RESTRICTED  WORLD TRADE  
ORGANIZATION  IP/C/M/63 
4 October 2010 
 
 (10-5059) 
Council for Trade-Related Aspects of 
Intellectual Property Rights  
 
 
 
MINUTES OF MEETING 
 
Held in the Centre William Rappard on 8-9 June 2010  
 
Chairperson:  Mr. Martin Glass (Hong Kong, China) 
 
  The present document contains the record of the discussion which took place during the 
Council for TRIPS meeting held on 8-9 June 2010. 
 
A.
 NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT ..........................................................6  
B. REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION ...............................................................6  
C. REVIEW OF THE PROVISIONS OF ARTICLE 27.3(b)........................................................................7  
D. RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND THE CONVENTION ON 
BIOLOGICAL DIVERSITY ..............................................................................................................7  
E. PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE .....................................................7  
F. NON-VIOLATION AND SITUATION COMPLAINTS ........................................................................22  
G. REVIEW OF THE IMPLEMENTATION OF THE AGREEMENT UNDER ARTICLE 71.1 ........................23  
H. REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON 
GEOGRAPHICAL INDICATIONS UNDER ARTICLE 24.2.................................................................23  
I. FOLLOW -UP TO THE SEVENTH ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE 
DECISION OF THE IMPLEMENTATION OF ARTICLE 66.2  OF THE TRIPS AGREEMENT ...................25  
1. Follow-up to the seventh annual review................................................................................25  
2. Arrangements for the ei ghth annual review.........................................................................27  
J. TECHNICAL COOPERATION AND CAPACITY BUILDING ...............................................................27  
1. Annual updates on technical cooperation activities.............................................................27  
2. Other ma tters .................................................................................................................. ........28  
K. LETTER FROM THE CHAIR OF THE GENERAL COUNCIL CONCERNING WAYS TO IMPROVE 
THE TIMELINESS AND COMPLETENESS OF NOTIF ICATIONS AND OTHER INFORMATION 
FLOWS ............................................................................................................................... ........33  
L. IMPLEMENTATION OF PARAGRAPH 6 SYSTEM ...........................................................................36  
M. ENFORCEMENT TRENDS .............................................................................................................49  
N. INFORMATION ON RELEVANT DEVELOPM ENTS ELSEWHERE IN THE WTO .................................68  
O. OBSERVER STATUS FOR INTERNATI ONAL INTERGOVERNMENTAL ORGANIZATIONS .................68  
P. OTHER BUSINESS .......................................................................................................................70  IP/C/M/63 
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1. In proposing the agenda for adoption, the Chairman
 said that item L on "Implementation of 
Paragraph 6 System" had been put on the proposed ag enda at the written request of the delegations of 
Brazil, China, Cuba, Ecuador, India, Indonesia, Pe ru and Venezuela, dated 26 May 2010, and that 
item M on "TRIPS-plus Enforcement Trends" had been  put on the proposed agenda at the written 
request by the delegations of China and India, also  dated 26 May.  He proposed that the Council adopt 
the agenda as proposed. 
2. The representative of Switzerland  said that, while his delegation had had an opportunity to 
discuss the intention behind item L in consultations and open-ended informal m eetings preceding this 
formal session, it had not received any information or supporting documentatio n with regard to the 
proposed agenda item M that that would explain what the proponents wished to discuss under it.  
Under such circumstances, his delegation found it difficult to adopt the agenda and asked the 
proponents to clarify the purpose of their proposal a nd what they wished to discuss under agenda that 
item. 
3. The representative of India  said that adequate notice had been given for agenda item M as per 
the rules of procedure.  In his view, the nomencl ature of the agenda item was sufficiently descriptive 
to convey the intended topic of discussion.  He al so referred to Article 68 of the TRIPS Agreement 
which stated that the Council for TRIPS "shall monito r the operation of this Agreement" and that it 
"shall afford Members the opportunity of consulting  on matters relating to trade-related aspects of 
intellectual property rights".  It was under these pr ovisions that India had brought the agenda item. 
4. The representative of Japan  said that, while the first new agenda item on implementation of 
Paragraph 6 system had been previously discussed at some sessions and informal consultations, no 
specific progress had been made during these discussi ons and there was no information showing any 
further progress so far.  As the annual review of th e functioning of the Paragraph 6 system was on the 
agenda for the Council's next session in October, he saw no specific reason why it should be discussed 
at the present session.  Having said that, he did no t disagree with the addition of this item on the 
agenda, but asked the proponents to explain why they be lieved this to be urgent, in the absence of any 
new specific problem. 
5. With respect to the second new agenda item on TRIPS-plus enforcemen t trends, he believed 
that Members had the right to sugg est agenda items for inclusion through written requests if they so 
wished.  At the same time, his delegation would appreciate it if the proponents could provide enough 
information on the content of the proposed item in advance, for example, by submitting documents, in 
order to use effectively the limited time availabl e in the Council, and to allow fruitful discussion 
based on sufficient information.  Since no conc rete information on this agenda item had been 
presented, his delegation preferred to discuss this item at the next or a later Council meeting once 
enough information on the matter ha d been provided to Members. 
6. The representative of China  said that she believed that it was any Member's right to make 
agenda proposals to the Council for TRIPS without  any procedural requirement to explain the 
proposed agenda item through a communication or any other form of document.  While it was true 
that, due to the workload of the Council for TR IPS and other WTO bodies, her delegation had not 
provided detailed information of the agenda item, I ndia had already pointed out that the agenda item 
was itself descriptive and gave Members a sense of th e topic that was to be discussed.  China agreed 
that enforcement was a long-term issue, but the publication of the draft Anti-Counterfeiting Trade 
Agreement (ACTA) in April 2010 had added a new el ement.  This was why her delegation hoped to 
have the opportunity at the present meeting to expr ess its views on this important event and on other 
developments.  She said that if that opportunity  was given, her delegation would give a full 
explanation of why this issue was raised and what were the concerns of China and other Members.   IP/C/M/63 
 Page 3 
 
 
  China believed that the WTO was a forum in whic h Members could discuss issues relevant to the 
Council for TRIPS, and she insisted that the agenda be adopted. 
7. The representative of the European Union  said that the discussion gave him a feeling of 
déja-vu , or to be grammatically correct, déja-entendu .  He was very pleased that China and India now 
suggested adding the issue of enforcement on the agenda  of this Council meeting.  He recalled that the 
European Union, together with other Members,  had initiated a discussion on enforcement several 
years ago, at which time China, India, Brazil a nd others had opposed putting the item on the agenda.  
The fact that these delegations now wanted to di scuss not only TRIPS enforcement, but TRIPS-plus 
enforcement, was a change of mind which was welcom e in principle and his delegation was as always 
ready to discuss this in a constructive spirit.  Ho wever, given that no communication had been tabled 
in connection with this request and recalling that hi s delegation had been reproached for not tabling a 
communication on enforcement when it had proposed the agenda item, he did not agree with the 
inclusion of this item on the agenda, unless it was renamed "TRIPS enforcement", or "IPR 
enforcement trends", which was definitely a topic his delegation wished to address.  The European 
Union would then, of course, reserve the right to table its own communications for future meetings.  
Unless this change was accepted, his delegation woul d oppose this item on the agenda, just like these 
very delegations had opposed adding enfo rcement on the agenda a few years ago. 
8. The representative of Ecuador  said that his delegation supported the inclusion of the item on 
implementation of the Paragraph 6 system as a standing item on the agenda and also endorsed 
inclusion of item M as put forward by India and Ch ina.  With respect to Japan's question why some 
delegations wished to deal with the first issue on a permanent basis without prejudice to the annual 
reviews under Paragraph 6, he said the reason was that Members' decisions in this Council had an 
influence on human life, particularly in countries that did not have the full capacity to manufacture pharmaceutical products.  With regard to enforcemen t trends, he said that it was important for 
Members to be aware of negotiations in other fo ra aimed at enhancing enforcement through other 
legal means and instruments, and which were theref ore of direct relevance to intellectual property. 
9. The representative of Switzerland
 said that he was not opposed to an enforcement item on the 
Council's agenda.  On the contrary, in view of Pa rt III of the TRIPS Agreement, he believed that 
enforcement was an important topic for discussion, which was very much within the purview of the 
Council.  He noted with satisfaction that China ha d confirmed that enforcement was a relevant topic 
for the Council.  However, the agenda item, as currently proposed, seemed to go beyond Part III of 
the TRIPS Agreement and concentrate more on elemen ts outside the TRIPS Agreement and the WTO.  
He believed that one solution could be to reword the agenda item in a more general fashion, for 
example as "enforcement developments", thereby allowing all WTO Members to adequately present 
their views discussing the topic of enforcement. 
10. The representative of Cuba  supported the inclusion of the item proposed by India and China 
on the agenda.  There was a worrying trend to go ab ove and beyond the enforcement standards set out 
in the TRIPS Agreement.  Her dele gation believed that it was highly relevant to discuss this topic in 
the Council, especially as Article 68 of the Agre ement clearly established the opportunity for 
Members to hold consultations on issues related to trade-related intellectual property rights. 
11. The representative of Brazil  noted the European Union's reference to the history of previous 
discussions about whether or not items on enforc ement should be included on the Council's agenda 
and said that he was fully aware of that history and of the position that Brazil had taken.  He 
supported the inclusion of the item proposed by Chin a and India as TRIPS-plus enforcement trends on 
the agenda of the present session of the Council. IP/C/M/63 
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  12. The representative of India
 said that the statements by the European Union, Japan and 
Switzerland reminded him of the fact that these thre e delegations had been among the four which had 
brought this item on the Council's agenda in eight  successive meetings in 2005, 2006 and 2007.  In 
response to the objections raised, he said that th e wording of the item was perfectly justified as his 
delegation did not wish to discuss general enforcemen t issues, but specifically the current trends in 
IPR enforcement that went well beyond the levels enshrined in the TRIPS Agreement.  Cuba had 
already referred to Article 68 of the Agreement wh ich afforded Members the opportunity to discuss 
issues regarding the implementation of the Agreement. 
13. In response to the European Union, he said that his delegation's position had not changed 
since the last time this agenda item had been di scussed, as India continued to hold that enforcement 
was not a permanent agenda item for the Council for TRIPS.  An agenda item could not become a 
permanent item just because a group of countries rai sed it systematically in successive meetings.  His 
delegation also continued to believe that IPR en forcement could not be treated separately from the 
objectives and principles contained in Articles 7 and 8 of the Agreement, and the implementation of 
the Agreement as a whole.  The submissions made in 2005, 2006 and 2007 by the United States, the 
European Union, Japan and Switzerland had been more apt for discussion under Members' obligations 
to notify laws and regulations under Article 63, instead  of Article 68, so that their compatibility with 
their rights and obligations of the Agreement could be scrutinized.  He said that, while holding this 
position, his delegation had never blocked a discuss ion on the issue, but had clarified in successive 
Council meetings that the inclusion of that agenda  item should not in any way be construed as India's 
acceptance of its inclusion as a permanent agenda ite m for the Council, or of its willingness to engage 
substantively on issues raised by Members under that  item.  Against that background, his delegation 
urged Japan, Switzerland and the European Un ion to accept the agenda item as it was. 
14. Referring specifically to Japan's question on why a separate item on the Paragraph 6 System 
had been proposed when an annual review agenda ite m already existed in the October meetings of the 
Council, he said that there were two explanations.  The first one was th at, as previous attempts to raise 
this item under "Other Business" had met with proce dural concerns from some delegations that there 
could not be any decision under "Other Business", th e item was now proposed fo r the regular agenda.  
The second point was that while there seemed to be  emerging consensus among Members to devote 
an entire day of the Council's October meeting to th e Paragraph 6 System, they had also considered it 
useful to have some discussion at this stage to deci de the nature of this engagement prior to that 
meeting.  It was to enable such a decision by th e Council that this agenda item had been proposed. 
15. In response to a question from Japan, the Chairman  said that in case the agenda were to be 
adopted with the proposed item L, that item would only be on the agenda of the current session unless 
a Member requested it to be added on the agenda for any subsequent meeting, or unless Members 
otherwise decided. 
16. The representative from Switzerland  said that, in light of Indi a's remarks, considering that 
agenda item M had been proposed by two delegations , and taking into account that it was the tradition 
in the WTO not to refuse agenda items proposed by  one or more delegati ons, his delegation could 
accept the agenda in the spirit of compromise as l ong as this did not imply Switzerland's acceptance 
of any of the two agenda items, L and M, as permanen t agenda items, and particularly with regard to 
item M, it did not imply its consent to discuss yet unknown issues.  His delegation would only decide whether to engage in this discussion once mo re information was available on the topic. 
17. The representative of Mauritius, sp eaking on behalf of the ACP Group
, said that he supported 
the inclusion of both items L and M.  In the li ght of informal discussions, he believed that a 
compromise could be struck concerning item L.  Concerning item M, he said India had fully explained that this was not intended as a permanent ag enda item, and that its description clearly stated 
what Members wanted to discuss.  Therefore, he urged Members to accept it.  IP/C/M/63 
 Page 5 
 
 
  18. The representative of Venezuela  said that, in his view, an agenda item could only be 
withdrawn by the Member that had proposed it.  He also requested the Secretariat to explain the rules 
of procedure with regard to proposal of items for the agenda. 
19. The Secretariat  said that the rules of procedure for the Council for TRIPS were those of the 
General Council with some modifications.  Rule 3 said that "[i]t shall be open to any Members to 
suggest items for inclusion in the proposed age nda up to, and not including, the day on which the 
notice of the meeting is to be issued", which under Rule 2 was 10 calendar days prior to the date set 
for the meeting.  Rule 4 said that ""[r]equests fo r items to be placed on the agenda of a forthcoming 
meeting shall be communicated to the Secretar iat in writing, together with accompanying 
documentation to be issued in connection with that item".  In this case, the Secretariat had received 
the written communications on 26 May. 
20. The Chairman  said that he sensed agreement among Members to include item L on the 
agenda.  With respect to item M, in view of the suggestion to amend it to something more general, he 
asked whether Members could accept to include item M on the agenda for the current meeting if it 
was re-titled as "Enforcement Developments", wit hout prejudice to what might happen in future 
meetings. 
21. The representative of Argentina  said that her delegation would like to put on record that it 
preferred the original title of "TRIPS-plus Enforc ement Trends" and did not agree with the amended 
title.  This being said, her delegation did not want to block the meeting. 
22. The representative of Venezuela , supporting Argentina's position, said that the item could also 
refer to enforcement de velopments and trends. 
23. The representative of Mauritius  said that the procedures were clear.  The mandatory 10-day 
time-frame for proposing items had been respected a nd it was therefore up to the proponents to decide 
whether they wanted to withdraw the item.  If other Members wanted to propose a more general 
agenda item, provided it was not a permanent item, th ey would be free to do so for the next meeting. 
24. The representative of the European Union  said that his delegation agreed with the Chair's 
suggestion to call the item "Enforcement Developments". 
25. The representative of China  said that her delegation would like to follow the rule that those 
who had proposed an item could with draw or amend it, and consequen tly it was up to China and India 
to come up with a title for the agenda item.  Sh e said that the title that they had proposed was 
"TRIPS-plus enforcement trends" and that they would prefer that this title be maintained.  However, 
her delegation was prepared to show flexibilit y in order to allow the meeting to go on. 
26. The representative of India  said that, like China, his delegation's preference was to retain the 
agenda item as proposed.  However, in the spirit of  compromise India could go along with a more 
general formulation such as "Enfor cement Trends" in order to fac ilitate the smooth conduct of the 
meeting. 
27. The Chairman  suggested that the Council adopt the proposed agenda with item M amended to 
read as "Enforcement Trends". 
28. The Council took note  of the statements made and so agreed . IP/C/M/63 
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  A. 
NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT  
29. The Chairman  said that, since its meeting in Marc h 2010, the Council had received a number 
of supplements and updates to ear lier notifications of laws and re gulations notified under Article 63.2 
of the Agreement.  Viet Nam had notified amendm ents to its Law on Intelle ctual Property and Penal 
Code, and a decree on sanctioning administrative viol ations of copyright and related rights;  Hong 
Kong, China had notified amendments to its pa tents, designs and trademarks ordinances and 
layout-designs regulation;  and the United States has no tified amendments to its trademark legislation.  
These notifications were being circulated in the IP/N/1/- series of documents. 
30. The Chairman urged those Members whose initia l notifications remained incomplete to 
submit the outstanding material without delay.  Sh e also reminded other Members of their obligation 
to notify any subsequent amendments of their laws and regulations without delay after their entry into 
force.  He recalled that document IP/C/W/543, circulated at the Council session in October 2009, 
provided a detailed summary of the most recent no tifications by each Member in its Annex 2 and 
encouraged Members to double-check whether their no tifications were up to date.  He reminded in 
particular those Members who had made any changes to their laws and/or re gulations to implement 
the Decision on TRIPS and Public H ealth and who had not yet notified such changes to the Council to 
do so.  To date, the Secretariat had received notifi cations from Norway, Canada, India, the European 
Union, Switzerland, the Philippines and Singapore. 
31. With respect to notifications of contact points under Article 69 for the exchange of 
information and cooperation on trade in infringing go ods, he said that, since the Council's meeting in 
March, Guyana, Saint Kitts and Nevis, and Viet Na m had notified their respective contact points.  In 
addition, updates to contact points notified earlier had been received from Ecuador, Germany, and the 
Czech Republic.  These notifications had been circulat ed together with an updated list of all contact 
points in document IP/N/3/Rev.11. 
32. The representative of Korea  said that Korea's domestic IPR laws had undergone a 
comprehensive revision during the last six months, and that his delegation would provide the list of 
laws under revision to the Secretariat shortly.  The full texts would be provided later when the 
translation into English was complete. 
33. The Council took note  of the statements made. 
B. REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION  
34. The Chairman  said that, as regards the reviews of na tional implementing legislation that had 
been initiated at the Council's meetings since April 2001, there were five reviews that still remained 
on the Council's agenda.  These reviews concerned C uba, Fiji, Grenada, Saint Kitts and Nevis and 
Suriname. 
35. Since the Council's last meeting in March 2010, Grenada had provided responses to all of the 
outstanding questions posed to it in its review.  These responses had been circulated in document 
IP/Q/GRD/1/Add.1.  He suggested that the review  of Grenada be deleted from the agenda, it being 
understood that any delegation should feel free to re vert to any matter stemmi ng from this review at 
any time. 
36. The Council so agreed.  
37. The representative of Switzerland  thanked Grenada for its responses, and said that his 
delegation did not have any follow-up questions.  IP/C/M/63 
 Page 7 
 
 
  38. The Chairman  urged the other delegations concerned to  provide the outstanding material as 
soon as possible, so as to allow the Council to complete these reviews. 
39. The Council took note  of the statements made and agreed  to revert to the matter at its next 
meeting. 
C. REVIEW OF THE PROVISIONS OF ARTICLE 27.3(b) 
D. RELATIONSHIP BETWEEN THE TRIPS AGREEM ENT AND THE CONVENTION ON BIOLOGICAL 
DIVERSITY  
E. PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE  
40. The Chairman  suggested that the Council continue it s past practice of addressing these three 
agenda items together on the basis of contributions  by Members.  He recalled that, at the Council's 
meeting in March 2010, Bolivia had presented a comm unication on the review of Article 27.3(b) of 
the TRIPS Agreement (IP/C/W/545 and Corr.1).  Since it had been made available just prior to that meeting, some delegations had indicated that th ey intended to make further comments on it at the 
present meeting. 
41. The representative of Bolivia
 said that its afore-mentioned communication addressed the need 
to conduct a thorough examination of Article 27.3(b) of the TRIPS Agreement in order to ensure that 
plants, animals and all life forms and parts thereo f were excluded from patentability.  He said that 
discussions on the review of Article 27.3(b) were not in conflict with the discussions being conducted 
on the disclosure requirement.  On the contrary, Bolivia's proposal aimed to complement this 
important initiative by deepening the analysis of  the problem relating to Article 27.3(b) and 
patentability of life forms.  The approval of the TRIPS Agreement and in particular Article 27.3(b) 
triggered a "race for patents" on plants, micro-orga nisms, genes, genetic sequences and so forth, the 
main objective being to profit from the monopoly right s that the system granted on the pretext of 
promoting innovation.  The review of the provision s of Article 27.3(b), which was supposed to be 
conducted four years after the entry into force of the TRIPS Agreement, had yet to take place.  It was 
essential that, in the framework of that review, th e Council urgently conducted an in-depth assessment 
of the ethical implication and the concrete impact  of Article 27.3(b) and of patents on life forms. 
42. He said that Article 27.3(b) pe rmitted the patentability of all life forms and parts thereof, and 
of biological processes.  Moreover, on the basis of an  artificial distinction between plants and animals 
on the one hand, and micro-organisms on the othe r, and between essentially biological processes on 
the one hand, and non-biological and microbiological processes on the other, Article 27.3(b) required 
countries to permit the patentability of certain fo rms of life and certain biological processes.  
Article 27.3(b) encouraged the ad option of national laws that perm itted the patenting of plants and 
plant varieties as well as plant genetic resources, incl uding cells and parts thereof, such as genes and 
gene sequences, genetic resources of animals and mi cro-organisms.  According to the information 
available, up to the year 2000, only five years afte r the entry into force of the TRIPS Agreement, more 
than 500,000 patent applications had already been  filed for genes and partial genetic sequences of 
living organisms, and more than 9,000 for human genes.1  From 2000 to 2003, six times as many 
patents on animal cells and cell tissue had been registered than during the period 1990-2000.2  I n  
2001, there had been already 918 patents on rice, maize, wheat, soybeans and sorghum.3 
                                                      
1 The Ethics of Genetics, Gene Watch, The Guardian, November 2000. 
2 Carlos Correa, Trends in IPRs related to genetic resources for food agriculture, October 2009. 
3 ActionAid, Crops and Robbers, 2001. IP/C/M/63 
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  43. He said that the patent system had turned  into a tool for the privatization and 
commercialization of life itself on a scale and magnit ude that warranted concern.  Article 27.3(b) 
reflected a vision of nature as a raw material that c ould be privatized and sold, which was contrary to 
the cultural norms of many societies and peoples.  Life was sacred for the indigenous peoples of 
Bolivia and of the world and under no circumstance s should it be appropriated privately or seen as a 
piece of merchandise.  Innovation and control of bi ological resources were concentrated in a few 
private hands as a result of the adoption of th e TRIPS Agreement and of Article 27.3(b).  The 
patentability of life forms had encouraged and enab led the private sector and major transnational 
corporations to take control of innovation.  He  said that, of the thousands of seed companies and 
public crop development institutions that existed 30 years ago, there remained only ten transnational 
corporations that controlled more than two-thirds  of world sales of seeds under intellectual property.  
Seventy per cent of the patents on the five main cr ops consumed in the world were held by six large 
agrochemical companies.  Of nearly 1,000 em erging biotechnology companies that had existed 
15 years ago, a mere 10 now accounted for three quar ters of the revenue from the sector.  Because it 
was possible to patent life forms, sectors as importa nt to peoples as food, agriculture and health were 
coming under private control, and this was a matt er of great concern for Bolivia.  The resulting 
monopolistic control provided the capacity to define the type of technology used and to block research 
and innovation.  This situation was particularly wo rrying with the proliferation of patents on genes 
and gene sequences which enabled entire segments of fundamental technology to be controlled. 
44. The high number of patents on plants gave rise to serious concerns in the agricultural sector 
generally speaking, and in Bolivia in particular, owing to their impact on the use of seeds and access 
to germplasm for the reproduction of species and a dditional research.  He said that the United Nations 
Special Rapporteur on the Right to Food
4 had warned of this situation in his report of July 2009 by 
stating that intellectual property rights over pl ants, genes and DNA gene sequences directly limited 
the possibilities available to farmers for innovatio n and created an imbalance between the private 
sector and the public sector.  The most worrying thing about this situation was that the system enabled 
companies to control and take possession of the most important resources for innovation and 
traditional, conventional breeding, and throughout th e food chain, adversely affecting prices and the 
availability of food, and potentially aggravating th e food crisis affecting, in particular, small 
producers in countries such as Bolivia, whose practi ces were based on the right to harvest, store and 
exchange seeds with other rural farmers. 
45. He said that Article 255 of paragraph II of th e Constitution of Bolivia tried to tackle this 
problem when it stated that the signature of treaties shall be governed by the principles of respect for 
the rights of indigenous peoples, harmony with natu re, protection of biodiversity and prohibition of 
private appropriation of plants, animals, micro-or ganisms and any living matter for exclusive use and 
exploitation.  However, there was not much that this  provision could do if the main problem lay in the 
international system, and this was what had encour aged the Bolivian Government to move ahead with 
this initiative aimed at enhancing awareness of the negative impact of the provisions of 
Article 27.3(b) and of the need to correct them. 
46. The representative of Brazil  highlighted the importance of the TRIPS/CBD issue, saying that 
there had been a good deal of debate on this issu e and there was now a broad convergence of views 
among Members, including the need to prevent misa ppropriation of genetic resources.  It was widely 
recognized that prior informed consent and equita ble sharing of benefits arising from the use of 
genetic resources might not only have a positive imp act on traditional or indigenous communities in 
which genetic resources had originated, but also contribute to a high degree of certainty in the granting of patents in the country where genetic re sources were eventually used.  He said that the 
growing awareness of the need to prevent misa ppropriation of genetic resources and associated 
                                                     
