WORLD TRADE  
ORGANIZATION  RESTRICTED 
IP/C/M/66 
2 September 2011 
 (11-4318) 
Council for Trade-Related Aspects of 
Intellectual Property Rights  
 
 
 
MINUTES OF MEETING 
 
Held in the Centre Willia m Rappard on 7 June 2011 
 
Chairperson:  Ambassador Federico A. González (Paraguay) 
 
  The present document contains the record of the discussion which took place during the 
Council for TRIPS meeting held on 7 June 2011. 
 
Subjects discussed Page nos. 
A.  NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT  ......................................................... 2  
B.  REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION  .............................................................. 2  
C.  REVIEW OF THE PROVISIONS OF ARTICLE 27.3( B) ...................................................................... 2  
D.  RELATIONSHIP BETWEEN THE TRIPS  AGREEMENT AND THE CONVENTION ON 
BIOLOGICAL DIVERSITY  ............................................................................................................. 2  
E.  PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE  ................................................... 2  
F.  NON-VIOLATION AND SITUATION COMPLAINTS  ....................................................................... 16  
G.  REVIEW OF THE IMPLEMENTATION OF THE AGREEMENT UNDER ARTICLE 71.1 ...................... 20  
H.  REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON 
GEOGRAPHICAL INDICATIONS UNDER ARTICLE 24.2 ............................................................... 20  
I.  TECHNICAL COOPERATION AND CAPACITY -BUILDING  ............................................................ 20  
1.  Arrangements for th e annual review .................................................................................... 20  
2.  Other matters ................................................................................................................. ......... 21 
J.  LETTER FROM THE CHAIR OF THE GENERAL COUNCIL CONCERNING WAYS TO 
IMPROVE THE TIMELINESS AND COMPLETENESS OF NOTIFICATIONS AND OTHER 
INFORMATION FLOWS  ............................................................................................................... 25  
K.  AUSTRALIA :  TOBACCO PLAIN PACKAGING BILL 2011  AND ITS COMPATIBILITY WITH 
THE TRIPS  AGREEMENT  ........................................................................................................... 26  
L.  INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO .............................. 37  
M.  OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS  ............... 38  
N.  OTHER BUSINESS  ...................................................................................................................... 39  
 
