WORLD TRADE  
ORGANIZATION  RESTRICTED 
IP/C/M/67 
15 February 2012 
 (12-0869) 
Council for Trade-Related Aspects of 
Intellectual Property Rights  
 
 
 
MINUTES OF MEETING 
 
Held in the Centre William Rappard  on 24-25 October and 17 November 2011 
 
Chairpersons:  Ambassador Federico A.  González (Paraguay) (24-25 October)  
and Mr. Martin Glass (Hong Kong, China) (17 November) 
 
  The present document contains the record of the discussions which took place during the 
Council for TRIPS meeting held on 24 -25 October and 17 November 2011. 
  
A.  N
OTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT  ......................................................... 5  
B.  REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION  .............................................................. 6  
C.  TRANSITIONAL REVIEW UNDER SECTION 18 OF THE PROTOCOL ON THE ACCESSION 
OF THE PEOPLE 'S REPUBLIC OF CHINA  ........................................................................................ 7  
D.  REVIEW OF THE PROVISIONS OF ARTICLE 27.3(B) ................................................................... 17  
E.  RELATIONSHIP BETWEEN THE TRIPS  AGREEMENT AND THE CONVENTION ON 
BIOLOGICAL DIVERSITY  ........................................................................................................... 17  
F.  PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE  ................................................. 17  
G.  REVIEW UNDER PARAGRAPH 8 OF THE DECISION ON THE IMPLEMENTATION OF 
PARAGRAPH 6 OF THE DOHA DECLARATION ON THE TRIPS  AGREEMENT AND PUBLIC 
HEALTH  .............................................................................................................................. ....... 28 
H.  NON-VIOLATION AND SITUATION COMPLAINTS  ....................................................................... 42  
I.  REVIEW OF THE IMPLEMENTATION OF THE TRIPS  AGREEMENT UNDER ARTICLE  71.1........... 47  
J.  REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON 
GEOGRAPHICAL INDICATIONS UNDER ARTICLE 24.2 ............................................................... 47  
K.  NINTH ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE DECISION ON THE 
IMPLEMENTATION OF ARTICLE 66.2  OF THE TRIPS  AGREEMENT  ............................................ 48  
L.  TECHNICAL COOPERATION AND CAPACITY -BUILDING  ............................................................ 53  
M.  LETTER FROM THE CHAIR OF THE GENERAL COUNCIL CONCERNING WAYS TO 
IMPROVE THE TIMELINESS AND COMPLETENESS OF NOTIFICATIONS AND OTHER 
INFORMATION FLOWS  ............................................................................................................... 60  
N.  AUSTRALIA 'S TOBACCO PLAIN PACKAGING BILL 2011 ........................................................... 61  
O.  ENFORCEMENT TRENDS  ............................................................................................................ 75  
P.  INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO .............................. 87  
Q.  OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS  ............... 88  
R.   ANNUAL REPORT  ...................................................................................................................... 90  
S.  OTHER BUSINESS  ...................................................................................................................... 91  IP/C/M/67 
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1. In proposing the agenda for adoption, the Chai rman said that item N on "Australia's Tobacco 
Plain Packaging Bill 2011" had been put on the proposed agenda at the written request of the 
delegation of Ukraine.  Item O on "Enforcement of  Intellectual Property Rights (Part III of the TRIPS 
Agreement)" had been put on the agenda at the requ est of the delegations of Australia, Canada, the 
European Union, Korea, Japan, New Zealand, Singapore, Switzerland and the United States.  As 
indicated in paragraph 4 of the proposed agenda, in  order to facilitate the participation of relevant 
experts, it was planned that the Council commence discussion of item G on the annual review of the 
functioning of the Paragraph 6 system in the morning of the second day of the meeting, in line with the procedure agreed for that annual review in 2010. 
2. The representative of Ukraine asked whether item N could either be discussed or his 
delegation could make a statemen t concerning it before 11.30 a.m. 
3. The representative of Pakistan asked the propone nts of item O to clarify whether the proposed 
item justified its scope and whether they were s eeking its inclusion on the agenda on a one-time or 
permanent basis.  Since an earlie r almost similar wordi ng for a proposed item on the Council's agenda 
had been objected to by some delegations, includi ng some of the proponents of the present item, he 
requested the proponents to clarify what was now di fferent in terms of discussing the enforcement of 
IPRs. 
4. The representative of Ecuador supported the statement by Pakistan. 
5. The representative of India questioned the need for the inclusion of item O on the agenda at 
the last moment.  If some Members wished to inform  about the recent developments in this area, they 
could do so under item S on "Other Business," or it might be appropriate to make a notification under 
Article 63 so that the compatibility of the measur es with the rights and obligations under the TRIPS 
Agreement could be scrutinized.  He said that the proponents had systemically attempted over eight 
successive Council meetings from June  2005 to October 2007 to raise the enforcement issue, trying to 
create an impression that it was a permanent agenda item.  During those meetings, enforcement had 
been taken up as an isolated issue, instead of trea ting enforcement as a part of the implementation of 
the TRIPS Agreement as a whole.  He asked them to clarify whether the item was intended to be a 
standing or a one-time agenda item. 
6. The representative of Australia, referring to th e request by Ukraine, said that, while his 
delegation was flexible with the timing, the de puty head of his mission who would be making his 
delegation's intervention was not available until midda y.  In response to a request from the delegation 
of Ukraine, he had communicated th is to it already the past week. 
7. The representative of Brazil sai d that there was no need for item O.  The proponents could 
inform the Council about the signing of Anti-Count erfeiting Trade Agreement (ACTA) under item S.  
She wished to understand the reasons for the propo sed item.  The too broad heading could more 
appropriately read "Information on ACTA". 
8. The representative of China said th at she shared the concerns of Pakistan, Ecuador, India and 
Brazil about the lack of information concerning  item O.  If the proponents wished to share 
information on ACTA, they could do so under ite m P on "Information on Relevant Developments 
Elsewhere in the WTO". 
9. The representative of Plurinational State of Bolivia said that he did understand the purpose of 
item O, and that any information could be shared under item S.   IP/C/M/67 
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  10. The representative of Japan said that that the pr oposed item O on "Enforcement of Intellectual 
Property Rights (Part III of the TRIPS Agreement)" was a relevant issue for the Council.  The Council 
had earlier agreed on this particular wording for a title of an item.  The item intended to respond to 
earlier criticism about lack of transpar ency with regard to enforcement. 
11. The representative of Egypt aligned himself with  the concerns of Pakistan, Ecuador, India, 
Brazil, China and Bolivia regarding the inclusion of  item O, and proposed that the issue be discussed 
under item S. 
12. The representatives of Honduras thanked the Vice Minister from the Minister of Economy of 
Ukraine for his presence and asked that item N be taken up first, given the Vice Minister's pressing 
timeframe. 
13. The representative of the United States said that  the proposed item O was squarely within the 
Council's mandate.  There would be a serious pr oblem if WTO Members could not discuss a positive 
IP enforcement item in the Council dedicated to IP protection and enforcement issues.  These 
objections were particularly problematic from the perspective of transparency. 
14. The proposed item was intended to provide an opportunity to discuss ACTA and the 
promotion of IP enforcement.  Specifically, it wo uld offer the ACTA participants the chance to 
answer questions posed by WTO Members in the C ouncil.  He found the objections curious in the 
light of those questions.  In 2010, there had been interest among many of those Members now objecting to discuss enforcement.  In the June 2010 meeting, one Member had specifically sought to 
discuss ACTA, noting that the agreement was "myste rious".  Members had asked questions about its 
provisions and objectives.  China, for example, had noted in June 2010 that, based on the draft 
agreement and acknowledging that the text was in brackets, there seemed to be an intention to 
broaden the scope of piracy and counterfeit.  To answer that question, ACTA did not broaden the 
scope of piracy and counterfeits.  As provided in the definitions section of the agreement, counterfeit 
and pirated goods were defined the same way as they were defined in the TRIPS Agreement. 
15. The agenda request satisfied the Council's pro cedural rules and surpassed them.  The request 
had been submitted to the Secretariat prior to the te n-day notice to Members pursuant to Rule 3 and in 
writing pursuant to Rule 4 of the Rules of Procedure.  In addition, the proponents had provided the ACTA text for the consideration of Members in the three official languages of the WTO.  In the past 
meetings, it had not been common practice for Members requesting agenda items to provide 
additional written documentation.  Th e item had been requested pursuant to the usual procedures for a 
meeting-specific agenda item.  Any future requests would be subject to further consideration by the 
Members of the requesting group.  He lo oked forward to questions under the item. 
16. The representative of Cuba said that the matter under the proposed item O could be dealt with 
under item S.  She believed that there was no mandate to reinforce the standards of enforcement.  The 
topic should not be treated as a standing item of the agenda. 
17. The representative of Indonesia said that item O should not be treated as a standing agenda 
item, and could be discussed under item S. 
18. The representative of the European Union said th at it was important to discuss the issue of 
enforcement in the TRIPS Council.  It was not possible at one TRIPS session to be accused of lack of 
transparency and three sessions later, when his de legation wished to provide information in all 
transparency, to be confronted with objections.  The concern about lack of transparency had earlier 
been raised under an enforcement heading.  He looke d forward to an informative debate at the present 
meeting and, if there was considerable interest by  Members, it could be pursued in future meetings. IP/C/M/67 
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  19. The representative of Pakistan said that if th e rationale for presenting ACTA was to create 
transparency and share experiences, he wished the proponents to honour the request by many 
Members to raise the issue of the Nagoya Protocol  and to invite the CBD Secretariat to share its 
experience and reflections, since that was also one of  the areas that was very much within TRIPS.  
The Nagoya Protocol had been signed by a large majority of Members as opposed to the eight 
signatories of ACTA.  He suggested that the title be  changed into something like "Presentation of the 
ACTA", because he was not convinced that ACTA was a normative standard for enforcement, which 
was covered by Part III of the TRIPS Agreement.  The mere heading of the agenda item could lead to an implication that this was becoming the norma tive standard, which he was not able to accept. 
20. The representative of Switzerland confirmed that the inclusion of item O had been requested 
in conformity with Rules 3 and 4 of the Rules of Pr ocedure.  The intention was to have this as an item 
for the present meeting, not as a permanent item.   Taking it up under "Other Business" was not 
adequate, because the purpose was not only to info rm the Council about ACTA but also to discuss the 
topic of enforcement, which was very much with in the scope of the TRIPS Agreement.  It was 
important for many Members that the issue could be discussed in the Council.   
21. He said that when a similar agenda item had b een proposed by China and India at an earlier 
meeting, there had not been any objections from his or any other delegation to discuss an item on 
enforcement, the objection at the time had rather been  against the particular formulation of the agenda 
item, which had been "TRIPS-plus Enforcement Tr ends".  At that time, the Council had had no 
advance information from those Members what they wished to discuss under the item.  Accordingly, 
the objection had not been against discussing an en forcement agenda item in the Council as such, but 
more to the particular formulation and the proce dural aspects.  The proposed title of the present item 
was exactly the same as the title of Part III of the TRIPS Agreement. 
22. The representative of Canada endorsed the co mments by Japan, the United States, the 
European Union, and Switzerland.  It was appr opriate to discuss the item at the present Council 
meeting, as it clearly fell within the scope of th e TRIPS Agreement.  The issue had not been put 
forward as a standing item, but to provide a b asis for discussion and an opportunity to answer 
questions that had been raised in the past about ACTA. 
23. The representative of India said that his delega tion had mentioned enforcement trends during 
a previous Council meeting, but this had been do ne under other business, and the objective had been 
to inform the Council about the TRIPS-plus agenda  under a plurilateral agreement signed by a few 
countries, and how this was going to undermine th e TRIPS Agreement.  While he was not against 
discussing enforcement, he said that TRIPS-plus or  ACTA was not part of the TRIPS Agreement and 
should not be a permanent agenda item, and that  the suggested title of the proposed item was not 
appropriate. 
24. The representative of China said that no Member had any objection against sharing 
information on national experiences.  The difference concerned what agenda item was appropriate for 
that discussion, be it item S, B or a separate ite m as proposed.  When Indi a and China had proposed 
an item on a TRIPS-plus issue, that had been opposed  by few Members.  The title had been changed 
into "Enforcement Trends", and in that form the agenda had been adopted.  She hoped that the 
proponents could consider discussing the matter under "O ther Business".  She al so shared Pakistan's 
concerns about sharing experiences by the CBD Secretariat on the Nagoya Protocol. 
25. The representative of the Dominican Republic endorsed the request made by Ukraine and 
sought Australia's indulgence, given th e time limits of the Vice Minister. 
26. The representative of Brazil said that, while sh e agreed with the proponents' objective of 
promoting transparency, this objective could be ac hieved under items B or S.  She was, however,  IP/C/M/67 
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  flexible if the heading could be changed, since it di d not make clear that the item was only an exercise 
in transparency regarding ACTA. 
27. The representative of the United States said that  Rule 25 of the Rules of Procedure provided 
that "[d]iscussions on substantive issues under 'O ther Business' shall be avoided".  The proponents 
wished to share information on the substantive provisions of ACTA and he understood that some 
other Members had some views about them.  Since th is was a substantive issue, it was inappropriate 
to discuss it under "Other Business".  The title was a ppropriate as proposed.  As to Pakistan's question 
with respect to discussion of the Nagoya Protocol by the CBD Secretariat, he did not see any linkage.  
Items D, E and F of the current agenda would pr ovide an opportunity to address the Nagoya Protocol 
by Members. 
28. The representative of the Bolivarian Republic of  Venezuela said that, in his view, it was 
difficult to talk about transparency since the ACTA process had begun behind the back of the 
multilateral system.  He recalled that, in the past y ear, the Council had agreed to change the title of an 
item proposed by China and India.  Rather than including a last minute item, the discussion could take place under item S. 
29. The representative of Ecuador said that he ag reed with Venezuela's view that ACTA 
negotiations had not been carried out in a transpar ent manner.  The proposal by Brazil to review the 
title would be a good solution, or alternativel y the matter could be discussed under item B. 
30. After consultations, the Chairman suggested th at the Vice Minister of Ukraine present his 
statement concerning item N first and that the C ouncil then revert to the proposed agenda and 
continue the discussion of the matter under that item.  He further suggested that the Council adopt the 
proposed agenda with item O amended to read as "Enforcement Trends". 
31. The Council took note of the statements made and so agreed. 
A. N OTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT  
32. The Chairman said that, since its meeting in Ju ne 2011, the Council ha d received a number of 
supplements and updates to earlier no tifications of laws and regulati ons notified under Article 63.2 of 
the Agreement: 
 China had notified its Revised Rules for the Impl ementation of the Patent Law;  some of its 
provisions were relevant for the impl ementation of the Paragraph 6 System; 
 
 the Maldives had notified its Law on Copyright and Related Rights;  and 
 
 the United States had notified the Leahy-Smith America Invents Act. 
 
33. As regards notifications of contact points unde r Article 69 for the exchange of information 
and cooperation on trade in infringing goods, he said th at an update to a contact point notified earlier 
had been received from Canada.  The information on the Members' transparency toolkit page had 
been updated accordingly. 
34. The representative of the United States said th at President Obama had signed into law the 
Leahy-Smith America Invents Act.   This Act woul d bring about the most comprehensive overhaul to 
the nation's patent system in over 60 years.  The new law would afford more certainty for patent 
applicants and owners, and would provide the Unite d States Patent and Trademark Office with the 
resources needed to operate efficiently and issue hi gh-quality patents.  Implementation of the new law IP/C/M/67 
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  would occur over a period of months, and the USPTO  would seek input from interested parties, and 
would provide updates, during the implementation pro cess.  Key elements of this new law included: 
 a fast track option to allow patent processing within 12 months; 
 
 a reduction of the current patent backlog, by providing more resources for patent 
examination; 
 
 a reduction of litigation by: expanding the opport unity for parties other than the patent 
applicant to submit information to the USPTO in  connection with the examination of a patent 
application; providing for supplemental examina tion at the request of the patentee;  and by 
providing a post-grant review procedure;  and  
 the adoption of a first-inventor-to-file system, which was more efficient and predictable than 
the prior system. 
 35. The Chairman urged those Members whose initia l notifications remained incomplete to 
submit the outstanding material without delay.  He also reminded other Members of their obligation to 
notify any subsequent amendments of their laws a nd regulations without delay after their entry into 
force.  He reminded in particular those Members who had made any changes to their laws and/or 
regulations to implement the Deci sion on TRIPS and Public Health a nd who had not yet notified such 
changes to the Council to do so.  
36. The Council took note of the statements made. 
B. REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION  
37. The Chairman said that, as regards the reviews of national implementing legislation that had 
been initiated at the Council's m eetings since April 2001, the reviews of three Members remained on 
the Council's agenda, namely those of C uba;  Fiji;  and Saint Kitts and Nevis. 
38. The representative of Cuba said that its legisl ation was in the final phase of the process 
towards approval, and she hoped that, in the cour se of 2012, Cuba would be able to make an 
appropriate notification. 
39. The Chairman said that, at the Council's mee ting in March 2011, the Maldives had informed 
the Council of its graduation from LDC status on 1 Janua ry 2011, and it had outlined the state of play 
of its implementation of the TRIPS Agreement.  The Council had agreed to come back to the 
arrangements for the review of the Maldives' im plementing legislation later in 2011, once it had 
received the necessary notifications of laws and regul ations.  As mentioned under the previous agenda 
item, the Maldives had now notified its Law on Copyri ght and Related Rights.  The Maldives had also 
informed the Council's March 2011 meeting of other on-going work in the area of IP.   
40. He said that, in scheduling the review of the Maldives' implementing legislation, enough time 
should be reserved for other Members to prepare ques tions to be posed to the Maldives in the context 
of this review.  The Council would also need to en sure that the Maldives would have sufficient time to 
prepare its responses.  Accordingly, he suggest ed that the Council schedule the review of the 
Maldives' legislation for the Council's second meeti ng in 2012, which had te ntatively been pencilled 
in for 5-6 June.   
41. In accordance with the standard pr ocedures for the review of legislation, he proposed that the 
Council set the following target dates for the submis sion of questions and answers in this review:  IP/C/M/67 
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   questions should normally be submitted to the Maldives, with a copy to the Secretariat, 
10 weeks before the meeting in which the re view would take place;  accordingly, he 
suggested a target date of 27 March 2012;  
 responses to questions posed within that dead line should normally be submitted four weeks 
before the meeting;  accordingly, he su ggested a target date of 8 May 2012. 
42. The representative of the Maldives said that the Maldives' Law on Copyright and Related 
Rights No. 23 of 2010 (document IP/N/1/MDV/1) had been done in Dhivehi, the national language, 
and had been subsequently translated  into English.  It had been p assed by the citizens of the Maldives 
in October 2010, just prior to the graduation.  The Maldives was working to fully implement the provisions of the TRIPS Agreement.  An industrial property act had already been drafted.  The Maldives was also working with donor agencies to create capacity and raise public awareness in the 
area of IP.  He thanked the WIPO Secretariat for its generous assistance in this work.   
43. The Council took note of the statements made and agreed to proceed as suggested by the 
Chair. 
C. TRANSITIONAL REVIEW UNDER SECTION 18 OF THE PROTOCOL ON THE ACCESSION OF THE 
PEOPLE 'S REPUBLIC OF CHINA  
44. The Chairman recalled that paragraph 18 of China's Protocol on Accessions required the 
TRIPS  Council to review the implementation by China of the TRIPS Agreement each year for eight 
years and report the results of such review promptly  to the General Council.  Thereafter there was to 
be a final review in year ten, which was the year  of the present meeting.  He further recalled that 
paragraph 18 required China to provide relevant information in cluding information specified in 
Annex 1A, to the TRIPS Council in advance of th e review.  The information submitted by China 
pursuant to this requirement, dated 20 October 2011 , had been circulated as document IP/C/W/564.  
Questions in connection with the review had been submitted by Japan (document IP/C/W/556). 
45. The representative of Japan said that his dele gation appreciated China's efforts to address 
intellectual property problems through various measu res including the development of new laws, but 
that counterfeiting and piracy remained a significant problem. 
Counterfeiting and Piracy 
46. As a large number of Japanese companies conti nued to face counterfeit and piracy problems 
in China he hoped that the Chinese Government woul d make further efforts to enhance intellectual 
property rights protection and to provide effectiv e enforcement against any act of infringement of 
IPRs in China.  His delegation was particularly co ncerned with three issues:  first, the disposal by 
administrative authorities of counterfeiting goods outside the channel of commerce did not work in an 
effective manner (IP/C/W/556:  paragraph 4).  Second,  the possibility of a judicial authority ordering 
a party to produce evidence, that  was prescribed by Article 43.1 of the TRIPS Agreement, was not 
used in an appropriate manner (IP/C/W/556:  para graph 3).  Lastly, thresholds for the criminal 
prosecution of counterfeiting cases were not applied in  an effective manner, especially in cases where 
an infringer kept the amount in question below a legal threshold for criminal enforcement by 
destroying the evidence (IP/C/W/556: paragraph 5). 
Technology Transfer Contracts 
47. He said that a further concern related to China's Regulation on the Administration of Import 
and Export of Technology was the discriminatory natu re of clauses for Chinese and foreign licensors 
(IP/C/W/556:  paragraph 7) and discretionary restric tions applied by administrative officers to royalty IP/C/M/67 
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  provisions in contracts (IP/C/W/556:  paragraph 8) .  His delegation believed that these measures were 
contrary to the principle of freedom to license by intellectual property right holders. 
Government Procurement 
48. His delegation further maintained a conti nued interested in the National Indigenous 
Innovation Product Accreditation Syst em and its relation to govern ment procurement, and was 
looking forward to receiving any revised version of that System (IP/C/W/556:  paragraph 11). 
49. The representative of the United States said that fo r this final transitional review of China his 
delegation wished to share with Members its observations on China's first 10 years of WTO 
membership. 
50. He recalled that the transitional review mech anism (TRM) had been created largely because 
China had joined the WTO before it had revised  or adopted laws and regulations necessary to 
implement its WTO obligations, and had been allo wed a variety of transition periods before full 
implementation.  The annual TRM meetings ther efore had provided Members with opportunities to 
review with China, in a multilateral setting, the efforts it had taken to implement specific 
commitments made in its Protocol of Accession, as  well as obligations it had assumed under the many 
agreements that make up the WTO Agreement and its efforts to comply with those obligations. 
51. Since the beginning of the transitional reviews,  he said that the focus of the reviews had 
changed over time.  While for the first five y ears of China's WTO membership the transitional 
reviews had focused predominantly on the scheduled  phase-in of key commitments that China had 
made in its Protocol of Accession, the focus of th e TRM had shifted and had focused more on China's 
compliance with its full range of WTO obliga tions, once the phase-in period had ended.   
52. During the initial phase-in period, China had im plemented a set of sweeping commitments, 
including reducing tariffs, eliminating non-tariff barrier s that had been identified in its working party 
report, and had made legal improvements in IPR pr otections and in transparency.  These actions had 
deepened China's integration in to the international trading system, and had facilitated and 
strengthened China's rule of law and economic re form.  Trade and investment had also expanded 
dramatically between China and its  many trading partners.      
53. He said that, since its accession, China had put in place a framework of laws and regulations 
which were aimed at protecting the IPR of domestic and foreign right holders, as was required by the 
TRIPS Agreement.  However, some critical reform s were still needed in a few areas such as: the 
further improvement of China's measures for the protection of copyright and trademarks in the context of the Internet, correction of continuing deficienci es in China's criminal IPR enforcement measures, 
and the provision of rem uneration to authors for the broadcast  of their works that had occurred 
between 2001 and 2009 - the period when Chin a had finally set default licensing rates for 
broadcasting recorded works. 
54. His delegation was also concerned about the ex tent to which China had provided effective 
protection against unfair commercial use and unauthori zed disclosure of undisclosed test or other data 
generated to obtain marketing approval for pharmace utical products.  In its accession protocol, China 
had agreed to provide six years of protection agai nst unfair commercial use for undisclosed test or 
other data that had been submitted to authorities in  support of applications for marketing approval of 
pharmaceutical and agricultural chemical products wh ich had utilized new chemical entities.  This 
protection was to prevent any person other than th e original applicant from relying on the submitted 
data for subsequent approvals for at least six year s from marketing approval of the original product.  
He said that examples of marketing approval granted to applications for follow-on products prior  to 
the expiration of the six-year period, and in so me cases even before approval of the originator 
product, indicated that further work needed to be do ne to ensure consistent and effective application  IP/C/M/67 
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  of this obligation.  The delegation looked forward to continued work with China on this and related 
matters.  
55. While China's laws on the books had been extensively overhauled to better reflect 
international standards for IPR protection, he said the inability or lack of political will in China to 
enforce these laws and to deter continued IP theft ha d led to sustained and unacceptably high levels of 
retail and wholesale counterfeiting, online piracy, and so ftware theft with severe adverse effects in the 
United States and third-country markets to whic h Chinese IPR-infringing goods were exported.  
Widespread IPR infringement continued to affect products, brands, and tec hnologies of a wide range 
of industries, which included movies, music, publishing, entertainment and business software, 
apparel, athletic footwear, tex tile fabrics and floor coverings, c onsumer goods, chemicals, electrical 
equipment, industrial products, information technology, and clean energy technology, among many 
others.    
56. He said that the United States was, however, en couraged by focused efforts to improve IPR 
enforcement in China in the past year.  His dele gation had closely followed the efforts made under 
China's "Special Campaign on Combating IPR Infringement and Manufacture and Sales of 
Counterfeiting and Shoddy Commodities" (Special  Campaign), and he believed that the new 
coordination and leadership structure which ha d been developed for the Special Campaign had 
enhanced the effectiveness of IPR enforcement dur ing the period of the campaign.  The delegation 
urged China to create a high-level management team  that could drive lasting improvements in IPR 
enforcement by making permanent the temporary lead ership structure created to manage the Special 
Campaign, including the key role of the Vice Premie r.  Institutionalizing this structure would give 
greater credibility to China's efforts to make a sust ained, long-term improvement in IPR enforcement. 
57. As a result of the Special Campaign, his de legation understood, several websites and online 
portals had been shut down, and three website operators had been arrested, convicted, and sentenced 
to prison terms and assessed significant fines.  Th e United States urged China to sustain its work on 
stemming piracy over the Internet.  With respect to  the use of the Internet to distribute counterfeits, 
the United States noted several positive developments in the past year, including new measures issued 
by the State Administration of Industry and Commerce that required Internet Service Providers to verify the identity of online traders and to take "n ecessary measures to protect registered trademarks."  
Reports indicating that local Administrations of Industry and Commerce (AICs) had demonstrated 
greater willingness to intervene directly against online advertisements of  counterfeit and pirated 
products were also encouraging. 
58. To effectively stem the manufacture of count erfeits, the United States urged the Chinese 
Government to ensure that equi pment used to manufacture counte rfeit products was also seized and 
destroyed, as counterfeiters could otherwise r esume their operations as soon as law enforcement 
officers had left their premises.  In addition, he  said, it was important for China to permit direct 
acceptance of serious IPR infringement cases by the Public Security Bureau (PSB) which could search and arrest counterfeiters, while administrativ e agencies such as the local AICs could only seize 
counterfeits.  Following the Special Campaign, the PSB should be given the authority to directly accept all cases involving manufacturers of  counterfeit and pirated products.   
59. In addition to the need for significant progress to fight counterfeiting and piracy, effective 
IPR enforcement in China also required attention to  the protection and enforcement of patents, trade 
secrets and other IP rights.  For example, the United States was troubled by several recent media 
reports of major cases of trade secret theft which ha d affected US firms doing business in China.  His 
delegation was further concerned about the enforcem ent implications of a range of challenges which 
had affected patent quality in China.  Patents that were of low quality, or unexamined, or both, could 
pose obstacles to Chinese and foreign innovators who sought to protect and enforce rights in 
legitimate inventions.  The delegate stated that e ffective enforcement of patents and trade secrets was IP/C/M/67 
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  not only key to the success of foreign companies, but was an essential for a business climate 
necessary to support investment from the kind of innovative industries that China would hope to 
attract and build. 
60. He said that China's goal of becoming an innovative society by fostering "indigenous 
innovation" had created a troubling trend toward in creased discriminatory policies which were aimed 
at coercing technology transfer. While his delegation recognised the critical role of innovation in the 
development and the improvement of  living standards in the United States and China, he remained 
concerned with regard to China's innovation-related industrial policies that had discriminated against 
or otherwise disadvantaged US exports or US inv estors and their investments.  The United States had 
been following the development of China's indigenous innovation and other intellectual 
property-related industrial policies a nd had paid particularly close a ttention to China's policies that 
required or compelled US parties to transfer their IPR to Chinese parties or to Chinese subsidiaries of 
US firms.  Chinese regulations, rules and other re gulatory measures frequently called for technology 
transfer, and in certain cases, conditioned, or pr oposed to condition, the eligibility for government 
benefits or preferences on intellectual property bei ng owned or developed in China, or being licensed, 
in some cases exclusively, to a Chinese party. 
61. In view of the IPR-related developments ove r the past ten years and looking towards the 
future he said that that China's legal framework for the protection and enforcement of IPR had been 
improved, but there were still many areas where fu rther progress was required.  While there was a 
growing awareness in China of the critical role of IPR protection and enforcement to China's 
long-term economic development, it was important th at this awareness be translated into sustained 
efforts to protect and enforce IPRs of both dome stic and foreign right holders.  It was equally 
important that China's desire to develop an innova tive and IP-intensive economy did not drive policies 
that discriminated against foreign IPR holders, either by according preferences to firms with 
indigenous IPRs and thereby lim iting participation by foreign IPR holders, or by implementing 
government policies to compel technology transfer or terms and conditions of IPR licenses, which should instead be left to the commercial consider ations of the parties without undue government 
interference. 
62. The United States would continue to work with Ch ina in the future, both bilaterally and at the 
WTO, on IPR protection and enforcement strategi es, innovation policies, and a range of other 
important IPR-related matters to ensure that Chin a would fully comply with its WTO obligations, to 
the benefit of the United States, China and their trading partners. 
63. The representative for the European Union said that his delegation acknowledged China's 
efforts and improvements in the protection of intell ectual property rights such as Special Campaign on 
the Enforcement of IPRs or the removal of certa in circulars on indigenous innovation.  Since 2004, 
the European Union and China had established a solid cooperation on intellectual property issues 
through, in particular, an intellectual property dial ogue and an intellectual property working group.  IP 
was a topic that was always raised in the global economic dialogues or during the annual EU-China 
summits.   
64. He said that the European Union's cooperation with China had addressed a wide range of IPR 
issues and progress had been noted in a number of those areas.  In particular, China had made 
concrete efforts to improve IPR protection and en forcement.  Despite these efforts, European 
businesses continued to face serious intellectual prop erty problems in China. Further improvement 
was still needed, especially regarding the specificities of the digital world.  The lack of effective 
protection and enforcement of IP in China conti nued to undermine the European Union's legitimate 
interests in areas such as high tech, quality and bran d name products.  IP rights violations remained a 
considerable problem for European businesses, with  85 per cent of all counterfeit goods seized at the  IP/C/M/67 
 Page 11 
 
 
  European borders in 2010 coming from China, an d seven in ten European businesses operating in 
China reporting that they had been victim s of intellectual property violations.   
65. He said that access to the Ch inese enforcement system, in particular, remained complicated 
and costly for foreign companies, notably small and medium-sized industries.  In addition, apart from 
the concerns mentioned by the United States, th e legalisation and notarisation requirements for 
litigation, the high thresholds for criminal enforcemen t and the failure of sanctions to pose a deterrent 
remained areas of grave concern for his delegation.  
66. With respect to the Trademark Law, he said th at the current revision process should be used 
to make further improvements.  The European Union was submitting comments on the latest Chinese 
draft law, which included comments on the rela tionship between trademarks and geographical 
indications, and remained concerned with the practi ce of bad faith registrations in China by Chinese 
owners of European trademarks.   
67. Further improvements should also be brought to the Copyright Law during the announced 
revision process.  The European Union continued to consider that the introd uction of broa dcasting and 
public performance rights for sound recording prod ucers and performers in the Chinese Copyright 
Law was a necessary and welcome step.   
68. He said that the Chinese patent system, c overing invention patents, utility models and 
industrial designs, was growing fast and had reach ed the accumulated number of five million patent 
applications in March 2009, with domestic appli cations growing 20 per cent faster than foreign 
applications.  But the merit of patent registrati on policy should not be measured only by the number 
of patents registered per inhabitant, but should rath er focus on the quality of the rights granted.  The 
European Union was working together with China in this area, putting together a task force on patent 
quality, and his delegation hoped to see benefits from this joint exercise soon.   
69. His delegation was also concerned by non-vol untary technology transfers through excessive 
standardization requirements, the requirement to disclose trade or business secrets, or other similar 
policies.  The so-called indigenous innovation issu e had also been a major concern vis-à-vis China 
over the last years, but the European Union be lieved that a breakthrough had been reached in 
December 2010, when China had indicated that it would not discriminate between products manufactured in China by foreign invested ente rprises and those manufactured by Chinese domestic 
enterprises.  He said it would be important now to monitor the implementation of this commitment 
both at the national as well as at the provincial level, and that this issue would remain very much at 
the top of European bilateral and multilateral discuss ions with China.  His delegation would continue 
to work together with China with the aim of pu tting in place an effective system of intellectual 
property protection and enforcement. 
70. The representative of India said that his de legation attached great importance to the 
transitional review under Section 18 of the Protocol on Accession of the People's Republic of China.  
With respect to China's rules prohib iting the grant of patent rights in respect of scientific discoveries, 
his delegation wished to request clarification of the meaning of the term "scientific discoveries" in 
Articles 5 and 25 of the Chinese Patent Law. 
71. The representative of Korea said that the TRM ha d been a useful mechanism that had helped 
to provide transparency in Ch ina's IPR regime, and had allowe d Members to better understand and 
assess China's progress in implementing and complying with its WTO obligations. 
72. His delegation noted in particular  the progress that had been made  by China in the area of IPR 
during recent years, and appreciated China's con tinuous efforts to improve IPR enforcement and 
protection.  It was his delegation's understanding that China had developed a detailed national IPR 
strategy which reflected its commitment to address IP R-related issues at the highest levels of China's IP/C/M/67 
Page 12  
 
  Government.  China's positive initiatives in IPR legisl ation included the action plan for IPR protection 
for 2008, the National Intellectual Property Strate gy, and the revision of its copyright law in 
February 2011, and his delegati on looked forward to seeing China c ontinuously pursue and intensify 
its efforts for an effective IP protection and enforcement system. 
73. Despite China's efforts, he sai d, Korean industries had continued to report high rates of 
copyright infringement within China and had requ ested further improvements of copyright protection 
measures by China.  In particular, it had been re quested that an adequate system of equitable 
remuneration to be paid to performers and prod ucers of phonograms for commercial uses would be 
introduced.  Given the fact that in 2007 Ch ina had acceded to the WIPO Performances and 
Phonograms Treaty (WPPT) which provided that cont racting Parties may provide for remuneration 
for broadcasting and communication to the public, his delegation looked forward to further efforts by 
China to ensure reasonable compensation to performers and producers. 
74. The representative of Canada welcomed the ma ny positive steps and improvements that had 
been outlined in the communication, and noted the recent large-scale enforcement operations against 
counterfeit products, the promotion of the use of  genuine software by both the government and 
enterprises, as well as efforts to enhance the tran sparency of the intellectual property rights 
adjudication process. 
75. Her delegation appreciated the challenges that Ch ina's size had posed in enforcing intellectual 
property rights, and was therefore pleased to note that China's communication reported a high level of cooperation between government ministries and agencies at  the central, provincial and local levels, in 
addition to the coordinated partic ipation of police departments and the judicial system.  Canada 
greatly valued China's participation in the Council as  well as their bilateral discussions on intellectual 
property matters, and looked forward to seeing furt her similar reports of continued improvements in 
China's administration and enforcemen t of intellectual property rights. 
76. The representative of Mexico said that his delegation wished to express some concerns 
relating to paragraphs 256 and 342 of  the Report of the Working Party on the accession of China.  He 
said that while China had made significant progress in the area of IPRs by having put in place national plans and strategies, there remained concerns about  the conformity of China's legislation with its 
TRIPS obligations, specifically with Articles 22, 23  and 24 of the TRIPS Agreement.  The lack of 
protection for geographical indications  and denominations of origin ga ve rise to serious concerns for 
Mexico as this could affect Mexican products protected  by appellations of origin such as, for example, 
TEQUILA and MEZCAL. 
77. He said that his delegation had detected c ounterfeit beverages that were not TEQUILA and 
which falsely indicated Mexico as their origin. A further case was the counterfeiting of the trademark 
"CORONA", which had still not been settled.  "C ERONO", a Mexican beer, was produced by Beijing 
Cerono Trade Limited Company, using bottles that were labelled with logos , lettering, colours and 
graphics identical to those used for the Mexican beverage. 
78. In other WTO fora, his delegation had also expressed its concern over China's lack of 
compliance with the Memorandum of Understanding which had been signed by Mexico as part of 
China's WTO accession process.  In that Me morandum China had committed to protect the 
denominations of origin of TEQUILA and MEZCAL, a nd to limit their use to products that originated 
from Mexico or from specific regions of the c ountry and which had been manufactured under the 
rules applicable to these beverages.  China had recently notified to the Committee on Sanitary and 
Phytosanitary Measures a draft regulation which reduced the maximum level of methanol for 
alcoholic beverages in a category which would pr event the commercialization of some types of 
TEQUILA and MEZCAL in the Chinese market.  Hi s delegation believed that this would violate 
obligations which China had assumed upon accession w ith regard to these two Mexican products.  IP/C/M/67 
 Page 13 
 