 
4 Olivier de Schutter, Report on the Right to Food, July 2009.  IP/C/M/63 
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  traditional knowledge was yet to be translated in to agreement on how to achieve it, especially among 
different international organizations. 
47. It was positive that this issue was being consid ered in different forums, as long as different 
perceptions did not lead to lose the sight of th e broad picture and towards a dead end.  Forum 
shopping on this matter should be avoided.  Curre nt negotiations on access and benefit sharing of 
genetic resources at the CBD could come to a successf ul outcome by the end of 2010.  He welcomed 
the new mandate of WIPO's Intergovernmental Committee on Intellectual Property and Genetic 
Resources, Traditional Knowledge and Folklore (IGC)  to negotiate legally binding instruments and 
the agreement on how to fulfil its new mandate.  He  said that a group of countries preferred the WIPO 
to the WTO as a body to discuss intellectual propert y aspects of the use of genetic resources.  Several 
countries, including Australia, Canada, New Zeala nd, Norway and the United States, had tabled a 
proposal at the sixteenth session of the WIPO IGC, which contained a draft set of objectives and principles of the protection of genetic resources.   The objectives included "to ensure that patent 
offices have available the information needed to make proper decisions on patent grant" and "to 
prevent patents being granted in error for i nventions that are not novel or inventive". 
48. The best way to achieve these objectives would be an amendment of the TRIPS Agreement 
establishing a mandatory requirement of disclosure of origin of genetic resources in patent 
applications, while a provision to that effect was now here to be found in the proposal.  He said that, 
like a vast majority of the WTO membership, his delegation considered the WTO as the most 
effective body to address the intellectual property di mension of the use of genetic resources and to 
prevent misappropriation of biodiversity.  The WTO was an institution umbrella for the TRIPS 
Agreement - the single most important and comprehe nsive international treaty on intellectual property 
rights.  Document TN/C/W/52 was the result of a serious attempt to find common ground and balance 
among different countries and groups of countries across three intellectual property issues under 
discussions in the Doha Round.  As one of the origin al co-sponsors of that document, he reiterated his 
delegation's strong commitment to the proposal therein.   He expected that th e Director-General would 
continue his consultations with a view to moving forward the debate. 
49. He said that the Bolivian proposal on the review of the provisions of Article 27.3(b) merited 
serious consideration in the Council.  He said that  the Brazilian legislation excluded from patentability 
any life forms with the exceptions of genetically mo dified organisms that met the three criteria of 
novelty, inventive step and industrial applicati on, and that plant varieties were protected by 
sui generis  system. 
50. The representative of Venezuela
 supported the Bolivian proposal to examine Article 27.3(b) 
according to the Doha Work Programme.  He said that Article 124 of the Constitution of the Bolivian 
Republic of Venezuela prohibited the registry of patent of genetic resources. 
51. The representative of Ecuador  supported a thorough examination of Article 27.3(b) as 
proposed by Bolivia in document IP/C/W/545.  He said that the objective was to agree on a 
multilateral solution to prevent the patenting of a ll life forms, including biological resources, 
micro-organisms, genes and non-biological a nd microbiological processes, which were among the 
most important issues to be resolved in the Doha Round.  He said that this issue, apart from being a 
matter of the built-in mandate, was a basic component of the development dimension of the Doha Round and, consequently, had been, was and, when  the time came, would be, appraised by Members 
as part of the package of the Doha Round.  He agr eed in principle with several points made by Bolivia 
as regards the need to:  (a) find a multilateral solution in the context of the WTO to the problem of the 
non-recognition of the collective rights of indi genous communities, peoples and nationalities as 
regards their practices in managi ng biodiversity and thei r natural environment;  (b) deliberate on a 
solution to the misappropriation of biodiversity -related knowledge, innova tions and practices of 
indigenous communities, peoples and nationalities;  (c ) on the basis of an in-depth discussion, work IP/C/M/63 
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  out a comprehensive and mandatory commitment regard ing the prohibition of the patenting of plants 
and animals and other biological or microbiological processes relating to life forms;  (d) ensure food sovereignty, through the TRIPS Agreement, on the b asis of the promotion, conservation and recovery 
of agro-biodiversity and associated ancestral knowle dge, and the use, conservation and free exchange 
of seeds. 
52. He said that it was essential to reach a mu ltilateral solution in the framework of the 
TRIPS Agreement on:  (i) recognition in the multilate ral trading system of States' sovereignty over 
their biodiversity and all its components through th e TRIPS Agreement;  (ii) facilitating regulation, 
through specific bio-security standards compatible with the CBD and the TRIPS Agreement, of the 
use and development of biotechnology and experi mentation and sustainable marketing thereof;  
(iii) promoting the sustainability of biodiversit y through recognition of the collective rights of 
indigenous communities, peoples and nationalities,  regarding their biodiversity management 
practices, already recognized in multilateral le gal instruments of organizations, such as the 
United Nations. 
53. He said that, as a co-sponsor of the proposals contained in documents IP/C/W/474 and 
TN/C/W/52, his delegation considered that these pr oposals were the result of a wide-ranging technical 
discussion of nearly 10 years which had demonstrated the seriousness of biopiracy, misappropriation and depredation of biological/genetic resources whet her or not related to traditional knowledge, and 
the fact that the collective rights of local and i ndigenous communities were unprotected and abused.  
Members therefore should draw particular attentio n to:  (i) the importance of developing a real 
synergy in the relationship between the CBD and th e TRIPS Agreement, as a basis for the prevention 
of biopiracy, equitable benefit sharing and prior in formed consent, with sp ecific legal consequences 
for non-compliance;  (ii) the importance of making u se of the existing intellectual property system in 
order to protect biodiversity and promote sustainabl e and sovereign biotrade that respected collective 
rights;  and (iii) the amendment of the TRIPS Agre ement as regards the disclosure of origin, the legal 
consequence of misappropriation a nd the importance of the WTO's role in intellectual property and 
biotrade.  It was important to use and ad apt the existing intellectual property system, inter alia , in 
order to protect biodiversity and traditional knowledg e and to promote fair and sustainable biotrade 
for the benefit of owners within the framework of  the multilateral trading system.  The promotion of 
such biotrade was particularly relevant as the WT O dispute settlement system attached considerable 
importance to the harmonization and protection of intellectual property rights.  The WTO could be a 
suitable mechanism, amongst others, for protecti ng biodiversity and associat ed traditional knowledge. 
54. The representative of India
 said that the year 2010 had been proclaimed as the International 
Year of Biodiversity.  This held a special  significance for India which was one of the 
12 mega-biodiverse countries of the world.  With only 2.4 per cent of the land area, India already accounted for seven to eight per cent of the recorded  species of the world.  This number was based on 
the survey of 65 to 70 per cent of the total geographical area of the country.  Over 47,000 species of 
plants and 81,000 species of animals had been r ecorded by the Botanical Survey of India and the 
Zoological Survey of India respectively.  It was antic ipated that some of the remaining areas, such as 
the Himalayan region, Andaman and Nicobar Islands, might be far richer in biological diversity than 
most of the areas already surveyed.  India was also one of the twelve primary centres of origin of 
cultivated plants.  India was equally rich in traditional and indigenous knowledge, both coded and 
informal. 
55. Pursuant to the ratification of the CBD, India had developed a comprehe nsive legislation on 
biodiversity, enacted Biological Diversity Act in 2002 and notified Biological Diversity Rules in 2004.  This Act gave effect to the provisions of  the CBD, including those related to access and benefit 
sharing and prior informed consent.  In 2003, th e National Biodiversity Authority had been set up.  
All matters relating to requests for access by foreign individuals, institutions or companies, and all 
matters relating to transfer of results of research  to any foreigner were dealt with by the National  IP/C/M/63 
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  Biodiversity Authority.  India also had a vast resource of traditional knowledge that was 
well-documented in many languages in cluding Sanskrit, Hindi, Urdu, Arabic and Tamil.  Before the 
Government had implemented th e Traditional Knowledge Digital Library (TKDL), it had been 
challenging for patent examiners across the wo rld to access this knowledge and assess claims of 
novelty in a patent application based on traditional Indian systems of Medicine.  With the TKDL 
initiative, language and format ba rriers had been overcome and information was now scientifically 
structured in five international languages with th e help of the information technology and a unique 
classification system called the Traditional Knowledge Resource Classification. 
56. India had signed the TKDL Access Agreement w ith the European Union, the United States, 
the United Kingdom and Germany.  Since July 2009, I ndia had identified 36 patent applications at the 
European Patent Office which concerned Indian syst ems of medicine in which third party evidence 
had been filed.  In two cases, the European Patent Office set aside its intention to grant patents after 
receiving the TKDL evidence.  In the other 11 cases in cluding an application by an Indian company, 
applicants themselves had decided to withdraw their f our to five year old applications when they had 
been confronted with the TKDL evidence.  While through the TKDL, India had created a defensive 
mechanism against erroneous patents, the TKDL re mained only one of the multiple tools required to 
address the much larger issue of misappropriatio n of genetic resources and associated traditional 
knowledge and could be a useful complement to a mandatory disclosure requirement in patent 
applications. 
57. He said that India looked forward to the 10th CBD Conference of Parties (COP) scheduled to 
meet in Nagoya, Japan in October 2010.  He said that negotiations on the Protocol to Access and 
Benefit Sharing of Genetic Resour ces and Associated Traditional Knowledge were the most important 
negotiating process in progress in th e CBD.  Without an effective In ternational Protocol on Access 
and Benefit Sharing, aimed at stopping biopiracy and providing legal certainty, the underlying causes 
that led to the loss of biodiversity and the impl ementation deficit regardi ng the fair and equitable 
sharing of the benefits arising out of the utiliza tion of genetic resources w ould not be fully addressed. 
58. He said that this effort would remain incomp lete without a mutually supportive relationship 
between the TRIPS Agreement and the CBD.  The most  appropriate way forward was contained in the 
disclosure proposal in document IP/C/W/474 and sub sequently, the key parame ters contained in the 
modalities text on three TRIPS issues in document TN /C/W/52.  He said that the TRIPS Agreement 
continued to ignore numerous intellectual property right-related obligations in the CBD.  This 
contradiction not only obstructed the proper implementation of the CBD but also caused an imbalance 
in the TRIPS Agreement.  The incomplete disclos ure requirement as contained in Article 29 of the 
TRIPS Agreement needed to be rectified.  This asp iration had been voiced by a vast majority of the 
WTO membership, including developed and de veloping countries.  About 110 Members had 
proposed key parameters contained in document TN/C/W/52 as a sound basis for the way forward on 
the substantive and procedural treatment of the i ssues of TRIPS-CBD, GI extension and GI register. 
59. He was appreciative of the consultations held  by the Director-General since March 2009 in 
accordance with the mandate contained in paragraph 39 of the Hong Kong Ministerial Declaration.  
The consultations had provided an opportunity for focused discussions among Members involved in the exercise to improve the understanding of techni cal and legal issues.  He recalled that, at the 
open-ended meeting of 12 March 2010, the Direct or-General had acknowledged that Members had 
agreed on the shared objectives in cluding combating misappropriation, complying with the conditions 
of prior informed consent and equitable benefit sh aring, and avoiding erroneous patents.  He was 
concerned that the momentum of such meetings had slackened of late.  During the year of 2010, only 
one meeting had taken place.  He urged the Direct or-General to intensify his consultations on the 
issues of TRIPS/CBD and GI extension in acco rdance with paragraph 39 of the Hong Kong 
Ministerial Declaration.  He also requested the Director-General to draw up a road map for his 
consultations on the TRIPS issues alongside the Special  Session process on the issue of GI register.  IP/C/M/63 
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  He reiterated that an outcome on the TRIPS issues w ould be an integral part of the Doha development 
package. 
60. The representative of Peru
 said that his delegation's position on the three agenda items was in 
line with India, Brazil and Ecuador.  While the CBD recognized national sovereignty over genetic 
resources, the TRIPS Agreement contained the prov isions that allowed the granting of patents on 
biological resources and did not prevent biopiracy.  Unlike the CBD, the TRIPS Agreement contained 
no provision that would ensure prior informed con sent or equitable sharing of the benefit with the 
owners of the biological resources used in invent ions.  Hence, his delegation was in favour of 
amending the TRIPS Agreement to introduce a requirement of disclosure of origin and source of genetic resources, whether or not related to tr aditional knowledge, and the evidence of compliance 
with prior informed consent and benefit sharing in patent systems.  He said that the multilateral and 
mandatory disclosure requirement would be the mo st efficient way to address misappropriation of 
genetic resources and traditional knowledge as it would allow all countries to track down the 
supplying country by requiring patent applicants to disclose the country of origin as well as evidence of compliance with prior informed consent and benefit sharing.  Furthermore, the disclosure 
requirement would provide a platform to facilita te the compliance with the CBD and to prevent 
biopiracy.  This would ensure the adequate co mpatibility between the TRIPS Agreement and the 
CBD. 
61. He said that the intellectual property system was an important tool for economic, social and 
cultural development in Peru.  This conviction, in  addition to the need to improve the intellectual 
property system and to prevent its misuse to the de triment of developing countries, had prompted Peru 
to co-sponsor document TN/C/W/52.  He said that Pe ru did not seek to prevent access to or use of its 
natural resources, but to protect the nature resource and to ensure its sustainable use, which would be 
of benefit to all Peruvians, particularly indigeno us communities and peoples.  Peru did not oppose the 
granting of intellectual property rights either, but wa nted to promote intellectual property rights in 
accordance with national and international laws.  The disclosure requirement recognized the rights of 
the WTO Members, local communities and indigenous peoples over their genetic resources.  Only by 
taking action against biopiracy would Members suc ceed in establishing a proper balance in patent 
systems and in intellectual property systems.  In tellectual property systems should be based on the 
promotion of innovation.  The WTO Members s hould contribute to improving the intellectual 
property system for the benefit of all Members, in  particular the local and indigenous communities in 
developing countries. 
62. The representative of Cuba
 said that these three items had been  discussed for nine years in the 
Council.  The TRIPS/CBD issue was one of the issu es and concerns related to  the implementation and 
therefore her delegation had committed itself to findi ng appropriate solutions.  Cuba had co-sponsored 
the proposals contained in documents IP/C/W/ 474 and WT/GC/W/590 respectively, which should be 
the basis for Members' work.  The introduction of a compulsory requirement of disclosure of origin of 
genetic resources could significantly contribute to  the protection of genetic resources against 
misappropriation and could have an impact on the achievement of the CBD objectives, in particular 
those related to biological resources and traditi onal knowledge.  The disclosure requirement would 
also facilitate the functioning of existing inte llectual property systems.  She appreciated the 
consultations held by the Director-General and appealed for more open-ended sessions to safeguard 
transparency.  While recognizing the ongoing work  in other forums, such as WIPO and CBD, she 
highlighted the relevance and importance of finding a solution in the WTO, and said the outcome in 
other forums would be complimentary to, but not  replace an amendment of the TRIPS Agreement. 
63. The representative of Indonesia  supported constructive refl ections and discussions of 
patentability of life forms in the context of review of Article 27.3(b).  He highlighted the importance 
of preventing misappropriation and misuse of genetic  resources, traditional knowledge and folklore 
and supported the disclosure proposal.  He said th at the deliberation in the Council could not be  IP/C/M/63 
 Page 13 
 
 
  separated from the development in  other forums and that all th e relevant forums should be 
complementary to each other. 
64. The representative of China  agreed with the overall objectives set up in the Bolivian proposal 
which aimed at protecting the rights of indigenous peoples and local communities.  She said that the proponents of document TN/C/W/52 wished to achieve these objectives, and that a number of 
consultations had already been held in order to find ways and means to achieve these objectives.  She 
said that the Council for TRIPS was the most appropr iate forum to address the TRIPS/CBD issue.  
She reaffirmed her delegation's endorsement of document TN/C/W/52, saying that detailed 
discussions should be conducted by the Director-Gen eral according to the Hong Kong mandate soon. 
65. The representative of Nigeria
 said that, after more than a decade of discussions in the Council 
for TRIPS, a majority of the WTO membership pr oposed to amend the TRIPS Agreement to provide 
for a mandatory requirement of disclosure of prior informed consent and equitable sharing of benefit 
arising from the use of genetic resources and asso ciated traditional knowledge.  The amendment 
would fulfil the objectives and principles provided for in Articles 7 and 8 of the TRIPS Agreement 
and establish an adequate and effective coordina tion between the TRIPS Agreement and the CBD.  
The amendment would ensure the mutual supporti veness between the TRIPS Agreement and the CBD 
and avoid potential conflict in their applications .  To this end, the Council for TRIPS was only for 
solving the problem of misappropriation of genetic  resources and associated traditional knowledge.  
The TRIPS Agreement was the only international agreement on trade-related intellectual property 
issues with the dispute settlement mechanism. 
66. He said that a report entitled "Pirating African  Heritage:  the Pillaging Continues" by the 
African Centre of Biodiversity brought to light the c oncern over the flexible nature of patents in some 
countries, which had been used to promote misappr opriation of biological resources and associated 
traditional knowledge from developing countries.  Biopi racy had become an international issue, which 
needed to be discussed at the international level.   While the protection of  patents, copyright and 
trademarks had already been subject to enforcemen t at the national level, IPR protection had been 
introduced into the WTO.  The disclosure requi rement would not impose undue burden on African 
applicants but rather would ensure legal certainty  in the patent system, thereby encouraging the 
investment in the field of biotechnology. 
67. He said that, according to the proposal of the draft modalities as contained in document 
TN/C/W/52, three TRIPS issues must be dealt with in parallel and expeditious ly.  The proponents had 
come to the conclusion that the only way to co mbat biopiracy and misappropriation of genetic 
resources and associated traditional knowledge was th rough an amendment of the TRIPS Agreement.  
The amendment would ensure the disclosure of orig in of biological resources, evidence of prior 
informed consent, and evidence of equitable benef it sharing.  The disclosure requirement would add 
value to resources in developing countries and woul d ensure the balance between indigenous peoples 
and intellectual property right holders.  He welcom ed the engagement of the Director-General as 
mandated by the Hong Kong Ministerial Declaration.   During the consultations held by the 
Director-General, all questions and answers helped to cl arify most, if not all, of the concerns raised by 
the opponents.  He called for the resumption of c onsultations, which would eventually lead to the 
modalities on the three TRIPS issues. 
68. The representative of Angola, speaking on behalf of the LDC Group , said that the LDC Group 
was particularly interested in ensuring that th e outcome of the review of the provision of 
Article 27.3(b) would not constrain LDCs from using the TRIPS Agreement to advance national 
development interests nor result in situations that would go counter to morality.  As highlighted in 
paragraph 19 of the Doha Ministerial Declaration, th e review of Article 27.3(b) was closely linked to 
the TRIPS/CBD issue, as well as the issue of pr otection of traditional knowledge and folklore.  The 
LDC Group appreciated the efforts undertaken by th e Director-General to conduct parallel informal IP/C/M/63 
Page 14  
 
  consultations on the issues of TRIPS/CBD and GI extension.  The review process should clarify 
Article 27.3(b) so that plants and animals as well as micro-organisms and a ll other living organisms 
and their parts should not be patented, and processes that produced plants, animals and other living 
organisms should not be subject to patent protec tion either.  He highlighted the importance of 
retaining the flexibility on the form of sui generis  systems to be developed and implemented by 
countries in protecting plant varieties based on i ndividual country systems and needs, which would 
contribute to improving food security situation of indi genous peoples by ensuring that their inventions 
were protected and access to seed was guaranteed. 
69. He said that the LDC Group welcomed the in formal consultations conducted by the 
Director-General.  Biodiversity was an important source of livelihood for populations living in rural 
areas in most LDCs, yet benefits arising from the appropriation of such resource and the use of their 
traditional knowledge by multinational corporations  had barely been shared with the communities 
concerned.  This was a matter of concern to th e LDCs requiring corrective action through a mandatory 
requirement of disclosure of country of origin of  the genetic resources and the associated traditional 
knowledge used in the invention.  Meanwhile, it was equally important to ensure that patent 
applicants demonstrated that they  had obtained prior informed c onsent from competent authorities in 
the country of origin of the genetic resources and that  arrangements to facilitate the sharing of benefits 
arising from the appropriation of such resour ces and traditional knowledge were in place. 
70. The representative of Pakistan
 attached great importance to the issues of biopiracy and 
misappropriation of traditional knowledge.  He sa id that although the Council for TRIPS had 
discussed these issues for a while, nothing had happene d so far.  He recognized the importance of 
document TN/C/W/52 and expected a positive and expeditious outcome from the process of the 
Director-General consultations.  He said that gene tic resources or biodiversity were basically primary 
intellectual property rights, and that patents we re secondary intellectual property rights.  The 
enforcement of secondary intellectual property righ ts was linked to the recognition of the primary 
intellectual property rights, which was important to developing countries.  If, as suggested by several 
Members, the issue of biopiracy be discussed in othe r forums, the issue of enforcement of intellectual 
property rights should then be discussed in another fo rum, and then Members would have less interest 
in intellectual property rights in the WTO.  He en couraged Members to take an expeditious approach 
to find solutions. 
71. The representative of Egypt  attached high importance to the protection of biological 
resources, traditional knowledge and folklore.  He said that it was an important developmental issue 
with implication on the preservation and development of natural and cultural heritage.  His delegation 
continued to support and seek engagement in full  negotiations on the TRIPS/CBD issue, which was a 
critical part of the implementation related issu es and concerns as contained in the Doha Work 
Programme.  He urged other Member s to engage in this issue of prime importance to developing 
countries as part of the hope for developmental gains of the Doha Development Agenda.  He said that 
technical discussions on this issue had been ongoing fo r almost a decade.  During this period, several 
submissions had been made with th e aim of clarifying the issues so that an effective and consistent 
framework could be established to enable WTO Me mbers to meet their obligations under both the 
TRIPS Agreement and the CBD.  In this regard, th e TRIPS Agreement should be  amended in order to 
provide that Members shall require an applicant for patents relating to biological materials or 
associated traditional knowledge to disclose the s ource and country of origin of the biological 
resources and associated traditional knowledge used in the invention.  Furthermore, the applicant shall 
also provide evidence of prior informed consent a nd evidence of fair and equitable benefit sharing 
under relevant national regimes.  He said that a solid case had been supported by a majority of the WTO membership for commencing text-based negotia tions as presented in document IP/C/W/474.  
The outcome of negotiations on the TRIPS/CBD issue should lead to the mandatory requirement of 
disclosure of origin of the biological material a nd the traditional knowledge used in the invention.  IP/C/M/63 
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  72. He welcomed the proposal submitted by Bolivia  on the review of Article 27.3(b) of the 
TRIPS Agreement.  He said that three issues raised in the proposal, mainly the patenting of life forms, 
the protecting of plant varieties and traditional kno wledge and the rights of indigenous communities 
represented central issues with key implication for developing countries.  He also agreed with the 
importance of the issues raised by Bolivia. 
73. The representative of Mauritius  said that his delegation, together with the ACP Group, had 
shown the spirit of compromise on three TRIPS issues, especially the TRIPS/CBD issue.  Document TN/C/W/52 reflected his delegation's stand.   While he appreciated the useful consultations 
held by the Director-General, t echnical discussions had been exhaus ted and political will and concrete 
action was now needed.  He urged the Director-Gen eral to accelerate the consultative process and to 
mainstream positive results in a broad process. 
74. The representative of Switzerland
 said that his delegation promoted the protection and 
patentability of inventions in the field of biotec hnology.  Switzerland had made use of the flexibility 
provided by the TRIPS Agreement to take that r oute in its national legal regime.  Switzerland was 
convinced that the field of biotechnology held par ticular promises for mankind both in developing and 
developed countries and thus investment should be stimulated through patent rights.  Drugs and 
vaccines, which were developed in biotechnologica l procedures, were becoming more important.  
Present clinical research – particularly in the treatment of cancer, viral and bacterial infections, autoimmune diseases such as multiple sclerosis or cardiovascular diseases, but also into many 
vaccines, e.g. against hepatitis B – was heavily depe ndent on biotechnology.  He said that it was not 
only in the area of drugs and vaccines that research in biotechnology was of paramount importance.  
The area of agro-chemical products was another one to  take into consideration.  Biotechnology would 
be indispensable as a means to gain better productivity in agriculture, i.e. to produce more food on less land and to help to feed more people in the wo rld.  Inventions in a ll fields of technology, 
including biotechnology, deserved to be adequately pr otected by patents.  Accordingly, he said that it 
was Switzerland's standpoint that the review of Article 27.3(b) should not lead to any lowering of the 
level of patent protection for biotechnological inventions. 
75. He said that Bolivia had raised several basic points about what should be patentable and what 
should be excluded when it came to the patenting of li fe forms.  He said that patent protection granted 
the inventor the exclusive right to prevent othe rs from using the invention commercially.  Mere 
discoveries of something new in the nature were not patentable.  In other words, life forms as such 
could not and shall not be patented .  Patents should only be granted for new, inventive, significant and 
not trivial contributions to the advancement of t echnologies which required a considerable effort and 
investment by the inventor.  He said that Article  27.3(b) was a balanced provision providing Members 
with the necessary flexibility ta king into account the various views and needs of Members.  
Article 27.3(b) required the protection of pl ant varieties through patents, an effective sui generis  
system, or a combination thereof.  This provision again offered adequate flexibility for Members to 
take into account their national needs and interests. 
76. Switzerland was a member of the UPOV.  Taking into account the negotiation history of 
Article 27.3(b) and the growing number of Contr acting Parties of the UPOV – currently 68 States – 
Switzerland viewed the UPOV system to be in the foreground as a reference for an effective 
sui generis  system of protection for plant varieties.  Nonetheless, Switzerland certainly agreed with 
Members who took the view that there might be other sui generis  systems of protection for plant 
varieties that met the requirements of Article 27.3(b).  The Swiss legislation foresaw farmers' 
privilege not only with regard to plant breeder rights,  but also with regard to patent rights.  These and 
other provisions of the Swiss laws on the plant va riety and patent protection allowed to adequately 
take into account the issues mentioned in the co mmunication by Bolivia and were evidence of the 
flexibility the TRIPS Agreement provided to Members. IP/C/M/63 
Page 16  
 
  77. He said that there were international discu ssions on the protection of traditional knowledge, 
especially the discussions in the WIPO IGC and the Wo rking Group on Article 8(j) of the CBD.  Both 
forums were in the process of elaborating measures for the protection of traditional knowledge, and the work of the IGC and its recently renewed mandate for the years 2010-2011 deserved particular attention.  He recalled his delegation's proposal for the establishment of an international gateway for 
traditional knowledge, which would electronically link existing local, national and regi onal databases 
on traditional knowledge, and thus facilitate access by patent authorities to information about 
traditional knowledge contained in these databases.  He also reca lled that Switzerland had submitted 
several proposals to WIPO and to the Council on ho w transparency could be enhanced in access and 
benefit sharing through a requirement of disclosure of source in patent applications.  He indicated that 
neither the gateway nor the disclosure requirement would by themselves be sufficient to resolve all 
issues arising in the context of access and benefit-sh aring.  They were only two elements to be 
integrated in a global approach that would comp rehensively address the issues related to access and 
benefit sharing.  In the view of Switzerland, addition al measures had to be taken, outside of the patent 
system, in other fields of law.  Such measures n eeded to be in harmony with and mutually supportive 
of relevant international instruments and fo rums, including the CBD and the United Nations 
Declaration on the Rights of Indigenous Peoples. 
78. Nevertheless, the disclosure of source in patent  applications was an area where patent law 
could make a contribution to a broader framework of  access and benefit sharing with regard to patents 
in the field of biotechnology based on genetic res ources and traditional knowledge.  The call for such 
a disclosure requirement made sense only if on e accepted the patentability of biotechnological 
inventions, as today, this sector accounted for a la rge number of the inventions relating to genetic 
resources and traditional knowledge.  If there was no pate nt application or patent, there was nothing to 
disclose, and no potential benefit to share.  Throu gh such a declaration of source of genetic resources 
and traditional knowledge as well as through the publication of the pa tent application and the public 
accessibility of the patent information once the patent  was granted the patent system contributed to 
and promoted transparency in the area of inventive t echnologies in general in particular with regard to 
the use of genetic resources and traditional know ledge used in inventions in particular. 
79. He recalled that Switzerland was a co-sponsor of  document TN/C/W/52, in which more than 
two-thirds of the WTO Members proposed key modality language for the three TRIPS issues.  He appreciated the Director-General for his engage ment and ongoing consultations on the issues of 
TRIPS/CBD and GI extension, as mandated in paragraph 39 of the Hong Kong Declaration and 
paragraph 12 of the Doha Ministeria l Declaration.  He said that the work done under this mandate was 
an important component of the Doha Development Ag enda, and that solutions needed to be included 
in the Single Undertaking of the Doha Round. 
80. The representative of Colombia
 said that Members shared the objectives of preventing 
misappropriation of genetic resour ces and erroneously granted patents, of ensuring that inventors 
using genetic resources and associated traditional kn owledge complied with the conditions of use and 
benefit sharing, and enabling patent offices to have  access to sufficient information to make decision 
on the granting of patents.  He said that Colombia , together with other Members with a wealth of 
biological resources, had submitted a fair number of cases in support of the proposal of amending the 
TRIPS Agreement to include the requirement of di sclosure of origin of genetic material and/or 
associated traditional knowledge, as contained in  documents IP/C/W/474 and TN/C/W/52.  He 
appreciated the Director-General's consultative pr ocess and was anxiously awaiting the result, which 
needed to be consistent with the development dimension, the CBD objectives, and the objectives and 
principles set forth in Articles 7 and 8 of the TRIPS Agreement.  He said that the consultations needed 
to be increasingly inclusive and transparent.  Memb ers should take constructive steps to find solutions 
in various international forums, including the WTO,  and that the solutions should be complementary 
and mutually supportive to each other.  He high lighted the importance of protection of traditional  IP/C/M/63 
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  knowledge and folklore, saying that discussion of this  subject should take into account the interest of 
indigenous peoples and local communities. 
81. The representative of Zimbabwe  associated herself with the statements made by Nigeria on 
behalf of the African Group, Angola on behalf of the LDC Group, China, Brazil, India and other 
developing countries.  She supported the draft m odalities for the three TRIPS issues as contained in 
document TN/C/W/52.  Like a majority of the WT O membership, Zimbabwe believed that biological 
resources and associated traditional knowledge coul d only be adequately protected through a 
mandatory requirement of disclosure of source and count ry of origin of biological resources, evidence 
of prior informed consent as well as evidence of fair and equitable benefit sharing in patent 
applications.  Such a requirement would play a significant role in preventing biopiracy and 
misappropriation of biological resources as well as ensu ring that those who contributed to innovations 
were adequately rewarded.  She urged Members to  commence text-based negotiations on the basis of 
document IP/C/W/474. 
82. The representative of Barbados  said that her delegation was aware of an important role which 
intellectual property played in social and economic development.  She said that small and vulnerable 
countries like Barbados were particularly exposed  to misappropriation of biological resources when 
dealing with mega companies.  She joined other Members in calling for an amendment of the TRIPS 
Agreement to include a mandatory disclosure requireme nt in patent applications in order to prevent 
misappropriation. 
83. The representative of the United States  noted that some Members had advocated commencing 
negotiations on the basis of a proposed text to ame nd the TRIPS Agreement.  He reiterated that his 
delegation did not support amending the TRIPS Agreement to address the concerns of the 
demandeurs,  and did not think that doing so would be the most effective way of addressing those 
concerns.  His delegation continue d to believe that Members should focus on their shared objectives 
that had been revealed to date.  He agreed that prior informed consent and equitable benefit sharing 
for the use of genetic resource and related trad itional knowledge were important issues, and also 
agreed on the importance of avoidi ng erroneously granted patents.  At a fundamental level, his 
delegation believed that the most critical element in  ensuring appropriate prior informed consent and 
access and benefit sharing was a development a nd strengthening of natio nal regimes and legal 
frameworks designed specifically to accomplish these obj ectives.  Bringing the patent system into the 
equation simply did not make sense if there was an absence of a well-functioning prior informed 
consent and access and benefit-sharing regime. 
84. The most effective way to ensure the effectiv e sharing of benefits was to bring about the 
generation of benefits in the first place.  Benefits  would be generated when  useful and good products 
were developed and commercialized.  And the exis tence of an incentive through the patent system 
was a critical element in encouraging such developm ent and commercialization.  When this happened, 
and when meaningful national prior informed con sent and access and benefit-sharing systems were in 
place, Members could then have confidence in th e common objectives that had been identified and 
Members work could be achieved.  He said that while his delegation had not seen evidence that the 
disclosure of origin of genetic resources and asso ciated traditional knowledge in patent applications 
would prevent misappropriation or avoid erroneous patents, it thought that further fact-based 
discussions at WIPO could be constructive in identifying Members' common objectives. 
85. Referring to Bolivia's submission, he agreed  with the points made by Switzerland that 
life forms and methods related to life forms should be patentable if they met the requirements of 
patentability, especially novelty, inventive step an d industrial applicability.  He recalled that the 
patenting of new plants did not diminish rights to us e plants already in existence.  Instead, the ability 
to obtain a patent on a new plant created an incentiv e to create new plants to address concerns about, 
among other things, food security and climate change.  A patent right could also give rise to financial IP/C/M/63 
Page 18  
 
  and other benefits that could be shared with tho se who contributed towards the invention, such as 
someone who supplied breeding material for a new pl ant.  He noted that, in March 2009, the WIPO 
Standing Committee on the Law of Patents had request ed the WIPO Secretariat to commission a study 
by external experts on exclusions, exceptions and limitations focused on but not limited to 
patentability of life forms, including from a public policy, socio-economic development perspective, 
bearing in mind the level of economic development.   The experts who would be conducting the study 
had been selected but the study had not been complete d.  The results of the study could be informative 
as to whether the exclusions, exceptions and limita tions to the patentability of life forms were 
appropriate. 
86. As to Bolivia's concerns about the need to pr otect genetic resources against misappropriation, 
he said that this was a common denominator to al l of Members' concerns .  Misappropriation could 
occur in many circumstances with very varied factua l patterns.  There might be a patent that was 
involved or there might be no intellectual property protection at all.  In that instance, the genetic resource could be owned by a sovereign government or a private entity, but regardless of ownership 
or whether patents were involved, the need to  protect against misappropriation was the same. 
87. The representative of the European Union
 said that his delegation did not see any need to 
amend Article 27.3(b) as it currently stood.  He said that the TRIPS Agreement provided Members 
with efficient flexibility to modulate their patent protection according to their needs, interests or 
ethical standards.  Article 27.3(b) in conjunction with Article 27.1 and 27.2 provided considerable 
leeway. 
88. Referring to the Bolivian proposal that Artic le 27.3 should be amended to prohibit the 
patenting of all life forms, including plants and animals and parts thereof, genes sequences, 
micro-organisms as well as all processes including biological, micro-biological  and non-biological 
processes for the production of life forms and parts ther eof, he said that living organisms could not be 
patented as they existed in the nature.  However, he did not favour a ban on the patenting of biological 
technological inventions.  He said that each WTO Me mber had considerable flexibility in setting their 
standards for biotechnological patents.  The TRIPS Agreement did not prevent Members from 
addressing ethical concerns and the European Union had done so in its Directive of 1998/44 on the 
legal protection of biological technological inventions. 
89. Referring to the Bolivian proposal that Article 27.3(b) should ensure the protection of the 
innovation of indigenous and local farming commun ities and the continuation of traditional farming 
practices including the right to save and exchange  seeds and sell their harvest, he said that WTO 
Members had also a considerable degree of  flexibility in establishing an effective sui generis  
protection of plant variety and that Members were a llowed to design their regimes appropriate to their 
specific national situations according to Article  27.3(b).  Although th e UPOV met the required 
standard of effectiveness, other models might be e qually effective.  As to farmers' exemptions in 
particular, that is, the exceptions to plant variety rights or patents allowing farmers to save new seeds 
of the protected variety, he said that such exemp tions could, under certain  conditions, be justified 
under Article 27.3 or Article 30 of the TRIPS Agre ement.  The special situation of LDCs or 
developing countries could be addressed by specific exceptions allowing substantive farmers or small 
farmers to save, replant, exchange, share and re- sell seeds, provided they did not use the commercial 
denomination of the variety.  On the other hand, farmers with significant commercial interests should 
remain subject to more stringent rules. 
90. He further said that Bolivia had also suggested that Article 27.3(b) should prevent 
anti-competitive practices which threatened food sove reignty of people in developing countries.  He 
said that the TRIPS Agreement sufficiently addr essed the issue of anti-competitive practises in 
Articles 31(k) and 40.  IP/C/M/63 
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  91. Referring to the Bolivian proposal that Article 27.3(b) should protect the rights of indigenous 
communities and prevent any private monopolistic in tellectual property claims over their traditional 
knowledge, he said that his delegation recognized th e importance of ensuring appropriate protection 
of traditional knowledge, especially for developi ng countries and traditional communities, and 
supported the ongoing work in WIPO and the CBD.  In  particular, his delegation supported further 
work towards development of international sui generis  models for the legal protection of traditional 
knowledge.  His delegation also supported preventive approaches to avoid misappropriation of 
traditional knowledge, such as databases on trad itional knowledge, which would help patent 
examiners establish prior art more accurately. 
92. He recalled that two-thirds of the WTO membership had co-sponsored a proposal of 
modalities language for three TRIPS issues as contai ned in document TN/C/W/52.  As a co-sponsor 
of the proposal, his delegation remained committed to this common platform on the TRIPS issues and 
supported a parallel treatment of them with a view to a decision on the modalities.  He reiterated that 
the European Union supported amending the TRIPS Agreement to introduce the disclosure 
requirement, which would allow Members to keep track of all genetic r esource-related patent 
applications at global level.  This would increase transparency and would enable patent examiners to 
establish novelty more accurately and thus contribute to prevent misappropriatio n of genetic resources 
and associated traditional knowledge.  He said that  a consensus of modalities could only be found if 
the three TRIPS issues were part of it.  He fully  supported the consultati on process which had been 
undertaken by the Director-General, and encourag ed him to continue this important process. 
93. The representative of Argentina  did not support the artificial pa rallelism between three TRIPS 
issues as contained in document TN/C/W/52.  She sa id that misappropriation of genetic resources and 
traditional knowledge was a serious problem but her delegation could not support the disclosure 
proposal.  Nevertheless, Members should conti nue discussions on the TRIPS/CBD issue while 
bearing in mind the substantive on-going work in WIPO and the CBD. 
94. The representative of Japan  said that the issues of the CBD compliance issue and erroneously 
granted patents should be discussed separately.  He  informed the Council that the discussion on the 
CBD compliance had been carried out actively at the CBD ABS Working Group toward the 
10th Session of CBD Conference of Parties to be held  in Nagoya in October 2010.  He said that the 
establishment of comprehensive databases for patent  examiners could be a solution to the issue of 
erroneously granted patents.  Referring to the Bo livian proposal, he said that the review of 
Article 27.3(b) should be limited to the review of optional exclusions and exception to the exclusions 
which were provided for in Article 27.3(b) ( see document IP/C/W/236).  The discussion in the 
Council should be limited to that mandate, while the Bolivian proposal extended that mandate.  He 
said that as there was no definition of indige nous communities, farmers' rights and traditional 
knowledge, Members might need to discuss the se definitions, such as on-going text-based 
negotiations at the WIPO IGC.  He informed th e Council that the WIPO IGC reached agreement on 
the modalities for its intersessional meetings in Ma rch 2010, and a new propos al on generic resources 
had been introduced.  Members should consider the progress made in WIPO.  In conclusion, he said 
that the three TRIPS issues should be dealt with individually based on their own merits. 
95. The representative of Australia  said that Bolivia's domestic law took advantage of the 
flexibilities in the TRIPS Agreement to exclude pa tents and animals from patent protection.  She 
agreed that these flexibilities allowed national implementation to reflect national policies on 
innovation and to take into account the circum stances of farmers and indigenous and local 
communities.  It was appropriate to retain these fl exibilities.  It was positive to see Members utilising 
these flexibilities to meet the unique domestic setting.   In relation to those who made reference to 
on-going discussions in other rooms of the WTO, she said that the cause for this work went beyond 
the scope of the Council for TRIPS.  The existin g agenda items in the Council for TRIPS were 
adequately broad to provide for discussion of Me mbers' concerns and views.  She suggested IP/C/M/63 
Page 20  
 