   
 IP/C/M/66 
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  A. N
OTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT  
1. The Chairman said that, since the Council's m eeting in March 2011, Saint Vincent and the 
Grenadines had notified its responses to the Check list of Issues on Enforcement.  These responses 
were being circulated in document IP/N/6/VCT/1. 
2. Ukraine had notified its contact point under Artic le 69 for the exchange of information and 
cooperation on trade in infringing goods.  The list of contact points under Article 69 on the 
transparency toolkit page of the WT O website had been updated accordingly. 
3. He urged those Members whose initial notifica tions of laws and regulations remained 
incomplete to submit the outstanding material w ithout delay.  He also reminded other Members of 
their obligation under the TRIPS Agreement to notif y any subsequent amendments of their laws and 
regulations without delay after their entry into for ce.  He in particular reminded those Members who 
had made any changes to their laws and/or re gulations to implement the Decision on TRIPS and 
public health and who had not yet notified such changes to the Council to do so. 
4. The Council took note of the information provided. 
B. REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION  
5. The Chairman said that, as regards the reviews of national implementing legislation that had 
been initiated at the Council's meetings since April 2001, there were three reviews that still remained 
on the Council's agenda.  These reviews concern Cuba;  Fiji;  and Saint Kitts and Nevis.  He urged the 
delegations concerned to provide the outstanding material as soon as possible, so as to allow the 
Council to complete the follow-up to these reviews. 
6. The Council took note of the information provided. 
C. REVIEW OF THE PROVISIONS OF ARTICLE 27.3( B)  
D. RELATIONSHIP BETWEEN THE TRIPS  AGREEMENT AND THE CONVENTION ON BIOLOGICAL 
DIVERSITY  
E. PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE  
7. The Chairman suggested that the Council continue its past practice of addressing the three 
agenda items together on the basis of contributions by Members. 
8. He recalled that, at the Council's meeting in March 2011, the Plurinational State of Bolivia 
had presented a paper further explaining its earlier proposal to amend the TRIPS Agreement to ban 
patents on life forms (document IP/C/W/554). 
9. He also recalled that, at that meeting, Japa n had made a presentation on the outcome of the 
tenth meeting of the Conference of the Parties (COP10) to the Convention on Biological Diversity 
(CBD) held in Nagoya in October 2010.  India a nd a number of other Members had still wished to 
hear from the CBD Secretariat on the outcome, and had reiterated their suggestion that it be invited to 
provide a briefing on a one-time basis. 
10. As requested by the Council, he said that he had consulted with a number of Members on that 
suggestion.  Those Members that had been in favour  of that suggestion explained that they had felt 
that the CBD Secretariat would be best placed  to give further in-depth information on the 
interpretation and implementation of the Nagoya Protocol on Access to Genetic Resources and the  IP/C/M/66 
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  Fair and Equitable Sharing of Be nefits Arising from their Utilization (the Nagoya Protocol).  
However, some others had felt that the countries that had negotiated the Nagoya Protocol would 
themselves be best placed to discuss any specific issues relating to it. 
11. In his consultations, Members had explored the idea that the CBD Secretariat would organize 
a side event in the margins of the Council's meeti ng.  Some Members had considered that as a good 
option, but some others had felt that, without a form al link to the Council's work, such an event would 
not add value.  There had been a proposal that, if a side event were to be organized, it should then 
result in a formal report to the Council, and that the CBD Secretariat would then be invited to a subsequent meeting of the Council.  However, some Members had felt th at Members themselves 
would be best placed to bring any issues ar ising from such an event to the Council. 
12. He had also discussed with Members the suggesti on El Salvador had made at the last meeting 
that the WIPO Secretariat be invited to brief the Council on the work of the WIPO Intergovernmental 
Committee on Intellectual Property and Genetic re sources, Traditional Knowledge and Folklore 
(IGC).  The reason for that suggestion was merely to provide the opportunity for all delegations 
present, particularly the smaller delegations that di d not cover work at WIPO, to have an update on 
proceedings in the IGC.  However, some Members had not found it necessary to have such a briefing 
at the Council's present meeting, but rather thought that such a briefing might be more useful at the 
meeting of October 2011.  Accordingly, the Counc il might wish to consider at its October meeting 
whether to invite WIPO Secretariat to speak on that matter. 
13. The representative of Plurinational State of Bolivia said that, at the TRIPS Council's meeting 
in March 2011, his delegation had submitted a second communication (IP/C/W/554) concerning the 
review of Article 27.3(b).  The adoption of Ar ticle 27.3(b) of the TRIPS Agreement had been 
conducive to an extension of the patent system to life forms and their components and to manipulations based on them.  Furthermore, laws allo wing the patenting of life in all its diversity had 
become widespread and his delegation was witnes sing the spread and multiplication of patents on 
forms of plant, animal or human life or on their co mponents such as genes, cel ls, substances, proteins 
or tissues. 
14. Figures showing the exact extent of such patent s were scarce, but those that did exist gave 
some idea of the consequences of the adoption of Article 27.3(b).  Already in 2000 there had been 
patents on 500,000 genes of living organisms, and 918 patents had been awarded in 1999 for seeds as 
essential as maize, rice, soya, sorghum or wheat.  By  2005, 20 per cent of all human genes had been 
patented in the United States.  It appeared that  660 animals had been patented by 2010 and patents 
awarded on animal tissues or cells had increased.  And those figures represented only the tip of the 
iceberg.  The tendency was undoubtedly even deeper and more widespread. 
15. For Bolivia, the proliferation of patents on life forms was a source of concern, primarily for 
moral or ethical reasons, or in other words because of the way it conceived of life.  Manipulated and patented life forms were labelled biotechnologies,  but life did not stop being life because human 
beings discovered or developed it or because it met the requirements for patentability.  A genetically 
modified microorganism, a gene for which a func tion had been discovered, or a patented seed, 
remained forms of life even if they were  assigned names of biotechnology inventions. 
16. Many peoples and cultures around the world saw life as the foundation and source of 
everything, as most precious possession, as something special which should on no account be treated as a thing or a commodity.  To treat life as some kind of technology was unacceptable.  Being so 
special and fundamental, life, whatever its form, should not fall within the scope of patentable 
material or be the subject of exclusive use rights or private monopolies. IP/C/M/66 
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  17. He said that the current syst em under Article 27.3(b) was fundamentally unjust.  For 
thousands of years, the peoples of Bolivia, like other peoples, had cared for life and safeguarded 
biodiversity, combining, crossing and developing new varieties and identifying their characteristics.  
Plants and animals had been identified, domesticat ed and developed for food, health or industry 
without a single claim to exclusive rights bei ng made.  Indeed, the knowledge and technologies 
acquired had been shared with the world.  Bu t today, the developed countries were claiming 
monopolies on resources from the very biodiversity  that Bolivia had preserved, identified and 
developed. 
18. Article 27.3(b) allowed a handful of transnati onal companies to appropriate and privatize our 
collective heritage, which was no more or less th an the silent theft of centuries of knowledge, 
technologies and practices developed collectively by the peoples.  Not only did the patenting of life 
raise issues of justice, or morality and ethics, it ha d serious consequences and adverse effects.  It was 
said that the patenting of life was necessary to  stimulate innovation and the development of 
biotechnologies, and that without patents there would be no one to work out solutions to humanity's 
major problems. 
19. The fact was that the patenting of life encouraged only a certain type of innovation:  the kind 
that enabled the large transnationals to strengt hen their monopolies and create more dependency for 
peoples, the kind that suited large-scale investors an d the owners of wealth.  And when there were no 
potential markets for establishing monopolies, no so lutions were worked out.  The gains that 
monopolies obtained through patents were not put towards financing research and innovation, but 
ended up in the pockets of large-scale investors. 
20. With the patenting of life, the future of the plan et was put in the hands of a few transnationals 
whose sole aim was profit and not the common good of humanity.  To prohibit the patenting of life 
would no doubt thwart their desire for gain, cont rol and monopoly.  But there had been and still were 
other models for innovation and research.  Monop oly was not the only means of encouraging and 
funding innovation and research.  Not all the player s involved in research and innovation were driven 
by an unquenchable thirst for gain or by the profit motive alone.  There were many who in fact 
already worked in a monopoly-free environment seeki ng solutions for the future of humanity and the 
good of peoples.  The complaint heard increasingl y among scientists now was that the patenting of 
life had adverse effects on innovation and limited the possibilities of research, particularly when such 
fundamental elements as genes were patented. 
21. The adverse effects of that system far outweighed the benefits.  It was a system that allowed 
patent owners to restrict access to innovations and fe tter the freedom of those that use them.  That had 
serious adverse consequences for peoples, particularly  in terms of health and access to medicines and 
treatment, or in terms of agriculture and food and acce ss to seeds.  The patenting of seeds was without 
doubt one of the main threats since under the patent  system royalties could be extracted from peoples 
and farmers thus limiting their freedoms and restri cting their traditional and ancestral practices.  
Farmers the world over had lost the freedom to tr ade their seeds and soon they would have to pay 
royalties to use seeds that belong to them.  Drugs we re sold at exorbitant prices by companies that 
have sole rights to produce and use them.  I ndigenous peoples saw their traditional practices 
threatened and soon they would have to pay royaltie s to carry on using their traditional medicines. 
22. A future worrying tendency that had been identified was the race to patent plants and plant 
components that had valuable traits for coping wi th climate change.  Those resources, on which the 
future of humankind might well depend, were now in  the hands of a few transnationals, the very 
companies that were largely responsible for cl imate change and to which peoples would end up 
paying royalties in order to use seeds that they developed using biodiversity.  By 2008, it would 
appear that more than 500 patents had been register ed on plant genes that were resistant to climate 
change.  IP/C/M/66 
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  23. The way forward was not for each  one to privatize and patent biodiversity and knowledge, but 
rather to free the world of all monopolies and exclusive use rights over what people hold to be most fundamental in that world, namely life, biodiversity and their components. 
24. In view of the foregoing, he reiterated Bolivia's  proposal to review and amend Article 27.3(b) 
with a view to prohibiting the paten ting of life forms and parts thereof. 
25. The representative of the Bolivarian Republic of  Venezuela supported Bolivia's proposal in 
view of the need, and the ministerial mandate, to conduct a review of Article 27.3(b) of the TRIPS 
Agreement.  Domestic legislation, specifica lly Articles 124 and 127 of the Constitution of the 
Bolivarian Republic of Venezuela, prohibited the regi stration 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 en tire world.  It was well established that morals 
were the foundation and source of rules and the law, since the law was there to respond to forms of 
life in society - in other words the law could not ex ist without some "moral" basis, the word "moral" 
coming from morada, meaning a dwelling, a place where one lived.  Thus, international 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 pa tent 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-
forgotten indigenous peoples of Venezuela were re presented 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. 
26. 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 stipulat ed 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 Octo ber 2010 who had said that the review had been 
intended not so much to revise content as to fo cus 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 la w 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. 
27. 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, and 
more importantly, because the issue of intellectual property was closely linked to human rights such 
as food security, education, health and the right to self-fulfilment, among others, which must be 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 Un ited Nations and the Millennium Goals, which were 
established in an attempt to make them more universal. 
28. Regarding the question of access to genetic resour ces, he highlighted the sovereignty of States 
and their indigenous peoples over their biological re sources, 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 Ve nezuela, its sovereignt y would be violated. 
29. The representative of Brazil said that the TRIPS- CBD issue had been the object of extensive 
and detailed technical discussions at the WTO over the past years.  The discussions had taken place 
not only in the TRIPS Council but also in the consultations conducted by Director-General Lamy.  The Director-General's report of 21 April 2011 (document WT/GC/W/633) covered the three TRIPS-IP/C/M/66 
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  related issues.  The report clearly indicated that  Members had covered many grounds and that the 
discussions had been useful for all parties involved. 
30. The report indicated that "Members have consis tently voiced support for the principles and 
objectives of the CBD, including the principle of prior informed consent and the principle of equitable 
sharing of benefits.  They have agreed on the need to take steps to avoid erroneous patents, including 
through the use of databases, as appropriate, to av oid patents being granted on existing traditional 
knowledge or genetic resources subject-matter.  N one of the proposals discussed, namely disclosure 
requirements, databases, or the use of contracts, was proposed as a stand-alone response or complete solution to all problems outlined.  Members con tinue to differ on whether the formulation and 
application of a specific, tailored disclosure mechan ism relating in particular to genetic resources and 
associated TK would be useful and effective in ensuring that the patent system promoted CBD 
objectives, or whether other mechanisms should be preferred."  The report was a concise and fair 
reflection of where Members stood at the moment. 
31. He said that there was a broad convergence of views on the prevention of both 
misappropriation of genetic resources and the grant of erroneous pate nts, while differences persisted 
on how to pursue those objectives.  Brazil remained  hopeful that further debate in the Director-
General's consultation process and in the TRIPS C ouncil would help bridge th e existing differences.  
He recalled that the group of countries including Br azil, China, Colombia, Ecuador, India, Indonesia, 
Peru, Thailand, the ACP Group and the African Group had tabled a new proposal on 15 April 2011 
(document TN/C/W/59), which was intended to amend the TRIPS Agreement by inserting a new 
article entitled "Disclosure of Origin of Ge netic Resources and/or Associated Traditional 
Knowledge". 
32. TN/C/W/59 had been drafted as a legal text, which should be one of the bases for further 
discussion.  Against the current background of uncerta inty as to the way forward in the Doha Round, 
while Members continued to favour the parallel trea tment of the three intellectual property issues in 
the Round, it did not mean that each issue could not be considered on its own merits.  The protection 
of genetic resources and associated traditional know ledge against misappropriation had always been a 
priority for the developing countries. 
33. He supported the proposal to invite the CBD Se cretariat to make a briefing on the Nagoya 
Protocol in the TRIPS Council, and was open to the proposal to invite the WIPO Secretariat.  He 
suggested that the Chair conduct consultations on th at proposal.  Given that there would be a key 
session of WIPO IGC in July 2011, he proposed that the TRIPS Council wait until October 2011 to 
invite WIPO to make such a briefing. 
34. The representative of Peru said that the three agenda items were of the utmost importance in 
view of the current climate surrounding the Doha  Round negotiations.  Memb ers were reflecting and 
consulting how to proceed over the next few months .  That included the possibility of achieving some 
result for the Ministerial Conference in Decemb er 2011 as an early harvest that would ensure 
subsequent results in the other areas of the Single Undertaking.  He said that any result in those 
negotiations must reflect the interests of the devel oping countries, particularly in the area of protection 
of genetic resources, traditi onal knowledge and folklore. 
35. Peru supported an amendment to the TRIPS Agre ement to bring it in line with the provisions 
of the CBD.  A requirement for multilateral and ma ndatory disclosure would be the most efficient 
way to address the problem of misappropriation of genetic resources and traditional knowledge, as it 
would allow all countries to identify the supplying c ountry by requiring patent applicants to disclose 
the country of origin as well as the evidence of co mpliance with prior informed consent and benefit 
sharing.  That conviction, in addition to the need  to improve the system to prevent biopiracy, had 
prompted Peru not only to co-sponsor, with so me 110 Members, document TN/C/W/52, but also  IP/C/M/66 
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  document TN/C/W/59 which aimed at enhancing th e relationship between the TRIPS Agreement and 
the CBD. 
36. The co-sponsors of document TN/C/W/59 called for the inclusion of an Article 29 bis in the 
TRIPS Agreement which would seek to establish a mutually supportive relationship between that 
Agreement and the CBD by incorporating the disclos ure of origin requirement as well as evidence of 
prior informed consent and benefit sharing in pa tent applications involving the use of genetic 
resources and/or associated traditional knowledge.  That requirement would facilitate the compliance 
with the provisions of the CBD, help to preven t biopiracy through the patent system, and ensure 
adequate compatibility between th e TRIPS Agreement and the CBD. 
37. Peru was not seeking to prevent access to or use of its genetic resources, but to protect them 
against biopiracy in order to ensure that they were  used sustainably to the benefit of all Peruvians, 
particularly indigenous communities.  Inclusion of the disclosure of origin requirement would ensure 
the recognition of legitimate rights of peoples over th eir genetic resources, thereby adding to their 
development potential.  
38. His delegation could not imagine a successful c onclusion of the Round without any results in 
that area.  Peru was fully convinced of the importa nce of intellectual property systems as a tool for the 
economic, social and cultural development of c ountries.  Because of that conviction and the 
development mandate of the Doha R ound, his delegation attached such importance to that issue as one 
of the outstanding implementation related issues ment ioned in paragraph 12 of the Doha Declaration.  
An outcome on that issue would enable Members to  establish a proper balance in the patent system 
and in the intellectual property system for the bene fit of all, particularly the local and indigenous 
communities of developing countries. 
39. Finally, he supported the proposal to invite th e CBD Secretariat to provide a briefing on the 
Nagoya Protocol, saying that the relationship between the TRIPS Agreement and the CBD was 
obvious.  He also said that it would be useful a nd appropriate for the WIPO Secretariat to provide 
Members with an update on the negotia ting process taking place within the IGC. 
40. The representative of India said that India was rich in biodiversity and associated traditional 
knowledge, which were both coded as it existed in ancient texts of I ndian systems of medicines, and 
also non-coded, as it existed in oral undocumen ted traditions.  India was one of the twelve 
mega-diverse countries.  With only 2.4 per cent of the land area, India already accounted for seven to 
eight per cent of the recorded species of the worl d.  That number was based on the survey of 65 to 
70 per cent of the total geographical area of the country.  Over 47,000 species of plants and 81,000 
species of animals had been recorded by the Botani cal Survey of India and the Zoological Survey of 
India respectively.  It was anticipated that some of the remaining areas, e.g. the Himalayan region and 
the A&N Islands might be far richer in biological diversity than most of the areas already surveyed.  
India was also one of the twelve primary centres of or igin of cultivated plants.  India was equally rich 
in traditional and indigenous know ledge, both coded and informal. 
41. Pursuant to ratification of the CBD, India had developed a compre hensive legislation on 
biodiversity.  It had enacted a Biological Dive rsity Act in 2002 and notified Biological Diversity 
Rules in 2004.  That Act gave effect to provisi ons of the CBD, including those relating to access and 
benefit sharing.  In 2003 the National Biodiversity Au thority had been set up.  All matters relating to 
requests for access by foreign indivi duals, institutions or compani es, and all matters relating to 
transfer of results of research to any foreigner were  dealt with by the Nationa l Biodiversity Authority. 
42. While India was undertaking a number of measures at the national level in order to prevent 
misappropriation of genetic resources and/or associ ated traditional knowledge, the problem had an 
obvious international dimension and needed an in ternational solution in order to be addressed IP/C/M/66 
Page 8  
 
