. 
Several provisions of the Decision had been eliminat ed, and others redrafted.  His delegation did not 
share this approach and consider ed that the WTO Decision was the result of a delicate balance that 
was difficult to strike.  The integrity of the De cision should, therefore, be preserved.  He then 
summarized the most problematic points of the African proposal.   
126. As regards product coverage in paragraph 1(a) of the Decision, the words "among others" had 
been added in the definition.  This would broaden the scope in an unacceptable manner.  The terms 
"products (…) of the pharmaceutical sector" used in the Decision would, for example, be broad 
enough to encompass vaccines, even though they were not  expressly included in the definition.  With 
respect to notification and transparency requirement s in paragraph 2 of the Decision, most provisions 
had been removed, including the requirement that the importing country must notify the name and 
expected quantities of the product needed, the conf irmation that the importing country had established 
a lack of domestic manufacturing capacity and detailed notification requirements applying to 
manufacturing companies and exporting countries. Those provisions were important and should be 
restored.   
127. Paragraph 3 of the Decision on remuneration had been substan tially changed, proposing that 
the remuneration should be paid in the importin g Member instead of the exporting Member as 
stipulated by the Decision.  Anti-trade diversi on measures by importing and exporting Members in 
paragraphs 4 and 5 of the Decision had been me rged in the African Group proposal, resulting in a 
weakening of the obligation on importing Members.   Maintaining the carefully drafted anti-trade 
diversion measures was a fundamental element to en sure that the system worked effectively and 
importing countries took their part of the responsibility, within reason, to prevent trade diversion.   
128. He noted that two important elements had b een removed in the African Group proposal as 
regards regional cooperation addressed in paragraph 6 of the Decision, namely the reference to the 
principle of territoriality of patent rights and to the establishment of regional patents.  It was not 
acceptable for his delegation to eliminate a fundamental  aspect of international patent law, such as the 
principle of territoriality.  As regards transfer of technology in paragraph 7 of the Decision, the 
proposed draft would completely change the origin al purpose.  Instead of overcoming the problem 
identified in paragraph 6 of the Doha Declarati on, the objective would now be to help importing 
Members establish their own manufacturing capaciti es in the pharmaceutical sector.  Finally, the 
requirement in paragraph 8 of th e Decision to conduct an annual re view of the functioning of the 
system had been completely removed.  These fe w examples showed that the African proposal 
contained substantive changes which were not accep table for his delegation since they would re-open 
the whole discussion on the Decision. 
129. As regards the communication from Rwanda on behalf of the African Group on legal 
arguments to support the African Group proposal, he  noted that his delegation could agree with 
several aspects raised therein.  For example, the footnote approach was not the most appropriate way 
to implement paragraph 11 of the Decision.  A footnote was acceptable only if its wording clearly set 
out a legal exception to Article 31(f).  An ame ndment of the TRIPS Agreement inserting textual 
changes in the body of the Agreement was preferable.  His delegation also agreed that the legal status 
of the Chairman's Statement should not be upgrad ed. However, the link between the Decision and the 
Statement should be preserved.  The suggestion by the African Group to read some form of the Chairman's Statement at the time of the adoption of the amendment could be considered, alongside 
other options.  His delegation was, however, not c onvinced by the justifications put forward by the 
African Group for the modifications to the Decisi on.  The amendment process should remain a purely 
technical exercise without any re-opening of the di scussion on substance.  The interpretation made by 
the African Group of the terms "based on the Decision,  where appropriate" contained in paragraph 11 
of the Decision was much too broad.  These terms could not be understood as meaning re-discussing 
every provision of the Decision. IP/C/M/47 
Page 26  
 
 130. As regards the report on the Geneva Workshop on the WTO Decision on Access to Medicines 
in October 2004, submitted by the delegation of Ba rbados on behalf of the Group of Commonwealth 
Developing Countries, he said that the outcome was ve ry useful, in particular for countries in the 
process of implementing the Decision.  An important issue had emerged from the discussion, i.e. the necessity to ensure that products supplied to count ries in need would meet the required quality and 
efficacy standards.  In most cases, the countries of  destination would not have the required regulatory 
or scientific capacities to carry out the necessary t esting of the pharmaceutical products manufactured 
under a compulsory licence.  Therefore, the license e could be asked by importing countries to prove 
the safety and efficacy of the products.  He confirme d that this concern had been taken into account in 
the draft EC legislation implementing the Decision.  To ensure that patients from countries in need 
benefited from the same level of safety, quality an d efficacy as European patients, the competent 
authorities in the EC would be entitled to deliver  a scientific opinion for medicinal products for 
supply outside the European market. 
131. The representative of Kenya
, referring to the issue of remuneration in paragraph 2(b) of the 
African Group proposal raised by the European Communities, said that the present drafting should be 
corrected so as to clarify that, where use was made  of the system by an eligible importing Member, 
adequate remuneration should be paid by the exporting Member, and not the importing Member. 
132. The representative of Korea  said that his delegation remained committed to reaching an 
agreement on the amendment by the March 2005 deadlin e.  The Decision was the result of difficult 
and long negotiations and reflected a delicate balan ce of interests among all Members.  Therefore, 
from the very start of the discussion on an amendment,   his delegation had supported the view that the 
amendment should remain a technical exercise and th at the substance of the Decision should not be 
re-opened.  The African Group proposal modified  the Decision by eliminating some provisions and 
re-drafting the wording of a few other provisions.  While it would be sensible to eliminate those 
provisions whose purpose had already been served, such as the Preamble and paragraph 11 of the 
Decision, he, however, was not convinced that the elimination or modification of other provisions 
would be necessary or justified.  For example, the African Group proposal introduced significant 
changes to paragraph 2, including the attached An nex, and paragraph 4, which set out important 
requirements for importing and exporting Members to ensure that the system worked as intended and 
prevented illegitimate product diversi on.  He did not believe that the existing provisions of the TRIPS 
Agreement provided a safeguard mechanism of simi lar effect as claimed by the African Group.   
133. He noted that the African Group proposal wa s based on an appropriateness test looking at 
whether a particular provision was necessary for the proper functioning of the amendment.  This 
approach posed a number of difficulties in applicati on.  In view of the difficulties Members had had in 
the course of reaching agreement on the Decision, and the problems raised by the African Group proposal, a more pragmatic approach could be to look at whether keeping certain provisions of the Decision would hamper the proper operation of th e amendment.  His delegation believed that the 
majority of the provisions in the Decision would not do so.  The African Group proposal itself had not 
stated that the provisions proposed for modificat ion or elimination would negatively affect the 
operation of the amendment.  It had merely claime d that those provisions were either redundant or 
covered by existing provisions of the TRIPS Agre ement.  Maintaining redundant provisions would be 
preferable to changing the substance of the Decision and the risk of not reaching an agreement within 
the timeframe.   
134. As regards the form of the amendment, his de legation could be flexible provided that the 
entirety of the substance of the Decision was preserve d.  The most straightforward and direct solution 
was to put the amendment text in the main body of the Agreement.  IP/C/M/47 
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 135. He agreed that the Chairman's Statement was an integral part of the solution that had led to 
the adoption of the Decision.  As explicitly stat ed therein, it represented several key shared 
understandings of Members regarding the Decision, its implementation and interpretation.  When 
amending the TRIPS Agreement, it would be necessary to ensure that the content of the Chairman's 
Statement remained valid.  He agr eed with the African Group that the legal status of the Statement 
should not be changed, in particular as regard s the voluntary opt-out commitments made by some 
Members, including Korea, on 30 August 2003.  The voluntary nature of those commitments would have to be preserved.  He, therefore, welcomed th e suggestion of the African Group which considered 
having some form of a Chairman's Statement read at the time of the adoption of the amendment.  This 
would offer a good solution preserving the content of the Chairman's Statement without changing its 
legal status.   
136. The representative of Canada
 agreed with those previous speakers that had said that the 
amendment process should be a technical exerci se reflecting the agreement WTO Members had 
reached in August 2003 and confirmed that his dele gation did not see the benefit of re-opening and re-
negotiating substantive issues.  While recognizing th e African Group's view that some provisions of 
the waiver system were not necessary, he noted th at those same provisions, including the Chairman's 
Statement, had been of great impor tance to other WTO Members.  Their inclusion in the system had 
been a key element in the consensus and conclu sion of those difficult and complex negotiations. 
137. Turning to the report on the Workshop on the WTO Decision on Access to Medicines 
presented by Nigeria, he said he believed that it co ntained some important information.  According to 
this report, "evidence had confirmed that the pri ces of certain patented products had fallen compared 
to the price levels prior to the period when negotiations for adoption of the WTO Decision had 
commenced.  In a few cases, the prices had fallen to n early one tenth of the prices charged previously.  
Moreover, the information in the case studies had hi ghlighted a greater willingness of patent holding 
companies to grant voluntary licences to domestic firm s for production of generic versions of patented 
products".  This had been the purpose of the Decisi on.  While recognizing that much more work had 
to be done and progress to be made, he said that th is indicated that the system established under the 
Decision worked and could be useful to address the public health concerns of developing countries.  
Taking into account that all delegations agreed on th e urgent need for the WTO Membership to act on 
the problems some developing countries faced in using Article 31 of the TRIPS Agreement, his 
delegation encouraged all potential exporters and im porters to implement and use the waiver system 
to address the public health needs of developing countries. 
138. The representative of Jamaica  wished to emphasize one specific aspect resulting from the 
Workshop on WTO Decision on Access to Medicin es, namely the issue of quality, safety and 
effectiveness in the use of products produced un der compulsory licences.  Her delegation had been 
particularly concerned about an assessment carried out by the WHO showing that between 50 to 90 
per cent of samples of anti-malarial drugs failed the quality control test and that more than half of the 
anti-retroviral drugs did not meet international standa rds.  She welcomed steps taken by countries, in 
particular exporting countries, to amend their legi slation to ensure that pharmaceutical products 
manufactured under compulsory licences for export met the standards of the respective drug regulatory authorities.  Countries with insufficien t manufacturing capacities in this area relied on 
expertise of regulatory authorities in developed coun tries.  She also noted the existence of a WHO 
scheme for pre-qualification for manuf actured products, which could be l ooked into in order to ensure 
the quality of products for export. 
139. Turning to the Decision, she said that her dele gation could support some of the views outlined 
in the African Group proposal regarding the legal fo rm of the amendment.  A substantive amendment 
to the text of the Agreement would be preferable  to a footnote for the reasons set out in document 
IP/C/W/440 introduced by Nigeria.  The Chairman's Statement should not be included.  It had been IP/C/M/47 
Page 28  
 