  maintaining and building on discussions under the th ree agenda items, which should include the full 
membership and have more transparency.  Finally, she said that her delegation rejected the artificial 
parallelism as proposed in document TN/C/W/52. 
96. The representative of Canada
 said that the attempt to make a linkage between three TRIPS 
issues and to include them as part of the Single Undertaking was not helpful as it would complicate 
efforts to successfully conclude the Doha Round .  The most meaningful way to advance the 
discussion on the TRIPS/CBD issue was to engage in  fact-based technical discussions of the various 
proposals with particular focus on those who had ei ther best practices to share or had experienced 
misappropriation.  Her delegation was committed to av oid erroneous patents, to secure the compliance 
with national arrangements on benefit sharing an d to ensure patent offices to have necessary 
information to make proper decisions on the granting  of patents.  Neverthele ss, her delegation had not 
been shown a contradiction between the TRI PS Agreement and the CBD and therefore the 
amendment of the TRIPS Agreement was not needed .  She said that her delegation was committed to 
accelerate the work of the WIPO IGC under its renewed mandate for th e budgetary biennium 
2010-2011 and the WIPO Development.  Referring to the joint proposal presented by Australia, 
Canada, the Netherlands, Norway and United States in  WIPO IGC, she said that her delegation looked 
forward to continuing to enga ge with all the parties in the next session of the IGC. 
97. Referring to the Bolivian proposal, she said that the review of Article 27.3(b) was meant to 
review Members' implementation rather  than to revise the content of this article.  Flexibility should be 
maintained in Article 27.3(b) to allow Members to implement it appropriately at domestic level. 
98. The representative of Chile  welcomed the discussion on the TRIPS/CBD issue in the Council.  
He supported the considerable progress made in the WIPO IGC and hoped that the CBD could 
achieve positive results in the course of this year.  Referring to the Bolivian proposal, he said that the 
three essential requirements for patentability set fo rth in Article 27.1 of the TRIPS Agreement, 
i.e. novelty, inventiveness and industrial application,  should be applied and respected in full, and that 
if this was the case, there should be no contradic tion or conflict with misa ppropriation of naturally 
occurring life forms.  It was essential that national and regional patent offices should have access to 
all the information available to avoid granting e rroneous patents that did not comply with the 
patentability requirements.  Recognizing the possible benefit of the disclosure requirement, he said 
that the disclosure proposal was worth exploring.  Nevertheless, the artificia l linkage between three 
TRIPS issues would complicate the discussion and make it difficult to achieve substantive progress. 
99. The representative of Norway  said that there was no conflict between the TRIPS Agreement 
and the CBD as these two instruments were mutually supportive.  However, the relationship between 
the TRIPS Agreement and the CBD would be enhanced  by introducing a mandatory obligation in the 
TRIPS Agreement to disclose the origin of gene tic resources and traditiona l knowledge in patent 
applications.  Accordingly, he r delegation had introduced a proposal of such an amendment in 
June 2006.  This proposal would support the aims of the CBD as well as be useful in ensuring that 
patents would not be granted contrary to the fundamental principles of patent laws. 
100. The representative of Chinese Taipei  said that her delegation ha d not yet decided its position 
on the TRIPS/CBD issue, although it had raised some important technical questions at the previous 
meetings, such as the definition of traditional knowle dge and the trigger of disclosure requirements.  
In the absence of satisfactory answers to these qu estions, she hoped that the ongoing Director-General 
consultations would provide clarities and that th e Director-General could increase frequency on 
holding open-ended consultations.  She said that he r delegation did not support the parallelism as each 
issue should be discussed on its own merits.  Give n the complexity of the TRIPS/CBD issue, her 
delegation had not come to a conclusion on the necessity of amending the TRIPS Agreement.  IP/C/M/63 
 Page 21 
 
 
  101. The representative of the Holy See  said that Article 27.3(b) allowed Members to exclude from 
patentability plants and animals, but not micro- organisms, and allowed Members to exclude from 
patentability biological processes which were essen tial for the production of plants and animals but 
not non-biological or microbiological ones.  The ra tionale behind this provision was to reinforce the 
international protection of patent and other in tellectual property rights on non-biological and 
microbiological life developments by linking such pr otection to the general legal framework and trade 
of other goods and services.  Such protection, how ever, should be promoted fairly and in full accord 
with the development objectives established by Article 7 of the TRIPS Agreement, with the 
provisions of Article 8 related to the political freedom  of States to protect public health and nutrition 
and to promote the public interest in sectors of vital importance to their socio-economic and 
technological development, and with the provisi ons of Article 27.2 which allowed Members to 
exclude from patentability inventions, the preven tion within their territory of the commercial 
exploitation of which was necessary to protect ordre public  or morality, including to protect human, 
animal or plant life or health or to avoid serious prejudice to the environment. 
102. He said that the patenting of life forms could sometimes serve as a tool to support 
biotechnology that was problematic both from the ethical point of view and from the point of view of 
a development-friendly intellectual property system.  In relation to human life, Article 4 of the 
Universal Declaration on the Human Genome and Human Rights stated that "The human genome in its natural state shall not give rise to financial gains"
5 while Article 21 of the Council of Europe 
Convention for the Protection of Human Rights and Di gnity of the Human Being with Regard to the 
Application of Biology and Medicine, stated that:  "The human body and its parts shall not, as such, 
give rise to financial gains".6  In this regard, the United Nations Declaration on Human Cloning7 
acknowledged the ethical concerns that certain app lications of rapidly developing life sciences might 
rise with regard to human dignity, human rights and the fundamental freedom of individuals, and 
called States to adopt all measures necessary to protect  adequately human life in the application of life 
science.  Thus, the TRIPS Agreement, other WTO ru les, and all other international, regional and 
bilateral trade and intellectual pr operty agreements should not redu ce the ability of States to govern 
the aspect of intellectual property rights related to human life and dignity. 
103. He said that mere commercial control of produc tion and distribution of new life forms could 
affect both food security and development prospect s of poor countries.  Private monopolistic rights 
should not be imposed over those biological resources, from which the basic food and medicine requirement of human life was derived.  An inclus ive approach to intellectual property rights should 
not ignore the major economic envi ronmental and ethical concern ove r the patenting of life, since 
such action would exert a negative impact on c onsumer rights, biodiversity conservation, 
environmental protection, indigenous rights, scien tific and academic freedom, and ultimately, the 
economic development of many developing countri es insofar as it depended on new technologies.  
Among agents of development, there was a significan t concern about patenting of varieties of seeds 
that were genetically engineered.  An unlimited application of patent procedures to biological, 
scientific and technical developments could be ha rmful to both traditional and modern methods of 
research and production, especially with regard to new varieties that were beneficial in the developing 
world.  Concentration of seed ownership could th reaten the autonomy of local farmers, who were 
forced to buy seeds every season from a handful of companies with whom they had little power to 
negotiate competitive prices.  The international co mmunity should render due attention to concerns 
about the concentration of tec hnology and resources in food production by a small group of entities 
and companies that were driven by purely commercial goals.  Special attention should also be given to 
                                                     
 
5 United Nations, A/53/152 of 9 D ecember 1998;  United Nations Educat ional, Scientific and Cultural 
Organization (UNESCO), Records of the General Conference, 29th Session, Paris, 21 October – 
12 November 1997, Resolution 6. 
6 Council of Europe, ETS N. 164, Oviedo, 4 April 1967. 
7 United Nations, A/RES/59/280 of 8 March 2005. IP/C/M/63 
Page 22  
 
  intellectual property protection of seeds discovered by individual farmers – both from developed and 
developing countries, to the rights of indigenous pe ople, and to the traditional use and ownership of 
those plants that were essential to their livelihoods and cultures. 
104. He said that the main goal of the international community should be to promote the common 
good.  Moreover, international trade rules and ne gotiations should aim towards the good of all, 
especially of those who were poor and vulnerable , and should ensure both the means for human 
sustenance, such as food, water, me dicines, health environment, and the means for the cultural, social 
and spiritual development of people.  Discussions of  international protection of intellectual property 
rights and scope and consequences of Article 27.3( b) should be guided in all sincerity by the 
promotion of the common good and human dignity, as st ated in the Marrakesh Declaration, the Final 
Act, the Preamble of the Marrakesh Agreemen t Establishing the World Trade Organization. 
105. The representative of Korea
 opposed the artificial paralle lism between the issues of 
TRIPS/CBD and GI extension.  Referring to the Bo livian proposal of prohibiting patenting of life 
forms and its ethical concern, he said that pa tenting of life forms had a great impact on the 
development of new medicines and the easing of chroni c food shortage.  It would also have an impact 
on the implementation of the Paragraph 6 system si nce a progress in this area would be difficult if 
there were no patenting of life forms. 
106. The Council took note  of the statements made under these three agenda items and agreed  to 
revert to them at its next meeting. 
F. NON-VIOLATION AND SITUATION COMPLAINTS  
107. The Chairman  recalled that, at the Seventh Session of the Ministerial Conference, Ministers 
had directed the Council for TRIPS to continue its examination of the scope and modalities for 
complaints of the types provided for under subp aragraphs 1(b) and 1(c) of Article XXIII of 
GATT 1994 and to make recommendations to their ne xt Session, which they had decided to hold 
in 2011.  It was agreed that, in the meantime, Me mbers would not initiate such complaints under the 
TRIPS Agreement.  At its last meeting, the Counc il had agreed to keep the item on non-violation and 
situation complaints on the agenda as a regular item so as to allow Members who would have new 
thinking to share it, and also enable the Council revert  to the question of the further organization of its 
work in the light of any future suggestions. 
108. The representative of Nigeria, speaking on behalf of the African Group , said that while 
non-violation complaints were possible for goods  and services, the African Group continued to 
believe that non-violation complaints were not a pplicable under the TRIPS Agreement.  He recalled 
that, in May 2003, the then Chairperson of the C ouncil for TRIPS had described four possible options 
for recommendations and most Members had favoured  banning non-violation complaints completely 
from the TRIPS Agreement.  No consensus had been reached to date, but fortunately the moratorium 
had been extended until 2011.  In order to avoid le gal uncertainty, he urged the remaining Members to 
join the consensus that would allow the Council to recommend banning the non-violation complaints 
in the TRIPS Agreement. 
109. The representatives of Ecuador  and India  supported the points made by the delegation of 
Nigeria on behalf of the African Group. 
110. The representative of the United States  said that his delegation's view continued to be that it 
was appropriate for non-violation and situation compla ints to be applicable to the TRIPS Agreement 
and that the moratorium would expire at the next Ministerial Conference.  IP/C/M/63 
 Page 23 
 
 
  111. The representative of Pakistan , supporting the statements made by Nigeria, Ecuador and 
India, asked the proponents of non-violation complain ts to explain how such complaints would apply 
to TRIPS.  While non-violation complaints could apply in the goods sector where rights were accrued 
according to well-defined lines, it was questionable wh ether those defined lines and limits existed in 
intellectual property.  He understood the stru cture of TRIPS as giving minimum standards but 
maximum enforcement levels, and that had been  the compromise that developing countries had 
accepted in the Uruguay Round.  In that context, how could Members now extend the limits of non-violation?  In view of the fact that, since th e creation of non-violation and situation complaints, 
only a small number had been used and successfully pleaded, Members should be factual and realistic 
and not ideological in this debate.  Due to this l ack of technical feasibility of such complaints under 
TRIPS, he supported a complete ban on non-violation and situa tion complaints under the TRIPS 
Agreement. 
112. The representative of Switzerland
 said that his delegation continued to believe that 
non-violation complaints in Article  64 paragraphs 2 and 3 were app licable to the TRIPS Agreement 
just as they were to other WTO agreements.  Ther efore, upon the expiry of the moratorium after the 
next Ministerial Conference, non-violation compla ints would also be applicable to the TRIPS 
Agreement.  For the details of Switzerland's position,  he referred Members to its statement recorded 
in the Council's minutes in document IP/C/M/61, star ting in paragraph 148.  Finally, he reiterated his 
delegation's willingness to participate in the Counc il in any meaningful examination of scope and 
modalities for non-violation complaints under the TRI PS Agreement, if other delegations felt that 
such further examination was necessary. 
113. The representative of Argentina  said that non-violation and situation complaints were not 
applicable to the TRIPS Agreement.  Her delegati on, together with other co-sponsors, had already 
submitted a communication in this regard  contained in document IP/C/W/385. 
114. The representative of Venezuela  said that he continued to belie ve that, while this type of 
complaints could be applied in the case of goods, it was not appropriate under the TRIPS Agreement. 
115. The Chairman  recalled that there were just over 12 months before the Council was due to 
provide recommendations to the Ministerial Conf erence in 2011, and urged Members who had any 
further ideas to share them as soon as possible, so as to allow the Council sufficient time to consider 
them. 
116. The Council took note  of the statements made and agreed  to revert to the matter at its next 
meeting. 
G. REVIEW OF THE IMPLEMENTATION OF THE AGREEMENT UNDER ARTICLE 71.1 
117. No statements were made  under this agenda item. 
118. The Council agreed  to revert to the matter at its next meeting. 
H. REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON GEOGRAPHICAL 
INDICATIONS UNDER ARTICLE 24.2 
119. The Chairman  recalled that Article 24.2 provided that the Council shall keep under review the 
application of the provisions of the GI Section of the Agreement.  He recalled that, at its last meeting, 
the Council had agreed to encourage Members to shar e information on and notify bilateral agreements 
related to the protection of geogra phical indications, which they had entered into, to the Council.  The 
Secretariat had issued on 26 April an Airgram (W TO/AIR/3550) reminding Members of this.  In 
response to this, the Council had received informa tion on such bilateral agreements from Peru and IP/C/M/63 
Page 24  
 
  Korea.  These communications ha d just been circulated in doc uments IP/C/W/547 and Add.1, 
respectively. 
120. Since its last meeting, the Council had also received responses from Croatia to the Checklist 
of Questions contained in document IP/C/13 and Add.1.  These responses were available as an 
advance copy of document IP/C/W/117/Add.33.  In a ddition, Croatia had informed the Council that it 
had not concluded any bilateral agreemen ts related to geographical indications. 
121. The representative of Korea
 said that his delegation had provided information on the GI 
provisions in its free trade agreements (FTA) with  Chile and the European Free Trade Association 
(EFTA).  There were also other FTAs with GI provisi ons, but they had not taken effect yet.  He said 
that his delegation would provide the releva nt information once they had taken effect. 
122. The representative of Brazil  said that Brazil had not yet concluded any bilateral agreements 
on geographical indications. 
123. The representative of the United States  said that his delegation was pleased to share 
information on some of its agreements dealing w ith geographical indications.  The United States was 
party to a number of bilateral and regional free trade agreements with provisions that addressed, 
among other things, the eligibility of geographical indications for the protection as trademarks, the 
relationship between GIs and trad emarks, and the grounds for re fusing protection, operation and 
cancellation of geographical indications.  Those ag reements could be found on the Office of the 
United States Trade Representative website at http://www.ustr.gov/trade-agreements .  Other 
international agreements to which the United States  was party, such as WIPO-administrated treaties 
concerning trademarks, might also be relevant to the protection of geographical indications. 
124. The representative of Peru  thanked the Chair for the opportunity to share with Members 
information on bilateral agreements recently signed by Peru relating to the protection of geographical 
indications as contained in docum ent IP/C/W/547.  The FTA betwee n Peru and Singapore had entered 
into force on 1 August 2009;  the FTA betwee n Peru and Canada on 1 August 2009;  and the 
Agreement between Peru and China on 1 March 201 0.  The official communications concerning the 
FTA between Peru, Colombia and the Europ ean Union were signed on 18 May 2010 and the 
agreement would be signed after the completion of the legal review.  The ne gotiations between Peru 
and EFTA member countries had taken place in 2007, and the negotiations on the FTA between Peru 
and Korea which contained an intellectual prope rty chapter were still continuing.  The Trade 
Promotion Agreement between Peru and United Stat es had entered into force on 1 February 2009.  
Further information on agreements wh ich were in force was available at 
http://www.mincetur.gob.pe/newweb . 
125. The Chairman  encouraged other Members to also sh are information on and notify bilateral 
agreements related to the protec tion of geographical indications, wh ich they had entered into.  In 
addition, he urged those delegati ons that had not yet provided responses to the Checklist of Questions 
contained in document IP/C/13 and Add.1 to do so.  Furthermore, those Members that had already 
provided responses could provide updates to the exte nt there had been any significant changes to the 
way they provided protection to geographical indications. 
126. The Council took note  of the statements made and agreed  to revert to the matter at its next 
meeting.  IP/C/M/63 
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  I. FOLLOW -UP TO THE SEVENTH ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE DECISION OF 
THE IMPLEMENTATION OF ARTICLE 66.2  OF THE TRIPS AGREEMENT  
1. Follow-up to the seventh annual review 
127. The Chairman  recalled that, at its meeting in Oc tober 2009, the Council had taken up its 
seventh annual review of developed country Member s' reports on their implementation of Article 66.2 
of the TRIPS Agreement.  Following up this revi ew at its meeting in March, the Council had had 
before it an advance copy of new detailed reports  from the European Union and individual member 
States (namely Austria, Belgium, the Czech Republic , Denmark, Finland, France, Germany, Spain, 
Sweden, and the United Kingdom).  Since then, th at report had been circulated in document 
IP/C/W/536/Add.7.  In concluding that item at that  meeting, the Chair had indicated that delegations 
would be provided an opportunity at the pr esent meeting to make further comments on the 
information submitted for that meeting that they  might not yet have been able to study. 
128. The representative of the Secretariat  recalled that, for the last two years, the annual review of 
the implementation of Article 66.2 had been compleme nted by informal workshops held back-to-back 
with the end-of-year meetings of the Council.  These workshops had drawn together LDC Members 
with those Members who had reported on their implem entation of that Article.  They had offered an 
opportunity to discuss that material in more depth and to strengthen dialogue on the practical implementation of that Article.  Feedback from par ticipants at those workshops had been positive and 
supportive of the continuation of these efforts, and it was therefore the Secretariat's intention to hold a further workshop along very similar lines in October, consciously building on the existing basis established by the last two workshops.  In line with  the overall efforts to enhance the accessibility and 
utility of notification materials relating to TRIPS in general, he expected that the workshop might be 
able to look at practical ways of using those not ifications for the benefit of LDC Members.  Those 
notifications contained a wealth of practical info rmation on the implementation of Article 66.2, and 
they had clearly been prepared with much effort  by the Members concerned.  Over 80 documents 
were now available, some running to over 120 pages, and it was a significant task to digest and make 
the best use of that unique information.  In dialogue with the LDC Members most concerned and 
conscious about considerable resource constraints,  the Secretariat was exploring how to best make 
this information available to LDC and other Members with an interest in Article 66.2. 
129. The representative of Bangladesh
 said that technology transfer from developed countries to 
LDCs was necessary to create a sound and viable technological base in LDCs.  Without technology transfer, LDCs could not increase their productive capac ity.  He was glad to hear that the Secretariat 
intended to hold another workshop on Article 66.2 at  the end of the year.  This was very important 
because previous workshops had proved to be very useful in bringing both donors and LDCs closer 
for better understanding and increased  cooperation.  He requested developed country Members to 
submit their reports regularly and underlined that those should be LDC-specific.  While reporting on 
Article 66.2 compliance, developed country Me mbers should not address TRIPS Article 67.  
Members should work together to devise a common fo rmat of reporting on Article 66.2 for the sake of 
transparency and LDC-friendliness.  He said that he would welcome short narratives from developed 
countries as to where, when and how they had actually transferred technologies to LDCs. 
130. The representative of Brazil
 stressed the need to  enforce Articles 66.2 and 67 of the TRIPS 
Agreement with the view to creating a solid and viable technological base enabling developing 
countries to reach their goals of social and economic  development.  IPRs should be an incentive to 
rather than a burden on development.  The impor tance of those objectives was reflected in the 
obligations enshrined in Article 7, which aimed at the creation of social and economic welfare.  Brazil 
welcomed the efforts of developed countries to implement the commitments on technology transfer 
and technical cooperation.  However, in his view a number of those projects might fall short of the 
demands brought by the growing complexity of the knowledge economy.  The simplistic idea that IP/C/M/63 
Page 26  
 
  exports of high technology products  to developing countries equalled to technology transfer as 
proposed for example by the delegation of Australia  in document IP/C/W/536/Add.2 was in need of 
being replaced by a holistic approach.  Furthermor e, technical cooperation should not include legal 
harmonization of national laws.  He recalled Brazil's proposal that the 14 recommendations of 
Cluster A of the WIPO Development Age nda should provide a guiding framework for 
development-oriented technical assistance, which should be demand driven, transparent, neutral, 
accountable, taking into account the special needs of  developing countries, in particular LDCs. 
131. In order to enhance and deepen the cooperati on and technology transfer among developing 
Members, Brazil had, for example, an ongoing proj ect with Mozambique to strengthen Mozambique's 
laboratory authority.  Document IP/C/W/513 presented  a report which demonstrated the application of 
the recommendations of Cluster A of the WIPO Deve lopment Agenda.  That bilateral project between 
Brazil and Mozambique fulfilled TRIPS Article 67,  the Doha Declaration on the TRIPS Agreement 
and Public Health and the United Nations Millenni um Goals of fighting epidemics and aiding child 
health.  Spreading the benefits brought by IPRs was only possible by putting to good use the Articles 
of the TRIPS Agreement related to technology transfer and cooperation and its flexibilities. 
132. The representative of Nigeria, speak ing on behalf of the African Group
, supported the 
statement made by Bangladesh and the LDC pos ition as enunciated at the Dar Es Salaam LDC 
Ministerial Conference, particularly on the establishment of a monitoring mechanism. 
133. The representative of Egypt  said that transfer and dissemination of technology was often a 
forgotten pillar of the intellectual property system.  While innovators acquired rights that were of an 
exclusionary nature, there were rights based on the obligation that the protection and enforcement of 
intellectual property rights should contribute to th e promotion of technological innovation and to the 
transfer and dissemination of technology.  This w as clearly reflected in the objectives of the TRIPS 
Agreement.  The effective transfer of technolog y to developing countries was a reflection of the 
effectiveness of an IP system that functioned to promote innovation.  Egypt fully supported the 
effective implementation of the obligation by deve loped Members to provide incentives to enterprises 
and institutions.  That would achieve effective technology transfer to LDCs. 
134. Transfer of technology was an issue that had received attention in many quarters, including 
but not limited to UNCTAD, UNIDO and WIPO.  It had also received attention at the WTO, not only in the Council for TRIPS, but equally so at the Working Group on Trade and Transfer of Technology, 
where considerable work had been undertaken since 2002 and where there was a need to achieve 
some concrete results at that stage.  In this rega rd, and over the past 15 years, Egypt was worried that 
the commitment shown by some Members to the impor tant issue of the transfer of technology had 
been less than what had been promised and hoped for at  the dawn of the TRIPS era.  In pursuit of this 
goal, Egypt believed that there were a number of means to ensure compliance with Article 66.2, as 
well as with the broader obligations enshrined in Article 7 of the TRIPS Agreement.  His delegation 
would remain engaged in ensuring this compliance and looked forward to a constructive engagement 
of all Members on the important issue of transfer of technology. 
135. The representative of Zambia, speaking on behalf of the LDC Group
, said that the focus of 
Article 66.2 was on facilitating tran sfer of technology to developi ng and least-developed countries 
through, among other mechanisms, capacity build ing initiatives, subsidies and incentives to 
enterprises.  She believed that, although that item had been on the Council's agenda for some time, 
lack of technology transfer continued to be a concern.  The LDC Group had wished to see a 
transformation in the reporting format under this age nda item in order to fac ilitate the assessment and 
monitoring of activities, aimed at transferring technology to LDCs.  To this end, she stressed the urgency and importance of establishing a monito ring mechanism to review how enterprises and 
institutions, within developed Memb ers, had provided technology transfer to LDCs as a result of 
incentives.  While training and workshops were im portant avenues for technology transfer, there was  IP/C/M/63 
 Page 27 
 
 
  a need to ensure that appropriate technology went  towards promotion of research and development in 
the recipient countries. 
136. The LDC Group had examined various reports submitted by Members pursuant to 
Paragraph 1 of the Decision on Im plementation of Article 66.2 of the TRIPS Agreement.  Efforts 
were certainly being made to facilitate transfer of  technology to LDCs.  However, there did not seem 
to be a significant involvement of developed country companies within the context of Article 66.2.  A 
number of the reports illustrated technical interven tions undertaken through official development 
assistance within the usual normal activities th at these Members would undertake to provide 
development assistance to LDCs as Aid for Trade for example.  She said that there was no 
additionality, no new expenditure specifically aimed at facilitating technology transfer, and that there 
were few tangible interventions with tangible r esults in transfer of technology in those reports. 
137. The representative of China  said that she believed that the reports were important and useful 
to ensure that incentives provided by developed Me mbers to encourage technology transfer to LDC 
Members would be effective in order to enable t hose LDCs to create a sound and viable technological 
base.  To this end, all the delegations were intere sted in how those incentives actually led to transfer 
of technology.  Specific examples in this regard w ould be very helpful so that good experiences could 
be shared among Members. 
138. The representative of India  recognized the importance of t echnical cooperation and capacity 
building in the TRIPS Agreement from the view point of developing countries.  Like Brazil, he saw a 
clear link between the work in the Council for TRIPS and the 14 recommendations of the 
Development Agenda that had been adopted by th e WIPO Assembly in 2007.  Technical assistance 
activities should be demand driven, transparent, neutral and accountable. 
2. Arrangements for the eighth annual review 
139. The Chairman  recalled that paragraph 1 of the Decision on the "Implementation of 
Article 66.2 of the TRIPS Agreement" provided th at developed country Me mbers shall submit annual 
reports on actions taken or planne d in pursuance of their commitments under Article 66.2.  To this 
end, they were to provide new deta iled reports every third year and, in the intervening years, provide 
updates to their most recent reports.  These reports  were to be submitted prior to the last Council 
meeting scheduled for the year in question.  Para graph 3 of the Decision determined the information 
that was to be provided in these reports.  New de tailed annual reports under the Decision had been 
presented to the Council's meeting in October 2 009.  Therefore, this year, developed country 
Members should submit a first set of updates to these reports prior to the Council's end of year 
meeting that had been scheduled for 26-27 October.  As provided in paragraph 2 of the Decision, the 
Council would review those updates at that meeting.   Accordingly, he suggested that developed 
country Members be requested to submit a first set of  updates to the reports they had provided in 2010 
on actions they had taken or planned in pursu ance of their commitments under Article 66.2 by 
1 October, i.e. about three weeks before the meetin g, in order to allow their timely circulation and 
review at the Council's meeting in October. 
140. The Council took note  of the statements made and agreed  to proceed as suggested by the 
Chair. 
J. TECHNICAL COOPERATION AND CAPACITY BUILDING  
1. Annual updates on technical cooperation activities 
141. The Chairman  recalled that the Council had traditionally undertaken its annual review of 
technical cooperation each autumn.  He therefore s uggested that the Council hold its annual review of IP/C/M/63 
Page 28  
 
  technical cooperation at its next meeting scheduled  for 26-27 October.  Accordingly, he suggested 
that the Council invite developed country Members to supply information on their activities pursuant 
to Article 67 of the TRIPS Agreement.  Other Members who also made available technical cooperation were encouraged to sh are information on these activities if they so wished.  He also 
suggested that the Council invite those intergovernment al organizations that had observer status in the 
Council for TRIPS to provide information on th eir activities of relevance and that the WTO 
Secretariat also be instructed to report on its activ ities.  He proposed that the Council request that this 
information be made available by 1 October in or der to allow its timely circulation before the 
meeting. 
142. The Council so agreed
. 
2. Other matters 
143. The Chairman  said that, pursuant to paragraph 2 of the Council's Decision of 
29 November 2005 on the "Extension of the Trans ition Period under Article 66.1 for Least-Developed 
Country Members", Bangladesh had presented inform ation on its priority needs for technical and 
financial cooperation to the Counc il's meeting in March 2010.  That  information that had been 
available only as advance copy had since then be en circulated in document IP/C/W/546.  Such 
information had been received earlier from two other Members, namely Sierra Leone and Uganda.  In 
addition, the Council had just received such inform ation from Rwanda.  This information had been 
circulated in document IP/C/W/548. 
144. The representative of Rwanda  said that his delegation aimed at complying with the TRIPS 
Agreement and building a sound and viable technol ogical base in Rwanda.  Document IP/C/W/548 
had been elaborated by the Ministry of Trade and Industry of Rwanda in  cooperation with ICTSD 
and, at the same time, UNCTAD had assisted Rwanda  in elaborating its IP policy.  That document 
had been submitted pursuant to the Council's Deci sion which had extended the period for LDCs to 
implement the TRIPS Agreement until 1 July 2013, taking into account relevant flexibilities such as 
the extension period with respect to pharmaceutical  products until 1 January 2016.  He recalled that, 
while providing this extension, Members had requ ested LDCs to provide as much information as 
possible to the Council on their individual priority needs for technical and financial cooperation in order to assist them in taking steps neces sary for implementing the TRIPS Agreement. 
145. It was in that context that Rwanda had submitted its document.  It contained two main parts.  
The first one was a report of the needs assessment, wh ich was in Annex 1, starting at page 7.  It 
contained the findings of the assessment.  The other part, attachment A, starting at page 33, was an 
outline of the IP Capacity Building Project.  It was still general.  It was an overall project including 
the main components and activities, and Rwanda w as still developing the full project with action 
plans, timelines and budget.   He briefly highlighted some of the priority needs for technical assistance 
and capacity building:  first, promoting inno vation, creativity and technology transfer for 
development;  second, assistance in area of IP policy and legal framework;  third, IPR administration;  
and fourth, IPR enforcement. 
146. In the area of innovation, creativity and technol ogy transfer, there was a need to conduct an 
innovation and creative industry survey in order to de fine the baseline with a view to undertaking a 
meaningful monitoring and evaluation mechanism fo r further recommendations, and to develop an IP 
policy strategy for public research institutions and industry support services a nd awareness, and help 
industry to identify relevant public domain t echnologies and examine terms and conditions of 
licensing agreements.  In the area of legal framewo rk, there was a need for assistance in implementing 
the national IP policy which aimed at achieving ma ny IP rights objectives, as well as in developing a 
national legislative framework for the protecti on of traditional knowledge and genetic resources, 
among others.  In the area of IP administration, ther e was a need to train the human resources in the IP  IP/C/M/63 
 Page 29 
 