 
  79. The representative of China said that his delegation had submitted the information required in 
the Annex 1A of its Accession Protocol in document  IP/C/W/564 which, he hoped, would help keep 
Members up to date with the latest development in both the legislative work and the enforcement 
efforts in China regarding the protection of intell ectual property rights.  His delegation had prepared 
detailed responses to the questions from Japan and w ould also touch on some of the issues raised by 
other previous speakers.  
Trademarks 
80. With respect to a service trademark which retailers  would use in stores, he said that the Nice 
Agreement Concerning the International Classificatio n of Goods and Services for the Purpose of the 
Registration of Marks ("Nice Agreement"), in his de legation's understanding, did not include the retail 
industry in the scope of service trademark protecti on, as what was being provided by retailers to 
consumers were tangible commodities rather than serv ices.  Therefore, like other members of the Nice 
Agreement, China did not accept serv ice trademarks applications for retail services for the time being, 
but was currently examining whether or not such applications for regist ration could be accepted. 
81. With respect to third party access to trademark documents, he said that documents concerning 
administrative decisions, the status of trademarks under review, or the opposition procedure, could be 
viewed at the official website of the trademark authorities ( http://www.ctmo.gov.cn ).  He specified, 
however, that the trademark review decisions or the rulings on trademark opposition itself were not 
yet open to the general public.  In the cases of review and adjudication of trademarks, since 
administrative decisions involved business informa tion of the parties to the case, the Trademark 
Review and Adjudication Board, in dealing with  applications of third party access to relevant 
administrative decisions concerning a trademark, would examine whether such access would damage 
the interests of the parties to the case.   Only if the third party had obta ined the consent of the parties to 
the case, or if there were other circumstances in wh ich the interests of the parties to the case would 
not be affected, would the Board allow the thir d party to consult an administrative decision. 
82. As to documents in judicial procedures, he sai d that judgments were pronounced in public by 
the Courts on all cases, and judgment documents including in trademark cases were open to the 
general public.  Any third party could view tradem ark-related judicial documents at the website 
sponsored by the IPR Court of the Supreme People's Court ( http://ipr.chinacourt.org ), in addition to 
other websites for judicial documents sponsored by lo cal Courts.  For documents that had not yet been 
uploaded to the Internet, there were othe r channels available for consultation. 
Enforcement  
83. With regard to the consistency of the Civil Procedure Law of the People's Republic of China 
with Article 43 of TRIPS Agreement, he said that in the relevant judicial interpretations of the 
Supreme People's Court, namely the Several Pr ovisions of the Supreme People's Court on the 
Evidence for Civil Actions, Article 17 stated that "if one of the following requirements is satisfied, a party concerned and his agent ad litem may apply to the Court for investigating and collecting 
evidence, the requirements are (1) the evidence under the application for investigation and collection 
belongs to documentary materials that shall be kept by the relevant authority of the State and must be 
transferred by the Court ex officio ;  (2) the evidence belongs to materials concerning State secrets, 
commercial secrets, or individual privacy;  or (3) the evidence belongs to other materials that cannot be collected by the party concerned and his agent ad litem  themselves due to impersonal cause."  
Therefore, if "the document held by the opposition party" in question met any of these requirements, 
an application could be made to the Court for investigation and evidence collection.  Otherwise, he 
said, the Court would refuse such an application. IP/C/M/67 
Page 14  
 
  84. In relation to criminal procedures for inves tigating and handling IPR criminal cases, he said 
that according to the Criminal Procedure Law of th e People's Republic of China, the police authority 
was to keep for examination any property and valuab ly items of the criminal suspects that had been 
seized, as well as the fruits accrued therefrom.  Thin gs that served as tangible evidence were to be 
transferred together with the case.  After a judgmen t rendered by the Court had become effective, the 
police authority was to handle the items involved in  the case in line with the judgment.  In law 
enforcement practices, the police authorities follo wed these requirements seriously and destroyed a 
large amount of IPR-infringing products. 
85. With respect to administrative la w enforcement, he said that Article 53 of the Patent Law of 
the People's Republic of China provided that the Administrative Author ity for Industry and 
Commerce could, upon having determined that an in fringement had taken place, order the infringer to 
immediately stop the infringing act, confiscate and destroy the infringing goods and any implements 
that had been specifically used to manufacture th e infringing goods and counterfeit representations of 
the registered trademark, and impose a fine. 
86. With regard to the issue that a person carrying out IPR infringements may escape criminal 
punishment by keeping the amount in question below the relevant threshold, has said that at present 
for any one act of trademark or copyright infringeme nt that did not reach the threshold of criminal 
punishment, the infringer could only be held res ponsible under civil liability or administrative 
responsibility to the IPR holders, and the relevant  administrative authorities could investigate and 
handle the case in accordance with th e law.  However, if an infringer had carried out multiple IPR 
infringement acts and had kept the amount of each  infringing act under the statutory threshold of 
criminal law enforcement with the aim of avoidi ng administrative handling or criminal punishment, 
the IPR holder could incur criminal responsibility u nder Article 14 of the Opinions of the Supreme 
People's Court, the Supreme People's Procuratorate and the Ministry of Public Security on Certain 
Issues of Application of Law in Handling the Criminal Cases of Intellectual Property Rights 
Infringement, which had been prom ulgated on 11 January 2011.  That  Article provided that "for 
anyone who has carried out multiple IPR infringeme nt acts without administrative or criminal 
punishment, the illegal business amount, illegal pro ceeds or sales amount shall be accumulatively 
calculated.  Anyone who has carried out multiple IPR infringement acts within two years without 
administrative punishment and whose accumulative am ount constitutes a crime shall be convicted and 
punished according to the law, and the period fo r prosecution shall be subject to the relative 
provisions in the Criminal Law without being limited by the aforesaid two-year period." 
87. Regarding repeated IPR crimes, he said that police authorities in China dealt with multiple 
IPR infringement acts in accordance with paragraph 2 of Article 12 of the Interpretation of the 
Supreme People's Court and the Supreme People' s Procuratorate on Issues Concerning the Specific 
Application of Law in Handling Criminal Cases of  Infringement of Intellectual Property Rights, 
which had been issued in 2004.  If such an act reac hed the "criminal threshold" stipulated by relevant 
laws or judicial interpretations and the infringer ha d been suspected of a cr ime, the police authority 
would crack down on such an act.  In the meantime, Article 3 of the Interpretation II of the Supreme 
People's Court and the Supreme Pe ople's Procuratorate on Issues Concerning the Specific Application 
of Law in Handling Criminal Cases of Infringement  of Intellectual Property Rights issued in 2007 
stipulated that suspended sentences generally did not apply to perpetrators of IPR crimes. In addition, 
it was stipulated in Article 65 of the Criminal Law of the People's Republic of China that "if a 
criminal commits another crime punishable by fixe d-term imprisonment or heavier penalty within 
five years after serving his sentence of not less than fixed-term imprisonment or after receiving a pardon, he is a recidivist and shall be given a h eavier punishment.  However, this shall not apply to 
cases of negligent crime."  The police authorities ha ve also followed these stipulations when handling 
criminal cases of IPR infringement.  IP/C/M/67 
 Page 15 
 
 
  Regulations on Administration of  Technology Import and Export  
88. Concerning the relationship between certain provi sions in the Regulations on Administration 
of Technology Import and Export and the national tr eatment principle, he said Article 24 of the 
regulation stipulated that "the t echnology supplying party shall ensure  that he or it is the legitimate 
owner of the technology supplied, or one who has the right to assign or license the technology.  Where the receiving party infringes another person' s lawful rights and interests by using the 
technology supplied by the supplying party, the s upplying party shall bear the liability therefore." 
Such provisions were consistent with Article 349 and Article 353 of the Contract Law of the People's 
Republic of China.  Article 349 stated that the tran sferor in a technological transfer contract should 
guarantee legitimate ownership of the technology provided, and guara ntee the technology provided to 
be complete, without fault, effective, and capable of attaining the contracted objective.  Article 353 
said that the transferor was liable for any infringe ments upon the legitimate rights and interests of 
others that occurred through the exploitation of th e patent or utilization of the technological know-
how by the transferee in compliance with the cont ract.  Consequently, Article 24 of the Regulations 
on Administration of Technology Import and Expo rt was not an obligation imposed only on the 
foreign right holder of technology. 
89. He said that Article 27 of the Regulations  on Administration of Technology Import and 
Export required that "within the term of validity of  a contract for technology import, an achievement 
made in improving the technology c oncerned belongs to the party making the improvement."  As the 
party making the improvement might be either the tran sferee or the transferor, the issue of a foreign 
holder of technology not enjoying national treatment did not exist.  In addition, in accordance with 
Article 2 of the Regulations on Administration of  Technology Import and Export, the criterion for 
judging whether a technology was imported or exported was the cross-boundary transfer rather than 
the nationality of the transferee or the transferor. 
90. As to whether the Government could interfere w ith contract licensing fees, he said that under 
the Regulations on Administration of Technol ogy Import and Export, imported and exported 
technologies were classified as prohibited, restrict ed, or those that could be imported and exported 
freely.  In relation to the latter category, the c ontract for import or export was only required to be 
registered with the competent authority without s ubstantive examination and there was no provision in 
the regulation to authorise the competent authority  to change licensing fees.  In practice, for 
technologies that could be imported freely, licensing  fees were determined through consultations of 
the parties to the contract.  As long as there ha d been no violation of law, the Chinese government 
would neither interfere nor demand enterpri ses to change prices in the contract.   
91. With respect to the China IPR Protection Ac tion Plan 2011, he said that the competent 
authority would, firstly, draft anti-monopoly guidelin es in regard to the abuse of IPR in line with 
relevant stipulations in China's Foreign Trade Law.   However, as the drafting would take some time 
and relevant studies were on-going, no specific time table for the promulgation of such guidelines had 
been set.  
92. Secondly, to implement the Patent Law of th e People's Republic of China which had been 
newly amended in 2008, the Decision of th e State Council on Amending the Regulations for 
Implementation of the Patent Law of the People' s Republic of China (State Council Decree No. 569) 
had been promulgated on 9 January 2010.  The amended regulation had been effective since 
1 February 2010 and had been notified to the WTO, as noted by the Chair at the beginning of the meeting. In this regard, the representative noted the question by India concerning China's Patent Law 
and said that due to the technical nature of the issu e, China could pursue the matter in detail bilaterally 
after the meeting. IP/C/M/67 
Page 16  
 
  Indigenous Innovation an d Government Procurement 
93. With respect to indigenous innovation and its relationship with government procurement, he 
said that his delegation wished to clarify that th e administrative measure that had raised Members' 
concern, namely the Notice Regarding the Launc h of the National Innovation Product Accreditation 
Work for 2009, issued on 30 October 2009, had b een an invitation for application for accreditation so 
that the products of the applicants could be accr edited as indigenous products.  The purpose of the 
paper had been to encourage the applicants to strengthen their innovation activities.    
94. In April 2010, China's relevant authorities had publicly solicited opinions and comments on 
the draft of the Notice Regarding the Launch of the National Innovation Product Accreditation Work 
for 2010.  In this document, it had been confirme d that products by dom estic and international 
manufacturers would be treated equally. 
95. In June and July 2011, to further confirm th at indigenous innovation policies and preferential 
government procurement treatment we re no longer linked, China's rele vant authorities had issued two 
Notices, according to which implementation of re levant administrative measures, including the 
Administrative Measures on Budgeting for Govern ment Procurement of Indigenous Innovation 
Products and the Trial Measures for Administrati on of the Accreditation of National Indigenous 
Innovation Products, had been terminated. 
96. With respect to the specific case s raised by the delegate of Mexico he urged the Mexican 
Government to contact China bilaterally or through  the Embassy of China for more details, and said 
that he would also send that message back to his capital after the meeting. 
97. In conclusion, his delegation wished to thank all Members for their constant support over the 
course of this transitional review, and their appreciat ion for China's efforts in further strengthening its 
protection of intellectual property rights.  Since its accession to the WTO ten years ago, China had 
fulfilled its tremendous commitments made upon accession, and in this course, as noted in the last 
TPR of China, Members had observed the strong political will of the Chinese government in that 
regard.  With respect to the TRIPS Agreement, China had not only established a sound legislative 
framework, but also an enforcement system that integrated both administrative and judicial measures.  
Another particular achievement was the enhanced aw areness of IPR protection in the whole society of 
China as one of the largest developing countries.  The Chinese government continued to attach great 
importance to IPRs and their protection as the va lue and importance of IPRs in an increasingly 
globalized world was well known.  Although the tran sitional review of China had now come to an 
end, China believed that its exchanges with Members on IPR issues and their protection would 
continue, and be further enhanced, in the future.  Ch ina would continue to participate in the work of 
the Council in an open and cooperative spirit. 
98. The delegation of Nigeria said that the trans itional review mechanism had been included in 
China's Protocol of Accession as a special precautiona ry instrument with the objective of monitoring 
and enforcing the implementation of WTO commitm ents, and in the case of the TRIPS Council, to 
monitor the implementation of the TRIPS Agreement,  in addition to promoting transparency and 
exchange of information in trade relations with Chin a.  In view of his delegation the review exercise 
in the TRIPS Council had provided a broad review of the IP regime on a scheduled basis and he 
thanked China for its detailed responses to the questio ns that had been raised.  Since Nigeria had been 
one of the first Members to recognise the market ec onomy status of China, his delegation shared the 
view that China was moving in the right direction and at the right pace, in spite of the enormous 
challenges and cost of the commitments it had unde rtaken.  The Nigerian delegation wished to 
encourage China to remain steadfast in its endeavour and, in particular, to pay special attention to the 
enforcement of the regulation relating to the expor t of sub-standard goods, which included copyright 
and patent infringement.  IP/C/M/67 
 Page 17 
 
 
  99. The Chairman thanked China for the informa tion it had provided, as well as other Members 
for their contributions.  Turning to the Council' s reporting obligation to the General Council, he 
suggested that the Council follow th e same procedure as in the past years, namely that the Chair, 
acting on his own responsibility, would again prepare a factual report.  The content of the cover page 
to the report would be similar to that of the repor t submitted by the Council in 2009 and the part of the 
minutes reflecting the discussions held under this agenda item would be attached. 
100. The Council took note of the statements made and agreed to proceed as suggested by the 
Chair. 
D. REVIEW OF THE PROVISIONS OF ARTICLE 27.3(B) 
E. RELATIONSHIP BETWEEN THE TRIPS  AGREEMENT AND THE CONVENTION ON BIOLOGICAL 
DIVERSITY  
F. PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE  
101. The Chairman suggested that the Council conti nue to discuss the three agenda items together 
on the basis of contributions by Members as has been th e practice at past meetings.  He said that, at its 
meeting in June 2011, the Council ha d requested him to continue cons ulting on the suggestion that the 
WIPO Secretariat be invited to brief the Council on the work of the Intergovernmental Committee on 
Intellectual Property and Genetic Resources, Traditi onal Knowledge and Folklore (IGC), and that the 
CBD Secretariat be invited to brief the C ouncil on the outcome of the Nagoya meeting. 
102. As regards the suggestion concerning the briefi ng on the work of the IGC, at the Council's 
meeting in March 2011, the delegation of El Salvador had, since, informed the Secretariat that it had 
recently been able to engage in the work of the IGC and had been, therefore, fully informed of its 
work.  In the light of this, he said that there w as no longer a need for such a briefing at the Council's 
meeting.  However, the WIPO Secretariat was re ady to assist any delegation who would wish to 
receive information on the current state of play.  Fu rthermore, the WIPO Secretariat had informed him 
that, prior to the next meeting of the IGC foreseen for February 2012, it intended to organize an 
informal information session for all delegations on 31  January 2012. 
103. As regards the possible CBD briefing on the outcome of the Nagoya meeting, at the Council's 
meeting in March 2011, Japan had made a presentation on that topic in its capacity as the host country 
for the CBD COP 10 in Nagoya.  However, India and a number of other delegati ons had said that they 
still wished to hear from the CBD Secretariat, and re iterated their request that it be invited to provide 
a briefing on a one-time basis.  In his consultati ons, these delegations had argued that while each 
Member had its own views, the CBD Secretariat ha d been neutral, had had the institutional memory 
and could report on all views.  Some other delegati ons reiterated that it had been the viewpoints of the 
CBD members rather than the CBD Secretariat that would give WTO Members a more complete picture.  Most delegations had been willing to c onsider, as a compromise, the possibility of a side 
event.  The views continued, however, to dive rge on whether there should be some formal link 
between such an event and the TRIPS Council's meet ing.  One delegation had presented a new idea of 
agreed terms of reference for the CBD Secretariat briefing at the Council. 
104. The representative of the Plurinational State of Bolivia said that the adoption of TRIPS 
Article 27.3(b) gave legal impetus to biopiracy a nd had harmful effects on the developing countries, 
in particular the indigenous peoples of Bolivia.  Th at article promoted appropriation and privatization 
of life forms and their parts.  The negative effect s could be seen not only in the fields of ethics and 
indigenous peoples' rights but also in the fields of agriculture, food, climate change and health.  There was no other multilateral standard on this subject since the TRIPS Agreement had been adopted.  
Therefore his delegation would like to seek multilateral solutions.   IP/C/M/67 
Page 18  
 
  105. Referring to documents IP/C/W/554 and IP/C/W/5 55, he said that his delegation could not 
deal with inventions in the biotechnical field in th e same way as in other fields.  Inventions could not 
be an isolation or characterization of biological  forms, which was a mer cantilist approach without 
considering humanity.  To permit the patentability of life forms or their parts would require a 
profound analysis and review of the most recent progress made in international law, inter alia,  the 
Declaration of the Rights of Indigenous Peoples adopted in the United Nations in 2007.  National 
legislation as proposed by Bolivia had ethical, moral,  and cultural effects and consequences on patents 
and technology, and access to and use of genetic r esources.  He reiterated that the Council must 
review and if necessary, amend Article  27.3(b) of the TRIPS Agreement. 
106. The representative of the Bolivarian Republic of  Venezuela supported Bolivia's proposal to 
review Article 27.3(b) of the TRIPS Agreement.  As requested by him, the statement his delegation 
made at the Council's meeting in June 2011 is reproduced below1. 
The representative of the Bolivarian Repub lic of Venezuela supported Bolivia's 
proposal in view of the need, and the mi nisterial mandate, to conduct a review of 
Article 27.3(b) of the TRIPS Agreement.  Domestic legislation, specifically Articles 
124 and 127 of the Constitution of the Bolivar ian Republic of Venezuela, prohibited 
the registration of patents for life forms.  The West had imposed its view of life, its institutions and its rules on the rest of humankind and these had been adopted as they 
were, for better or worse, by the entire wo rld.  It was well established that morals 
were the foundation and source of rules a nd the law, since the law was there to 
respond to forms of life in society - in other words the law could not exist without 
some "moral" basis, the word "moral" coming from morada, meaning a dwelling, a 
place where one lived.  Thus, internationa l agreements, which were nothing if not 
laws, must be based on morals and on ethics.  Those principles and the laws of Venezuela could not be invoked in attempting to patent life in many forms it took in 
nature and to convert it into a tradable commodity that could be assigned a price, 
particularly now that the ever-forgotte n indigenous peoples of Venezuela were 
represented in National Assembly and there was an undertaking, now in the form of 
a law, to respect their way of life, their customs, their genetic resources and their traditional knowledge. 
He said that what Bolivia sought in its paper was a review of Article 27.3(b), as 
provided for in the last sentence of Article 27.3(b), which stipulated that there shall 
be a review after four years, but none had ever been conducted.  The content of that 
Article would appear not to have been so construed by one Member at the meeting of 
October 2010 who had said that the review had been intended not so much to revise content as to focus on implementation.  He disagreed, because Article 71 of the 
TRIPS Agreement already made provision for a full review of TRIPS 
implementation at regular intervals, and in light of the general principle of law that 
he who could do most could do least, the express provision - which was restrictive, specific and time-bound -to review Article 27 would be meaningless, since any law must be interpreted as a coherent and structured whole. 
It clearly emerged from a reading of Article 71 that periodic review of the entire 
TRIPS Agreement was fully warranted and necessary, not only because it needed to 
be adapted to the constantly arising changes of a globalized world with its 
fast-developing technologies, but also, a nd more importantly, because the issue of 
intellectual property was closely linked to human rights such as food security, education, health and the right to sel f-fulfilment, among others, which must be 
                                                      
1 Paragraphs 25-28 of IP/C/M/66.  IP/C/M/67 
 Page 19 
 
 
  reviewed on an on-going basis so that they  could be increasingly enjoyed by more 
and more people, in full conformity with the principles of the United Nations and the Millennium Goals, which were established in an attempt to make them more universal. 
Regarding the question of access to genetic resources, he highlight ed the sovereignty 
of States and their indigenous peoples over their biological resources, and the 
authority to determine access to genetic resources therefore lay with national governments and was subject to national legislation.  As regards traditional 
resources, they should not come within the traditional purview of intellectual property, and in the case of legislation of Venezuela, its sovereignty would be 
violated. 
107. The representative of Ecuador shared the con cerns expressed by the Plurinational State of 
Bolivia.  He said that the Council should continue  its discussion on Bolivia's proposal.  He also 
supported the proposal of amendment of Article 27.3( b) to make a binding provision on the exclusion 
of patentability. 
108. The representative of India said that, as one of the twelve mega-diverse countries, India 
already accounted for seven to eight per cent of the recorded species of the world with only 
2.4 per cent of the land area.  Its biological diversity  was seen in its forests, its wetlands and in its 
marine areas.  On account of that richness in bi odiversity a large number of scientific, research and 
technological institutions were actively engaged in th e activities relating to biodiversity.  Pursuant to 
the ratification of the CBD, India had developed a comprehensive legislation on biodiversity setting 
up several institutions to deal with that issue.  
109. India also possessed rich traditional knowledge of  ways and means to treat diseases afflicting 
people.  That knowledge had generally been p assed down by word of mouth from generation to 
generation.  Documentation of that existing know ledge available in the public domain on various 
traditional systems of medicine had become imperative to safeguard th e sovereignty of that traditional 
knowledge and to protect it from being misappropria ted in the form of patents on non-original 
innovations, which had been a matter of national concern.   
110. In view of the large number of patents grante d in developed countries which had to be later 
contested by India, the Government of India ha d established Traditional Knowledge Digital Library 
(TKDL) to provide information on India's trad itional knowledge in langua ges and in a format 
understandable by patent examiners at internationa l patent offices (IPOs).  The TKDL was aimed at 
preventing the grant of wrong patents, and acted as a bridge between the traditional knowledge 
information existing in local languages and the pate nt examiners at IPOs.  While, through the TKDL, 
India had created a defensive mechanism against er roneous patents, TKDL remained only one of the 
multiple tools required to address the much larger issue of misappropriation of genetic resources and 
associated traditional knowledge and could be a useful complement to a mandatory disclosure 
requirement in patent applications. 
111. He said that it was unfortunate that the TR IPS Agreement continued to ignore the numerous 
IPR-related obligations in the CBD  which were of interest to the developing countries.  That 
contradiction not only obstructed the proper implementation of the CBD but also caused an imbalance 
in the TRIPS Agreement.  The TRIPS-CBD issu e was a critical implementation issue for the 
developing countries and a positive outcome on that i ssue would be an important deliverable for the 
developing countries.  The Council had done a lot of wo rk on that issue over a long period of time.    
The disclosure proposal contained in document IP/C/W/474 submitted in 2006 had been followed by 
document TN/C/W/52 submitted in June 2008 with the support of 108 countries.  The latest 
submission on that issue - document TN/C/W/59 - had been proposed by a vast majority of the IP/C/M/67 
Page 20  
 
  membership.  The submission captured the developm ents in the past, including the Nagoya Protocol 
on Access to Genetic Resources and the Fair and E quitable Sharing of Benefits Arising from their 
Utilization to the Convention on Biological Divers ity (Nagoya Protocol) which had been signed by 
192 countries and contained a significant implementi ng legislation for the CBD issues regarding prior 
informed consent and access and benefit sharing.  The submission could be a good basis for future 
negotiations and would maintain the credibility of the patent system.  India remained committed to 
move that process forward and expected c onstructive engagement from other Members. 
112. Referring to the deadlock over the issue of formally inviting the CBD Secretariat for a 
briefing on the Nagoya Protocol, he said that it w as unfortunate that while the CBD Secretariat had 
done the presentations in WIPO and WHO, the WTO had been deprived of its briefing on account of 
objections by only a few Members.  He reiterate d the demand for a formal briefing by the CBD 
Secretariat in the interest of the larg e majority of the developing countries.  
113. The representative of China noted that the debate among Members on those three agenda 
items had mostly focused on whether the discussion should lead to an amendment of the TRIPS 
Agreement.  Some Members believed that contractual arrangements and prior art requirements were 
enough to achieve the objectives of harmony and synergy between the CBD and the TRIPS 
Agreement, while many others believed that the ma ndatory requirement of prior informed consent and 
benefit sharing in patent applications was indispen sable to achieve those objectives.  In the view of 
China, the CBD had recognized and established a le gitimate right over genetic resources, which must 
be respected and honoured by pate nt applicants when they accessed and used the genetic resources for 
their inventions.  The disclosure requirement w as consistent with the transparency principle 
established in the multilateral trading system.  It wo uld not be burdensome for the patent applicant to 
fill in a form with the information of prior informed consent and access and benefit sharing as 
indicated in document TN/C/W/59, considering the legitimate objective it would achieve.   
114. Contractual arrangements and the novelty requi rement in patentability were not enough for 
the protection of genetic resources because th e contractual arrangeme nt depended on voluntary 
behaviour and fulfilment of parties to contracts,  and the novelty requirement played a second hand 
role in preventing erroneously granted patents.  Da tabases and other information that patent examiners 
might have access to before granting a patent was limited compared to the large quantity of genetic 
resources existing in the world.  As one genetic r esource could generate thou sands or even tens of 
thousands of patents, it would not be enough to re ly upon patent examiners to prevent the use of 
genetic resources without prior informed consent and access and benefit-sharing requirement.  The 
responsibility to respect the sovereign right over ge netic resources should re ly upon legal or natural 
persons who accessed or used the genetic resources and associated traditional knowledge at first hand. 
115. She reiterated the proposal to invite the CBD Secretariat to make presentations in the TRIPS 
Council, which would facilitate the work of the C ouncil and contribute to th e cooperation between the 
WTO and other international organizations. 
116. The representative of Turkey said that WTO Me mbers should find appropriate solutions to 
prevent misappropriation of gene tic resources and associated traditional knowledge and to avoid 
erroneously granted patents.  She supported the in troduction of an appropria te mandatory disclosure 
requirement in patent applications, which would c ontribute to transparency of utilization of genetic 
resources and associated knowledge, help to achieve  shared objectives and combat biopiracy.  She 
also reiterated that her delegation was open to the pr oposal to amend the TRIPS Agreement in order to 
introduce prior informed consent and access and benefit-sharing requirements.  She expected 
significant movement on three TRIPS-related issues in 2012.  In her view, the issues of TRIPS-CBD 
and GI extension were an integral part of the wo rk programme and part of the Single Undertaking.  IP/C/M/67 
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  117. The representative of Korea said that review of Article 27.3(b) should not lead to denying the 
patenting of life forms.  All fields of technolog y, including biotechnology, deserved adequate patent 
protection.  The world had treme ndously benefited from the recent adva ncement in biological science.  
Biotechnology had huge potential to enhance human we lfare in public health, and therefore it should 
be incentivized rather than discouraged.  In th e absence of incentives provided by patent protection 
for research and development in that field, impor tant pharmaceutical products would not be invented 
in the first place. 
118. The representative of Brazil supported the in troduction in the TRIPS Agreement of a 
mandatory disclosure requirement of the origin of genetic resources as well as prior informed consent 
and access and benefit-sharing.  She also supported th e proposal to invite the CBD Secretariat to make 
a briefing on the Nagoya Protocol in the TRIPS Council.   
119. The representative of Peru said that his dele gation's position on the three agenda items was 
fairly well known and was in line with what had been said by the delegations of India, China, Turkey 
and Brazil among others.  In Peru's view, a mu ltilateral and mandatory disclosure of origin 
requirement would be the most efficient way to address the international problem of misappropriation 
of genetic resources and traditional knowledge in th at it would allow all countries to identify 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.  
120. That conviction had prompted Peru not onl y to co-sponsor, with some 110 Members, 
document TN/C/W/52 but also more recently to submit, together with a considerable number of delegations, document TN/C/W/59 which aimed at enhancing the relationship between the TRIPS 
Agreement and the CBD.  In that proposal, the co-spo nsors called for the inclusion of an Article 29bis 
in the TRIPS Agreement with a view to establishi ng a disclosure of origin requirement as well as 
evidence of prior informed consent and benefit shar ing in patent applications involving the use of 
genetic resources and/or asso ciated traditional knowledge. 
121. Unfortunately, there had not been more opportu nities to examine and discuss that proposal, 
especially given the current climate surrounding the Doha Round.  However, his delegation wished to 
repeat that it could not imagine a successful conclusion to those negotiations without any results on the proposed.  Any outcome in the negotiations must reflect the interests of the developing countries, 
particularly when it came to the protection of gene tic resources, traditional kn owledge and folklore.  
Only a solution that dealt with the problem of bi opiracy would enable Members to establish a proper 
balance in the patent system and in the IP system in general for the benefit of all, particularly the local 
and indigenous communities of the developing countries. 
122. Finally, he supported the initiative to invite the CBD Secretariat to make a presentation to the 
Council on the results of the Nagoya Protocol negotiations.   
123. The representative of Colombia said that the ma in issue to be discussed was the need to 
amend IP systems and incorporate mechanisms that would help address the difficulties in monitoring 
and following up biopiracy.  It was necessary to id entify points of convergence between the rules on 
IP protection and those relating to the conserva tion of biological diversity and the use of its 
components, including genetic resources, so as to en sure that both regimes were consistent with each 
other and were thus mutually supportive, pursuant to Article 16.5 of the CBD and Article 4 of the 
Nagoya Protocol.  That in turn would make it possible to address the mandate provided for in 
paragraph 19 of the Doha Declar ation in a constructive manner. 
124. The proposal co-sponsored by Colombia had been prompted by the obvious need to 
implement tools for monitoring compliance with the provisions on access to genetic resources and traditional knowledge, such as the international certifi cate and disclosure of origin.  It was also aimed IP/C/M/67 
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  at discouraging biopiracy through the establishment of deterrent measures of an administrative, legal 
or criminal nature to.  It was important to note that such a tool provided for checkpoints to monitor a genetic resource at every stage in keeping with th e provisions of Article 17 of the Nagoya Protocol.  
In the case of a patent utilizing genetic resources or products derived therefrom and/or traditional 
knowledge, an initial step towards developing the prin ciples agreed to in the CBD was to establish the 
country of origin.  That step was a vital one in determining whether access had been legally obtained.  
Biotechnology developers needed to be quite clear that any profits derived from the application of 
their inventions should not only represent gains for themselves but should also for humanity as a whole. 
125. That being so, Members could not ignore the fact  that IPRs were a mechanism that sought to 
provide benefits to the inventor and thus encourag ed investment.  In an area such as biodiversity, 
however, the development of an invention based on such products should not impair legal access to 
the genetic material and/or its derivatives on which th e invention was based.  Further, it meant that not 
only that the inventor would be entitled to benefits  from the invention but also the States providing the 
resources, and where appropriate, the traditional communities concerned. 
126. The representative of Chile said that the three fundamental requirements for patentability set 
forth in Article 27.1 of the TRIPS Agreement, i. e. novelty, inventiveness and industrial applicability, 
should be applied and respected in full by IP offi ces, and were that to happen, there should be no 
contradiction or conflict with th e appropriation of naturally occurri ng life forms.  In line with the 
above, it was essential for national and regional patent offices to have access to all of the information 
available so as to avoid granting erroneous patents that did not comply with some of those 
patentability requirements.  Databases could be very useful in that respect.  
127. Chile possessed endemic genetic resources wh ich was its unique heritage.  Based on 
preliminary investigations, such genetic material , which might have economic potential for Chile was 
reportedly being unlawfully exploited.  Chile was therefore considering the development of a legal 
framework that would provide ad equate regulation in a manner consistent with international 
commitments.  In that regard, Chile recognized the potential benefits of a disclosure of origin 
requirement for genetic resources.  His delegation was extremely satisfied with the work being carried out within the framework of the IGC, where im portant agreements had been reached:  namely, 
renewing the IGC's mandate and inte nsifying its meeting schedule in 2012.  He was confident that the 
work of the IGC would make substantive progress. 
128. The representative of the United States said that, at the June meeting of the TRIPS Council, 
Switzerland posed a number of questions regarding th e contractual approach.  He referred Members to 
his answers contained in paragraphs 99 through 1 01 of the Council's minutes (document IP/C/M/49).  
As to the specific question of how the contract a pproach would address the need for transparency in 
access and benefit sharing, he noted that certain ag reements could be made available to the public.  
For example, the US National Park Service enco uraged research in national parks, and might 
negotiate a benefit-sharing agreement with biopros pectors.  Information about areas where research 
needs had been identified, and which permits ha d been issued, was posted on the National Park 
Service website: https://science.nature.nps.g ov/research/ac/ResearchIndex .  By posting where the 
National Park Service was encouraging research and information about granted permits, the contract-
based approach of the US government pr ovided certain avenues for transparency. 
129. He said that it would not be appropriate to  request for the CBD Secretariat to make a 
presentation to the Council on the Nagoya Protocol .  The Nagoya Protocol had 65 signatories, but 
would only enter into force 90 days after deposit of  the fiftieth instrument of ratification.  No 
countries had yet deposited an instrument of ratificat ion.  The eleventh meeting of the Conference of 
the Parties of the CBD would take place in India from 8 to 19 October 2012, and was the target for convening the Nagoya Protocol's first meeting of the Pa rties.  He was confident that the next year the  IP/C/M/67 
 Page 23 
 