  effectively.  In the past, there had been several  instances of misappropriation of genetic resources 
and/or traditional knowledge.  Studies undertaken in the year of 2000 by the Indian Council for Scientific and Industrial Research (CSIR) had estimated that about 2,000 wrong patents concerning 
Indian systems of medicine alone were being granted every year at the international level.  India had 
been a major victim of biopiracy. 
43. While India had pioneered the Traditional Know ledge Digital Library (TKDL) to overcome 
language and format barriers, the results could only be limited.  Improving prior art searches through 
the TKDL was only one part of the solution.  Furt her, the TKDL represented a subset of the universe 
of available traditional knowledge.  The realm of traditional knowledge in areas other than herbal 
cures and genetic resources was not covered by the T KDL.  The flip side of databases in general was 
that they might attract undesirable attention and mi ght actually become a tool for misappropriation of 
genetic resources and traditional knowledge and furt her aggravate the problem if they were not 
handled carefully. 
44. India and other developing countries had propo sed viable solutions contained in document 
TN/C/W/59.  A mandatory disclosure requirement in  patent applications to include disclosure of 
origin and evidence of prior info rmed consent and access and benefit sharing, would, in addition to 
combating biopiracy, further strengthen the credibilit y of the patent system by facilitating assessment 
of the novelty and inventiveness criteria. 
45. He reiterated that the TRIPS-CBD issue was one of the outstanding implementation issues 
and positive outcomes on outstanding implementation issues were one of the most important deliverables of the Doha Round for the developing c ountries.  Exhaustive discussions alone in the last 
ten years on the TRIPS-CBD issue were not eno ugh.  Members needed constructive engagement 
which was sadly missing on part of some developed Members.  The recent document TN/C/W/59 could be a good basis for future work and his de legation stood ready for discussions to move that 
process forward. 
46. He noted that some Members could not agree to a presentation by the CBD Secretariat on the 
Nagoya Protocol.  He said that the CBD had alre ady made similar technical presentations in WIPO 
and the WHO and that it was ironical that the sa me Members who opposed a presentation by the CBD 
Secretariat in the WTO had had no problem in WIPO  and the WHO.  He reiterated his delegation's 
demand for a presentation by the CBD Secretariat on the Nagoya Protocol.   In response to the suggestion that the CBD Secretariat be asked to ma ke a presentation in an informal meeting, he said 
that Caterpillar, a private entity, could be invited to make a presentation in a NAMA meeting, but the 
CBD Secretariat, an intergovernmental organizati on with 193 members, was either not being allowed 
or was being asked to make a presentation in an informal setting. 
47. Responding to the suggestion that the CBD Secretar iat be invited to make a presentation in a 
side event, he said that, in order to move the process forward, his delegation could consider that 
suggestion only as an integrated  package where the CBD Secretariat would make a presentation on 
the Nagoya protocol in a side event;  with a report on the presentation to be considered in the TRIPS 
Council; and with an opportunity given to the CBD Secretariat to respond to Members' questions in 
the TRIPS Council. 
48. In conclusion, he quoted paragraph 2 of the Doha Ministerial Declaration, reading "the 
majority of WTO Members are developing countries. We seek to place their needs and interests at the heart of the Work Programme adopted in this Decl aration."  He said that the TRIPS-CBD issue was 
one such issue which was important for developi ng countries and needed a speedy resolution. 
49. The representative of Colombia said that genetic resources were of great interest to the 
biotechnology industry since they offered viable, hi gh-potential alternatives for resolving problems in  IP/C/M/66 
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  areas such as health, food security, production, a nd protection of the environment.  Such resources 
and associated traditional knowledge were a fundament al part of the wealth and culture of mega-
diverse countries such as Colombia, and were thus i nherent in their communities and strategic to their 
sustainable development.  
50. Members had long shared and supported the following objectives:  (i) to ensure authorized 
access to genetic resources, i.e. that prior informed consent is obtained;  (ii) to achieve equitable 
sharing of benefits arising from the use of genetic  resources and traditional knowledge;  and (iii) to 
prevent the erroneous granting of patents.  In th at connection, the main issue that had been under 
discussion was the need to revise intellectual prop erty systems and incorporate mechanisms that 
would help address the monitoring and follow-up di fficulties highlighted by mega-diverse countries 
dealing with biopiracy. 
51. The debate should be geared towards identifyi ng points of convergence between the rules on 
intellectual property protection in the TRIPS Agre ement and those relating to the conservation of 
biological diversity and the use of its components,  including genetic resources, which were governed 
by the CBD.  The goal was that the regime covering access to genetic resources and benefit sharing 
should be consistent with the objectives of both systems and that these should thus be 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 provi ded for in paragraph 19 of the Doha Declaration 
in a constructive manner. 
52. The communication and proposal recently submitted by a group of Members in 
document TN/C/W/59 was in line with such objectiv es.  The proposal sought to establish legality of 
access as a prerequisite for engaging in research fo r and the development of any invention in the 
biotechnology field and the use of biological or ge netic resources or products derived therefrom, and 
the demonstration of such legality of access in a patent application for the product or process 
involved. 
53. He acknowledged that the Director-General's c onsultations by the ministerial mandate had 
sought to lend structure to that de bate.  He nevertheless also noted that all those endeavours had failed 
to deliver concrete results.  That debate concer ned one of the implementation-related issues.  By 
"implementation" he meant the problems encounter ed by developing countries in particular in 
implementing the current WTO Agreements, i.e. the Agreements arising from the Uruguay Round 
negotiations, including the TRIPS Agreement. 
54. He said that the Ministers in Doha had handled the implementation-related issues in two 
ways.  First, they had adopted around 50 decisions clarifying the obligations of developing country 
Members.  As regards the other implementation-related issues, the Ministers had agreed in Doha on a future work programme.  To the extent that the la tter issues had remained unresolved, the system still 
owed an outstanding debt to developing countries.   The relationship between the TRIPS Agreement 
and the CBD fell into that second category.  He urge d the membership and the Director-General to act 
with a sense of urgency so as to deliver an  expeditious outcome satisfactory to all. 
55. The representative of Indonesia highlighted th e important relationship between the TRIPS 
Agreement and the CBD and the protection of traditio nal knowledge and folklore .  As a proponent of 
documents TN/C/W/52 and TN/C/W/59, he believed that it was time to take bold steps to address that 
issue in the TRIPS Council in order to achieve progress.  The problem of biopiracy and misappropriation of genetic resources and traditiona l knowledge had been taking place for such a long 
time.  Many developing countries continued to lo se economic benefits that had been acquired from 
genetic resources and traditional kn owledge.  Instead they were payi ng more for new inventions that 
were created by using those genetic  resources and traditional knowledge. IP/C/M/66 
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  56. The Nagoya Protocol was a major step to end that situation.  It stipulated procedures 
concerning prior informed consent and benefit shar ing for access to genetic resources and associated 
traditional knowledge.  Paragraph 19 of the Doha Declaration gave a mandate to WTO Members to 
review Article 27.3(b) and examine the relations hip between the TRIPS Agreement and the CBD and 
the protection of traditional know ledge and folklore.  In acco rdance with that mandate, WTO 
Members should continue working to improve a nd strengthen the mutual supportiveness of the TRIPS 
Agreement and the CBD. 
57. To that end, and taking into account the new development with the adoption of the Nagoya 
Protocol, Indonesia reiterated the importance of  amending the TRIPS Agreement to include a 
disclosure requirement of origin of genetic resour ces and associated traditi onal knowledge in patent 
applications.  As one of the co-sponsors of docu ments TN/C/W/52 and TN/C/W/59, Indonesia was of 
the view that the amendment of the TRIPS Ag reement was one of the important development 
outcomes in the area of trade that Doha Developm ent Agenda should deliver.  The TRIPS-CBD issue 
together with the issues of GI register and GI ex tension should be discussed in parallel in the TRIPS 
Council as part of the Single Undertaking. 
58. The representative of China said that WTO Members should take appropriate and effective 
measures to prevent misappropriation of genetic r esources and avoid erroneous patents. The TRIPS 
Agreement, the CBD and the Nagoya Protocol should operate in a mutually supportive way.  As one 
of the co-sponsors of documents TN/C/W/52 an d TN/C/W/59, China believed that mandatory 
disclosure requirements would improve the transparency  of the utilization of genetic resources and/or 
associated traditional knowledge, and help  to achieve the shared objectives. 
59. He appreciated the Director-General's consultations on the issues of TRIPS-CBD and GI 
extension as outstanding implementation-related i ssues in the Doha Round.  Negotiations on those 
issues should be an integral part of the Work Pr ogramme, and the outcome of the negotiations should 
be treated as part of the Single Undertaking.  The consultations should be c ontinued based on a legal 
text. 
60. He supported the proposal to invite the CBD Secr etariat to make a presentation in the TRIPS 
Council, and was open to the proposal to invite the WIPO Secretariat to make a presentation, as those 
presentations would help improve Members' understa nding of the Nagoya Protocol and the work of 
the WIPO IGC, which would contribute to the co operation between the WTO and other international 
organizations. 
61. The representative of Turkey said that negotiations  on the three TRIPS issues were part of the 
Doha Round and the outcomes an integral part of the Work Programme and the Single Undertaking.  
She welcomed the Director-General's report on his consultations on the issues of GI extension and 
TRIPS-CBD, which had been circulated together  with all other Doha Development Agenda 
documents. 
62. She welcomed the submission of documents TN/C /W/59 and TN/C/W/60.  With regard to the 
TRIPS-CBD issue, she supported the view that th e TRIPS Agreement should be amended to introduce 
a mandatory disclosure requirement, but her delega tion had an open mind on the introduction of prior 
informed consent and access and benefit-sharing requirements. 
63. The representative of Ecuador supported the c ontinuation of the debate based on Bolivia's 
submission.  Members could take into account the discussion on the exclusion of patentability as 
provided in Article 27 of the TRIPS Agreement as an intermediate step to address some Members' 
concerns.  IP/C/M/66 
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  64. According to the mandate provided for in Ar ticle 27.3(b) of the TRIPS Agreement and 
paragraphs 12 and 19 of the Doha Ministerial Decl aration, it was important for the TRIPS Council to 
find a multilateral solution on biopiracy and protec tion of traditional knowledge.  Therefore, his 
delegation had co-sponsored the disclosure proposal contained in document TN/C/W/59.  Given the 
lack of efficiency and effectiveness of regional and national laws to tackle the issue of biopiracy, the 
solution should be found at the international level.  The Director-General's suggestion to put some of 
the outstanding implementation issues in the slow la ne was not a viable solution, because they were 
matters of urgency. 
65. Referring to India's proposal to invite the CBD S ecretariat to make a report, he supported that 
proposal as it was vital for the TRIPS Council to unde rstand the Nagoya Protocol in order to move its 
work forward. 
66. The representative of Thailand said that the Dir ector-General's consultations on the issues of 
TRIPS-CBD and GI extension that led to the subm ission of two text-based proposals, both of which 
had been co-sponsored by Thailand.  He followe d the negotiations on the three TRIPS issues in 
parallel as part of the Single Undertaking and looked  forward to the next TNC meeting to clarify the 
way to move forward. 
67. The representative of Japan said that the biopira cy issue could be divided into two issues: 
erroneously granted patents and the CBD complia nce.  Appropriate solutions should be sought 
respectively, bearing in mind that those solutions  should not have adverse impacts on intellectual 
property systems.  Regarding the CBD compliance,  the Nagoya Protocol had provided solutions and 
Members should focus on how to implement these agreed solutions. 
68. He said that the WIPO IGC had made meani ngful progress on its work on the protection of 
genetic resources.  The objectives and purposes id entified through discussions provided a good basis 
for future work, since without well-defined obj ectives and purposes it was impossible to reach 
appropriate options.  The TRIPS Council could learn a lot from the exercises in the IGC. 
69. With regard to the Bolivian proposal, he reite rated the importance of patent systems as an 
incentive for technological development in the field of biotechnology. 
70. The representative of Australia  said that, as a mega-diverse country, Australia had a unique 
indigenous culture and a strong interest in a bala nce between holders and users of genetic resources 
and associated traditional knowledge.  As a Party to the CBD, Australia shared relevant objectives in 
relation to genetic resources and associated trad itional knowledge, including to facilitate access to 
genetic resources with prior informed consent and on  mutually agreed terms, to take measures aimed 
at equitable sharing of the benefits of the utilizati on of genetic resources, and to respect, preserve and 
maintain traditional knowledge.  In that regard, Aust ralia's access and benefit sharing system provided 
for access and benefit sharing in relation to gene tic resources and associated traditional knowledge 
consistent with their obl igations under the CBD. 
71. Australian national experience indicated that effective benefit-sharing regimes could be 
implemented without making changes to the patent system.  Accordingly, the TRIPS Agreement and 
the CBD were consistent and could be implemente d in a mutually supportive manner.  Nevertheless, 
Australia was prepared to engage constructivel y in discussions on genetic resources in relevant 
international forums, including WIPO, the WTO, the CBD and the WHO. 
72. Australia considered that disclosure require ments might merit further consideration in 
conjunction with other options such as databases.  In that regard, the WIPO IGC was undertaking a 
detailed consideration of the rela tionship between intellectual prope rty and genetic resources as well 
as traditional knowledge and folklore.  The WIPO IGC had been requested to submit the text of an IP/C/M/66 
Page 12  
 