 
  administration unit, focusing on on-the-job training a nd advanced IP courses, computerization and IT 
support for the IP administration unit.  Regarding IP enforcement, there was a need to raise awareness 
on the importance of innovation and creativity among different stakeholders, and also training for 
enforcement agencies, such as police,  customs officials, judiciary officials, and also to provide them 
with relevant equipment and knowledge, includi ng the testing equipment and other relevant 
equipment. 
147. The IP reform was part of the wide range of micro-economic policies and sectoral policies 
undertaken by Rwanda since 2000, which were aime d at modernizing the economy, focusing on trade, 
development and investment promotion.  The World Bank Doing Business report showed that 
Rwanda was among the top reformers in doing busin ess.  One could register a company from one's 
office and pay the fee with a Visa card.  In only one hour, one could have the company registered.  So, 
enhancing and developing innovation and protecting IPRs, Rwa nda definitely attracted more 
investors, which in time would contribute to ra ising productivity, creativity and development of the 
Rwandan economy. 
148. He thanked the different providers, both bilate ral and institutional donors, for the support they 
had already given to Rwanda, and hi s delegation looked forward to further partnering with them in a 
new phase of implementing its IP policy as a key part  of its wider efforts to promote development by 
strengthening the country's creativity and its scien tific and technological base.  He expressed a hope 
that its partners could engage mo re once Rwanda had finalized its detailed action plan with timeline 
and budget. 
149. The representative of the Secretariat  recalled that he had given an extensive report on 
technical cooperation and capacity building at th e Council's meeting in March 2010, and that the 
present update would therefore focus only on the major developments since then.  The Council's decision on the extension of the transition period unde r Article 66.1 had established three elements of 
a needs assessment for the LDC Members.  The fi rst element was that LDC Members would provide 
as much information as possible about their indivi dual priority needs for technical and financial 
assistance, to help them take th e necessary steps to implement th e TRIPS Agreement.  The second 
element of the Decision was that developed country Members were asked to provide technical and 
financial assistance to the LDCs to address their iden tified needs effectively.  And, finally, the WTO 
was asked to enhance its cooperation with WIPO and other relevant inte rnational organizations. 
150. That present update covered each of those three elements of the Decision.  Firstly, the main 
developments that were highlighted in the Secret ariat's report to the Council in March had now been 
implemented or were in the process of being im plemented.  A programme of regionally focused 
workshops for LDC Members, est ablished at the request of the LDC Group of Members had now 
been initiated.  It built on the successful workshop that had b een convened in October 2009.  A 
dedicated website had been established to enhance th e flow of information about this process and to 
provide a basis for sharing of experiences.  A draft guide book was under preparation to share 
experiences in undertaking the needs assessment exer cise and to assist LDC Members in identifying 
the appropriate resources to fulfil the need once iden tified.  And coordination with other international 
organizations, notably WIPO and UNCTAD, had been enhanced, including through the direct 
participation in the WTO activities rela ting to the needs assessment process. 
151. The first in the series of regional workshops  on the LDC needs assessment process was held 
on 1-3 June in Entebbe, Uganda.  It had been focused on the Anglophone LDC Members from the 
African region.  The workshop had been greatly f acilitated by the support, guidance and hospitality of 
the hosts, the Government of Uganda.  Engineer Ne lson Wambosi, Minister of State for Trade, had 
opened the workshop with a thoughtful and insight ful reflection on the development aspect of 
intellectual property.  The Council for TRIPS delega te, Ms Elizabeth Tamale, of the Ministry of 
Tourism, Trade and Industry, and her colleagues from the Government of Uganda had provided IP/C/M/63 
Page 30  
 
  extensive practical support and insights based on th eir own experiences in the development of a needs 
assessment for Uganda and the subsequent experience in seeking to implement it.  He thanked all the 
LDC Members and Observers who had taken part in the workshop and made sure it had been a very 
helpful practical dialogue, as well as the develope d country Members who had taken part, including 
Germany, Japan, the United Sates, the Euro pean Union and the ot her intergovernmental 
organizations, including ARIPO, WIPO and UN CTAD, and the two experts, Mr. Mosongo and 
Mr. Mengesti, who had outlined their practical ex perience with needs assessment projects in the 
African region.  The workshop had consumed three very full days and had focused on the three aspects of the process which were set out in the C ouncil for TRIPS Decision, namely the LDC needs 
assessment itself, novelizing developed country Me mber support for fulfilling needs identified and 
coordination across the international system.  Th e workshop had been opened with an informal 
exchange of practical experience, and there had been no attempt to establish any formal outcome.  
Some general observations could be made.  Firstly, many countries were already undertaking various 
forms of national planning exercises,  directly related to the needs asse ssment activity, in the form of a 
national IP strategy or of more specific sectoral planning exercises.  There had been strong interest in 
using these existing processes to inform and facilita te the needs assessment process, so as to avoid 
duplication of the same kind of policy making analysis  and the same kind of prioritization of needs in 
parallel processes. 
152. A number of participating countries had either  concluded or were finalizing their needs 
assessments and were looking for sustainable ways of building up coordination with the providers of 
technical and financial resources so as to ensure th at the needs identified could be systematically and 
sustainably met.  A valuable feature of the Ente bbe workshop was a series of bilateral coordination 
meetings, which had enabled LDC re presentatives to discuss the specific needs and priorities directly 
with potential technical cooperation partners.  Equall y, there had been strong interest in building up 
practical coordination on the ground and the avoi dance of duplication in programme designing 
delivery.  The need for closer coordination with the Aid for Trade and Enhanced Integrated 
Framework programmes, an issue already explored  at the Geneva workshop in 2009, had been 
discussed in practical terms.  There was now a substantial body of practical experience in the 
undertaking of needs assessments, which could be drawn together for the benefit of others, but 
without creating any kind of standard template or format, given that the emphasis in this process 
continued to lie on individual priority needs of LDC Members. 
153. The material from the Entebbe workshop and othe r practical resources would continue to be 
uploaded to the dedicated webpage to facilitate fu rther coordination and a flow of information.  
Already, the practical lessons shared in Entebbe w ould be drawn on for subsequent exercises in these 
series, in particular, the next re gional workshop, which was scheduled to be held in Bangladesh at the 
end of July, with the support of the delegation of Bangladesh.  That workshop was to be convened for 
the benefit of LDC Members and Observers from Asia  and the Pacific region.  Invitations had been 
sent and he encouraged LDC Members in this regi on and interested developed country Members to 
take part in the event. 
154. The representative of Bangladesh
 said that, by submitting its needs assessment report at the 
Council's meeting in March 2010, Bangladesh had fu lfilled, following the example of Uganda and 
Sierra Leone, its obligation enshrined in the D ecision of 29 November 2005 that had extended the 
transition period for LDCs up to 1 July 2013.  Other LDCs were in the pipeline.  He hoped they would 
not feel discouraged by the experience up to date.  He congratulated Rwanda for the submission of its 
needs assessment and hoped Member s would respond positively to Rw anda's request.  This brought 
the total number of LDCs needs assessment reports to four.  He requested other LDC colleagues to 
submit their own reports.  He also urged develope d country Members to play their part.  Bangladesh 
was ready to engage bilaterally as well as multilatera lly.  At the Council's meeting in March 2009, the 
delegate of Switzerland had shown interests in the needs assessment report of Bangladesh.  He 
requested the European Union, the United Stat es, Japan, Canada, Australia, Norway and other  IP/C/M/63 
 Page 31 
 
 
  Members who were in a position to do so to enga ge with Bangladesh both in Geneva and in the 
capital.  He looked forward to enga ging with developed country Members in the near future.  Without 
an adequate response, a further extension of the tr ansition period would have to be sought.  This was 
not his preferred option. 
155. The representative of Ecuador  said it was important that the Council recognize the hard work 
done in other forums to establish close links with  technical assistance and capacity building, as 
evidenced by the adoption in 2007 of WIPO's intell ectual property-related Development Agenda and 
WIPO's ongoing work to ensure its full implementation.   In this connection, Brazil's communications 
in documents IP/C/W/513 and IP/C/W/513/Add.1, which took up the 14 proposals under "Cluster A" 
of the Development Agenda, reflected developing countries' genuine concern that the IP -related 
technical assistance and capacity building provided by the WTO and a number of developed country 
Members should not be limited to ensuring the most efficient implementation of the provisions of the 
TRIPS Agreement for the protection and enforcemen t of IPRs but should also, as stated by the 
Brazilian delegation at the Counc il's meeting in March 2010, encompass a wide-ranging view of 
cooperation so as to make better use of all the flex ibilities in the Agreement and effectively achieve 
both the objectives set forth in Article 7 and applicati on of the principles laid down in Article 8 of the 
Agreement regarding technology transfer.  Effici ent implementation of the Agreement also meant 
on-going and active efforts to incorporate a deve lopment dimension in t echnical cooperation and 
capacity-building activities carried out by the Secretar iat and the Membership.  To that end, effective 
incorporation of that dimension, in that case the de velopment dimension pursuant to Article 67, meant 
re-focusing the way intellectual property was viewed so  that it was not seen as an end in itself but as a 
tool to achieve the social and economic development of all WTO Members.  In short, in the field of 
intellectual property it was wrong to adopt a "one-fits -all approach" that failed to take into account 
asymmetries and different levels of development. 
156. As regards the proposals in Brazil's two doc uments, which he endorsed, he quoted from a 
statement made in April by Brazil and a group of  developing countries now known at WIPO as the 
Development Agenda Group, to which Ecuador belonged:  "Technical assistance and capacity 
building has to go beyond generating IP awareness and capacity building in national IP offices aiming 
at facilitating more efficient award and protection of IP rights.  It should focus on promoting domestic 
innovation, fostering a development-oriented IP cu lture and provide balan ced advice on appropriate 
national IP strategies based on available flexibilities,  exceptions and limitations.  It should ensure the 
transparency, neutrality and effectiveness of tec hnical assistance and capacity building programmes 
… [it] … should support the development of nationa l scientific and technological infrastructure in 
developing countries… ". 
157. The representative of Egypt  believed that technical cooperation and capacity building 
activities were core function and manda te in the TRIPS system as well as in the broader context of the 
international intellectual property system.  These act ivities were to be provided in a balanced manner 
based on some of the following principles.  First,  technical cooperation and capacity building had to 
go beyond generating IP awareness and capacity build ing in national IP offices, aiming at facilitating 
more efficient award and protection of IP right s.  Second, it should focus on promoting domestic 
innovation, fostering a development-oriented IP culture and the provision of balanced advice on 
appropriate national IP strategies based on available flexibilities, exceptions and limitations.  Third, it 
should ensure the transparency, neutrality and e ffectiveness of technical assistance and capacity 
building programmes.  Fourth, it should suppor t the development of national scientific and 
technological infrastructure in developing countries in accordance with their priorities as well as the 
different levels of development of Members.  A nd finally, such efforts should promote a development 
oriented IP culture, promote measures that would he lp countries deal with intellectual property related 
anti-competitive practices, further develop infrastructure and other facilities with a view to making 
national IP institutions more efficient and prom ote a fair balance between intellectual property 
protection and the public interest.  In this regard , Egypt believed that the principles contained in IP/C/M/63 
Page 32  
 
  Cluster A of the WIPO Development Agenda provid ed universally agreed principles on technical 
assistance and capacity building in the intellectual property field that should be valid in other 
institutional settings, both multilaterally, such as in th e WTO context, and bilaterally and regionally. 
158. The representative of Australia
 said that her delegati on had been cooperating and 
participating in the workshops that had been held by the Secretariat and had found them very useful 
and productive.  She had also reviewed with inte rest Bangladesh's document IP/C/W/546, circulated 
on the 23 March 2010, and was currently seeking su pport from the capital to see what could be done. 
159. The representative of the European Union  said that his delegation was ready to look with a 
positive spirit at LDC submissions on their individual priority needs for technical and financial cooperation.  But it was of utmost importance to  ensure maximum coordination among the providers 
of technical assistance to avoid waste of resources and duplication of effort s.  Uganda and Sierra 
Leone had submitted their individual needs and hi s delegation had been in contact with these 
countries on how to assist and supp ort them.  More specifically, his delegation had agreed to support a 
number of activities identified by Uganda in its submission and Uganda had already benefited from 
several projects.  The European Un ion had also been working with Si erra Leone and hoped to be able 
to provide shortly the same kind of assistance.  His delegation also welcomed the requests recently 
submitted by Bangladesh and Rwanda, and was ready to consider them favourably in the context of 
existing programmes.  Moreover, his delegation fu lly supported the three sub-regional workshops 
planned in 2010 on the needs assessment for En glish-speaking African LDC Members, for the 
Asia-Pacific Region in Bangladesh in July;  and for French-speaking African LDC Members in early 
November.  His delegation had participated in the fi rst workshop in Entebbe in June.  The European 
Union stood ready to consider any submission of priority needs that would be submitted by other 
LDC Members, in coordination with initiatives undert aken by other providers, and encouraged other 
developed country Members to contri bute to this important process. 
160. The representative of Cuba
 said that her delegation supported the statements by the 
delegations of Ecuador and Egypt.   In her view, it was both appropr iate and advisable to work on 
establishing a link between the recommendations of th e WIPO Development Agenda, particularly the 
fourteenth recommendation in Cluster A, and th e work of the Council for TRIPS on technical 
assistance and capacity building.  The work bei ng done in WIPO's Committee on Development and 
Intellectual Property, and the Development Agenda's guiding principles could usefully be taken into 
account in technical assistance and capacity bui lding programmes and coul d be relevant when 
applying the provisions of TRIPS Article 67.  It wa s a question of ensuring that technical assistance 
was development-oriented, demand-driven and tran sparent, taking into account the priorities and 
special needs of developing countries, especially LDCs , as well as the different  levels of development 
of Members. 
161. The representative of the United States  said that his delegation engaged in IPR technical 
assistance and capacity building as well as activities that  facilitated private sector technology transfer 
to LDCs on a regular basis.  The US annual Artic le 66.2 and Article 67 reports to the Council for 
TRIPS provided information on its comprehensive activities.  His delegation looked forward to 
continuing improving its reporting and providing upda tes when necessary.  The United States was 
happy to discuss further with other Members, in cluding colleagues from Bangladesh, bilaterally if 
they had specific questions about the US IPR tec hnical assistance, capacity building and facilitation of 
technology transfer activities.  The US assistance agen cies worked closely with their counterparts in 
the capitals of other countries on these issues. 
162. The representative of Argentina  said that her delegation had promoted the WIPO 
Development Agenda and actively participated in th e negotiations that had resulted in its adoption.  
She believed that the principles of the Developmen t Agenda also applied in the Council for TRIPS.  IP/C/M/63 
 Page 33 
 
 
  163. The representative of Japan  said that technical cooperation a nd capacity building were very 
important for Japan.  At the WTO organized even t the previous week, his delegation had discussed 
this topic with Uganda in order to show its cooperative spirit.  Hi s capital was currently examining the 
contents of the communication from Bangladesh.  Jap an intended to contribute to the discussions at 
the event to be held in July in Bangladesh. 
164. Responding to the submissions made by Banglad esh, Rwanda, Uganda and Sierra Leone, the 
representative of Switzerland  joined the intervention of the Eu ropean Union which had highlighted 
the importance of a coordinated response to the n eeds submitted.  Referring to Switzerland's earlier 
interventions, he recalled the role that existi ng multilateral instruments such as the Integrated 
Framework could play in this context.  He enc ouraged LDC Members, when preparing and submitting 
their priority needs assessments, to channel those needs into their Diagnostic Trade Integration Study 
(DTIS) within the Enhanced Integrated Framew ork (EIF) context.  Switzerland supported the 
Secretariat's initiative for the regional workshops .  Responding to Bangladesh, he said that his 
authorities were still reviewing its very comprehensive priority needs assessment. 
165. The representative of Canada  said that his delegation was committed to development 
assistance, including the trade-related commitment under the TRIPS Agreement.  A multilateral 
approach was the most effective in providing such a ssistance.  As part of that commitment, Canada 
had announced its intention to provi de CAN$19.2 million over five years to the Enhanced Integrated 
Framework.  Canada also contributed CAN $400,000 a year to the World Trade Organization 
Development Agenda, a global trust fund which had financed a number of technical assistant 
activities related to TRIPS.  His delegation had b een in contact with its development assistance 
officials on the Bangladesh paper.  They were ex amining how it might fit w ith Canada's bilateral 
programme in that country.  In the meantime, he encouraged countries such as Bangladesh to explore 
those avenues for technical and financial assistance and to ensure that their DTIS reflected their 
priorities. 
166. The representative of Norway  said that her delegation attached great importance to the 
priority needs that had been submitted and would consider them with interest. 
167. The representative of Angola  encouraged partners to maintain their support for LDCs who 
would be submitting their needs assessments. 
168. The Chairman  encouraged those LDC Members who had not yet completed their individual 
needs assessments to do so as soon as possible so that the Council could have a clear picture of what 
was required. 
169. The Council took note  of the statements made and agreed  to revert to the matter at its next 
meeting. 
K. LETTER FROM THE CHAIR OF THE GENERAL COUNCIL CONCERNING WAYS TO IMPROVE THE 
TIMELINESS AND COMPLETENESS OF NOTIFICA TIONS AND OTHER INFORMATION FLOWS  
170. The Chairman  recalled that, at its past three meetings , the Council had had on its agenda the 
letter from the Chair of the General Council concerning ways to improve the timeliness and 
completeness of notifications and ot her information flows in the area of its responsibility.  In order to 
facilitate the Council's consideration of this issue,  the Secretariat had presented to the October 2009 
meeting a factual background note IP/C/W/543 it ha d prepared at the Council's request that 
summarized the relevant procedures and provided in formation on the use of these procedures, as well 
as contained suggestions on how to improve the tr ansparency and user-friendliness of the notification 
system.  Furthermore, the Secretariat had orally re ported on further developments in this area.  He 
recalled that those delegations th at had spoken on this issue had s upported the suggestions contained IP/C/M/63 
Page 34  
 
  in that note to improve the transparency of the sy stem, and had encouraged the Secretariat to pursue 
this task. 
171. The representative of the Secretariat
 recalled that, at the Council's meeting in March 2010, he 
had provided an extensive briefing on the Secretariat's various efforts to improve the workability and user friendliness of the notification mechanisms set  up under the Council, stressing that the activities 
undertaken had been carefully confined to th e existing procedures and arrangements already 
established by the Council, and essentially concerned th e use of information technology to make them 
more workable and less burdensome fo r Members to use.  In his update  on this work to facilitate the 
notification of laws and regulati ons relating to TRIPS, he wished to report on three specific 
developments:  (i) the launch of the TRIPS transparency  toolkit;  (ii) clarification of preferred formats 
for submission of texts;  and (iii) creation of the WIPO-WTO Common Portal as an optional means of 
submitting texts. 
172. As foreshadowed at the Council's discussi ons at its meetings in October 2009 and 
March 2010 under this agenda item, the Secretariat ha d established a single transparency toolkit page 
on the WTO website that provided a single access point  to various notifications and other reports from 
Members, as well to related formats, guidelines and background materials.  The transparency toolkit 
could be accessed from the general TRIPS gateway page, or directly at http://www.wto.org/english/tratop_e/trips_e/trips_toolkit_e.htm
. 
173. As emphasized during the Council's earlier discu ssions under this agenda item, a major 
obstacle to the efficient handling of notifications as well as accessibility and practical use of notified 
texts had been the use of paper-based or incompatible  digital formats (such as image pdf).  Therefore, 
for any new notification, it was strongly encouraged for submissions to be made as a digital file in a 
standard text-searchable document format (such as  rtf, doc, or pdf (text pdf, not image)), with a 
minimum of special formatting (such as headers and f ooters, or multiple columns).  This step alone 
would greatly facilitate and accelerate the pro cessing and dissemination of texts submitted for 
notification purposes. 
174. Further to its earlier report to the Council, the Secretariat had continued coordination with the 
WIPO Secretariat on the modernization and simplific ation of practical mechanisms for submitting and 
handling of laws and regulations notified to th e WTO under the TRIPS Agreement, and to WIPO 
under the Berne and Paris Conventions.  The two Secr etariats had coordinate d on the development of 
a common electronic depository (the "WIPO-WTO Common Portal") that would enable on-line submission of texts to either or both Organizations. 
175. The Common Portal served as an alternativ e means of submitting texts through what was 
effectively a single electronic mailbox.  It did no t replace the existing pro cedures established by the 
Council for receiving and processing notifications (see in particular document IP/C/2).  Nor did it 
change the administrative roles of either Secretaria t.  The Portal was only used as an optional means 
of transmitting texts to be notified – it could not be  used to access notified legal texts, which would 
continue to be available on the WTO website in the existing manner.  The Portal could be accessed 
through the transparency toolkit page.  The S ecretariat would be ready to advise any Member 
contemplating to notify new or re vised laws or regulations on how  to make use of the Portal, 
including through organizing access to it by delegates and other nominated officials.  He, therefore, encouraged any Member intending to make a notif ication under the TRIPS Agreement in the near 
future to contact the Secretariat before proceeding,  as this could facilitate the process for the Member 
concerned as well as speed up the processing and disse mination of the notified texts.  Annex 2 of 
document IP/C/W/543 could serve as a useful checkli st for any delegation wishing to check on their 
most recent notifications made under the Agreement.  IP/C/M/63 
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  176. He added that the Secretariat was incorpora ting notification procedures and the practical 
reference to notified materials as an integrated part of its technical c ooperation programmes relating 
to TRIPS.  This had already led to a positive fee dback, including through e nhanced relevance and the 
tailoring of technical assistance activities to th e expressed needs and priorities on its technical 
assistance partners. 
177. The representative of WIPO  said that the WIPO-WTO Common Portal was now available for 
notification of IP laws and regulations.  Both Me mbers of the Council for TRIPS and WIPO member 
states, the latter through their national IP offices, had recently been informed of the preliminary steps 
needed to be able to gain access to it.  This was a first and joint initiative between WIPO and the 
WTO to provide an alternative paperless and electr onic means for notifying IP laws and regulations 
within the existing legal framework.  Following its recent communication to national IP offices, 
WIPO had received requests for access from several of its member states.  Echoing the WTO Secretariat's statement, she said that WIPO was l ooking forward to also Members of the Council for 
TRIPS requesting to obtain access to the Portal. 
178. This Common Portal served as a temporary holding area for notifications and submissions.  
The ultimate destinations for these notifications a nd submissions were the database of IP laws and 
regulations of WIPO and of the WTO.  WIPO's le gal database, which was a result of the WIPO-WTO 
Cooperation Agreement of 1995, was undergoing fu rther development and it would be publicly 
available in the latter part of 20 10, and it would be called WIPO LEX.  As part of a larger initiative, 
WIPO had recently launched WIPO GOLD, a larger  portal consolidating u nder one umbrella the 
information and data resources that WIPO had c oncerning intellectual property.  WIPO LEX would 
be situated within WIPO GOLD.  It was intended to be authoritative, up to date and complete, and for 
this reason it would be a process while WIPO sought to provide complete information on the 
IP systems of all member States of WIPO, the Me mbers of the WTO and, eventually, of the entire 
UN membership.  WIPO LEX was essentially in line with one of WIPO's st rategic goals, which was 
to be the world source of IP information and anal ysis, and this was essen tially portrayed with the 
launching of the larger portal WIPO GOLD. 
179. WIPO hoped that this first initiative at a pa perless electronic means for transmitting the 
Members' IP laws and regulations to the Secretar iats of both WIPO and the WTO would prove to be 
helpful and facilitate compliance with Members' ob ligations to notify.  WIPO strongly encouraged 
Members to make full use of this particular elect ronic channel and looked forward to receiving the 
Members' legal texts within the next weeks or months. 
180. The representative of the European Union
 thanked the Secretariat for the excellent work it 
had done on timeliness and completeness of notificati ons and other information flows.  He welcomed 
the recent developments, including the transparency  toolkit, the appropriate electronic format for 
submission of texts, and the creation of the WIPO-WTO Common Portal.  He encouraged the 
Secretariat to further pursue this task and in formed the Council's next meeting of any further 
developments. 
181. The representative of Australia  thanked the Secretariat for its work on this very important 
issue that she hoped would make the work of the memb ership and the Secretariat much more efficient. 
182. The Chairman  suggested that the Council revert to ma tter at its next meeting, in order to 
provide Members a further opportunity to share any comments they might have on this matter and to permit the Secretariat to inform the Council of an y further enhancements to its services improving the 
transparency and user-friendliness of the notification system. 
183. The Council took note
 of the statements made and so agreed . IP/C/M/63 
Page 36  
 
  L. 
IMPLEMENTATION OF PARAGRAPH 6 SYSTEM  
184. The Chairman  said that the item on "Implementation of Paragraph 6 System" had been put on 
the agenda at the written request, dated 26 May 2 010, of the delegations of Brazil, China, Cuba, 
Ecuador, India, Indonesia, Peru and Venezuela.  He  recalled that the "Operation of the Paragraph 6 
System" had been discussed under "Other Business" at  the Council's previous m eeting in March.  At 
that meeting, his predecessor had reported on the co nsultations she had held  on 12 February at the 
Council's request.  The purpose of those consultati ons had been to provide a platform to share 
experiences and to look at concerns in an informal setting without prejudging the outcome.  
Subsequent discussions seemed to indicate that, wh ile there was readiness to share experiences and to 
engage in fact-based discussions with a view to reaching a full understanding of the system's 
functioning, there were different views as to whet her that could be best done by organizing a 
dedicated workshop, or within the existing annual review which had been built into the system, and 
also whether further discussions should be held in  an open-ended meeting involving all relevant 
stakeholders or limited to Members only.  In concluding the discussion, Ambassador Tan had asked 
him as the incoming Chair to contact interested delega tions in order to explore how best to proceed on 
the matter.  Accordingly, he had consulted with delegations to explore the matter, including at an 
informal meeting on the previous morning. 
185. He said that there was agreement to set asi de the second day of the Council's meeting 
scheduled for the 26 and 27 October for the next annua l review of the Paragraph 6 system in order to 
make it a more meaningful exercise.  That would make it easier also for capital-based delegates to 
attend that discussion.  It would also respond to the concern expressed by some that not enough time 
had been dedicated for the reviews at the Council's end-of-year meetings. 
186. There was also a basic willingness among delegatio ns to have some form of discussion prior 
to the next annual review in order to have a full understanding of the system's functioning.  However, 
this was from where the views continued to di verge, despite lengthy discussions.  One group of 
delegations believed that this c ould be best done by organizing a dedicated workshop involving all 
relevant stakeholders, with presentations fro m non-governmental organizations (NGOs), the 
pharmaceutical industry and other experts, so as to receive information on all aspects of the operation 
of the system and related concerns.  That would then provide input for the Council's annual review.  
Another group of delegations felt that, at this stage,  what was most needed wa s an in-depth discussion 
among Members on their experiences, including why pot ential beneficiaries had not used the system 
so far, as well as on matters, such as government pr ocurement policies and ot her matters of domestic 
implementation.  In their view, that kind of in formation could best be provided by the Members 
themselves.  Therefore, at this stage those delegati ons would prefer to stay within the existing annual 
review mechanism. 
187. He said that, as a possible compromise, he had explored the option of holding an informal 
Council meeting in mid-September, around the tim e of the WTO Public Forum scheduled for 
15-17 September, in which Geneva a nd capital-based delegates would pa rticipate.  This meeting could 
be well-structured, its aim being to facilitate the sharing of experiences and understanding of concerns 
through presentations by Members.  Delegates woul d of course be free to consult in advance with 
outside experts to get their input in order to prepare for this meeting.  In parallel, there could also be 
an event organized on this subject at the WTO Public Forum that would be open to all, whether delegates or representatives of NGOs, generic pha rmaceutical companies, R& D-based pharmaceutical 
companies, or any other interested party.  However,  at the informal meeting the previous morning, the 
Council had not yet been able to bridge the remain ing gaps on how to proceed with its preparations 
for the next annual review, apart from the two points of agreement already indicated.  IP/C/M/63 
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  188. The representative of India  said that his delegation was hope ful of achieving constructive 
engagement towards the removal of any obstacles to  a dedicated workshop on the implementation of 
the Paragraph 6 system.  Sadly, such engagement had been lacking during the informal part of the 
meeting.  However, he welcomed the consen sus on setting aside the second day of the October 
Council for TRIPS meeting for the annual review.  He said that he had noted an emerging consensus 
that there should be substantive engagement prior to the October meeting, as otherwise the latter 
might well be another ritualistic consideration of the Paragraph 6 system under the annual review.  
Some Members, particularly the delegations of Jap an and Switzerland, had c ontended that difficulties 
regarding the use of the Paragraph 6 system had not  been demonstrated.  That was precisely why a 
dedicated workshop had been requested in order to shed light on the difficulties in the implementation 
of Paragraph 6.  The representative of Canada had referred the previous day to the unique experience 
of using the Paragraph 6 system.  However, di scussions of that unique case could never be a 
comprehensive way to examine the implementation or lack of implementation of the system. 
189. He said that he was aware of several other e fforts to use the Paragraph 6 system which had 
not fructified and those attempts were equally, if  not more, important.  Members needed to examine 
valid questions such as why the system had been  used only once so far, and why the pace of 
acceptance of the protocol for amending TRIPS w as so slow.  His delegation was not making any 
assumption that the Paragraph 6 system was unworkable or that it needed to be amended, but that it had been sub-optimally utilized thus far, and that a thorough analysis needed to be undertaken. 
190. He said that the idea of a workshop was not new, and was common in NAMA, services and 
other areas, in which participants included represen tatives of intergovernmental organizations as well 
as of the private sector.  It was interesting to  note that those Members opposing the Paragraph 6 
workshop proposed and actively participated in tho se workshops.  He said that the statement of the 
representative of China that public health should be the easiest issue on which to reach consensus, as 
life was more important than trade issues, had been  proven wrong.  He thought that the intention of 
the proponents of the dedicated workshop had not b een correctly understood.  His own delegation was 
seeking a fact-based substantive discussion, and c onsidered that such a discussion could not be 
complete without the participation of all rele vant stakeholders.  Although some Members had 
expressed the view that participation should be Me mbers only, he emphasized the need to have the 
appropriate combination of Members and other stake holders.  His delegation, therefore, proposed that 
the workshop should include companies as well as ci vil society organizations which had first-hand 
experience in using the system.  However, participat ion was an issue that Members needed to further 
deliberate upon under the Chairman's guidance. 
191. He said that an event at the WTO Public Foru m would not be appropriate, since the Public 
Forum would not feed into the formal WTO process.  Further, an ideological discussion could not be 
ruled out in such a forum because of its open-ended participation. 
192. Based on suggestions from the delegations of Pe ru and China, he proposed that a dedicated 
workshop be held comprising of a session for Members only, followed by a session for relevant 
stakeholders to make presentations on specified t opics and provide an opportunity for Members to ask 
questions.  The stakeholders could be those nor mally invited to attend WTO technical assistance 
workshops, including intergovernmental organizatio ns, such as the WHO and WIPO, and NGOs such 
as Médecins Sans Frontières (MSF), and the International Federation of Pharmaceutical 
Manufacturers and Associations (IFPMA).  He said that his delegation had an open mind as to which 
stakeholders to invite, or what the scope of the workshop should be. 
193. The dedicated workshop should be held as soon as possible, and certainly before the October 
Council meeting, to allow for substantive discussions during the annual review.  On the preceding day, the US delegation had rightly said that the out put of the annual review depended on the input into 
it.  Therefore, a substantive fact-based discussion in a dedicated workshop was essential, in order to IP/C/M/63 
Page 38  
 