 
  Government of India could, like Japan had done pr eviously in the Council, provide an excellent 
explanation of the recent work of the CBD in that forum. 
130. The representative of Nigeria reiterated the African Group's position on the amendment of the 
TRIPS Agreement to bring it in line with the provisi ons of the CBD.  He said that the amendment of 
the TRIPS Agreement would ensure a multilateral disclosure requirement that would prevent 
misappropriation of genetic resources.  Regarding th e contractual approach, he said that it was highly 
difficult to prove that there had been a contractua l obligation or agreement between the owners of 
those resources and the users.  Some cases had run into ten to twenty years before they had been resolved.  The African Group supported the suggestion that the CBD Secretariat be invited to make a 
presentation on the Nagoya Prot ocol in the TRIPS Council. 
131. The representative of Japan stressed the importance of considering the problem of 
misappropriation of genetic resources by dividing it in to two aspects:  erroneously granted patents and 
the CBD compliance.  An appropriate solution shou ld be sought in each case, bearing in mind that 
such solutions should achieve each objective in a manner which would not have an adverse effect on 
the IP system. 
132. Japan had proposed the establishment of one-clic k databases to prevent erroneously granted 
patents.  His delegation would like to continuously  hold discussions toward the implementation of the 
system with the broad support from other Members.  He also attached a great deal of importance to 
the Nagoya Protocol, and expected Members' effort s toward the implementation of the modality of the 
Protocol.   
133. With regard to the Bolivian proposal, he reite rated that the patent system provided a critical 
incentive for technical development in the field of biotechnology, which was essential for the world at 
large.  
134. The representative of Ecuador said that Ecuador had four natural regions:  Costa, Sierra, 
Oriente and the Galapagos Islands.  Each one of t hose regions had different ecosystems and habitats, 
such that Ecuador was considered to be one of the most biodiverse countries in the world, having 
among the largest species of animals and plants per square kilometre.  It ranked second in terms of 
diversity of endemic vertebrates, third in terms of  the number of amphibians, fourth in terms of the 
diversity of birds, and had more than 16,087 spec ies of vascular plants within its territory.  In 
addition, Ecuador hosted a great diversity of cultur es, with 14 nationalities, 17 indigenous peoples, the 
Montubio and Afro Ecuadorian peoples, and a variety of ancestral and rural communes and 
communities.  That mega-diverse and multicultura l heritage must be protected, preserved and 
promoted.  
135. He said that traditional knowledge, traditional cultural expressions and genetic resources 
should be protected for a variety of reasons:  (i) they  constituted a human right;  (ii) they had intrinsic 
value;  (iii) they helped to overcome inequity;  (i v) they formed part of an ancestral cosmo-vision;  
(v) there were IPRs associated with  them;  (vi) many helped to deve lop or facilitate scientific research 
and shorten the time devoted to bioprospecting;   (vii) their protection was mandated by the 
Constitution and stemmed from international obligations  that had been assumed;  and (viii) it was one 
of the objectives of Ecuador's National Development Plan. 
136. The genetic information derived from biodivers ity was used to develop new and specific 
processes and products through biotechnology, in pa rticular in the cosmetics, agricultural and 
pharmaceutical areas.  The annual world market for products derived from genetic resources in 
particular in the above mentioned areas, was current ly estimated at some US$50 to 800 billion.  In 
other words, the economic and social importance of  those resources was unquestionable, particularly IP/C/M/67 
Page 24  
 
  when genetic resources belonged to the State and it  was the State's responsibility to protect public 
interests in them. 
137. Ecuador approached that subject from the standpoint of collective rights.  That did not mean 
that it did not recognize the individual contributions made, for example, by the shamans and wise persons, but that those contributions also formed part of the rights of communities, and that the 
communities owned the traditional knowledge and tr aditional culture expressions.  It was therefore 
with the communities that access to  traditional knowledge and traditional cultural expressions was 
negotiated, and it was the communities that received the fair and equitable share of the benefits, 
according to their own practices and customs.  Both under the CBD and the national constitution, 
genetic resources and biodiversity in general were th e property of the State.  Consequently, the State 
was responsible for authorizing access to genetic res ources, and it was with the State that the fair and 
equitable sharing of the benefits was negotiated. 
138. Ecuador was still exploring the link between IP  and traditional knowle dge, genetic resources 
and traditional cultural expressions, but it had fou nd certain areas of possible relationship.  For 
example, with respect to copyright communities co uld, in accordance with their own consent rules 
(including among themselves), authorize phonographic, audio-visual or photographic productions to 
be made for subsequent sale, thus ensuring that they  received a fair and equita ble share of the benefits 
obtained.  The same applied to designs and publications. 
139. With regard to trademark law, there were ca ses in which third parties had registered, as 
trademarks, items relating to cosmo-vision and the history of the indigenous and local communities, 
not only within the country, but outside the country as well.  There was concern over the use that was 
made in many developed countries of  terms that were specific to indigenous cultures or to the natural 
endemism of megadiverse countries.  For example, the case of "Palo Santo", in which the Italian company Linpha Vitale had filed a lawsuit against an Ecuadorian citizen, Mario Jerez, in Italy, to 
prevent that indigenous Ecuadorian native of the Otavaleno community from selling Palo Santo chips 
on the grounds that it was the owner of that trademark protecting essences and incense.  There were 
no statistics on the number of violations that had b een committed, or were currently being committed. 
140. In the area of patent law, Ecuador advocated th e disclosure of origin of genetic resources and 
declaration of the presence of traditional knowledge in  relevant inventions that were the subject of 
patent applications.  The importance of disclosure of origin related to the sharing of benefits.  When a 
genetic resource was declared to have been taken fro m the sovereign territory of a State, that meant 
that the resource in question should have been obtaine d in conformity with the laws of that country. 
141. Recognition of the geographical origin of a genetic resource was not only linked to the fair 
and equitable sharing of benefits, but also had to do with respect for the sovereignty of States and for 
human rights and legitimacy.  Indeed, the removal of  a country's resources without its consent was a 
form of biopiracy, aggravated by the fact that it often did serious damage to the biodiversity of the 
territory concerned, particularly in cases of endangered species.  The problem with requiring 
disclosure of origin without considering the geogr aphical area from which the genetic resource came 
was that it could be awkward for researchers who, in principle, would not necessarily need to know 
the geographical origin of the resources they were using in their invention and would perhaps only be 
required to reveal the source (for example, some foreign university).  However, declaring only the 
source could lead to the granting of rights in resp ect of a genetic resource that had been biopirated. 
142. He said that it was also important to declare geogr aphical origin in the case of plant varieties.  
The Ecuadorian IP authority had received applica tions for plant breeders' rights from a European 
company which had declared that the material it ha d used for its plant breeding was from an African 
country without attaching the access contract for that  resource.  In those cases, cooperation and cross 
checking between offices was important.  Ecuador would begin notifying the counterpart offices in  IP/C/M/67 
 Page 25 
 
 
  other countries of applications for rights relati ng to its genetic resources (once published in the 
Journal) and, where possible, to its traditional knowledge, its traditional cultural expressions, and 
other resources of its indigenous and local communities. 
143. All of those data served to demonstrate th e importance for mega-diverse and multicultural 
Members, notably the developing countries, of  genetic resources, traditional knowledge and 
traditional cultural expressions.  Consequently, the economic, technological and commercial potential 
of those resources needed to be protected, and they should remain the property of their legitimate right 
holders.  That required a multilateral system that w as consistent with those needs and respectful of 
those rights. 
144. He reiterated his delegation's support for document TN/C/W/59 of 19 April 2011, which 
reflected the concerns and consid erations mentioned above. He also  reiterated his delegation's support 
for India's proposal that the CBD Secretariat should report, at a formal session of the Council, on the 
results of the Nagoya Protocol. 
145. The representative of Cuba supported the amendmen t of Article 29 of the TRIPS Agreement, 
which would require patent applicants to disclo se the source and country of origin of biological 
materials and to provide the evidence of prior in formed consent and benefit sharing.  She also 
supported the initiative to invite the CBD Secretariat to make a presentation in the TRIPS Council.   
146. The representative of Angola, speaking on behalf of the LDC Group, said that, as highlighted 
in paragraph 19 of the Doha Ministerial Declarati on, the discussion on review of Article 27.3(b) was 
closely linked to the discussion on the items of TR IPS-CBD and protection of traditional knowledge 
and folklore.  He reiterated the LDC Group's position on review of Artic le 27.3(b), that is, to clarify 
the patentability of plants and animals as well as mi croorganisms and all other living organisms.  The 
LDC Group was interested in ensuring that natura l processes that produced plants and animals and 
other living organisms should not be subject to pate nt protection.  He stressed the importance of 
maintaining flexibility with respect to the sui generis  regime for the protection of plant varieties, that 
is, implementation should be base d on an individual country's systems and needs.  The flexibility 
would contribute to improving food security by ensu ring that indigenous peoples' inventions were 
protected and access to seed was guaranteed. 
147. He said that biodiversity was an important source of livelihood for the population living in 
rural areas in most of the LDCs.  Yet benefits ar ising from the appropriation of such resources and use 
of their traditional knowledge by multinational c ooperation had been shared with the community 
concerned.  It was a matter of concern to the LDCs, which should be addressed by having a 
mandatory requirement under the provisions of the TRIPS Agreement for disclosure of the country of 
origin of the genetic resource and associated trad itional knowledge used in the invention.  It was 
equally important to ensure that patent applicants  demonstrated that they had obtained or acquired 
prior informed consent from the competent authority in the country of origin of the genetic resource 
and that the arrangements to facilitate the sharing of benefits arising from the appropriation of such 
resource and traditional knowledge were in place.   
148. The LDC Group took note of the progress made in  other international forums, such as WIPO 
and CBD.  The WIPO General Assemblies had re newed the mandate of the IGC and the Nagoya 
Protocol had been concluded in October 2010.  Therefore, the LDC Group supported the request 
raised by India to invite the CBD Secretariat to  make a presentation in the TRIPS Council.  The 
observer status should be granted to other inte r-governmental and non-govern mental organizations, 
such as South Centre. 
149. The representative of Australia said that, as a mega-diverse country with a unique indigenous 
culture, his delegation had a strong interest in a balance between holders  and users of genetic IP/C/M/67 
Page 26  
 
  resources and associated traditional knowledge.  As pa rties to the CBD, Australia shared the relevant 
objectives in relation to genetic resources and traditional knowledge.  Australia had actively 
participated in the negotiations for the Nagoya Pr otocol and welcomed the outcome.  The Nagoya 
Protocol set terms on how countries would permit ac cess to genetic resourc es, share the benefits 
arising from their use, and cooperate with one another in allegations of breach of domestic 
requirements.   
150. Australia considered that the TRIPS Agreemen t and the CBD were consistent and could be 
implemented in a mutually supportive manner.  Hi s delegation had strong interest in the issue and 
welcomed the significant progress made in the IG C, especially the recent decision of the WIPO 
General Assemblies to renew the IG C's mandate and would continue its constructive engagement in 
WIPO.   
151. The representative of New Zealand said that his country had a high degree of unique endemic 
flora and fauna, and therefore his delegation had a strong interest in preventing the misappropriation 
of its genetic resources and associated traditional knowledge.  As a party to the CBD, New Zealand 
was committed to the effective implementation of its three objectives, including the third objective 
related to the fair and equitable sharing of benefits  arising from the utilization of genetic resources.   
152. New Zealand also had a systemic interest in the stability of the patent system.  Measures 
which prevented the granting of erroneous patents we re critical to maintaining the integrity of that 
system. There was widespread agreement amon gst Members over the need to prevent the 
misappropriation of genetic resources and associated traditional knowledge.  There was, however, still 
much disagreement over the appropriate policy res ponses that would best achieve that objective.  
There were a multitude of different approaches in use to address misappropriation.   
153. New Zealand's domestic policy was still evolving on the subject, but it was committed to 
engaging constructively in relevant  international forums to address it.  The IGC was undertaking a 
detailed consideration of the re lationship between IP and geneti c resources as well as traditional 
knowledge and traditional cultural expressions.  It was currently working on a text of an international 
instrument or instruments on the protection of the th ree subject matters.  New Zealand considered it to 
be an appropriate forum to discuss in detail IP issues related to traditiona l knowledge and genetic 
resources.  New Zealand was active and constructiv e in the IGC and was committed to the fulfilment 
of the IGC mandate.  The IGC would meet for eight days in February to focus on genetic resources 
issues, including options for a draft legal text.   
154. In closing, she informed the Council of the r ecent release of the Waitangi Tribunal's report on 
the Wai 262 indigenous flora and fauna and IP cl aims.  The relationship between the New Zealand 
Crown and Maori was founded on the Treaty of Wa itangi which had been signed in 1840.  The 
Waitangi Tribunal was a permanent commission of enquiry charged with making recommendations 
on claims brought by Maori relating to actions or om issions by the Crown that allegedly breached the 
Treaty of Waitangi.  In July 2011, the Waitangi Tr ibunal had released its report on the Wai 262 claim.  
That claim had alleged that the Crown had failed to adequately protect Maori interests in relation to a 
wide range of cultural knowledge and cultural prac tices as well as in their relationships with 
indigenous flora and fauna.  The Tr ibunal had distilled the issues of the claim into four key areas:  IP 
and works based on Maori knowledge;  access to a nd control over biological resources, flora and 
fauna and taonga species; the protection and e xpression of Maori knowledge, including Maori 
language and cultural customs; a nd relationships with the envir onment and with taonga species, 
environmental natural resources and conservation mana gement and traditional medicines and healing.  
The report contained a number of non-binding recommendations across those four areas.  The Government of New Zealand was currently analysi ng the findings of the report to determine the 
response to those recommendations.  The report was available online at www.waitangi-
tribunal.govt.nz .  IP/C/M/67 
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  155. The representative of Chinese Taipei believed th at the flexibility provided by Article 27.3(b) 
allowed Members to implement rele vant domestic provisions appropria tely and to take into account 
their own needs and interests.  Members were able to take advantage of that flexibility to suit their 
particular unique domestic conditions .  The review of Article 27.3(b) should not lead to lowering of 
the level of patent protection for biotechnological inventions.   
156. The TRIPS-CBD issue concerned a number of diffe rent stakeholders.  For owners of genetic 
resources and traditional knowledge, a mechanism to  ensure access and benefit-sharing and prior 
informed consent was needed.  Fo r investors, it was necessary to motivate inventions and innovation.  
For patent offices, the legal certainty of the patent  system had to be maintained without increasing 
unnecessarily the burden on either patent examiner s or applicants.  On-going discussions and 
consultations should take those pr inciples into consideration.  
157. The representative of South Africa supported the proposal to amend the TRIPS Agreement to 
incorporate a mandatory disclosure requirement.  He welcomed the developments at WIPO and the 
Nagoya Protocol, but said that they were not suffici ent to address the problem in its entirety.  That 
issue should be tackled by the Council because of the unique mandate of the WTO, particularly of the 
Council.  He supported the statement made by Ni geria on behalf of the African Group, which 
proposed to invite the CBD Secretariat to make a presentation in the TRIPS Council, and also supported the timelines identified initially by India.  
158. The representative of Canada said that, as not only a user but also a provider of genetic 
resources, Canada took that issue very seriously.  The TRIPS Agreement and the CBD were mutually 
supportive, and therefore there was no need to am end the TRIPS Agreement.  WIPO remained the 
best forum for technical discussions of aspects of  IP related to genetic resources, traditional 
knowledge and traditional cultural expressions.  The IG C had been given a clear, renewed mandate to 
undertake text-based negotiations to reach an agreem ent on the text of one or more international 
instrument or instruments to ensure the eff ective protection of gene tic resources, traditional 
knowledge and traditional cultural expressions. Canada looked forw ard to working with other 
members as the IGC pursued its recently renewed mandate.  
159. She said that provisions for review of Article 27.3(b) of the TRIPS Agreement were meant to 
focus on Members' implementation issues rather th an on revising the content of that provision.  
Flexibilities should be maintained in that provision to allow Members to implement it domestically as 
appropriate.  For example, Canada was committed to continuing its work to avoid the grant of 
erroneous patents, to secure compliance with nati onal agreements on benefit-sharing regimes and to 
ensure patent offices have available the information n eeded to make proper decisions on patent grant.   
The existing patent system was well-equipped to prevent the grant of erroneous patents.  He 
encouraged Members to consider other non-patent -based mechanisms to protect biodiversity and 
prevent misappropriation of genetic resources, such  as developing broader, more globally accessible 
and functional prior art databases, using mutually agreed terms in material transfer agreements, 
licensing, codes of conduct and contracts betwee n users and providers. Canada would be fully 
engaged in the ongoing consu ltative process on the outstanding implementation issues.  
160. The representative of Indonesia highlighted th e importance of the issues of TRIPS-CBD and 
protection of traditional knowledge  and folklore.  As a proponent of document TN/C/W/52, Indonesia 
remained consistent in its view that all Members should take bold steps to address that matter so that 
the Council not only produced fruitful results but also contributed to substantive progress on the 
subject.  Given the fact that the protection of ge netic resources, traditional knowledge and folklore 
was very crucial for developing countries, the discl osure requirement would undoubtedly contribute to 
the success of development.  The WTO, as an organi zation that valued development, must come up 
with rules and parameters that would enhance the benefit of such a system for development.  The 
potential of genetic resources, combined with tr aditional knowledge, could become one of the key IP/C/M/67 
Page 28  
 
  elements for economic welfare for people in the de veloping countries, especially that of megadiverse 
nations.   
161. As the Nagoya Protocol had been adopted, he  encouraged all Members to consider the 
importance of that issue.  It would be in all Memb ers' best interest to articulate further, through the 
TRIPS Agreement, with an aim to offer a sufficien t level of protection to genetic resources and to 
provide fair practice for their use.   It became mo re relevant and appropriate  for Members to take the 
necessary steps to incorpor ate the values and principles of the CBD into the TRIPS Agreement and to 
create a regime that was truly beneficial so that  the relationship between the TRIPS Agreement and 
the CBD could be developed in a mutually suppor tive way.  He hoped that Members could sincerely 
engage in a constructive dialogue, strengthen thei r commitments and accomplish the desired result. 
162. The representative of Pakistan, referring to the argument that existing patent systems were 
sufficient to address the problem of erroneously granted patents, questioned whether the existing 
enforcement systems were sufficien t in the context of ACTA negotiations.  Were the existing systems 
not in compliance with the TRIPS Agreement or not  sufficient enough that Members needed to make 
them stronger?   
163. As a member of the WIPO, his delegation respect ed all its mandates, and would like to refer 
to WIPO work in the TRIPS Council.  He also suppor ted the proposal to invite the CBD Secretariat to 
make presentations on the Nagoya Protocol in the TRIPS Council, saying that Members were able to 
refer to the work taking place in other relevant bodies, whether in or outside the WTO, which was 
consistent with the principle and rationale some Members opted for in other issues.   
164. The representative of Zimbabwe jo ined those that had called for the review of the provisions 
of Article 23(b), and reiterated the position that had been articulated by the coordinator of the African 
Group.  The protection of traditional knowledge a nd folklore and genetic resources would enable 
peoples and communities to benefit from their biodiversity.   
165. The Council took note of the statements made and agreed to revert to the matter at its next 
meeting.   
G. REVIEW UNDER PARAGRAPH 8 OF THE DECISION ON THE IMPLEMENTATION OF PARAGRAPH 6 
OF THE DOHA DECLARATION ON THE TRIPS  AGREEMENT AND PUBLIC HEALTH  
166. The Chairman said that, as requested by the Counc il, he had held consu ltations with a number 
of Members on how best to structure the Council's di scussions in order to make the review as useful 
as possible.  In light of these consultations, he had faxed to the Members a list of topics and issues for 
discussion on 14 October 2011.  The list merged the list of six topics for discussion prepared for the 
System's annual review at the Council's meeting in  October 2010 with the list of issues for further 
discussion or information identified by Members whic h the then Chairman had faxed to Members in 
February 2011 to guide the discussion on the follow- up to the annual review at the Council's meeting 
in March.  While the Chairman clarified that wh ile this approach was based on the structure and 
content of the 2010 review and represented a natura l continuation of what was well received at that 
time, it was not necessarily exhaustive.  Members s hould therefore feel free to raise any additional 
issues during the review. 
167. He said that during his consultations, some de legations had reiterated their proposal for an 
open-ended workshop involving all the key stakeholde rs.  However, views continued to diverge on 
that proposal.  The last topic on the list, namely "Next steps and recommendations", would enable the 
Council to continue the discussion of this point.    IP/C/M/67 
 Page 29 
 
 
  168. Regarding the purpose of the TRIPS Council's a nnual review and the report to the General 
Council, he said that paragraph 8 of the waiver  Decision provided that the Council would annually 
review the functioning of the System set out in the Decision with a view to ensuring its effective operation and annually report on its operation to th e General Council.  Such a review would be 
deemed to fulfil the review requirements of Article IX:4 of the WTO Agreement. 
169. The Secretariat had circulated a draft cover note for the Council's report modelled on previous 
years' reports (JOB/IP/4).  It contained factua l information on the implementation and use of the 
System established under the Decision, discussion s regarding its operation, and the status of 
acceptances of the Protocol Amending the TRIPS Agre ement.  In accordance with the way that the 
Council had prepared its reports in pr evious years, the part of the minutes of the meeting that reflected 
the discussions held under the agenda item  could be attached to the cover note. 
170. The Secretariat had also circulated an update to the note on the status of acceptances of the 
Protocol that the Council had requested it to  prepare at its meeting in October 2006 
(IP/C/W/490/Rev.8).  Since the circulation of that  document, Argentina and Indonesia had deposited 
their instruments of acceptance on 20 October, a nd New Zealand had deposited its instrument on 
21 October (WT/Let/830, 831 an d 832, respectively).  37 notifications of acceptance of the Protocol, 
including from the European Union (formerly the Eu ropean Communities), had thus been received.  
He reminded Members that the Protocol would ente r into force for the Members concerned when it 
had been accepted by two thirds of the Members.   
171. Turning to the consolidated list of topics a nd questions for discussion in the annual review, 
the Chairman said that this list combined the list of topics for discussion that had been prepared for 
the October 2010 review and the list of issues for further discussion or information identified by 
Members that had been prepared to guide the fo llow-up discussion at the Council's meeting in March 
2011.  The follow-up questions were grouped unde r the appropriate headings.  The footnotes 
indicated the delegations that had posed those foll ow-up questions and the further information that 
had already been provided in response to those questions at the Council's meeting in March.  
Therefore, there was no need to repeat or duplicate what had already been said on the record.  He said 
that structuring the discussion this way should help the Council carry out the review with most continuity on the basis already established, and t hus ensure a productive and useful discussion of the 
System that would help Members better unders tand the Paragraph 6 Syst em's operation and any 
concerns related to it. 
1. Experience of Members who have used or  considered using the Paragraph 6 System 
2. Implementation of the System into domestic legislative and regulatory framework  
172. The representative of Canada said that her dele gation had provided extensive information on 
its experience at the last annual review of the Paragraph 6 System in October 2010.  She updated 
Members on the status of Bill C-393, which had s ought to amend Canada's Access to Medicines 
Regime (CAMR).  It had died on the Order Paper at  the end of the last parliamentary session before 
the May 2011 general federal elections  in Canada.  No similar bill ha d yet been introduced in the new 
session of Parliament.  
173. She recalled that her delegation had asked a numbe r of questions at the Council's meeting in 
October 2010, to which responses remained outstan ding.  The Paragraph 6 System, while a useful 
tool, should not be viewed as a panacea for the co mplex problem of ensuring access to medicines.  
The impact of intellectual property rights on access to  medicines, in particular on their price and on 
healthcare as a whole, had to be viewed as comme nsurate with the role of intellectual property 
alongside other factors that affected the price and availability of medicines.  Those factors included 
infrastructure, rational use of medicines, health systems, and tariffs on medicines and related commodities that merely taxed the sick. IP/C/M/67 
Page 30  
 
  174. The Paragraph 6 System should therefore not be viewed as the only solution - which it was 
not, and had never been intended to be - but rather as a mechanism that sought to modulate one of the 
factors, i.e. intellectual property rights, which a ffected the price of medicines.  She recalled the 
genesis of the Paragraph 6 System, wherein Ministers had recognized the need for the TRIPS Agreement to be part of the "wider national a nd international action" that addressed grave public 
health problems such as HIV/AIDS, malaria and t uberculosis.  The difficult negotiations that had 
ensued resulted in a mechanism th at had not been designed to be a tool to lower medicines prices 
generally, but rather to help address acute public health crises. 
175. She therefore urged Members to focus their efforts on ensuring that the Paragraph 6 System 
worked as it had been intended to and called on all Me mbers that had not already done so to deposit 
their instruments of acceptance of the Protoc ol Amending the TRIPS Agreement.  Innovative 
financing mechanisms, such as pooled procuremen t and voluntary licensing, should be welcomed.  
Key issues such as the need for prevention strategi es and rational medicine use, the strengthening of 
health systems, and the training of health work ers should also be addressed by WTO Members in the 
WTO and other multilateral fora, such as the WHO, as well as bilaterally. 
176. The representative of China said that public hea lth was a comprehensive issue and intellectual 
property rights were but one element of the framework  that impacted public health.  Given that it was 
difficult for her delegation to conclude that the Pa ragraph 6 System in its present form provided an 
expeditious solution to public health problems, sh e invited the Council to consider whether there was 
room for any improvement that could be made to the System.  Recommendations could also be made 
regarding other factors that could have a role in im proving public health.  Work in the Council would 
benefit from looking at any burdensome elements, clarifying the issues and discussing the legal 
framework as established by the System.   
177. Referring to Bill C-393, which had been introdu ced to the Canadian Parliament and had not 
been pursued because of elections in May 2011, sh e wondered whether the domes tic debate in Canada 
had identified burdensome elements in CAMR, which needed to be improved.  A review of those 
elements by the Council could also serve as an example for its work on the functioning of the 
Paragraph 6 System.  She therefore suggested that the delegation of Canada share further information 
with the Council in that regard.  For example, there was a range of conditions established by CAMR 
which were not required by the Paragraph 6 System, such as the limited list of products to which it 
applied, the two year limit which applied to any compulsory licence granted under CAMR, as well as 
limitations on prices and profit margins for geneti c manufacturers.  Her delegation would like to 
understand whether those elements had been reviewed  in the parliamentary debate in Canada, or 
whether other WTO Members were concerned about  them.  For elements also required by the 
Paragraph 6 System, such as case-by-case decisions on  a country-by-country basis or the need to 
make prior efforts to obtain a voluntary licence firs t, she asked whether they stood in the way of a 
well-functioning mechanism that provided effective and expeditious solutions. 
178. While some of the elements referred to may have  been touched upon, it was possible that they 
had not been thoroughly explored.  As her delegation was not sure wh ether this could be addressed by 
the Council and did also not have any experiences to share in this regard, a dedicated workshop with 
the participation of all stakeholders  could be a useful step to answer  some of the open questions and to 
gather experiences.  This would allow Members to better understand the functioning of the System. 
179. The annual review had already been conducted eight times without reaching a conclusion as 
to whether the System worked well, provided an effective and expeditious solution, or could be 
improved.  Her delegation was open as to how to conduct the review .  If Members agreed that the 
exchange of experiences had been exhausted at thei r level, a dedicated open-ended workshop could be 
conducted in order to better unde rstand the System's functioning and to look at possible 
recommendations to improve it.    IP/C/M/67 
 Page 31 
 
 
  180. The representative of India thanked the delegati on of Canada for its role in initiating the 
implementation of the Paragraph 6 System and s upplying much-needed medicines to Rwanda under 
CAMR.  However, the fact that their actual delivery had taken almost three years was a matter of concern, as was the lack of any information on whet her patients had received the medicines in time.  
His delegation had not obtained convincing replies to  a number of basic questions during the System's 
annual reviews which the Council had conducted for sever al years.  It would be interesting to learn 
more about the debate on Bill C-393 that had taken pl ace in the Canadian parliament, in particular the 
objections that had been raised.  He wondered whet her the Bill would be reintroduced and whether the 
amendments that had been suggested w ould be reflected in the new version. 
181. In response to the questions raised by the dele gations of China and India, the representative of 
Canada said that Bill C-393 had not been put fo rward or supported by her Government.  Since a 
private member had introduced the Bill, it was not po ssible to predict whether there would be another 
initiative of this kind.  Her Govern ment had no intention of amendi ng CAMR.  It had opposed the Bill 
because it was convinced that CAMR worked in its present form, reflecting Canada's commitment to 
improving access to medicines.   
182. Taking up the point made by the delegation of India with respect to the time it had taken for 
the medicines to reach Rwanda, she said that gove rnment action had been expedited and the licence 
had been granted within 15 days.  This indicated that the system had worked and that the delay had 
not been caused by lengthy administrative procedures.  
3. Process of acceptance 
 
183. The representative of New Zealand said that he r Government had deposited its instrument of 
acceptance with the WTO on 21 October 2011.  In 20 08, when the Government had initially agreed to 
the acceptance of the Protocol, it had been made contingent upon the passage of domestic 
implementing legislation.  Provisions that woul d enable New Zealand to become an exporting 
Member under the System had been inserted into th e draft Patent Bill, which currently awaited its 
second reading before Parliament.  Having reached  the understanding that the acceptance of all WTO 
Members' entitlement to use the Paragraph 6 System  was distinct from the domestic implementation 
of the System, her Government had agreed to accept the Protocol in advance of the current deadline 
for acceptance of 31 December 2011.  Her delegation remained fully committed to the principles 
underpinning the Protocol.  By accepting the Protocol, it had committed to accepting that the additional flexibilities for all WTO Members became an  integral part of the TRIPS Agreement.  She 
encouraged other Members to deposit their instrument s of acceptance in order to reach the two-thirds 
majority required to bring the amendment into force. 
184. The representative of Turkey said that her de legation attached great importance to the 
Paragraph 6 System, which provided additional flex ibilities to facilitate access to medicines under the 
TRIPS Agreement.  It supported the entry into fo rce of the Protocol Amending the TRIPS Agreement 
in order to make the System established under the 2003 Decision a permanent part of the TRIPS 
Agreement.  Her delegation had in itiated domestic procedures for the acceptance of the Protocol and 
hoped to finish them as soon as possible. 
185. The representative of Costa Rica said that his country's legislative assembly had approved the 
acceptance of the Protocol Amending the TRIPS Agre ement on 2 October 2011.  The instrument of 
acceptance would be submitted once the re maining formalities were completed. 
186. The representative of Indonesia said his delega tion had submitted its instrument of acceptance 
of the Protocol Amending the TRIPS Agreemen t to the Director-General of the WTO on 
20 October 2011.  With the WTO Ministerial Conference approaching, he invited Members to seize the momentum and submit their acceptances. IP/C/M/67 
Page 32  
 
  187. The representative of the Secretariat updated the Council on the work of the Secretariat in 
supporting Members in the acceptance process.  In view of the interest that had been expressed during 
the System's annual review in the Council's mee ting in October 2010, the Secretariat had provided 
further information in order to help Members draw up their instruments of acceptance of the Protocol, 
based on the discussions that had been  recorded in the minutes of that meeting.  He stated that many 
delegations had sought practical in formation on procedures for the acceptance of the Protocol and that 
similar questions had often arisen in capacity building activities on TRIPS and public health.  The 
Secretariat had therefore developed a webpage which described the acceptance procedure and 
provided a model instrument of acceptance.2   
188. He recalled that a Member could accept the Protocol independent of domestic implementation 
of the Paragraph 6 System as the two actions were clearly distinct. Acceptance of the Protocol was a 
legal act whereby a Member expressed its consent th at all Members were entitled to use the System.  
The process of acceptance needed to follow both the relevant  Member's own constitutional 
requirements, and the content requirements which applied to the instrument of acceptance.  A 
Member that wished to take advantage itself of the additional flexibilities provided in the Protocol 
might need to put in place implementing laws or re gulations through normal domestic legislative and 
regulatory processes.  On the other hand, the a dditional flexibilities under the Paragraph 6 System 
were already available under the waivers that had been provided in the 2003 Decision.  A Member 
could therefore also choose to put in place domes tic implementing legislati on before having deposited 
its instrument of acceptance. 
189. The representative of the Bolivarian Republic of  Venezuela said that accepting the Protocol 
was different from the implementation of the Syst em into domestic legislation, which made the 
introduction of new flexibilities possible.  The fact that his delegation had not yet accepted the 
Protocol reflected a lack of trust in the System , which would persist until further clarification was 
obtained.  The advent of the TRIPS Agreement ha d further complicated access to medicines because 
of the requirement to provide for full patent protecti on in the pharmaceutical sector.  He said that the 
Members who had signed the Protocol were the main  producers of medicines.  While the System had 
been established to address public health problems in an expeditious manner, there was still a need for 
further clarification of issues related to its func tioning and the problems Members were encountering 
in the process of accepting the Protocol.  In support of  the delegation of China, he therefore agreed on 
the importance of having an open-ended workshop,  which would involve all key stakeholders, 
including from civil society and industry.  No convincing argument against holding such a workshop had been brought forward since last year's annual review. 
4. Capacity building on the Paragraph 6 System and related TRIPS flexibilities 
 
190. The representative of the Secretariat provided an  update on technical assistance activities that 
had been undertaken with a bearing on the Paragrap h 6 System and other flexibilities as they related 
to public health.  The implementation, legal a nd policy context, and the acceptance process of the 
Paragraph 6 System had been a major theme of technical assistance activ ities conducted by the 
Secretariat in increasingly close collaboration with sister organizations, in particular the WHO and 
WIPO.   
191. A specific example of this cooperation was the most recent workshop on intellectual property 
and public health held by the Secretariat in co llaboration with WHO and WIPO.  The seventh in its 
series, the workshop had been a specialist progra mme for 23 developing country officials that had 
been convened earlier in the month.  Its focus had be en building the participants' capacity to help their 
countries make use of flexibilities for pharmaceuticals under the TRIPS Agreement.  To this end, the 
workshop had utilized presentations, discussions a nd practical exercises to study the TRIPS 
                                                      
2 Available at:  http://www.w to.org/english/tratop _e/trips_e/accept_e.htm .  IP/C/M/67 
 Page 33 
 
 
  Agreement and the management of intellectual prope rty rights as applied to concrete health-related 
projects.  Participants had been  familiarized with the key con cepts under the TRIPS Agreement and 
other intellectual property instruments, and how th ose provisions, including the Paragraph 6 System, 
could be implemented in national law.  
192. Among other issues covered had been pricing an d procurement policies as a key element in 
securing access to medicines, as well as ensuring th e safety, efficacy and quality of medicines, 
technology transfer and local production, the role  of competition policy, and intellectual property 
rights provisions in regional or bilateral free trad e agreements and their link to public health.   
193. A diverse range of speakers had shared their practical experiences and views on key issues 
directly relevant to public health, including a wi de range of expertise on legal, policy and economic 
issues from WTO, WHO and WIPO, as well as UNCTAD, representatives from some WTO 
Members, including Geneva delegations, the Commissioner of the South African Competition 
Commission, the President of the Ecuadorian Institu te of Intellectual Property, the research based and 
generic industries, Médecins sans Frontières (D octors without Borders), the Global Fund, the 
Medicines for Malaria Venture, and Health Acti on International.  These experts had provided a 
well-rounded view of the issues at the crossroad between intellectual property rights and public 
health.  
194. He said that TRIPS flexibilities in the area of pub lic health had also figured prominently in 
other WTO national and regional technical cooperati on events. In addition, in order to advance 
cooperation between the WTO, WHO and WIPO and to focus on technical cooperation and enhance 
available information materials, a series of policy symposia were being undertaken.  A third in the 
series was expected early next year.  The working ma terials developed in this  programme of trilateral 
cooperation, along the lines of the themes and content of the first trilateral symposium held in 2010, 
were being developed and collate d in the form of a trilateral study prepared as a resource for 
continuing technical cooperation and capacity building.  In addition, as a further tool for technical 
assistance, a set of models for notifications under the Paragraph 6 System had been made available on 
the WTO website.3 
195. The representative of the WIPO Secretariat  recalled that the Development Agenda, agreed 
upon by the Member States of WIPO in 2007, c ontained 45 recommendations to enhance the 
development dimension of the Organization's ac tivities.  Key among tho se were Recommendations 
13, 14, 17, 22 and 25, focused on enhancing th e understanding and use of flexibilities in the 
intellectual property system.  Since its incepti on, the Committee on Development and Intellectual 
Property (CDIP) had met twice each year at WIPO to discuss the planning, implementation and 
mainstreaming of Development Agenda projects within WIPO's work. 
196. As regards the implementation of flexibilities unde r the Development Agenda, he said that at 
the fourth session of the CDIP which had been he ld in November 2009 the Committee had, in the 
context of discussions on Recommendation 14, request ed WIPO to prepare a document on flexibilities 
in the area of patents.  Accordingly, WIPO had prepared a document on Patent-Related Flexibilities in 
the Multilateral Framework and their Legislative Impl ementation at the National and Regional Levels 
(CDIP/5/4 Rev.).  At the Committee's request, WIPO  had subsequently prepared the second part of 
the document on flexibilities in patents (CDIP/7/ 3).  In total, those two documents provided 
information on implementation of ten patent-related flexibilities. 
197. At its fifth session, in April 2010, the Committe e had requested WIPO to prepare a proposed 
future work programme on flexibilities for its consid eration.  At its sixth and seventh sessions, in 
November 2010 and May 2011 respectively, the CDIP had considered a document setting out a future 
                                                      
3 Available at:  http://www.wto.org/english/tratop_e /trips_e/par6_modelnotifs_e.pdf . IP/C/M/67 
Page 34  
 
  work programme on flexibilities at WIPO (CDIP/6/10).  In response to a request made at the seventh 
session, the Secretariat had updated the strategy for implementation of the work programme on flexibilities and revised the annex providing details of  WIPO's activities in this area, addressing work 
in the area of patents, and taking stock of WIPO's activities relating to flexibilities in the IP system 
and technical assistance in the use of flexibilities (CDIP/8/5). 
198. He informed the Council of WIPO's implementa tion of the agreed components of the work 
programme on flexibilities. Information on IP fl exibilities had been incorporated in the WIPO 
technical assistance programme.  The Regional Bur eaus and the concerned sectors had been requested 
to ensure that, at the request of member States, information on flexibilities was appropriately included 
in the provision of technical assistance. 
199. Furthermore, a webpage dedicated to flexibilities in the IP system had been developed and 
published in English, French and Spanish on the WIPO website.
4  As agreed upon by the member 
States, the webpage contained (i) a roadmap pr oviding guidance on WIPO's work on flexibilities in 
the substantive sectors and Committees;  (ii) a da tabase containing provisions on national legislation 
related to flexibilities in the IP system, draw n from the agreed documents on patent-related 
flexibilities in the IP system;  and (iii) links to literature and resources on flexibilities produced by the 
Secretariat and WIPO-commissioned experts, as well as links to resources on flexibilities produced by 
other relevant international orga nizations, such as the WTO, the WHO, the FAO, and UNCTAD.  In 
this respect, WIPO was actively collaborating with ot her international organizations involved in work 
related to flexibilities in order to gather informati on and ensure a coordinate d and effective provision 
of resources on the issue to the Member States.  WI PO had researched and provided links to the work 
of such organizations, and would c ontinue this outreach to ensure the most effective use of resources 
in this area. 
200. In addition, steps had been taken through inte rnal communications and briefings to ensure 
that staff involved in providing technical assistance acr oss the sectors of the Secretariat were aware of 
this strategy on the use of flexibilities in intellectua l property, and continued to integrate appropriate 
techniques for diffusion of information to Member St ates.  Finally, at the request of member States, 
national and regional level seminars  had been organized and were pl anned in future activities with a 
view to exchange practical experiences on the impl ementation of flexibilities.  In this respect, in 
March 2011, a Regional Seminar on the Effective Use of Several Patent-Related Flexibilities had been 
held in Bangkok, Thailand, involving participants  from 16 countries in the Asia and Pacific Region 
for discussions on patent-related flexibilities a nd enabling sharing of experiences on the 
implementation of flexibilities at the national level.   
201. The representative of WIPO said that over time,  the joint participation of WHO, WIPO and 
WTO in a number of activities and their participation as observers in respective meetings of the three 
organizations had contributed to building up a we ll-functioning working relationship among the three 
organizations on issues related to public health, intellectual property and trade.  This working 
relationship, which was supported by WIPO's Deve lopment Agenda Recommendation 40 to intensify 
cooperation on IP-related issues with UN agencies, had matured into the informal and practical 
trilateral cooperation his organization had reporte d in earlier meetings.  One example of this 
cooperation in the current year was the Workshop on Patent Searches and Freedom to Operate, held 
on 17 February 2011, which had introduced participan ts to the basic concepts involved in carrying out 
patent searches and freedom to operate analyses.5  Other collaborative activities included (i) the Joint 
Technical Symposium on Access to Medicines, Patent  Information and Freedom to Operate, held on 
18 February 2011,6 which had addressed the growing importa nce of patent information for public 
                                                      