  international legal instrument or instruments on th e protection of the three subject matters to the 
WIPO General Assembly in September 2011.  The WI PO IGC had undertaken work in that area, and 
it was an appropriate forum to discuss in detail intellectual property issues relating to traditional 
knowledge and genetic resources. 
73. Australia had participated actively in the Dir ector-General's informal consultations on the 
TRIPS-CBD issue.  However, significant divergences remained, and her delegation remained 
unconvinced that there was a need to amend the TRIPS Agreement as proposed in document 
TN/C/W/59. 
74. The representative of Nigeria said that, fro m document TN/C/W/474 to TN/C/W/59 via 
TN/C/W/52, the African Group, together with the large group of developing countries, had been 
advocating for the amendment of the TRIPS Agreem ent in order to introduce a mandatory disclosure 
requirement in patent applications.  To achieve a mandatory requirement in the TRIPS Agreement, the 
proposal contained in TN/C/W/59 could be a basis for further work in addressing the problem of 
misappropriation of genetic resources and traditiona l knowledge.  In that regard, the African Group 
welcomed the provisions contained in the Nagoya Protocol, in particular those regarding prior 
informed consent and access and benefit sharing.  That issue being part of an outstanding 
implementation issue needed to be given high prio rity in consultations on the way forward in the 
DDA negotiations because an outcome on that issue was a step forward in assuring the developing 
countries that the Doha Round was a development round. 
75. He fully concurred with the proposal made by I ndia to invite the CBD Secretariat to make a 
presentation in a side event whereby the report of th e side event would be considered in the TRIPS 
Council, and thereafter the CBD Secretariat would be invited to respond to questions raised by 
Members. 
76. The representative of Switzerland said that his delegation attached great importance to 
ensuring food security, health and efficient action agai nst climate change.  In the view of Switzerland, 
new technology was key to address those challenges.  It considered the patent system as an important 
tool to incentivize and disseminate such innovation.  Therefore, it would not be  appropriate to exclude 
biotechnology or any other technical field from patent protection. 
77. Article 27.3(b) of the TRIPS Agreement provide d sufficient flexibility to take the specific 
needs of developing countries and indigenous peoples into account.  The way in which the patent 
system was implemented in Switzerland showed that  different interests could be integrated and 
balanced.  Switzerland shared the view of Bolivia th at patents shall only be available for inventions, 
not for discoveries, as reflected in Article 27.1 of the TRIPS Agreement.  Different tools could 
improve patent quality to ensure that patents were  only granted to products or processes that were 
new, involved an inventive step and were capable of industrial application. 
78. Databases helped avoidi ng patents on inventions which did not fulfil the novelty requirement.  
Switzerland had proposed the establishment of an international gateway for traditional knowledge 
(see documents IP/C/W/284, paragraphs 16-19, an d IP/C/W/400/Rev.1, paragraphs 30-32).  That 
gateway would electronically link existing databases and thus facilitate access to their contents by 
patent authorities. 
79. Another tool to enhance transparency in pa tent application procedures was the disclosure 
requirement.  In that regard, Switzerland had subm itted proposals to WIPO and to the TRIPS Council 
respectively and also co-sponsored document TN/C/W/52, containing proposals for three TRIPS 
issues under negotiation in the Doha Round, and the pr oposal for a disclosure requirement in patent 
applications.  At the national le vel, Switzerland had introduced a disclosure requirement for patent 
applications in relation to genetic  resources and traditional knowledge.  IP/C/M/66 
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  80. As a transparency measure, the disclosure require ment could help to pr event the granting of 
bad patents.  During the patent application, the exam iner had to select databases for prior art searches.  
The patent examiner's awareness of the source of genetic resources or traditional knowledge on which 
the invention was based might help the examiner to decide which databases he had to include for prior 
art searches.  Therefore, traditional knowledge da tabases and disclosure requirements were both 
efficient mechanisms to increase patent quality, to avoid patents on discoveries and ultimately to 
ensure a fair and equitable participation of all stakeholders in biotechnological inventions. 
81. At the TRIPS Council's March 2011 meeting, several Members, including the United States, 
had expressed concerns vis-à-vis the disclosure require ment in patent applications.  He said that the 
disclosure requirement should not hamper the patent  system and should not be burdensome on patent 
applicants and patent offices.  When designing inte rnational proposals and the provisions of the Swiss 
Patent Law, great care had been taken to avoid those pitfalls and to come up with a balanced 
approach.  For those reasons, Switzerland had chosen the concept of "source". 
82. Referring to the case study of "Velcro", he said that the hook-and-loop fastener had been 
invented in 1941 by a Swiss engineer, Georges de Mestral.  The idea had come to him one day after 
returning from a hunting trip with his dog in the Al ps.  He had had a close look at the seeds of the 
thistle plant "burdock" that had ke pt on sticking to his clothes and his dog's fur.  He had examined 
them under a microscope, and noted their hundreds of "hooks" that had caught on anything with a 
loop, such as clothing, animal fur, or hair.  He  had seen the possibility of binding two materials 
reversibly in a simple fashion.  It had taken te n years to create a mechan ized process to produce the 
hook-and-loop fastener.  De Mestral had received pa tents for his invention in numerous countries in 
the mid-1950s. 
83. In response to the question of whether the di sclosure of source requirement in the Swiss 
Patent Law would apply to the Velcro case, he assu med a situation where de Mestral would have filed 
the patent application after the entry into force of  the CBD and of the disclosure of source requirement 
in the Swiss Patent Law in 2008.  The disclosure of  source requirement in the Swiss Patent Law did 
apply – in addition to traditional knowledge – to "gen etic resources."  That term was defined in the 
CBD as genetic material, i.e. any material of plant, animal, microbial or other origin containing functional units of heredity that is of actual or po tential value.  As previously stated, the objective of 
the disclosure of source requirement in the Swiss Patent Law was to increase transparency in access 
and benefit sharing.  Both Article 5 (fair and e quitable benefit sharing) and Article 6 (access to 
genetic resources) of the Nagoya Pr otocol applied only as far as the utilization of genetic resources 
was involved.  The recently adopted Nagoya Protoc ol defined "utilization of genetic resources" as 
conducting "research and development on the genetic  and/or biochemical composition of genetic 
resources, including through the application of biot echnology."  Based on that definition, the Velcro 
case was not a case of utilization of genetic resour ces.  The inventor of Velcro did not conduct R&D 
on the genetic or biochemical composition of the plan t involved.  Accordingly, the patent application 
submitted by de Mestral would not have had to disclose the source of the plant used in the 
development of the invention. 
84. For the sake of the argument, if the disclosure of source requirement would  apply to the 
Velcro case, de Mestral as the patent applicant w ould simply have to declare the source, i.e. the 
location where he had found the plant in question, i. e. the specific location and place, e.g. a forest, a 
moor, a mountain, a natural reserve, or others.  Th at was information readily available to him.  The 
Swiss legislation was an example of how a discl osure requirement could be implemented without 
burdening patent applicants.  More detailed informat ion on the concept of "source" was available in 
document IP/C/W/423, in partic ular paragraphs 14 to 23. 
85. Regarding contractual and national approaches,  he questioned how those purely national and 
contractual approaches could address problems aris ing from transboundary access and benefit sharing, IP/C/M/66 
Page 14  
 