  achieve meaningful discussions during the annual revi ew.  Further details re garding participation, 
timing, and scope could be discussed during inform al consultations held by the Chairman.  He 
proposed that the Council take a decision regarding the holding of a dedicated workshop accordingly. 
194. The representative of Ecuador
 said that his delegation suppor ted the conclusions outlined in 
the Chairman's report, particularly those concerni ng convergence on an in-depth analysis during the 
second day of the Council's meeting.  He said that Ecuador had a firm public health policy aimed at 
increasing life expectancy and the quality of life of the population through universal access to drugs.  
Accordingly, his country wished to ensure the a ppropriate functioning of the flexibilities in the TRIPS 
Agreement, which implied compliance with the ma ndate established in paragraph 8 of the Decision 
Implementing Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, 
which established that the Council shall review the f unctioning of that system to ensure its effective 
operation.  In that context, his delegation, along with other Members, had requested the inclusion of 
that item on the Council's agenda, so as to enhance appropriate and effectiv e consideration of the 
positions and policies of Members. 
195. He said that, in October 2008, his delegation had flagged and voiced concerns about the 
possible inefficiency of the Paragraph 6 mechan ism, about possible weaknesses of its design and 
architecture.  At the time, his delegation had ma de reference to the first and only experience of 
recourse to the Paragraph 6 mechanism, noting th at it would seem that the procedures for the 
implementation of that mechanism could be complex,  burdensome, costly and lacking in flexibility.  
These procedures would impact on the very objective of that mechanism of ensuring an expeditious 
solution to enhance access to drugs in countri es with little or no manufacturing capacity in the 
pharmaceutical sector in the light of their public health needs.  His delegation's position was that 
consideration be given to a dedicated workshop with  broad high-level participation where all sectors, 
including the pharmaceutical industry and other industr ies, as well as other interested parties, such as 
the public sector and civil society organizations, c ould put forward substan tiated positions on all the 
different aspects and challenges pertaining to the functioning of the Paragraph 6 system. 
196. He said that, as the delegation of India had stat ed, the dedicated workshop would be similar to 
those decided upon in other areas of work in the Organization, for instance the workshops organized 
by the Financial Services Committee and NAMA, whic h were, in effect, work programmes entailing a 
whole series of workshops on different issues and eval uations.  Therefore, it would be an appropriate 
tool to evaluate the solutions which had truly e nhanced the best implemen tation of the Paragraph 6 
system.  Consequently, his delegation agreed with the delegation of India on its two options, as being 
the two possible ways of moving forward with that  proposal.  He said that it was essential that the 
convergence principle around the evaluation of the Paragraph 6 system be structured within the context of the different bodies of the WTO. 
197. The representative of China
 said that, although the delegation of India had stated that the 
delegation of China might be wrong in saying that pu blic health issues would be easy for Members to 
agree upon with each other because life was more impor tant than trade issues, she still believed that 
Members differed with each other about the means rath er than the end.  Her delegation attached great 
importance to the implementation of  the Paragraph 6 Decision, since it was closely related to public 
health issues mandated nine years ago in the Declar ation on the TRIPS Agreement and Public Health 
by Ministers in Doha.  Her delegation had noted th at Members of the Council for TRIPS, in order to 
assist the efficient and meaningful conduct of the formal annual review of the implementation of the 
Paragraph 6 Decision, had put forward at least thre e modalities thus far in the process, to which the 
Chair had made a constructive contribution.  Firstly,  her delegation was in agreement with the Chair's 
proposal to dedicate the whole of the second day of the upcoming Council for TRIPS to conducting a 
thorough and meaningful review of the implementa tion of the Decision on the Paragraph 6 system.  
She was hopeful that the Chairman would enter into  consultations with Members shortly after the 
present meeting on how to organize such a review.  Second, after comparing the three modalities on  IP/C/M/63 
 Page 39 
 
 
  the table on how to prepare for the October review, namely, informal consultations, a session at the 
WTO's Public Forum, or a dedicated workshop on that issue, her delegation was of the view that a dedicated workshop held before the October review  would best serve the purposes of Paragraph 6.  
However, two workshops would be preferable:  one  open to all Members, and the other open to all 
stakeholders. 
198. After six years, less than two thirds of th e Membership had yet to adopt the Paragraph 6 
Decision and among those who had adopted it, the m echanism had only been used once by a Member.  
She said that there were doubts and reservations, both multilaterally within the WTO and outside the 
WTO, on how the system operated.  It was the obligation of Members to identify the problem and see where the weaknesses were.  Her delegation was in agreement with a factual investigation on that 
issue without prejudging the outcome.  She said that  her delegation was hopeful that the opponents of 
a dedicated workshop would provide further explana tion of the reasons for their objections.  On the 
informal consultations, she said that, provided they were not intended to replace a dedicated 
workshop, her delegation would welc ome informal consultations being held by the Chair open to all 
Members.  Such consultations were a routine element of the WTO's work, and would be a good 
preface for a preliminary exchange between Members, allowing them to communicate freely with 
each other in order to reach a formal decision by consensus.  She said that workshops, including the 
examples given by the delegations of India and Ecuador, were a common and efficient practice in 
other areas of the WTO, and she hoped that th ose opposing a workshop would give further 
consideration to the matter, especially in light of  future work, not only within the Council for TRIPS 
but also in other areas of the WTO. 
199. The representative of Cuba
 said that her delegation supported the idea of a dedicated 
workshop devoted to the implementation of the Paragr aph 6 system.  It was preferable that such a 
workshop be open to both Members and other interest ed parties.  This was an appropriate way of 
enhancing their understanding of problems that underp in the system, and that have made the system 
ineffective thus far.  It was important to recall that Members had committed themselves in Doha to 
finding a solution to the difficulties faced by Me mbers with insufficient or no manufacturing 
capacities in the pharmaceutical sector.  Member s had made this commitment because great 
difficulties were being encountered in making effe ctive use of compulsory licensing under the TRIPS 
Agreement.  She said that she did not know why th ere was continued rejection for such a workshop, 
which would be an ideal forum to have an excha nge of views on the Paragraph 6 system, which was 
meant to overcome the serious difficulties faced by some Members.  She said that the conclusions 
and/or recommendations of the debate in the dedi cated workshop could then be submitted to the 
Council and recommended that such a workshop be  organized just before the October Council 
meeting in order to facilitate the par ticipation of capital-based officials. 
200. The representative of Brazil  said that Paragraph 6 on the Declaration on TRIPS and Public 
Health had mandated the Council for TRIPS to fi nd an expeditious solution to the problem of 
Members having insufficient or no manufacturing capacities in the pharmaceutical sector and to report 
back to the General Council before the end of 2002.   That was how the Paragraph 6 system had been 
created in 2003.  Since then, despite high hopes placed  on the system, it had been used only once in an 
operation involving a Canadian company and Rwanda.  The previous day, the delegation of Canada 
had stated that the whole operation represented a challenge.  During informal consultations on the 
matter, delegations had been informed that, while the process was concluded relatively fast in Canada, 
within two weeks, it took eight months for Rwanda  to take all the legal and administrative steps 
required to approve the purchase of the needed me dicine.  Other delegations had stressed that 
consideration should be given to the fact that some countries could not even afford medicines 
produced under compulsory licensing, which would expl ain, at least in part, the lack of demand for 
the use of the Paragraph 6 system.  All of those we re valid explanations wh y the Paragraph 6 system 
had fallen short of expectations.  There might well be other explanations, which was why the 
delegation of Brazil had joined the group of count ries requesting the opportunity to listen, in a IP/C/M/63 
Page 40  
 
  workshop to be held under the auspices of the Council for TRIPS, to the views of all stakeholders in 
that matter.  Unfortunately, it had not been so far possible to reach consensus on how to organize such 
a dedicated workshop.  He said that his delega tion, however, remained confident that under the 
Chairman's leadership they would find common ground on a possible format to organize a thorough review of the operation of the system between now and the next session of the Council.  Whatever the 
format chosen, his delegation stood ready to shar e with others its experience in using TRIPS 
flexibilities to provide access to  affordable medicines. 
201. The representative of Peru
 said that, in the informal session of the previous day, his 
delegation had considered it most appropriate to hold a dedicated workshop aimed at examining the 
implementation of the system.  He fully supported the interventions by several delegations, including 
those of India, China, Cuba, Brazil, and Ecuador  and expressed his delegation's willingness to support 
a compromise solution that would make it possible to hold a dedicated workshop in order to examine the different problems, challenges and opportunities that would enhance the implementation of the 
Paragraph 6 system.  He called upon Members to s how flexibility and commitment so as to find a 
compromise solution which would be satisfactory to all. 
202. The representative of Indonesia
 said that he would like to highlight the importance of a clear 
and practicable mechanism for the implementation of  the Paragraph 6 system.  He said that, having 
observed the current situation, the complexity of  the mechanism was one of the predominant issues 
that hindered its implementation.  This was not itself in line with the spirit of the Paragraph 6 system.  
The mechanism should be designed to facilitate an expeditious solution for countries without 
manufacturing capacity in the pharmaceutical sectors to  make effective use of compulsory licensing 
under the TRIPS Agreement.  Therefore his delega tion supported the proposal for a WTO technical 
workshop to review the implementation of Para graph 6 and find the most appropriate way for 
implementing the system as it was intended, namely, to help developing countries to ensure that the 
patent system did not hinder appropriate access to health and medicine.  He said that his delegation 
believed that all Members should aim at improving the forum in the future and strongly hoped that 
would be an improvement of the outcome and decisions. 
203. The representative of Venezuela  thanked the Chairman for his efforts in seeking an 
agreement.  In his view, the issue should not have  been controversial.  He said that a number of 
questions had been raised the previous day about  the Paragraph 6 system, including for whom it was 
intended, by whom it had been designed, why it ha d not worked, and why it had entailed an appeal for 
extension or postponement.  He said that rules coul d not be static, and requi red constant review and 
interpretation to verify whether they had lost their rele vance, if they ever had any, or whether they still 
had any relevance.  This was precisely why courts existed to interpret rules.  However, here there 
were no courts, which was why it was necessary to have an open dedicated workshop in order to 
know exactly what had happened with the mechanism under the Paragraph 6 system. 
204. He said that the Paragraph 6 system had been  somewhat separated from reality and had not 
gone beyond a statement of good intentions.  It was re quired to establish, on the basis of Paragraph 6, 
how the system could be effectively and efficiently  used for least developed and developing countries 
for which it was intended.  It was striking that  it was precisely developed countries which were 
opposed to discussing the reasons for which the system had not worked, which was not very 
democratic.  Here the position was to oppose maki ng changes in order that everything remained 
unchanged, in particular, access to medicine bei ng denied for millions of people.  The proposed 
workshop with outside participants did not constitute  a solution but would shed some light on how to 
proceed in order to better implement the system. 
205. The representative of Argentina  said that her delegation believed that such consultations 
should be ongoing and the issue re quired a further exchange of positions.  Her delegation also 
welcomed the issue being dealt with on the sec ond day of the October Council for TRIPS.  Her  IP/C/M/63 
 Page 41 
 
 
  delegation was open to any initia tive which was intended to assess the functioning of the Paragraph 6 
system. 
206. The representative of Bolivia  said that his delegation was interested in having a structured and 
in-depth analysis of the reasons that had made  it impossible to fully implement the Paragraph 6 
system.  At the informal session of the preceding da y, his delegation had been somewhat surprised to 
learn that some Members failed to see any problems w ith the implementation of the system.  He said 
that if a costly hospital had been built, which had ta ken a long time to build and if in the six years 
since its inauguration it had only been used once, an investigation would be  launched involving all 
stakeholders to find out the reason.  Something similar had occurred in the implementation of the 
Paragraph 6 system, since more than six years had elapsed and the system ha d been used only once 
and, moreover, had been ratified only by a small numb er of Members.  He said that now would be the 
right time to have an in-depth analysis, consu lting all interested parties and international bodies 
specializing in health matters, NGOs that were committed to health, the pharmaceutical industry and 
governments.  That was why a dedicated workshop had been suggested to establish why the system 
was not functioning.  He said that his delegation be lieved that the suggestions  of the delegations of 
India and China as to a two-day work shop, one just for Members and the other for interested parties in 
general, would be the best way to  move forward towards a solution.  His delegation also supported the 
suggestion of the delegation of Cuba that the work shop be held prior to the next Council for TRIPS 
scheduled for October. 
207. The representative of Mauritius  said that he appreciated the spirit of compromise shown by 
Members, which had shown that practical consider ations could override ideological ones.  All the 
delegations were aware of the genesis of paragr aph 6 and that it was a hard-earned outcome for 
developing countries, especially the vulnerable ones.  In fact, it was one of the rare occasions where 
TRIPS could be positively used to alleviate human suffering and save human lives without the need to 
focus on profits and trade.  However, the Paragrap h 6 system had ended quickly in disillusion, and 
surprisingly few countries had ratified it, even among the demandeurs , including vulnerable countries.  
Therefore it would be an opportune time to consider the merits and demerits and shortcomings of the 
system.  As stated by the representative of India, a mere ritualistic and formalistic review was not sufficient.  Nothing had come out of the six reviews which had been carried out thus far. 
208. He said that several Members had outlined their positions on that issue and one had 
mentioned that Members had not identified the difficu lties.  However, his delegation believed that the 
very fact that the system was not working properly showed that not only were there difficulties, but 
there was a problem with the whole system.  For the vulnerable and developing countries, there was a 
need to understand the complexity of the mechanis m, to diffuse any apprehension and ensure that 
some important private stakeholders did not put undue pressure on these countries to ratify or to use 
the system.  Another argument that had been put forward by one or two Members was that private 
stakeholders should not be brought on board;  he failed to understand the basis of that argument, given 
that the mechanism provided for interplay between Members and private stakeholders, especially the 
pharmaceutical industry.  Therefore, it would be importa nt to have the first-hand experiences of those 
companies which were involved and to have an in-d epth consideration of the difficulties encountered 
by the only Member which had tried to use the syst em.  In concluding, he expressed his delegation's 
support for the compromise suggested by the Chairman and welcomed his holding a half-day dedicated session where Members would have the opportunity to discuss their difficulties with the 
system, and another half-day dedicated session in the afternoon, where a number of NGOs, private 
stakeholders and other experts would be able to enlighten Members on the inherent difficulties found 
in the Paragraph 6 system. 
209. The representative of Angola, speaking on behalf of the LDC Group
, said that access to 
affordable medicines by the majority of LDCs  to address public health concerns relating to 
tuberculosis, HIV and malaria was a matter of life and death.  The LDC Group considered the IP/C/M/63 
Page 42  
 
  adoption of the Decision of 6 December 2005 to ame nd the TRIPS Agreement in order to respond to 
the difficulties experienced by countries with insu fficient or no manufacturing capacities to be an 
important milestone.  It was, however, disheartening to note that five years since the adoption of the Decision few Members had deposited the instrument of acceptance of the amendment.  It was important to establish why countries were not coming  forward so that corrective measures could be 
taken.  The LDCs welcomed the informal consulta tions on 12 May, 3 June and the previous morning 
that had been held in order to get a sense of wher e the impediments lay to the ratification process and 
how their removal could be facilitated, including th rough expedient ratification of the amendment by 
individual countries.  LDCs considered that such a workshop would be relevant to prepare Members 
to address the issue of ratifying the amendment to the TRIPS Agreement in regional and national 
technical assistance and capacity building activities unde rtaken by the Secretariat.  He said that LDCs 
were ready to follow the consensus on how to address this important issue. 
210. The representative of Canada
 said that his delegation appreciated the constructive solutions 
that the Chairman had brought forward to the C ouncil as to how to address the way forward on the 
operation of the Paragraph 6 system .  His delegation was pleased to note that some progress had been 
made with respect to establishing a dedicated session at the next Council for TRIPS meeting to further 
enhance the annual review of the Paragraph 6 syst em.  However, referring to a number of comments 
that had been made following up the informal meeting the previous morning, he said that he found it somewhat puzzling one was starting to hear rhetoric  such as "opponents to the workshop" that perhaps 
suggested that there was lesser investment or inte rest in access to medicines.  He did not actually 
recollect any delegation that had suggested that a workshop be ruled out altogether;  on the other 
hand, he recalled his own delegation's words that priority should be given to the October annual 
review process and that the interim period be used to find ways to ensure that the review was as 
successful as possible. 
211. He said that there had been suggestions that wo rkshops, such as those organized for financial 
services and NAMA, had been effective tools in othe r committees.  However, he  had not been party to 
those particular discussions;  his understanding was that those workshops had been the result of 
constructive substantive discussions among Member s, which had shaped the structure and the 
contents of those workshops.  However, Members were being asked to do the reverse in the Council 
for TRIPS, namely to outsource their work to outside  stakeholders and be dictated to by them.  He 
found that to be an odd construction.  He said that if they were to consider the workshop as a tool, 
then first they would have to do the underlying work as Members.  It was the responsibility of 
Members and they had the mechanism to  undertake that work in October. 
212. In an earlier intervention, a delegation had not ed that it was aware of other examples where 
Members had given consideration to the Paragraph 6 option, but had decided not to use it.  That was 
precisely the kind of information his delegation was seeking to discuss within the context of the Council for TRIPS as to why such decisions were take n or not taken.  Statements heard thus far had 
been general about burden and complexities, but no specific details had been given either in recent 
discussions or in previous annual review meetings.  The October meeting could be used to learn the 
specific problems that Members had faced in using the system. 
213. He thanked the representative of Brazil fo r raising the Canadian example from his 
intervention the preceding day.  He said that th e challenge Canada had faced had been in the 
construction of its access to medicine regime.  After the August 2003 decision, Canada had been 
provided with a roadmap on how to construct a regime.  The challenge it faced was to build the 
system from ground up.  The result was a balanced  regime allowing Canada to be an exporting 
country.  When the system was operationalized in the Canada-Rwanda case, the process ran efficiently.  In this regard, he referred to the minut es of the Council's meeting in March.  Indeed there 
were some issues associat ed with the Canada-Rwanda case, such as government procurement, that his 
delegation had raised in the past and could be furthe r explored.  However, with  regard to the operation  IP/C/M/63 
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  of the regime itself, he said the regime had operated to his delegation' s satisfaction and could 
definitely not be characterized as difficult or a challenge. 
214. He said that Members should make the best use of the dedicated day for the October review, 
perhaps more than they had done in the past.  Me mbers also had the possibility of using the interim 
period, in an informal meeting in September, wh ere they could exchange information on potential 
questions and areas that would require further cl arification so as to better organize the October 
meeting itself, and so that delegations could ensure  that they had proper representatives there.  In 
concluding, he expressed the hope that those delega tions that had not yet endorsed the Chairman's 
proposal, would give additional c onsideration to it in order to move forward with the process. 
215. The representative of Colombia  said that he hoped the next annual review would be a more 
substantive exercise than in the past.  He welcom ed the Chairman's suggestion that the second day of 
the October session would be devoted exclusively to th e review.  As to the preparation for that review, 
his delegation supported those delega tions that had requested that a dedicated workshop be held just 
before the October Council meeting which would include all stakeholde rs.  Furthermore, that would 
provide an opportunity for prior work to be acco mplished before the workshop, as the delegation of 
Canada had stated.  Consideration should be given at the workshop to the difficulties, challenges and 
the opportunities to improve the implementation of Paragraph 6. 
216. The representative of Mexico  said that she was flexible in seeking consensus that would allow 
Members to make progress on the issue and was in their best interest.  If more consultations were required, they should be open to all Members. 
217. The representative of Nicaragua
 said that her delegation supported the proposal for a 
dedicated workshop to be held in two separate s essions:  a session for Members, followed by another 
open to all stakeholders.  Her delegation was hopeful that if consensus on the proposal was not 
reached at the present meeting, the Chairman could be able to bring positions closer together in 
subsequent consultations.  It was important th at the workshop comprise of two specific sessions 
would allow capital-based officials from developing c ountries to participate and benefit from these 
discussions, including informal discussions at the ma rgins of the workshop, and that it also would 
include other stakeholders providing a useful poi nt of contact.  That would not be the case if a 
Members-only workshop was held separately and subse quent to a Public Forum session, as had been 
suggested by the Chairman.  She requested the Chairman to continue his consultations to bring 
positions closer together and hopefully use any fina ncial resources available for the participation of 
capital-based officials from developing countries. 
218. The representative of New Zealand  said that his delegation was prepared to accept the 
Chairman's compromise.  While his delegation was not opposed to a worksh op, it only made sense 
once a proper and substantive discussion had taken place among Members.  That had not been the 
case, as reflected in the records of the reviews of th e last three years, and that was not from lack of 
opportunity.  In October 2009, it had been proposed that the Chairman hold consultations to identify 
obstacles, through the sharing of experiences that  had prevented developing countries from making 
full use of the system.  Those consultations had yet to take place. 
219. He said that, contrary to expectations, there had been no sharing of experiences by developing 
countries at the informal meeting held on 12 Febr uary 2010, as only the delegation of Canada had 
shared its experience of the Rwanda case.  His dele gation had been surprised and disappointed to note 
that demandeur s for the workshop had not shared any of their experiences at that meeting.  He said 
that the delegation of India had earlier stated that  it was aware of several other efforts to use the 
Paragraph 6 system, but that problems had eventuated .  While agreeing that this should be explored 
further, he asked why that exercise had not been undertaken in February.  He wondered whether it 
was really necessary for private companies and NGOs  to provide the answers these questions.  That IP/C/M/63 
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  was a sad reflection on Members' engagement and willingness to make the WTO function as it 
should. 
220. He said that his delegation considered the issue was a systemic one of lack of engagement.  
His delegation was opposed to outsourcing, or, in the words of the delegation of the European Union, 
"sub-contracting", Members' work.  If Members woul d put as much effort into sharing of experiences 
and analyzing the issues as they had put into debatin g the process in the last few months, then they 
would be well prepared for a useful meeting in October. 
221. The representative of Chile
 said that, since its adoption, the Paragraph 6 mechanism had 
become an important instrument, whereby the international community  had recognized that access to 
medicines was an essential right and th at the intellectual property system must be used in a balanced 
manner.  While it was true that the Paragraph 6 system was a mechanism that enabled export of 
medicines to countries without production capacity, it had proven to be less effective and efficient.  
As stated in the informal consultations the previous  day, the fact that only a small number of countries 
had accepted the amendment and that the system had only been used once showed that certain 
elements might need to be reviewed.  Because th e matter was crucial, that exercise should focus on 
analyzing technical aspects that coul d influence the use of the system. 
222. He said that his delegation also supported the proposal of devoting a day to the examination 
of that issue during the Council's next meeting in Oc tober.  As regards the practical arrangements for 
such a review, work should begin with a workshop, without prejudging the results.  He agreed with the representative of Canada that Members had th e main responsibility for determining the reasons 
why the system was so seldom used.  However, if  Members were aware of the technical difficulties 
that might exist at the implementation stage or we re able to hear directly from the different 
stakeholders about their experiences, Members w ould be in a better position to make informed 
decisions.  His delegation was entirely open to alte rnative solutions in seeking consensus or that 
would enable progress, though he did not consider the two to be incompatible. 
223. The representative of Egypt
 said that his delegation fully su pported the delegations that had 
requested the addition of the item to the agenda.  In 2001, the African Group had taken the initiative 
to bring the critical issue of access to medicine to the Council for TRIPS in an attempt to target an 
important public health problem, and not a mere  issue of legal tweaking or fine tuning of 
interpretations of legal texts.  Over the years si nce then, Members had engaged in laborious work on 
consulting and discussing drafting language as a way ou t of that critical public health crisis.  When 
agreement was reached on the 30 August Decision, it  had been their hope that the problem had been 
resolved.  His delegation had communicated its acceptance of the protocol amending the TRIPS 
Agreement in 2008 in the belief that it was expedient to  do so to provide room for a solution to urgent 
public health needs, and that it would be able to pr ovide urgently needed medi cines to countries that 
required them. 
224. His delegation considered that that issue pertaining to the functioning of the solution to 
guaranteeing access to medicines to countries with limited or no manufacturing capacities was critical 
for developing countries, and particularly for Africa.   He said that his delegation was concerned that 
the system had not been as helpful in addressing that  critical public health problem as it had hoped.  
The fact that the system had only been used once ra ised questions as to its effectiveness, let alone 
expeditiousness.  Likewise, the failed drive to ac cept the amendment protocol was incomprehensible 
in its own right.  He said that many questions ha d arisen that needed to be addressed, including 
administrative and regulatory complexity of the system, lack of appreciation of business methods in 
supplying markets and associated overhead co sts, as well as constraining requirements.  IP/C/M/63 
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  225. He said that his delegation welcomed the dedication of the second day of the upcoming 
Council for TRIPS session to discuss that issue and also strongly supported the proposal to organize a 
dedicated workshop that would include participants  from among the various stakeholders to address 
those questions and others of relevance.  Accord ingly, his delegation urged all Members to join 
consensus on the convening of a dedicated workshop w ith the participation of all stakeholders to 
discuss those questions in a constructive manner, a ddressing the critical need for developing countries 
and Africa in particular. 
226. Thanking the delegations of Ca nada and New Zealand for thei r comments with regard to 
where the responsibility lay for the functioning of th at system, he said that clearly the responsibility 
for the functioning of the system lay with the Me mbers of the WTO.  However the question they had 
posed seemed like the cart and horse issue.  Did Members begin by discussing among themselves 
first, or take inputs, suggestions, recommendations , and experiences of those that had actually used 
the system and those that would be potential users of  the system?  He said that there was no harm in 
proceeding with a dedicated workshop, bearing in mind that the discussions and the issues that would 
be raised would then be food for thought in the discussions by Members. 
227. He said that it was interesting to note that in  June 2001 when the Council had first tackled the 
issue of public health, a workshop had been held on the issue of public health and access to medicine 
only a few months later.  Now there was a contradic tion that there was the need to engage thoroughly 
first among Members on an issue and then take up the discussion in a workshop with the actual stakeholders of the system.  He said that they needed  to engage first with those that had the experience 
in order to enrich their debate.  Given the fact th at workshops were the practice in other areas of the 
WTO, he said that it was in everyone's interest to listen to stakeholders, even if it was possibly not 
comfortable for some to do so. 
228. The representative of the United States
 said that his delegation appreciated the progress made 
by the Chairman in developing a plan for the a nnual Paragraph 6 review.  His delegation wished to 
associate itself with the delegation of Canada on possible constructive ways to use the time before the 
October review.  The perspective of his delegation was that Members should make effective use of the 
mechanisms they already had mandated for them selves before entering into a debate on new 
approaches.  For that reason, and for the reasons expressed in greater detail by the delegations of 
Canada and New Zealand, his de legation did not support the idea of having the Council for TRIPS 
itself organize a workshop or seminar on the Para graph 6 system as proposed.  His delegation had 
taken note of the concerns expressed about the annual  review process and, in that context, continued 
to believe that what Members obtained from such revi ews was a function of what they put into them.  
It was Members who implemented the Paragraph 6 system, and who had the experiences of implementation and they could provide informa tion on their experiences as input for the October 
review.  As already touched upon by the delegation of Canada, it was an inherent function of each 
government to gather and sift through information fr om interested parties in developing its own policy 
and practices.  If Members wished to bring into the Council's review any perspectives they had 
gleaned from stakeholders, such as ci vil society and the private sector, they could do so.  He said that 
his delegation looked forward to participating in further discussions among Members at the 
forthcoming October review. 
229. The representative of Switzerland
 said he appreciated the consu ltations the Chair had held in 
the last few weeks and months to find a solution an d a way forward on this issue.  His delegation was 
in favour of discussing Members' views on and co ncerns about the Paragraph 6 mechanism, and 
wished to understand exactly what those concerns were and asserted problems relating to the use of 
the mechanism.  Despite a number of opportunities at annual reviews in the past, the Council had not 
yet had a detailed and fact-based substantive di scussion about the workability of the Paragraph 6 
mechanism.  Those Members that had concerns a bout the implementation and use of the Paragraph 6 
system should specify their concerns in more detail with regard to the elem ents and the mechanisms IP/C/M/63 
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  as set up by the Membership in 2003 and 2005, and identify potential obstacles which might prevent 
or deter them from making use of the Paragraph 6 system.  Until Members had had such a substantive 
discussion among themselves, he considered it prematur e to request the WTO Secretariat to organize 
a workshop with open-ended participation.  The Para graph 6 mechanism was first and foremost a tool 
that could be made use of by Members that qualified under the system.  It was thus their 
responsibility, first of all, to review the mechanism,  to clearly outline and specify their concerns and 
problems they might meet in practice in making use of the system.  That should be a constructive, 
fact–based discussion and analysis. 
230. He said that there could be many reasons why a WTO Member without manufacturing 
capacity in the pharmaceutical sector and with the ne ed to address a public health problem might not 
ultimately have used the Paragraph 6 system.  The system had been conceived as a fallback solution, 
as was the case for compulsory licences in general, i. e. being the exception to the rule, where a more 
expeditious solution to the need for a particular i nvention – and in the case of the Paragraph 6 system 
for an innovative medicine – could be found w ithout breaking the patent.  A scenario why in a 
particular case a Member might not have had recourse to the Paragraph 6 system in the past few years 
could, for example, be a favourable outcome of pr ocurement negotiations with the patent holder as a 
result of the government's strengthened negotiati on position resulting from the availability of the 
Paragraph 6 system and thus the possibility to c onsider issuing a compulsory licence as a fallback 
option.  Another example could be a situation wh ere the needed pharmaceutical product was available 
from a country with manufacturing capacity where no patent protection applied, or where such protection had expired.  The point was that it seemed  too simplistic to assume that the Paragraph 6 
system was not workable merely because it had not been used often so far. 
231. The Paragraph 6 system had been established for the use of Members in a Paragraph 6 
situation.  It was thus Members themselves and not other stakeholders who first and foremost had to 
specify and discuss their concerns about their difficu lties in having recourse to the system.  He asked 
to which features of the system their concerns related:  was it the notification requirement;  or the 
anti-diversion measures that should guarantee that the medicines actually reach the country in need of 
the medicine;  finding a generic producer w illing to produce the pharmaceutical product under a 
compulsory licence;  or how to ensure the safety and efficacy of the medicines manufactured under a 
Paragraph 6 compulsory licence, an issue to which a delegate from an African country had referred to 
in the informal discussion on the preceding day?  Th e Council would need to discuss specifically and 
in a practical manner whether it was those or other features of the Paragraph 6 system that caused the 
concerns. 
232. He said that the Council should ensure that there would be sufficient time for the annual 
review at its meeting in October.  His delegation was thus ready to set aside half or even a full day of 
that meeting for the review.  It could also agree to  hold an informal Council meeting in September to 
prepare and initiate the forthcoming review, if the Council would find it useful.  He looked forward to 
an in-depth and constructive discussion of Member s' specific concerns regarding the Paragraph 6 
system. 
233. The representative of Japan
 said that his delegation believed that the Paragraph 6 system and 
the Protocol Amending the TRIPS Agreement provi ded a useful mechanism.  Some Members had 
concerns about the effectiveness of the system due  to the limited number of Members that had had 
recourse to the system or the number of countries that  accepted the Protocol to date.  However, it was 
too early to draw conclusions about the effec tiveness of the Paragraph 6 system based on the 
aforementioned aspects.  His delegation believed th at any discussion, including the question of how 
other mechanisms were complementary to it, should be undertaken in an analytical and 
comprehensive manner based on practical examples.  IP/C/M/63 
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  234. If the limited number of countries using the system or the number of countries that had 
already accepted the amendment was indeed the problem,  reasons for that needed to be analyzed.  It 
could be that there were specific difficulties in us ing this system, in which case they would appreciate 
being informed of these.  However, if the reason was simply that Members had no need to use the 
system, then there was no problem.  From that point of view, the explanations from the representative 
of Canada at the informal consultation on 12 Febr uary and at the present meeting had been productive 
and constructive. 
235. The Council was responsible for the review of th e mechanism pursuant to the decision of the 
General Council.  In that context, Members had had ample opportunities to discuss that issue.  
However, no specific problems had been identified thus far.  Therefore, his delegation was of the view 
that the current annual review mechanism was the suitable place to deal with that issue. 
236. As to the suggestion for a workshop with the pa rticipation of the repr esentatives of NGOs, 
pharmaceutical industry and others, he said that the governments of Members were the main implementers of the Paragraph 6 system, yet they had failed to identify the reasons for the limited use 
of the Paragraph 6 system.  Therefore, his delega tion did not consider such a workshop to be the 
appropriate way forward.  If some Members felt th ey needed more opportunities, his delegation would 
continue to work on that issue, either at the regul ar session or in the informal consultations, in order to 
identify any specific problems and address them, as the WTO was a Member-driven organization.  In 
conclusion, his delegation considered that the Ch airman's compromise proposal was the appropriate 
way forward. 
237. The representative of Korea
 said that he would not contend that the Paragraph 6 system was 
not working properly, as that had not yet been est ablished.  However, there was a reasonable ground 
to believe that the annual review mechanism might not work in the current setting.  Therefore, his 
delegation welcomed the holding of a dedicated work shop, which could be a useful tool and provide a 
fresh outlook.  Some Members had rightly said that the WTO was a Member-driven organization, but workshops were often used to pr ovide new inputs and information in other negotiating areas, such as 
in NAMA.  The reality w as that some major players were not in favour of the idea.  The Chairman 
had proposed a compromise solution, but many developing countries were not in agreement.  The delegations of Canada, Japan a nd New Zealand had spoken in favour  of the October annual review 
mechanism.  The question was whether those delega tions were open to the idea of holding a workshop 
after the annual review in October if th at meeting failed to produce a result. 
238. The representative of Costa Rica
 said that the matter was worth discussing in order to 
improve the implementation of the system.  As stated  by the delegation of Chile, it seemed that there 
was agreement to discuss the operation of the system in order to enhance its implementation.  Until 
then, the Council had mainly focused the mechanisms  for it.  As the delegation of New Zealand had 
stated, it had not discussed the challenges or problems th at could be encountered with this system.  He 
welcomed the agreement to hold a dedicated sessi on at the October session which would improve the 
annual review and also supported a dedicated workshop to be held just before the October meeting.  
But it should be held among Members only, although his delegation was open to discussing the participation of experts.  He said that the WTO Secretariat had in the past organized several seminars on Paragraph 6 and would be organizi ng others in the future with the participation of experts from 
capitals.  It would appropriate to consider how those seminars could be used to enhance the 
functioning of the system or to provide input into the annual review. 
239. The representative of Australia
 said that her delegation had welcomed the General Council 
decision in December 2005 to amend the TRIPS Ag reement and had accepted the protocol.  She was 
ready to consider the idea of a workshop, although the preceding discussion strongly suggested that 
there was still room for a dialogue among Members that  would lead to an objective analysis of the 
practicable operation of the system.  Therefore, she en couraged Members to participate in that kind of IP/C/M/63 
Page 48  
 