 intended as a confidence building mechanism to reach  an agreement on the Decision in 2003 and had 
served its purpose.  
140. The representative of Argentina
 considered the African Group proposal as a substantive and 
positive contribution which could help to conclude work on the amendment to the TRIPS Agreement 
within the set timeframe.  Nothin g in paragraph 11 of the Decision required a transposition without 
changes.  It merely asked for the amendment to be  based on the appropriate parts of the Decision.  
This had been part of the balance struck in 2003.  Her delegation concurred with the comments 
contained in paragraph 10 of document IP/C/W/440 submitted by the African Group.  The Decision 
requested additional and excessive information.  In  particular, the limitations in paragraph 2(b)(i) 
could prevent industry from supplying pharmaceutical products under the system.  Paragraph 2(b) 
imposed stricter requirements than for trade of w eapons or toxic products and would not be in line 
with usual commercial practice.  Paragraph 2(c) created an add itional obligation, modifying the 
practice in implementing the Agreement.  In addi tion, the establishment of regional patent systems 
had nothing to do with the Doha Declaration.   
141. She said that the Chairman's Statement should not be part of the amendment.  It had been a 
unilateral statement which had not received general endorsement.  Turning to the legal form of the 
amendment, she said that using a footnote was ne ither the right approach nor provided a safe legal 
basis for the straightforward interpretation of Artic le 31 of the TRIPS Agreement.  Members needed 
clarity in carrying out activities which were not perm itted at present.  In the absence of any precedent 
regarding such amendments, it was not advi sable to rely on the footnote approach. 
142. The representative of Japan  said that the amendment should remain a technical exercise, 
implementing what had been agreed into the TRIPS Agreement without interpreting it.  As regards the 
legal form of the amendment, his delegation pref erred a footnote referring to the Decision and the 
Chairman's Statement in order to amend the TRI PS Agreement.  Since both texts had been agreed 
upon, they should not be separated.  A footnote would be the simplest and most  secure way to reflect 
the Decision in the TRIPS Agreement and would avoi d re-negotiating substantive issues.  Other forms 
of amending the TRIPS Agreement could lead to re-opening the discussion.  
143. He said that his delegation had difficulties with the African Group proposal in document 
IP/C/W/437.  First, it had omitted some paragraphs of  the Decision, such as paragraphs 2(b)(i) and 4.  
Second, parts of the Decision had not been adequately  reflected or incorporated in the proposal.  The 
proposal did not refer to the Chairman's Statemen t.  The legal arguments submitted in document 
IP/C/W/440 to support the African Group proposal further highlighted the discrepancy between the 
proposal and the Decision.  This illustrated how difficult the amendment of the TRIPS Agreement 
would become if the footnote approach were not used. 
144. The representative of Uganda , associating himself with documents IP/C/W/440 and 439, said 
that the Decision was an important step toward s ensuring that countries with no or insufficient 
manufacturing capacities had access to pharmaceutical pr oducts at affordable prices required for the 
treatment of diseases that were prevalent in their te rritories.  Uganda had been looking forward to a 
stable and predictable mechanism for the strengthe ning of the Decision and ha d hoped that this would 
enable countries faced with emergencies to purchase the needed products from cheaper sources.  This 
would guarantee access to drugs for HIV, malari a and other epidemics at affordable prices, 
particularly for the poor sections of the world community. 
145. He said that Uganda supported the statement made  by Nigeria on behalf of the Geneva Group 
of Commonwealth developing countries in respect of the findings and the conclusions of the 
Workshop on the WTO Decision on Access to Medici nes.  The strength of the Decision should not be 
watered down through regional trad e agreements that promote the interests of the pharmaceutical 
industry at the expense of access to drugs in developing countries.  In relation to this, he requested the  IP/C/M/47 
 Page 29 
 
 
 US delegation to clarify the statement that had been made at the Workshop by a US delegate that the 
free trade agreements that the United States had en tered into with some developing countries "would 
not stand in the way of" or affect the utilizati on of the TRIPS health solution reached on 30 August 
2003 to ensure that developing countries that lack manufacturing capacity may import medicines. 
146. Uganda welcomed the recommendation made at the Workshop that a regional patent system 
be developed to promote the development of the production and trade in pha rmaceutical products on a 
regional basis, and proposed that a regional workshop  be held to explore the implementation of this 
recommendation. 
147. The representative of Israel  welcomed the three new submis sions and hoped that agreement 
on the amendment could be reached by the end of March.  While underlining the importance of the 
amendment, he recalled that a system already exis ted that enabled those in need to receive the 
required medicine.  However, work had to continue to find a solution that would fit the needs of all Members.  Referring to the comments made by a nu mber of Members that the amendment should not 
change the substance of the Decision, he said th at, while Israel accepted that the Decision and the 
Chairman's Statement formed a pack age solution, the voluntary nature of Israel's opting out of using 
the system as an importing Member in certain circ umstances was a matter of substance.  Therefore, 
making the entirety of the Chairman's Statement pa rt of the amendment would change the substance 
of the Decision.  While Israel remained flexib le on whether the amendment would appear as a 
footnote or in the text of the agreement, it had to  insist that no changes should affect the manner in 
which Members had voluntarily opted out of using the system. 
148. The representative of Turkey
 said that he was committed to finding a solution within the 
deadline.  He favoured a technical amendment that w ould transpose the Decision into the body of the 
TRIPS Agreement, although he could also go along with an outcome which would satisfy the needs of 
the Decision's target group, namely the African Group, or developing countries and LDCs.  Turkey 
was still unsure about the legal appropriateness of  the footnote approach, although it remained 
flexible.  A substantive amendment to an intern ational agreement, such as the TRIPS Agreement, 
should be made through a textual change in the body of the Agreement.  The Decision and the 
Chairman's Statement reflected a precarious balanc e which had been reached after long and difficult 
negotiations.  The future amendment should not alter the rights and obligations of Members, 
particularly the legal status of the Chairman's St atement.  It reflected the voluntary nature of the 
choice by some Members, including Turkey, to opt out of using the system as an importer in certain circumstances, and its status should not be elevat ed.  Therefore, Turkey agreed with the African 
Group proposal that the Chairman's Statement be re-r ead in some form at the time of the adoption of 
the amendment. 
149. The representative of Chinese Taipei
 said that the amendment should remain essentially 
technical and neutral in nature and clearly translate into the text of the TRIPS Agreement exactly what 
had been decided, without any risk of alterna tive interpretations.  He noted that, in its new 
submission, the African Group had explained that para graphs 2(a)(i) and 2(b)(iii) of the Decision were 
redundant because the patent owner had to be info rmed under Article 31(b) of the Agreement.  
However, he believed that these paragraphs served important transparency purposes and should not be 
eliminated. Any voluntary undertaking expressed in the Chairman's Statement should remain 
voluntary in nature and, therefore, he would not s upport any suggestions that would lead to changing 
its legal status.  In addition, he recalled that the Chairman of the General Council had stated at the 
meeting of 30 August 2003 that "thi s statement is limited in its imp lications to paragraph 6 of the 
Doha Declaration on the TRIPS Agreement and public health". 
150. The representative of Hong Kong, China  said that the three new submissions were helpful in 
the search for a solution before the end-March d eadline.  In order to meet that deadline, the 
amendment exercise should be a technical one, and Members should avoid renegotiating the IP/C/M/47 
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 substantive provisions reflecting the delicate balance that had been reached in the Decision.  While 
remaining open-minded as to the form of the ame ndment, he shared the concern expressed by the 
African Group and some other Members about the legal certainty of the footnote approach and believed that a substantive textual amendment to th e TRIPS Agreement would be a preferable option.  
His delegation shared the view expressed by th e delegations of Korea, Israel, Turkey and 
Chinese Taipei that the legal status of the Chairman's Statement should not be changed and that the 
voluntary nature of the partial opt-out by some  Members should be preserved and should not be 
turned into an obligation. 
151. The representative of Switzerland
 said that he was committed to concluding the work on the 
amendment by the end of March.  It was essential that any outcome would reflect the entirety of the 
substance of the consensus and the solution that had been found by the Membership on 
30 August 2003.  Only a purely technical amendment could faithfully translate this consensus, which 
had been achieved only after very  long and difficult negotiations and which represented a delicate 
balance of interests of Members.   
152. The communication by the African Group suggested the elimination of a number of 
provisions of the Decision on the grounds that th ey were considered redundant. Various substantive 
parts and provisions had not been included in the draft amendment and others had been shortened, 
reworded or simply deleted.  In consequence, the proposal by the African Group would change the 
substantive contents of the consensus that ha d been reached among Members in an unacceptable 
manner.  This pick and choose approach would r esult in re-opening the negotiations.  The Decision 
that had been the basis of  the consensus reached on 30 August 2003 was an integral whole and it was, 
therefore, not possible to cut out or re-phrase whole paragraphs.  
153. A number of Members, including Switzerland, we re presently revising their national laws in 
order to quickly and faithfully implement the pa ragraph 6 solution as adopted by the WTO General 
Council.  Any re-opening of the consensus found by the General Council would seriously undermine 
these national revision processes and would endanger – if not prevent – a transparent and uniform use 
of compulsory licences for the export of pharmaceuticals under the terms and conditions of the 
paragraph 6 mechanism.  Any re-opening of th e delicate balance found on 30 August 2003 would 
have grave consequences for Members needing to address a serious public health problem who could 
benefit from the currently ongoing national revisions  to implement the possibility of compulsory 
licences for the purpose of exporting needed  pharmaceuticals to such countries.  
154. What remained to be done by the Council w as to find a way to technically transpose the 
30 August 2003 solution into the TRIPS Agreement in the most expeditious and efficient manner.  For 
the reasons of legal security, expeditiousness a nd efficiency, Switzerland had proposed the footnote 
approach as a practical and straightforward solutio n. By means of a reference in a footnote to 
Articles 31 (f) and (h), the five-page text of the De cision could be incorporated as an Annex into the 
Agreement without upsetting its structure or co mpromising its readability or comprehensibility.  
155. The Chairman's Statement was part of the c onsensus found on 30 August 2003 and, therefore, 
an integral part of the paragraph 6 solution.  Everybody was aware that there would not have been any solution without the Statement. Thus, it needed to be  reflected adequately in the amendment.  This 
could be done in the form of a reference to th e minutes of the General Council meeting of 30 August 
2003 in the footnote to Article 31(f) and (h) of the Ag reement.  In that way, the legal status of the 
Decision and the Chairman's Statement would not be ch anged.  He suggested that the Chairman of the 
TRIPS Council or his successor should continue informal consultations with the support of the 
Secretariat in small group constellations so that  he could come forward as soon as possible with a 
draft text on how best to technically integrate the consensus of 30 August 2003 as a whole in the TRIPS Agreement.   IP/C/M/47 
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 156. The representative of the United States , in response to the question from Uganda, confirmed 
that the provisions in US free trade agreements did not stand in the way of the effective utilization of 
the TRIPS/health solution reached in August 2003, to  ensure that developing countries that lacked 
pharmaceutical manufacturing capacity may import medicines.  In the context of US free trade agreements with developing countries, such as CA FTA, Morocco and Bahrain, the United States had 
expressly agreed with these trading partners that not hing in the intellectual property chapter affected 
their ability to take measures neces sary to protect public health.  Specifically, the United States had 
confirmed with its FTA partners  the understanding that the intellectual property chapter did not 
"affect the ability of either Party to take the n ecessary measures to protect public health by promoting 
access to medicines for all, in particular concer ning cases such as HIV/AIDS, tuberculosis, malaria, 
and other epidemics as well as circumstances of extreme urgency or national emergency".  The United 
States had also expressly agreed in the context of these free trade agreements that the IPR provisions 
would not prevent effective utilization of th e 30 August 2003 WTO consensus solution allowing 
developing countries that lacked pharmaceutical  manufacturing capacity to import drugs under 
compulsory licences.  In this light, the United Stat es' FTAs with developing countries did not prevent 
a country from taking the necessary measures to protect  public health, or prevent effective utilization 
of the 30 August 2003 solution.  
157. The representative of Brazil
 welcomed the proposals put forth during the present session, 
especially the African proposal which was an interest ing and positive contribution to the task that the 
Council had been mandated to carry out by the Deci sion.  The issue at hand was essential to Brazil 
and had very broad social and humanitarian conse quences.  While understanding certain delegations' 
concerns with regard to the qua lity of drugs, he said that the primary concern was the access to 
pharmaceutical products, in terms of affordability and availability in the required quantities, that were 
essential to ensure public health in developing coun tries.  The issue of quality was an issue of a 
different nature which could be dealt with under other available frameworks. 
158. The amendment to the TRIPS Agreement had been  mandated in the Decision, and there was a 
clear difference between the legal status of the Decision and the Chairman's Statement.  For his 
delegation the exercise at hand was to transpose the substance of the Decision into the TRIPS 
Agreement.  The African proposal, being the only one on the table so far, was a good basis for the 
Council's work and compatible with what was stated in paragraph 11 of the Decision, namely that the 
amendment would be based, where appropriate, on the Decision.  The amendment should not be made through a footnote as this would not bring about the pr edictability, the legal status and the weight that 
this subject of utmost importance should have.  Th e amendment should transpose the elements of the 
Decision, which was self-contained and expressed the consensus among Members.  The Chairman's Statement should not be included in any amendment to the Agreement. 
159. The representative of India
 said that there was only one textual contribution on the table, 
which he welcomed as a good basis for further discussions with the view to completing the 
amendment exercise by the end of the month.  He agreed with those many delegations who had 
previously said that this should be a technical exerci se and that the technical work should be based on 
paragraph 11 of the Decision.  His delegation was prepar ed to work in any format in order to arrive at 
the solution by the end of the month.   
160. The representative of Kenya  expressed his hope that the exer cise could be completed by the 
end of March 2005.  He said that Members had frequently been reminded to preserve the minimum 
standards contained in the TRIPS Agreement.  The same should apply when incorporating the 
solution into the Agreement, namely that the mini mum standards that all Members were committed to 
should be retained.  It was for this reason that the African Group had left out some parts of the 
Decision that were redundant or repe titive.  He said that he had not heard a complete rejection of the 
African Group proposal by anybody, and expr essed his surprise at the European Communities' 
suggestion that the Chairman prepare a text to serve  as a basis for discussion.  Given that the African IP/C/M/47 
Page 32  
 