  that is, where genetic resources and traditional knowle dge were used outside the scope of application 
of national provisions;  how the purely contractual approach could address cases where no contract on 
access and benefit sharing had been concluded between  the provider and the user of genetic resources 
and/or traditional knowledge;  how those approaches could resolve the need fo r transparency in access 
and benefit sharing;  how those approaches would ta ke into account the general long-term nature of 
research and development activities involving genetic  resources;  and how the purely contractual 
approach could ensure that the obligations arising from the contract would be fulfilled even if between 
the conclusion of the contract and the end of the research activities lay several years, and the parties 
originally involved might no longer be involved or exist.  He also questioned what specific proposals 
beyond the establishment of databases those Members had that would increase transparency in access 
and benefit sharing. 
86. He said that all those questions, as contained in document IP/C/W/446, were still pertinent, 
and replies to them from those delegations prom oting the purely contractual approaches would be 
useful for discussions in the TRIPS Council. 
87. The representative of New Zealand said that, wh ile few patents originated from New Zealand 
in the global scheme, her delegation had a systemic in terest in the stability of the patent system.  It 
also had a significant indigenous interest in pr eventing misappropriation of New Zealand's genetic 
resources and traditional knowledge.   
88. While New Zealand's domestic policy was still evol ving, it was clear that its interests were 
much wider than erroneous patents and misappr opriation of genetic resources.  A narrow WTO 
response related to patent disclosure would detract  from the broader issues associated with protection 
of traditional knowledge and biological resources.   Many issues were not directly related to 
intellectual property, and could therefore not be r esolved through intellectual property systems.  For 
that reason, solutions should be de veloped within the WIPO IGC, whic h was able to look at all related 
issues in a holistic and coordinated way.  New Z ealand was active and constructive in the IGC and 
was putting all of its efforts into the fulfilment of the IGC mandate. 
89. The representative of United States said that  all Members agreed on the need to avoid 
erroneous patents and on ensuring that patent offi ces had available the information needed to make 
proper decisions on patent grants for inventions linked to genetic resources and traditional knowledge.  
His delegation was committed to meet ing those needs, and also recognized the general principles of 
prior informed consent and equitable sharing of benefits and the importance of securing compliance 
with national benefit-sharing regimes. 
90. As one of the top twenty mega-diverse countries, the United States recognized the value 
biodiversity contributed toward society.  The US  National Park Service required prior informed 
consent or permit which was publicly available, f acilitating transparency, be fore genetic resources 
were taken from the parks, and reserved the right, in appropriate circumstances, to require benefit 
sharing. 
91. Regarding the mechanisms to achieve common obj ectives, he said that the best approach 
would be to employ a contractual model within a national system in connection with the use of 
databases and third party prior art submissions, among others.  For example, the contractual 
relationship between the biologists who conducted research in the US  national parks and the National 
Park system could be enforced in court, and th e United States had not encountered difficulties with 
that system.  Issues of access and benefit sharing coul d be determined at their source rather than at 
some indeterminate point in the future, if any,  such as the filing of a patent application. 
92. One reason for the US positive experience was th at universities and other entities generally 
followed "Ethical Codes of Conduct" which requi red prior informed consent before research was  IP/C/M/66 
 Page 15 
 
 
  begun, and a Material Transfer Agreement to show  that the materials were  legitimately in the 
possession of the researcher.  Without that pape rwork, universities and other entities would not 
release the research funds to a llow the research to continue. 
93. Likewise, work in WIPO had resulted in the sh aring of best practices regarding databases, 
such as databases of traditional cultural expression s, traditional knowledge and genetic resources.  
India's TKDL, Japan's proposed one-click datab ases and the Swiss traditional knowledge gateway 
proposal were consistent with those best practices  and that further such work could be undertaken. 
94. While some Members had questioned the use of  those mechanisms as ineffective to pursue 
the shared common objectives, his delegation looked forward to hearing more details regarding why 
such mechanisms were insufficient, exactly which na tional laws were alleged to have been violated, 
what kind of contractual obligations had been in adequate, and how database s could be improved to 
make them more informative. 
95. Regarding amending the TRIPS Agreement to ma ndate a disclosure requirement, he said that 
it would not advance those objectives because of  significant time delays, limited coverage, the 
problem of identifying origin, and negative impact on benefits.  On timing, many years, if not 
decades, might pass between the sourcing of a genetic resource and the filing of a patent application, 
as Switzerland had confirmed.  On coverage, only a tiny fraction of genetic resources found their way 
into patent applications.  Origin could be impossible to determine, particularly when there might be 
multiple countries of origin.  Additionally, many genetic resources were available on the open market 
legitimately and had been for decades. 
96. Regarding the example of Velcro in Switzerland,  if the disclosure requirement had applied to 
that example, he questioned how origin would have b een determined with respect to de Mestral's hike 
in the Jura, when that range was in both France and Switzerland. 
97. As patent disclosure requirements increased uncertainty and litigation exposure, research and 
investment in the innovation that ultimately provide d the benefits would decrease, thereby frustrating 
rather than facilitating the fundamental objectives.   Document TN/C/W/59 raised all of those 
concerns.  Ultimately patent systems were designed to promote innovation and might lead to benefits 
to be shared.  Patent systems were not, however , designed to enforce regulatory compliance.  His 
delegation had strong reservations a bout a patent disclosure requirement and whether it would hinder 
rather than support the shared objectives. 
98. In response to the suggestion to invite the WI PO Secretariat to make a presentation of its 
work, he said that it should not prejudge the nego tiations of the WIPO IGC.  Furthermore, it was 
premature to decide whether a presentation in Oct ober 2011 would be appropriate .  He encouraged the 
Chair to continue to hold consultations on that issue. 
99. As to the suggestion that the CBD Secretariat be  invited to give a presentation, he said that it 
was the viewpoints of the CBD members rather th an the CBD Secretariat that would give WTO 
Members a more complete picture of the Nagoya Pr otocol.  He welcomed further consultations on 
that matter. 
100. The representative of Chinese Taipei considered  the TRIPS-CBD issue to be a crucial issue 
concerning a number of different stakeholders.  For owners of genetic resources and traditional 
knowledge, a mechanism to ensure fairness and equita ble benefit sharing was needed.  For investors, 
it was needed to ensure that the incentive to invent and innovate w as not reduced.  For patent offices, 
the legal certainty of the patent system had to  be preserved without placi ng undue burden on either 
patent examiners or applicants.  Those principles we re important criteria when delegations joined in 
discussions and consultations. IP/C/M/66 
Page 16  
 
  101. Referring to Bolivia's proposal, she said that th e flexibilities provided for in Article 27.3(b) 
allowed Members to implement the relevant provisions  appropriately at the domestic level and to take 
into account their own needs and interests.  Members were able to take advantage of those flexibilities 
to suit their own particular and unique domestic conditions.  She agreed that the review of 
Article 27.3(b) should not lead to any lowering of the level of patent protection for biotechnological 
inventions. 
102. She reiterated that her delegati on did not support any artificial parallelism in the three TRIPS 
issues and that the attempt to make a linkage betw een the three TRIPS issues and to include them 
jointly as part of the Single Undertaking was not helpful.  Each issue should be discussed and 
considered on its own merits. 
103. The representative of Korea said that her delega tion was not convinced of the necessity to 
revise the provision of the TRIPS Agreement as Article 27 reflected a balance between the incentive 
mechanism of patent systems and the public interest .  Revision of Article 27.3(b) to prohibit the 
patenting of all life forms was not desirable for the overall welfare of humanity, as biotechnology had greatly contributed to combating disease and relieving food shortage.  The patent system was essential 
to make those innovations happen in the field of biotechnology. 
104. There was no contradiction between the TRI PS Agreement and the CBD because those two 
agreements dealt with different subject matters and different objectives.  Inserting a mandatory 
disclosure requirement in the TRIPS Agreement was not a solution to address the issue of access and 
benefit sharing of genetic resources and associat ed traditional knowledge.  As indicated by the 
European Community in document IP/C/W/254, intellectual property rights did not aim to regulate 
the access and use of genetic resources or to regul ate the terms and conditions  for bio-prospecting or 
the commercialization of IPR-protected goods and services, and patents authorities were not there to act as an enforcement agency for the third party's legislation on access to genetic resources, but to 
examine whether inventions satisfied patentability criteria. 
105. The mandatory disclosure requirement was an is sue of burden sharing.  The burden sharing 
under the current patent system was beneficial to researchers and developers.  If the burden sharing 
was skewed at the expense of researchers, it would be disadvantageous to r esearch and development. 
106. Although Korea shared Article 17 of the Nagoya Pr otocol, it did not share the view presented 
in document TN/C/W/59.   Her delegation was not  convinced that inserting disclosure requirements 
and imposing sanctions on the violation of the re quirements could help to achieve the objectives of 
the Nagoya Protocol and the CBD.  The best solution was that each Member developed and 
implemented national access and benefit-sharing system s.  In that regard, the proposals of searchable 
databases and post-grant opposition pr ocedures could achieve the objective of preventing erroneously 
granted patents. 
107. The Chairman suggested that the Council request  the Chair to continue consulting on the 
suggestion that the CBD Secretariat be invited to  brief the Council on the outcome of the Nagoya 
meeting, as well as the suggestion that the WIPO S ecretariat be invited to brief it on the work of the 
IGC. 
108. The Council took note of the statements made under these three agenda items and so agreed. 
F. NON-VIOLATION AND SITUATION COMPLAINTS  
109. 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/66 
 Page 17 
 