  dialogue to provide information on the Paragraph 6 sy stem and to engage formally and informally on 
how the system operated in practice.  Her delega tion supported the Chairman's proposal on the way 
forward. 
240. The representative of Venezuela
 said that several Members had stated that they should not be 
told what to do from outside.  However, Memb ers were not islands a nd there were numerous 
stakeholders his delegation would like to invite to  a workshop.  Many of those Members that were 
using that argument were conditioning what was ha ppening in this Organization by the G-20, a group 
that had nothing to do with the ma ndate conferred by 154 WTO Members.  At the informal session of 
the preceding day, the representative of Canada had first described the process as difficult and then, 
correcting himself, as a challenge, and, earlier in the present meeting, as neither difficult nor a 
challenge.  The use of these different words in the Ca nadian statement showed that even talking about 
the mechanism was difficult.  It would therefore be  important to ask Rwanda what it thought of the 
Paragraph 6 system.  Nobody could say which orde r would most enlighten Members – whether it 
would be more appropriate to hold a workshop first or  a review first.  But it was clear that such a 
discussion had not yet taken place.  A workshop might help to provide information on the difficulties 
of the process. 
241. The representative of South Africa  commended the Chair for the stellar work he had done on 
the issue of paragraph 6.  Being disappointed that  Members had been unable to reach consensus, he 
urged all Members to do so expeditiously.  Althoug h he welcomed the suggestion of dedicating the 
second day of the upcoming Council for TRIPS meeting to  the review of Paragr aph 6, he considered 
essential some prior discussion on the issue.  He theref ore joined the delegation of India and others in 
calling for a dedicated workshop to be held, speci fically engaging all stakeholders who might be 
relevant in implementing Para graph 6 to its full potential. 
242. The representative of the European Union  said that access to essential medicines for 
developing countries was of the utmost importan ce.  That was why his delegation had actively 
participated in the lengthy and difficult negotiati ons culminating in the 30 August 2003 Decision and 
in the TRIPS amendment, and had taken the necessa ry steps to implement the Decision at the EU 
level (Regulation 816/2006) a nd to accept the amendment. 
243. He said that his delegation did not claim th at the system established by the 30 August 
Decision and the TRIPS amendment were perfect.  It was a compromise among some 150 countries who should make the system work, and his delegation was committed to making it work.  He said that 
any appropriate assessment of the system should be  made on the basis of the experience acquired by 
Members who were its users, and not by NGOs or ph armaceutical companies.  The use of the system 
was triggered by a notification by a Member.  Th e question was why only one Member, Rwanda, had 
used the system.  It had done so successfully, whic h demonstrated that the system could work when 
used. 
244. Accordingly, his delegation took note of the proposal of a workshop, and also of the 
comments of the Indian delegation that it should be undertaken a priori  and not on a pedagogical 
basis, although in his experience public discussions on that topic usually degenerated quickly into non-fact-based discussions.  While he was ready to re flect to appropriateness of a workshop, he said 
that the question that needed to be addressed coul d only be answered by Members themselves.  These 
included the question referred to by the delegation of Mauritius, namely why so many Members had 
not yet ratified or implemented the Paragraph 6 syst em.  The delegation of India had said that some 
Members would have attempted to implement the sy stem but that would not have fructified.  He 
inquired who were those Members and what were the problems encountered.  Only those Members 
that had sought to use the system could answer t hose questions.  He noted that the representative of 
Brazil had said that some Members could not afford medicines, even on the basis of a compulsory licensing system.  Again it would be interesting to  hear from the Members concerned whether that  IP/C/M/63 
 Page 49 
 
 
  was true and why.  This incidentally would also de monstrate that the solution to the problematic issue 
of the access to medicine did not lie with intellectual property alone. 
245. He said that the arguments made justified hi s delegation's position that Members have to 
tackle that important debate inside the Counc il among Members.  His delegation did not support a 
rampant privatization of their duties, or sub-cont racting their obligations to private companies or 
associations.  He, therefore, supported the Chairm an's suggestion to continue to hold informal 
consultations on the best way forward. 
246. The Chairman  suggested that the Council agree to set aside the second day of its meeting in 
October for the annual review.  As to the revised pr oposal by the delegation of India to devote a day 
in September for an informal discussion among Me mbers only, and then a second day to a workshop 
involving third parties, he said that there still was no consensus on whether and when to have a 
workshop involving third parties.  Another issue that  might need to be examined further was whether 
such a workshop should be organized outside th e ambit of the Council for TRIPS or under its 
auspices.  He suggested that he continue his consu ltations on how to proceed with the preparations of 
the review. 
247. The Council took note  of the statements made and so agreed . 
M. ENFORCEMENT TRENDS  
248. The Chairman  recalled that this item had originally been put on the proposed agenda at the 
written request, dated 26 May 2010, of  the delegations of China and India and, at the adoption of the 
agenda, its title had been amended to read "Enforcement Trends". 
249. The representative of China  said that she appreciated the oppor tunity to introduce this agenda 
item.  Why did developing Members used to oppose this enforcement issue at previous meetings 
while proposing such a topic now?  Why did they introduce it as a separate new agenda item rather 
than raising it under "Other Business".  While th e TRIPS Agreement only set a minimum level of 
protection of IPRs by other Members, why was TRIPS-plus a problem?  What was the ground for addressing this issue before the Council?  These we re all pertinent questions worth answering. 
250. Ever since the entry into force of the Ag reement, multilateral disciplines concerning 
IP protection had been set in the area of internationa l trade.  The first few years after the establishment 
of the Agreement witnessed compliance requirement s usually by developed country Members towards 
developing country Members as regard s their domestic IP legislation.  As time went by, enforcement 
became a prime concern for the demandeurs .  They were not only pushing TRIPS consistent 
IP legislation by Members, but also pushing protecti on standards to be enhanced to a higher level in 
different international forums, including in WI PO, the WHO and the WCO.  While a multilateral 
approach seemingly did not succeed in achieving this , bilateral, plurilateral or regional approaches 
were much easier to handle.  That was why the recently concluded FTAs or  RTAs usually contained 
provisions or a chapter on IPRs, many of which required a level of protection or standards of 
enforcement higher than provided by the TRIPS Agre ement, especially when at least one of the 
parties to the FTA or RTA was a developed country Member.  With the rapid proliferation of RTAs 
and FTAs the so-called "TRIPS-plus enforcement trend"  was more prevailing than ever before.  This 
trend became even more phenomenal and strong when the mysterious Anti-Counterfeiting Trade 
Agreement (ACTA) was officially unveiled on 20 April 2010 after several years of secret negotiations among some Members of the WTO. 
251. She believed that as a Member of the WTO, China had the legitimate right to stand up to 
comment at the WTO on ACTA once it had appeared on official websites of some of the Members.  
The proper way to do it was by proposing an item on the agenda on the Council which seemed to be IP/C/M/63 
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  the most relevant body of the WTO for this topi c.  The representative of the European Union had 
appeared surprised by the propo sal by China and India after ACTA had been put on its website.  
Contrary to what the EU representative had said, China's position had never changed on the 
enforcement issue.  Based on the draft agreement, much of which was still in brackets, it could be 
foreseen that the current text intended to broaden the scope of piracy and counterfeit, enhance the 
standards of protection through a broa dened scope of several criminal and border measures, as well as 
set up a special discipline for the digital envi ronment, all of which went beyond the TRIPS 
Agreement.  For example, the draft would apply no t only to importation of goods, but also to goods 
destined for exportation, goods in transit, and g oods under custom supervisi on.  Moreover, the scope 
for ex officio enforcement had been remarkably extended and standards for initiation significantly 
lowered. 
252. Her delegation was concer ned about the TRIPS-plus enforcem ent trend and its implications.  
In her view, the TRIPS-plus trend might cause at least the following problems.  First were potential 
legal conflicts and unpredicta bility.  Though TRIPS required only minimum standards of 
IP protection and allowed Members to implement in  their laws more extensive protection, it also 
provided certain conditions for applying such extensiv e protection.  First, such protection should "not 
contravene the provisions" of TRIPS.  Secondly, it required Members to ensure that measures and 
procedures to enforce intellectual property rights did not themselves become barriers to legitimate 
trade.  Thirdly, these extensive protections should not inappropriately restrict the inbuilt flexibilities 
and exceptions in the TRIPS Agreement.  Fourthly , according to the chapeau of Article 20 of GATT 
1994, if applied as border measures, they should not  violate other covered agreements under the WTO 
and not be applied in a manner which would constitute a means of arbitrary or unjustifiable 
discrimination among Members or a disguised restri ction on international trade, and only measures 
necessary to secure compliance with laws or regulat ions could be applied, which was the so-called 
necessity test. 
253. Her first concern was whether extensive pr otection under TRIPS-plus provisions might 
possibly violate the provisions of the TRIPS Agreem ent or other covered agreements of the WTO.  
The cases which Brazil and India had recently initiate d against the European Union and one member 
State on the Custom Regulation and the seizure of goods in transit were good examples to show that 
there at least was real potential for such violations.  Conflicts might also be created by the provisions 
on national and MFN treatment within these FTAs and RTAs on IPRs.  As the standards or the scope 
of protection varied between these RTAs, FTAs and regional IP Agreements and they all contained 
provisions of national and MFN treatment, the pot ential for conflicts and unpredictability was huge 
and tremendous difficulties would arise in the process of implementation of these provisions. 
254. Secondly, she was concerned about possible distortio ns to legitimate trade.  The first sentence 
of the Preamble of the TRIPS Agreement made it cl ear that TRIPS was aimed at reducing distortions 
and impediments to international trade.  This w as also the ultimate goal of the WTO.  Yet as 
explained above, the various TRIPS-plus standard s had made the international legal framework on 
IPRs extremely complicated and unpredictable, whic h might cause an adverse impact on international 
trade.  It was estimated that the trade volume of ACTA parties accounted for 70 per cent of the world 
trade.  Thus the impact on trade would be even larger if ACTA could be concluded at any foreseeable future.  To illustrate how extensive protection mi ght cause problems to legitimate trade, she said that 
if, for example, the threshold for seizure of suspected pirated or counterfeit goods by customs 
authorities was to be lowered, then anyone or an y right holder with little evidence or inadequate 
guarantees might be able to stop trade or ex offici o actions could do the same, while in most cases the 
loss was irreparable.  These kinds of loopholes could easily be abused by competitors in international 
trade.  IP/C/M/63 
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  255. Thirdly, there was a systemic concern over breaking the balance within the TRIPS 
Agreement.  The TRIPS Agreement was an internati onal agreement that had been intended to strike 
delicate balances in several aspects  in the process of long-term arduous negotiations.  First of all, 
balance had been sought between the three pillars  of GATT, GATS and TRIPS.  Especially, when 
agreeing to incorporate the TRIPS Agreement into the WTO, developing Members were expecting the 
integration of agriculture and textiles into GATT.  Of course, independent scholars would have their 
assessments of whether or not these intentions and goals had been met in reality.  Secondly, the 
TRIPS Agreement had not only tried to strike a ba lance between developed and developing countries, 
rights and obligations, technology innovation and transfer and dissemination of technology, the 
advantage of producers and interests of users of t echnology, but also the economic welfare and social 
welfare including public health and nutrition.  Th erefore, a unilateral increase of the level of 
protection would break these delicate balances and ca use systemic concerns over international trade 
relationships. 
256. Due to the gap in technology, there was an imba lance of interests between the developed and 
developing world in IP protection.  TRIPS-plus en forcement trends in RTAs , FTAs and ACTA would 
reduce the balance of interests that the TRIPS Agre ement had tried to establish and make it easier to 
build so-called technological barriers, with pot ential conflict between IP  and other institutional 
arrangements.  From a domestic point of view, even the balances between producers and users of 
technology were nowadays somewhat controversia l.  IP holders were not the only group of 
constituencies that national governments needed to re present.  Increasing the level of protection might 
cause additional social costs and consumer welfar e loss.  For example, the rapid advances of 
telecommunication and Internet technology had caused  the scope and forms of IP to extend quickly 
and widely into the cyber world.  Internet and mobile communications should not only be a tool for 
right holders to reap profits but should also bene fit the general public.  While piracy was a problem 
that should be resolved, one should also consider  how to define fair use in the digital era. 
257. IPRs were two edged weapons that exemplified efforts to balance different social and 
economic policy objectives when they were firstly designed.  Therefore, TRIPS-plus enforcement 
trends posed systemic concerns at both domestic and inte rnational levels. 
258. She said that her fourth concern was the alloca tion of public resources.  Human beings were 
facing a variety of challenges such as hunger, povert y, environmental degradation, water shortages, 
forest shrinking, illegal drugs, malnutrition, public  health, human trafficking, child labour, food 
safety, social instability and terrorism.  All these were externalities that required public enforcement 
by necessary governmental input.  IPRs were private rights.  Theoretically speaking, the cost of 
enforcing IPRs should be borne by private parti es themselves.  Yet in reality, due to the strong 
lobbying power of multinationals and outside pressu res from developed countries, many developing 
countries, including China, had put IPRs as a prior ity of their enforcement activities, though public 
resources available to them were limited.  The TRIPS-plus trend would put developing countries at 
even more difficult position since there would be increasing outside pressure on them to use their 
limited public resources to enforce private IP rights. 
259. Based on this, her delegation suggested that  the Council for TRIPS adopt the following 
principles, which had already been prescribed by TR IPS, for both the current and future RTAs, FTAs 
and regional IP agreements with which any WTO Me mber party to such agreements should comply 
with:  (i) the IP chapter or provisions of an RTA, FTA or regional agreement to which a WTO 
Member was party shall not be inconsistent with th e TRIPS Agreement of WTO;  (ii) the enforcement 
of IPRs shall not create distortive effects on legitima te international trade;  and (iii) no WTO Member 
shall be restrained from the autonomy for utilizing its public enforcement resources. IP/C/M/63 
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  260. Her delegation urged Members who were negotiating these TRIPS-plus enforcement 
provisions to reconsider their rationale to do so, to have the commitments under the TRIPS 
Agreement be fully accomplished, and not to vi olate the provisions of TRIPS or any other 
WTO-covered agreement in any form. 
261. Having said that, she wished to reiterate Ch ina's unchanged position on the protection of 
IPRs.  The protection of IPRs was a national poli cy in China.  The 2008 national IP protection 
strategy was but one piece of evidence of such a national policy.  China recognized the importance of 
protection of IPRs in establishing an innovative and intelligent society and in boosting the economy 
with invention on science and technology.  China also recognized that enforcement of IP was a long-term issue in the process of China's modernizat ion.  China's commitment on enforcing IP in due 
course according to the law and regulation of China would never be changed.  She believed that China 
could boast with the largest IP enforcement team in  the world.  She said th at when she was an IP 
official in Beijing, she was told that it amounted to over one or two million people, which was a new 
means of creating jobs in China. 
262. In conclusion, she said that unilateral or plurila teral enhanced IP enforcement standards that 
she had referred to as TRIPS-plus trend, might cause serious adverse impacts.  She believed that this 
was not a wise way to address the issue.  It was not  because of lack of harsh enforcement standards or 
insufficient numbers of policemen on the streets th at caused the severity of piracy, counterfeiting or 
other forms of IPR infringement.  According to an  ancient Chinese philosopher Lao Zi, of 3000 years 
ago, "the more the criminal codes, the more the stealers".  Actually, IPR infringement was largely a 
problem during the process of development.  Therefore, development was the crux of the matter.  If 
there was a failure to address the root causes, things would not get better.  Therefore, she believed that 
Members had common interests and only cooperation w ould lead to a win-win result.  She said that 
China stood ready to discuss with Members on how to make the Council's work contribute to the issue 
of development.  Given its full schedule, the Council should make good use of its precious time. 
263. As regards the procedural steps relating to this agenda item, she said th at the adoption of the 
agenda for this meeting was a good lesson for the de veloping and other Members of WTO.  China and 
India had filled all the procedural requirement s governing a request for an agenda item, but 
Switzerland and the European Union opposed it beca use there had been no detailed explanation to go 
along with it.  Had India and China not shown flex ibility on the EU suggestion to amend the title as 
originally suggested by India and Ch ina, the Council might not have been able to have its meeting at 
this time.  Members should consider how to use th eir legitimate procedural rights and how to deal 
with decision making based on consensus.  The Bible to ld us to "treat others as the way you want to 
be treated", and China's Confucius similarly stated  that "please don't give others you don't want".  
These citations illustrated that there were commonalities among different cultures of the mankind.  She hoped that the spirit expressed in these citations could guide the Council's work in the future and 
that the future work could proceed smoothly and productively. 
264. The representative of India
 supported China's statement that had drawn the broad canvas 
against which TRIPS-plus enforcement trends need ed to be seen and raised several fundamental 
concerns which required further delib erations in the Council.  He also wished to draw attention to 
some systemic implications of the multitude of in itiatives launched by a group of largely developed 
country Members to enforce the TRIPS Agreement in  a manner that was considerably more extensive 
than the level found in the TRIPS Agreement.  India had had to expend significant resources and 
make legislative changes to prot ect and enforce IPRs in line with  the TRIPS Agreement within the 
10-year transition period which ended only in 200 5.  Among the developing countries, the least-
developed were still in the trans ition period until 2013, and 2016 for so me cases.  His concerns arose 
from the surge of TRIPS-plus initiatives in multilate ral forums, RTAs and plurilateral initiatives like 
ACTA.  Texts of such RTAs and more recently the negotiating text of ACTA had appeared in the 
public domain.  Such high levels of protection were likely to disturb the balance of rights and  IP/C/M/63 
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  obligations in the TRIPS Agreement enshrined in, inter alia , the Preamble, the objectives and 
principles in Articles 7 and 8, and had the potentia l to constrain the flexibilities and policy space 
provided by the TRIPS Agreement to developing count ry Members, like India, particularly in areas 
like public health, transfer of technology, socio-ec onomic development, promotion of innovation and 
access to knowledge.  They also potentially negate d decisions taken multilaterally, such as the Doha 
Declaration on the TRIPS Agreement and Public Hea lth in the WTO and the Development Agenda in 
WIPO. 
265. There was no doubt that IPR enforcement in WTO was an issue of fundamental importance 
which India took very seriously.  However, its co ncerns emanated from the levels of enforcement 
which far exceeded those foreseen in the TRIPS Ag reement.  Although the Agreement was usually 
considered to be a minimum level agreement, enforcem ent levels could not be raised to the extent that 
they would contravene the Agreement.  TRIPS-plus  measures could not be justified on the basis of 
Article 1.1 since the same provision also stated th at more extensive protection could only be granted 
"provided that such protection does not contravene th e provisions of this Agreement".  In addition to 
laying certain minimum standards, the Agreemen t also provided ceilings, some of which were 
mandatory and clearly specified in it.  Moreover, the Agreement had achieved a very careful balance 
of interests of right holders, on one hand, and so cietal interests including development oriented 
concerns, on the other hand.  Enforcement measures c ould not be viewed in isolation of the objectives 
contained in Article 7.  TRIPS-plus enforcement measures could have a trade distorting effect.  The 
chapeau provisions of the enforcement section in Ar ticle 41.1 stated that "these procedures shall be 
applied in such a manner as to avoid the creation of  barriers to legitimate trade and to provide for 
safeguards against their abuse".  The TRIPS-plus standards in RTAs and plurilateral initiatives like 
ACTA could short-change legal processes, impede legitimate competition and shift the escalated costs 
of enforcing private commercial right to governme nts, consumers and tax payers.  They also 
represented a systemic threat to the rights of legitimate traders and producers of goods and fundamental rights of due process for individuals. 
266. The TRIPS Agreement was clear about resource a llocation, and gave due consideration to the 
limited resources of developing country governments to  enforce IPR laws relative to other laws which 
might call for more urgent priority.  Article 41.5 was cognisant of the capacity constraints of Members and therefore created no obligation with th e respect to distribution of resources as between 
the enforcement of IPRs and the enforcement of law in general.  IPRs were private rights, and it was 
not the responsibility of governments to defend each right, but rather to provide means for individuals 
and firms to enforce those rights.  The Agreemen t elaborated such means which were necessary. 
267. Another systemic concern was that IPR negotia tions in RTAs and plurilateral processes like 
ACTA completely bypassed the existing multilate ral processes.  While GATT and GATS provisions 
allowed for further liberalization of trade in goods and services through RTAs, there were also 
provisions to monitor regional and plurilateral initiatives by the WTO.  Concerns had already been 
voiced in the General Council and the 7
th Ministerial Conference held at the end of 2009.  However, 
the possible impact of the proliferation of RTAs wa s to undermine multilateral trade.  It was a lack in 
the TRIPS Agreement that there were no similar syst emic checks with regard to IPR aspects of RTAs 
and plurilateral agreements. 
268. This was made worse by the fact that while Article 24 of GATT and Article 5 GATS allowed 
Members to limit the benefits of further trade liber alization to partners in RTAs, any TRIPS-plus 
protection secured by one trading partner unde r FTA, RTA or a plurilateral agreement was 
automatically and unconditionally applicable to all other WTO Members.  Therefore, it was even 
more important to discuss the IPR dimension of re gional and plurilateral initiatives in this Council so 
that they would not undermine the TRIPS Agreement.  The systemic impact Members should be aware of was that even if some Members were not parties to plurilateral initiatives like ACTA, they 
could still have to enforce ACTA provisions due to cr oss-referencing.  As an example, in accordance IP/C/M/63 
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  with commitments under the EU-CARIFORUM Eu ropean Partnership Agreement (EPA), the 
CARIFORUM members might be obliged to enfo rce ACTA enforcement provisions, which might 
require additional resource allocation and be incompa tible with the level of economic development of 
CARIFORUM members.  He wonde red about repercussions sin ce several CARIFORUM members 
were small and vulnerable economies. 
269. Turning to ACTA provisions relating to trans it, he said that he was aware that several 
provisions were still in square brackets, which meant that their inclusion was well within the realm of 
possibility.  The ACTA text required countries to pr ovide procedures for the customs seizure of goods 
in transit suspected of infringing trademarks, copyrigh ts and also other IPRs.  According to the ACTA 
text, in transit included both customs transit and tr ans-shipment.  Seizure of goods would be allowed 
even where there was a mere prima facie case of IP  infringement.  In view of the recent seizure of 
generic drug consignments, provisi ons relating to goods in transit in all likelihood would create 
barriers to access to es sential generic medicines, as well as to access to critical climate change 
technologies.  These provisions could concretize th e legal framework of the European Union, as 
already instituted through its Council Regula tion 1383/2003 which had been responsible for 
empowering customs and border officials to seize legitimate generic medicines as exported by India 
to several developing countries including LDCs.  He said that the European Union had so far not provided India any legally satisfactory solution to  recurring drug seizures, leaving it with no option 
but to request, on 11 May 2010, for consultations under the WTO dispute settlement mechanism. 
270. As an example of how the draft ACTA provisions  could restrain TRIPS flexibilities, he said 
that India's right to exercise flexibilities such as granting compulsory licences would be interfered 
with by the mandatory application of border measures to goods in transit.  Indian exporters could be 
constrained from shipping goods produced under its  own exception to countries where there was no 
applicable IP protection because transit might be  blocked by an intervening transit country's 
application of domestic IPRs.  Sim ilarly, under the draft ACTA, data  exclusivity could be invoked by 
a transit country's customs authorities as a basis fo r seizing pharmaceutical products in transit even if 
there was no exclusivity in the exporting or im porting countries.  This would obviously act as a 
significant constraint on exporting countries such as I ndia.  Benefits intended by the Doha Declaration 
on TRIPS and public health could also be effectivel y negated by transit provi sions.  The Paragraph 6 
system was aimed at making effective use of compul sory licences for countries with insufficient or no 
manufacturing capacities.  Mandatory application of border measures to such drugs in transit could 
again deny the potential benefits in term s of access to much needed medicines. 
271. The released ACTA text showed a general shif t in the focus of enforcement which enhanced 
the power of IP holders beyond reasonable measu re.  One ACTA option would mandate that each 
party provide enforcement for the full range of IPR infringement actions at the border of an importing 
country.  This would permit IP holders to assert infringement and demand se izure of goods before 
customs administrative authorities instead of initiati ng their claims in domestic courts.  Under the 
present TRIPS Agreement rules, except with respect to trademark counterfeiting and copyright piracy, 
a Member could require that infringement claims be pursued in courts, including for obtaining 
preliminary relief.  The draft ACTA limited the pr otections otherwise due to accused infringers under 
the TRIPS Agreement, potentially lowering knowle dge thresholds, limiting new process requirements, 
limiting evidentiary requirements, and did not specify the type of authority empowered to make critical decisions.  This shift to summary administra tive action could dramatically curtail the rights of 
accused infringers to defend patent infringement claims, ordinary trademark and copyright 
infringement claims, actions alleging violation of marketing exclusivity rights, and so forth.  The draft 
ACTA therefore would shift the negotiated balance of the TRIPS Agreement in favour of IP holders 
by shifting the enforcement foru m towards customs administrative authorities and away from civil 
courts.  IP/C/M/63 
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  272. He said that these were not the concerns of In dia or developing countries alone.  Politicians, 
civil society and IP experts and ACTA member  countries had expressed concerns regarding the 
substance and modus operandi  of ACTA negotiations.  It was a well-known fact that 633 members of 
the European Parliament had supported a resolution in the European Parliament on 10 March 2010 
imploring ACTA negotiations for bypassing the multilateral framework provided by the WTO and 
WIPO.  Several such MEPs had written to Director-G eneral Lamy and also the Director-General of 
WIPO requesting an impact assessment of the extent to which ACTA, as proposed, would exceed 
obligations in the current IP instruments and excl ude flexibilities and exceptions contained in them.  
Even the US Government Accountability Office had r ecently raised serious questions about the data 
that had been relied upon by proponents of ACTA that supported their effort.  IP experts were 
increasingly challenging the concept of minimum standards and calling for enforcing maximum 
standards or ceilings so that there would be legal security and predictability about the boundaries of IP 
protection, protection of users' rights and free movement of goods, services and information. 
273. He said that, while India was committed to dea ling with IPR enforcement issues in line with 
its TRIPS obligations, the introduction of inclusiv e IPR enforcement rules applicable to goods and 
services in international trade did not represent a r easonable or realistic response.  A response, if 
required, had to emerge from a multilateral and tran sparent process as was available in the Council for 
TRIPS and should fully conform to the objectives and principles of the TRIPS Agreement and the 
balance of rights and obligations enshrined in th e Agreement.  As goods and services of developing 
countries were becoming competitive with those of developed country producers, TRIPS-plus 
measures like ACTA sought to introduce a new set of non-tariff barriers to trade that would 
preponderantly hinder developing c ountry exports.  He urged developed country Members to keep 
these concerns in mind while dealing with IPR enfo rcement issues.  Agreements such as ACTA had 
the potential to completely upset the balance of ri ghts and obligations of the TRIPS Agreement.  The 
WTO could not remain a silent observer to such a de velopment.  It was important that this issue be 
deliberated in the Council in detail. 
274. The representative of Barbados  said that she understood some but not all of the concerns 
expressed by India.  India had referred to the CARIFORUM EC EPA and indicated that 
CARIFORUM countries might be bound by ACTA.  He r interpretation was different.  Article 139 of 
the CARIFORUM EC EPA did not bind CARIFORUM c ountries to ensure an adequate and effective 
implementation of treaties to which the European  Union was party and CARIFORUM was not.  Her 
interpretation of Article 139.1 was that each party was only bound to ensure adequate and effective 
implementation of the international treaties to which that party was a signatory. 
275. The representative of Mauritius, speaking on behalf of the ACP Group , said that he fully 
supported the statement made by India.  He therefore also requested a full deliberation on the TRIPS-plus issues.  Nothing prevented some proact ive Members to have TRIPS-plus agreements and 
enforcement measures.  However, these should not breech TRIPS provisions, its very spirit, and also 
the delicate balance of rights and obligations entr enched in the TRIPS Agreement.  He invited 
Members to read carefully Article 1 of the TRIPS Agreement, which stated that "Members shall give 
effect to the provisions of this Agreement.  Memb ers may, but shall not be obliged to, implement in 
their law more extensive protection than is required by this Agreement, provided that such protection 
does not contravene the provisions of  this Agreement".  In light of that specific provision, he invited 
Members to comply with the letter and spirit of the Agreement when taking TRIPS-plus and 
enforcement measures. 
276. The representative of Peru
 thanked India and China for intr oducing the agenda item and said 
that his delegation was convinced of the importance of the intellectual property system as a tool for 
countries' economic, social and cultural development.  That conviction had led Peru to maintain an 
ambitious enforcement regime to ensure compliance with IPRs in line with the TRIPS Agreement, so 
as to allow the promotion of innovation and develo pment.  One example was the introduction in its IP/C/M/63 
Page 56  
 