4 Available at:  http://www.wipo.int/ip-developm ent/en/agenda/flexibilities/ . 
5 http://www.wipo.int/meetings/en/ details.jsp?meeting_id=22342   
6 http://www.wipo.in t//meetings/en/2011/who_ wipo_wto_ip_med_ge_11/    IP/C/M/67 
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  health with respect to freedom to operate strategi es, procurement of medicines, technology transfer 
and setting of research priorities and strategies;  (ii) the WTO Workshop on Intellectual Property and 
Public Health, organized in Geneva by the WTO Secr etariat in collaboration with the Secretariats of 
WHO and WIPO from 10 to 13 October 2011;  and (iii)  work on a trilateral  study on "Promoting 
Access and Medical Innovation:  Intersections Betw een Public Health, Intellectual Property and 
Trade" that would be combining the three Secret ariats' specific expertise in order to support and 
objectively inform technical cooperation and policy discussions.  
202. He said that the agenda of the 16th session of the WIPO Standing Committee on the Law of 
Patents (SCP)7 from 16 to 20 May 2011 had included an agenda item on Patents and Health.  The 
delegation of South Africa had submitted a proposal to the SCP on behalf of the African Group and 
the Development Agenda Group (SCP/16/7).  The WI PO Secretariat, as well as representatives from 
the WHO and the WTO, had briefed the SCP on work being carried out in relation to that agenda 
item.  The topic would remain on the agenda of the 17th session of the SCP.   
203. He also informed the Council that, as of 13 October 2011, the Access to Research for 
Development and Innovation (A RDI) programme of WIPO had become a full member of 
Research4Life.  Research4Life was a public-private partnership between WIPO, WHO, FAO, UNEP, 
the International Association of Scientific, T echnical and Medical Publishers (STM), Cornell 
University, Yale University, and several technical partners, including Microsoft.  The goal of the 
partnership was to enable free or low-cost onlin e access in developing and least developed countries 
to critical scientific research, with ARDI provi ding a particular focus on applied science and 
technology. 
204. He drew the Council's attention to the launc h of "WIPO Re:Search – Sharing Innovation in 
the Fight Against Neglected Tropical Diseases"8 on 26 October 2011.  Through WIPO Re:Search, a 
range of public and private sector institutions ha d come together to increase the availability of 
valuable intellectual property assets to the gl obal research community in order to address the 
challenges represented by neglected tropical diseases, particularly the need for more research.  The 
WHO was supporting this initiative by providing tec hnical advice to WIPO.  WIPO Re:Search was 
founded on the belief that intellectual property and knowledge could be used creatively to stimulate 
greater investment in research and development for new health solutions.  The mechanism worked 
entirely on a voluntary basis for all participating parties, namely providers and users, and had no 
impact on any legal instrument.  WIPO Re:Search allowed public and private sector organizations to 
make valuable intellectual property, including compounds, compound libraries, unpublished scientific 
results, regulatory data and dossiers, screeni ng technologies, platform technologies, know-how 
licenses and patent licences, available to qualified researchers anywhere in the world seeking to 
develop new solutions for neglected tropical diseas es, malaria and tuberculosis.  Licenses for product 
distribution in least developed countries would be royalty-free. 
205. The representative of the WHO Secretariat said that special emphasis had been given in his 
organization's capacity building activities to the im plementation and use of flexibilities in accordance 
with the TRIPS Agreement and the Doha Declarat ion on the TRIPS Agreement and Public Health.  
The aim had been to ensure that public health in terests were adequately taken into account in the 
formulation of national policies and legislation on  trade and intellectual property.  Many of the 
activities, especially in the field of training,  capacity building and technical assistance, thus 
encompassed TRIPS flexibilities.  Support was direct ed towards assisting Member States on how to 
safeguard public health interests while adhering to their obligations under international trade 
agreements.  In particular, this included devel oping public health sensitiv e patent legislation and 
                                                      
7 http://www.wipo.int/meetings/e n/topic.jsp?group_id=61   
8 More information available at: http://www.wipo.int/research/en/ . IP/C/M/67 
Page 36  
 
  incorporating TRIPS flexibilities into domestic legisl ation.  Technical support was carried out in close 
collaboration with WHO country and regional offi ces and relevant intern ational organizations. 
206. Turning to specific activities, he reported that in March 2011, WHO, along with the United 
Nations Development Programme (UNDP) and UNAI DS, had published a policy brief on the use of 
TRIPS flexibilities to improve access  to HIV/AIDS treatment.  The paper reviewed how countries 
could use and had used TRIPS flexibilities in order to increase access to HIV treatment.  To provide 
ministries of health in the Eastern Mediterranean Re gion with a clear analysis of the public health 
implications of provisions included in bilatera l free trade agreements, the WHO Regional Office for 
the Eastern Mediterranean had also published a po licy guide on "Public hea lth related TRIPS-plus 
provisions in bilateral trade agreements". 
207. In 2011, WHO had taught for the first time a module on "Public health and Intellectual 
Property" in the framework of the Master's Degree in Intellectual Property at the Africa University in 
Zimbabwe, jointly organized by WIPO, the Afri can Regional Intellectual Property Organization 
(ARIPO) and Africa University. 
208. He recalled that WHO had provided substantia l support to the organization of the annual 
WTO "Workshop on Intellectual Property and Pub lic Health" that took place in Geneva in 
October 2011.  The workshop had addressed TRIPS pr ovisions and flexibilities of relevance to public 
health as well as other relevant issues ranging from procurement to regulatory questions and prices of 
medicines.  WHO Headquarters and the WHO Eur opean Regional Office had collaborated with WTO 
in the organization of a Regional Workshop for Ce ntral and Eastern European and Central Asian 
Countries on Intellectual Property and Public Policy that  had taken place in Vienna in January 2011.  
WHO Headquarters and regional offices had also continued providing, upon request and in 
collaboration with relevant intern ational organizations, technical and policy support to favour use and 
management of intellectual property in a manne r that maximized health-related innovation and 
promoted access to medical technologies.  
209. The representative of the European Union said that  it had been reported to his delegation that 
the WTO Workshop on Intellectual Property and Publ ic Health had provided informative and helpful 
support to those Members seeking to utilize TRIPS fl exibilities.  Specific presentations on pricing had 
been particularly useful.  They had clarified that  there were many components relevant to the pricing 
of pharmaceuticals in addition to intellectual proper ty.  The inclusion of external speakers with 
various backgrounds had stim ulated an open debate. 
210. The representative of Nigeria recognized the work done to build capacity to use the 
Paragraph 6 System, and asked whether there ex isted a model voluntary licensing agreement that 
could be used to guide developing countries in d ealing with companies to establish or enhance their 
local manufacturing capacity.  
5. Any alternatives to the use of Paragraph 6 System to achieve the objective of access to 
medicines, procurement policies, and other rel ated aspects affecting access to medicines 
raised by Members  
 
211. The representative of the United States said that his delegation strongly supported the 
Paragraph 6 System as established under the 2003 wa iver Decision and the 2005 Protocol Amending 
the TRIPS Agreement in order to allow medicines to be exported under a compulsory license under the terms set out in that decision and the accompanying Chairman's Statement.  His delegation had 
been the first Member to notify its acceptance of  the amendment. Members who had already notified 
their acceptance were developed, developing, a nd least developed countries and that though some 
were pharmaceutical producers, most were not.  He encouraged other Members to notify their acceptance of the amendment so that th e amendment could enter into force.  IP/C/M/67 
 Page 37 
 
 
  212. Although the Paragraph 6 System represented an  important failsafe, it was only one tool for 
addressing the larger issue of access to medicines. In discussions with stakeholders in recent years, his 
delegation had consistently heard that the issue of  access to safe and effective medicines was being 
addressed by a variety of other means.  His Govern ment had also been actively working to address the 
factors that had been shown to reduce access to safe and effective medicines, including tools to deploy 
trade policy to promote trade in, and reduce obstacl es to access, innovative and generic medicines.  It 
had also been supporting the innovation and inte llectual property protection that was vital to 
developing new medicines and achie ving other medical breakthroughs. 
213. Those tools included (i) enhancing legal certain ty for manufacturers of generic medicines;  
(ii) eliminating tariffs on medicines and medical devices, thereby decreasing costs for hospitals, 
clinics, aid organizations and consumers, among othe rs;  (iii) reducing customs obstacles to medicines 
by minimizing import barriers, such as discriminatory, burdensome, and unpredictable customs procedures, that impeded access to innovative and generi c medicines;  (iv) curbing trade in counterfeit 
medicines by making customs and criminal enfor cement measures available to prevent medicines 
bearing counterfeit trademarks from entering nati onal markets, and thus supporting efforts of 
countries to address the serious risks to patients po sed by such counterfeits;  (v) reducing internal 
barriers to distribution of medicines by  guaranteeing importing, exporting, and distribution rights with 
respect to medicines and minimizing internal barri ers that could stand in the way of efficiently 
distributing medicines to those in need;  a nd (vi) minimizing unnecessary regulatory barriers by  
promoting transparent and nondiscriminatory regulatory structures to facilitate the availability of safe 
and efficacious medicines to the public, while also  improving coherence of future rules across the 
region.  He recalled that his delegation had elabor ated those systemic issues in the Council's annual 
review carried out in 2010 (IP/C/M/57, paragraphs 198 to 201).  The list of other tools demonstrated 
that one policy alone could not solve the challenges relating to access to medicines.  Rather, a variety 
of tools, including the Paragraph 6 System, were needed to promote access to medicines. 
214. Regarding the proposal of some Members to hold a workshop which would include 
non-governmental actors, he said that his delegatio n did not support the idea of having the Council 
organize such a seminar.  Members were free to bring into the C ouncil's review of the Paragraph 6 
System perspectives they had gleaned from stakeholde rs, such as companies or civil society.  What 
Members got out of the review was very much a function of what they put into it.  His delegation had hoped that Members would provide information on their experiences as input for the Council's 
discussions of the System's functioning at the current  meeting, but it was disappointed by the details 
of experiences that had been provided.  It coul d be that the Paragraph 6 System had not been 
necessary, and for this reason many Members had not implemented it, or that capital-based experts from health ministries could simply not attend the Council's meeting because of other competing demands.  He reiterated hi s delegation's interest in hearing othe r Members' experiences and views on 
how best to gather additional information. 
215. The representative of Ecuador said that the Syst em was not effective and could be further 
improved. His Government was therefore not ready to proceed with the acceptance of the Protocol. 
His delegation, like other Members, had considered alternatives to the use of the Paragraph 6 System 
by compiling and evaluating other countries' practices  in respect of the implementation of Articles 30, 
31 and 44 TRIPS.  Those practices were of signi ficant importance in enabling Members to take 
informed policy decisions as they strove to transfor m into reality the spirit of the Doha Declaration on 
the primacy and safeguarding of public health and the promotion of access to medicines. 
216. In that context, he requested that the Eur opean Union provide clarification on the Italian 
Competition Authority's granting of three compulsory licences between 2005 and 2007, which seemed to have occurred under Article 31(k) of th e TRIPS Agreement.  Under that provision, the 
conditions established in Article 31(f) could be waived if a licence was granted to remedy a practice 
determined after judicial or administrative process to be anti-competitive. IP/C/M/67 
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  217. In the first case, the Italian Competition Au thority had launched an  investigation in 
February 2005 regarding the abuse of dominant pos ition by Merck for its refusal to grant licensing 
rights in respect of the patent-protected active ingr edients, which were used  to produce the antibiotic 
Imipenem Cilastatin.  On 21 June 2005, the Ita lian Competition Authority had granted a compulsory 
licence on the relevant patents for the active ingredie nts needed for the manufacture of the antibiotic 
concerned.  The product had been patented only in  Italy and not in other European countries.  The 
Italian generics industry had sought a licence to produ ce and market the product in the rest of Europe 
(not for the Italian market), where this product had not been protected. 
218. The second case concerned a decision by the Italian Competition Authority of 
8 February 2006 to grant a compulsory licence for the manufacture in Italy of the patent-protected 
active ingredient Sumatriptan Succinate needed to produce medicines to treat migraine.  The licence 
had been requested by the chemical company Fabbrica Italiana Sintetici SpA  (FIS), following GSK's 
refusal to negotiate a voluntary licence.  Initially, FIS had used the compulsory licence primarily for 
the purpose of supplying the export market by se lling its product to generic companies, which 
marketed it in other countries such as Spain, where th e relevant patent had e xpired.  This had been 
done outside the Paragraph 6 System, from which th e EU and its member States had opted out of as 
beneficiaries. 
219. The third case related to the Italian Competiti on Authority call upon Me rck on 21 March 2007 
to "grant free licences to allow the manufacture and sale in Italy of the active ingredient Finasteride 
and related generic drugs two years before th e 2009 expiration of the Supplementary Protection 
Certificate".  Finasteride was the active ingredient of a drug initially marketed under the brand names 
Proscar and Propecia.  It was used to treat prosta tic hypertrophy, prostate cancer and male pattern 
baldness.  The royalty-free compulsory licences is sued by the Italian Competition Authority had 
remedied Merck's refusal to license its patents to local manufacturers of pharmaceutical active ingredients.  Those licences had once again involved exports to other European countries. 
220. He asked the delegation of the European Union to provide the Council with further 
information on these three compulsory licences including, but not limited to, administrative 
procedures, decision-making processes and the legal a nd factual basis for the grant of the licences.  
He also requested that the European Union pr ovide examples of other uses under Article 31(k) 
relating to the export of medical technologies. 
221. The representative of India said that the issue of Members' experiences using alternatives to 
the Paragraph 6 System to achieve the objective of  access to medicines had been raised and discussed 
for several years, but Members were still short of inputs.  He therefore reiterated his delegation's 
demand for a dedicated workshop that would, as the delegation of Ecuador  had mentioned, help 
strengthen the Paragraph 6 System and where Memb ers would have an opportunity to discuss other 
experiences.  The workshop would also help those delegations develop faith in the System who had 
cited a lack of faith as the reason for not accepting the Protocol Amending the TRIPS Agreement.   
222. Turning to the role of compulsory licensing to  provide access to medicines, he recalled that 
Articles 30 and 31 of the TRIPS Agreement provided a mechanism to that extent.  Article 30 was a 
substantive exception which detailed three criteria to  be met for any exception to apply to exclusive 
patent rights.  Article 31, in contrast, was pr imarily procedural in nature, detailing a list of 
requirements that applied to other uses without au thorization by the patent right holder.  Both 
provisions taken together defined the scope of lim itations to exclusive patent rights available under 
the TRIPS Agreement.  Additionally, Article 44 ou tlined flexibilities with respect to the right to 
provide permanent injunctions.  
223. He drew Members' attention to two particular cases in the Un ited States.  Shedding light on 
those cases could help address the problem of provi ding access to medicines without recurring to the  IP/C/M/67 
 Page 39 
 
 
  complicated Paragraph 6 System.  In eBay v. Me rcExchange, the US Supreme Court had determined 
that the plaintiff in infringement cases had to satis fy a four-factor test before a court could issue a 
permanent injunction.  This four-factor test incl uded demonstration of the following elements by the 
plaintiff, i.e. that:  (i) he had suffered full and irrepa rable injury;  (ii) remedies  available at law such as 
monetary damages were inadequate to compensate fo r that injury;  (iii) considering the balance of 
hardships between the plaintiff and defendant, a reme dy in equity was warranted;  and (iv) public 
interest would not be disserved by a permanent injunc tion.  In Edwards Lifesciences v. CoreValve, a 
compulsory licence had been granted for manufacturing a medical device in the United States exclusively for exportation.  He requested that the United States and other countries where similar 
judgments had occurred explain to Members why the restrictions on exports under compulsory 
licences as established by Article 31 of the TRI PS Agreement did not apply in those cases.   
224. The representative of Switzerland referred to hi s delegation's intervention at the last annual 
review, which was recorded in paragraph 175 of th e Council minutes (IP/C/M/64).  In response to the 
question from the delegation of Ecuador on prog rammes put in place by his Government to address 
public health problems in developing countries, he not ed that his delegation was active in many such 
programmes.  Public health was one of the focus poi nts of its development work at both the bilateral 
and multilateral levels.  As regard s programmes specifically linked to intellectual property, he referred 
to the reports that his delegation had submitted on technical cooperation, as well as on the obligation 
under Article 66.2 to provide incentives to transfer technology to least developed country Members.  
The 2011 report provided more details, in particular  in paragraphs 28, 29 and 34 (IP/C/W/558/Add.5).  
Regarding programmes with a particular focus on de velopment and health, but not specifically linked 
to intellectual property, more information could be accessed on the website of the Swiss Federal 
Agency for Development and Cooperation.9 
225. With respect to any alternativ es to the use of the Paragraph 6 System, he referred to his 
delegation's intervention at last year's annual revi ew (IP/C/M/64, paragraphs 285 to 287).  Turning to 
the proposal for an open-ended workshop to be held to gather information on the functioning of the 
System, which had been made by some delegations who considered that the exchange of experiences 
among Members had been exhausted,  he maintained his delegation's view that holding such a 
workshop at this stage was premature.  So far, it had not heard much from countries that were 
potential beneficiaries under the Paragraph 6 System.  Most countries that had intervened were either 
potential exporting countries or countries with manufacturing capacity.  However, those were not the countries that WTO Members had had in mind when  devising the Paragraph 6 System.  While his 
delegation was not in principle against the idea of holding a workshop, it was important to first 
establish within the Council the problems that potenti al beneficiaries had encountered, as well as their 
concerns with respect to the Paragraph 6 System.  Before having heard thos e concerns, it would be 
difficult to even decide who should be invited to such a workshop and what specific problems should 
be highlighted and discussed.   
226. The representative of Japan recalled that the Paragraph 6 System aimed at enhancing access 
to medicines in Members with insufficient or  no manufacturing capacities in the pharmaceutical 
sector. He noted that according to the information th at had been provided at the trilateral Symposium 
on "Access to Medicines: Pricing and Procurement practices" that had been organized by the WHO, WIPO and WTO in July 2010, only 5 per cent of the medicines on the WHO list of essential 
medicines were protected by patents.  Therefore, the Paragraph 6 System was only one of many tools 
to address public health problems.   Other important elements included the procurement of medicines 
and tariffs.  
227. The specific concerns of potential importing Memb ers were indispensable parts of the review. 
Those Members were best qualified to share thei r experiences with the Council regarding specific 
                                                      
9 http://www.deza.admin.ch/en/home/themes/health  IP/C/M/67 
Page 40  
 
  obstacles or concerns faced, but only a few Me mbers had done so.  Until discussions within the 
Council were completed, it would be premature to  hold a workshop on the Paragraph 6 System.  
228. The representative of Cuba shared the con cerns expressed by other delegations on the 
implementation of the Paragraph 6 System.  As regards the acceptance of the Protocol Amending the 
TRIPS Agreement, she noted that it was the respons ibility of Members to create suitable rules that 
provided a lasting solution and did not  require frequent revision. In that context, it was important that 
further discussions be held in the Council before  Members rushed to accept the Protocol.  Those 
should aim at clarifying any doubts about the Sy stem's functioning, and address the reasons why it 
had been rarely used.  To this end, the organiza tion of a workshop would be desirable in order to 
provide greater clarity on the effectiveness of the implementation and operation of the System. 
229. The representative of the European Union said that access to essential medicines for 
developing countries was of utmost importance to his delegation.  This explained why it had taken an 
active part in the negotiations that had led to the 2003 waiver decision and to the TRIPS amendment. 
Subsequently, it had taken the necessary steps to impl ement the Paragraph 6 System at the EU level 
and to accept the amendment.  He st ressed the need to make the Syst em work, as well as the fact that 
his delegation was committed to do so.  Rather than  reopening a debate on the System as a whole, it 
was important to have a focused discussion within the framework of the Council's annual review.  To 
that extent, the list of issues for discussion which th e Chairman had circulated was helpful.  However, 
his delegation was disappointed about the debate, as it had hoped to learn more about the reasons why 
the developing countries for whom the System had been designed, apart from Rwanda, had not used 
it.  He disagreed with those Members that claimed that the operation of the System would be hindered 
by legal, procedural, commercial and other obstacl es.  There were few conditions required for the 
System to work properly. 
230. Several reasons could explain why the System ha d not been used more often.  These included 
the fact that 90 per cent of essential medicines were in the public domain.  Least developed countries 
were also not obliged to implement any TRIPS oblig ations with respect to patents and test data 
protection in the area of pharmaceuticals until 1 Janua ry 2016.  Moreover, ther e were other channels 
developing countries could use to get access to chea p medicines, including, for instance, through the 
use of existing TRIPS flexibilities and direct negotiation with pharmaceutical companies.  The Paragraph 6 System was equally effective when it w as used as when it was not used due to its effect 
as both a negotiating chip and a strong deterrent.  It  would be interesting to hear more about the 
System's impact on negotiations and on pricing since it had been put in place.   
231. In his delegation's view, those who criticized the System as being too burdensome without 
real life experience of the matter were discourag ing developing countries from using an instrument 
which could help them secure access to affordable medicines.  Positions taken by some countries like 
Ecuador who had said that they would not accept the System were unfair, since those countries had domestic manufacturing capacities that other countries that really needed the System lacked. 
232. In response to the questions which the delegati on of Ecuador had addressed to his delegation, 
he said that it was not clear whether those were mean t to demonstrate how the System had been put in 
place or whether they were addressing an unrelated matter, such as the use of compulsory licences 
under normal circumstances.  He clarified that, in any event, European countries were not using the 
System as importers.  Addressing those issues would require some research, but his delegation would be prepared to do so under the relevant agenda item. 
233. As regards the two judicial decisions referred to  by the delegation of India, the representative 
of the United States clarified that those decisions had specifically addressed procedural aspects of the 
provision on injunctive relief.  The findings in those cases were therefore limited and the analysis  IP/C/M/67 
 Page 41 
 
 
  which the delegation of India had made of them wa s not necessarily within the scope of the matters 
before the courts.  
234. Noting his country's experience regarding the import of generic medicines under the 
Paragraph 6 System, the representative of Rwanda  supported the permanent incorporation of the 
System through the proposed amendment to the TRIPS Agreement.  He informed the Council that his 
Government would ratify the Protocol Amending th e TRIPS Agreement no later than by the extended 
deadline for acceptance. 
235. Taking note of the response given by the delega tion of the European Union, the representative 
of Ecuador further clarified the issues he had raised  in his earlier statement.  The Paragraph 6 System 
constituted one of the mechanisms  to waive the otherwise appli cable condition under Article 31(f) 
TRIPS and to issue compulsory licences for export pu rposes.  Other provisions that could also assist 
Members who faced difficulties with the restric tive condition established by Article 31(f) included 
Article 31(k) which permitted unauthorized usage to remedy a practice determined after a judicial or 
administrative process to be anti-competitive.  In th e three cases he had referred to before, compulsory 
licences had been granted under Article 31(k).  Hi s delegation would welcome learning more about 
such practice, which seemed to represent a valid and useful alternative to overcome problems posed 
by the implementation of Article 31(f). 
6. Next steps and recommendations 
 
236. The Chairman said that the discussion of this topic should provide the Council with an 
opportunity to discuss whether there was a need for a follow-up to the annual review, and, if so, what 
it should be.  
237. The representative of the Bolivarian Republic of Venezuela noted that many Members who 
had intervened on the issue were developed countr ies who had stated that there was no need to re-
open the discussion on the System's functioning.  Hi s delegation's concern was that Members who had 
not yet accepted the Paragraph 6 System and thus could not share their experiences were reluctant to speak on the issue.  The fact that they had not im plemented the System combined with their silence 
indicated the existence of unaddressed concer ns and the need for greater clarity.  
238. The representative of Turkey said that, in the interest of understanding the Paragraph 6 
System well, holding a workshop open to all stak eholders could provide a good opportunity to 
introduce it to potential users.  Such a forum w ould allow the civil society, the pharmaceutical 
industry, exporting Members and least developed count ry Members to share their views, experiences, 
and questions on the implementation of the System.  
239. The representative of China said that the Counc il needed to make a decision regarding the 
follow-up to the eighth annual review.  There app eared to be a lack of consensus among Members on 
whether the legal procedures or commercial stake holders prevented developing countries from using 
the Paragraph 6 System.  Her delegation therefore strongly supported that an open-ended workshop 
for all stakeholders be  held. It would help achieve greater transparency, promote a holistic 
understanding, and perhaps a solution to the current deadlock.  
240. The representative of Canada supported the dele gations of Switzerland and Japan in that it 
would be useful to hear more specific views a nd experiences from potential beneficiaries regarding 
any obstacles posed by the System.  It was not clear what could be gained from an open-ended workshop that could not be gained through discussi ons in the Council. Delegations could gather 
information from stakeholders and share it with the Council.  IP/C/M/67 
Page 42  
 
  241. The representative of the European Union said th at his delegation shared the views expressed 
by the delegations of Canada, the US, Japan, and Switzerland.  Experiences with the System heard so 
far either indicated that the System had worked, th at it had had some impact even when it had not 
been used in the end, or that it had been a usef ul negotiating chip.  Holding an open-ended workshop 
would therefore be premature and unnecessary. 
242. The Chairman suggested that he consult on next steps, including the issue of a possible 
workshop. 
243. The Council took note of the statements made and so agreed. 
244. Turning to the draft report to the General C ouncil on the annual review  of the Paragraph 6 
System, the Chairman recalled that the Secretariat had circulated a draft cover note for the Council's 
report modelled on previous years' reports (JOB/I P/4).  It contained factual information on the 
implementation and use of the System establishe d under the Decision, discussions regarding its 
operation, and the status of acceptances of the Protocol Amending the TRIPS Agreement.  In accordance with the way that  the Council had prepared its reports in the previous years, the portion of 
the minutes of the meeting that reflected the discu ssions held under the specific agenda item could be 
attached to the cover note. 
245. As regards paragraph 15 of the report, he r ecalled that Argentina, Indonesia and New Zealand 
had recently accepted the Protocol.  There was also a minor error in the paragraph, namely that 
Uganda should have been included in the list of Members that had notified their acceptance.  This 
paragraph would be updated and corrected accordingly.  
246. The Protocol had originally been open fo r acceptance by Members until 1 December 2007. 
Upon proposals by the TRIPS Council, the General C ouncil had twice extended that period for further 
two-year periods.  The period for acceptance was currently due to expire on 31 December 2011.  
Given the proximity of that date, the Chairman s uggested that the Council consider again submitting a 
proposal to the General Council for a decision to ex tend the period for the acceptance of the Protocol.  
For that purpose, a draft decision that could be  submitted to the General Council for adoption was 
included in Annex 2 to the draft report.  It did not yet contain a new deadline for the extended period 
for acceptances.  In the light of the consultations he  had held on this matter, he suggested that the 
Council propose to extend the period by a further two years until 31 December 2013. 
247. The representative of Turkey supported the appro ach suggested by the Chairman.  This would 
also provide her delegation with additional time to complete its internal procedures.  
248. The Chairman proposed that the Council agr ee on forwarding to the General Council the 
proposal for a decision to extend the period of accep tance by Members of the Protocol Amending the 
TRIPS Agreement until 31 December 2013.  He suggested  that the last paragraph of the draft decision 
by the General Council contained in Annex 2 to th e draft report (JOB/IP/4) be complemented by 
inserting this date.  He also proposed that the C ouncil agree to the cover note to the report contained 
in JOB/IP/4, and also that the Council minutes contai ning the record of the discussion be attached to 
it. 
249. The Council took note of the statements made and so agreed. 
H. NON-VIOLATION AND SITUATION COMPLAINTS  
250. The Chairman recalled that, at the Seventh Session of the Ministerial Conference, Ministers 
had directed the TRIPS Council 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  IP/C/M/67 
 Page 43 
 