 Group proposal was the only one on the table, he would have instead expected the European 
Communities to submit a position paper, as the Un ited States had done, and then discuss how some of 
the issues raised could be incorporated into the African Group proposal.   
161. He said that there was agreement between Members that the mandate of paragraph 11 clearly 
provided that the amendment would be based "whe re appropriate, on the Decision", and not on the 
Decision and the Chairman's Statement.  The Afri can Group proposal fulfilled that mandate as it was 
based on the Decision.  Regarding the comments on the technical nature of the exercise, he said that 
the African Group had indeed carried out technical work.  The approach had been to look at the 
Decision and at the TRIPS Agreement, maintain the minimum standards and incorporate what the 
Group had thought was appropriate to accommodate the Decision.   
162. He said that Nigeria had already answered ma ny of the questions raised regarding certain 
specific paragraphs.  The issue of whether the Prea mble of the Decision was still needed had already 
been discussed at the last Council meeting.  In his view, there was no need to be repetitive and include 
sub-paragraphs 1(b) and (c).  Similarly, the issu es addressed in sub-paragraphs 2(a)(i) and (ii) and 
2(b)(i) were already covered in the existing provisi ons of Article 31 of the Agreement, and, hence, 
there was no need to be repetitive.  The same was true of many other provisions, including the one 
dealing with annual reviews, which would become superfluous once the waiver had been turned into 
Article 31 bis.  Neither was there any need to mention the i ssue of regional patent systems;  this advice 
contained in the Decision did not need to become pa rt of the Agreement.  Also, the reaffirmation of 
rights and obligations of Members under paragraph 9 did not need to be repeated as these were 
already in the Agreement.   
163. Accordingly, the amendment should be a technical  exercise that would incorporate what was 
appropriate, not what was inappropriate.  If the Decision was to remain as it was today, it could remain unchanged.  However, if there was to be a permanent solution in the Ag reement, then some of 
the provisions contained in the Decision would have  to disappear in order to maintain the minimum 
standards that all Members were committed to and to make sure that there was no repetition. 
164. The Chairman's Statement was not referred to in the African Group's draft, because it was not 
mentioned in the mandate of paragraph 11 of the D ecision.  However, he was not opposed to having 
another statement read out by the Chairman providing some clarifications, but it should not be part of 
the permanent solution.  Regarding the footnote appr oach proposed by the Unit ed States, he said that 
the African Group did not regard this as an appropriate way to amend a text and quoted the following passage from a book:  "Many writers have argued that the biggest interruption to the reader's train of 
thought is a footnote.  Burying an argument in a footnote and expecting a reader to excavate it is 
simply inexcusable.  If the material in the footnote is relevant or germane to the point one is making, 
the correct place for it is in the main text".  The African Group paper had quoted the most modern 
English dictionaries in which a footnote was describ ed as providing additional information which was 
not very important.   In contrast, the issue at ha nd was not merely additional information, but crucial 
and important to those Members facing this problem  and in need of this permanent solution.   
165. Regarding the mention in the Chairman's Statement that the solution should not be used for 
commercial or industrial purposes, he said that, ev en before the solution had been finalized, the 
question had been raised how the addressees of th e Decision were then to establish capacity.  
Members with capacity could rely on Article 31 as it was, but those who lacked capacity needed this 
solution;  the amendment should be seen from this a ngle.  Members which were either suppliers or 
consumers both needed to benefit from the so lution.  The African Group proposal made some 
progress in this direction while taking into considera tion all the concerns that had been raised.  He 
urged Members to read the proposal over again and see the points which the African Group was trying to raise, even if some of the language used might not  have been very clear.  It would become apparent 
that there was no inconsistency between the Decision and the proposed amendment.  IP/C/M/47 
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 166. He said that only such elements that were alr eady in the Agreement had been left out.  It was 
in the nature of any amendment that only new elements would be brought in, as duplication did not add any value.  Those Members that were concerne d with matters that had been left out would find 
that all elements were captured in the Agreement,  which was a minimum standards agreement.  These 
minimum standards should not be raised but retained at the level that all Members had agreed to.   
167. Regarding further work, he said that one option would be to stop the clock and continue 
consultations to see how far one could a dvance by the end of the month.   
168. The Chairman
 said that his impression of the discussion was that there had been no new 
suggestions regarding the way forward.  For exam ple, no one had supported the EC proposal that the 
Chair should work on a neutral draft.  However, as he sensed a willingness to continue to work on the 
issue, he suggested that he suspend the meeting and thus allow for the possibility of reconvening it 
before the end of March to deal with any poten tial agreement that might come out of continued 
informal process. 
169. The representative of the Philippines  said that he had no objections to the way forward 
suggested by the Chair and that ther e was a need to engage in furthe r consultations in whatever shape 
or form and to intensify the discussions for the purposes of trying to meet the deadline which had 
been set for March 2005.  He noted that a number  of interventions had focused on the so-called 
technical exercise and that a particular delegation ha d been implying that, rather than adhering to the 
technical exercise, some Members were in fact attempting, through this amendment process, to 
retrieve what they had not been able to gain in  the waiver decision negotiations.  However, many 
Members, and in particular his delegation, had vi ewed the negotiations leading up to the adoption of 
the waiver decision as part of a broader humanitarian context.  He said that many Members had in fact 
been compelled to agree to the terms of the D ecision in August 2003 because of this humanitarian 
element and the need to have something urgently agreed upon by Members, notwithstanding the fact 
that there had still been some very legitimate conc erns arising from certain provisions of the draft 
Decision.  There had been a recognition, that could clearly be seen in the records of the TRIPS 
Council meeting at which the decision to endorse the draft Decision to the General Council had been 
made, that Members had agreed to the Decision in th e context of this humanitarian concern.  Against 
this background, he believed that it would be inacc urate to characterize some Members' efforts to 
rectify certain elements which had not been fully agreeable at the time the Decision was adopted as 
being an attempt to gain back what they had fa iled to obtain in those waiver decision negotiations. 
170. He welcomed the African Group proposal as a very good basis for proceeding with 
discussions on a possible amendment and found it difficult to appreciate the comments made by 
certain delegations that the proposed text was not justified because it unravelled the substance of the 
Decision.  Following a paragraph by paragraph assessment of the Decision, it was clear that there was a good basis for the suggestions that the African Gr oup had made.  For instance, most if not all the 
elements mentioned in paragraph 10 of document IP/C/W/440 had been correctly characterized as 
self-eliminating elements.  It was clear that the Pr eamble would not need to be reflected in an 
amendment and the same was true for paragraphs 6( ii) and 8 of the Decision, for the very reasons 
cited in the African Group proposal.  He noted that th e reference in the tiret of IP/C/W/440 that dealt 
with paragraph 8 should have been to Article IX:4 of the WTO Agreement, rather than Article X:4.  
The reference to Article IX in the Decision had been in direct relation to the review requirement for a 
waiver.  Once an amendment had been made into th e text of the TRIPS Agreement, Article IX would 
no longer be relevant but Article 71 of the TRIPS Agreement would be the more relevant provision.  
Similarly, paragraph 11 of the Decision would no longer be necessary once an amendment was in place.  The treatment of paragraph 9 of the Decision might need careful review.  The context in which 
that paragraph had been agreed in August 2003 had been that the waiver decision was not intended to 
preclude importing countries or trading partners  from availing themselves of other flexibilities IP/C/M/47 
Page 34  
 
 existing in the TRIPS Agreement in order to enab le the issuance of compulsory licences.  To his 
knowledge, one or two Members had already a ttempted to do that in practice.   
171. Regarding paragraph 11 of IP/C/W/440, he sai d that most of his delegation's points had 
already been captured in the justification contai ned in the various tirets and in the explanatory 
interventions made by other Members, including Ar gentina, Kenya and Nigeria. With regard to the 
last tiret of paragraph 11 of that document con cerning paragraph 4 of the Decision relating to re-
exportation and the important notion of trade di version, he reiterate d his understanding that 
paragraph 4 of the Decision was a "best endeavour " undertaking on the part of eligible importing 
countries.  He was concerned that an amendment might not necessarily capture this best endeavour 
language and, in this context, welcomed the propo sed change in the language on trade diversion that 
had been suggested by the African Group.  This w as of particular relevance, as in a preliminary 
review of the legislation put in place by potentia l exporting countries so far, his delegation had had 
the impression that if a country had failed to adopt  the measures referred to in paragraph 4 of the 
Decision, such countries might in fact be rem oved from eligibility as a potential eligible importing 
country insofar as that particular exporting count ry was concerned.  Although his delegation had 
noted that this applied essentially to non-WTO Members, it was nonetheless a cause for concern that 
something which was essentially a best endeavour obligation had now been made a ground for non-
eligibility or disqualification from using the paragr aph 6 solution insofar as the legislation of a 
particular country was concerned.  He emphasized that this was just a preliminary observation on the 
basis of a continuing review of this legislation. 
172. He said that paragraph 11 of the Decision pr ovided that the amendment would be based where 
appropriate on that Decision, and not on the Decisi on and the Chairman's Statement.  Nor did it say 
that such an amendment would be based, where appropriate, on this "solution".  There was no 
reference in any of the documents  from the preparatory work or subsequent to the adoption of the 
Decision that explicitly referred to the Decision and the Chairman's Statement as part of a concrete 
solution.  In that sense, he disagreed with the continuous references to the 30 August solution as 
necessarily including both the Decision and the Chairman's Statement.   
173. Even the explanation in sentence 3 of paragraph 12 of the United States' paper IP/C/W/444 
said that the Statement had made a consensus solu tion possible by addressing and resolving questions 
concerning aspects of the Decision that had been unclear or had not been addressed.  If one was applying the rules of interpretation under the Vienna  Convention, then this sentence clearly indicated 
that, at the very most, the Chairman's Statemen t provided a merely interpretative context or a 
supplementary means of interpretation in relation to the Decision, precisely because of the way that 
this sentence in the submission was couched.  Furt her applying the rules of interpretation, one could 
make the argument that his delegation did not see and had not been pointed to any particular provision 
which was unclear in the treaty or in this 30 August Decision.  Therefore, if there was nothing unclear 
in the Decision, then it should be examined within  the four corners of that Decision itself and no 
recourse should be sought to any other context or  interpretative context such as the Chairman's 
Statement. 
174. In this respect, he said that he doubted the legal status which was sought to be attributed to the 
Chairman's Statement and was of the view that any amendment to the TRIPS Agreement necessarily 
had to exclude the Chairman's Statement as part of  the text.  Notwithstanding that, his delegation was 
open to examining the proposal made by the African Group of having the Chairman's Statement read 
at the time of the adoption of the amendment on c ondition that all Members could likewise read out 
their own statements, setting forth their unders tanding or interpretation of the amendment. 
175. The representative of Switzerland
 said that his delegation was aware of the details and the 
background which had been underlying the negotiations  and ultimately led to the Decision.  Against 
this background and for the sake of a quick impl ementation of the consensus of 30 August, his  IP/C/M/47 
 Page 35 
 