  domestic legislation of the mandatory requirement  to disclose the origin and source of genetic 
resources - whether or not associated with traditiona l knowledge - which was not provided for in the 
TRIPS Agreement.  His delegation was therefore promoting amendment of the TRIPS Agreement to 
ensure protection, at the international level, of genetic resources and the traditional knowledge 
associated with those resources.  This was one of the reasons why Peru had included ambitious 
enforcement provisions in some of the trade agre ements it had negotiated and recently signed.  The 
international protection of genetic  resources and associated traditio nal knowledge that Peru promoted 
was strictly consistent with the intellectual prope rty system which was recognized and supported by 
all Members, including Peru.  And it was precisely because of such a view that his delegation shared some of the concerns expressed by delegations such  as those of China and India about the negotiating 
process concerning ACTA, which was chiefly prompted by the possible implications for the 
intellectual property system enshrined in the TRIPS Ag reement.  It was clear that provisions of that 
type could not and should not unde rmine the use of flexibilities or affect matters that were not 
regulated by or provided for in the TRIPS Agreemen t.  Accordingly, he expressed concern about the 
scope of the provisions of ACTA, in particular those pertaining to border measures, injunctions, 
distribution of resources and enforcement through the Internet, insofar as such provisions could 
jeopardize the balance of rights and obligations  that the TRIPS Agreement sought to ensure. 
277. He considered it absolutely necessary that Me mbers should have the opportunity, as had been 
the case in the Council for TRIPS, to engage in the kind of brainstorming exercise where they could air all the concerns or preoccupations they might  have about a closed negotiating process from which 
the vast majority of developing countries had been ex cluded.  In order to enha nce the debate, he urged 
those Members that were involved in the ACTA ne gotiations to share their views on this process and 
what they hoped to achieve with that agreemen t, especially in the light of ACTA's possible 
implications for the multilateral intellectual property system that all Members had worked so hard to 
establish and were endeavouring to strengthen. 
278. The representative of the United States
 recalled that his delegation, joined by a number of 
other Members, had sought to engage in a discu ssion about IP enforcement in the Council for TRIPS 
a few years earlier.  To guide the discussions, the proponents had circulated papers on the issues of concern.  So, when he had seen the item on enforcem ent trends inserted on the agenda, he would have 
liked to see supporting documents.  Instead, he had had to approach the discussion without any 
official indication of why or for what purpose that  item had been proposed.  He said that he would 
appreciate receiving an e-mailed copy of the proposals earlier made by China as well as India's 
comments.  But, he was pleased that a general an d neutrally-worded agenda item had been agreed 
upon for TRIPS enforcement trends or developments, a nd trusted that in the future all delegates would 
cooperate in permitting a discussion to occur, whiche ver Member might be seeking to raise issues of 
interest, and without excluding any of the various perspectives that other Members might wish to 
share. 
279. Responding to what had been said earlier, he said that the notion that "TRIPS-plus 
enforcement" standards were somehow a trend was a problematic one and was misplaced.  It could be said that every national IP enforcement regime, incl uding those of the proponents of the agenda item, 
was TRIPS-plus in the sense that national implem enting measures for IP enforcement were necessary 
to address numerous procedural and substantive i ssues for which there was no TRIPS requirement.  In 
other words, it was necessary and appropriate that  national IP regimes covered matters not addressed 
in the TRIPS Agreement. 
280. As other Members had stated earlier, improving IP enforcement was a very important issue, 
and he believed that Members should be evaluating better and more effective ways of combating the 
grave threats of counterfeiting and piracy.  That  should include a willingness to examine possible 
improvements both on the national level and in inte rnational discussions and therefore he welcomed 
any conversations on IP enforcement.  His delega tion had been concerned about the issues of weak  IP/C/M/63 
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  enforcement of IP rights for quite some time, partic ularly in the context of counterfeiting and piracy.  
Members were well aware of the negative impacts that counterfeit and pirated products posed to 
governments and companies.  As just one example,  the OECD had estimated that annual trade in 
counterfeit and pirated products accounted for more than US$200 billion in recent years.  
Unfortunately, those activities were also increasingly a ffecting the everyday life of citizens.  Besides 
the often-copied luxury goods and blockbuster movi es, counterfeiters and pirates were now taking 
liberties with common household articles:  everyt hing from home appliances to toothpaste.  The 
appearance of counterfeit medicines and items such  as counterfeit spare parts for cars, buses, and 
planes posed threats to public and consumer health  and safety that simply could not be ignored. 
281. He said that, for example, under the WTO's existin g minimum standards, if  an official at the 
border saw a container of knockoff electrical equipmen t bearing counterfeit trademarks, that official 
might not have any ex officio power to stop it, because there was nothing in the WTO minimum standards that called for Members to give border o fficials such ex officio au thority.  Consequently 
shipments of potentially dangerous products bearing even the most obvious counterfeit marks might be waved through border checks by powerless officials, and be on their way to consumers.  When that 
happened, legitimate commerce suffered.  So did consumers, who might unwittingly purchase 
substandard, potentially unsafe counterfeit goods. 
282. In recognition of threats that counterfeiting and piracy posed to legitimate commerce and 
consumers, in recent years, the United States had joined with colleagues fro m the European Union, 
Japan, and Switzerland to support a dialogue in th e Council for TRIPS on the implementation of the 
existing enforcement obligations under the TRI PS Agreement, and to identify solutions to 
implementation deficiencies.  However, he had seen very clearly, through the course of past meetings 
of the Council, that Members of the WTO had widely divergent views on the nature of the enforcement provisions of the TRIPS Agreement a nd even, regrettably, on the appropriateness of 
discussing those provisions in the Council.  The Un ited States was committed, however, to carrying 
forward a reasonable, fact-based, and non-confronta tional discussion of enforcement matters in the 
Council for TRIPS.  Past meetings had showed that this was possible.  At the same time, given the 
scope and severity of the global counterfeiting and piracy problem, it was critically important for 
countries sharing concerns on those matters to m ove forward in meaningful ways.  Therefore, 
Members should not be surprised to see the concer ned Members seeking to combat this threat 
elsewhere.  Indeed, as noted before, counterfeiting a nd piracy were activities that crossed borders and 
continents. 
283. Turning to ACTA, he said that the agreement would establish an international framework for 
participating governments' efforts to more effectiv ely combat the proliferation of counterfeiting and 
piracy, which undermined legitimate trade and the sustainable development of the world economy.  
ACTA would concentrate on three areas:  (i) c ooperation among the ACTA parties to address the 
challenges of cross-border trade in counterfeit and pirated goods;  (ii) establishing a set of 
enforcement best practices that we re used by authorities;  and ( iii) setting up a legal framework of 
enforcement measures.  ACTA was intended to focus on commercially-oriented counterfeiting and 
piracy.  There was evidence to suggest that orga nized criminal organizations were increasingly 
involved in the manufacture, distribution and sale of  those illegal goods.  ACTA was an effort that 
had been pursued independently of the WTO and ot her established institutional structures, but it was 
in no sense a replacement for or a rival to the impor tant work undertaken in those structures.  The 
parties to ACTA considered the approach of a sta nd-alone agreement entirely appropriate to pursue.  
Yet, the partners involved in ACTA continue d to value the important work of multilateral 
organizations, such as WIPO, WTO, APEC, and OECD. 
284. Responding to some of the points made by the pr oponents of the agenda item, he said that the 
TRIPS Agreement was a minimum standards agreement and clearly contemplated that Members 
might seek to provide higher standards than that pr ovided in the Agreement.  In fact, even without IP/C/M/63 
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  ACTA, as already noted, it was necessary and appropriat e that the national IP enforcement regimes of 
Members already provided rules and procedures not  necessarily required by the TRIPS Agreement.  
Furthermore, the participants in ACTA had made  clear publicly that "ACTA is not intended to 
interfere with a signatory's ability to respect its c itizens' fundamental rights and civil liberties, and will 
be consistent with the WTO TRIPS Agreement and will respect the Declaration on TRIPS and Public 
Health".  He hoped that, once signed, ACTA woul d expand to encompass a larger number of 
countries. 
285. He said that a number of Members had underlined the importance they attached to innovation.  
Indeed, Members from all over the world benefite d from their creative and innovative forces.  In 
difficult economic times, it was especially regr ettable when local economic development was 
hindered due to counterfeit and pi rated products.  Counterfeiting a nd piracy potentially threatened 
consumer health and safety, but also reduced the ability for pr oviding incentives for innovation, and 
robbed governments of much needed tax revenue.  This was true for both developed and developing 
countries.  Indeed, developing countries should have an interest in higher IP enforcement standards 
and ACTA, given the damaging effect that count erfeiting and piracy had on their economies. 
286. In concluding, he said that he looked forward to an opportunity to provide any interested 
Member with additional information on ACTA through b ilateral contacts.  He also directed interested 
Members to the numerous facts sheets as well as the public text of ACTA for more information.  However, while he welcomed discussion on IP enforc ement, he did not believe it was appropriate to 
engage in a more detailed discussion of  ACTA, as it was an ongoing negotiation. 
287. The representative of Korea
 said that the ACTA participants, including Korea, had actively 
been engaged in the negotiations with the comm on goal of strengthening IPR enforcement standards 
and seeking best means to enhance internationa l cooperation to fight ag ainst counterfeiting and 
piracy.  Despite many concerns and misinterpreta tions raised by ACTA and its relationship with the 
TRIPS Agreement, she said that Article 1.1 s howed that "Members may ... implement in their 
domestic law more extensive protection than is re quired by this Agreement, provided that such 
protection does not contravene the provisions of this Agreement".  The TR IPS Agreement therefore 
set up minimum standards that all WTO Members should abide by.  Whether a Member would go 
beyond the TRIPS Agreement and establish a strengt hened enforcement mechanism rested on each 
Member's own decision.  More specifically, she said that footnote 13 to Article 51 of the TRIPS Agreement clarified that it was not mandatory to  apply border measures with regard to goods in 
transit.  But, at the same time, it did not forbid a Member to do so, and any Member had the right to 
apply enforcement measures on goods in transit if necess ary.  Finally, she said that the public text of 
ACTA stated that "[n]othing in this Agreement sh all derogate from any inte rnational obligation of a 
Party with respect to any other Pa rty under existing agreements to which both Parties are party."  
There was nothing more than this to clarify the con cerns raised.  She disagreed with the apparent view 
of China that the WTO was the only place to deal with IPR issu es.  Principles which China had 
mentioned were already in both the TRIPS Agre ement and ACTA.  She welcomed any constructive 
discussions in the WTO on how to strengthen th e enforcement part of the TRIPS Agreement. 
288. The representative of Cuba
 thanked the delegations of India and China for including the topic 
of enforcement trends on the Council for TRIPS' age nda and associated herself with the statements of 
both delegations.  She said that she had noted for some  time now, with major concern, that there was a 
proliferation of increasingly broad standards on en forcement and some of those were higher than 
those that were enshrined in the TRIPS Agreement.  Initiatives had been undertaken, inter alia , in the 
World Customs Organization, in the World Health Organization and in the Universal Postal Union.  Only a few weeks earlier, extensive sessions had been dedicated to that particular issue in the World 
Health Organization.  The control of generic medi cines in transit in the European Union which had 
been denounced in the previous meetings in the Council for TRIPS and which had been the object of  IP/C/M/63 
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  consultations the previous month,  were unequivocal displays of the negative consequences of those 
ambitious enforcement standards. 
289. Although the ACTA negotiations ha d started in 2005, the text of that agreement had been 
circulated only in April 2010.  She was concerned ab out the repercussions that that type of agreement 
could have on the success of bilateral, regional a nd international negotiations in the field of 
intellectual property.  In addition to the lack of transparency in those nego tiations, there was a clear 
will to seek solutions outside the multilateral framework, which was extremely negative.  The 
provisions of that type of agreement with ne w and broad enforcement standards in copyright, 
trademarks, patents and other exclus ive rights could in fact have an impact, for example, on access to 
medicines, dissemination of information and t echnology as well as access to knowledge.  Cuba was 
also concerned with the problems of bio-piracy a nd counterfeiting.  She said that her delegation had 
been calling for one party to comply with the mo st-favoured-nation principle enshrined in the TRIPS 
Agreement.  In 2002, there had been a ruling of the Dispute Settlement Body, but its recommendations remained ignored.  That encouraged  trademarks to be counterfeited in her country. 
290. The representative of Bolivia
 welcomed the initiative of China and India to begin a debate on 
the proliferation of TRIPS-plus initiatives on enfor cement which had been emerging in several forums 
and which could have very nega tive consequences for developing countries.  To the list of the 
problems that India and China had already mentione d, he added a particular problem for developing 
countries:  developing countries were often imposed , for example in bilateral agreements, conditions 
that they never had negotiated because they had b een debated, in their absence, in other forums. 
291. The representative of Ecuador  thanked the delegations of China and India for including the 
topic of enforcement trends on the agenda and said that the actions of States in the international 
community were founded on the principles of equal rights and sovereign equality.  Unfortunately, those principles were at risk of being violated  when rigid standards of  IPR enforcement were 
promoted without any consideration for the economic and social realities of developing countries or 
the additional burden that they would impose upon them.  Ecuador was concerned about any 
negotiations on IPR enforcement that implied an in crease in enforcement commitments and had noted 
with alarm the rise in irregular processes under the practice known as "forum shopping".  
Unfortunately, the somewhat opaque negotiations of the ACTA agreement were precisely taking this 
undesirable course and there was a high degree of likelihood that they would translate into TRIPS-plus provisions under bilateral agreements , for example.  The current IPR enforcement 
systems and measures were already extremely ri gid and onerous, and the onus should not become 
heavier still.  The enforcement of IPRs was to adhere to the provisions of the TRIPS Agreement and 
specifically Articles 7 and 8.  In other words, the focus should be on the promotion of technological innovation and the transfer of technology, taking in to account the mutual advantage of right holders 
and users of technological knowledge, and seeking to  achieve social and economic welfare, under a 
balance of rights and obligations. 
292. Combating piracy and counterfeiting and the ha rm they caused was a legitimate objective, 
and Ecuador had been resolute in implementing en forcement policies and programmes to that end, 
such as " Ecuador Original " and " Legalizate:  usa soft-ware libre " (Be legal:  use free software).  Just 
as considerable efforts were made at the interna tional level to combat counterfeiting and piracy, he 
also wished to see concrete results of action to comb at bio-piracy in the multilateral trading sphere but 
that, regrettably, was not yet the case.  Ecuador was convinced that IPR enforcement should not be 
viewed as an end but as a tool for development and that it should limit itself to the commitments 
already established in the TRIPS Agreement. 
293. The representative of Japan
 regretted that his delegation had not been in position to 
appropriately prepare for effective participation in  the discussion due to lack of prior information 
about the substantive contents a nd context to be taken up under the present agenda item.  He believed IP/C/M/63 
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  that enforcement was an important issue in view of e ffective protection of IPRs.  It was in fact part of 
fundamental infrastructure that w as essential for the realization of sustainable economic, social and 
cultural development, since it promoted innovation and creation and by protected trade confidence.  Therefore, he underlined firstly that discussion on enforcement should be undertaken in a balanced 
and comprehensive manner, bearing in mind that enfo rcement had such essential role of effectively 
protecting IPRs. 
294. Secondly, in regard to the relationship be tween the TRIPS requirements and the actual 
enforcement practices adopted by Members, it was quite normal and inevitable that many aspects of 
the actual enforcement measures taken by the Memb ers were defined by the Members themselves so 
long as those measures were consistent with the WT O Agreement, including the TRIPS Agreement.  
Members, including the proponents of the prese nt agenda item were inevitably engaged in 
TRIPS-plus enforcement, in a sense, by taking en forcement measures particularly designed in their 
own country in a manner consistent with the TRI PS Agreement.  Therefore, it was not useful to 
debate over the desirability of so-called TRIPS-plus  enforcement trends as such.  In accordance with 
the provision of Article 1 of the TRIPS Agreemen t, Members were free to implement in their law 
more extensive protection than was required by the Agreement, and also free to negotiate and 
conclude bilateral or plurilateral agreements so long as those agreements were consistent with the 
obligations of the WTO and TRIPS Agreements. 
295. Thirdly, discussion on enforcement practices should be conducted in a fact-based and 
analytical manner taking into account concrete situati ons and the types of measures to be considered.  
It might be useful to discuss what the best prac tices were with a view to effectively cope with a 
specific situation.  Such a constructive discussion could provide best practices that each Member 
might wish to follow and could contribute to appropriate intellectual property enforcement. 
296. Fourthly, the concerns regarding ACTA were  not founded.  Participants to the ACTA 
negotiations were committed to make ACTA fully consistent with the WTO and TRIPS provisions.  
Furthermore, there would be no new barriers or dist ortions on legitimate trade flows.  Finally, there 
would be no impact on the balance of protection of  IPRs, in the sense that the ACTA initiative aimed 
to define effective procedures for enforcing existi ng IPRs, and not to expand or enhance the level of 
protection itself. 
297. The negotiations were undertaken in recognition of  the risks and damage associated with the 
increasing proliferation of counterfeiting and piracy throughout the world.  The risk was not merely 
for legitimate trade and businesses.  There was also a significant risk posed to consumers' interests, 
including human health, safety or even life in certa in cases.  For those who were preoccupied with a 
possible negative impact of ACTA on trade of legiti mate generic medicines, he assured that the scope 
of obligation in border measures provisions of ACTA did not include patents at that stage, as was known from publicly available draft provisions.  Theref ore, ACTA could not have an adverse effect 
on trade in legitimate generic medicines.  ACTA negotiating parties were keen to provide as much 
transparency as possible within the limits inherent  in a negotiating process among States.  There were 
already a number of fact sheets and other documents  publicly available, and also the negotiated text 
itself was publicly released in April 2010.  He welc omed any opportunity to provide any interested 
Members with additional information on ACTA through bilateral contacts. 
298. The representative of Egypt
 said that he supported the delegations that had requested the 
addition of the item enforcement trends on the agenda.  His delegation was concerned about 
increasing instances relating to the enforcement of IPRs that negatively affected the flexibilities 
enshrined in the TRIPS Agreement.  He was pa rticularly concerned that, as a result of these 
TRIPS-plus enforcement trends, there was an er osion of policy space in key public policy areas 
including but not limited to public health, food  security, and access to knowledge.  These trends had 
occurred in a manner that distorted and ran counter  to the TRIPS Agreement, and were symptomatic  IP/C/M/63 
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  of a broader push to instil enforcement provisions  globally that went beyond those commensurate 
with the TRIPS Agreement requirements, and counter to developing country interests.  Those recent 
trends that were manifested in multilateral, plur ilateral and bilateral setti ngs and arrangements were 
part of a systematic attempt to instil more stringe nt enforcement norms globally.  Those trends risked 
to ultimately upset the balance in the TRIPS Agre ement between rights and obligations, as they would 
increasingly lead to the creation of barriers to legitimate trade, and to instances of abuse. 
299. At the multilateral level, he perceived the wi der drive to TRIPS-plus enforcement trends 
present in intergovernmental organizations such  as the World Customs Organization, the World 
Health Organization, and the Universal Postal Un ion, to introduce IPR enforcement measures that 
could run counter to the 2001 Doha Declaration on th e TRIPS Agreement and Public Health.  At the 
plurilateral level, initiatives such as the draft ACTA , focusing on IP enforcement measures, had raised 
a number of concerns.  There was a serious lack of transparency in the process with only a recent, yet 
welcome, attempt to begin addressing this problem.  He appreciated the intervention of the European 
Parliament in that regard.  Similarly, he was concerned that the process sought to circumvent the 
debates in regular multilateral forums.  It also a dvanced discussions on IPR enforcement without input 
from developing countries, running counter to th e WIPO Development Agenda recommendation 45.  
At the bilateral level, initia tives such as some Economic Partnership Agreements and Free Trade 
Agreements run counter to the spirit of the need to guarantee that the enforcement of IPRs did not 
create barriers to legitimate trade.  A systema tic consideration of these TRIPS-plus enforcement 
trends was an important priority for the work of the Council for TRIPS, which was the ultimate 
custodian of the TRIPS Agreement. 
300. The representative of South Africa  expressed his appreciation to the delegations of India and 
China for initiating a discussion on this agenda item.   He was committed to the multilateral process in 
the Council for TRIPS, in the WTO, in WIPO and ot her forums.  For that reason, he was concerned 
about discussions outside the Council for TRIPS th at ultimately might have an impact on the 
flexibilities that were in the TRIPS Agreement.  He recognized Members' rights to introduce more 
stringent measures in their own jurisdictions, but he believed, from the past experience, that the 
international frameworks that were referred to part icularly by the delegation of the United States 
could ultimately find their way into the multilate ral process.  Whilst not being party to the 
negotiations, his delegation looked forward to further discussions. 
301. The representative of Canada  said he was concerned about the growing illicit trade in 
counterfeit and pirated goods.  It not only negatively impacted legitimate trade, but it also often 
threatened health and safety and created opportunities for organized criminal groups to flourish.  The 
international community had taken note of these deve lopments and had decided to take action against 
them.  Like the United States, Canada recalled that some Members had rejected previous attempts to 
engage on these issues of enforcement at the Council for TRIPS.  He welcomed now the opportunity 
to have an informed discussion on these issues.  Th e effective enforcement of IPRs was a fundamental 
aspect of the TRIPS Agreement that was not only a matter of establishing procedural remedies, but 
also of improving cooperation, capacity building and communication. 
302. The objective of ACTA was not to undermine the TRIPS Agreement but to complement it by 
focusing on improving aspects of enforcement, including legal procedures, cooperation and 
communication, that the Council for TRIPS had so fa r been prevented from considering.  Canada and 
the other parties participating in the ACTA ne gotiations were aiming to  improve the legal and 
capacity framework for cooperation among countries co mbating piracy and counterfeiting to ensure 
more effective action against IPR infringement.  As a further example, he said that ACTA was also 
designed to improve enforcement practices with in each Member such as better communications 
among competent authorities or increasing experti se or raising public awareness about the serious 
problems of piracy and counterfeiting.  This meant sharing information on practices or on statistical 
data and a commitment to capacity building and t echnical assistance where appropriate.  Finally, IP/C/M/63 
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  ACTA was being undertaken with a view to be  inclusive, not exclusive, as an agreement on 
improving enforcement was more effective with more not fewer Members. 
303. The representative of Australia
 said that she was encouraged by the addition of 
IP enforcement on the agenda of this meeting.  She welcomed the opportunity to discuss enforcement 
within the Council for TRIPS.  Her delegation had sought  in the past to have such a conversation, and 
would be very keen to engage actively in any future  discussions.  She was particularly interested in a 
discussion about Members' experiences, lessons l earnt and best practices in relation to IP 
enforcement.  Australia very much welcomed the re lease of the ACTA negotiating text in April.  She 
regarded the release of the text prior to finaliz ing trade negotiations as setting a very high bar in 
transparency which provided an opportunity to ope nly discuss enforcement measures.  She believed 
that ACTA could usefully complement existing inte rnational IP efforts.  Standards in ACTA were 
largely built upon those negotiated within the WTO,  and reflected the TRIPS consistent measures 
already in place in many WTO Member countries.  Au stralia saw that many of the measures proposed 
in ACTA as useful to counter international trade in counterfeit and pirated material.  She looked 
forward to a more elaborate discussion on enforcement issues in the WTO. 
304. The representative of Chile  said that his was one of the countries that had signed a large 
number of free trade agreements both with develope d and developing countries.  In many of these 
international instruments Chile had incorporated pr ovisions on intellectual property that implemented 
the rights and obligations under the TRIPS Agreement, as well as some provisions that went further than those contained in the TRIPS Agreement.  Su ch action had been taken in the full awareness that 
intellectual property was a tool which, if properly used, could benefit Chile's citizens and in a manner 
consistent with its policies relati ng to innovation.  Accordingly, reforms in recent years had radically 
changed the legislative and institutional panorama in  the intellectual property field, including the 
establishment of specialized brigades in the police service to combat piracy and the organization of 
specialized public prosecution services for the prosecution of IP crimes. 
305. However, in each of the trade agreements that  incorporated intellectual property provisions, 
he said, Chile had also made it clear to all tr ading partners that although intellectual property 
protection and enforcement was a tool for promoting research and development, it was not an end in 
itself for Chile.  It could not be viewed in isola tion but had to be coherent  and consistent with each 
country's circumstances in order to achieve the ai m of stimulating research and the development of 
new technologies, without acting as a barrier to legitimate access by the population to essential 
cultural goods and medicines. 
306. He said that even today when Chile's intell ectual property system contained enforcement 
provisions consistent with the TRIPS Agreement a nd with the highest international standards, his 
country had made sure that such provisions were consistent with the objectives and principles set out 
in Articles 7 and 8 of the TRIPS Agreement.  Th is enabled national authorities to adopt measures 
necessary to protect, in particular, public health and nutrition, and to adopt measures which prevent 
the use of intellectual property rights that is anti-co mpetitive or which adversely affect the transfer of 
technology. 
307. Therefore, while Chile promoted and recognized the importance of a proper use and 
enforcement of intellectual property rights, it also  consider it to be essential that international 
intellectual property rules - whether they be bilatera l, multilateral or plurilateral – be consistent with 
the principles and objectives of the TRIPS Agreement and maintain a proper balance.  These were the 
principles his delegation had supported in bilate ral and multilateral nego tiations and which it 
continued to maintain today.  IP/C/M/63 
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  308. The representative of Switzerland  said that his delegation had not opposed agenda item M. 
proposed by China and India on the grounds that no accompanying documentation had been 
submitted.  Switzerland had merely requested China and India as the proponents of this agenda item 
to provide more information in order to understand what the proponents wished to discuss under this 
item.  He believed that this was Switzerland's right  as a Member of this Council, and his delegation 
would expect and accept to be asked the very same  question by China, should it table an agenda item 
without providing Members with any advance informa tion.  Switzerland and others had requested that 
the agenda item be framed in a manner sufficien tly broad and neutral to allow all Members to 
meaningfully participate in the Council's discussion under this agenda item. 
309. Turning to the substance of item M, he said th at Switzerland attached great importance to the 
topic of IPR enforcement.  To grant intellectual property rights without enabling right holders to 
effectively enforce their rights against infringeme nts was useless.  His delegation believed that 
enforcement as set out in Part III of the TRIPS Ag reement was the realm and the competence of the 
Council for TRIPS.  He believed the Council c ould and should discuss IPR enforcement issues 
relating to Part III of the Agreement, and Member s should share and exchange national experiences 
on implementing these obligations and on what strategies and tools assisted them in doing so. 
310. When looking at enforcement trends, he said it wa s important to realize that such trends were 
reactions to the development of constantly rising  and more sophisticated counterfeiting and piracy 
activities over the last decade.  Large-scale commercially oriented  counterfeiting and piracy had a 
negative impact on global trade and on public hea lth and safety in both developing and developed 
countries.  These activities, often linked to organi zed crime, undermined a whole range of domestic 
government policies as well as the regulatory framework of international trade. 
311. Apart from the systemic element it was for these reasons that Switzerland believed these 
issues to be of direct concern to the WTO in gene ral and the TRIPS Agreemen t more particularly, and 
that the Council should discuss and analyze them thoroughly under its mandate to monitor the operation of this Agreement in accordance with its Article 68. 
312. The WTO Agreements, including TRIPS, set multila teral minimum standards for global trade.  
It was the prerogative of every WTO Member in its b ilateral trade relationships to agree to a trade and 
regulatory framework that built on the multilateral mi nimum standards.  This was just as legitimate 
for intellectual property as it was for trade in good s or services, as long as such agreements were 
consistent with the WTO obligations. 
313. He said that the group of WTO Members negotiating ACTA, including Switzerland, wished 
to make a pro-active step in addressing the cha llenge of ever growing counterfeiting and piracy, 
particularly the large-scale, commercially-oriente d activities in the black market business.  In a 
number of interventions, concerns and potential negative consequences of a future ACTA had been 
raised by a number of delegations :  that ACTA might shift the burden of enforcement of IPRs as 
private rights from the right holder to governments;  that ACTA might lead to distortion of legitimate 
trade;  that ACTA might negate the benefits and flexibilities confirmed in the Doha Declaration on the 
TRIPS Agreement and Public Health;  and that AC TA may destroy the balance and negatively impact 
on broader societal interests.  He said that none of this was the goal of ACTA or its negotiating 
parties, and they had provided ample public info rmation about the goals and contents of ACTA 
confirming this. 
314. What was true, however, he said, was that this plurilateral ACTA initiative was being 
undertaken because thus far, attempts to even only discuss issues relating to the growing problem of 
counterfeiting and piracy in an open and constructiv e spirit in multilateral foru ms such as the Council 
for TRIPS had met with absolute rejection by some delegations, including China and India as the IP/C/M/63 
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  proponents of today's agenda item M, arguing that enforcement as such lay outside the purview and 
competence of the Council for TRIPS. 
315. Switzerland considered its participation in the ACTA negotiations as additional to its 
commitment and efforts at the multilateral level, pa rticularly the WTO and WIPO.  It would therefore 
continue to engage in the Council for TRIPS in a meaningful discussion on IPR enforcement related 
to the TRIPS Agreement and the challenge of cons tantly growing counterfeiting and piracy faced by 
Members.  His delegation stood ready to answer qu estions of interested Members or to provide 
information in bilateral contacts regarding the purpose, goals and inte nded contents of ACTA. 
316. The representative of Brazil
 said that attempts to discuss intellectual property rights 
enforcement in the Council for TRIPS had a relati vely long history which was registered in the 
minutes of several Council for TRIPS sessions, most ly during the years 2005, 2006 and 2007.  He 
said that Brazil had always taken the position that enforcement was essentially a matter of domestic policy making and priority setting that had no place on th e agenda of the Council.  His delegation still 
preferred that the sharing of national experiences on enforcement could instead take place at WIPO's 
Advisory Committee on Enforcement that had b een specifically designed for that purpose. 
317. Brazil found, however, that there were new elemen ts in the agenda item tabled by China and 
India proposing to discuss "TRIPS enforcement measur es".  As had become clear from the statements 
of the two countries, their primary focus of attention was centred on the possible systemic impact of the planned ACTA on the balance of rights and ob ligations under the intellectual property system. 
318. This was, in his view, a legitim ate cause for concern.  Although the draft ACTA text released 
on 21 April still contained many square brackets whic h prevented to some extent a deeper analysis, 
the continued presence of such a high number of pending matters after more than two years of 
negotiations was in itself a symptom of the cont roversial nature of the text and its potential 
divisiveness.  Brazil shared the main thrust of the statements by China and India, emphasizing two 
points of particular concern.  The first one w as the ACTA negotiating process which lacked the 
legitimacy of initiatives conducted in multilateral organizations and had been conducted in a 
non-transparent atmosphere of secrecy that was not conducive to trust.  The second one was that 
ACTA might, in addition to being TRIPS-plus, e nd up being TRIPS-minus to the extent that it 
contributed to narrowing down the scope for flexibilities. 