 
  GATT 1994 and to make recommendations to their next Session.  It was agreed that, in the meantime, 
Members would not initiate such complaints under the TRIPS Agreement.  The eighth Ministerial 
Conference was to be held in Geneva on 15-17 December 2011.  
251. He further recalled that, at the Council's meeti ng in June, he had indicated his intention to 
hold consultations on the issue with a view to en abling the Council to agree on its recommendation to 
the Ministerial Conference at the present meeting.  While most delegations th at he had consulted had 
indicated that their preference remained to determin e non-violation complaints inapplicable to TRIPS, 
they had nonetheless been willing to compromise by agreeing to recommend the extension of the 
moratorium until the next Ministerial Conference.  In particular, it had been suggested that the 
language should follow as closely as possible the langua ge used by Ministers in their Decision of 
2 December 2009 on "TRIPS Non-Violation and Situa tion Complaints".  A few delegations had said 
that their view continued to be that the non-viola tion moratorium should expire.  However, they had 
shown flexibility in being ready to engage with a view to reaching a decision. 
252. The representative of the United States said that he looked forward to e ngaging constructively 
with the Chair and other Members on the issue.  His delegation maintained that non-violation 
complaints were fully appropriate in the contex t of the TRIPS Agreement.  The possibility of 
non-violation disputes had been part of the GATT dis pute settlement system since the beginning.  The 
TRIPS Agreement had been carefully negotiate d to accommodate different legal regimes and 
Members' needs to achieve policy objectives.  Th e availability of non-violation complaints would 
merely assist Members in their efforts to preserve the balance of concessions and to protect against 
measures that frustrated legitimate expectations.  A failure to allow for the possibility of non-violation 
disputes in connection with the TRIPS Agreement could invite Members to seek creative ways to 
avoid their TRIPS obligations.  His delegation thus continued to be of the view that it was entirely 
appropriate for non-violation and situation complaints  to be applicable to the TRIPS Agreement and, 
further, that the moratorium should expire at the next Ministerial conference. 
253. The representative of Nigeria, speaking on behalf of the African Group, said that non-
violation and situation complaints  should not apply to the TRIPS Agreement.  The Agreement was not 
designed to protect market access or balance of concessions, but rather served to establish minimum 
standards of intellectual property rights.  Arti cle 3.2 of the Dispute Settlement Understanding 
provided that both panels and the A ppellate Body must be guided by the rules of treaty interpretation 
as set out in the Vienna Convention, and that th e recommendations and rulings of the DSB could not 
add or diminish the rights and obligations provide d in the WTO Agreement.  As the Council had not 
reached agreement on the scope and modalities of th e non-violation complaints, the issue at present 
was whether the moratorium should expire.  If so, it mi ght be left to panels and the Appellate Body to 
consider the application of Article 3.2 of the DS U.  A pragmatic way to move the process forward 
would be to extend the moratorium.  In the absence of any consensus, he en couraged the Chair to 
continue with his consultations with a view to arriving at a decision.  
254. The representative of India said that the Doha Decision on Implementation-Related Issues had 
underlined the importance of the on-going examinat ion mandated under Article 64.3.  His view was 
that, unless and until the scope and modalities of non-violation and situa tion complaints were 
finalized, the moratorium should be extended. 
255. The representative of Pakistan thanked the Chai r for his continued efforts and expressed his 
appreciation for the flexibility that the delegation of  the United States had demonstrated in relation to 
this issue.  He expressed the hope that a solution might be found by the Ministerial Conference in 
December.   
256. He asked those delegations that deemed that non-violation complaints were appropriate to 
clarify, first, how they would quantify the expect ed or accrued benefits to the rights holder;  and IP/C/M/67 
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  secondly, how they would hold the State responsible fo r non-violations.  The nature of IP transactions 
was different from goods:  with regard to IP transactions most of the rights and use or misuse of rights were between private parties without essentially involv ing a filter or a control by the State.  On the 
other hand, in the case of goods one might have bor der measures, or other fiscal and other measures to 
address those concerns.  However, in the context of  IP and especially in the light of technological 
advancements, it would be difficult to ask the State to  have an enforcement role.  So in that sense, 
would the State be held responsible for actions that  were beyond the State's legal or jurisdictional 
systems;  if something was not working due to the lack of the capabilities or capacity, would that 
constitute a situation of non-violation?   
257. Only a few cases of non-violation and situa tion complaints had been brought under the 
dispute settlement system.  In services there ha d only been one complaint, in which case the 
complainant had failed to prove that there was non-vi olation or denial of the benefits due to non-
violation.  In the context of IP it would be even mo re difficult to prove.  Therefore, it might be useful 
to have at some stage a real s ubstantive debate to unde rstand whether non-violati on was practicable or 
not.  Considering that the Ministerial Conference w ould take place shortly, it would be advisable to 
extend the moratorium so as to allow the Council to establish how better to deal with those questions. 
258. The representative of South Africa, supporting th e statement by the delegation of Nigeria, 
said that the issue had been on the Council's agenda since the Ministerial Conference in Hong Kong.  
He recognized that Members clearly had diffe rent views concerning the application of 
subparagraphs 1(a) and 1(b) of  Article XXIII of GATT 1994 under the TRIPS Agreement.  As a 
Member of the WTO, South Africa was fully committed to upholding its obligations and 
commitments as set out in the various agreements of the WTO, including the TRIPS Agreement.  The 
purpose and aim of Article XXIII subparagraphs  1(a) and (b) of GATT 1994 was to ensure 
compliance with GATT rules and principles by providing Members with an opportunity to make representation under the situa tion provided for in subparag raphs 1(a) and (b).   
259. On the other hand, TRIPS was a sui generis agreem ent.  It was not aimed at promoting market 
access or harmonizing the standards of Member States with regard to the protection and enforcement 
of intellectual property rights.  It provided for minimum standards for the protection and enforcement 
of intellectual property rights.  The insertion of Article XXIII subparagra phs 1(a) and 1(b) of 
GATT 1994 under the TRIPS Agreement would undermin e the sovereign rights of the respective 
Members in putting into place laws for the prot ection of intellectual property within their 
jurisdictions.  Furthermore, such an insertion woul d restrict the flexibilities provided to Members and 
defeat the balance that had been maintained under the TRIPS Agreement.  While recognizing the need 
for the protection and enforcement of intellectual prope rty rights, he considered that the insertion of 
non-violation and situation complaints would be impractical under the TRIPS Agreement. 
260. The representative of Brazil said that the application of non-viol ation and situation complaints 
to the TRIPS Agreement was a matter of concern to  Brazil.  Unlike the other WTO Agreements, the 
TRIPS Agreement was sui generis:  it was not designed to protect market access or the balance of 
tariff concessions, but rather it served to establish minimum standards of IP protection.  Hence he 
considered that the application of non-violation and situation complaints under the TRIPS Agreement 
was not appropriate and could be problematic.  For instance, it could prevent developing countries 
from successfully using the flexibilities contained in  the Agreement, including those related to the 
protection of public health.  The extension of the non-violation remedy to the TRIPS Agreement 
might also entail consequences for the predictabilit y and security of the multilateral trading system.  
The uncertainties surrounding the remedy would make it harder for countries to rely on the text of the Agreement to define their rights and obligations.  Moreover, it might give rise to incoherence among 
the WTO Agreements.  Furthermore, such uncerta inty was likely to increase further public concern 
over the impact of the TRIPS Agreement on importa nt issues, such as public health, biodiversity 
protection and transfer of technology.  For that r eason, his position was in line with that of other  IP/C/M/67 
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  Members who had suggested that, until they had fou nd a definite solution, the moratorium should be 
extended for another two years.   
261. The representative of China, associating her de legation with the positions of the African 
Group as articulated by the delegation of Nigeria and of India, South Africa and Brazil, said that the 
nature and structure of the TRIPS Agreement di ffered from GATT 1994.  China therefore considered 
that the application of non-violation and situa tion complaints to the TRIPS Agreement was highly 
inappropriate and problematic and, moreover, su sceptible to fundamental concerns among Members 
of the WTO.  However, in a spirit of flexib ility and aiming at a successful conclusion of the 
Ministerial Conference at the end of the year, she suggested that Ministers at the Eighth Ministerial 
Conference agree to a further extension of the mo ratorium on non-violation and situation complaints 
under the TRIPS Agreement, at least until the next Ministerial Conference in 2013. 
262. The representative of the Bolivarian Republic of Venezuela said that non-violation and 
situation complaints should not be applicable to the TRIPS Agreement.  For the time being there 
appeared to be little likelihood of achieving a resolution of the issue.  Therefore, he was willing to be 
flexible with regard to the extension of the moratorium until the next Ministerial Conference. 
263. The representative of Angola, speaking on behalf of the LDC Group, supported the statement 
by Nigeria that had articulated the position of the African Group, and thanked the Chair for his efforts 
to achieve a compromise solution according to which the moratorium would either expire or be further extended.  Noting that the Chair had b ased his evaluation on what he had heard from the 
majority of Members, he said that the Chair s hould consider suggesting that the moratorium be 
extended for another two years until the Ministerial Conference in 2013. 
264. The representative of Ecuador believed that the view that non-violation and situation 
complaints should not be applicable to the TRIP S Agreement had merit.  However, in order to 
facilitate the Council's work, he recommended a tem porary solution for the Ministerial Conference, 
which would ensure minimum legal certainty in the field of IPRs.  His delegation shared the 
willingness expressed by various other dele gations to extend the moratorium. 
265. The representative of Colombia said that a tran sparent, predictable and equitable mechanism 
for settling trade-related disputes in the context of IP  was of crucial importance.  However, the TRIPS 
Agreement, unlike other WTO Agreements, provide d for minimum standards of IPR protection.  
Non-violation and situation comp laints were unnecessary to protect the balance of rights and 
obligations inherent in the TRI PS Agreement, which were reflected  in the Agreement's principal 
obligations and flexibilities.  The Agreement explicitl y stated that WTO Members were not obliged to 
implement more extensive protection.   He reiterated his delegation's view that the moratorium should 
be extended.  Accordingly, he expressed his de legation's readiness to work towards a satisfactory 
solution in the short term with a view to reachin g an agreement to extend the moratorium at the 
Ministerial Conference in December. 
266. The representative of Peru, endorsing the statements  by the delegations of Pakistan, Nigeria, 
South Africa, Brazil and others, recalled that  in 2002 his delegation had presented a document 
IP/C/385 jointly with 14 other de legations outlining its position on the matter.  Non-violation and 
situation complaints were unnecessary to protect the balance of obligations inherent to the TRIPS 
Agreement.  Those were already reflected in the ma in obligations and flexibilities of the Agreement.  
The Agreement specifically provided  that Members were not obliged to apply broader protection.  
Peru thus considered that non violation and situa tion complaints were inapplicable under the TRIPS 
Agreement.  However, in a spirit of compromise, hi s delegation was in favour of an extension of the 
moratorium from the upcoming Ministerial Conference until the next. IP/C/M/67 
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  267. The representative of the European Union said that his delegation's view was that non-
violation and situation complaints  were not applicable to the TRIPS Agreement.  However, it was 
willing to go along with the growing consensu s on an extension of the moratorium.  
268. The representative of Cuba stressed that, since it had been shown that there was no consensus 
on the expiry of the moratorium, there was no choice other than extending it.  The grounds for 
disputes under subparagraphs 1(b) a nd 1(c) of Article XXIII of the GATT 1994 did not apply to IP.  
The moratorium which prevented their application shoul d remain in force.  However, he also referred 
to the existing consensus of unlinking the obliga tion of that article to the TRIPS Agreement. 
269. The representative of Chile said that, sin ce the Council was unable to overcome their 
substantive differences concerning non-violation an d situation complaints, he supported the renewal 
of the moratorium for a two-year period until the following Ministerial Conference.  
270. The representative of Switzerland said that his delegation's view on the application of non-
violation complaints under the TRIPS Agreement was well known, and re ferred delegations for 
details to statements made by his delegation under that agenda item in previous meetings of the 
TRIPS Council.  Both from a systemic and a legal point of view, Article 64.2 and 64.3 of the TRIPS 
Agreement was clear and unambiguous with regard to the principle that non-violation complaints 
were applicable under the TRIPS Agreement once the moratorium expired.  Broadly speaking, the 
TRIPS Agreement was part of an overall WTO regulatory framework for market access.  His 
delegation considered that the Dispute Settlement  Understanding provided su fficient guidance with 
regard to non-violation and situati on complaints in the TRIPS context.  The moratorium provided for 
under Article 64 allowed for an examination of the scope and modalities of such complaints in the 
TRIPS context.  However, since the moratorium  had been further extended, no proposals or 
submissions had been received by the Council on the issue of such scope and modalities.  
Accordingly, his delegation was of the opinion that  the moratorium should expire at the forthcoming 
session of the Ministerial Conference in Geneva.  He said that his delegation took a constructive 
approach to the Chair's continuing his consulta tion on the way forward and thanked him for his 
efforts. 
271. The Chairman proposed that the Council agree to  keep this agenda item open and that he 
continue his consultations.  He sai d that he hoped to be able to re convene the Council once the further 
work was sufficiently mature, with a view to  the Council agreeing on a recommendation to the 
Ministerial Conference. 
272. The Council took note of the statements made and agreed to proceed as suggested by the 
Chair. 
273. The Council reconvened on 17 November.  In view of the absence from Geneva of the Chair 
of the Council, Ambassador González (Paraguay) , the Council elected Mr. Martin Glass (Hong Kong, 
China) as an interim Chair for the reconvened meeting. 
274. The Chairman recalled that, at its meeting of 24-25 October 2011, the Council had agreed to 
keep open the agenda item on non-vi olation and situation complaints and that the Chair continue his 
consultations on the matter.  In the light of the consultations Ambassador González and he had held 
on the matter, he suggested that the Council agr ee to recommend, pursuant to the 2009 Ministerial 
Decision on "TRIPS Non-Violation and Situation Co mplaints" (WT/L/783), that the Eighth Session of 
the Ministerial Conference decide as follows: 
"We take note of the work done by th e Council for Trade-Related Aspects of 
Intellectual Property Rights pursuant to our Decision of 2 December 2009 on 'TRIPS 
Non-Violation and Situation Complaints' (W T/L/783), and direct it to continue its  IP/C/M/67 
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  examination of the scope and modalities for complaints of the types provided for 
under subparagraphs 1(b) and 1(c) of  Article XXIII of GATT 1994 and make 
recommendations to our next Session, which we  have decided to hold in 2013.  It is 
agreed that, in the meantime,  Members will not initiate such complaints under the 
TRIPS Agreement." 
275. The representative of the United States said th at the US position on this issue was well 
known.  Her delegation believed that non-violation and situation compla ints were fully appropriate in 
the context of TRIPS Agreement and that a consen sus decision of the TRIPS Council was required to 
extend the moratorium on the use of such compla ints, which was set to expire at the upcoming 
Ministerial Conference.  The possibility of non-viol ation disputes had been part of the GATT dispute 
settlement system since the beginning.  The TR IPS Agreement had been carefully negotiated to 
accommodate different legal regimes and to acc ommodate Members' need to achieve policy 
objectives.  The availability of non-violation compla ints would merely assist Members in their efforts 
to preserve the balance of concessions and to pr otect against measures that frustrate legitimate 
expectations.   
276. As her delegation had noted in the past, the fa ilure to allow the possibility of non-violation 
disputes in connection with the TRIPS Agreements could invite Members to seek creative ways to 
avoid their TRIPS obligations.  It continued to be  of the view that it was entirely appropriate for 
non-violation and situation complaints to be applic able to the TRIPS Agreement and further, that 
without a consensus decision of the TRIPS Council,  the moratorium would expire at the upcoming 
Ministerial Conference.  However, her delegation was prepared to join consensus at the present 
meeting and could agree to extend the moratorium  on non-violation and situation complaints until 
MC9.  Of course, its decision at the present meeting was without prejudice to its continued position that non-violation and situation co mplaints were fully appropriate  in the context of the TRIPS 
Agreement. 
277. The representative of Switzerland said that hi s delegation's position on the matter was well 
known.  It was particularly for systemic reasons that it was of the opinion that non-violation and 
situation complaints should appl y to all WTO Agreements and therefore also to the TRIPS 
Agreement.  However, it was prepared to join th e consensus and was ready to have the moratorium 
extended until the ninth Ministerial Conference. 
278. The Council agreed on the recommendation as proposed by the Chair.   
I. REVIEW OF THE IMPLEMENTATION OF THE TRIPS  AGREEMENT UNDER ARTICLE  71.1 
279. No statements were made  under this agenda item. 
280. The Council agreed to revert to the matter at its next meeting.  
J. REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON GEOGRAPHICAL 
INDICATIONS UNDER ARTICLE 24.2 
281. 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.  The principal tool used to 
coordinate the review process had been a Checklist of Questions contained in document IP/C/13 and 
Add.1, which a number of Members had submitte d, but many had so far not completed. 
282. In addition, at its meeting in March 2010, th e Council had agreed to encourage Members to 
share information on and notify to the Council bila teral agreements related to the protection of 
geographical indications, which they have entered into.  This had already produced some useful and IP/C/M/67 
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  informative material.  Peru and Korea had provide d information on various bilateral agreements 
(documents IP/C/W/547 and IP/C/W/547/Add.1, respectively).  At the Council's meeting in June 2010, Peru and Korea had pr ovided additional information on b ilateral agreements that were 
under negotiation and which had not ye t entered into force.  The United States had indicated that it 
was party to a number of bilateral and regional free trade agreements with provisions that addressed 
GIs and trademarks, and that these were available from the USTR's website.  Brazil and Croatia 
informed the Council that they had not yet conc luded any bilateral agreements on geographical 
indications. 
283. At the Council's meeting in October 2010, the European Union informed the Council that it 
was party to a number of bilateral and regional free trade agreements with provisions that addressed 
the protection of geographical indications and that those agreements could be found on the website of 
the Directorate-General for Agriculture of the Eu ropean Commission.  China also informed the 
Council of two FTAs which contained a chapter on geographical indications, one of which had 
already been notified by Peru in document IP/C/W /547.  The other FTA could be found on China's 
portal for FTAs at http://fta.mofcom.gov.cn , which contained English la nguage versions of FTAs. 
284. In line with the Council's recommendation made in March 2010, the Chair encouraged any 
Member that was party to any such bilateral agreem ent and had not yet shared such information with 
the Council to do so. 
285. As the question of GI protection remained a c ontinuing interest and discussion, he urged those 
delegations that had not yet provi ded responses to the Checklist of Qu estions to consider doing so.  
Equally, those Members that had already provided responses could provide updates to the extent there 
had been any significant changes to the way they provided protection to geographical indications.  
There was a considerable benefit to having up -to-date, accurate and geographically more 
representative material available as the basi s of the on-going review process.   
286. The Council took note of the information provided and agreed to revert to the matter at its 
next meeting.  
K. NINTH ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE DECISION ON THE IMPLEMENTATION 
OF ARTICLE 66.2  OF THE TRIPS  AGREEMENT  
287. The Chairman recalled that, at its meeting in February 2003, the Council had adopted a 
decision on the "Implementation of Article 66.2 of  the TRIPS Agreement".  Paragraph 1 of the 
Decision provided that developed country Members were to submit annually reports on actions taken 
or planned in pursuance of their commitments under Article 66.2.  To that end, developed country 
Members were to provide new detaile d reports every third year and, in the intervening years, updates 
to their most recent reports.  Those reports were to be submitted prior to the last Council meeting 
scheduled for the year in question.  The third set  of detailed annual reports  under the Decision had 
been presented to the Council's meeting in October 2009.  At its meeting in June 2011, the Council 
had requested developed country Members to submit  a second set of updates to those reports for the 
present meeting.  The Secretariat had issued on 28 July an airgram (WTO/AIR/3788) to remind 
developed country Members of that request. 
288. The Council had received updates to the th ird set of detailed annual reports from the 
following developed country Members:  Norway;  Japan;  New Zealand;  Australia;  Canada;  
Switzerland;  the United States;  and the European Union and individual member States, namely, Austria, Denmark, Finland, France, Ireland, Lithuania, Slovakia, Spain, Sweden and the United Kingdom.  This documentation had been circulated in document IP/C/W/558 and addenda.  The 
report from the European Union had b een circulated as an advance copy.  IP/C/M/67 
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  289. In addition, the Council had received two submissions from the delegation of 
Angola: document IP/C/W/561 containing a proposal by the LDC Group for a format for reports on the implementation of Article 66.2;  and documen t IP/C/W/562 containing questions posed by the 
LDC Group concerning the reports that had been  submitted for the eighth annual review and 
circulated in document IP/C/W/551 and addenda. 
290. He recalled that, as regards the purpose and c onduct of the review of that information, 
paragraph 2 of the Decision on the Implementation of Article 66.2 of the TRIPS Agreement explained 
that the annual review meetings should provide Me mbers with an opportunity to pose questions in 
relation to the information submitted and request add itional information;  to discuss the effectiveness 
of the incentives provided in promoting and enco uraging technology transfer to least developed 
country Members in order to enable them to creat e a sound and viable technological base;  and to 
consider any points relating to the operation of th e reporting procedure established by the Decision. 
291. Since some of the information had been received only recently and most of it was available 
only in its original language, he said that he inte nded to provide an opportunity, at the Council's next 
meeting, for Members to make further comments on the information submitted thus far that they 
might not yet have been able to study, and to comment on any additional information that might yet 
be provided before that meeting. 
292. He said that for the fourth year in a row the Secretariat had organized, at the request by LDC 
Members, a workshop on transfer of technology unde r Article 66.2 of the TRIPS Agreement, back-to-
back with the Council's end-of-year meeting.  The workshop had been convened on the morning of 
Friday, 21 October.  It had again brought together  LDC and developed country experts to discuss the 
subject at a very practical level, building on ear lier workshops.  It was his understanding that the 
workshop had provided an opportunity once again for a constructive exchange of views, which had 
been useful to both LDC and developed country delegations. 
293. The representative of the United States said th at his delegation had submitted an extensive 
report on its efforts relating to the implementa tion of Article 66.2, detailing many activities 
undertaken by enterprises and institutions in th e United States for the purpose of promoting and 
encouraging technology transfer to least developed c ountry Members in order to enable them to create 
a sound and viable technological base.  He highlighted two aspects of the report: the US activities with respect to international students;  and best  practices of universities that facilitated technology 
transfer.   
294. With respect to international students, he sai d that the United States promoted the enrolment 
of students worldwide in its national universiti es.  US universities were largely established as 
tax-exempt entities, and the education they provided was subsidized by the US taxpayer in the form of 
foregone tax revenues.   Welcoming foreign stude nts to universities in the United States not only 
helped in building a sound technological base in developing countries, but also enhanced the US 
university system with the unique expe riences of international students.   
295. In 2010, 690,923 international st udents were enrolled in US institutions of higher education, 
representing 3.5 per cent of the total US higher educa tion enrolment.  The top three countries of origin 
for foreign students in the United States were Ch ina (127,628 students), India (104,897) and South 
Korea (72,153);  and the top four fields of stud y for foreign students were business and management, 
engineering, physical and life sciences, and mathem atics and computer science, all of which were 
significant sources for technology transfer.  The le ast developed country with the most students 
enrolled in US institutions of higher education in  2010 was Nepal with 11,233 students.  The total 
2010 enrolment in US institutions of higher ed ucation for all least developed countries was 
26,685 students altogether.  IP/C/M/67 
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  296. Once their education was completed, many of those students returned home, bringing with 
them new technologies, new processes, new research approaches and an understanding of the role of 
open markets and democracy in the US innovative soci ety.  They had the skills to create and enhance 
their own nation's sound and viable technological base, including contacts in the United States and 
throughout the world who could c ontribute to that process.   
297. He said that the best practi ces that encouraged technology transfer from US universities 
included: 
 The publication of research results in open academ ic literature that were accessible globally 
through the Internet; 
 
 Personal interaction between creators and user s of new knowledge (e.g . through professional 
meetings, conferences, seminars, industr ial liaison programs and other venues);  
 
 Collaborative research projects;  
 
 Entrepreneurial activity of faculty and students occurring outside the university without 
involving university owned intellectual property (IP);  and 
 
 Licensing of IP rights to established firms or to new start-up companies. 
 
298. The representative of Australia reaffirmed her country's commitment to assisting least 
developed Members in the area of technology tr ansfer pursuant to the Council's Decision on the 
implementation of Article 66.2 of the TRIPS Agreement.  She welcom ed the holding of workshops on 
that issue, in which Australia had participated since their inception in October 2008, including the 
most recent meeting held the previous week.  The workshops provided a useful forum for an exchange 
of views to enhance understanding on both sides on the preparation and reading of the reports.   
299. Australia had submitted an updated report fo r 2011 providing examples of development 
assistance over the preceding year which might have a technology transfer component.  In Australia's 
report, technology transfer was understood to incl ude training, education and knowledge.  Australia 
recognized that technology transfer was best fo stered in an open and market-based economy and 
fundamental to that requirement was good governan ce.  Australia provided extensive governance 
capacity building and technical assistance to least de veloped countries.  Australia considered that 
education of LDC nationals and their training in the use and management of technological equipment 
constituted two of the most effective means fo r the transfer of tec hnology and knowledge.  A 
significant proportion of Australia's assistance was directed at providing education and training.  In Australia's updated report the total value of Aust ralian assistance to least developed countries in 
2010-2011 was approximately $A860 million.   
300. The representative of Switzerland thanked the Secretariat for organizing another useful 
workshop.  In that context he referred to the s uggestion by Angola, on behalf of the LDC Group, for a 
standardized format for reports submitted by th e developed country Members under Article 66.2 and 
of how future reporting could be streamlined.  Alth ough some standardization could be envisaged, he 
stressed the need for further discussion.  He emph asized that, generally, reporting should be kept as 
lean as possible and should not be reporting for its own sake.  The longer and more complicated 
reports became, the bigger the risk that they were not  being read and made use of.  With regard to the 
LDC Group's list, Switzerland might gi ve consideration to points 1, 2, 11, 12, 13 and 14 as relevant 
for its reporting, as well as who was a beneficiary in which country, and possibly also the field or 
sector of technology transfer, provided that there was a set of relevant and defined categories to 
choose from.  He said that he would take the LDC Group's feedback and proposal back to capital and  IP/C/M/67 
 Page 51 
 
 
  that the input would be further examined in conn ection with the drafting of the following year's new 
report. 
301. The representative of Angola, speaking on beha lf of the LDC Group, thanked developed 
country Members for their 2010 reports concerning the implementation of Article 66.2, as well as for 
their availability and the responses provided at the wo rkshop.  He also thanked the Secretariat for its 
valuable contribution to the work and for holding the workshop. 
302. The mechanism established by the 2003 Decision of the TRIPS Council for ensuring the 
monitoring of Article 66.2 had laid the groundw ork for improving the full implementation of 
developed Members' obligations in providing incen tives to enterprises and institutions for the purpose 
of promoting and encouraging technology transfer to  least developed countries.  The overall objective 
was to assist LDC Members in designing their c ontribution to move forward significantly the 
implementation process articulated in Article 66.2.  To that end, it required the adoption by developed 
countries of incentive measures for promoting and encouraging technology transfer to the least 
developed countries.  The optimal objective was to  enable them to create a sound and viable 
technological base for development in accordance w ith the position articulated by the LDC Minister 
in the Dar-Es-Salaam Declaration of 2009.  In the light of that final objective, developed countries 
were therefore required to provide  their annual updated report to the Council to be in compliance with 
their obligation.  
303. An analysis of the 2009 reports submitted by developed countries under Article 66.2 on 
measures undertaken the previous year shed light on some key points for ensuring effective implementation of that provision.  In the first place, it demonstrated that the content and format of 
reports should be structured and harmonized in orde r to ensure consistency of data from all developed 
country Members.  He said that some progress had been made at the individual level by some developed country Members.  For example, Canada  had made substantial progress in following the 
structure of the table presented by LDCs during the previous workshop, and also Switzerland had 
made use of it. 
304. Two substantive issues remained critical, namely, a lack of a common definition of 
technology transfer coupled with a lack of common understanding of the type of incentive required for effective technology transfer.  The reports reveal ed a lack of common definition, in particular in 
the area of technology transfer.  In his view tech nology transfer was a process involving/requiring 
physical objects or equipment.  Incentives for technology transfer could encompass financial 
incentives, a grant facility, a loan, a tax exemption sch eme, an investment, but they could also include 
technical advice, training, infrastructure- related to programmes and the like.   
305. In his view, further work was needed to address those issues. There was also need for greater 
clarity in defining and circumscribing the benefi ciaries of Article 66.2.  Article 66.2 required 
developed countries to provide incentives for the purpose of promoting and encouraging technology transfer to least developed countries.  Even so, some  of the projects contained in the reports related to 
developing countries in some cases.  For example, the EU report referred to several programmes that 
were unrelated to LDCs, including one project related to an IP office in Ukraine.   
306. He stressed the non-binding nature of the wo rking document and that it could be improved 
through their debate.  There was a need for agreem ent on the key points, namely what should be seen 
as technology transfer and what types of incentives should be provided.  It would also be important to know whether the enterprise benefiting from the incentive was located a least-developed, or 
developing country or elsewhere.  
307. The representative of the Secretariat recalled that the purpose of the workshop convened by 
the Secretariat at the request of the LDC Group had been to enable the Members most concerned to IP/C/M/67 
Page 52  
 
  discuss current documents in a more detailed and inform al way than was possible in the Council itself.  
A very interactive discussion had taken place on the extensive reports from each of the reporting 
developed countries.  He had observed a positive f eedback loop, a discernible effort by reporting 
developed countries to take up some of the prop osals from previous workshops to develop more 
focused and more LDC-specific information.   
308. One of the cross-cutting issues concerned how  to distil from broader reports on overseas 
development assistance the specific technology transfer component, both in terms of defining particular activities, and in terms of the actual ex penditure or the size of the funding behind that 
component of the activities.  One of the continuing themes in that workshop, as in preceding workshops, was exactly how to define the scope of "technology transfer".   
309. One other practical aspect concerned the ove rlap between reporting under item Article 66.2 
and the broader process of reporting TRIPS-related technical assistance programmes under Article 67.  
There were discussions on exactly how to draw th at distinction between these two reporting processes 
as well as comments that there were inevitably ove rlaps between the two and in some cases those 
were deliberately reported under both items.   
310. He said that there had been a positive and pro ductive spirit in the workshop, and a strong 
interest in continuing that kind of process to keep the feedback loop working.  Unless other 
procedures were set up, he said that the Secretariat was prepared to organize a similar workshop at the 
same juncture next year, a particularly important juncture given that 2012 represented the due date for 
the full detailed report, rather than the updated re port from developed countries.  He thanked, on the 
part of the Secretariat, the delegations concerne d for their participation and for their efforts in 
preparing for three very productive mornings' work.  He also thanked his colleagues in the IP Division 
for their hard work and said that their energies where indispensable in ma king the workshop a success 
workshop. 
311. He said that, from a purely practical and operatio nal point of view within the Secretariat, 
given its central task of processing and dealing w ith the information submitted in that process, the 
increasing use of the material to respond to the de mands of technical cooperation in this area, the 
growing resource implications for the WTO in pr esenting and formatting this information, and the 
practical challenges that users of this information had in gaining a synoptic overview of the extensive 
information submitted in the notifications, there might be some practical value in continuing the discussions about more systematic or more conve rgent formats and struct ures for notifications, 
particularly in view of the fact that it was in th e coming year, 2012, that the next batch of new detailed 
reports fell due.  Similar considerations might al so apply to the submission of updates and reports 
under item L on technical assistance, given especia lly the acknowledged overlap between reports 
under both items that was discussed at the workshop. 
312. The representative of Angola, speaking on behalf  of the LDC Group, said that he believed 
that developing countries that were in a position to do  so could also be invited to make contributions 
on a non-compulsory basis on South-South cooperation.  As regards the suggestion by some 
developed country Members that LDCs identify the needed technology, he said that the needs assessments for technical cooperation conducted by si x LDCs mentioned the need for research centres 
to have information exchange between academics, researchers, and experts in terms of innovation, 
creativity, and the like.  This could be another basi s on which delegations could work.  In addition, a 
technology assessment had been c onducted through the national ad aptation programme of action 
called NAPA in the framework of negotiations on the environment.  Forty-seven countries had 
already submitted their needs assessments, including the least developed countries who had submitted 
their needs in terms of technology, adaptation, etc.  That was another source that could be consulted.    IP/C/M/67 
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  313. He looked forward to continuing discussi on on the proposed format for reports under 
Article 66.2 and expressed the hope that the following year the majority of reports would take into 
account one or two areas of the suggested format and that a specific format would be decided for more particular information. 
314. The representative of Norway said that some qu estions had been posed concerning its report 
under Article 66.2.  Since her delegation had been unabl e to participate in the workshop, she said that 
it would reply to those questions in writing. 
315. The representative of Haiti welcomed the ve ry constructive workshop organized by the 
Secretariat that had provided an opportunity for Members to speak freely.  He expressed his 
appreciation to the delegations whose reports ha d included Haiti as a beneficiary of some of the 
programmes.  He expressed the hope that other de legations would also include his country in the 
context of the implementation of Article 66.2.  He trusted that the fifth workshop which would 
undoubtedly be convened the following year would ensure more clarity, with a focus on enhanced 
understanding and broader application in terms of transfer of technology.  To that end, he fully 
supported the communication presented by Angola on  behalf of the LDC Group Members concerning 
the proposed format for reports submitted by the de veloped country Members under Article 66.2.  He 
believed that focusing on the various issues raised by Angola should help in improving the quality of 
reports and moving forward even more.  He l ooked forward to achieving progress towards enhancing 
the quality of the reports and was confident that th e Secretariat would facilitate the achievement of 
that common objective, with a continuing focus,  whether by developed or developing country 
Members, to permit efficient partic ipation of developing countries in  the multilateral trading system.  
316. The Chairman expressed his appreciation to the delegations concerned and the Secretariat for 
their contributions and preparations that had made the workshop held the previous week very useful 
and constructive.  He encouraged those delegations to continue their discussions in order to facilitate 
their work and enhance the quality of reporting.  He urged those developed country Members who had 
not yet provided reports to do so as soon as possible,  and reiterated his intention to provide another 
opportunity, at the Council's next meeting, for Memb ers to make further comments on the information 
submitted for the present meeting that they  had not yet been able to study. 
317. The Council took note of the statements made. 
L. TECHNICAL COOPERATION AND CAPACITY -BUILDING  
318. The Chairman recalled that the Council had agr eed at its meeting in June 2011 to hold its 
annual review of technical cooperation at the present m eeting.  He suggested that , in that context, the 
Council also discuss other issues relating to the agenda item, including LDC priority needs for 
technical and financial cooperation. 
319. In preparation for the annual review, deve loped country Members had once more been 
requested to update information on their technical and financial cooperation ac tivities relevant to the 
implementation of the TRIPS Agreement in time for the meeting.  Other Members who had also made 
available technical cooperation had also been enco uraged to share information on those activities if 
they so wished.  The Secretariat had issued on 28 July an airgram (WTO/AIR/3787) reminding 
Members of that request. In addition, intergovern mental organizations who were observers to the 
Council as well as the WTO Secretariat had also been invited to provide information. 
320. The Council had received information from th e following developed country Members:  
Norway;  Japan;  New Zealand;  Australia;  Canada;  Switzerland;  the United States;  and the 
European Union and individual member States and ag encies, namely Austria, Belgium, Bulgaria, the 
Czech Republic, Finland, France, Germany, Italy, Li thuania, Portugal, Romania, Slovenia, Spain, and IP/C/M/67 
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  the United Kingdom, as well as the European Patent Office (being circulated in document IP/C/W/560 
and addenda).  Updated information had been  received from the following intergovernmental 
organizations:  the WCO, WHO, UNCTAD and WIPO (document IP/C/W/559 and addenda).  
Updated information on the WTO S ecretariat's own technical cooperation activities in the TRIPS area 
could be found in document IP/C/W/557. 
321. In addition, Canada had provided an update to its notification of a contact point for technical 
cooperation on TRIPS.  The information on the Memb ers' transparency toolkit page had been updated 
accordingly. 
322. With regard to LDC needs assess ments, he recalled that para graph 2 of the TRIPS Council's 
2005 decision on the "Extension of the Transiti on Period under Article 66. 1 for Least-Developed 
Country Members" provided that "with a view to  facilitating targeted technical and financial 
cooperation programmes, all the le ast-developed country Members will provide to the Council for 
TRIPS, preferably by 1 January 2008, as much information as possible on their individual priority needs for technical and financial cooperation in order to assist them taking steps necessary to implement the TRIPS Agreement".  Such information had been received from six Members, namely 
Sierra Leone, Uganda, Bangladesh, Rw anda, Tanzania and Senegal.   
323. The Council's 2005 Decision also provided that developed country Members were to provide 
technical and financial cooperation in accordance with  Article 67 in order to effectively address the 
needs identified by LDCs.  Furthermore, the Deci sion called for the WTO to enhance its cooperation 
with WIPO and other relevant in ternational organizations with a view to making technical assistance 
and capacity building as effective and operational as possible. 
324. He recalled that, at the Council's meeting in  June 2009, the LDC Group had requested the 
WTO Secretariat to arrange a series of events to discuss LDCs' priority needs and the coordination of 
technical assistance to respond to the needs identifie d by LDC Members.  Following up earlier similar 
activities it had organized in response to that request , the Secretariat had held the previous week a 
three-day Symposium on LDC Priority Needs for Technical and Financial Cooperation, which was 
convened to build on the lessons learned from i ndividual needs assessments and from the series of 
regional workshops held in 2010.  The purpose of the Symposium was to bring together key 
representatives from the least developed countries, c ooperating partners in developed countries and 
international and regional organizati ons with a view to sharing experiences on the process thus far, as 
well as on-going activities and outstanding needs to complete the process. 
325. The representative of the Secretariat said that th e details of its technical cooperation activities 
concerning TRIPS undertaken between 1 Octobe r 2010 and 30 September 2011 could be found in 
document IP/C/W/557.  The report recalled that the Secretariat's technical cooperation activities 
relating to TRIPS continued to focus on assisti ng Members to understand the rights and obligations 
under TRIPS, including flexibilities and the full range  of available policy options.  An increasing 
focus was laid on building self-sustaining capacity in developing countries, including through the 
training of trainers and strengthe ning regionally-based expertise ra ther than relying on centralized 
expertise.  Technical cooperation continued to be essentially demand driven  against a background, 
however, that Members were expressing an increasing di versity of needs and interests.  This in turn 
was leading to an increased tailoring and focussing of technical assistance activities on specific areas 
of interest or sectoral policy themes, compleme nting long-standing activities that provided general 
overviews of the TRIPS Agreement.   
326. The past focus on ensuring complementarity and cooperation with other inter-governmental 
organizations had been further enha nced with a particular focus on  coordinating on public health and 
IP technical assistance with its sister organizations, the WHO and WIPO.  IP/C/M/67 
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  327. Highlighting two Geneva-based specific activities,  he first mentioned the eighth joint WIPO-
WTO Colloquium for teachers of IP from developing countries.  The colloquium corresponded with a broader programme objective of building capacity w ithin the academic community in developing 
countries, so as to strengthen self-sustaining know-how  and research and policy analysis capacity in 
those countries, with a view to strengthening the independent and teaching capacities of developing 
countries on IP law and policy.  The papers pres ented at the Colloquium in 2010 were of such a 
quality and value that they had been collated a nd published jointly by WIPO and the WTO as a 
resource, so as to provide a unique and authoritati ve insight for researchers and analysts covering 
contemporary IP and TRIPS issues within a wide ra nge of developing countries, a wider range that 
was often covered in conven tional academic publishing.   
328. The same period saw the third joint WIPO-WTO Advanced Course on Intellectual Property, 
which drew on the experience of earlier successful co lloquia for teachers of IP, and applied a similar 
programme structure and pedagogic strategy, but w as tailored and focused on government officials 
and public sector policymakers from the developing wo rld.  The course was able to work from a truly 
advanced baseline given the high level of applica tions and expertise involve d among participants and 
thus was able to explore cutting edge issues through in teractive debate and practical case studies, so as 
to strengthen the capacity of government official s and policy makers to critically review policy 
options and their implications, and to learn from th e wide range of practical experiences that were 
available in those programmes.  
329. The technical cooperation activities outside Gene va had been led by the evolving demand 
from Members leading to an increasing focus on th e interplay between TRIPS and specific areas of 
public policy, including public health, but also bi otechnology, traditional know ledge and biodiversity, 
geographical indications, current copyright issues a nd environmental issues, including climate change.  
A key objective had continued to be a focus on h ealth-related flexibilities in the TRIPS Agreement 
and policy options in the public health field, includi ng the implementation of the Paragraph 6 system.  
The planning of such activities followed a new a nd improved format designed to respond to demands 
from Members to put WTO and TRIPS technical assista nce into the larger context of policy choices 
with a particular focus on current developments and challenges.   
330. The reporting period had also seen an incr eased focus on activities with the sister 
organizations that applied especially in the field of public health.  The Secretariat had organized 
jointly with WHO and WIPO a technical symposiu m on "Access to Medicines, Patent Information 
and Freedom to Operate".  The objective of the sympos ium had been to build on the first event in that 
series of joint symposia but more specifically to high light the value of access to patent information in 
the context of ensuring access to medicines.  It had provided an opportunity for participants with 
different backgrounds from government, civil society organizations and industry to share experiences, 
to take stock and look at future needs in that field. 
331. The symposium on the LDC needs assessment process had been a structured activity 
stemming from the 2005 Decision of the TRIPS Counc il concerning LDC individual priority needs 
relating to TRIPS implementation and in particular the request made by Angola and Tanzania on 
behalf of the LDC Group at the Council's meeti ng in June 2009.  That process included regional 
workshops for Francophone Africa, for Anglophone A frica and for the Asia-Pacific region and so the 
previous week's activity had been a culminating even t that had drawn together experience harvested in 
each of those regional workshops a nd to consider informally the way ahead.  The structure of the 
workshop conceptually followed the main elements of the 2005 Decision of this Council, involving 
the three steps of the identification of individual priority needs by LDC Me mbers;  the response by 
developed country Members to the needs identified;  and the coordination role of the WTO vis-à-vis 
other international organizations.  In particular , the workshop had focussed on the experience of the 
Members concerned, particularly those Members who had notified the Council of their individual 
priority needs.  It also consid ered the role of intergovernmental organizations, including the WTO, IP/C/M/67 
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  WIPO, UNCTAD and active NGOs involved in the n eeds assessment process, i.e. the ICSTD, as well 
as reports by a number of active developed county Members on their relevant technical assistance 
programmes so as to promote coordi nation between the needs identified and the responses available.   
332. The Symposium had used a process that had wo rked very well in the regional symposia, 
namely a series of informal bilateral meetings , matchmaking meetings that enabled the least 
developed countries concerned to sit down with donors, IGO and developed country programmes so 
as to look for opportunities concretely for respon ding to the needs identified.  The programme 
concluded with a roundtable review session wh ich touched on a number of important points of 
potential follow up.  Among those was the challenge of  meeting the needs that had been identified, in 
particular the needs identified in  the six submissions already tabled  to the Council.  The discussion 
had focused on strategies to ensure  availability of coordinated and effective resources to address the 
needs identified.  Proposals included better use of  contact points, the existing contact point list 
established under the Council for technical assist ance, as well as developed countries taking up 
specific elements in the assessments and l ooking for follow-up in those areas.   
333. A proposal had been discussed concerning specifi c coordination events that would focus on 
the specific needs assessments that had been tabled, country by countr y, and that would bring together 
development assistance partners for a coordinated discussion and follow up on the specific elements of needs assessments, particularly those elements that had not been responded to so far.  Those 
activities could be stand-alone or could be incorpor ated in other events, such as a further series of 
such symposia, if it was agreed to go ahead with a further series.   
334. He said that there was a strong focus on bette r coordination for existing technical assistance 
programmes that went beyond the obvious label of TRIPS implementation and touched on other areas 
of development cooperation that  were relevant to TRIPS and sectoral interests under TRIPS 
implementation, as well as better use of the notif ications made to the Council under Article 67 to 
identify relevant programmes.  In addition, a tool kit was under development that would draw together 
a great deal of the experience in that area and that  would be used as a repository for sharing practical 
experience so far as well as identif ying relevant programmes.   
335. A continuing focus had been on improving inte r-agency coordination with the possibility of 
more frequent coordination meetings  than the relatively infrequent meetings that had been taking 
place so far, as well as looking at the important role  of regional and subreg ional organizations, and 
communicating practical experience with optimal national strategies for both coordinating on the 
needs assessment process and the responses to needs identified.  He said that the Secretariat would 
continue to do what it could to support further c oordination in the light of directions received from 
Members, including from the Members most concerned, the Group of LDC Members. 
336. The representative of Angola, speaking on behalf of the LDC Group, thanked the Secretariat 
and the other relevant organiza tions, in particular WIPO and UNCTAD, for the work they had 
undertaken in relation to the needs assessment proces s.  He said that, since the implementation of the 
Decision of the Council for TRIPS of 29 Novemb er 2005, only six LDC Members  had submitted 
their individual needs assessment between 2005 to  2008, namely, Sierra Leone, Uganda, Rwanda, 
Tanzania, Bangladesh and Senegal, and to date no clear response had been received concerning 
funding.  He cited the example of Uganda, who ha d identified its priority needs and submitted its 
needs assessment to the Council in 2008.  The total amount that it had requested in order to introduce 
reforms on the domestic level to implement the TRIPS Agreement was US$11,000 dollars over five 
years, a figure known to the World Bank.  To date there had been no response.  He also cited the 
example of Senegal who had submitted its needs as sessment to the Council in 2010 and had assessed 
its needs as amounting to US$8.5 million.  That assess ment had been evaluated by WIPO but to date 
no response had been forthcoming to their fundi ng request. Furthermore, in 2006 Bangladesh had 
carried out its assessment amounting to US$71.4 million, which included the enhancement of a  IP/C/M/67 
 Page 57 
 