 
 delegation was hesitant to follow an exercise in wh ich the Decision would be examined paragraph by 
paragraph in order to discuss Members' percepti ons on what was and what was not appropriate and 
what should ultimately be part of the TRIPS Agreem ent.  Such an exercise would risk opening the 
Pandora's box of restarting the negotiations.  If Memb ers were serious in fulfilling their mandate in 
time, he saw that the only workable way forward wa s to focus on the technical possibilities of how to 
integrate the Decision as a whole into the Agreemen t.  In other words, the discussions should concern 
whether this should be done by way of a footnote, by way of a new Article in the TRIPS Agreement, 
by way of amending Article 31 or by way of an Anne x, or by any other formal way.  However, one 
should avoid discussing any details of the Decision. 
176. He noted that different opinions had been voiced  regarding the Chairman's Statement.  He 
recalled that the introduction to the note from the Ch airman of the TRIPS Council containing the draft 
statement (JOB(03)/177) read:  "I have been worki ng on the text of a Statement to be made by the 
Chairman of the General Council that would enable  all Members to join the consensus on adopting 
the draft Decision ...".  This showed that, without this Chairman's Statement, not all Members could 
have joined the consensus on adopting the draft Deci sion.  Line four of the second paragraph of that 
note read as follows:  "Before adopting this Deci sion, I would like to place on the record this 
Statement which represents several key shared unde rstandings of Members regarding the Decision to 
be taken and the way in which it will be interprete d and implemented".  The goal of the Chairman's 
Statement was to give guidance to Members on how  to interpret and implement the Decision, and 
ignoring it now would not be acceptable for his delegation. 
177. The representative of Malaysia  said that in view of the different opinions of Members there 
was a need for further consultation and that an in formal session to examine in a substantive manner 
the provisions of the African Group proposal would be useful.  She welcomed the new communication IP/C/W/440 as having provided gr eater clarity to the proposal in document 
IP/C/W/437 for an amendment to the TRIPS Agr eement.  The mandate unde r paragraph 11 provided 
that the amendment should be based where appr opriate on the Decision and the African Group 
proposal was based on this premise.  Regarding th e form of the amendment, her delegation agreed 
with the arguments in the African Group proposal ag ainst a footnote and supported an amendment of 
the text of the Agreement.  Regarding modifications  to the Decision, she noted that provisions that no 
longer served their original purpose in the context of the amendment should be discussed further.   
178. Regarding the Chairman's Statement, her delega tion was opposed to upgrading the legal status 
of the statement that accompanied the Decision by inco rporating it as part of an amendment.  It also 
opposed having a Chairman's Statement read as part of the adoption of any amendment, because such 
an amendment was already a substantive change to  the TRIPS Agreement and there was no need for a 
Chairman's Statement to reinterpret that amendmen t. This would only add fu rther legal uncertainties 
to an amendment. 
179. The representative of the United States
 agreed with Switzerland that a paragraph by paragraph 
approach would re-open individual issues, which would be contrary to the current objective of 
preserving the entire consensus reflected in the Decisi on and the Chairman's Statement.  He said that 
his delegation was willing to participate in whatev er consultations the Chair deemed appropriate. 
180. Noting the positions of Switzerland and the Un ited States regarding the paragraph by 
paragraph approach, the representative of Kenya  suggested that they propose an alternative way of 
establishing which paragraphs were appropriate and which were not, as paragraph 11 clearly said 
"where appropriate" and that c ould not be ignored.  Commenting on Switzerland's statement on the 
background of the negotiations, he said that Memb ers had been prevailed upon to accept the statement 
and that the explanation that had been given at th at time was not the same as was being given today. IP/C/M/47 
Page 36  
 
 181. The Council agreed
 to suspend the meeting, with the possibility that it be reconvened if 
necessary, so as to allow for continued consultati ons with a view to meeting the March 2005 target 
date. 
182. Reconvening the meeting on 31 March, the Chairman  referred to the further consultations he 
had held to see whether progress could be made  towards a TRIPS Council recommendation to the 
General Council by the end of March on an amen dment to the TRIPS Agreement to replace the 
provisions of the paragraph 6 Deci sion.  These consultations had show ed a continuing divergence of 
views among delegations on some key issues, especia lly relating to the content of the amendment.  
Since then, he had been contacted by some dele gations and, in the light of their request, had 
reconvened the suspended formal meeting of the Council in order to provide an opportunity for 
delegations to make statements  on TRIPS and public health. 
183. The representative of Rwanda, speaki ng on behalf of the African Group , said that the 
President of the United States, referring to the case  of Terri Schiavo who had been in a vegetative 
state for the last 15 years, had said that "where th ere are serious questions and substantial doubts, our 
society, our laws, and our courts should have a presu mption in favour of life.  It should be our goal as 
a nation to build a culture of life".   The dedication "to build a culture of life" should be stronger, more 
urgent and immediate in the TRIPS Council which had been mandated to find a permanent solution 
on how to ensure a sustainable supply of essential ge neric medicines to the millions of people dying 
every day, particularly in Africa, for not havi ng access to life-saving affordable medicine because 
they lacked the manufacturing capacity.  Unfortunate ly, this dedication and de termination seemed to 
be lacking.  Four years had passed since Members had recognized the problem faced by WTO 
Members with insufficient or no manufacturing capac ity in the pharmaceutical sector in making use 
of compulsory licensing under the TRIPS Agreemen t, and the African Group was disappointed that 
Members had not moved closer to finding a permanen t solution to this problem.  The African Group 
had submitted a proposal on how to incorporate the te mporary waiver into the TRIPS Agreement.  It 
had provided a detailed explanation a bout the proposed amendment.  It had also explained that certain 
parts of the Decision were redunda nt and should not form any part of the permanent solution.  
However, it appeared that some Members were not  engaging constructively in this discussion. For 
instance, they acknowledged that some parts of the waiver were redundant but to date no concrete 
proposal had been tabled by any of them.   
184. She said that, at the time the Decision had b een agreed to, the African Group had proposed 
many options that would have allowed countries to export and import affordable generic medicines to 
satisfy the public health needs of people worldwid e.  However, it had faced a lot of pressure from 
some Members which had imposed many conditions that  were difficult to meet.  Finally, after months 
of discussion and debate, an interim solution in the fo rm of a waiver of Article 31(f) and (h) had been 
agreed to by Members.  The African Group and many other developing and least-developed countries 
had not been entirely happy with this solution and this had been made very clear during the TRIPS 
Council meetings.  The Group had agreed to this "interim solution" on the precise understanding that 
it was only an interim solution, while discussions to  find a permanent solution would continue.  This 
understanding was reflected in para graph 11 of the Decision which stated:  "The TRIPS Council shall 
initiate by the end of 2003 work on the preparation of  such an amendment with a view of its adoption 
within six months, on the understanding that the am endment will be based, where appropriate, on this 
Decision".  The ordinary meaning of the sentence "the amendment will be based, where appropriate, 
on this Decision" indicated that it had never been th e intention of Members to use the entire Decision 
as the amendment.  Only those parts of the Decisi on that were appropriate were to be used.   
185. With regard to the Chairman's Statement, it w as important to understand the circumstances in 
which the Statement had come into being, so that it could be put in its proper context.  The reading of 
the Chairman's Statement, when the Decision was adopted, had been more of an attempt to provide 
comfort language to assuage the concerns of some pharmaceutical industries that generic  IP/C/M/47 
 Page 37 
 
 
 manufacturers would gain a strong foothold in th e pharmaceutical market.  During the informal 
TRIPS Council meetings, some developing and le ast-developed countries' delegates had expressed 
their reservations over the content of the statement,  which was a clear indication that this statement 
had never been intended to form any part of the permanent solution.   
186. The main reason why those countries with re servations had agreed to go along with the 
Chairman's Statement had been because they had fe lt an urgent need to make a contribution to the 
success of the Cancún Ministerial Conference.  WT O Members might recall that there had been a 
strong feeling at that time that a solution, even if it was an interim one, had to  be concluded before the 
Cancún meeting so that the meeting could focus on  other issues and thus have a better chance of 
success.  It had been felt by all that a Chairman's  Statement would help facilitate a quick conclusion 
of an interim solution.  But it had also been th e understanding that this would only be an interim 
solution, and that a permanent solution would require  more careful consideration, taking into account 
all the aspects, including how th e mechanism chosen could be operationalized in practice. 
187. She said that the Chairman's Statement should thus be seen as a facility that served a 
particular purpose at that time, mainly to meet the deadline of having a temporary settlement before 
the Cancún meeting.  However, the circumstances had been temporary and they no longer existed.  In 
line with the context in which the Chairman's Stat ement had come into being, the Decision that had 
been agreed to in document IP/C/W/405 did not make  any reference to the Chairman's Statement.  It 
was only later that a footnote referring to the Chai rman's Statement had been added, without the 
express consent of Members.  Indeed, he said th at the African Group was puzzled as to how that 
footnote came to be added and that it wished to have  a clarification on this.  Moreover, it had to be put 
on record that it had been added without the consen t or consensus of Members.  Thus, the African 
Group which made up a large portion of the WTO’s Membership could not and would not accept an interpretation of paragraph 11 that said that the D ecision and the Chairman's Statement in its entirety 
should form the amendment. 
188. She recalled Members' commitment in the Doha Declaration to interpret and implement the 
TRIPS Agreement "... in a manner supportive of WTO Me mbers' right to protect public health and, in 
particular, to promote access to medicines for a ll".  The African Group was not convinced that the 
Decision together with the Chairman's Statement as it stood at that time would fulfil the commitment 
to protect public health and promote access to medicin es for all.  Indeed, concerns had been raised by 
policy makers in African countries that the "i nterim solution" as it presently stood could pose 
problems and obstacles to the realization of the go al of access to affordable medicines for all. 
189. An African regional workshop on Patents and Ac cess to Medicines organized by the African 
Union Commission and attended by policy makers from  the health ministries and patent departments 
of 35 African countries had discussed the issue and had expressed concerns on the workability of the 
"interim solution".  It had also supported the position of the African Group in the WTO on its approach to seeking a permanent solution.  A Stat ement adopted by participants at the workshop 
stated: 
"Participants stressed that the issue of th e effects of patents on access to medicines is 
very crucial for the African region which among all continents in the world is the 
poorest and its people are most affected by  serious diseases, and therefore the need 
for access to affordable effective medicines is a must. Deaths attributable to HIV/AIDS alone in 2004, estimated at 2. 5 million, are equivalent to ten times the 
devastation caused by the Tsunami of December 2004.  It is urgent that all countries 
act individually and collectively to rem ove all obstacles to securing sustainable 
supplies of essential medicines for the people of the region." IP/C/M/47 
Page 38  
 