319. The representative of Nigeria, speaking on behalf of the African Group
, said that the African 
Group believed that the protection and enforcement of  intellectual property rights should contribute to 
the promotion of technological innovation and to th e transfer and dissemination of technology to the 
mutual advantage of producers and users of technol ogical knowledge, in a manner conducive to social 
and economic welfare, and to a ba lance of rights and obligations.  His delegation was concerned about 
the erosion of policy space that might curtail Me mbers' ability to access medicines critical for the 
African continent, about TRIPS-plus provisions in regional trade agreements and about curtailing the 
legitimate transit of goods and services.  The Group was also concerned about the issue of 
counterfeiting and piracy which ha d an economic impact in Members countries as many industries 
were closing down.  He believed therefore that the issue of counterfeiting and piracy was an issue that 
should be discussed. 
320. The representative of Chinese Taipei  said that her delegation appreciated the importance of 
protecting intellectual property rights in the world trading system and the efforts made by many Members to strengthen that protection.  Some were  attempting to do so by signing FTAs or RTAs, 
others through their discussions on plurilateral ag reements, the latest being the Anti-counterfeiting 
Trade Agreement (ACTA).  Her delegation had always paid close attention to worldwide 
developments on IPR protection and wished to stress that subjects such as the allocation of administrative resources, cost and benefit analysis , free trade market access, and the influence on  IP/C/M/63 
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  consumers and traders, should all take into consid eration the time when intellectual property rights 
protection comes into force.  Chinese Taipei would continue to pay close attention to this issue. 
321. The representative of New Zealand  said that, as Australia, his delegation hoped that this 
agenda item would result in a constructive discussion among Members that focused on experience-sharing on IP enforcement, lessons learnt, and on best practices.  He said that, like in the 
Paragraph 6 issue, refraining from political rhetoric and getting down into practical 
experience-sharing was the key to ensuring a useful discussion.  In his view, there were at least two 
important themes running through the interventions on th is issue:  the need to ensure that enforcement 
of IPRs did not unduly impede legitimate trade;  a nd the need to ensure that the fundamental balance 
in the TRIPS Agreement was not changed.  His delegation shared both these objectives but, as with 
many questions of balance, the answer se emed to be in the eye of the beholder. 
322. He said that, as an example, many of the Members expressing concerns about so-called 
TRIPS-plus  enforcement were in another context actively seeking TRIPS-plus  enforcement outcomes 
for geographical indications (GIs).  The GIs elemen ts of the W/52 proposal had been explained by 
some proponents explicitly in terms of improving the enforceability of GIs.  His delegation believed 
that such enhanced enforceability would unduly impe de legitimate trade in generic products.  The 
fundamental balance in TRIPS between IPR-protect ed and generic products would be undermined by 
the W/52 proposal.  With this, he said, his delega tion was not trying to provoke but to demonstrate 
that this issue was not black and white, and that in terests of Members could not be compartmentalized 
in a simple manner. 
323. In contrast to the GIs context, the evidence regarding the problem of trademark counterfeiting 
and copyright piracy showed clearly that this was real and a growing global issue that had become a 
concern for many countries, including New Zealand.  His concerns were in particular the adverse 
effects that such activities had on the economy, as we ll as on public health and safety.  New Zealand 
was participating in ACTA because his delegation believed it would be an important tool to more 
effectively combat this increasingly prolific tr ade in counterfeit and pi rated goods, through better 
enforcement mechanisms for intell ectual property rights, including through international co-operation. 
324. The representative of the European Union
 thanked China and India for allowing Members to 
discuss TRIPS enforcement issues in the Council fo r TRIPS.  It was a difficult topic and his 
delegation had struggled with it in the past.  His delegation was glad that TRIPS enforcement would 
no longer be blocked from the agenda and hoped th at the discussion was going to be constructive.  
While he did not understand Brazil's logic that see med to suggest that TRIPS enforcement belonged 
to WIPO, whereas TRIPS-plus enforcement belonged to the WTO, he said the essential thing was that 
Members could now discuss the functioning of  the TRIPS Agreement under Article 68. 
325. With respect to the statement that ACTA w ould create obstacles to exports, he said that, as 
ACTA represented already 70 per cent of volume of world trade, this would mean that, if it did create obstacles, this could only be true for the remaining 30 per cent of world trade.  He doubted that ACTA 
would create obstacles, but if it did, he was sure that the Members not happy with its effects would 
refer the matter to WTO dispute settlement.  He be lieved that the example of export customs controls 
given by China was wrong because the easier and the qui cker counterfeits could be detected, the more 
the chances to intercept them increased.  He said he was pleased to note that China had a very 
efficient customs export control regime which his de legation had praised in their bilateral discussions 
on IP enforcement.  With respect to the references to other types of  obstacles, like green technology 
and the detention of generic medicines, he sa id that, as Members could read from the published 
ACTA text, there was no provision in the customs border measures chapter for controls on patented 
goods, be it green technology or generic, and he did no t believe that such measures could be effective. IP/C/M/63 
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  326. With respect to the concern that ACTA nego tiations circumvented the WTO, he said that 
while this was neither the intention nor the rea lity of the negotiations.  Those Members who where 
concerned about the negotiations should ask why th ey had been started and why it had been done in 
this particular manner.  The answer was very simple .  Fifteen years after the entry into force of the 
TRIPS Agreement, the level of counterfeiting and piracy, including the dangers associated with it, 
amounted to US$250 billion worth of counterfeit physi cal goods.  This amount was still increasing.  
In Europe alone, the customs detentions of IPR co unterfeits had multiplied by ten times in six years 
between 1998 and 2004.  Although there clearly was a problem, when his delegation had been willing 
to discuss the best way to enforce the existing TRI PS Agreement it had been denied the right to do so, 
or it was at least made extremely difficult for it.  He said that he failed to understand why Members 
who rightly enjoyed the flexibilities under the TRI PS Agreement had to prevent other Members from 
also enjoying the flexibilities under the TRIPS Agreement to tackle a growing problem, the 
consequences of which in terms of risks for safety and health, and in terms of criminal organizations, 
were even worse in developing countries that had less means, and were more exposed to traffic of 
spurious medicines. 
327. He said that it was important to understand that ACTA was an enforcement treaty, not a 
substantive treaty, and it would therefore never a ffect the balance achieved in the TRIPS Agreement 
between the rights of the right holders and the le gitimate goal of disseminating innovations.  ACTA 
would be based on existing laws and, with respect to  the European Union, nobody could deny that its 
existing laws were balanced and were not preventing citizens from exercising civil liberties while at 
the same time trying to do as much as possible to fight counterfeiting and piracy.  Against that 
background, in his view, the concerns raised by Members were not justified. 
328. The representative of Angola
 said that his delegation agreed with the points raised by China, 
India and the European Union.  Some delegations  were weary that the ACTA negotiation process 
advanced with a lack of transpar ency.  At the same time, some ACTA negotiators had stated after 
their last meeting in Wellington that they had reached "a type of consensus" and that they were close 
to a final agreement.  He suggested that, as the ne xt meeting was to take place in Switzerland, ACTA 
negotiators should share the document with Members before concluding this treaty so they could see 
that it was consistent with the TRIPS Agreement a nd the Declaration on TRIPS and Public Health.  It 
was important for Members to have the text and be able  to look at the various articles.  This could also 
allay concerns, dispel any misunderstandings, an d contribute to a better understanding between 
Members. 
329. The representative of China  thanked Members for their comments, including the 
encouragement and the criticism, and said that sh e believed Members had benefited from hearing the 
different perspectives.  The purpose of adding this agenda item had been achieved, as India and China 
had been able to share their concerns with Member s and to urge opponents to further reflect on ACTA 
in the context of the TRIPS-plus enforcement trends .  Her delegation also welcomed the clarification 
from some of the Members negotiating ACTA that  they believed they were bound by the TRIPS 
Agreement. 
330. After the thorough discussion on this issue, her delegation wished to share a few observations 
with Members.  Firstly, China believed that IP was a complicated policy tool, a two-edged sword that needed to be deployed cautiously by policy makers at both the national and the international level.  
Like the old philosophers of China, she believed that Members could benefit from the treasure of 
history in WTO negotiations.  According to the old be liefs of China, everything had two extremes but 
it was advisable to keep away from any of the two ex tremes.  Here, the two extremes in terms of IP 
enforcement could be seen as enforcem ent standards that were either too high or too low, or a scope 
of protection that was either too broad or too limited.   So the best way to tackle this problem was to 
keep to the middle and take a balanced approach, ra ther than a kind of extreme TRIPS-plus approach.   IP/C/M/63 
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  While some might challenge the definition of TRIPS- plus, she believed that here it meant a level of 
protection which was above the level pr ovided for in the TRIPS Agreement. 
331. She said that the second point she wished to menti on was the constant rise of piracy that some 
Members had mentioned as an explanation for ACTA .  While she understood Members' concerns in 
this regard she also wanted to raise the question of why there was a constant rise in the phenomenon 
of piracy and related issues.  While people had different answers to that, she said that from a 
philosophical approach she believed that either th e level of protection was too high, the scope of 
protection too broad, or the level of development t oo low.  The discussion had to get down to the root 
causes of this, and China had made clear in its intervention, that it saw this as a problem of 
development.  It was therefore important to make  IP work for the promotion of development, and 
China was ready to work with other Members for that purpose. 
332. A further concern she wished to share was that, although all were Members of the WTO, 
some Members seemed to try to deviate from the mu ltilateral approach and to encourage plurilateral 
engagement on the interests and concerns they had.  It was unclear whether these Members were encouraging all other Members or some sub-group of  Members to do the same and to perhaps resolve 
the biopiracy issue also through a plurilateral approach.  China not only strongly supported the 
multilateral approach, but also believed that the mult ilateral system needed to be strengthened by all 
its Members.  Lastly, she said she agreed with th e European Union that ACTA was an enforcement 
treaty that could not change the substantive oblig ations under the TRIPS Agreement.  However, 
enforcement provisions were a part of the TR IPS Agreement and were themselves substantive 
obligations, even if they were only procedural provi sions.  Therefore, elevating the enforcement level 
did create substantive obligations on Members and consequently had an impact on them. 
333. The representative of India
 also thanked Members for engaging in the discussion and for 
sharing or responding to some of the concerns ra ised by his delegation.  He said Members should 
differentiate between the attempt by some develope d-country Members to bring enforcement on the 
agenda vis-à-vis  India's and China's proposal of the current  agenda item on enforcement trends.  As 
Brazil had mentioned, a group of developed-country Members had ma de systematic attempts over 
eight successive meetings spread over 2005, 2006, and 2007 to raise the enforcement issue and to 
create the impression of a permanent agenda item.  Enforcement was taken up at these occasions as an 
isolated issue instead of treating enforcement as pa rt of the implementation of the TRIPS Agreement 
as a whole.  He said that in comparison to that time, there was no change in his delegation's position 
that enforcement was not a permanent agenda item fo r the Council for TRIPS and that an agenda item 
could not become permanent simply because a gr oup of countries raised it systematically in 
successive meetings.  India also continued to belie ve that IP and enforcement could not be treated 
separately from the objectives and principles and th e implementation of the TRIPS Agreement as a 
whole.  Submissions on experience sharing, partic ularly on border measures and best practices could 
be discussed better in WIPO's Advisory Co mmittee on Enforcement or the World Customs 
Organization.  While India had neve r encouraged discussion on this issue, it had however clarified in 
successive Council for TRIPS meetings that an in clusion of an agenda item on enforcement should 
not in any way be construed as an acceptance of its inclusion as a permanent agenda item, or of India's 
willingness to engage substantively on issues raised by Members under that agenda item.  In contrast 
to the enforcement discussions at those meetings , India and China had requested this agenda item 
regarding recent enforcement trends in the systemic  context of the TRIPS Agreement and not in the 
context of experience sharing of best practices. 
334. The representative of the European Union , in response to Angola's request for publishing the 
final draft text, said that the European Union woul d certainly request that an updated version of the 
negotiation text would be published, but that this  required the agreement of all other negotiating 
partners who worked on a basis of consensus.  With respect to China's comment that the growing 
volume of counterfeited and pirated goods was due to a lack of development, he said that there was IP/C/M/63 
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  indeed a certain link between economic development and the spreading of counterfeiting, namely that 
no economy could base its economic development on counterfeiting and piracy because it would 
always be lagging behind the lead.  In contrast, the largest producers of counterfeited and pirated 
goods were far from being the least-developed econom ies.  It remained true, however, that the 
growing counterfeiting and piracy in these count ries would certainly not help their economic 
development, if only because this black economy did not contribute to the general fiscal policy of the 
state, not to mention the other criminal aspects it entailed. 
335. The representative of China
 said she did not agree with the assessment made by some 
Members on the current status of developing country Members on the counterfeiting and piracy issue.  In her view, it was important to make an objectiv e assessment, both in terms of the efforts made by 
the government and by the people of the country, in  order to take a serious position on this matter. 
336. The Council took note
 of the statements made. 
N. INFORMATION ON RELEVANT DEVELOPM ENTS ELSEWHERE IN THE WTO  
337. The Chairman  said that, by means of a communication dated 11 May 2010, India had 
requested consultations with the European Union and a member State regarding seizure of generic 
drugs in transit (document IP/D/28).  The fo llowing Members had requested to join these 
consultations:  Canada, Brazil,  Ecuador, Turkey, China and Japan (documents WT/DS408/2-7, 
respectively). 
338. Furthermore, by means of a communication dated 12 May 2010, Brazil had requested 
consultations with the European Union and a memb er State regarding seizure of generic drugs in 
transit (document IP/D/29).  The following Memb ers had requested to join these consultations:  
Canada, Ecuador, India, Turkey, China and Jap an (documents WT/DS409/2-7, respectively). 
339. As regards the status of acceptances of the Protocol Amending the TRIPS Agreement, he said 
that, since the Council's meeting in March, th e Former Yugoslav Republic of Macedonia had 
deposited its instrument of acceptance on 16 Marc h 2010 (document WT/Let/671).  The Secretariat 
had circulated an update to the note on the stat us of acceptances of the Protocol in document 
IP/C/W/490/Rev.6.  He encouraged those Members that had not yet notified their acceptance of the 
Protocol to ensure that necessary measures were  being taken in their capitals to allow the 
consideration of the acceptance in a timely fashion. 
340. The Council took note  of the information provided. 
O. OBSERVER STATUS FOR INTERNATI ONAL INTERGOVERNMENTAL ORGANIZATIONS  
341. The Chairman  recalled that the list of the 17 pending requests for observer status in the 
Council for TRIPS by other intergovernmental organizations was c ontained in document 
IP/C/W/52/Rev.11.  Since the Council's meeting in  March 2010, the WTO Secretariat had received a 
letter from the Executive Secretary of the Secret ariat of the Convention on Biological Diversity 
(CBD), dated 18 May 2010, in which he renewed the CBD Secretariat's request for observer status in 
the Council for TRIPS.  Recognizing that prior requests for formal observer status had not been 
successful, he wrote that the CBD Secretariat would welcome receiving an ad hoc invitation whenever 
the relationship between the CBD and the TRIP S Agreement was on the Council's agenda.  The 
Chairman said that this letter had been faxed to all Members before the meeting. 
342. The Chairman further recalled that the Council had discussed these pending requests at its 
previous meetings, but had not been able to reach c onsensus on any of them.  At its last meeting, the 
Council had focused on the requests from the CB D Secretariat and from two African regional  IP/C/M/63 
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  intellectual property organizations, namely the African Regional Industrial Property Organization 
(ARIPO) and the African Intellectual Property Or ganization (OAPI).  In respect of these three 
organizations, the proposals on the table were that those organizations be granted ad hoc observer 
status on a meeting-by-meeting basis. 
343. As agreed by the Council at its meeting in March, he had continue d consultations on the 
pending requests, including at the Council's informal meeting the previous morning.  In the light of 
these consultations, he proposed that the Council agree to grant ad hoc observer status on a 
meeting-by-meeting basis to ARIPO and OAPI, and th at he continue his cons ultations on the request 
from the CBD Secretariat. 
344. The representative of India  welcomed the consensus that had evolved on inviting ARIPO and 
OAPI as observers on an ad hoc meeting-by-mee ting basis.  He thanked the Chair for the 
consultations he had held.  In the informal discussi on the previous morning, he had provided reasons 
for observer status for the CBD Secretariat, which in cluded the relevance of its work to the work of 
the Council for TRIPS, the precedents in the WT O and the WTO rules of procedure regarding 
observer status for intergovernmental organizati ons.  He had seen widespread support by both 
developed countries and developing countries for ad hoc observer status for the CBD Secretariat.  
Interestingly, Members who opposed such status had agreed at WIPO in December 2009 to invite it to 
update its members on the status of CBD negotiatio ns since the work of CBD had a bearing on the 
discussions in the WIPO IGC.  Based on the same l ogic, he wondered why the CBD Secretariat could 
not be invited to the Council.  The reasons finall y provided by the US delegation regarding the point 
that the CBD was not a mainstream IP organization had prompt him to examine the relevance of other 
observers of the Council.  He noted that several of  them, such as the FAO, the IMF, the OECD, the 
World Bank, the WHO, UNAIDS, WCO and the UN, were not primarily IP organizations.  The 
continued opposition by a Member without providin g credible reasons made his delegation believe 
that they had hit an ideological or possibly a political stone wall.  Such stone walls, reminding him of 
some accession processes, were no doubt difficult to permeate. 
345. The representatives of Ecuador  supported the statement by India. 
346. The representative of Brazil  supported the statement made by India, and asked the delegation 
opposing consensus on the CBD request to explain the reasons for its position. 
347. The representative of the European Union  supported the request by the CBD Secretariat for 
observer status in the Council for TRIPS.  Seve ral topics which needed to be discussed had a 
connection with the CBD, not the least the IP-related DDA issues.  He regretted the fact that, due to 
the opposition by only one Member, it could not be gr anted ad hoc observer status in the Council. 
348. The representative of Cuba  associated herself with the delegations of India, Brazil and 
Ecuador.  None of the many pending requests for obser ver status by other international organizations 
was as important as the one by the CBD Secretariat of the CBD, since there was a direct relationship between what was happening at the CBD and the thr ee standing items on the Council's agenda.  In the 
CBD, there were currently negotiations on the intern ational regime and in the present year there had 
been and would be further meetings that were hi ghly important, culminating at the summit in Nagoya, 
Japan. 
349. The representative of South Africa
 supported India's statement.  He saw no reason why the 
CBD Secretariat should not be invited on an ad hoc basis.  He felt that the issues which were being 
discussed in the CBD were directly relevant to issues that were before the Council for TRIPS.  To the 
extent the topics were relevant, the CBD Secretaria t should be invited on an ad hoc basis as might be 
required from time to time. IP/C/M/63 
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  350. The representative of Egypt
 thanked the Chair for his consulta tions on this important issue.  
He wished to see the CBD Secretariat invited under the formula of ad hoc basis from one meeting to 
the next, given that it was of direct relevance to  discussions under particular agenda items in the 
Council. 
351. The representative of Mauritius  said that a number of organizations, including the ACP 
Group, had made a request for observer status.  He supported granting the CBD Secretariat this status.  
He invited Members to show more flexibility in the name of more transparency, consistency and 
reasonableness to allow these organizations to have observer status. 
352. The representative of Chile  requested that the statement below that his delegation made at the 
informal meeting the previous morning be included in the record of the meeting. 
353. In Chile's view, the presence of the CBD Secretar iat in meetings of the Council for TRIPS as 
an ad hoc invitee, as requested by it in its lette r to the Director-General of 18 May 2010 - was an 
excellent idea, and would enable the CBD Secretariat to provide Members of this Organization with important information.  It was perfectly logical  that the CBD Secretariat should be allowed to 
participate as an ad hoc invitee whenever th e Council was examining the relationship between 
Article 27.3(b) of the TRIPS Agreement and the CBD , a topic which was permanently on the agenda.  
Neither did his delegation see any problem in inviting ARIPO and OAPI as observers. 
354. The representative of Angola
 thanked delegations who had s hown flexibility to allow ARIPO 
and OAPI to obtain ad hoc observer status.  He  echoed what many dele gations from developing 
countries and also from developed countries had sai d regarding granting the CBD Secretariat this 
status. 
355. The representative of the United States  welcomed the two organizations based in Africa 
whose work on IP was very integral IP for their member economies.  ARIPO and OAPI both 
participated in the technological development of their member States and substantively examined 
patent, trademark, design and other IP applications on behalf of their members.  They could in many 
senses be considered national IP offices for their members.  In fact, ARIPO provided training in 
IP and was responsible for other important task s.  These two organizations provided significant 
assistance in TRIPS implementation, an ongoing activity of their member States.  But in the light of 
its continuing concerns about the CBD Secretar iat, the Chair's statement provided the most 
appropriate course of action. 
356. The Chairman  reiterated his proposal that the Council ag ree to grant ad hoc observer status on 
a meeting-by-meeting basis to ARIP O and OAPI, and that he continue  his consultations on the request 
from the CBD Secretariat. 
357. The Council so agreed . 
P. OTHER BUSINESS  
358. The Chairman  recalled that the delegation of Ecuador had indicated that it wished to inform 
the Council under "Other Business" about recent de velopments concerning compulsory licensing in 
Ecuador. 
359. The representative of Ecuador  said that, with its customary transparency, Ecuador had 
decided to take the opportunity afforded by this meeting to inform Members of the Council about its 
experience in using the flexibilities included in th e TRIPS Agreement.  At various meetings the 
Council had held since October 2008 , Ecuador had pointed out that its National Development Plan 
2007-2010, in force since April 2008, aimed under Objective No. 3, Policy No. 3.3, to "ensure  IP/C/M/63 
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  universal access to essential drugs, consolidate the State's authority and sovereignty in the 
management of phytotherapeutic dr ugs and resources", and that with the firm political support of the 
President of the Republic, economist Rafael Correa, Ecuador was in the process of devising a programme for universal access to essential drugs so as to optimize resources, reduce costs and 
expand coverage and access to health services, with  effective, timely and high-quality treatment for 
the people of Ecuador, particularly the poorest among them. 
360. On that basis, the Intellectual Property Institu te of Ecuador (IEPI) had circulated a working 
document in August 2009 entitled "Adm inistrative guide for the issuing of compulsory licences for 
pharmaceutical products in Ecuador", which set out th e legal and technical bases for the issuing of 
compulsory licences for reasons of public health, including:  Articles 3, 32 and 363 of the Political 
Constitution of Ecuador which established health as a human right;  Article 65 of Andean Community 
Decision No. 486 on compulsory licensing;  Article 31 of the TRIPS Agreement which authorized compulsory licensing;  the Doha Ministerial Declaration on the TRIPS Agreement and Public Health of 2001, which interpreted the TRIPS Agreement an d recognized that Members had a sovereign right 
to adopt measures to protect public health;  and various resolutions of the United Nations and the 
World Health Organization on access to drugs and public health. 
361. The ideas and concepts set forth in the above -mentioned working document laid the bases for 
a substantive debate in Ecuador with civil societ y, representatives of the pharmaceutical industry, 
academic circles and competent government agen cies, which was carried on in seminars and 
workshops and through technical c onsultation and advisory activities both in Ecuador and abroad.  
Thanks to this debate, Ecuador had gained a clearer picture of how best to exercise its sovereign rights 
in terms of promoting public health while at the same time meeting the co mmitments undertaken in 
the context of the TRIPS Agreement. 
362. This part of the process had lasted for about  one year, starting with the adoption of the 
above-mentioned National Development Plan and cu lminating with the most intense phase of the 
debate between Augus t 2009 and the final results - based on the technical input received - which took 
the form of Executive Decree No. 118, adopted on 23 October 2009 whereby the President of the 
Republic, Rafael Correa had decreed in Article 1 that  "... access to medicines us ed for the treatment of 
diseases which affect the Ecuadorian population and wh ich are a public health priority is a matter of 
public interest, and compulsory licences may accordi ngly be issued on patents of such drugs for 
human use as are needed for their treatment ...". 
363. The Decree also made the IEPI responsible for determining, in light of the circumstances of 
each case, whether or not a compulsory licence wa s to be granted and for setting the amount and 
conditions of payment of royalties to the patent hold ers, and conferred authority on the Ministry of 
Public Health of Ecuador for ascertaining the safety and reliability of drugs produced under 
compulsory licence.  The Decree furthermore estab lished that any decision as to the grant of a 
compulsory licence must be taken jointly by the IEPI  and the Ministry of Public Health of Ecuador. 
364. In order to facilitate full implementation of the provisions of the above-mentioned Executive 
Decree and to ensure their consistency with the pr ovisions of Article 31 of the TRIPS Agreement, the 
IEPI issued Resolution No. 10-04-P-IEPI of 15 Jan uary 2010 setting forth an "Instruction for the 
Grant of Compulsory Licences on Drug Patents".  This instrument incorporated, as did Executive 
Decree No. 118 on a general level, the legal concep ts established in TRIPS Article 31, such as:  
non-exclusivity, principal supplier to the domestic market, payment of adequate remuneration to the 
patent owner, legal review - either administrative or judicial - of the compulsory licensing measure, 
and the requirement that compulsory licence app licants certify their undertaking to fulfil the 
conditions laid down in the "Instr uction" and the "Executive Decree". IP/C/M/63 
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  365. On 14 April 2010 Ecuador had decided in R esolution No. 000001-DNPI-IEPI (Compulsory 
Licence) issued by its intellectual property authority, the IEPI, to grant to the firm Eskegroup S.A a compulsory licence for invention patent No. PI-97-1142 pertaining to retroviral protease inhibiting compounds, the process for making such compounds and the pharmaceutical compositions that 
include them, which was owned by Abbott Laborator ies, marketed under the name "Kaletra", and 
contains the active ingredient ritonavir.  Th e resolution specifies that  the licence is for the 
manufacture, offering for sale, sale or use of the product, and its importation for these purposes, and that it is intended for non-commercial public use.  It also specifies that Eskegroup S.A. is to pay the 
patent owner adequate remunera tion calculated according to the Tiered Royalty Method (TRM). 
366. With regard to the TRM, it should be noted that use of this method of setting royalty 
compensation in the event of compulsory licen sing stemmed from a 2005 study conducted jointly by 
the United Nations Development Programme (UND P) and the World Health Organization (WHO) 
entitled "Remuneration Guidelines for Non-Voluntary Use of a Patent on Medical Technologies".  
Authored by James Love, the study had become the international guide for de termining royalty rates 
for pharmaceutical products.  It explained that th e TRM method consisted in determining the royalty 
rate not from the price of the generic equivalent, but from the price of the patented product in the 
high-income country.  On this basis, the royalty in  Ecuador in the case of this compulsory licence was 
reckoned to amount to five per cent of the price of  the patented product in the high-income country, 
and that price was then adjusted  to take account of the per capita income of the Ecuadorian 
population. 
367. By granting this compulsory licence, Ecuador had opened the door to competition in generic 
drugs and this, according to its preliminary evaluatio ns, had already reduced the price of treatment for 
Ecuadorian patients suffering from HIV/AIDS from US$1,000 per person to US$800, and a 
50 per cent reduction was anticipated by the end of  this year.  Clearly, for developing Members 
which, like Ecuador, had limited available resource s, the ability to reduce costs and thus meet the 
public health policy objective of securing access for all to essential drugs, was something to be 
acknowledged and emulated. 
368. He noted that the compulsory licence grante d was totally unrelated to the Paragraph 6 
mechanism adopted by the WTO General Council on 30 August 2003, since the generic product under 
compulsory licence which would be imported was not patent protected in the producing/exporting 
country. 
369. In short, Ecuador had issued appropriate re gulations to facilitate use of the flexibilities 
contained in Article 31 of the TRIPS Agreement.  To do so, it had first held numerous public events 
and specialized consultations to examine all aspect s of implementing the flexibilities so as to ensure 
that the regulations were fully compatible with th e requirements of the TRIPS Agreement.  Similarly, 
in the process that had led up to the granting of the first compulsory licen ce for an essential drug for 
the treatment of diseases affecting the Ecuadorian po pulation and which were a public health priority, 
all rights, whether of the patent owner or the appli cant, had been respected.  Indeed, according to the 
policy that Ecuador applied and which was reflect ed in the above-mentioned regulations, where a 
compulsory licence was granted, the right-owner or patent beneficiary was entitled to seek a review of 
the terms and conditions of the compulsory licence, or  even its revocation, either by applying to the 
Ecuadorian intellectual property aut hority or through inde pendent judicial proceedings.  What was 
more, because compulsory licensing was non-exclusive,  patented products were free to compete with 
pharmaceuticals marketed under compulsory licence. 
370. At a meeting of South American Ministers of P ublic Health that had taken place in April 2010 
within the framework of UNASUR, Ecuador had received the unanimous support of all South 
American States for the measure it had taken rega rding the use of the flexibilities allowed by the 
TRIPS Agreement with the aim of promoting public health and granting compulsory licences to meet  IP/C/M/63 
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  public health needs, and pointed out the importan ce of following Ecuador's example.  Ecuador had 
always fulfilled its multilateral commitments in this area, and with the transparency that had marked 
its conduct in the WTO, would continue to be a l eader in asserting all the rights afforded under the 
TRIPS Agreement and, in particular, would take a dvantage of the flexibilities the Agreement allowed. 
371. The representative of India  thanked the delegation of Ecua dor for sharing this important 
information with Members.  India was happy to be associated with the use of a compulsory licence by 
Ecuador and thereby make its contribution to promoting access to affordable, quality, safe and 
efficacious medicines.  His delegation regarded compulsory licensing as one of the most important 
flexibilities on patent protection included in the TRIPS Agreement. 
372. The representative of Cuba  thanked the delegation of Ecuador for sharing relevant 
information in a transparent way with the Counc il He supported the adoption of the measures and 
recalled that Article 8.1 of the TRIPS Agreemen t allowed Members to adopt measures necessary to 
protect public health.  The measures that Ecuador ha d taken were within the Declaration on the TRIPS 
Agreement and Public Health and the flex ibilities under the Agreement and were highly 
recommended in cases that were important for public h ealth.  He referred to the right of all to enjoy 
physical and mental health.  LDCs should review their laws and policies to see whether they had fully 
used the flexibilities in TRIPS or whether they have a dopted more strict measures.  In the latter case, 
they should review the laws to  fully use the available flexibilities.  Furthermore, the TRIPS 
Agreement as well as free trade agreements had had a negative impact on prices and the availability of 
drugs and had created obstacles for countries that wanted to promote public health. 
373. The representative of Egypt  thanked the delegation of Ecuador  for sharing with the Council 
this rare example of a developing country using a compulsory licence.  In fact, compulsory licensing 
was predominantly used by developed countries where it was seen as part of th e mechanisms of the IP 
system.  He was encouraged to see it being used also  in a developing country to deal with issues of 
public policy of high concern.  He believed that this was a way of fighting the stigma associated or that had been associated with compulsory licensing.  In some instances, some quarters had described 
the use of compulsory licensing as the equivalent of  a weapon of mass destruction when it comes to 
the IP system.  WIPO through its Committee on De velopment on Intellectual Property had witnessed 
instances where delegations had requested that part of the projects of the Development Agenda would 
make reference to the importance of sharing expe rience on compulsory licensing.  He invited the 
delegation of Ecuador to similarly share this e xperience within the context of the Committee of 
Development of Intellectual Property at WIPO. 
374. The Council took note
 of the statements made. 
__________