 
  GATT 1994 and make recommendations to their next S ession.  It was agreed that, in the meantime, 
Members would not initiate such complaints under the TRIPS Agreement.  The eighth Ministerial 
Conference would be held in Geneva on 15-17 D ecember 2011.  At its mee ting in March 2010, the 
TRIPS Council had agreed to keep the item of non- violation and situation complaints on the agenda 
as a regular item so as to allow Members who would ha ve new thinking to share it, and also enable 
the Council to revert to the question of the further or ganization of its work in the light of any future 
suggestions. 
110. He said that he had used the occasion of hi s consultations on a number of matters in 
preparation of this meeting to also remind delegati ons of this approaching deadline.  While he did not 
have any new thinking to report on this matter, he reminded Members that the matter was to be 
addressed at the Ministerial Conference and that, apart from the present session of the Council, there 
would only be one regular session of the Council, in  October, to reach any recommendation on this 
matter.  He therefore urged delegations to turn th eir minds to this question with a view to reaching 
consensus at the next meeting in October. 
111. The representative of India said that the appli cation of non-violation and situation complaints 
to the TRIPS Agreement raised fundamental con cerns.  The TRIPS Agreement, unlike other WTO 
Agreements, was a sui generis  agreement that was not designed to protect market access or the 
balance of tariff concessions, but rather to estab lish minimum standards of intellectual property 
protection.  The Agreement explicitly stated that WTO Members were not obliged to implement more 
extensive protection.  Non-violation complaints mi ght have the effect of creating new, non-negotiated 
responsibilities in the TRIPS Agreement and also in  other WTO agreements.  Unlike tariff bindings, 
obligations under the TRIPS Agreement could no t be revised as between individual parties.  
Consequently, the non-violation remedy might allo w a Member claiming non-violation to express the 
impairing Member the threat of retaliatory reactio ns equivalent to those available in the case of a 
violation of the TRIPS Agreement, if th e impairing measure was not withdrawn. 
112. The creation of non-negotiated responsibilities w as inconsistent with Article 3.2 of the 
Dispute Settlement Understanding (D SU), which provided that rulings of the Dispute Settlement 
Body (DSB) must not add or diminish the rights a nd obligations provided in the covered agreements.  
Non-violation complaints, currently inapplicable in  TRIPS-related disputes, could potentially function 
as a tool to circumscribe developing country Members from effectively using flexibilities concerning public health in the TRIPS Agreement.  The app lication of non-violation complaints might further 
unbalance the TRIPS Agreement by elevating priv ate rights over the inter ests of the users of 
intellectual property, both within and between c ountries, and over public policy considerations.  
Non-violation complaints might be used to pressure  developing countries not to fully explore their 
rights to use measures such as compulsory licensing  to ensure access to essential medicines or to 
guarantee access to technology.  Unilateral pressure based on non-violation complaints might also be 
applied to constrain the adoption of national measur es under TRIPS Article 8 to protect public health 
and nutrition and to promote public interest in sect ors of vital importance to the socio-economic and 
technological development. 
113. He believed that extending the non-violation remedy to the TRIPS Agreement might also 
entail consequences for the predictability and sec urity of the multilateral trading system.  The 
uncertainty surrounding the remedy would make it harder for countries to rely on the text of the 
TRIPS Agreement to define their rights and obligati ons in the face of unilateral pressure by other 
more powerful WTO Members.  A number of Members had noted with concern that non-violation 
complaints under the TRIPS Agreement might give rise to incoherence among the WTO agreements.  
The danger of incoherence had been raised in th e Canadian paper (document IP/C/W/249), which had 
noted that otherwise WTO consistent measures, su ch as taxes or advertis ing requirements, could 
potentially be challenged under the TRIPS Agreement.  It had noted that "it is highly questionable 
whether WTO Members would be in favour of leaving the option open for countries to file a IP/C/M/66 
Page 18  
 
  non-violation complaint under the TRIPS Agreement if the measure is found to be in full compliance 
with multilateral provision under GATT and its annexed agreements or the GATS".   Such uncertainty 
was likely to further increase public concern over the impact of the TRIPS Agreement on important 
issues such as public health, bio-diversity protection and transfer of technology. 
114. There had been substantial discussion on the scope and modalities of non-violation and 
situation complaints in the TRIPS Council since 1999.  The discussions and submissions made by 
Members led him to believe that non-violation and si tuation complaints were not necessary to protect 
any balance of rights and obligations inherent in th e TRIPS Agreement.  Rights and obligations in the 
TRIPS Agreement were best performed through good faith application of its provisions in accordance 
with the established principles of international la w recognized by the Appellate Body and did not 
require recourse to the legally imprecise notion of non-violation and situation complaints. 
115. He proposed that the TRIPS Council recommend to the next Ministerial Conference that the 
violations of the type identified  in subparagraphs 1(b) and 1(c) of Article XXIII of GATT 1994 be 
determined inapplicable in the TRIPS Agreement, or  at least imposing a moratorium for a substantial 
period such as 10 years before taking up the review. 
116. The representative of Ecuador said that the i ssue was autonomous by nature and therefore 
could not be linked to issues in other areas of work of the WTO.  Given the character and nature of 
the TRIPS Agreement, these kinds of complaints c ould not be encapsulated under it.  Rather than 
laying out maximum levels of enforcement, th e Agreement only set out a minimum standard of 
protection, and it did not touch upo n tariff levels.  Therefore, on the basis of the recommendations 
made to the TRIPS Council in May 2003 and give n the understanding of the majority of the 
membership, he agreed with India's view that the Council should recommend to the next Ministerial 
Conference that Ministers also exclude the application of non-violation complaints in the TRIPS context. 
117. The representative of the Bolivarian Republic  of Venezuela said that, in his view, 
subparagraphs 1(b) and (c) of  Article XXIII of GATT 1994 could not be applied to the TRIPS 
Agreement.  If that assertion were to be wrong, such  application would require the consensus of the 
entire membership, as stipulated in Article 64.3 of the TRIPS Agreement.  Such application would be 
completely at odds with what many Members ha d stated in the Council's meetings, where ever 
increasing support was being expressed for a recommendation to the Ministerial Conference that the content of the above-mentioned GA TT 1994 provisions be determined inapplicable to intellectual 
property.  Moreover, the lack of any concrete c ases for evaluation by the Council with a view to 
examining the scope and modalities for complaints of  the types provided for u nder subparagraphs 1(b) 
and 1(c) of Article XXIII of GATT 1994, as establishe d in Article 64.3 of the TRIPS Agreement, was 
evidence that it was patently impossible to consid er intellectual property as a good.  The reasons for 
this were extensively set out in document IP/C/W /385, sponsored by Venezuela and a group of other 
countries and submitted in October 2002.  This pape r explained the factual and legal reasons that 
challenged the possibility of addressing the issue of intellectual property as a good. 
118. The representative of Cuba endorsed the statemen ts made by India, Ecuador and Venezuela. 
119. The representative of China said that the TRIPS Agreement was quite different from 
GATT 1994 in its nature and structure.   He believed that the applica tion of non-violation and situation 
complaints under the TRIPS Agreement was not appr opriate and would be problematic.  It would 
cause fundamental concerns and might also limit the use of the flexibilities of the TRIPS Agreement. 
120. He suggested that the eighth Ministerial Conference decide on an extension of the 
moratorium, if Members would not agree upon a permanent suspension.  IP/C/M/66 
 Page 19 
 
 
  121. The representative of Pakistan said that he sh ared the views expressed by India and other 
previous speakers.  TRIPS had a very different nature .  He recalled that he had been asking for quite a 
long time what was the nature of non-violation and s ituation complaints and th is question was still to 
be addressed.  Previous TRIPS dispute settlement cases had not clearly showed what TRIPS violations were.  He therefore wondered how agre ement could be achieved on the application of non-
violation complaints.  Non-violati on and situation complaints would touch the enforcement area.  One 
delegate had earlier pointed out that the "patent sy stem is not designed to touch upon the regulatory 
systems or to take into account the regulatory system s".  This statement could apply to all of the other 
IP systems and, therefore, non-violation and situa tion complaints should not be applicable in the 
TRIPS enforcement area. 
122. He supported India's proposal that if an agre ement on a permanent moratorium could not be 
reached, a long-term moratorium should be approved by Ministers.  Since this issue had been on the agenda of previous Ministerial Conferences, there mi ght be a benefit of discussing it in its entirety to 
see what were the possible scenarios, where non-viola tion could be applicable or where it could not. 
123. The representative of the United States said that he continued to be of the view that it was 
entirely appropriate for non-violation and situati on complaints to be applicable to the TRIPS 
Agreement.  This was no less true now than when these complaints were included within the TRIPS 
Agreement.  While Members had agreed to exte nd the moratorium on non-violation and situation 
complaints in the past, this concession was signifi cant.  The availability of these complaints would 
provide security and predictability to help ensure th at Members' legitimate expectations with respect 
to the TRIPS Agreement were not frustrated. 
124. He said that the moratorium was set to expire at the upcoming Ministerial Conference and 
that it should expire. 
125. The representative of Colombia said that Co lombia was one of the countries that had 
endorsed document IP/C/W/385 mentioned by Venezuela.   The concerns spelled out in this document 
continued to be valid.  He was willing to take part  in any consultations that might take place on the 
matter before the Ministerial Conference. 
126. The representative of the Bolivarian Republic of Venezuela said that nothing in Article 64 of 
the TRIPS Agreement envisaged the possibility of the expiry of the moratorium, since its paragraph 3 
stipulated that decisions in this regard should be  made by consensus by the membership, a consensus 
that clearly was not available. 
127. The representative of Switzerland said that he had consistently made the point over the years 
that the TRIPS Agreement was one of the three ma in pillars of the WTO system. There was thus a 
systemic reason in favour of the application of the principle of non-violation al so in the context of the 
TRIPS Agreement.  Further, Switzerland also read  Article 64.2 and 64.3 of the TRIPS Agreement as 
making clear and unambiguous reference to non-violati on and situation complaints.  The very fact of 
Article 64 providing for a moratorium for their application meant that, after its expiry, such 
complaints would become applicable under the TRIP S Agreement.  Switzerland believed that with the 
DSU, there was sufficient guidance in case non-violati on or situation complaints should occur in the 
TRIPS context.  During the last two years of  additional extension of the moratorium, those 
delegations who had in earlier years expressed con cerns as to the exact scope and modalities of non-
violation and situation complaints in the TRIPS context beyond those provided in the DSU had not come forward with submissions or proposals on how their concerns could be addressed through 
additional modalities. IP/C/M/66 
Page 20  
 