 
  research centre for the implementation of the TRI PS Agreement.  However to date no response had 
been received.   
337. He noted that of the 32 LDC Members of the WTO most still had to submit their needs 
assessment reports.  The workshop had raised a crucia l point concerning the lack of available funding 
to conduct needs assessments, in the light of the economic and financia l crisis, and budgetary 
problems.  It was well known that countries were a ffected by the current crisis, in particular the 
developed country Members, which had led to a lack of  follow up in financial assistance.  In light of 
the economic crises, the LDC Group of Members were unsure whether they were in a position to fulfil 
their obligations within the additional transiti on period under the 2005 decision that would expire.  
For that purpose, they would welcome any financial assistance to support them.  
338. He believed that it was crucial to give careful  consideration to a possible extension of the 
transition period for instance until 2020.  The LDC Group intended to submit a proposal based on the 
same reasoning that was put forwar d for the waiver in 2005 which con tinued to be valid.  It believed 
that an extension should be requested in the light of the economic crisis to assist LDC countries and 
obtain the necessary funding.  
339. The representative of Nigeria, speaking on behalf of the African Group, expressed his 
appreciation of the reports on the implementation of Article 67 of the TRIPS Agreement.  As regards 
the needs identified by Sierra Leone, Uganda, Rwa nda, Senegal and other LDCs, he noted that there 
had been some movement in some of the areas with regard to the requests but not in others.  To that 
end, he suggested that, if acceptable to it, the S ecretariat would prepare a note at least trying to 
indicate the areas that had been implemented in  those countries that had submitted their needs 
assessment, as well as the outstanding areas.  That would give the Council a general picture of what 
was happening and would help Members to see how to implement Article 67. 
340. The representative of the World Health Organiza tion said that, given its distinctive mandate, 
the WHO only undertook technical cooperation activiti es to further the interest of public health. 
Technical cooperation activities on IP were not und ertaken with the purpose of implementing the 
TRIPS Agreement as such, but to support the app lication and management of IP in a manner that 
enhanced health-related innovation, especially to me et the R&D needs of developing countries, and 
promoted access to medicines for all.  
341. The WHO technical cooperation was driven by demand and based on its mandate derived 
from the Global strategy and plan of action on public health, innovation and IP as well as other 
relevant resolutions adopted by the World Health  Assembly.  The focus of implementation activities 
was on technical cooperation, including transfer of  technology, capacity building and training as well 
as direct technical assistance to Member States.  De tails of the activities carried out in the past two 
years were contained in document IP/C/W/559/Add.1. 
342. Further to the adoption of the Global strategy and plan of action, the WHO, WIPO and WTO 
had strengthened their efforts to coordinate work in  the field of public health and IP to foster the 
understanding of public health policy and IP and to increase efficiency in capacity building and 
technical cooperation.  Within the scope of that trilateral collaboration, the three organizations had 
started to organize a series of joint technical sympos ia to enhance the dialogue between the relevant 
organizations and provide a platform for exch anging information and experiences.  The second 
symposium on "Access to medicines, Patent Informa tion and Freedom to Operate" had been held in 
18 February 2011 at the WHO in Geneva.  
343. Currently, the three organizations were pr eparing a joint study on "Promoting access and 
medical innovation: intersections between public h ealth, intellectual property and trade". The study 
was meant to be a sequel to the joint study by the WHO and WTO Secretariats on WTO agreements IP/C/M/67 
Page 58  
 
  and public health published in 2002.  The study woul d not only cover the relevant IP issues, but also 
issues about procurement, regulatory issues, mark ups in the supply chain, voluntary license agreements and tiered pricing, ta xes, tariffs and other elements. 
344. Following the negotiations on Pandemic Influen za Preparedness Framework, WIPO and the 
WHO had been jointly developing a global patent landscape on paten ting trends in the field of 
vaccines.  Until then, no comprehensive overview on pa tent trends in the field of vaccines existed. 
The patent landscape report was intended to provide an overview on what was being patented in terms 
of disease targets and approach, who was doing the pa tenting, where patents were filed and on how 
patent policies had changed over time. 
345. To implement the 2006 Global Pandemic Influenza Action Plan (GAP), the WHO had 
facilitated transfer of influenza vaccine production technology to eleven developing country vaccine 
manufacturers.  
346. To facilitate access to live attenuated influenza vaccine technology for producing a high-yield 
low-cost vaccine that was easy to administer, the WHO, on behalf of developing country vaccine manufacturers, had negotiated and acquired a transfer able non-exclusive licence to that technology.  
Sub-licences to that technology had been granted to three developing country vaccine manufacturers 
and one of those was already marketing the resulting vaccine.  
347. In vaccine production, adjuvants were used to  enhance the immune response to an antigen, 
and enable the use of less antigen  per dose of vaccine and hence, an increase in the number of doses 
that could be produced.  To overcome current know-how barriers, the WHO had facilitated the 
establishment of an adjuvant technology transfer hub that was using the information described in 
patents on adjuvants to establish pr oduction processes in developing co untries where the patents were 
not filed or granted.  The technology had thus fa r been transferred to one developing country and 
technology transfer to another developing country was in process. 
348. As part of the on-going trilateral collaboration,  the WHO had also participated actively in 
training and capacity building workshops organized by and in collaboration with the WTO and WIPO. 
349. In response to a question earlier raised by Nigeri a with regard to voluntary licences, he said 
that the WHO had seen an increase in vol untary licensing programmes by research-based 
pharmaceutical industry in the past years.  Tho se voluntary licence agreements concentrated on HIV 
Aids products and anti-viral treatment against infl uenza.  While welcoming that development, he 
agreed with the delegation of Nigeria that little research had been undertaken concerning the detailed 
provisions in such licence agreements and what cr iteria from a public health perspective should be 
included. Further research and guidance was needed to increase the public h ealth impact of such 
agreements. 
350. The representative of the United States said that he  wished to take the opportunity to reflect 
further on Nigeria's proposal with respect to a report to be produced by the Secretariat.  On a 
preliminary basis, he said that he had some questions concerning the entity which should be 
responsible for collecting and providing that informa tion.  He welcomed a further chance to review 
those elements. 
351. The representative of the European Union sai d that the European Union had played a 
significant role in helping least developed countri es to fulfil their TRIPS obligations, and not only 
those who had submitted their needs assessments to the WTO.  In particular, it had already funded 
technical assistance with Bangladesh, Uganda a nd Zambia and had engage d in talks on how to 
provide assistance to Sierra Leone.  It had al so funded regional work, including with COMESA, 
OAPI and ARIPO.  IP/C/M/67 
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  352. The European Union funded its assistance in  the ACP and overseas territories through the 
European Development Fund, and with other regions through the Development Cooperation 
Instrument.  There were also EPA (Economic Partnership Agreement) components within the 
European Development Fund, such as the EPA Eastern African Community Support Programme – 
those had been used to pr ovide IP-related assistance. 
353. The European Development Fund financed a nu mber of organizations who worked closely 
with least developed countries in the ACP region, including TradeCom, BizClim, and the ACP-MTS Programme, who could assist least developed countries in formulating requests for technical assistance. 
354. As to the more recent submissions by Bangl adesh, Rwanda and Tanzania, the European 
Union would be looking to help them and see ho w it could provide assistance in the context of 
existing EU programmes and in coordination perhaps with other projects. 
355. Uganda, who had submitted its individual need s earlier, had recently benefited from two 
projects financed by the European Union within existing programmes.  The first project involved technical assistance by BizClim w ith the objective of strengthening public-private dialogue to update 
Uganda's national IP policy legal and regulat ory framework; the second co-involved technical 
assistance by TradeCom to the Uganda Ministry of T ourism, Trade and Industry in the area of IPRs.  
The European Union was also in contact with Si erra Leone who had submit ted its individual needs 
recently.   
356. Following on from the excellent Symposium that had been held in the WTO the previous 
week over three days, the European Union looked forward to dealing with requests as they came in.  
He assured Members that they would be given serious consideration.  
357. The representative of Tanzania supported the statement by the delegation of Angola and 
expressed her appreciation to the developed count ry Members for their reports.  She said that 
Tanzania had submitted its assessment of priority  needs for technical and financial cooperation in 
October 2010 pursuant to the Decision of the TRIPS Council of 29 November 2005. According to 
paragraph 2 of that Decision, all the least devel oped countries were required to submit their priority 
needs assessment preferably by 1 January 2008.   However, given the various difficulties they faced, 
the deadline had not been met by many LDCs.   
358. With regard to the submission of its assessment , Tanzania had benefited from the support of 
some Members, which had led it to believe that it would receive the necessary technical and financial 
support from developed Members and donors with a vi ew to building its IPR trade-related capacity.  
However, one year afterwards, no Member or donor had fulfilled their obligations as yet under 
Article 66.1 following the submission of Ta nzania's priority needs assessment.   
359. Her delegation called on Members to fulfil their obligations to support LDCs pursuant to the 
TRIPS decision and requested developi ng country Members who were in a position to do so to help in 
that common task.  Tanzania was in need of th eir assistance at present more  than ever before, and 
with it other Members who had alread y submitted their needs assessments.  
360. The representative of Rwanda welcomed the tr ade support provided by the European Union, 
especially to the countries that had already submitte d their needs assessment and urged it to continue 
its support.  His delegation looked forward to  discussing how to best provide such support. 
361. The representative of Switzerland thanked the WTO Secretariat for organizing the recently 
held symposium.  It had provided an opportunity for least developed and de veloped country Members 
to share their views on the needs assessment proc ess, as well as focusing on the steps required for IP/C/M/67 
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  further implementation, and making contact and exchanging information.  He commended the 
delegations of Senegal, Tanzan ia, Rwanda, Bangladesh, Uganda a nd Sierra Leone for the work 
achieved and for sharing the information among WTO Members. 
362. The symposium had shown that a number of ope n questions remained to be answered.  
Smaller countries needed to provide assistance w ith a focus on LDC Members in which they had 
substantial experience and resources available for development cooperation.  Over the last year, 
Switzerland had intensified its work in the context of its technical assistance with Bangladesh.  The 
next significant step towards implementation of th e projects was planned to be taken shortly.  
Switzerland's bilateral cooperation for technical  assistance could then be intensified.   
363. His delegation expressed its interest in followi ng closely the Secretariat's on-going work to 
ensure enhanced coordination between the various  stakeholders involved. Those efforts and any 
further exploration of the crucial funding issue w ould facilitate their moving to the next stage of 
meeting the important needs of LDCs stemming from their priority needs assessment. 
364. The representative of Nigeria noted the statemen t by the delegation of Tanzania welcoming 
the pledge by the European Union to provide supp ort, and said that Sierra Leone and Uganda had 
submitted their needs assessment already in 2007 a nd 2008, respectively.  He wondered how the Chair 
intended to proceed with his suggestion that the Se cretariat prepare a note with a view to engaging 
Members in the next Council meeting, also noting that that the delegation of the United States had 
said that it needed some time to consider the matter.    
365. The Chairman proposed that, since a delegation ha d indicated that it needed further time for 
consideration, the Council revert to the s uggestion by Nigeria at its next meeting. 
366. The Council took note of the statements made and so agreed. 
M. LETTER FROM THE CHAIR OF THE GENERAL COUNCIL CONCERNING WAYS TO IMPROVE THE 
TIMELINESS AND COMPLETENESS OF NOTIFICATIONS AND OTHER INFORMATION FLOWS  
367. The Chairman recalled that, at its past few 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 that issue,  the Secretariat had presented to the October 2009 
meeting a factual background note (IP/C/W/543) it had prepared at the Council's request that summarized the relevant procedures and provided inform ation on the use of those procedures.  It also 
contained suggestions on how to improve the tran sparency and user-friendliness of the notification 
system.  Furthermore, at the subsequent meeting,  the Secretariat had orally reported on further 
developments in that area.  Those delegations  that had spoken on the issue had supported the 
suggestions contained in that note to improve the transparency of the system, and encouraged the 
Secretariat to continue to pursue that task.  At its last meeting, the Council had agreed to revert to the 
agenda item at the present meeting so as to provide  Members with a further opportunity to share any 
comments that they might have on the matter, and al so to allow the Secretariat to inform the Council 
on any further enhancements to its services improvi ng the transparency and user-friendliness of the 
notification system. 
368. The representative of the Secretariat said that  a core objective of the work on the timeliness 
and completeness of notifications a nd other information flows was to make that material available in a 
more user-friendly way.  The exercise was undertaken  entirely within the parameters already set by 
the Council's own decisions and by the TRIPS Agreem ent itself, and followed directly the outline set 
out in document IP/C/W/543.  The current focu s was on reviewing the body of notifications, a 
collection of over 15 years' worth of documents that  amounted to a massive body of data, data which  IP/C/M/67 
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  was indispensable and highly useful for a number of  practical uses, but taken together represented a 
significant information management challenge.  Hence the increasing focus was on examining ways of using appropriate informati on technology tools to improve the usability and the accessibility of 
those data and to reduce wasteful and expensiv e paper-based approaches.  That work took place 
within the context of a broader effort across th e Secretariat towards a more integrated holistic 
approach to managing notification data.   
369. In addition, there was a particular focus to a ddress the backlog of notified material that was 
not yet available in text-searchable form.  A furt her focus would be to work towards more user-
friendly web tools for accessing and using the informati on contained in notifications, notifications that 
were essentially circulated or had been circulat ed solely as Council documents, rather than more 
accessible forms of information.  That work woul d build on the initial work already undertaken as a 
pilot project in converting the contact point lists from a series of Council documents to a more easily 
consulted drop-down web list.  The successful impl ementation of the common portal with WIPO for 
the submission of legislative texts and the improvement in timeliness and completeness of 
notifications that it had facilitated suggested that it might be possible also to look at other avenues for 
further cooperation along those lines, given the overlapping responsibilities between the WTO and 
WIPO that were recognized in the TRIPS Agreemen t itself.  Other avenues might include facilitating 
the submission of texts through a notification tool  and the continuing focus on suggested standard 
notification formats to facilitate the work, both of  delegations and of tho se seeking to manage and 
process the data.   
370. The notification materials were increasingly being used in technical cooperation activities 
responding to the demand from Member s for information at a very practical level and in a factual way 
of the approaches taken by Members in relation to  various areas of IP, la w and policy.  Further 
technical assistance activities had also promoted un derstanding of the notification processes, so as to 
advance the timeliness and completeness of notifications under the TRIPS Agreement. 
371. The Chairman suggested that the Council revert to this agenda item at its next meeting so as 
to provide Members a further opportunity to share any comments they might have on the matter, and 
also to allow the Secretariat to  inform the Council of any further enhancements to its services 
improving the transparency and user-fri endliness of the notification system. 
372. The Council took note of the statements made and so agreed.  
N. AUSTRALIA 'S TOBACCO PLAIN PACKAGING BILL 2011   
373. The Chairman said that this item had been put  on the agenda at the written request of the 
delegation of Ukraine. 
374. The representative of Ukraine said that his de legation had already expressed its concern over 
Australia's proposed Tobacco Plain Packaging Bill 2 011 at the Council's meeting in June 2011, stating 
its view that enacting the proposed legislation into law as drafted would violate a number of Australia's WTO obligations.  These included several  obligations under the TRIPS Agreement as well 
as certain provisions of the Paris Convention for th e Protection of Industrial Property that had been 
incorporated into the TRIPS Agreement. 
375. Since the Council's last meeting, he said, there had been a number of important and highly 
troubling legislative developments in Australia on the Tobacco Plain Packaging Bill 2011 and the 
accompanying Trade Mark Amendments Bill 2011,  as the legislation had passed the House of 
Representatives in late August without any substantiv e amendments and was currently pending before 
the Senate, where it was expected to be voted on an d passed soon.  He said that it was not yet clear 
whether there would be substantive amendments to the legislation in the Senate that would render it IP/C/M/67 
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  more compatible with Australia's international treaty obligations, but his government continued to 
hope that such amendments would be  offered and passed in the Senate. 
376. The plain packaging measures contained in the legislation now moving through the Australian 
Parliament continued to be cont roversial and of serious concern to the Ukraine and several other 
governments, as well as to IP and business groups both within Australia and internationally.  These 
concerns had recently been recorded directly in wr iting with the Australian Parliament in the context 
of enquiries carried out first by the House Standing Committee on Health and Aging in July and August prior to the  passage of the legislation in  the House and then by the Senate Legal and 
Constitutional Affairs Committee in August and Sept ember.  In both these enquiries, the committees 
in question had requested and received comments fro m the public in the form of written submissions, 
which were then posted on the websites of these committees for public scrutiny. 
377. He said that his delegation would like to tha nk Australia for inviting comments in connection 
with its Parliamentary enquiries.  He noted that that the Government of Ukraine had made a written 
submission to the Senate Legal and Constitutional Affair s Committee expressing its regret that the 
Government of Australia had provi ded no substantive responses to Uk raine's questions and concerns 
regarding the WTO consistency or the efficacy of  the proposed plain packaging measures.  The 
submission had also urged the Australian Senate to take up amendments to the legislation in 
conformity with Australia's WTO obligations.   
378. He said that from the perspective of IP, whic h was the focus of this Council, the enquiries by 
the Australian Parliamentary committe es were particularly instructiv e because in their submissions, 
leading IP and business organizations both from Au stralia and around the world had described in 
detail the violations of international law and th e adverse business impact for individual trademark 
holders that these measures would entail, as well  as the broader negative implications for IP 
protection in general.   
379. In order to illustrate the breadth and depth of concern about the plain packaging measures 
from an IP perspective, he said that it was wort hwhile recalling some of these organizations who had 
voiced concerns.  The Institute of Patent and Trade Mark Attorneys of Australia had made a 
submission on 2 September 2011 to the Austra lian Senate Standing Committee on Legal and 
Constitutional Affairs.  On 26 July 2011, the In ternational Association for the Protection of 
Intellectual Property (AIPPI), a politically neut ral, non-profit organization headquartered in 
Switzerland with more than 9,000 members repres enting more than 100 countries, had expressed 
concerns on behalf of its Australian members to the Australian House Standing Committee on Health 
and Ageing.  The International Trademark Associ ation (INTA), which represented 5,700 trademark 
owners and professionals from over 190 countries, had written to the House Committee on Health and 
Ageing on 22 July 2011.  The International Cham ber of Commerce (ICC) and it Business Action to 
Stop Counterfeiting and Piracy (BASCAP) had wr itten to the Senate Legal and Constitutional 
Committee on 30 August 2011.  From among leadin g international business groups, BusinessEurope, 
the pan-European business organization, as well as  the US Chamber of Commerce, which is the 
world's largest business federation representing the in terests of more than three million businesses had 
written to the Senate Legal and Constitutional Committee. 
380. He said that, as already previously stated, his delegation did not question the health objectives 
of the Government of Australia as all governments de vised and implemented health policies that best 
served the welfare of their citizens, but simply re quested that that Australia and all governments 
formulated their health policies in a manner consis tent with their interna tional obligations.  With 
respect to TRIPS, his delegation had indicated bot h to this Council and directly to the Australian 
Government its view that the plain packagi ng measures passed by the Australian House of 
Representative and now pending before the Australia Se nate violated important TRIPS obligations of 
Australia. As he had already noted, a number of  other governments and numerous leading IP and  IP/C/M/67 
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  business organizations in Australia and around the world shared this view.  He expressed his 
delegations' hope that the Australia n Senate would take eth necessary steps to ensure the conformity 
of the pending plain packaging legislation with Au stralia's international treaty obligations, including 
those under the TRIPS Agreement.  
381. The representative of the Dominican Republic said that his delegation wished to reiterate its 
concern about the plain packaging measures that had been introduced in the Australian Federal 
Parliament in the course of the year and were curre ntly being considered in the Senate, including the 
detailed draft implementation regula tions for cigarettes and other tobacco products, such as cigars.  
He said that the Dominican Republic, along with  other WTO Members, had expressed its concern 
regarding these unprecedented measures both in th e Council for TRIPS and in the Committee on 
Technical Barriers to Trade and various trade associations representing a wide range of industries had 
also stated their concern. 
382. He said that the Australian plain packag ing measures were not an issue exclusively 
concerning tobacco, but were to be viewed more generally as a threat to the protection of IP, a vital component of international trade, and should therefor e be a matter of concern to all WTO Members.  
The proposed measures specifically ran counter to Australia's obligations under the TRIPS Agreement 
and the Paris Convention, incorporated into the TRIPS Agreement. 
383. As the term itself suggested, "plain packaging"  as stipulated in the bill and its regulations 
required all packets for retail sale to be of the same size, shape and colour.  Trademarks were 
removed, since the proposed measures banned the use of design and trademark features.  Although the 
measures permitted use of the brand name and varian t of the product, these could only appear on the 
lower part of the front and the top and bottom of the packet.  Moreover, the brand name and the 
variant name had to be displayed in a statutorily standardized font style, size and colour.  The graphic health warnings would cover 75 per cent of the front and 90 per cent of the back of the packet.  By definition, the Australian plain packaging measures would therefore make it impossible to differentiate between competing products.   
384. His delegation considered that these measures would violate IPRs and would not succeed in 
promoting the public health goals pursued by Austra lia.  On the contrary, unwanted effects might lead 
to higher rather than lower tobacco consump tion as prices tend to drop as a result of the 
"commoditization" of tobacco products and plai n packaging would make it easier to produce 
counterfeit tobacco products and thus facilitate trade in illicit products. 
385. Regarding the legal implications, he said that the Dominican Republic considered Australia's 
plain packaging measures to violate Article 20 of the TRIPS Agreement and Article 10 bis of the Paris 
Convention.  Analysis of the measures in the light of Article 20 showed that the "use" of trademarks 
relating to tobacco products woul d be "encumbered" by "special requirements" as the measures 
prohibited the use of any design feature on packets of tobacco products for retail sale, allowing only 
the brand name and variant to be used in a pr edetermined font style and size on an identical 
background.  These special requirements imposed by Australia were detrimental to the trademark's 
capability to distinguish the goods or services of one  undertaking from those of other undertakings. 
386. At the previous Council for TRIPS meeting in June 2011, Australia had contended that the 
measures in question were justified by objectives of  public health, and had referred to a number of 
studies, but his delegation understood that the scientific evidence underpinning Australia's plain packaging measures had been challenged in p ublic documents submitted to the Australian 
Government.  The Dominican Republic requested an explanation from Australia as to how it 
reconciled the divergent views on scientific evidence.  IP/C/M/67 
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  387. The plain packaging measures would also violate Article 10 bis of the Paris Convention, 
which prohibited "all acts of such a nature as to cr eate confusion by any means whatever with the 
establishment, the goods, or the industrial or commerc ial activities, of a competitor".  As stated at the 
previous meeting of this Council, the measures in question posed a serious risk of confusion as they 
would eliminate all design features and impose virtua lly identical packaging for all tobacco products.  
The Dominican Republic therefore urged Australia to  reconsider its position an d to take into account 
the concerns raised in this statement, and co nsequently to honour its obligations under the 
WTO Agreements. 
388. He said that his delegation considered this to be a very serious case. Tobacco was an 
indigenous product of the Dominican Republic wh ich exported more than $400m worth of tobacco 
products, and where tobacco represented 10 per cent of  the domestic agricultural sector and more than 
100,000 domestic jobs.  In  addition, tobacco was called a demo cratic product because it was produced 
by small producers and small share holdings.  Furthermore, more than half of the 100,000 workers in 
tobacco production were women who had special facilities in this respect. While his delegation 
acknowledged that there may be a health probl em, imposing measures that banned the use of 
trademarks on products that carry health risks w as not an option and would not only violate the TRIPS 
Agreement, but create a serious impediment for world trade. 
389. The representative of Brazil said that the interpla y between public health and IP had now been 
discussed for a number of years from different angl es and in different fora, and the international 
community had now agreed on a solid international regul atory framework to deal with this issue.  At 
the World Health Organization's Conference on Social De terminants of Health he ld in Rio de Janeiro, 
Brazil's foreign minister, Ambassador Antonio Patriota, had stressed the fact that "the whole 
international community acknowledges that the fl exibilities included in international treaties on 
intellectual property constitute a consolidated legal fr amework, either in the WHO, at the WTO or at 
WIPO."   
390. With respect to the WTO, he said that Ar ticle 8 of the TRIPS Agreement specifically 
authorized Members to adopt measures necessary to protect public health and nutrition in addition to 
those intended to promote the public interest in sectors of vital importance to social, economic and 
technological development.  The Doha Declaration on the TRIPS Agreement and Public Health also 
made it clear that the TRIPS Agreement did not and should not prevent Members from taking 
measures to protect public health and that it coul d and should be interprete d and implemented in a 
manner supportive of the WTO Members rights' to protect public health.  Finally, in the WHO, 
172 countries, parties to the Framework Conventio n on Tobacco Control had reaffirmed in the 
Punta del Este Declaration their commitment to prioritize the implementation of health measures designed to control tobacco consumption and had reasserted the right of states to define and implement national public health policies to protect their people.   
391. In conclusion, he said that it was Brazil's view that all countries were allowed, by the present 
body of international rules on IP to adopt whatever  measure they deemed it fit to protect the public 
health of their respective populations.  Tobacco cont rol was clearly a public health priority worldwide 
and nation-wide. 
392. The representative of Mexico said that her delegation requested Australia to provide 
information on the status of the proposed measures in terms of implementati on and instrumentation.  
It also asked Australia to respond to the formal request Mexico had lodged with the relevant focal 
point in May 2011, and provide information th at would explain how the proposed measure was 
consistent with the TRIPS Agreement. 
393. The representative of Nigeria said that his dele gation had referred the matter of Australia's 
plain packaging bill of 2011 to capital for consider ation.  As Nigeria had important manufacturing  IP/C/M/67 
 Page 65 
 
 
  facilities in the tobacco sector that generated employment and provided re venue for the government, 
his delegation was trying to assess the impact that Aust ralia's bill would have on the sector in Nigeria.  
It was his delegation's view that the proposed me asures would be inconsistent with Australia's 
obligation under Articles 20 of the TRIPS Agreement and Article 10 bis of the Paris Convention, as a 
ban on use of the logo on cigarette packages would make it difficult to distinguish one brand of 
cigarettes from another, thereby conf using the product purchaser.  In view of the concerns raised in 
the Council today and on previous occasion, Nigeria wished to ask Australia to bring its proposed tobacco measures into consistency with the TRIPS Agreement. 
394. The representative of Cuba said that, since this was the second time the Tobacco Plain 
Packaging Bill was debated in the TRIPS Council, he r delegation hoped to recei ve satisfactory replies 
from Australia at this time.  Since the bill had been discussed for the first time in the Council in 
June 2011, it had been approved by the House of Representatives in August and would soon go before 
the Senate.  Its scope remained unc hanged and it appeared that neithe r the questions nor the concerns 
raised regarding its commercial impact would be taken into account.  Her delegation's concerns were 
further heightened by the fact th at the measures which the Australian  Government submitted to public 
enquiry on 30 September would also be applie d to non-cigarette tobacco products.    
395. She was concerned that banning the use of a trademark's distinctive features on all tobacco 
retail packaging, including for products sold per unit, negated the functions of a trademark, in 
particular brand association of a product with an  origin, a producer, or a tradition.  Under the 
proposed measures, it would no longer be possible to use the seal of guarantee which identified and 
ensured a product's authentic Cuban origin which wa s especially relevant for artisanal Cuban tobacco 
that was hand-made and 100 per cent natural.  Appl ying the bill to such a product would prevent 
consumers' association between the Cuban tradem arks and the product, and therefore strip the 
products of their commercial value in Australia while at the same time restricting the consumer's right 
to choose on the basis of the quality of a product associated with its trademark. 
396. Her delegation was further concerned by the ri sing trade in illicit tobacco products, knowing 
that it would become much easier to produce counterfeit packaging if use of a trademark were to be 
prohibited.  The method proposed to prevent the production of counterfeit goods was a unique 
alphanumerical code, but this code  could also be reproduced on counterfeit packaging.  It was not 
obvious what effect the measures would have on cons umers for whom it would be impossible to know 
whether they were in fact consuming a real or a counterfeit product. 
397. She said that Cuba continued to recognize the importance of protecting public health and the 
responsibility of governments in that regard.  Ne vertheless, it remained an open question whether 
Australia had considered the possibility of implemen ting other, less restrictive measures that would 
achieve the same health objectives.  She noted that Articles 5, 11 and 13 of the WHO's Framework Convention on Tobacco Control did not require the u se of plain packaging and that, in almost five 
years since the Convention had come into effect, Australia was the first country to adopt such a 
measure. 
398. She said that, in light of Article 8 of the TRIPS Agreement, her delegation insisted on the 
need for scientific evidence for a direct link betw een the proposed measure and the health protection 
objectives sought.  Australia had still not provided guarantees to protect the rights of trademark 
owners under Article 16 of the TRI PS Agreement, or to ensure th at owners were protected from 
counterfeiting or unfair competition.  Her delegation would be grateful for any effort on the part of the 
Government of Australia to allay its concerns, and to  take them into consideration during the process 
of final approval of the bill in the Senate. 
399. The representative of Nicaragua said that his de legation wished to join previous speakers who 
had expressed concerns regarding Australia's  Tobacco Plain Packaging Bill 2011 and the IP/C/M/67 
Page 66  
 
  implementing regulations thereof.  The consultati on paper confirmed that the measure would apply 
not only to cigarettes but also to cigars, one of Nicaragua's main e xport products, and proposed 
making retail packaging for cigars the same ugly da rk grey as proposed by Australia for tobacco 
products.  This measure would seriously undermine the protection of IPRs and unnecessarily restrict 
trade in cigars in the same way as the measure th at the Australian Government seeks to apply to 
cigarettes. 
400. He said that the Government of Nicaragua a nd various other governments had already raised 
concerns and questions regarding the legislation th at Australia was now seeking to apply with equal 
effect to cigars and other tobacco products, both  at a bilateral level and within the WTO.  
Unfortunately, the Australian Government had not  provided any substantive responses to these 
questions and concerns regardi ng the WTO consistency of such measures.  Nicaragua recognized 
Australia's right to legislate to protect public hea lth, provided that such measures were consistent with 
WTO rules and other existing international treat y commitments.  However his delegation believed 
that, regrettably, the proposed measures fall far short of WTO compliance and would set a harmful precedent that would undermine protection for IPRs in Australia and other countries. 
401. It was his delegation's view that, while the me asure would not hinder tobacco consumption in 
Australia, it would have significant negative economic  and social repercussions in a considerable 
number of the countries represented in the WTO, the vast majority of which were developing countries with small economies. 
402. The representative of Honduras said that her de legation wished to join the Dominican 
Republic and other delegations who had expressed concerns regarding the Australian Bill which 
would effectively prohibit the use of trademarks on the packaging of all tobacco products such as 
cigars, cigarettes and Havana tobacco, allowing only the brand name to be displayed in a standard 
font on a small part of the packet. 
403. Her delegation believed that in establishing a plain packaging requirement, Australia would 
be in contravention of its commitments under Ar ticle 20 of the TRIPS Agreement, which clearly 
stated that:  "The use of a trademark in the cour se of trade shall not be unjustifiably encumbered by 
special requirements, such as use with another trad emark, use in a special form or use in a manner 
detrimental to its capability to distinguish the go ods or services of one undertaking from those of 
other undertakings".  In her view , any measure that constituted a "special requirement" in respect of 
one of the uses listed in this Article - such as use w ith another trademark or use in a special form -  
meant that the use of a trademark was, by de finition, being "unjustifiably encumbered". 
404. Consequently, her delegation be lieved that the restrictions on trademarks set out in the 
proposed Australian measures violated this Article by imposing "special requirements" in the case of 
logos and design marks and by requiring the use of a br and name in a special form  in the case of word 
marks.  Australia's measures therefore imposed prohi bitions and restrictions on the use of trademarks 
that clearly impaired its capability to distinguish  the goods of one undertaking from those of another. 
405. While respecting Australia's intention in a dopting this kind of measure, her delegation 
believed that the end did not justify the means.  Such measures needed to  be duly backed up by 
evidence that demonstrated both that they met th e public interest objectives which warranted their 
implementation and that the mechanisms employed ta llied fully with the set objective.  In this case, 
Honduras believed that there was insufficient eviden ce to prove that plain packaging was genuinely 
effective in discouraging tobacco consumption.  Furthermore, she said that measures should not be 
more restrictive than necessary to achieve the set  public health objective.  Finally, and more 
importantly, her delegation believed that any measure adopted to  achieve such objectives had to be 
fully consistent with the commitments undertaken un der the various trade agreements, in this case the 
TRIPS Agreement.  IP/C/M/67 
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  406. Although her delegation recognized Australia's ri ght as a sovereign state to adopt legitimate 
public health policies, her intention was to under line that the measures adopted had to meet the 
commitments made in the WTO and take into acc ount the negative impact they would have on trade 
for small producers in the small and vulnerable econo mies of developing countries, as these would set 
a detrimental precedent in this organization.  In vi ew of the foregoing, her delegation considered it 
necessary to find a suitable balance between public health measures and the protection of IPRs of 
trademark owners. 
407. The representative of Zimbabwe said that his de legation associated itself with the statements 
of Ukraine, Cuba, the Dominican Republic, Nicara gua, Honduras, Nigeria and Mexico.  He said that, 
although this controversial Plain Packaging Bill 2011 wa s meant to protect health, it would not be in 
keeping with Article 2.2 of the TBT Agreement whic h stated that "technical regulations shall not be 
more trade restrictive than necessary to fulfil a legitimate objective, taking account of the risks 
non-fulfilment would create" and that "in assessing such risks, relevant elements of consideration are, 
inter alia , scientific evidence and technical informati on, related processing technology or intended 
end-use of products".   
408. He said that the TBT Agreement further require d all "technical regulations" to be "no more 
trade restrictive than neces sary" to pursue a legitimate objective.  As there was no evidence that plain 
packaging influenced consumer behaviour, imposing this new technical regulation would restrict trade 
without doing anything to achieve a legitimate objective, and therefore create unnecessary obstacles to international trade.  It would also be in vi olation of Article 12.3 of the TBT Agreement which 
required Members to ensure that their technical  regulations "do not create unnecessary obstacles to 
exports from developing country Members". 
409. Furthermore, he said, plain packaging could not be justified under the TRIPS Agreement. 
Plain packaging had to be seen as an unjustifiable encumbrance under Article 20.  Article 8.1 of the 
TRIPS Agreement stated that any measure adopted to  protect public health must be consistent with 
the provisions of the TRIPS Agreement, which plain packaging was not.  Article 17 further stated that 
only limited exceptions to the rights under the TR IPS Agreement were permissible and that the 
legitimate interests of trademark owners always had to be taken into account.  By completely 
prohibiting the use of some marks and strictly mandating the form of use for others, plain packaging could not be considered a "limited" exception and did not even attempt to consider the rights of 
trademark owners in its "one size should fit all" approach. 
410. He said that Zimbabwe, as one of the major tobacco producers, would be adversely affected 
by the proposed bill as it would negatively affect its trade, and the social impact on thousands of 
people whose livelihoods depended on the producti on of tobacco products would be severe.  His 
delegation once again urged the Aust ralian Government to realign its proposed Bill to conform to the 
relevant articles of the TRIPS Agreement. 
411. The representative of Uruguay said that his dele gation wished to reiterate its support for 
Australia's Tobacco Plain Packaging Bill.  Protection of public health fell clearly within the sovereign 
authority of States and accordingly every country was entitled to legislate in the public interest, a fact 
recognized by all countries, including the proponents of  this agenda item.  Australia had undertaken 
not to violate its international obligations in the defence of its public health interests and Uruguay 
agreed with the explanations and justifications  it had provided.  His delegation further endorsed 
Brazil's statements with regard to the concept of flexibility within the scope of the international IP 
treaties and wished to add that this defence of flexibility in the implementation of IPRs should be 
coherent and consistent in all instances.  Agai nst that background, Uruguay was of the view that 
Australia's proposed measures were clearly not in  breach of Article 20 of the TRIPS Agreement. IP/C/M/67 
Page 68  
 