 190. In relation to the Decision, it stated that  "this decision imposes several conditions on 
importers and exporters who wish to make use of  the waiver, which may affect the ability for the 
mechanism to meet its goal",  which was the suppl y of essential generic medicines to countries with 
insufficient or no manufacturing capacity.  The Stat ement further called for "a more appropriate 
'permanent solution' that revises TRIPS and that removes the Article 31(f) constraint without placing 
new constraints so that the export and import of ge neric medicines can be smoothly facilitated".  The 
representatives at this workshop had also expressed th eir support for the position and efforts of the 
African Group in the WTO. 
191. From the statement, it was evident that policy ma kers at the national level considered that the 
interim solution contained shortcomings that might affect the operational effectiveness to meet the 
goal of supplying affordable medicines, that an a ppropriate permanent solution was urgently required, 
and that they supported the proposal submitted by the African Group for the amendment.  She said 
that the issue at hand was critical to the African c ontinent and people worldwide.  Members could not 
and should not delay this matter any longer.  A lthough an interim mechanism existed, it had its 
shortcomings which might account for the fact that it had not been used up to now.  In addition, this 
waiver was subject to review and could be termin ated at any time.  The African Group thus sought a 
solution that was permanent, sustainable, secure and predictable.  It had put forward a proposal based 
on the appropriate elements of th e Decision and had already explained that proposal in detail.  The 
Group now sought the understanding and agreement of other Members.  
192. The modality for achieving a permanent solution was expressly spelled out in paragraph 11 of 
the Decision.  Therefore, the Group requested all Me mbers of the WTO to share its interpretation of 
paragraph 11 of the Decision, and to engage constructively with the intention of resolving 
expeditiously the Doha Declara tion's paragraph 6 problem, in fa vour of supplying affordable 
medicines to those who were most in need.  Fina lly, the Group was of the view that a permanent 
solution was within reach if Members acted in accord ance with the letter and spirit of paragraph 11.  
She expressed her hope that the consultations to be  undertaken by the new Chairman of the TRIPS 
Council, would finalize the amendment so that a De cision could be adopted at the General Council 
meeting to be held in May 2005. 
193. The representative of Zambia, speaking on behalf of the LDC Group
, said that the group 
agreed with the statement of the African Group.  He said that, at the height of the discussion on how 
to resolve the paragraph 6 problem, major de veloped country Members had made a number of 
promises to other Members in order to obtain their support for the Decision and the Chairman's 
Statement.  His delegation had been informed that  the Decision was intended to be only an interim 
solution and that discussions towards finding a perm anent solution in the form of an amendment of 
the TRIPS Agreement would continue.  The unde rstanding of Members on how these discussions 
should proceed was reflected in paragraph 11 of the Decision.  The Group's understanding was that 
the intention had never been to regard the Decisi on as a consensus solution and that it had been, and 
remained, only an interim solution.  Only appropriate elements rather than the entirety of the Decision 
should be adopted as part of the amendment.  IP/C/M/47 
 Page 39 
 
 
 194. He said that the group had reservations over the content and the status of the Chairman's 
Statement.  There had never been an agreement or any kind of understanding among Members that all the elements of the Chairman's Statement should form part of the amendment and, therefore, 
Members should be guided by paragr aph 11 of the Decision.  He said that the view held by some 
Members, that certain groups of countries wished to  re-open the debate that had conclusively ended in 
August 2003, had no basis because it was not supported by paragraph 11 of the Decision.  He called 
upon those Members to refrain from making statements that misinterpreted the circumstances that had 
been prevailing and the understandi ng that had been reached at the time of the adoption of the 
Decision.  The African Group proposal, consistently with paragraph 11, had selected the most appropriate elements of the Decision to form the amendment.  He urged Members to engage 
positively to discuss the proposal or to submit proposals that would build on it constructively.  The 
Group called upon the Membership to come up with a comprehensive and predictable solution to this 
matter and underlined the urgency and the importance of the issue of TRIPS and access to medicines 
for all vulnerable constituencies.  For his group, this  was not a matter of procedural debate, but an 
emergency with social and economic  implications on which the well-be ing and lives of millions of its 
people depended.  It was, therefor e, a matter of life and death for many countries to urge the Members 
to continue working for a permanent solution fo r adoption by the General Council meeting in May 
2005.  
195. The representative of Argentina
 said that his delegation had no commercial interests or 
companies behind it.  It was seeking a solution to he lp save the lives of millions of people in line with 
the Declaration of 2001.  The solution that had b een reached in 2003 was an interim solution and he 
was concerned about the lack of agreement over the last two years in trying to solve this urgent 
question.  There was a danger that this interim solution would become the permanent solution.  
Although the Doha Declaration on TRIPS and Pub lic Health was distinct from the other Doha 
Declarations, there was an undeniable link between th em and it would be naïve to think that the Doha 
Round could end in a satisfactory manner unless a satisfactory solution was found to the question 
raised in the Declaration on health.  He urged all delegations to continue wo rking constructively to 
urgently find a solution and respond to the goal specified in the Declaration on TRIPS and Public Health. 
196. The representative of Benin, speaking on behalf of the ACP Group
, said that the group 
associated itself with the statements by the African Group and Zambia.  He underscored the 
importance of access to medicines, particularly for those countries with no or insufficient production 
capacity.  The Decision was intended to be an inte rim solution until such a time as a permanent one 
could be reached.  He supported the African Gr oup's suggestion on how to move forward and urged 
Members to work with a view to reaching a useful  and helpful solution by the May meeting of the 
General Council. 
197. The representative of Cuba  agreed with Rwanda, Zambia and Benin that it was urgent that an 
adequate Decision be taken on this issue.  The Deci sion was an interim Decision.  It was clear that not 
all aspects of it could be taken into consideration in  an amendment.  She urged all Members to engage 
in a constructive and positive manner in consultations to find an appr opriate and adequate solution to 
this problem. 
198. The representative of Kenya  said that the statements by the coordinators of the African Group 
and the LDCs were indicative of the journey that ha d been covered so far since 2001.  Just as Britain 
respected its written and unwritten constitution, Afri ca respected the written and unwritten promises 
that had been made behind the scenes and that w as why they had accepted the solution.  However, 
those promises seemed to have evaporated as s oon as the exercise to amend the TRIPS Agreement 
had begun, and they needed to be brought back to the table so that this exercise could be concluded 
immediately.  Since one could not go back in time  and revise the damage already done, one should at IP/C/M/47 
Page 40  
 
 least take action at the present time to make things better for the future and make every effort to 
conclude the exercise by May. 
199. The representative of Brazil
 said that a constructive and a positive attitude should be shown 
by all to achieve a quick consensus regarding a solution for an amendment.  The African Group 
proposal had received widespread support from the African countries, the LDCs as well as the ACP 
countries and he welcomed it as a good basis for furthe r work.  He agreed with their interpretation of 
paragraph 11 of the Decision.  The Decision was an  interim solution and the Chairman's Statement 
was not part of the mandate for the amendment.  His delegation was willing to  engage constructively 
to achieve a permanent solution to this  pressing and urgent humanitarian issue. 
200. The representative of India  said that he shared the disappoi ntment expressed by Rwanda that 
no final decision on the proposed amendment to the TR IPS Agreement could be reached by the end of 
the deadline.  His delegation had already expressed its support for the African proposal in previous 
meetings and continued to give full support to an y discussions at any time that would enable the 
Council to reach a decision on this matter. 
201. The representative of the Philippines  said that his delegation fully supported the statement 
made by Rwanda on behalf of the African Group an d expressed his regret that certain Members had 
refused to engage constructively in discussing a permanent solution through an amendment of the 
TRIPS Agreement.  He reiterated that the wording of paragraph 11 – "the amendment will be based, 
where appropriate, on this Decision" – did not m ean a simple adoption or transposition of the 
Decision into an amendment, nor did it mean the adoption or transposition of the Decision together 
with the Chairman's Statement.  Despite certain  delegations' insistence on using the phrase "August 30 
solution" rather than "August 30 Decision", paragra ph 11 clearly referred to the Decision only.  There 
was no reference in the Decision nor any consensu s in the TRIPS Council discussions subsequent to 
the Decision that the amendment exercise would be a simple technical exercise, as a few delegations continued to insist. 
202. Viewed in the context of Members' interv entions in the TRIPS Council's meeting of 
28 August 2003 approving the Decision, and sub sequently in the General Council meeting of 
30 August 2003, it was clear that Members like the Philippines had agreed to the Decision on the 
premise and in the belief in the word of the then Chair as well as certain key players in these 
negotiations that their concerns would be address ed or could be rectif ied during the amendment 
process.  Members had acquiesced with such an appeal for approval at that time, given the urgency for 
a need to establish a mechanism to address th e problems of developing countries with no or 
insufficient manufacturing capacity in the pharmaceu tical sector.  To be confronted now with a 
situation where it was incumbent upon them to sh ow that the amendment would have to include 
certain substantive rectifications and to be told th at these were not possible in this amendment process 
was something he found difficult to accept.  If the WTO was keen on confiden ce-building, then it was 
incumbent upon the trading partners, on whose word his delegation had trusted before, to live up to 
that word.  
203. He said that it was not only the General C ouncil Chairman's Statement that had provided 
context for the Decision.  A number of statements, including one by his delegation, had been read out 
at the TRIPS Council meeting and at the Gene ral Council meeting in August 2003 to set forth 
Members' understanding or interpre tation of both the Decision and th e Chairman's Statement, and 
these should equally be seen as providing an interpreta tive context for the Decision.  He reiterated his 
full support for the African Group's suggestion for the incoming Chair of the TRIPS Council to 
conduct extensive consultations to  reach a permanent solution for an amendment to the TRIPS 
Agreement before the May General Council meeting.   IP/C/M/47 
 Page 41 
 