  128. Considering this and recalling that the moratorium had been extended four times already, he 
did not see any reason to recommend a further extens ion of the moratorium, which would expire at 
the next Ministerial Conference in December 2011, as it was the nature of moratoria. 
129. The Chairman said that it was his intention to hold consultations in various formats on the 
matter prior to the Council's meeting scheduled fo r 25-26 October with a view to enabling the Council 
to agree on its recommendation to the Ministerial Conf erence at that meeting.  He added that his door 
was open to all delegates who would like to shar e ideas and consider what kind of common position 
could be reached. 
130. The Council took note of the statements made and agreed to revert to the matter at its next 
meeting. 
G. REVIEW OF THE IMPLEMENTATION OF THE AGREEMENT UNDER ARTICLE 71.1 
131. No statements were made  under this agenda item. 
132. The Council agreed to revert to the matter at its next meeting. 
H. REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON GEOGRAPHICAL 
INDICATIONS UNDER ARTICLE 24.2 
133. 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. 
134. He recalled that, at its meeting in March 2010,  the Council had agreed to encourage Members 
to share information on and notify bilateral agreem ents related to the protection of geographical 
indications, which they had entered into.  This ha d already produced some useful and informative 
material.  He therefore encouraged any Member th at was party to any such bilateral agreement and 
had not yet shared such information with the Council to do so. 
135. As the question of geographical indication prot ection remained a continuing interest and 
discussion, he also urged those delegations that had not yet provided responses to the Checklist of 
Questions 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.  He said that  there was a considerable benefit to having up to 
date, accurate and geographically more representativ e material available as the basis of this ongoing 
review process. 
136. The Council took note of the statements made and agreed to revert to the matter at its next 
meeting. 
I. TECHNICAL COOPERATION AND CAPACITY -BUILDING  
1. Arrangements for the annual review 
137. The Chairman recalled that the Council had tr aditionally undertaken its annual review of 
technical cooperation each autumn.  He therefore s uggested that the Council hold its annual review at 
its next meeting scheduled for 25-26 October. Ac cordingly, he suggested that the Council invite 
developed country Members to s upply information on their activities pursuant to Article 67 of the 
TRIPS Agreement.  Other Members who also made available technical cooperation were encouraged  IP/C/M/66 
 Page 21 
 
 
  to share information on these activities if they so wish ed.  He also suggested that the Council invite 
those intergovernmental organizations that had ob server status in the Council for TRIPS to provide 
information on their activities of relevance and that the WTO Secretariat also be instructed to report 
on its activities.  He proposed that the Council request  that this information be made available by 
30 September in order to allow its tim ely circulation before the meeting. 
138. The Council so agreed. 
2. Other matters 
139. The Chairman recalled that, at its meeting in October 2010, the Council had held its previous 
annual review of technical cooperation.  Since that meeting, the Council had received additional 
information from the European Union and individual  member States and agencies, namely Austria, 
Belgium, Bulgaria, the Czech Republic, Finland, France, Germany, Hungary, Portugal, Romania, 
Spain, Sweden, and the United Kingdom, as well as the European Patent Office (IP/C/W/550/Add.7). 
140. As regards LDC needs assessment, he recalle d that paragraph 2 of the TRIPS Council's 2005 
decision on the "Extension of the Transition Peri od under Article 66.1 for Le ast-Developed Country 
Members" provided that "with a view to facilitatin g targeted technical and financial cooperation 
programmes, all the least-developed country Me mbers will provide to the Council for TRIPS, 
preferably by the 1 January 2008, as much inform ation 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".  The Council had just received such information from Senegal (being circulated 
as IP/C/W/555).  Such information had earlier been received from five other Members, namely Sierra 
Leone, Uganda, Bangladesh, Rwanda and Tanzania. 
141. The representative of the Secretariat recalled that, at previous meetings of the Council, he had 
reported on a range of activities undertaken at the re quest of LDC Members to support this process.  
The Secretariat's work had been guided by the Council's 2005 decision, and in particular the three operational elements of that decision, the first elem ent being that the LDCs were asked to provide the 
Council with as much information as possible on what  was needed as a priority for technical and 
financial assistance.  The second element was for deve loped countries that were asked to provide the 
technical and financial help required by the LDCs to address the identified needs effectively.  The 
third element was of direct relevance to the Secr etariat as it was a requireme nt to enhance cooperation 
with the World Intellectual Property Organization and with other relevant inte rnational organizations.  
The organizations concerned were i ndeed cooperating more closely in this area.  In the case of WIPO 
in particular, this cooperation was required directly in response to the specific request of the Council, 
and was also based on the existing cooperation agre ement as well as the joint initiative on technical 
cooperation for LDCs, which had been  launched in 2001.  Accordingly, this partnership remained a 
key element of this activity and perhaps it had beco me even more important with the elaboration of 
the WIPO Development Agenda and the programme established for LDCs in particular.  Cooperation 
had also been enhanced with UNCTAD, which itsel f had contributed to the needs assessment process 
early on at the request of several of the countries which had since reported to the Council, and with 
other organizations dealing with specific subject areas, such as the stepped up cooperation with the 
World Health Organization on the public health dimension. 
142. The Secretariat had been asked to undertak e a series of activities by the LDC Group of 
Members in 2009, in particular a series of regional workshops, which had been planned to harvest the 
experience so far with the LDC needs assessmen t process, but also to lay the groundwork for 
improved coordination of the deliv ery of technical and financial assistance to meet the needs 
identified.  The Secretariat had also  been requested at that time to hold a final workshop in Geneva, at 
the end of the current year and at the culmination of the regional workshops, to draw together the 
wide range of experience that had been harvested a nd to reinforce coordination with the providers of IP/C/M/66 
Page 22  
 
  assistance and the concerned intergovernmental orga nizations.  Accordingly, the regional workshops 
and the final Geneva workshop had been included in the biannual tec hnical assistance and training 
plan for the current biennium 2010/11.  The regiona l workshops had since then been undertaken in 
Uganda, Bangladesh and Senegal, and the contri bution of the host governments was acknowledged 
with appreciation. 
143. The planning for the Geneva workshop was s till underway in consultation with the LDC 
Group and intergovernmental partners, in particular  WIPO and UNCTAD.  The current plan was for 
the event to be held back-to-back with the Co uncil's October meeting so as to facilitate the 
participation of delegates and concerned officials.  In practice, this would mean holding the workshop 
from 19-21 October as the most practical dates.  Based on the past experience and the lessons learnt 
from the regional workshops, the important ingredie nts for the workshop would be, firstly, as far as 
possible, capital-based participation from those LD C Members who had a strong interest in this 
process in close coordination with the Geneva missions concerned and the LDC Group from whom 
the Secretariat would continue to take guidance.  Secondly, the participation by a wide cross-section 
of national agencies and intergovernmental organi zations with responsibilit y for coordinating and 
administering technical assistance programmes, the resources and the programmes that would respond 
to the needs identified.  Thirdly, scope for some info rmal bilateral interaction as part of the workshop 
structure;  this had been a well-received aspect of the regional workshops allowing for practical 
coordination at a very informal level between LDC Members who had communicated their individual 
priority needs and those who were responsible fo r technical assistance programmes and the other 
necessary resources to respond to the needs identifie d.  There were ongoing resourcing and logistical 
issues for the workshop, but the Secretariat was work ing on a format that would make a concrete and 
tangible contribution to advancing all three aspect s of the TRIPS Council decision and create a robust 
and practical basis for the next phase of the process of communicating and responding to individual priority needs of LDCs and focussing the res ources on the needs identified, as well as resource 
mobilization through enhanced coordination.  The Secretariat would continue taking the guidance of 
LDC Members as an immediate priority as this wo rk would unfold through to the Geneva workshop 
and following through on any outcomes or reco mmendations from the wo rkshop and the Council's 
October meeting. 
144. The representative of Senegal introduced the document on Senegal's priority needs for 
technical and financial cooperation with a view  to implementing the TRIPS Agreement (being 
circulated in IP/C/W/555).  He recalled that the TRIPS Council's 2005 decision had extended until 
1 July 2013 the transition period granted to LDC Members for the implementation of the 
TRIPS Agreement.  LDCs were, in addition, free of the obligation, with respect to pharmaceutical 
products, to implement or apply Sections 5 and 7 of  Part II of the TRIPS Agreement or to enforce 
rights provided for under these Sections until 1 January  2016.  Paragraph 2 of the 2005 decision called 
on LDC Members to 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 in taking steps neces sary to implement the TRIPS Agreement. 
145. In the context of the Biennial Technical A ssistance Plan 2010-2011, Senegal had put WTO 
support and advice to good use in identifying its priori ty needs.  It had also benefited from WIPO's 
technical assistance in drawing up its National Intellectual Property Development Plan (PNDPI).  Senegal had a fairly substantial le gal IP framework.  It consisted of legal texts that dealt with the 
matter directly and others that addressed only certain aspects of IPRs.  Senegal was also a party to 
several international, regional and multilateral ag reements and treaties on IP currently in force. 
146. This legal arsenal, however, needed a certain amount of adapting and updating, and the texts 
administered by bodies with remits that touched on IP  issues (trade, customs) needed to be reviewed 
or supplemented.  There were a number of obstacles in the path of IP development, one being that 
several bodies dealt with these matters and coordinati on between them was a problem for users of the  IP/C/M/66 
 Page 23 
 
 
  system (SME - SMI, CR&D and cultural players).  The bodies involved were:  the Ministries of 
Industry, Culture, the Interior, Scientific Rese arch, Trade, Higher Education and Justice.  
Furthermore, the institutional framework had proble ms regarding the availability of material and 
financial resources, creating and building the cap acities of players (staff and right holders), 
IP teaching in higher education, and the development of research. 
147. In order to set up a framework for more effectiv e enforcement of IPRs in Senegal, the main 
stakeholders had identified a number of priority needs for technical and financial cooperation:  
organization of awareness-raising campaigns;  traini ng for the staff of the bodies responsible for rights 
enforcement, including the police, customs, and th e judiciary;  provision of detection and testing 
equipment;  development of IPR enforcement manuals  for the main enforcement agencies;  access to 
case law and research resources for the commercial c ourts, including through the establishment of a 
special IP section. 
148. Senegal had the potential for i nnovation and creation.  Unfortunately, it had not managed to 
set up a suitable IP regime.  The public sector ha d a dominant role in research initiatives, while the 
private sector used the results without really par ticipating.  Yet, public sector R&D was unable to 
meet growing market demand.  Most of the country's industries suffered from inadequate 
development, in particular because the necessar y R&D facilities were lacking.  Although the 
technologies used were for the most part imported,  technology transfer was extremely limited.  
Virtually no patents were registered locally.  Artic le 66.2 of the TRIPS Agre ement required developed 
country Members to provide incentives to encourag e technology transfer to LDCs for the purpose of 
capacity building, but its enforceability remained a problem. 
149. He said that Senegal had just drawn up a Na tional Intellectual Property Development Plan 
(PNDPI), which set out a strategy for IP developmen t, the aim being to create a framework to protect 
and promote the IP system so that it could be  used effectively in implementing the country's 
economic, social and cultural development policy.  The PNDPI also focussed on the development of 
intellectual creation.  It pursued four major obj ectives corresponding to priority areas of action, 
namely:  (i) strengthening the legislative and regulatory framework;  (ii) modernizing IP 
administration;  (iii) promoting the use of IP by companies;  and (iv) promoting IP in the education and research sector. 
150. The main results expected from the PNDPI coul d be summarized as follows:  (i) an improved 
legal framework aligned with the objectives, principl es, rights, obligations and flexibilities set out in 
the TRIPS Agreement and with other commitments under international and re gional IP standards;  
(ii) a modern, service-based, accessible and automate d IPR administration, designed for enterprises, 
creators and inventors in Senegal;  (iii) a stre ngthened institutional frame work and improved IP 
coordination countrywide;  (iv) an increased aw areness and use of IP as a tool for economic 
development and integration;  (v) a structured expansion of IP education, training and research 
institutions within a common national network;  and (vi) increased capac ities for effective and 
efficient enforcement and regulation of IPRs among bodies responsible for IPR administration such as 
the police, public prosecutors and the judiciary. 
151. The representative of Senegal said that a memorandum for implementing the PNDPI had been 
recently signed with WIPO for an amount of CFA 8.5 billion (i.e. nearly 13 million Euros).  The 
memorandum established a framework for cooperation with WIPO, which would enable Senegal to 
create an environment conducive to IP development.  However, there had as yet been no real 
commitments to implementing the activities of the various programmes covere d in the PNDPI and the 
needs expressed in the context of the PNDPI would in all like lihood expand, which would require 
additional funding.  Hence the need to include the programmes already identified under the PNDPI 
among the priority needs that Senegal had expressed  in view of the impending implementation of the 
TRIPS Agreement. IP/C/M/66 
Page 24  
 