  412. He added that his delegation objected to the description of tobacco pr oducts causing "health 
problems", as this description did not adequately reflect the matter of life and death that these 
products presented.  On the same grounds he reject ed any parallels being drawn between cigarettes 
and other products that caused "health problems " as a review of the related figures sufficed to 
illustrate the vastly different health impact. 
413. The representative of Norway said that public h ealth in general, and tobacco control in 
particular, was a topic very dear to her delegation.   Apart from implementing revisions to its tobacco 
policy, Norway was currently working on a new fi ve-year tobacco-related strategy that would be 
implemented from 2012 to 2016.  Her delegation was therefore very interested in, and supportive of, 
similar processes in other Members.  The FCTC could make the greatest single contribution to 
preventing non-communicable diseases.  Implementation by parties of the provisions of this 
international framework convention was a pressing pub lic health issue.  As most WTO Members were 
parties to this convention, her de legation did not see an inherent c ontradiction between regulating the 
use and presence of tobacco products and other intern ational obligations.  It was within the rights of 
each Member to regulate the health needs of its pe ople.  Article 8 of the TRIPS Agreement provided 
Members the flexibility to adopt measures necessary to protect public health and it was Norway's firm 
view that the FCTC and the WTO rights and obligations were mutually supportive.   
414. Tobacco control policies and preventive measu res such as the ones being proposed by 
Australia had the legitimate objective of protecting public health by reducing smoking.  Article 11 in 
the FCTC and the accompanying guidelines explic itly mentioned plain packaging as one of the 
options for achieving this objective.  Norway wished to signal clear support to Australia concerning 
the right to introduce plain packaging as a measure  designed to fulfil its obligations under this 
international convention in order to protect public health.  Her delegation tr usted that Australia's 
legislation would be implemented in a way that  complied with all their international treaty 
obligations.  Norway would continue to follow this case with a very  keen interest and was prepared to 
continue to defend the interests of public health  while complying with all its international treaty 
obligations.  
415. The representative of Chile said that, at the previous Council meeti ng, his delegation had 
referred on a preliminary basis to two systemic aspects it considered noteworthy in the light of the 
information provided by Australia and the issues raised by the Dominican Republic, Ukraine and 
other delegations.  Chile shared Australia's concern for public health protection and in particular the 
noxious effects of tobacco, and, like Australia, Chile  believed it legitimate to take measures to reduce 
tobacco consumption, in particular among the young est members of the population.  To put this into 
context, he said that the reduction in the prevalen ce of tobacco consumption, particularly smoking 
among school-goers and women of child bearing age was also among the specific objectives that Chile's health sector had set itself. 
416. His delegation had indicated previously that the Plain Packaging Bill which Australia was 
seeking to implement further strengthened the legitim acy and importance of the flexibility afforded by 
the TRIPS Agreement, particularly in the field of public health, since this case illustrated that the 
Agreement's flexibilities were useful and necessary not only for developing countries, but are also for 
developed countries.  Having said that, pointed out that the use of flexibility provided in the TRIPS 
Agreement had to be consistent w ith the provisions governing the protection of IPRs, in this instance 
those pertaining to trademarks under Article 15 et sequitur  of the Agreement.  Article 8 of the TRIPS 
Agreement was clear on this matter, allowing Memb ers to take measures to protect public health 
provided that these were consistent with the Agreement. 
417. He said that Chile would continue to scrutinize the Australian bill, in particular its relation to 
Article 20 of the TRIPS Agreement and the releva nt provisions of the Paris Convention, and his 
delegation reserved the right to retu rn to this issue in the future.  IP/C/M/67 
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  418. The representative of New Zealand said that her delegation welcomed the Australian 
Government's decision to legislate for the plain p ackaging of tobacco products.  The negative effects 
of smoking, which was the leading preventable cause  of early death in New Zealand, could not be 
overstated.  She said that it was within a Member's  right to implement necessary measures to protect 
public health and her delegation had noted the clear assurances by Australia in past discussions that it 
had paid close attention and respected its WTO obligations in developing its plain packaging 
proposal.  She further noted the numerous scientific  studies demonstrating that plain packaging of 
tobacco products could lead to positive public h ealth outcomes by reducing the attractiveness and 
desirability of smoking and increasing the prominen ce of public health warnings.  It was her 
delegation's view that, as part of a comprehensive suite of tobacco control measures, plain packaging 
could contribute to efforts to reduce smoking rates.  
419. The representative of El Salvador said that her delegation thanked the Dominican Republic 
for having presented this concern in the last mee ting of the Council and shared the concerns with 
respect to the identification of products.  She said that while her dele gation was analysing the 
documentation received so far and reserved the right to  intervene once again on this point, El Salvador 
wished to indicate that it would submit a number of questions to Australia with respect to the 
implementation of this draft bill.  She noted that  her delegation had also followed up on Australia's 
presentation of the concerned measures in the TBT Committee and said that notification and analysis 
of the measures and their implementation in th e TRIPS Council was equally important given the 
systemic concerns raised by the measures. At th e same time, she said that her delegation recognized 
Australia's right to establish measures protecting pub lic health for its own citizens, and noted that 
El Salvador also had domestic legislation regard ing labelling and packaging that contained health 
warnings.  Her delegation would follow up on th is matter both in the TRIPS Council and the TBT 
Committee. 
420. The representative of China said that the Austra lian bill had the legitimate objective to protect 
human health by introducing plain packaging of to bacco products with the aim of reducing the appeal 
to consumers and increase the effectiveness of health warnings.  A second bill provided some 
assurance for the effect of trademarks or industrial  designs, stipulating that use of a trademark or 
industrial design could be prevented on tobacco pr oducts on the condition that such use could be 
specified.  In the context of the debate on th e compatibility with the TRIPS Agreement, China 
believed that Members should have th e right to take measures to protect public health, and that such 
measures should not contravene th e TRIPS obligation.  His delegation would continue to follow the 
development of this issue.  
421. The representative of Switzerland said that his delegation shared Australia's concerns with 
regard to the damaging effects of smoking for indi viduals and public health and was thus generally 
supportive of public health measures in the area of  anti-smoking.  However, his delegation also 
wished to reiterate that such h ealth measures - as any other measures - needed to be compatible with 
international obligations and fundamental rights, including proprietary rights such as those of 
trademark holders.  Among these international obliga tions to be respected were the substantive 
provisions of Part II of the TRIPS Agreement, as c onfirmed for public health measures in Article 8.1 
of the TRIPS Agreement.  
422. He said that such public health measures ha d to be appropriate, i. e. proportionate and 
effective. In this respect, his delegation noted that the consultation paper on the plain packaging 
amendment, submitted to interested stakeholders fo r comments in spring 2011, mentioned on page 11 
that the draft legislation made a caveat to the full ban of use of a trademark, meaning that under 
certain circumstances a trademark could be used  on the packaging of the product under the new 
legislation, albeit under restrictions imposed by a regulation.  His delegation wished to request the 
delegation of Australia to inform the Council on what  Section 11(2) of the draft Bill provided in this 
respect in its latest version, as well as the regulati on referred to in the consultation paper and whether IP/C/M/67 
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  the consultation process had resulted in any new cons iderations and adjustments in the draft submitted 
to the House of Representatives or to be submitted to the Senate.  
423. The representative of India said that the issue ra ised very important questions on the interplay 
between the TRIPS Agreement and the right of a Me mber to protect public health.  While refraining 
from specific comments on the Australian measures, his delegation wished to make some 
observations on the larger systemic issue of protecti on of public health and the TRIPS Agreement.  He 
said that the framers of the TRIPS Agreement had provided inherent flexibility to create a delicate 
balance between the rights of the IP holders and the interests of the people.  While Article 1 provided 
the Members had certain freedom to implement the provisions of the agreement, Article 8 of the 
TRIPS Agreement provides enough flexibility to Members to adopt measures necessary to protect 
public health and nutrition and to pr omote public interest in sectors of vital importance to their socio-
economic and technological development.  This had al so been reiterated by the Doha Declaration.  
424. With respect to the Australian tobacco plain packaging bill he said that Members' views 
differed between those preferring to protect trademar ks, and others preferring to advance public health 
through initiatives like plain packaging to discourag e the consumption of attractiveness of tobacco.  
Some countries felt that these initiatives could be mo re focused rather than targeting all tobacco 
products, and other expressed concern over a potent ial increase of counterfeit products and illicit 
trade, thus adversely affecting public health. Agains t this background, his de legation believed that the 
TRIPS Agreement provided for enough flexibility to a ddress the issue of public health, but that this 
should be addressed through an approach based on studies, facts and empirical data.  
425. The representative of the European Union said that his delegation was closely examining the 
proposal from Australia and, in the TBT Committee, had requested information on the scientific data, 
studies, impact assessment summary and background th at had prompted Australia to propose the Bill.   
The European Union would also be interested in  learning whether Australia had evaluated other 
legislative solutions and why these alternative soluti ons had been considered less effective than the 
proposed approach for achieving the legitimate health objective pursued.  In this regard his delegation 
recalled that the legitimate public h ealth interests needed to be c onsistent with the provisions of 
TRIPS, including its trademark rules.  Finally, his delegation also wished to enquire about the 
envisaged legislative process and timing for the adoption of the proposal. 
426. The representative of Australia said that her delegation welcomed the interest of other 
Members in its proposed legislation on the plai n packaging of tobacco products and the support 
received for these important measures.  Since the la st meeting of the TRIPS Council in June 2011, the 
Tobacco Plain Packaging Bill 2011 and the associated Trade Marks Amendment (Tobacco Plain 
Packaging) Bill 2011 had been introduced into the Australian Parliament on 6 July 2011.  Both Bills 
had passed the House of Representatives on 24 Augu st 2011 with no amendments and were expected 
to be considered by the Senate be fore the end of 2011.   She said that Australia's Minister for Health 
and Ageing, Nicola Roxon, had issued a media rele ase on 12 October 2011, indicating that as a result 
of the delays in passing the Bill, the Government  was now reconsidering implementation timelines in 
the context of which representations from industry about the timelines were also being considered. 
427. She said that in recent months her delegation had met with all WTO delegations that had 
raised this issue in previous TRIPS Council and TBT Committee meetings to explain the purpose and 
details of the proposed measures and to provide de tailed information in relation to the questions 
raised.  
428. With regard to the purpose of the measures, her delegation had outlined at the previous 
meeting of the Council that Australia was implementi ng this legislation in the interests of promoting 
public health and in particular in the area of re ducing tobacco consumption.  She said that three 
million Australians still smoked, a nd 15,000 of them died every year causing a staggering bill of  IP/C/M/67 
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  $A36 billion to the Australian tax payer.  In that c ontext, her delegation was confident that, as part of 
a comprehensive package of tobacco reforms, th e bill would make an effective contribution to 
reducing smoking, and thereby reduce the health im pact of smoking on Australian individuals and the 
community at large.  Tobacco packaging was one of  the last remaining forms of tobacco advertising 
in Australia and the plain packaging legislation wa s therefore the next logical step in Australia's 
tobacco control efforts. 
429. She said that the effect of the legislation would be that tobacco company branding, logos, 
symbols and other images that might have the eff ect of advertising or promoting the use of the 
tobacco product would not be able to appear on tob acco products or their packaging.  The brand name 
and variant name would continue to be allowed on  packaging, as would be information required by 
other legislation or regulations, such as trad e descriptions and graphic health warnings.  
430. The plain packaging of tobacco products was d esigned to reduce the attractiveness and appeal 
of tobacco products to consumers, particular ly young people; to increase the noticeability and 
effectiveness of mandated health  warnings; to reduce the ability of the tobacco product and its 
packaging to mislead consumers about the harms of smoking;  and, through the achievement of these 
aims in the long term, as part of a comprehensive suite of tobacco control measures, contribute to 
efforts to reduce smoking rates.  She said that plain packaging needed to be c onsidered in the context 
of Australia's long term efforts on tobacco control.  Over the past 30 years Australia had implemented 
a number of measures to reduce smoking rates, in cluding extensive and con tinuing public education 
campaigns on the dangers of smoking; age restri ctions on tobacco purchase;  pricing measures 
through excise and customs duties;  comprehensiv e bans on tobacco adve rtising, promotion and 
sponsorship; bans on smoking in certain places to reduce the impact of second hand smoking; bans 
and restrictions on the retail display of tobacco products; mandatory graphi c health warnings on 
tobacco product packaging; and 'quit smoking'  support services including free counselling and 
subsidised pharmaceutical products. 
431. Guidelines agreed by the Conference of the Parties to the WHO Framework Convention on 
Tobacco Control (FCTC) in 2008 for the implem entation of Articles 11 and 13 of the FCTC 
recommended that Parties consider the introduction of plain packaging.  The proposed legislation was consistent with recommendations made to the Government by Australia's National Preventative 
Health Taskforce which had been based on extensive research evidence that e xplored the impacts of 
tobacco packaging and tested the reactions of r espondents exposed to different packaging options 
under experimental conditions.  The weight of the evidence indicated th at a plain packaging 
requirement, as part of a comprehensive suite of tobacco control measures, would help to reduce 
smoking rates.  Her delegation wished to urge Me mbers to examine carefully any so-called evidence 
to the contrary which was funded by the tobacco industry.  She said that her delegation had been 
responsive to comments from trading partners and other stakeholders, and that Australia remained 
fully committed to its international obligations to  protect IPRs, including the rights of trademark 
owners.  
432. Her delegation had notified the measures to the WTO on 8 April 2011.  As noted by Ukraine 
in its intervention, the Australia n Government had undertaken ex tensive public consultation on the 
proposed legislation.  Prior to the introduction into  Parliament of the Bills, the Australian Government 
had also consulted widely with trading partne rs, including tobacco exporting developing countries, 
through a series of outreach meetings to explain the proposed measures.  These comments were taken 
into account and had led to changes to the Bill and draft regulations where the changes were in line 
with the Government's policy objectives.  This in cluded responding to concerns about the protection 
of the rights of trademark owners, with chang es made to ensure their effective operation. 
433. Amendments to the Tobacco Plain Packaging Bill had been proposed to ensure the trademark 
owners' ability to protect their trademarks from use by other persons, and the ability to register and IP/C/M/67 
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  maintain the registration of a trademark had been preserved.  A parallel Trade Marks Amendment Bill 
had been introduced to allow the Government to st rengthen those protections should uncertainty arise. 
The import offences for non-compliant tobacco produc ts had also been removed from the bill in 
response to submissions received a nd public consultations.  This cha nge allowed tobacco products to 
be imported into Australia in non-compliant retail packaging, and then rep ackaged for retail sale in 
Australia.  She said that the bill required complianc e with plain packaging requirements from the first 
on-sale (whether wholesale or retail) of importe d products in the supply chain in Australia.  
434. She said that her delegation did not accept claims that Australia's plain packaging proposal 
would have a significant impact on illicit trade in tobacco products.  Trade in illicit tobacco in Australia was low and her delegation did not expect this to change as a result of these measures.  It 
was important to understand that counterfeiters now  seemed to have little trouble replicating branded 
tobacco packages and it was worth repeating that smoking of any tobacco product, whether licit or 
illicit, was fundamentally harmful to human health .  Nevertheless, given concerns were expressed 
about counterfeiting and illicit trade in tobacco pro ducts, allowances had been made to ensure that 
protective markings could be used for anti-counte rfeiting purposes.  These included the use of unique 
alphanumeric code markings on each pack and cigare tte stick, and covert markings in compliance 
with other aspects of the Bills. 
435. With respect to the applicability of the measur e to other products she said that the proposed 
plain packaging legislation related only to tobacco  products and retail packaging of those products 
and the Australian Government did not consider  extending the measure to other products.   
436. According to the World Health Organization, "t obacco is the only legal consumer product that 
kills up to half of those who use it as intended and recommended by the manufacturer." She said that 
tobacco products cause extraordinary harm and requi re appropriate measures.  At the same time, she 
said that Australia was fully committed to its inte rnational obligations to protect IPRs, including the 
rights of trademark owners.  She said that, in framing  its policy on plain packaging, Australia had paid 
full regard to its obligations under the TRIPS Agre ement and would ensure that the new policy was 
implemented in a manner that consistent with that Agreement. 
437. The representative of Zimbabwe said that he would encourage Australia to be broad enough 
in its consultations to include Zimbabwe. 
438. The representative of the World Health Orga nization thanked the Council for the opportunity 
to address the floor on this critical public health issue.  As previously stated in this forum, tobacco use 
was one of the greatest threats to public health  the world has ever faced, and the single most 
preventable cause of death in the world.  Globally , tobacco consumption had killed nearly six million 
people a year through both direct use, and the deadly  effects of second-hand sm oke - more than 70 per 
cent of whom resided in low- and middle-income countries.  In addition, tobacco represented the 
leading modifiable risk factor in the fight against the growing epidemic of non-communicable 
diseases (NCDs).  NCDs, primarily cancers, diabetes, cardiovascular and chronic lung diseases, were 
accountable for 63 per cent of all deaths worldwid e. Those diseases killed an astounding 36 million 
people each year, with nearly 80 per cent of deat hs were occurring in low- and middle-income 
countries. 
439. He said that, as strong tobacco control measur es were implemented in developed countries, 
the tobacco industry, through aggressive marketing a nd interference practices, had shifted its focus to 
new markets in the developing wo rld. As a result, tobacco-attributable mortality was rapidly 
increasing in developing countries, a nd, by 2030, more than 80 per cen t of the world's tobacco deaths 
would occur in low- and middle-income countries.   Given that smoking caused 30 per cent of all 
cancers, which included over 70 per cent of all lung cancers, 40 per cent of chronic respiratory 
diseases, and nearly 10 per cent of all cardiovascula r diseases, it was a critical moment in the global  IP/C/M/67 
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  fight against the tobacco epidemic for the introducti on of strong public health interventions like the 
measure under consideration. 
440. He said that that the economic costs of tobacco  use were equally as devastating as the public 
health costs.  Although the tobacco industry had ro utinely cited the economic contribution of tobacco, 
the reality had been that tobacco use puts an enor mous financial burden on countries, in addition to 
the fact that tobacco and poverty were inextricably linked at the individual level.  Nationally, the costs 
of tobacco use encompassed increa sed health-care costs, lost productivity due to illness, premature 
death, and widespread environmental damage.  Thus, he said, as tobacco consumption rates and tobacco-related illnesses increased in developing countri es, so did tobacco-related healthcare costs. 
Additionally, conservative estimates suggested that tobacco's more than US$500 billion drain on the 
world economy exceeded the total annual health e xpenditures in low- and middle-income countries. 
The economic burden of NCDs, with tobacco representi ng the largest risk factor, was also staggering. 
441. Recent macroeconomic simulations suggested th at, over the next two decades, cardiovascular 
disease, chronic respiratory disease, cancer, and di abetes, would cause a cumulative output loss of 
more than US$30 trillion, which represented 48 per cen t of global GDP in 2010.  This in turn would 
push millions of people across the planet below the poverty line.  Because NCDs would result in long-
term macroeconomic impacts on labour supply, capit al accumulation and GDP worldwide, with the 
consequences most severe in developing countries, strong public health interventions, like the plain 
packaging measure under deliberation, were re levant in addressing both health and economic 
concerns. 
442. The representative noted that the impact of tobacco and NCDs on bot h public health and 
country economies has been highlighted at the r ecent United Nations High-level Meeting of the 
General Assembly on the Prevention and Control of Non-communicable Diseases, which had been 
held in September 2011 in New York.  There, th e UN General Assembly, comprised of Heads of 
State, had adopted a Political Declaration recognizing  the fundamental conflict of interest between the 
tobacco industry and public health; and wherein Me mber States unanimously had committed to the 
advancement of the implementation of multi-sectoral , cost-effective, population-wide interventions in 
order to reduce the impact of NCD risk factors. 
443. He said that the WHO was of the view that  the implementation of plain tobacco product 
packaging, which represented a legitimate tobacco control measure, would have a substantial impact 
on tobacco consumption, was fully in line with th e spirit and intent of the outcome of the UN High-
level Meeting, and was in accordance with interna tional legal obligations under the WHO Framework 
Convention on Tobacco Control. 
444. Regarding the relevance of the WHO Framewor k Convention on Tobacco Control (FCTC) in 
this context, another representative of the WHO said that the FCTC, in force since 2005, had been 
negotiated under the auspices of the WHO in respon se to the globalization of the tobacco epidemic. 
Its provisions were based on evidence and had been specifically designed by the international public 
health community to be effective in the face of the tobacco epidemic. As with other international legal 
instruments, states that were parties to the FCTC undertook certain obligations pursuant to it.  Since the last time the Council had met, the number of parties to the Convention had risen to 174 - only 12 of the 153 WTO Members were not party to the FCTC. 
445. She said that the FCTC contained a number of pr ovisions that were relevant to the issue of 
plain packaging of tobacco products. As had been noted during the last session of the TRIPS Council, 
the FCTC set out in Article 3 the collective objectives  of the parties in the establishment of the FCTC, 
as well as the general Article 5 obligation on parti es, which included, inter alia, the obligation to 
"develop, implement, periodically update and revi ew comprehensive multi-sectoral national tobacco 
control strategies, plans and progr ammes in accordance with" the FCTC. IP/C/M/67 
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  446. The recognition by the States Parties of the effectiveness of comprehensive multi-sectoral 
measures in the fight against the global tobacco ep idemic was a theme that recurred throughout the 
Convention and the obligations it contained. It  was through the implementation of such a 
comprehensive multi-sectoral approach that the toba cco control measures contained in the FCTC were 
most effective. In relation to the plain packagi ng measures for tobacco currently under discussion, the 
representative noted that Article 11 of the Conve ntion required Parties to adopt and implement 
effective measures in respect of the packaging and labelling of tobacco products, which included 
health warnings and other appropriate messages.  
447. In accordance with the recent party reports on implementation, which were required pursuant 
to Article 21 of the Convention, 65 per cent of par ties - i.e. 88 of them - had banned descriptors on 
packaging and labelling that were misleading, deceptive or likely to create an erroneous impression of 
the product; and 82 per cent - or 111 parties - had adopted policies which required tobacco product 
packaging to carry health warnings which descr ibed the harmful effects of tobacco smoke. In 
addition, 74 per cent of parties - or 100 of them - had introduced measures to ensure that health warnings are large, clear, visible and legible.  Mo reover, after five years of  implementation, Article 11 
was one of the Articles of the Convention which attracted the highest implementation rates among 
Parties.  
448. She said that another specific provision of the FCTC previously noted in the Council was 
Article 13, which required Parties to undertake a comprehensive ban of all tobacco advertising, 
promotion and sponsorship.  That co mprehensive ban had to be read in  light of the broad definition of 
“tobacco advertising and promotion” which, in accordance with Article 1(c) "means any form of 
commercial communication, recommendation or action with the aim, effect or likely effect of 
promoting a tobacco product or tobacco use either di rectly or indirectly.”  The Guidelines for the 
implementation of Article 13 whic h were adopted by consensus by the parties included "packaging 
and product design features" on the indicative list of fo rms of advertising, prom otion and sponsorship.  
She noted that the most recent Party reports indicated that 55 per cent of Parties - i.e. 74 of them - had 
introduced a comprehensive ban on tobacco a dvertising, promotion and sponsorship. 
449. Information submitted by parties that had repor ted twice had allowed an analysis of the 
progress in implementation of various obligations under the Convention.  Between one-third and one-
half of Parties that had reported twice had re gistered progress through the introduction of stronger 
health warnings and in banning advertising, promo tion and sponsorship.  This indicated that Parties 
were undertaking progressively more stringent to bacco control measures in  accordance with their 
Article 11 and Article 13 obligations. 
450. Finally, as had been noted in the Council during its June session, the governing body of the 
Convention, the Conference of the Parties or COP,  had met for its 4th session in November 2010.  At 
that session, the COP had adopted the Punta del Este Declaration (FCTC/COP4(5)) in relation to 
public health policy, international trade and the activ ities of the tobacco industry.  The Punta del Este 
Declaration reiterated the firm commitment of Part ies to the FCTC "to prioritize the implementation 
of health measures designed to control tobacco consumption" and made specific reference to 
Articles 7 and 8 of the TRIPs Agreement, as well as to  paragraphs 4 and 5(a) of the Doha Declaration 
on the TRIPs Agreement and Public Health, which was adopted by the 4th session of the WTO Ministerial Conference in November 2001. 
451. In light of concerns expressed regarding illicit trade in tobacco products, she noted that the 
negotiation of the first protocol to the FCTC, the dr aft Protocol to Eliminate Illicit Trade in Tobacco 
Products, was in its final stages, and the last sessi on was expected to be held in 2012.  Moreover, 
work was continuing in respect of the identifica tion of economically sustainable alternatives to 
tobacco growing in relation to Ar ticles 17 and 18 of the Convention.  IP/C/M/67 
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  452. The representative of South Africa said that hi s delegation recognized the sensitivity of this 
issue and the tension between on one hand the right to protect and promote public health and on the 
other hand the right of the intellectual property right holder.  As the debate in this Council had not yet 
matured in any degree, his delegation suggested that  Members fully and sufficiently apply their minds 
to it before the discussion was broadened.  He sai d that, while he appreciated the views and the 
unquestionable expertise of the WHO, he felt that at this point it was best to allow Members to apply 
themselves to the issue.  His delegation wished to emphasize again that it recognized both the right of 
Members to protect and advance public health in the same way that it recognized the rights of the 
right holder of the IP.  
453. The representative of Zimbabwe said that he had listened to the WHO representatives and 
wondered whether or not they were making a pitch on behalf of Australia.  While it was clear that 
Australia had the sovereign right to present its case, he said he was puzzled as to the basis of their 
interventions and looked forward to the ma nner in which the Chair would conclude.  
454.  The Chairman recalled that, as Members were aw are, the rules of procedure established that 
observer international intergovernme ntal organizations take the fl oor once all Member delegations 
had spoken.  It was in applying these regulations  with Members' agreement that the WHO, which 
enjoyed observer status, had been given the floor to make its statement.   
455. The Council took note of the statements made. 
O. ENFORCEMENT TRENDS  
456. The Chairman said that this item had been put  on the proposed agenda at the written request 
of the delegations of Australia, Canada, the Europ ean Union, Korea, Japan, New Zealand, Singapore, 
Switzerland and the United States and that, at the ad option of the agenda, its title had been amended 
to read "Enforcement Trends".  In advance of the meeting, the Council had received a communication from Australia, Canada, the European Union, Kor ea, Japan, New Zealand, Singapore, Switzerland and 
the United States entitled "Enforcement of Intellectual Property Rights" (IP/C/W/563). 
457. The representative of Japan offered his delegati on's appreciation for the opportunity to report 
on the latest developments related to the Anti- Counterfeiting Trade Agreement (ACTA) and hoped 
that he could respond to Members' interest in th e Agreement as well as their requests for transparency. 
458. After ACTA had been discussed in the Council twice in the past year, and following the 
completion of translation and technical work, th e Agreement had been opened for signature on 
1 May 2011.  On 1 October 2011, the Government of  Japan had hosted a signing ceremony in Tokyo, 
which had been attended by representatives of al l ACTA participants. Representatives of eight 
governments who had already completed their respective domestic procedures had signed the 
Agreement, namely Australia, Canada, Japan, Ko rea, Morocco, New Zealand, Singapore and the 
United States.  His delegation looked forward to the other participants - the European Union, Mexico 
and Switzerland - signing as soon as was practicable.  ACTA would remain open for signature until 
1 May 2013 and would enter into force 30 days after the sixth instrument of ratification, acceptance or 
approval was deposited with the Government of  Japan, the Depository of the Agreement. 
459. The magnitude of proliferati on of counterfeit and pirated goods in recent years had been 
significant.  Reasons for this proliferation include d the rapid advancement of digital technology and 
thus of sophisticated counterfeiting a nd pirating techniques.  To tackle this and to maintain sustainable 
development of economic activities including IP re lated ones, countries had been working on ACTA. 
460. Beyond a general argument of "TRIPS Plus or Minus", ACTA presented a concrete set of 
provisions and framework for enhanced IPR enforcem ent, which ACTA participants believed to be IP/C/M/67 
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  not excessive, but rather practical and pragmatic in addressing current issues and global development 
in the 16 years since TRIPS had come into effect.  Moreover, he noted that some WTO Members were already equipped with domestic system or prac tice that corresponded, even if partially, to the 
provisions of ACTA.  This exemplified the Agreem ent's concurrence with the needs and requisite 
practices for fighting against IPR infringement, par ticularly the proliferation of counterfeiting and 
piracy, in the new century.  
461. With respect to the apprehensions and concerns th at had so far been expressed with respect to 
the Agreement, he reiterated that  ACTA had no provisions that were in direct conflict with any 
specific provisions of TRIPS.  In implementing the Agreement, it was the Parties' utmost concern to ensure that trade distortions were avoided.  On  the issue of balance between right holders and 
defendants, for example, the Agreement provided th at competent authorities would have the authority 
to require a right holder requesting suspension at  borders to provide a reasonable security or 
equivalent assurance sufficient to protect the defe ndant and the competent authorities and to prevent 
abuse (Article 18).   Throughout ACTA there were  numerous optional provisions, carefully crafted 
definitions, and a huge amount of flexibility that would allow autonomous regulation to be designed 
by Parties in accordance with their respective needs and contexts.   
462. ACTA also specifically provided for internati onal cooperation including information sharing 
and capacity building, and ACTA participants we re open to constructive advice on implementation 
from other Members.  His delegation, together with colleagues from other ACTA participants, 
welcomed other WTO Members' interest in this Agreement and was willing to  respond to any request 
by Members for explanation, exchange or discussion on the Agreement, either individually or in other 
appropriate formats.   
463. He concluded by inviting Members' attention to  the fact that ACTA was open for signature 
not only by the original participants but also  by WTO Members until 1 May 2013 and that the 
window for participation would s till be open after that date. 
464. The representative of the United States said that  his delegation appreciated the opportunity to 
share with colleagues from other WTO Members its views on the importance of enforcement and to 
provide some additional information on ACTA.  The parties had concluded ACTA because 
counterfeiting and piracy had been spreading faster  than governments could effectively react, robbing 
individuals and businesses of billions of dollars.  They had realized that because this was a global 
problem it needed a global solution.   
465. For example, counterfeiters and pirates coul d currently move shipments through multiple 
ports to hide the origin of the shipment and lower th e risk of detection by customs.  The Internet had 
also provided counterfeiters and pira tes with an extremely fast and efficient tool to distribute their 
illicit products – with the ease of a click of a m ouse, pirated movies, music and games could be 
uploaded or downloaded;  counterfeit foods and medici nes could be sold and sent.  That had not been 
the case when the TRIPS Agreement had been concluded.  
466. The key substantive chapters of ACTA dealt w ith the legal framework, enforcement practices, 
and international cooperation. Th e Legal Framework chapter of th e Agreement concerned the legal 
tools that were needed by enforcement authorities to effectively respond to current counterfeiting and 
piracy problems.  The Enforcement Practices chap ter encouraged the creation of mechanisms to 
combat the proliferation of those illicit products.  Fi nally, the chapter on International Cooperation, a 
very important element of the Agreement in his delegation's view, encouraged close global 
cooperation.  
467. ACTA would promote the enforcement of IPRs through a variety of means.  It would:  IP/C/M/67 
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   create a first-of-its-kind alliance of trading pa rtners who would represent more than half of 
world trade and cooperate in the figh t against piracy and counterfeiting; 
 require that border enforcement authorities be  empowered to act on their own initiative 
against both imports and exports of counterfeit and pirated goods;  
 require Parties to make criminal penalties ava ilable when piracy or counterfeiting was carried 
out for commercial advantage (such as companies using pirated software); 
 require that criminal authorities be able to act on their own initiative ( "ex officio" ) in IP cases 
rather than having to wait for a complaint; 
 include new commitments as well as commitments on  criminal seizure and destruction of fake 
goods, seizure of the equipment and materials used in their manufacture, and seizure of the criminal proceeds from IP offenses;  clarify ex isting international requirements for remedies 
against circumvention of technological protecti ons used in the digital environment (such 
passwords or encryption) and trade in circumvention devices; 
 call on Parties to address widespread distribu tion of pirated copyrighted works on digital 
networks while preserving fundamental principles such as freedom of expression, fair 
process, and privacy;  and 
 enhance the TRIPS Agreement framework on ci vil enforcement provisions and deal with 
issues such as damages, provisional measures, re covery of costs and attorneys' fees, and 
destruction of infringing goods. 
468. ACTA would promote practices that contributed to effective enforcement of IPRs, such as 
specialization, data analysis, in ternal coordination, stakeholder consultation, risk management, 
transparency, and public awareness.  He concl uded by noting that ACTA was open to any WTO 
Member to apply to join. 
469. The representative of the European Union said that products and services based on IPRs were 
usually difficult and expensive to create but were cheap to replicate and reproduce.  Organized and 
large-scale infringement of IP had become a gl obal phenomenon and was causing worldwide concern.  
Copycats deprived creators of appropriate rewa rds, created barriers to innovation, harmed 
competitiveness, destroyed jobs, decreased public fina nces and potentially threatened the health and 
safety of citizens.  
470. In order to boost the competitiveness of pro ducers abroad, it was essential that their 
innovations, creation and brands we re adequately protected in their export markets through IPRs.  
ACTA therefore aimed at improving the level and effectiveness of enforcement of IPRs 
internationally.  It had been nego tiated by the EU and 10 other parties10, in a total of 37 countries. 
471. ACTA did not create new IPRs but instead was concerned with procedures and measures to 
enforce existing rights and to act against larg e scale infringements, often pursued by criminal 
organizations.  It was not about limiting civil liberti es or harassing consumers and was in line with the 
current EU regime for enforcement of IPRs – whic h fully respected fundamental rights, freedoms and 
civil liberties such as the protection of personal data. 
                                                      