 
 204. The representative of Sri Lanka  said that, as his country had insufficient manufacturing 
capacity for pharmaceutical products, it was particular ly concerned with finding a permanent solution.  
AIDS had caused twice as many people to die than  the tsunami catastrophe.  In 2003, the adoption of 
the Decision had triggered praise from the press that the WTO was capable of responding to humanitarian needs.  Further delay in finding a pe rmanent solution would not live up to that public 
view and he, therefore, urged Members to agree on the necessary amendment to the TRIPS 
Agreement by May. 
205. The representative of Lesotho
 said that, although her delegation was aware that there was 
some pressure for commercial opportunities from ph armaceutical companies in developing countries, 
the dominant pressure to amend the TRIPS Agreem ent came from the people dying of AIDS every 
day.  She asked Members to show compassion.  
206. The representative of Pakistan  said his delegation supported the statement by the African 
Group.  The solution reached in August 2003 w as only an interim solution and the Chairman's 
Statement was not part of that solution.  Had the solution been intended to be permanent, it would 
have clearly stated it and would not have used fo rmulations like "where a ppropriate" and "where the 
interim solution will cease to operat e when provisions for permanen t solution are in place".  These 
words indicated clearly that there had been no co nsensus on this being a permanent solution at the 
time.  Rather, the background to the negotiations  had been as Kenya and the African Group had 
described it.  He urged Members to engage in a positive dialogue and come to a solution along the 
lines of the African proposal. 
207. The representative of Uganda  said that he shared the interpretation of paragraph 11 by the 
African Group, the LDC Group and the ACP Group and urged Members to work towards a solution.  
He informed Members that demonstrations on that issue had taken place in Uganda the previous week 
and that the Indian High Commission had been request ed that India should not take any decision that 
would have repercussions for the people living with AIDS.   
208. The representative of Rwanda  thanked all Members that had supported the African Group 
proposal and said that this support was a clear indica tion of Members' will to find a solution prior to 
the General Council meeting to be held in May. 
209. The representative of Peru  said that his delegation supported the statement made by the 
African Group that a rapid and effective solution to  the concerns should be found.  He noted that 
delegates at the Commission on Human Rights in session at the United Nations had also expressed their commitment in the area of public health and urge d Members to find a solution also in this forum. 
210. The representative of the United States
 said that his delegation remained committed to 
reaching a consensus on an amendment to the TRI PS Agreement that fully preserved the solution of 
30 August 2003.  This solution represented a comprehe nsive and balanced system to allow those that 
lacked the capacity to manufacture drugs, to import the drugs that they needed without these drugs 
being diverted to other markets.  The agreem ent reached on 30 August 2003 had garnered support 
from all WTO Members and had met their objectives.  Its transformation into an amendment should 
be a technical exercise and substantive issues should not be re-opened.  Therefore, his delegation did 
not consider that any substantive provisions of th e Decision would be inappropriate for incorporation 
into the amendment.  His delegation was not familia r with promises that may have been made or 
broken or whether these were relevant, and e xpressed its concern over the presence of such 
allegations without further clarity.  His delegation' s recollection of this process, in which the United 
States' Ambassador had been fully engaged, was that  the range of benefits and viewpoints had been 
reflected in the solution, and that without this balance a consensus would not have been possible. IP/C/M/47 
Page 42  
 
 211. He said that the task of agreeing to an amendment that preserved all aspects of the 
30 August 2003 consensus would be very difficult if Members were seeking to change the content of 
that solution.  His delegation disagreed with the ch aracterization of the Chairman's Statement made at 
the present meeting and with the attempt of some Members to re-characteriz e the circumstances under 
which the consensus had been agreed upon.  Th e Chairman's Statement represented key shared 
understandings of Members.  It was an integral part  of the solution that had been reached and had to 
be preserved in the amendment.  The United St ates strongly supported the 30 August 2003 solution 
and noted that the waiver was currently in for ce and would remain in force until the amendment 
process was completed.  This had permitted Memb ers such as Canada, Switzerland, Norway, the 
European Communities and potentially others to act  to implement the solution and the United States 
also encouraged and supported Members to make e ffective and appropriate use of that solution.  
212. The representative of Kenya
 said that, while there were no records of the informal process 
that lead to the Decision, one could still trace so me of the statements made during the informal 
consultations as these had been attached to the mi nutes of the General Council meeting in document 
WT/GC/M/82.  For instance, the Kenyan Ambassador had said in her statement that "[w]e are also 
comfortable in the knowledge that it will not a ffect in any way our intention to improve our 
manufacturing capacity, which is our medium - as well as long-term objective, and that this is a 
temporary solution which will come to an end afte r the permanent solution envisaged in paragraph 11 
of the draft Decision is in place".  Similar statements had been made by Venezuela, Nicaragua, Senegal and others.  It could also be seen from the st atement by Canada at the time that the issue had 
not only been of interest to developing countries.   Canada's Ambassador had among others extended 
his thanks to the African countries with the words:   "the final thank you goes to all my African 
colleagues.  It was their countries and their c itizens who were always recognized as the primary 
beneficiaries of the Declaration on TRIPS and Public  Health.  It was their people who had the most 
need.  And yet, they have demonstrated remarkable pa tience with us, on such a 'life and death' issue.  I 
am not sure many of us, in similar circumstan ces, would have acted as honourably".  The first 
paragraph of the opening statement by the African Group was a testimony to what the Canadian 
Ambassador had said at that time.   
213. Members should not forget the degree of activit y that had taken place behind the scenes in the 
few days before and right up to the meeting in which the Decision had been taken.  The promises that 
had been made were not in the Decision, but some Members had been told that all their concerns and 
problems could be addressed during the amendment process.  His delegation had even prepared a 
statement which it had been prevailed upon by othe r Members not to issue.  If Members were still 
doubting this background, he could produce this stat ement as proof and disclose the details of the 
topics discussed behind the scenes and in capitals at the time of the Decision.  This issue was as 
urgent today as it had been four or five years ago when it had been raised by the African Group.  It 
had not subsided, but it had actually intensified, a nd other regions were at an even bigger risk than 
Africa.  This solution would not just be a solution for Africa, it would be a solution for the whole 
world.  The material was in front of Members, and their work was cut out in paragraph 11 of the 
Decision.  He urged Members to work on that  basis to put a solution into place by May.  
214. The representative of Switzerland
 said that his delegation remained committed to the process 
of implementing the Decision and that the details of  its position and proposals were contained in its 
statement of 8 March.  It remained key to his de legation that any implementation solution would have 
to reflect the entirety of the substance of the con sensus and the solution fou nd by the Membership on 
30 August 2003.  Only a purely technical amendmen t could faithfully translate that consensus which 
had only been achieved after a long and difficult ne gotiation process and which represented a delicate 
balance of interests of Members.  It had to be taken into consideration that a number of Members, 
including Switzerland, were presently revising their national laws in order to quickly and faithfully 
implement the paragraph 6 solution as adopted by the General Council.  Any re-opening of the 
consensus found by the General Council would serious ly undermine these national revision processes  IP/C/M/47 
 Page 43 
 
 
 and would endanger, if not prevent, a transparen t and uniform use of compulsory licences for the 
export of pharmaceuticals under the terms and conditions of paragraph 6 mechanism.   
215. For reasons of legal security, expeditiousn ess and efficiency, Switzerland had proposed the 
footnote approach as the form for the implementation of the paragraph 6 solution in the TRIPS Agreement as a practical and straightforward solu tion.  The General Council Chairman's Statement 
had been part of the consensus found on 30 August 2003 and, therefore, was an integral part of the 
paragraph 6 solution that had been found that day.  Accordingly, the statement  had to be reflected 
adequately in the amendment.  It was the view of  his delegation that the matter should be put on the 
agenda of the next session of the TRIPS Council for further discussion. 
216. Referring to his delegation's earlier intervention under this agenda item, the representative of 
the European Communities
 said that his delegation remained committed to finding a solution in line 
with paragraph 11 of the Decision and ready to en gage in whatever process was deemed appropriate.  
While being ready to join others in working towa rds the May General Council meeting as the target, 
he noted that there would be a lot of ground to cover in  a short time.   He shared the view that the link 
to the Chairman's Statement needed to be preserved in any solution without upgrading its legal status, 
and said that this was an important point which could not be ignored.  He disagreed with the 
suggestion that the Chairman's Statement and othe r statements made at the same General Council 
meeting had the same relevance to the amendment pro cess.  He said that a constructive and perhaps at 
times even creative approach was needed, and recalled that that his delegation had expressed a view in 
the past as to how the process might be conducted, which remained its view. 
217. The Chairman  expressed his personal regret that he was leaving the Chair without having 
been able to find a solution.  He said that th ere appeared to be a general willingness among Members 
to continue consultations in the period until the 26-27 May General Council m eeting with a view to 
enabling the General Council to take action at that  time, as suggested by the African Group, and that 
Ambassador Choi Hyuck ha d signalled his preparedness to undertake the task. 
218. The Council agreed  to proceed as suggested by the Chair. 
219. Regarding the clarification sought by the repr esentative of Rwanda on the asterisked note in 
document WT/L/540, a representative of the Secretariat  clarified that this asterisked note was not part 
of the legal text of the Decision.  Its purpose had been to provide factual information about the way 
the Decision had been adopted in the belief that this  would be found helpful.  If there were Members 
who did not find this information helpful in the te xt of the Decision as circulated, and maybe even 
found it confusing, one course of action might be to  re-issue the Decision without this note.  Of 
course, doing this would not affect the status of th e Chairman's Statement and its link to the Decision;  
these were governed not by the note to document WT/L /540 but by the action that had been taken by 
the General Council at its meeting of 30 August 2003, as recorded in the minutes of that meeting. 
I. FOLLOW -UP TO THE SECOND ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE DECISION ON 
THE IMPLEMENTATION OF ARTICLE 66.2  OF THE TRIPS  AGREEMENT  
220. The Chairman  recalled that, at its meeting in Decemb er, the Council had taken up, pursuant to 
paragraph 2 of the decision on the "Implementati on of Article 66.2 of the TRIPS Agreement", its 
second annual review of developed country Members'  reports on their implementation of Article 66.2 
(circulated in document IP/C/W/431 and addenda).  Since that meeting, an additional report had been 
received from Norway (subsequently circulated in document IP/C/W/431/Add.6). 
221. No statements were made  under this agenda item. IP/C/M/47 
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 J. T
ECHNICAL COOPERATION AND  CAPACITY -BUILDING  
222. The Chairman  recalled that, on 14 June 2001, the WIPO  and WTO Secretariats had launched 
a Joint Initiative on Technical Cooperation for L east-Developed Countries.  Since then, the WTO 
Secretariat had kept the Council informed about  the implementation of the Joint Initiative. 
223. A representative of the WTO Secretariat  said that, since the Council's last meeting, the WIPO 
and WTO Secretariats had organized, under the Join t Initiative, a joint national seminar on TRIPS in 
Niamey, Niger in December 2004.  Two activities sp ecifically addressed to LDCs were foreseen for 
the first half of the year 2005, namely a national sem inar in Lesotho, that had originally been planned 
for December but postponed at the request of the L esotho authorities, and another national seminar in 
Chad.  As part of the WTO Tec hnical Assistance Plan for 2005, the Secretariat was organizing four 
regional or sub-regional workshops wh ich also covered LDCs.  The first of them had been held in Fiji 
in January 2005 in response to requests from Paci fic island countries.  The remaining three were 
planned to be held in Gabon for French-speaking Afri can countries at the end of May, in Zambia for 
English-speaking African countries at the end of July , and the last in one of the Caribbean countries 
later in the year. 
224. He also drew attention to the second "WIPO-WTO Colloquium for Teachers of Intellectual 
Property Law" that was being organized jointly by th e two organizations from 27 June to 8 July 2005.  
It was part of each of the two Organizations' capacity building programmes, aimed, in this case, at enhancing the capacity of universities and teachers in developing countries with respect to the 
activities and instruments of WIPO and the WTO.  On ly 20 places were available for the colloquium.  
Information on the colloquium, including online appli cation forms, was available from the websites of 
WIPO and the WTO.  He suggested that interest ed Members might wish to encourage eligible 
intellectual property teachers within their countries to apply before the deadline of 15 April 2005. 
225. A representative of WIPO
 thanked the Government of Niger for its cooperation and 
hospitality during the seminar in December.  
226. The Council took note  of the statements made. 
K. REQUEST FROM MALDIVES FOR AN EXTENSION OF THE TRANSITION PERIOD UNDER 
ARTICLE  66.1  OF THE TRIPS  AGREEMENT  
227. The Chairman  recalled that, at its last two meetings , the Council had had before it a request 
from the Maldives for an extension of the transition period under Article 66.1 of the TRIPS Agreement for a further five years (IP/C/W/425).  Th e Council had agreed that consultations be held 
on this request, and that the arrangements for these be coordinated between the Chair of the TRIPS 
Council and the Chair of the CTD. 
228. Since then, the delegation of the Maldives had not  been able to attend the meetings of the 
CTD and there had, therefore, not yet been an opportu nity to organize consultati ons on this matter.  At 
the meeting of the CTD held on 22 February 2005, the Chair of that body had informed Members that 
the Maldives had provided a written communication to the Committee stating that it wanted the UN to 
re-examine its position concerning the recent decision to graduate the Maldives from LDC status 
because of the devastating effects of the December tsunami on its economy (WT/COMTD/52).  The CTD had agreed to revert to the matter at its next meeting scheduled for 11 May 2005.   
229. The Chairman informed Members that, on 20 December 2004, the United Nations' General 
Assembly had adopted a decision on "Smooth transi tion strategy for countries graduating from the list 
of least-developed countries".  Paragraph 3(e) of that decision provided that "[t]hree years following 
the decision of the General Assembly to take  note of the recommendation of the Committee for  IP/C/M/47 
 Page 45 
 