10 Australia, Canada, Japan, Korea, Mexico, Morocco, New Zealand, Singapore, Switzerland and the 
United States. IP/C/M/67 
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  472. With ACTA, creators, innovators and brand holde rs within the "ACTA space" would be able 
to count on efficient and clear enforcement rules, ve ry similar to the ones that were in place in the 
European Union, regarding the kind of action they could obtain from police, from customs or from a court, how damages would be calculated, what kind of urgent protection they might get, what kind of 
evidence would be collected and preserved, wh at would happen to seized fake goods, etc. 
473. He said that ACTA contained rules on civil enforcement, border measures, criminal 
enforcement measures (for more serious violatio ns, made wilfully and on a commercial scale by 
criminal actors) and digital environment measures (for specific infringements taking place on the internet or involving technical protection mechanis ms). It also contained a number of enforcement 
"best practices" and provisions that would en sure better internati onal cooperation between 
enforcement entities. 
474. ACTA would benefit a wide range  of exporters that relied on co pyrights, trademarks, designs, 
geographical indications and, in certain situations, patents.  He noted that the European Union had a 
wide and diversified basis of right-holders ; a farmer who produced products protected by 
geographical indications or a textile company creati ng designs could also be victims of counterfeiting 
and needed to be protected.  
475. The Agreement would therefore help the European Union's export businesses , of all sizes,  
protect their work from violations, especi ally in the arts, culture, agriculture , industry and science 
sectors, and thus maintain their competitiveness  and jobs.  At the same time, ACTA would be able to 
strike an appropriate balance between the need to  protect innovations and creations and the rights of 
citizens and the concerns of stakeholders such as consumers or internet providers. There were no 
provisions in ACTA that could directly or indirectly affect legitimate trade in generic medicines or, 
more broadly, global public health.  On the contrary, ACTA contained the necessary guarantees to safeguard access to medicines and internet freed om.  Moreover, these principles have been re-
affirmed by all ACTA negotiating parties on numerous occasions. 
476. ACTA provided its parties with the necessary flex ibility to establish a balance that would take 
into account their economic, political and social objec tives, as well as their legal traditions.  This was 
to be expected from an agreement that had been ne gotiated with a view to be inclusive and welcome 
accessions from other countries. 
477. The representative of New Zealand said that , after many years of discussion about the 
standards of protection that shoul d be provided to various IPRs, it was timely to have a discussion on 
how those standards needed to be enforced.  Th e worldwide trade in counterfeit goods and pirated 
copyright works had been growing steadily over the past decade and had become a global problem in 
need of a global solution.  The sale of counterfeit goods and pirated works deprived not only New Zealand business, but all businesses of legitimate earnings and undermined the investment in 
producing quality goods.  Counterfeit goods also misled and deceived consumers as to the source and 
quality of goods and potentially exposed them to si gnificant health and safety risks from sub-standard 
products.  
478. International cooperation had to be an essential i ngredient if enforcement efforts were to be 
successful.  Enhanced cooperation would allow countr ies to effectively break up distribution lines of 
illicit goods without disrupting trade in legitim ate goods.  ACTA thus provided a cooperative 
framework to base Parties' collective efforts at tackling the international problem of counterfeit 
trademark goods and pirated copy right works.  The provisions in Chapter III focused on promoting 
and encouraging better domestic enforcement pr actices and Chapter IV provided the basis for 
international cooperation and the sharing of inform ation concerning the enforcement of IPRs.    IP/C/M/67 
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  479. She stated that there had been many misleadi ng statements made about the possible negative 
impacts of ACTA, and that it was timely to address some of those misperceptions in the current forum.  Firstly, ACTA was not a vehicle to in troduce new standards for the protection of IPRs. 
Instead, ACTA created a new benchmark for IPR en forcement that was consistent with the TRIPS 
Agreement.  In addition, ACTA could not creat e any obligations for non-signatory states.   
480. ACTA had also been unreasonably accused of being a vehicle for obstructing trade in 
legitimate generic drugs, but the Agreement would not address the cross-border transit of legitimate 
generic medicines.  It would not affect the rules under which pharmaceutical companies filed 
applications for patent protection or extended patent terms.  Import antly, the final text included a 
reference in the initial provisions to the objec tives and principles of TRIPS, Articles 7 and 8 
respectively to ensure that aspects of TRIPS were  fully reflected under ACTA.  Accordingly, ACTA 
would not affect a party's ability to use the Protoc ol amending the TRIPS Agreement to implement the 
Doha Declaration on TRIPS and Public Health.  Sh e strongly believed that all Members had the right 
to take measures necessary to protect public health .  Finally, and as had already been mentioned by 
Japan and the United States, she emphasized that  ACTA provided all WTO Members the opportunity 
to apply to join the Agreement. 
481. The representative of Switzerland noted that his country was a negotiating Party of ACTA 
and, like the other 37 ACTA Parties, a WTO Member.  ACTA dealt with measures to effectively 
enforce IPRs and more specifically to fight agai nst counterfeiting and piracy. These issues were also 
dealt with in Part III of the TRIPS Agreem ent, and thus concerned the TRIPS Council. 
482. For those reasons and for the sake of transpar ency, ACTA Parties wished to provide the 
Council with relevant information on ACTA and had circulated its te xt, now that it was final and had 
been signed by the first set of ACTA negotiating pa rties.  Switzerland was finalizing its own internal 
procedures in light of the signature of ACTA. 
483. At the national level, the Swiss Anti-Counte rfeiting and Piracy platform, which was called 
STOP PIRACY, represented an instrument that a llowed for enhanced coordination and cooperation 
among competent government agencies as well as be tween the public and private sector.  Relevant 
information on that platform could be found in Switzerland's submission of 31 May 2007 (IP/C/W/492).  Switzerland's participation in ACTA would reflect and reinforce those national efforts 
at the international level.  Counterfeiting and piracy had transnational character, and he was 
convinced that successful efforts to combat those criminal activit ies effectively necessarily relied on 
closer international cooperation and coor dination, which ACTA provided for.  
484. The Agreement focused on comme rcially-oriented counterfeiting and piracy.  It established 
an international framework for governments' efforts to more effectively combat the proliferation of 
counterfeiting and piracy, which continued to u ndermine legitimate trade and the sustainable 
development of the world economy.  
485. In its Chapter II, building on the TRIPS Agre ement, ACTA set out effective enforcement 
standards for existing IP rights.  In Chapter III,  the Agreement promoted important enforcement 
practices at the national level and Chapter IV provided for enhanced cooperation between the 
countries party to ACTA, among others, by facilitati ng the exchange of information, expertise and 
capacity building in the field of enforcement.  
486. He said that concerns had been expressed by some Members that ACTA could negatively 
impact legitimate trade with and access to ge neric medicines in developing countries. ACTA 
negotiating Parties had strongly negated such claims  and had publicly stated that ACTA would not, 
and had never been intended to, produce such effects.  IP/C/M/67 
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  487. The negotiating Parties had taken concerns that  had been expressed regarding public health 
into account by introducing, for example, a specifi c reference to the Doha Declaration on the TRIPS 
Agreement and Public Health in the ACTA text.  To preclude any doubts on potential effects of 
ACTA on the legitimate trade in generic medicines,  the negotiating Parties had decided that patents 
would not fall within the scope of the ACTA provisions on border measures.  
488. He reiterated that the focus of ACTA was on commercially-oriented counterfeiting and piracy 
and that the Agreement represented an important effort by a group of like-minded countries, both 
developing and developed, to coope rate and support each other in their efforts to more effectively 
combat these illegal and harmful activities.  He encouraged other WTO Members to join ACTA 
participants in that effort and said that his dele gation was ready to respond to any questions Members 
might have on ACTA, both at the current Council m eeting and later meetings, as well as bilaterally.  
489. The representative of Mexico said that, as it had made clear during its participation in the 
ACTA signing ceremony on 1 October 2011, he r Government remained committed to the 
international protection of IPRs and, in par ticular, to ACTA and its scope and objectives. 
490. Accordingly, Mexico had engaged in an intens ive process of consultation and dialogue in an 
effort to raise awareness and provide information about the objectives, scope and benefits of ACTA.  
Her delegation was convinced of the need to pursu e dialogue and would theref ore exhaust all avenues 
of consultation and exchange with other sectors, such as the legislature and representatives of civil 
society, in furtherance of reaching its final decision on signing ACTA. 
491. Mexico recognized the importance of signing th e Agreement and the benefits that it would 
afford at national and international level, esp ecially since ACTA took as its starting point the 
provisions of the TRIPS Agreement. 
492. She noted that for her Government, ACTA offe red the chance to be part of a valuable 
international effort to combat counterfeiting and piracy  effectively.  It was an opportunity to aim for 
full implementation of and complia nce with WIPO treaties and the TRIPS Agreement, which would 
in turn enhance domestic and fo reign investment flows, and boost the competitiveness of Mexican 
companies through innovation. 
493. The Agreement also had the praiseworthy objectiv e of fostering international cooperation in 
the field of IP protection, an issue that was und oubtedly of relevance to the discussions in which 
Members were currently engaged.  She conclude d by stating that her delegation applauded the 
signatories of ACTA for the action that they had taken. 
494. The representative of Singapore said that he r delegation appreciated the opportunity to 
present ACTA to other WTO Members, provide tran sparency, and share its views on the enforcement 
of IPRs.  With global economic activity increasingly dr iven by innovation, it was important to protect 
IPRs more effectively.  A robust IPR regime w ith effective enforcement would strengthen economies 
and was essential to encouraging innovation, crea tivity and the growth of industry and commerce.  
That would give businesses and individuals the c onfidence that their propriety knowledge would be 
protected.  It had contributed to helping Singapore's economy move up the value chain.  
495. At the same time, the increasingly internati onal character of commercial counterfeiting and 
piracy posed significant challenges to the effectiv e protection of IPR.  For instance, technological 
advances allowed the unauthorized replication, sale and distribution of copyrighted material and counterfeit goods across borders, whic h had had ramifications on her G overnment's efforts to develop 
viable and creative industries.  That also ha d implications on public awareness and education 
programmes that were targeted at building respect for IP.    IP/C/M/67 
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  496. She also noted that with the need to strike  a reasonable balance between private commercial 
rights and public policy interests, enforcement policy had to be considered in the context of national 
IP policy objectives and domestic circumstances.   
497. It was in this context that Singapore had par ticipated in and signed ACTA.  International 
cooperation was essential for effective IPR enforc ement and Chapter Four of ACTA contained a 
framework for international cooperation and shar ing of information on enforcement practices.  
Enhanced international cooperation would improve e fforts amongst ACTA parties to deal with flows 
of illicit goods without disrupting trade in legitimate goods.  This was a positive step in wider international efforts combat IPR infringement more e ffectively, and in particular the proliferation of 
counterfeiting and piracy. 
498. At the national level, ACTA encouraged the promotion and development of better domestic 
enforcement practices, captured in Chapter Three of  the Agreement.  For Singapore, this would mean 
a strengthening of existing multi-agency efforts to promote internal coordination in IPR enforcement 
and increasing public awareness of the importance of respecting IP. 
499. As a small country with strong interests in  international trade, Singapore placed great 
importance on the multilateral rules-based system.  It  remained a priority for her Government to 
ensure that bilateral and plurilateral agreements it signed were consistent  with and strengthened 
existing international IP agreements, in particular TRIPS, and did not create new barriers to trade.  
Increased cooperation in IPR enforcement would stre ngthen the relevance and importance of TRIPS.   
500. The representative of Canada said that ACTA represented an important initiative to more 
effectively combat the growing and internationa lly recognized problems of large-scale trademark 
counterfeiting and copyright piracy and achieve progress on enhancing IP enforcement.  Increased 
global trade in counterfeit and pi rated goods had negative impact s for knowledge-based economies 
and cost billions of dollars each year in lost reve nues and trade.  Canada, like many other countries, 
had suffered consequences which had negatively im pacted its economic growth and the health and 
well-being of its citizens.  
501. ACTA set new standards for the enforcement of  existing IPRs, which were consistent with 
and complementary to those that had been provided in the TRIPS Agreement.  In encouraging higher 
standards, there was no intention to exclude any co untry from joining efforts to combat counterfeiting 
and piracy.  In fact, the Agreement had been nego tiated with a view to be inclusive and attract 
accessions from other countries.  It would foster mu tually beneficial cooperation between partners by 
facilitating information exchange, such as statistical da ta or best practices, as well as capacity building 
and technical assistance, where appropriate.  
502. ACTA was also consistent with the TRIPS Agreement and the Declaration on TRIPS and 
Public Health and would not hinder the cross-border transit of legitimate gene ric medicines.  Canada 
would continue to work closely with other ACTA pa rticipants and other interested partners to halt 
once and for all the negative impacts of  trade in counterfeit and pirated goods. 
503. The representative of Australia said that Australia had signed ACTA in Tokyo on 
1 October 2011, along with other ACTA negotiating parties.  He associated his delegation with 
previous interventions, particularly the presentation by Japan as the ACTA depository.  ACTA had been negotiated to ensure wide membership by including provisions that would allow any WTO 
Member to apply to join.  The Agreement usefully complemented and built upon existing civil, 
criminal and border TRIPS enforcement standards a nd further reflected TRIPS-consistent measures 
that were already in place within WTO member countries.  Although ACTA had been negotiated as a 
plurilateral agreement, his dele gation looked forward to engaging other countries in the WTO and 
relevant multilateral fora in discussions on ACTA st andards and the role they played in supporting IP/C/M/67 
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  innovation and world trade in innovative products.  His delegation encouraged WTO Members that 
were not part of ACTA negotiations to look closely at the final agreement and to consider ratification 
or accession to further enhance global standards.   
504. In that context, it was important to stress th at ACTA built upon the existing flexibilities of the 
TRIPS Agreement.  He said that ACTA countries had been very careful to include language in ACTA 
that would ensure that the Agreement captured impor tant elements of the balance struck in TRIPS 
between the use and protection of IP.  Article 2 of ACTA stated that the objectives and principles in 
Part 1 of the TRIPS Agreement, in particular in Ar ticle 7 and 8, would apply as relevant to ACTA.  
Inclusion of that language reflected the balance th at was required in WTO Member countries' laws.  
The preamble provided that the Agreement should operate in a manner that was mutually supportive 
of international enforcement work and cooperation th at was conducted within relevant international 
organizations.  ACTA was therefore an instrume nt which could complement the work on IP 
enforcement that was already being done in other multilateral organizations and was thus suitable for 
broad membership.   
505. The representative of Korea stated that his G overnment was proud to have signed ACTA and 
believed that the enhanced coopera tion of ACTA signatories would be an effective way of combating 
the proliferation of counterfeiting and piracy.  It  was a commonly known fact that counterfeiting and 
IPR piracy harmed fair competition in the market, shifted jobs from right holders to infringers, and 
funnelled money from where it rightfully belonged to underworld operators.  All the harm caused, 
when added up, resulted in damage to the process of innovation, which was vital to economic growth 
and welfare.  The perils of counterfeiting and IPR pi racy were not limited by borders and thus global 
cooperation was necessary to address the epidemic.  
506. He said that Korea was aware that some dele gations had concerns about the possibility that 
ACTA would cause serious adverse impacts, includi ng potential legal conflic ts and unpredictability, 
possible distortions to legitimate trade, and inco mpatibility with TRIPS or other IPR agreements.  
However, his delegation believed th at ACTA could usefully complement existing international IP 
efforts.  Standards in ACTA had been largely bu ilt upon those that had been negotiated within the 
WTO, and reflected TRIPS-consistent measures that were already in place in many WTO member countries. 
507.  In addition, the preamble of ACTA made it clear that measures and procedures to enforce 
IPR should not become barriers to legitimate trade.   ACTA was thus compatible with the TRIPS 
enforcement rules and went beyond the current re gime to more efficiently counteract the adverse 
effects of increasing trade in counterfeiting goods and copyright piracy.  
508. He reiterated the importance of higher IP enfo rcement standards, give n the damaging effect 
that counterfeiting and piracy had in both deve loped and developing econom ies.  ACTA would be 
implemented in a manner that would ensure legitima te trade and sustainable development of the world 
economy.   
509. The representative of India said that, during past several TRIPS Council meetings, India along 
with other countries had been consistently highli ghting the systemic implications of TRIPS-plus 
initiatives launched by a few Members.  The ensu ing discussions had demonstrated the concerns 
echoed by a vast majority of Members about how  ACTA through its TRIPS-plus provisions could 
disturb the fine balance of rights and obligations th at had been provided in  the TRIPS Agreement and 
could negate decisions like the Doha  Declaration on Public Health.  
510. After years of negotiating in comparative secrecy, he appreciated that ACTA signatories had 
finally become transparent and had taken the in itiative to brief the Council about ACTA under the  IP/C/M/67 
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  current agenda item.  He thanked those Members fo r their constructive engage ment in having changed 
the title of the agenda item and clarifying that  it would not be a permanent agenda item.   
511. He wished to highlight some important speci fic and systemic concerns that India had 
regarding ACTA.  The scope of ACTA was broad and he felt that it would target generic medicines, 
which had served as a lifeline by providing access to medicines at an affordable cost in developing 
countries.  The signatories to ACTA had said th at the Agreement was intended to help them 
effectively combat the proliferation of counte rfeiting and piracy and to protect consumers from 
potentially dangerous products like counterfeit medici nes.  However, ACTA did not limit itself to 
counterfeits, a category of products defined na rrowly in the TRIPS Agreement as involving the 
deliberate or fraudulent use of trademark in order to  deceive consumers.  Instead ACTA targeted all 
forms of IP infringement under the guise of targeti ng counterfeits.  ACTA civ il enforcement measures 
applied broadly in connection with IP infringement , although the parties had the option of excluding 
patents and undisclosed information from the scope of civil enforcement.  Goods that were suspected 
of infringing IP, broadly defined, might be sei zed by customs officials under ACTA. This was 
worrisome especially from a public health point of view as ACTA measures would target generic 
medicines. 
512. He said that ACTA border measures, which were  TRIPS-plus on several grounds, constituted 
a grave threat to trade in generics.  The custom s detention of legitimate Indian generics in the 
European Union on account of the EU border measur es demonstrated the adverse impact that such 
border measures could have on public health on a gl obal scale, including lifesaving medicines to treat 
HIV/AIDS, heart diseases etc.  Under ACTA, such seizures would continue.  The Agreement 
provided for the imposition of border measures follo wing requests by right holders or as a result of 
ex officio action by customs officials.  ACTA al so provided for border measures for goods in transit 
through a signatory – even if they did not infringe  any IP in the place of production or where they 
would be consumed.  His apprehension was that AC TA would pose grave risks for international trade 
in generics and thereby adversely affect public  health initiatives in developing countries. 
513. Under ACTA, third parties supplying inputs or services in support of the manufacture or 
commercialization of allegedly IP infringing products could be subject to civil and criminal sanctions. 
The imposition of third party liability would dissuade suppliers from selling inputs and services to genuine generic manufacturers as well.  In addition, ACTA also required that officials be authorized 
to grant injunctions, including against third parties allegedly contributing to IP infringement, in order 
to prevent the infringing goods from entering channe ls of commerce.  ACTA language on aiding and 
abetting could affect providers of inputs including those that unknowingly supply labels, materials or 
services to IP infringers.  That would have an adverse impact on the availability of affordable 
medicines globally. 
514. ACTA rules provided that an infringer, who knowingly or unk nowingly engaged in 
infringement, might be ordered to pay damages in or der to compensate for injury to the right holder 
and introduce  TRIPS-plus rules for calculating dama ges.  The calculation method of using the lost 
profits on account of alleged infri ngement would act as a deterrent for involvement with a generic 
manufacturer, deterring generic producers from entering new markets. 
515. As far as systemic concerns went, ACTA bypassed the multilateral processes of WTO or 
WIPO and went far beyond the en forcement levels laid down in the TRIPS Agreement.  The MFN 
provisions of the TRIPS Agreement would mean th at any TRIPS-plus protection secured by trading 
partners via an RTA or a plurilateral agreement, would be ipso facto app licable to all other WTO 
Members.  Thus the Agreement would have direct bearing even on Members that were not involved in 
ACTA, but who would subsequently enter into RT As with ACTA signatories.  ACTA had thus 
inalterably changed the balance of rights and oblig ations of the parties to the TRIPS Agreement, 
without their having participated in the negotiation of ACTA.  IP/C/M/67 
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  516. It further caused concern when enforcement was seen as divorced from other obligations in 
the TRIPS Agreement.  He recalled that Articles 7 and 8 of the TRIPS Agreement referred to transfer 
of technology, socio economic development, prom otion of innovation and access to knowledge.   
517. He drew the attention of Members to the Tr ans Pacific Partnership Agreement (TPP), which 
was still under negotiation.  There had been unconfirme d reports in the media about the proposals that 
had been made by a developed country regarding the IPR chapters of the TPP Agreements.  That 
agreement could also seriously hamper public health  efforts in developing countries.  That alleged 
stance of some parties at the TPP, if agreed upon, would result in creating monopolies for big 
pharmaceutical companies and would drive generi c manufacturers out of the global market.  
According to these reports, there were proposals th at could undermine the provisions and flexibilities 
in the TRIPS Agreement by requiring patentability of new uses and minor variations of older known 
drugs. That would result in the indefinite lengthe ning of patent life and would thus undermine the 
generics industry.  There was also a proposal to lengthen the patent period by taking into account the 
time required for getting marketing approval, a measure that would introduce an element of 
subjectivity in determinacy of pate nt life and consequently delay th e entry of generic drugs.  There 
were also provisions against pre-grant opposition and compulsion to provide for patent linkage, 
indicating that even a spurious drug could act as a ba rrier due to the presence of patent linkage in the 
Agreement.  Also of concern were the reports that pricing of drugs in the country would be dictated 
by large pharmaceutical companies,  including essential medicines.  
518. He concluded by expressing his deep concern re garding ACTA and other agreements like the 
TPP that were under negotiation and were aimed at  enforcing TRIPS-plus measures against WTO 
Members, whether directly or indirectly.  While India was committed to dealing with IPR 
enforcement issues in line with its TRIPS obligatio ns, the introduction of intrusive IPR enforcement 
rules had set up extremely high non-tariff barriers in  the multilateral trading system and his delegation 
could not remain oblivious to tho se developments.  It was necessary to avoid exaggerating the issue of 
counterfeiting and piracy since there was no available empirical data and further work was needed in 
that area.  Members needed to wo rk collectively to maintain the san ctity of the international trading 
environment by respecting the multilaterally negotiated agreements like TRIPS. 
519. The representative of Angola said that he agreed on the need to protect and respect IP and that 
he shared the concerns about counterfeiting, piracy, a nd transborder crime.  He noted that even if an 
agreement were negotiated outside of the WTO, if a country correctly interpreted the Paris 
Convention, it might not apply.  He did not want to exclude certain topics from discussion, and asked 
all delegations to have an open mi nd in relation to all topics.  He sought clarification on a number of 
points:  first, whether the member States of th e European Union were included separately in the 
number of ACTA participants;  second, what tec hnical and financial cooperation was available in 
particular to build the necessary infrastructure for border enforcement;  and third, what other 
international laws would be applicable with respect  to customs enforcement.  As to enforcement of 
IPRs in the digital environment, he asked whet her ACTA contained any additional standards as 
compared to those already contained in the WI PO Copyright Treaty (WCT) and WIPO Performances 
and Phonograms Treaty (WPPT).  He further raised qu estions on the practical evaluation standards for 
enforcement measures under Articles 14 and 18 of ACTA.   
520. The representative of Ecuador stated that the questions raised by the delegation of Angola 
were both interesting and relevant.  In its commit ment to protecting IP, Ec uador had developed new 
mechanisms to directly combat piracy in add ition to traditional enforcement mechanisms.  That 
strategy included providing legal access by distribu ting free software via public institutions and 
libraries to replace the use of pirated software.  In  this manner, Ecuador had been able to ensure 
access while guaranteeing fair compensation for rights holders, thus ensuring effective enforcement.   IP/C/M/67 
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  521. Ecuador had also been working on fostering a culture of respect for creations by others, 
through the use of social networking sites for another campaign called "Ecuador Crea" (Ecuador 
Creates).  In that campaign, faces or images of creators were shown and the public was invited to 
learn more about the creative processes, which ther eby generated greater pub lic awareness of what 
being a creator of a work or giving expression to  an idea actually meant in practical terms. 
522. The fight against infringements of IPRs dema nded considerable efforts from developing 
countries, especially if there were no legal alternatives for accessing culture, education and 
technology.  Given that not many developing countri es were considered to be  attractive markets for 
investment, the only option they had in terms of acc ess was to take the illegal path.  It was important 
to build consensus so that right holders understood th e efforts that all Members had to make to fight 
piracy, and to seek legal alternatives that, thanks  to information and communications technology, 
were currently feasible and economically viable. 
523. He believed that it was the responsibility of all Members to also explore new ways to promote 
IPRs that produced better results in combating in fringement of those rights by developing means of 
legal access and fair compensation. 
524. Additionally, he requested clarification from one of the Members that were taking part in the 
Trans-Pacific Partnership negotiations to inform th e Council as to the extent IP matters that were 
being negotiated in that forum were more restrictiv e than the provisions that were set out in ACTA 
and in the free trade agreements that the partic ipants in that process had agreed to amongst 
themselves.  In particular, he sought clarificati on in relation to Article X, paragraph 2 of that 
Agreement, which was being negotiated but had not yet been confirmed, and whether it could limit 
the implementation of the Doha Declaration on Public Health. 
525. The representative of Brazil said that the presen t agenda item had been put on the proposed 
agenda as "Enforcement of Intellectual Property Ri ghts (Paragraph III of the TRIPS Agreement)", but 
the discussion had not been about the TRIPS Agre ement or enforcement overall.  Instead, ACTA 
participants had presented that agreement and encour aged other Members to sign it.  The WTO was a 
multilateral forum, and ACTA was a plurilateral ag reement that had been deliberately negotiated 
outside the WTO.  He voiced his delegation's c oncern regarding plurilate ral agreements being 
advocated in a multilateral forum such as the WT O and shifting focus away from its multilateral 
nature. 
526. The representative of China said that his dele gation had expressed its concerns regarding 
ACTA in the past at the TRIPS Council.  The lega l system to protect IPRs should be comprehensive 
and well balanced;  it needed to protect rights holde rs as well as the public interest.  There had been 
controversies even in those countries that had par ticipated in ACTA negotia tions, including concerns 
about transparency and inconsistencies with domestic  legislation.  ACTA s hould be implemented in a 
way consistent with WTO rules and the TRIPS Agre ement.  It was important that protection and 
enforcement did not contravene the provisions of TR IPS;  indeed, Members were required to ensure 
that matters and procedures to enforce IPRs did not  themselves become barriers to legitimate trade, or 
create distortive effects on legitimate internati onal trade.  The additional protection under ACTA 
could not inappropriately restrict the inbuilt fl exibilities and exceptions in the TRIPS Agreement. 
527. The representative of Chile said that he recogni zed the importance of IPRs and upheld them 
accordingly.  Intellectual property and its enforcement were crucial tools in promoting research and 
development, and were subject to  growing demands and challenges.   However, IP enforcement, 
including civil penalties, possible criminal penalti es, border measures and so forth, could not be 
considered in isolation but had to be coherent and consistent with each country's situation.  
Enforcement tools had to, for example, be in keepin g with the financial resources available for other 
areas of primary public necessity, particularly give n that IPRs were, after all, private rights. IP/C/M/67 
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  528. Likewise, enforcement measures had to be cons istent with the legal system and could not 
constitute a barrier to the population's legitimate access to protected works and essential goods such 
as cultural goods and medicines.  In  that regard, any provision on enforcement included in bilateral or 
plurilateral agreements needed to respect and be consistent with the objectives and principles set out 
in Articles 7 and 8 of the TRIPS Agreement.  Those pr ovisions had to, in particul ar, be consistent with 
ensuring that the enforcement of IPRs furthered te chnology transfer that was beneficial to producers 
and users alike.  That had been Chile's fo cus in all negotiations on IP enforcement. 
529. Although ACTA negotiating parties had stated in  previous interventions that the Agreement 
was open to any WTO Member to join, Article 43. 2 of the Agreement, which concerned accession, 
stated that Committee member s, the original parties to ACTA, coul d define the terms of accession for 
each new applicant.  He sought clarification on whet her this referred simply to procedural matters 
such as time limits for entry into force, or whet her Parties deciding on a new Party's accession could 
request compliance with substantive measures that w ould be more stringent than those that had been 
incumbent on the original Pa rties to the Agreement. 
530. The representative of the Bolivarian Republic of  Venezuela, supporting the statement by 
Brazil, said that his delegation preferred multilatera lism and transparency.  It was his understanding 
that ACTA would raise IP standards to a highe r level and that it was a TRIPS-plus measure.  
Recognizing the information that was made available,  he regretted that the process of negotiations had 
not been transparent. 
531. The representative of Zimbabwe was concerned that ACTA was a plurilateral agreement that 
did not embrace all WTO Members. He sought clarification with respect to the clear lacunae in the 
TRIPS Agreement that ACTA participants  claimed ACTA sought to address.   
532. The representative of the United States, responding to the questions raised by Angola, said 
Article 35 of ACTA did provide for capacity building and technical assistance for Members and 
prospective Members.  As to Article 14.2 of AC TA, on small consignments and personal luggage, he 
noted that Article 14.2 had been taken from Article 60 of the TRIPS Agreement.  As to other treaties 
such as the WIPO WCT and WPPT, ACTA implem ented key provisions of those treaties. 
533. He said that the concerns raised regard ing "TRIPS-plus" provisions were somewhat 
confusing.  The TRIPS Agreement was a minimum standards agreement, a nd its Article 1 provided 
that Members “may…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.” 
Many Members had chosen to do so, many of whic h were not ACTA participants.  In fact, several 
WTO Members that were not ACTA participants had already adopted ACTA provisions in their 
domestic law.  It was curious that Members oppo sed ACTA because it was TRIPS-plus on one hand, 
but implemented ACTA provisions in their law on the other. 
534. Regarding ex officio  authority , for example, Article 16(1)(a) of ACTA required border 
enforcement authorities to be empowered to act  on their own initiative against both imports and 
exports of counterfeit and tradem ark goods. He pointed out that, for instance, the India Customs 
Department would ex officio  suspend the clearance of alleged co unterfeit goods if the department had 
prima facie evidence or reasonable grounds to belie ve the goods to be counterfeit, which had been 
provided for in Notification No. 47/2007 – Cus. (N .T.) of 2007.  As the delegation of China had 
confirmed in the discussion under item C of the age nda, Chinese Law, specifically Article 16 of the 
Regulation on the Customs Protection of Intellectual Property Rights, also provided for ex officio  
action at the border, as long as the right holder registered its IP with customs and followed certain 
procedures.  IP/C/M/67 
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  535. Likewise, WTO Members had already implemen ted provisions on damages and statutory 
damages that closely followed those in ACTA.  China's law, for instance, was similar to ACTA 
Article 9 on determining the amount of damage that ha d been suffered by the right holder.  He further 
noted that Article 65 of China's Patent Law, Artic le 56 of China's Trademark Law and Article 49 of 
China's Copyright law aligned closely with ACTA Article 9.  The same provisions of Chinese law 
also had provisions on pre-established and statutory damages like those that were contained in ACTA 
Article 9.3 
536. The representative of the European Union said that the many interesting comments made and 
questions raised showed that that this was a usef ul debate to have.  Although it was impossible to 
reply to all of them, he might be able to do so at a future occasion.  As to the alleged secrecy of the 
negotiations, he said that draft versions of the ACTA  text had been made available publicly and that 
all ACTA participant countries had conducted stake holder consultations.  The European Union had 
done so at least once a year during the three y ears when the Agreement was under discussion, and 
hundreds of persons from the civil society, various sectors of the industry, press etc. had participated.   Activists and NGOs had participated in several of  the negotiating rounds and had discussed the issues 
with the negotiating parties.  He further noted th at it was understandable that in negotiating bilateral 
free trade agreements, for example, there would be some level of discretion involved.  Despite this, 
the misconception regarding secrecy had unf ortunately lasted a long time.  
537. The European Union was not requesting the topi c to be a permanent agenda item, but it was 
not waiving its right to request the item to again be put on the agenda of a future meeting. 
538. With respect to the concern that with ACTA th e detention of Indian goods would continue, he 
said that the incidents in 2007 and 2008 had been isolated, and very serious measures had been taken 
to prevent them from being repeated.  Regrettably, he could not say that they would never again be 
repeated, since a human error could take place.   
539. On the point that Brazil had raised, that ACTA  had deliberately been negotiated outside the 
WTO, he recalled that there had been great di fficulties in discussing enforcement at the TRIPS 
Council, so at some stage, Members had thought th at it might be necessary to discuss the issue among 
interested parties and work to im prove enforcement mechanisms.   
540. In response to China's intervention, he reitera ted that ACTA parties remained committed to 
the provisions of the TRIPS Agreement and did not seek to contravene them.  
541. With respect to the question on accessions under Article 43.2 raised by Chile, he said that 
while many internal rules still needed to be discu ssed, there was no intention to hold new Members to 
a higher standard than the one that had been laid out in ACTA.  
542. The representative of Japan thanke d all the Members that had taken the floor, and noted that 
the numerous interventions had indicated a high level of interest and a need for on-going dialogue on 
ACTA issue.   
543. The Council took note of the statements made. 
P. I NFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO 
544. The Chairman recalled that, under this agenda ite m, information had usually been provided in 
relation to new accessions to the WTO and developmen ts in the area of dispute settlement, as well as 
about acceptances of the recent TRIPS amendment.   However, information on acceptances of the 
TRIPS amendment had been provided under item G, and on this occasion he had no other new 
developments to report in these areas. IP/C/M/67 
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  Q. O
BSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS  
545. The Chairman said that the Secretariat had ci rculated the list of 15 pending requests for 
observer status in the TRIPS Council by other intergovernmental organizations in document 
IP/C/W/52/Rev.12.  At its meeting in June 2011, th e Council had requested the Secretariat to contact 
the international intergovernmental organizations whose requests for observer status were pending to 
request up-to-date information, including on the nature  of their work and the reasons for their interest 
in being accorded observer status.  So far, the S ecretariat had received updated information from the 
European Free Trade Association (EFTA), faxed to  all Members on 7 October, and from the South 
Centre and the Conférence des Ministres de l'Agri culture de l'Afrique de l'Ouest et du Centre 
(CMA/AOC), faxed to all Memb ers on 17 October, and from the Cooperation Council of the Arab 
States of the Gulf (GCC).  Given that this inform ation had been shared with Members only recently 
and that more information from other IGOs could be  expected, he suggested that he consult with 
Members on the requests for observer status with a view to seeing if any decisions could be taken at the next meeting. 
546. The representative of Nigeria, speaking on behalf of the African Group, recalled that the 
African Regional Intellectual Property Organizati on (ARIPO) and the African Intellectual Property 
Organization (OAPI) had already been granted an ad hoc  observer status on a meeting by meeting 
basis in the TRIPS Council.  Given that the func tions performed by these two bodies had a bearing on 
the work of the Council (in this regard, he referre d to the enumeration of the functions of the two 
organizations made at the last Council meeting by th e representative of Kenya, speaking on behalf of 
the African Group), it would be pertinent that they be granted a permanent rather than ad hoc  observer 
status. 
547. The representative of Angola, speaking on behalf  of the LDC Group, said that the activities of 
OAPI and ARIPO, both of which undertook substantive examinations of patents and trademarks and 
were also responsible for the grants, had a bearing on the work of the TRIPS Council.  Therefore, it 
was time to try to grant them observer status on a perm anent basis.  It would al so be pertinent to give 
observer status to other international organizations , such as the South Centre and the Convention on 
Biological Diversity.  
548. The representative of Egypt supported the Chair's proposal regarding conducting 
consultations.  He also said that granting observer st atus to international organizations was a systemic 
issue.  Clear procedures, criteria and rules were ne eded to be dealt with and addressed in a holistic 
approach, not on a case-by-case basis.  In the past, there had been no generally applicable precise and 
objective conditions regarding the granting of ob server status for international organizations. 
549. The representative of Cameroon supported the vi ews expressed by Nigeria and Angola.  He 
said that OAPI had its headquarters in Yaoundé and his delegation had a moral responsibility to 
support the request of this organization.  If Egypt  was objecting granting a permanent observer status 
to OAPI, he wondered what would justify such a pos ition.   It was good to mention systemic issues, 
but it was also pertinent to state why granting permanent observer status would pose a systemic 
problem.  He also supported the request made by ARIP O.  Both sister organizations worked in Africa 
to serve the continent.  Granting observer status  on a meeting-by-meeting basis did not enable the 
Council to address the issue calmly and in a credible way.   
550. The representative of the United States supported the proposal by Nigeria, Angola, Cameroon 
and others to include OAPI and ARIPO as permanent observers. 
551. The representative of Brazil supported the stat ement by Nigeria to grant ARIPO and OAPI 
permanent observer status.  IP/C/M/67 
 Page 89 
 
 
  552. The representative of India reiterated that the request by the CBD Secretariat had a direct 
relevance to the issues being discussed in the Counc il.  The CBD Secretariat fulfilled all the criteria 
for observership at WTO.  It was an intergovernment al body, and it had more Members than even the 
WTO.  The overwhelming majority of the WTO Me mbers were also party to the CBD.  He urged 
again the Council to positively and expeditiously consider the request of the CBD and until then ad 
hoc invitations should be extended on a meeting-by-meeting basis. 
553. The representative of Zimbabwe said that he  supported Nigeria with respect to granting 
ARIPO and OAPI permanent observer status.  He referre d to the master's degree in IP that was being 
offered at the Africa University in Mutare, Zimb abwe, with the support of WIPO and ARIPO, and 
thought it would be prudent to give these sister or ganizations a permanent observer status.  He also 
said that, at the last meeting, Egypt had been ambiva lent on this issue.  A cl arification would therefore 
be necessary.  However, given what had already been said by Brazil, the United States, Nigeria, 
Cameroon and Angola, he believed that it would be right to give ARIPO and OAPI permanent 
observer status.  
554. The representative of the European Union suppor ted that ARIPO and OAPI, two respectable 
IP organizations with whom the European Uni on had close cooperation links, become permanent 
observers of the TRIPS Council. 
555. The representative of China supported India's proposal and said that the CBD Secretariat 
should be granted observer status as TRIPS/CBD was an important issue at the TRIPS Council.  He 
also supported the proposal by Nigeria to grant OAPI and ARIPO permanent observer status. 
556. The representative of South Africa supported the proposal by Nigeria, Angola and Cameroon.  
He also agreed with the proposal to grant pe rmanent observer status to the CBD Secretariat. 
557. The representative of Ecuador supported Indi a's position with respect to recognition of 
observer status for the CBD on an ad hoc  basis.  His delegation was willing to continue contributing 
to the Chair's consultations on this matter, given the lengthy list of organizations to be evaluated.  He 
also said that the South Centre would as well be a valuable contribution as observer. 
558. The representative of Egypt said that he was not opposing any specific organization to be 
granted observer status.  He had only mentioned the systemic issue and the need to address it in a 
holistic approach.  The requests from various inte rnational organizations, including the CBD, should 
be examined in an overall manner.  He also conf irmed that he supported fu rther consultation on this 
issue. 
559. The representative of Indonesia supported the sugg estion to invite the CBD Secretariat as an 
observer to the Council's meetings and said that th e adoption of the Nagoya Protocol had made it 
more relevant for Members to discuss the relationship between the TRIPS Agreement and the CBD.  He believed that observer status for the CBD Secr etariat was necessary to enrich and deepen the 
discussion. 
560. The representative of Japan supported the pe rmanent observer status for ARIPO and OAPI 
which were relevant to  the TRIPS Council. 
561. The representative of Mauritius, speaking on behalf of the ACP Group, supported the 
proposal of Nigeria.  From what Egypt had just said, an implicit consensus had emerged concerning 
granting permanent observer status to ARIPO and OAP I.  He therefore recommended that the Council 
decide accordingly.  Although Members would need  more time to consider other requests, he 
expressed his support to the admission of the South Centre and the CBD Secretariat. IP/C/M/67 
Page 90  
 
  562. The representative of the United States said that he maintained his position, and that he was 
not in a position to join other Members seeking to include the CBD as an observer.  He looked 
forward to continued consultations. 
563. The representative of Angola, speaking on behalf  of the LDC Group, noted that Egypt had a 
systemic concern it had expressed on behalf of the Ar ab Group.  This had to be addressed in a positive 
way.  He recalled that the status of ARIPO a nd OAPI had been under consideration for nearly one 
year.  Time had been given for things to ripen and so he was ready to have consultations with respect 
to other organizations, for example, with the AC P Group, the South Centre and the GCC. A global 
approach was necessary to establish parameters to discuss this.  However, a fixed approach did not 
seem to be appropriate.  Positions might change, and there was, therefore, a need to be open, as it was 
important in multilateralism to have an open mind.   
564. The representative of Egypt said that, regarding ARIPO and OAPI, ad hoc  observer status had 
been granted, and he was not against consensus.  He just asked for further consultations about the 
other organizations. 
565. The representative of Nigeri a, speaking on behalf of the African Group, thanked the 
delegations that had supported his request for permanent observer status for ARIPO and OAPI.  
Referring also to the master's degree offered by the Africa University, WIPO and ARIPO, he said that 
it was an African institution that was trying to edu cate Africans on IP issues. The bearing was similar 
with the TRIPS Council.  Since there was no consen sus, he welcomed the Chair's consultations and 
hoped that he would come up with a positive conclusion, at least before the eighth Ministerial Conference. 
566. The representatives of Zimbabwe and Angola requ ested that Egypt clarify whether it agreed 
to grant ARIPO and OAPI permanent observer status or whether the requests from these organizations 
should be considered together with other pe nding requests in further consultations.   
567. The representative of Egypt said that he supported ARIPO and OAPI having ad hoc  observer 
status in the TRIPS Council, and affirmed the n eed for further consultations regarding all pending 
requests, including from ARIPO and OAPI.  He said th at he did not have a rigid position.  While he 
had talked about the systemic issue, he was not  opposing any specific organization to be granted 
observer status in the TRIPS Council.   
568. The Chairman suggested that he continue his c onsultations on the issue of observer status for 
international intergovernmental or ganizations and that the Council revert to the matter at its next 
meeting. 
569. The Council took note of the statements made and agreed to proceed as suggested by the 
Chair. 
R.  A NNUAL REPORT  
570. The Chairman said that the draft Annual Re port of the Council to the General Council had 
been circulated in document JOB/IP/5.  It still needed  to be updated so as to reflect the discussions at 
the present meeting.  He suggested th at the Secretariat be requested to update the draft to reflect the 
discussions at the present meeting.  This draft woul d be faxed to Members, who would have one week 
to comment on the updated parts of the draft repor t once it had been circulated by the Secretariat.  IP/C/M/67 
 Page 91 
 
 
  571. The Council so agreed.11 
572. At its reconvened meeting of 17 November, the Chairman suggested that the Council adopt an 
update to the Report covering the reconvened meeti ng, which the Secretariat had prepared at the 
request of the Council and made ava ilable at the reconvened meeting. 
573. The Council so agreed.12 
S. O THER BUSINESS  
(i) Dates of the Council's meetings in 2012 
574. The Chairman suggested that the Council agree on the following dates for its meetings in 
2012:  Tuesday and Wednesday, 28 and 29 February;  Tuesday and Wednesday, 5 and 6 June;  and 
Tuesday and Wednesday, 6 and 7 November. 
575. The Council so agreed. 
 (ii) Invitations to ARIPO and OAPI 
576. The Chairman recalled that, at its meeting in J une 2010, the Council had agreed to grant an ad 
hoc observer status on a meeting-to-meeting basis to the African Regional Intellectual Property 
Organization (ARIPO) and the African Intellectual Pr operty Organization (OAPI).  He suggested that 
the Council again invite ARIPO and OAPI to atte nd the Council's next formal meeting on an ad hoc  
basis. 
577. The Council so agreed. 
578. The representative of Ecuador informed the Council that Ecuador was analysing the 
presentation of a document on technology transfer a nd climate change.  The purpose of the document 
that was being drafted was to facilitate combatting the harmful effects of climate change on the part of 
developing countries who did not have the necessary technologies to do so.  His delegation would be 
carrying out consultations before the next Counc il session, and would circulate the document in a 
timely fashion to Members so that they could assess it. 
__________  
 
                                                      
11 The Annual Report (2011) of the Council for TRIPS was subsequently circulated as 
document IP/C/59. 
12 An addendum to the Annual Report (2011) of the Council for TRIPS was subs equently circulated as 
document IP/C/59/Add.1.