 
 Development Policy to graduate a country from the li st of least developed c ountries, graduation will 
become effective;  during the three-year period, th e country will remain on the list of least developed 
countries".  The General Assembly had then take n note of the recommendation of the Committee for 
Development Policy to graduate Maldives from the group of least-developed countries.  Maldives 
would thus retain its LDC st atus until 20 December 2007. 
230. Given this three-year period in which the Mald ives would retain its LDC status, there was no 
issue about it benefiting from the TRIPS transition period until the end of year 2005.  The Chairman 
suggested, therefore, that the Council consider late r in 2005 what action it should take in response to 
the Maldives' request for a five year extension of its transition period under the TRIPS Agreement, 
taking into consideration any further developments  concerning the Maldives' status as an LDC and 
any further discussions in the CTD context on this matter. 
231. The Council so agreed . 
L. NON-VIOLATION AND SITUATION COMPLAINTS  
232. The Chairman  recalled that the General Council decisi on of 1 August 2004 on the Doha Work 
Programme provided, under the title "Other elements of the Work Programme", that the moratorium 
on non-violation and situation compla ints covered by para graph 11.1 of the Doha Ministerial Decision 
on Implementation-Related Issues and Concerns ha d been extended up to the Sixth Ministerial 
Conference.  This matter had been on the agenda of the last Council meeting and had been discussed, inter alia , on the basis of an updated Secretariat summary note on the points raised in the Council's 
substantive discussion of this matter so far (IP/C/W/349/Rev.1). 
233. The representative of Korea
 said that his delegation shared the view of the vast majority of 
Members that non-violation and situ ation complaints were a concept primarily intended for market 
access agreements.  Their applica tion in the context of the TRIPS Agreement would introduce a 
degree of uncertainty, which was undesirable for the sound operation of any intellectual property 
regime.  He noted that the moratorium on non-viol ation and situation complaints had been extended 
several times and that such repeated extensions, without reaching a conclusion on the applicability of 
such complaints, undermined the stability of th e TRIPS system.  He hoped that Members would be 
able to reach consensus at the Sixth Ministeria l Conference to the effect that non-violation and 
situation complaints were not app licable to the TRIPS Agreement. 
234. The representative of Peru  said that his delegation believed that it was time to put paid to the 
issue of the moratorium on non-violation and situ ation complaints and that this issue could be 
wrapped up at the Hong Kong Ministerial Conference. 
235. The representative of Ecuador  said that he agreed with Korea.  He reiterated his delegation's 
position reflected in documents submitted to the Council, namely that non-violation and situation 
complaints were intended for situations other th an those existing under the TRIPS Agreement.  He 
hoped that the legal uncertainty resulting from the mo ratorium could soon be resolved and the item 
removed from the agenda. 
236. The representative of India , supporting the statements made by Peru and Ecuador, recalled 
that the three delegations, together with a num ber of other Members, had co-sponsored document 
IP/C/W/385 circulated in October 2002.  He cite d from paragraph 11 of document IP/C/W/349/Rev.1 
which read:  "It has been argued that applying the non-violation remedy under TRIPS would provide security and predictability and help ensure that th e TRIPS Agreement's flexibility is not misused in 
order to avoid legitimate obligations."  Commenting on the use of the term "legitimate obligations" in 
this sentence, he said that the flexibilities of the TR IPS Agreement were a part of the balance of rights 
and obligations within the TRI PS Agreement and that these legitimate flexibilities were parts of IP/C/M/47 
Page 46  
 
 legitimate rights.  When shifting from violation co mplaints to non-violati on complaints, panels and 
the Appellate Body had usually referred to  legitimate expectations arising not from obligations  but 
from legitimate expectations , as the term had been understood in the jurisprudence.  Therefore, he did 
not believe that any further security and/or predicta bility was required to be provided in respect of the 
TRIPS Agreement's flexibilities or possibilities to use these flexibilities, which could not and should 
not be characterized as misuse of legitimate obligations. 
237. The representative of Malaysia
, joining the delegations of Ko rea, Peru, Ecuador and India, 
reiterated her delegation's position that non-violation and situation complaints were not applicable to 
the TRIPS Agreement.  There were no legal or ot her facts that showed any need for non-violation 
remedies in the TRIPS Agreement.  Making no n-violation complaints available would impose 
systemic difficulties in the operation of a predic table and rules-based multilateral system, because 
non-violation complaints would introduce elements of legal uncertainty.  Their existence would result 
in and compel actions that went beyond the TRI PS Agreement as a minimum standards agreement.  
The Secretariat summary note referred to a long list of reasons given by Members why non-violation and situation complaints should not be applicable  to the TRIPS Agreement.  She hoped that this 
chapter of discussions could be closed as soon as possible.   
238. The representative of the United States
 said that his delegation continued to consider that non-
violation complaints were fully appropriate in th e TRIPS context and expected the moratorium to 
expire at the Sixth Ministerial Conference.  In response to the comments from other delegations, he 
said that the application of NVNI complaints to th e TRIPS Agreement would not upset the balance of 
rights and obligations in TRIPS.  It was unambiguously clear that, in Article 64 of the TRIPS 
Agreement, the provisions of Article XXIII 1(b) a nd (c) of GATT 1994 had been contemplated in the 
context of the TRIPS Agreement and that that was an integral part of the final package negotiated 
during the Uruguay Round.  The objective of NVNI complaints was to discourage actions that might evade obligations without directly violating them.  No clear reason had been provided why the TRIPS Agreement should not benefit from that objective.  Th e failure to allow this possibility in connection 
with the TRIPS Agreement could invite Members to  seek creative ways to avoid TRIPS obligations.  
The United States remained willing to discuss how  the NVNI remedies applied to the TRIPS 
Agreement.  In this respect, Article 26 of the DSU was helpful and provided important guidance for 
Members when considering NVNI complaints under TRI PS.  The United States felt that Article 26 of 
the DSU provided all the necessary assurances and safeguards for Members to handle any disputes alleging non-violation nullificati on and impairment under the TRIPS Agreement and to prevent any 
abuse of the dispute settlement process. 
239. The representative of the Philippines
 associated himself with the statements by Malaysia, 
India, Peru and Ecuador calling for the closure of  the chapter on the applicability of non-violation 
complaints under the TRIPS Agreement.  It would be  inappropriate if non-violation complaints were 
deemed applicable in the TRIPS context after the Sixth Ministerial Conference, as the TRIPS Council 
had not reached any conclusion on the scope and modalities of the applicability of such complaints. 
240. The representative of Canada  said that she shared the position of most other Members, 
namely that NVNI complaints should not apply in the context of the TRIPS Agreement.  The reasons for this had been elaborated in several written s ubmissions in recent years.  Agreeing to now apply 
NVNI complaints under the TRIPS Agreement would sh ift the balance of rights and obligations that 
Members had maintained in the TRIPS Agreement since the Uruguay Round.  The onus was on the 
Members proposing the applicability of NVNI complaints to explain why the Council should agree to 
change that status.  
241. The representative of Brazil
, agreeing with the statements ma de by Canada, India, Malaysia, 
the Philippines, Ecuador, Peru and Korea, said that he expected the Hong Kong Ministerial  IP/C/M/47 
 Page 47 
 
 
 Conference to agree, in accordance with the opinion of the overwhelming majority, that non-violation 
and situation complaints did not apply in  the context of the TRIPS Agreement. 
242. The representative of Argentina  said that, like the delegations of Brazil, the Philippines, 
Malaysia, Ecuador and the Dominican Republic and th e majority of the Council, she hoped that this 
issue would be solved along the lines of the proposal presented by her and certain other delegations in 
document IP/C/W/385. 
243. The representative of Japan  said that the Council should continue to study and discuss the 
scope and modalities of non-violation complaints in  order to ensure the predictability of their 
application. 
244. The representative of the European Communities  said that his delegation considered that non-
violation complaints should not be applicable in the TRIPS context. 
245. The Council took note  of the statements made and agreed  to revert to the matter at its next 
meeting. 
M. SPECIAL AND DIFFERENTIAL TREATMENT PROPOSALS REFERRED TO THE COUNCIL  
246. The Chairman  said that, in its Decision on the Doha Work Programme of 1 August 2004, the 
General Council had recalle d Ministers' decision in Doha to review all special and differential 
treatment provisions with a view to strengthening  them and making them more precise, effective and 
operational, and recognized the progress that had been  made so far.  As regards all those WTO bodies 
to which proposals in Category II had been referr ed, the General Council had instructed them to 
expeditiously complete the consideration of these proposals and report to the General Council, with 
clear recommendations for a decision, as soon as possi ble and no later than July 2005.  This matter 
had been on the agenda of the last Council meeting,  where the Council had had before it an informal 
Secretariat note summarizing the Council's work so far on the Category II proposals on special and 
differential treatment referred to it (JOB(04)/164).  No comments had been ma de on the item at that 
time. 
247. The representative of Kenya  requested clarification of the status of the two proposals that 
Members had been discussing under this item at prev ious meetings.  He said that he had been under 
the impression that the Council had already worked on  one proposal dealing with exclusive marketing 
rights and had forwarded it to the relevant body and that it was only the LDC's proposal on extension 
that was still pending. 
248. A representative of the Secretariat  responded that, as described in Document JOB (04)/164, 
there were two proposals, the second of which had two elements.  With regard to one of these 
elements contained in the second proposal, agreemen t had been reached amongst participants and that 
proposal had been forwarded at that time by the Ch airman of the TRIPS Council to the Chairman of 
the General Council to be included in the package that was going to Cancún.  As no action had been 
taken at Cancún, it remained a text that had been agreed at the level of the members of the TRIPS 
Council, but which had not yet been formally acted upon and put into force at the final level. 
249. The Council took note  of the statements made and agreed  to revert to the matter at its next 
meeting. 
N. INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO 
250. The Chairman  informed the Council that panel reports on European Communities – 
Protection of Trademarks and Geographical Indica tions for Agricultural Products and Foodstuffs , IP/C/M/47 
Page 48  
 
 complaints by the United States and Australia, we re expected to be circulated on 15 March in 
documents WT/DS174/R and WT/DS290/R, respectively. 
251. The representative of th e European Communities
 said that his delegation wished to raise the 
issue of compliance by the United States with DSB rulings on intellectual property matters.  While it 
was the duty of the Dispute Settlement Body to  keep under surveillance the implementation of 
recommendations and rulings in dispute settlement  cases, the TRIPS Council nonetheless had a clear 
interest in following developments in this area fro m a broader perspective, as clearly provided by 
Article 68 of the TRIPS Agreement.  He drew Memb ers' attention to the fact that there were two 
outstanding disputes concerning intellectual propert y matters, both of them concerning US laws, in 
relation to which the United States was under an oblig ation to bring its legislation into conformity 
with the TRIPS Agreement.  The first case concerned Section 110(5)(B) of the US Copyright Act, 
which a WTO panel had found in 2000 to be inconsis tent with the US obligations under Section l, 
Part II of the TRIPS Agreement.  The United States had been granted a period of one year to comply 
with the ruling, i.e. until July 2001. However, the US Copyright Act had still not been amended. 
252. The second case concerned a piece of US legisla tion affecting the renewal and enforcement of 
certain trademarks and trade or commercial names.  This legislation had been condemned more than 
three years previously.  On several occasions, th e European Communities had taken into account the 
difficulties of the United States to comply with th e DSB ruling and had accepted the extension of the 
implementation period.  He said that the European  Communities hoped that the United States would 
finally respect its compliance duty by 30 June 2005.  Since the reasonable period of time for withdrawing the TRIPS-inconsistent measure was still running in this case, he said his statement 
would focus only on the first of these two disputes. 
253. He said that a situation where a WTO Member  did not comply with its TRIPS obligations 
even after an adverse panel ruling was a cause of concern for the European Communities and for the 
WTO membership as a whole.  Such a situati on might have a broader negative impact on the 
application of the TRIPS Agreement around the worl d. Therefore, in accordance with Article 68 of 
the TRIPS Agreement, the European Communities cons idered that the TRIPS Council should at this 
stage monitor more closely the Un ited States' compliance with its copyright obligations as laid down 
in TRIPS. 
254. The European Communities believed that it was in  the best interest of the WTO Membership, 
including the United States, to ensure that appr opriate information was available to the TRIPS 
Council about the steps that the United States was ta king to amend its copyright legislation, in order 
to dispel any doubts about the United States' commitment to respect intellectual property rights.  Such 
a constructive approach should induce other Members to  take similar steps in similar situations.  He 
said that his delegation was confident that the United States would have no problem in answering some specific questions, as a proof of its strong  interest in the respect for the WTO rules on 
intellectual property.  By providing full informati on about the specific steps that it had taken to 
comply with TRIPS internally, the United States woul d be able to prove that it was willing to apply at 
home what it requested from other Members. 
255. He requested the United States to provide res ponses to the following three questions.  First, 
whether there were any specific legislative initiatives in the United States to bring the Copyright Act 
into compliance with the TRIPS Agreement;  in other words, whether, during the past four years, the 
US Congress had discussed any piece of legislatio n amending Section 110(5) of the US Copyright 
Act.  Secondly, what specific step s the US Administration was taking to  ensure that the United States 
would bring its Copyright Act into conformity with  the TRIPS Agreement and whether there had been 
any written communication to Congress that the United States could share with the Council.  Thirdly, 
when did the United States expect to finalize its wo rk to comply with the WTO ruling that had been 
adopted in July 2000.  IP/C/M/47 
 Page 49 
 
 
 256. The representative of the United States  said that, since he had not received advance notice of 
these questions, he would relate them to his capital and respond in the course of coordination with the 
European Communities.  He said that the US administration had been consulting with the 
US Congress on this matter and would continue to work with Congress and to confer with the 
European Communities in order to reach a mutually satisfactory solution on this matter.  He said that 
these points had also been made by his delegation in  the DSB, which his delegation viewed as a more 
appropriate forum for the discussion of disputes,  including compliance issues related to those 
disputes. 
257. In response, the European Communities  recalled that Article 68 of the TRIPS Agreement 
stated that the TRIPS Council should monitor the ope ration of this Agreement and, in particular, 
Members' compliance with their obligations ther eunder.  While the DSB was the right forum to 
discuss specific issues related to disputes, his delegation believed that the TRIPS Council had an 
interest in examining special situations of non- compliance with TRIPS obligations.  The matters 
raised in the present meeting went beyond the specifics of a particular dispute and posed an important systemic issue in view of the fact that more than four years had lapsed since the adoption of the panel 
report.  The TRIPS Council was, therefore, entitled to discuss the consequences of such a situation for 
the overall operation of the TRIPS Agreement. 
258. The Council took note
 of the statements made. 
O. OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS  
259. The Chairman  said that the list of the 16 pending requests for observer status in the TRIPS 
Council by other intergovernmental organizations wa s contained in document IP/C/W/52/Rev.10.  He  
recalled that the Council had discussed these pending re quests at its previous meetings, but had not 
been able to reach consensus on any of them.   
P. OTHER BUSINESS  
260. The representative of the European Communities  recalled that the TRIPS Agreement had 
entered into force ten years previously and that much  had been done during this period to comply with 
its provisions, in particular those relating to enforcement, ensuring a balance between creating 
incentives for innovation through private rights and ser ving society's interest in the dissemination of 
knowledge through the limitation of these rights.  However, during this period, counterfeiting and 
piracy had been increasing worldwide and had be come a threat to the economy as a whole, and 
potentially dangerous counterfeit a nd pirated goods such as pharmaceuti cals, foodstuff and drinks, car 
and aeroplane spare parts, electrical devices and indus trial machinery were threatening consumers' or 
users' health and safety. 
261. He said that effective enforcement of IPRs was cl early in the interest of all WTO Members, in 
particular developing countries which had an inte rest in attracting foreign investment, developing 
R&D activities, encouraging technology transfer and,  above all, protecting th eir consumers who were 
often particularly exposed to sales of dangerous pr oducts, such as counterfeit medicines.  Given the 
apparent contradiction between th e introduction of the first compre hensive, multilateral set of IP 
enforcement rules and the increase in the levels of counterfeiting and piracy, his delegation wished to 
initiate a debate on this issue in the TRIPS Council pursuant to Article 68 of the TRIPS Agreement.  
He said that his delegation intended to submit a communication on this issue to the TRIPS Council at 
its next session in June.  In order to organize th e discussion in a structured and focused way, he 
suggested that a specific item on enforcement be added permanently to the agenda of the TRIPS 
Council.   IP/C/M/47 
Page 50  
 
 262. The representative of Brazil
 said that, since Members were confronted with this proposal 
from the European Communiti es for the first time and without an y advance notice, it was difficult for 
them to take a position on it at the present time.  He  said that he was looking forward to receiving the 
document foreshadowed by the European Commun ities.  However, in the absence of more 
information and clarity on the nature, extent and obj ectives of the proposed exercise, he believed it to 
be entirely unreasonable to expect Members to agree to having a new item added to the agenda of the 
Council's next meeting.  Therefore, he suggested th at the Council should not agree to include the new 
item proposed by the European Communities on its agenda.  The European Communities could raise 
the issue again under "Other Business" at the Counc il's next meeting and intr oduce its submission at 
that time.  In the meantime, other Members could obtain proper instructions from their capitals in 
order to be able to respond to the proposal. 
263. The representative of Argentina  said that it was not clear to her what should be the scope of 
any debate ensuing under the proposal and that she preferred to wait for additional information in the 
document foreshadowed by the European Communities.  In order to request instructions from her 
capital, she would need to know more details concer ning the scope of and objectives pursued by that 
proposal. 
264. The representative of India  said that he would need instructions from his capital before being 
able to agree to the inscription of this new item on the Council's agenda, in particular as it was 
suggested as being a permanent item on that agenda .  He hoped to receive the proposal well in 
advance of the Council's next meeting in order to be able to obtain instructions from his capital in 
time.  
265. The representative of the Philippines  said that it was of course the prerogative of any Member 
to seek the inclusion of any item on the agenda of a subsequent meeting, but it was equally the right of 
other Members not to agree to that agenda item, par ticularly if it was seen as falling outside the ambit 
of the jurisdiction of the TRIPS Council in this par ticular case.  As a matter of procedure, since the 
matter had been raised under "Other Business", hi s delegation believed that  the Council should not 
take any decision insofar as having the item inscri bed permanently on the agenda of all TRIPS 
Council meetings, as this was not an appropriate de cision to be taken under the heading of "Other 
Business".  While acknowledging the information that the European Communities was offering 
regarding their intentions in respect of the Council's next meeting, he was not in a position to agree to 
the inscription of this item as a permanent ag enda item in the Council's future meetings. 
266. The representative of Switzerland  said that Article 68 prescribed that the Council should 
monitor the operation of the Agreement, of which Part III on "Enforcement of Intellectual Property 
Rights" formed a part.  Furthermore, Article 68 pr ovided that Members be afforded the opportunity of 
consulting on matters relating to tr ade-related aspects of intellectual property rights.  This would be 
the first time that a delegation was told to table a paper under "Other Business" with regard to a 
subject which clearly fell under the TRIPS Agreement.   He noted that the agenda contained a number 
of items that his delegation disliked, but that did not mean that he would even consider demanding 
their deletion.  He supported the EC proposal to include the item on the agenda of at least the 
Council's next meeting, so that the proposal coul d be tabled and correctly discussed under a clear-cut 
agenda item.  To his knowledge, an item remained on the agenda for as long as it was being discussed 
by Members.   
267. The representative of Cuba  agreed with the statements made by Brazil, Argentina, India and 
the Philippines, and said that, in order to appr ove the inclusion of the aforementioned item on the 
agenda, she would need more informa tion and instructions from her capital.  IP/C/M/47 
 Page 51 
 
 
 268. The representative of Japan  welcomed the EC initiative as his Government was interested and 
engaged in the issues of enforcement and counterfei ting in the area of intellectual property.  He had 
no difficulty in adding enforcement as a new age nda item and was looking forward to receiving the 
EC submission and starting a new discussion at the Council's next meeting. 
269. The Chairman  referred to Rules 3, 4 and 6 of  the Rules of Procedure for Meetings of the 
General Council, and said that any item request ed by any Member would appear on the agenda 
proposed for the subsequent meeting.  Beyond that, he said that it had never been a tradition, neither 
in the years of the GATT nor of the WTO, to bar any item from discussion unless it was found to be outside the terms of reference of the body concerned.  
270. The representative of India
 said that he had wanted to stress that the agenda item should be 
phrased in the form of a proposal and that no Member  could have any objection to an agenda item in 
the style of "EC's Proposal on Enforcement".  Furtherm ore, he said that he did not see any language in 
the General Council Rules supporting a decision to inscribe an item as a permanent item on the 
agenda.  It was for these two re asons that he had suggested circ ulating the proposed submission well 
in advance to enable delegations to recei ve proper instructions from their capitals. 
271. The representative of Malaysia  said that, in view of the Rules of Procedure, the Council 
would be obliged to discuss a subject brought to it by a Member.  In the context of enforcement, however, her delegation wanted to highlight Article  7 of the TRIPS Agreement, according to which 
the protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissem ination of technology, to the mutual advantage 
of producers and users of technological knowledge a nd in a manner conducive to social and economic 
welfare, and to a balance of rights and obligati ons.  She expressed her delegation's hope that the 
subject of enforcement received a balanced treat ment, as in any discussion in the TRIPS Council. 
272. The Council took note
 of the statements made. 
Q. ELECTION OF CHAIRPERSON  
273. The Chairman  said that, at its meeting of 15 Febr uary, the General Council had noted the 
consensus on the slate of the names of chairp ersons for WTO bodies.  On the basis of the 
understanding reached, he proposed that the Counc il for TRIPS elect H.E. Ambassador Choi Hyuck 
of Korea as its Chairman for the coming year by acclamation. 
274. The Council so agreed . 
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