  152. Senegal also planned to take account of the n eeds thus identified when updating its diagnostic 
trade integration study (DTIS) and action matrix, so  that partial funding could be obtained through 
broader initiatives for LDC support, in particular  the Aid-for-Trade initiative and the Enhanced 
Integrated Framework (IEF).  Initiatives such as  these afforded opportunities to strengthen and 
coordinate efforts made to meet the individual priori ty needs identified by LD Cs in the area of TRIPS. 
153. The PNDPI identified particular areas of action requiring technical and financial assistance.  
In this connection, Senegal was awaiting with inte rest such aid as the multilateral institutions and 
WTO Members might provide for its implementation. 
154. The document that had been submitted had two annexes.  Annex A highlighted the main 
priorities in terms of financial and technical elemen ts allowing the necessary steps to be completed for 
the implementation of the TRIPS Agreement, taking as a basis the IP development strategy worked 
out from the responses and suggestions made in the course of consultations with the various 
stakeholders and in the context of talks held at na tional level.  The needs evaluation covered IP policy 
and legal framework, administration, IPR observan ce and regulation, the promotion of innovation, 
technology transfer incentives and the use of IP as a tool for development.  Annex B contained an 
indicative timeframe of a long-term national programme aimed at capacity building for IP 
development in keeping with Senegal's needs. 
155. The representative of WIPO said that WIPO con tinued to provide support to LDCs in the use 
of the IP system to help meet their economic, so cial and cultural development goals.  This included 
providing technical assistance and capacity building support in relation to the WTO LDC needs assessment exercise.  WIPO looked to support all developing countries, in particular LDCs, in 
developing national IP and innovation strategies.  These strategies aimed to provide a holistic 
framework for the delivery of WIPO's tec hnical assistance and capacity building work. 
156. WIPO had assisted Senegal in drafting and a dopting the National IP Development Plan for 
the period 2011-2015.  A memorandum of understandi ng relating to the Plan had been signed by the 
Minister of State, Minister of Mines, Industry, Agro-Industry and SMEs of Senegal, with the 
endorsement of the Minister of Culture, and also signed by the Director General of WIPO earlier in 
2011.  The IP Plan was a forward-looking document whic h set the vision of Senegal in using IP for its 
economic development endeavors.  It made a diagnos is of the IP system of the country and all the 
stakeholder institutions and their po tential contributions to  an IP-led development process.  It set out 
clear targets to be attained by 2015, including a revamping of the institutional framework of IP 
management in the country w ith the establishment of the Conseil National de Coordination de la 
Propriété Intellectuelle  (CNCPI), in which the ministries in charge of IP and of Culture were 
represented. 
157. The IP Plan emphasized the attainment of the goal set under the Grande Offensive pour 
l'Agriculture, la Nourriture et l'Abondance  (GOANA), a flagship government programme for 
self-sufficiency in food production and transformation;  capacity building and human resource 
development;  access to and use of technology in formation through the strengthening of the network 
Centre de Recherche Développement  (CRD).  It also sought to involve SMEs in a more dynamic way. 
158. WIPO had supported Senegal in the establishm ent of Technology Information Support 
Centres (TISC) in Dakar.  Following the signing of  a Service Level Agreement, training had taken 
place and would continue for the c onsolidation of the TISC  network.  TISCs were one of the seven 
deliverables of WIPO for LDCs, which would contri bute to an increase in the building of a knowledge 
base in order to promote creativity, innovation and competitiveness of business, industry, enterprises, 
academics and researchers throughout Senegal.  IP/C/M/66 
 Page 25 
 
 
  159. WIPO was currently in the process of finaliz ing a WIPO commissioned study on Traditional 
Cultural Expressions of Senegal.  WIPO had also  organized a number of LDC High Level Forums 
aimed at supporting LDCs by providing a platform fo r Ministers and senior officials to discuss issues 
related to IP policies and implementation strategies.  Senegal had participated at a senior Ministerial 
and senior officials level in all of those events. 
160. The Ministerial Declaration on WIPO Deliverables for LDCs had been adopted by 
acclamation at the WIPO Ministerial Forum in Is tanbul, which had taken place in parallel with the 
fourth UN LDC Ministerial Conference.  Senegal w as one of the countries that would benefit from its 
implementation.  WIPO would continue to work cl osely with Senegal and with all LDCs as well as 
with the WTO Secretariat to support the WTO LDC needs assessment process. 
161. The Council took note of the statements made. 
J. LETTER FROM THE CHAIR OF THE GENERAL COUNCIL CONCERNING WAYS TO IMPROVE THE 
TIMELINESS AND COMPLETENESS OF NOTIFICATIONS AND OTHER INFORMATION FLOWS  
162. The Chairman recalled that, at its past six m eetings, the Council had had on its agenda the 
letter from the Chair of the General Council concerning ways to improve the timeliness and 
completeness of notifications and ot her information flows in the area of its responsibility.  In order to 
facilitate the Council's consideration of this issue,  the Secretariat had presented to the October 2009 
meeting a factual background note IP/C/W/543 it ha d prepared at the Council's request that 
summarized the relevant procedures and provided in formation on the use of these procedures, as well 
as contained suggestions on how to improve the tr ansparency and user-friendliness of the notification 
system.  Furthermore, the Secretariat had orally re ported on further developments  in this area.  Those 
delegations that had spoken on this issue had s upported the suggestions contained in that note to 
improve the transparency of the system, and had encouraged the Secretariat to pursue this task. 
163. The representative of the Secretariat said that the Secretariat had reported in great detail in 
previous sessions of the Council on this unfolding work and therefore would simply update the main 
elements that were relevant.  Document IP/C/W/543 set out the state of play and described the various 
directions that the work could pursue.  All of this  work was undertaken strictly within the procedures 
and the decisions already established by the Council and simply amounted to ways of more efficiently 
using resources to manage this now immense wea lth of information that had been notified. 
164. The work that was under way included clarifying in  a new useful way the best format for the 
input of notifications and the establishment, in c ooperation with WIPO, of a joint portal to facilitate 
the submission of texts, where the two Organizati ons had joint competence.  That had been reported 
on in the past, but it was now fully operational and th e partnership with WIPO was a particular benefit 
of this arrangement.  A transparency toolkit w as now available on the WTO website to facilitate 
understanding of notification procedures, to facilitate  the submission of up-to-date notifications and to 
provide better access to notified materials that we re available online.  The Secretariat had also 
incorporated both the notification procedures and the practical use of notified materials into a wide 
range of technical cooperation activities, putting these materials in the hands of beneficiaries to make 
them more useful tools.  The Secretariat had im plemented pilot projects to supplement the traditional 
paper-based circulation of such information as cont act points through the creation of more accessible 
formats, in this case, a drop down list for greater eas e of access.  That pilot project paved the way for 
a more comprehensive approach to making the materi al available online.  The future work and the 
ongoing work and its current directions would depend on available resources, especially the 
availability of necessary IT resources, because it w as moving into a more IT-intensive phase.  The 
envisaged work included improving online access to  and searchability of the notified materials, 
including addressing the backlog of materials that currently remained in di fficult to access formats, as 
well as developing possible links with other elements of the Secretariat IT infrastructure to provide a IP/C/M/66 
Page 26  
 
  more accessible, better integrated and user-fri endly interface for access to and use of notified 
materials.  The Secretariat was currently worki ng on the groundwork of these next steps, coordinating 
in-house, because it was very much a cross-Secretariat programme.  He therefore proposed to update 
the Council at the October meeting. 
165. The Council took note of the statements made and agreed to revert to the matter at its next 
meeting. 
K. AUSTRALIA :  TOBACCO PLAIN PACKAGING BILL 2011  AND ITS COMPATIBILITY WITH THE 
TRIPS  AGREEMENT  
166. The Chairman recalled that this item had been put on the agenda at the written request by the 
delegation of the Dominican Republic. 
167. The representative of the Dominican Republic said that, on 8 April 2011, Australia had 
notified to the Committee on Technical Barriers to  Trade the "Tobacco Plain Packaging Bill 2011" 
("the Bill") (G/TBT/N/AUS/67).  That notification also referred to a "Plain Packaging of Tobacco 
Products Consultation Paper" ("the Consultation Pape r") which described further provisions and other 
measures that Australia was considering for a doption for the purpose of implementing the Bill or 
regulating the packaging of tobacco products.  Sh e said that the Dominican Republic was seriously 
concerned about the impact of the measures proposed and their compatibility with the TRIPS 
Agreement and the TBT Agreement.  Concentrating for the moment only on the issues that concern 
the TRIPS Agreement, her delegation was partic ularly worried about the impact the proposed 
measures could have on small economies that are la rgely dependent on the production and export of 
tobacco and tobacco products. 
168. She said that the Bill would authorize the adoption of a series of regulations requiring "plain 
packaging for tobacco products", amounting to a ba n on the use of registered trademarks, logos and 
other distinguishing features on tobacco packagi ng apart from the brand name, which would be 
subject to specified lettering and placement.  The Consultation Paper laid down the steps proposed for 
implementation of the Bill as it concerned cigarette packaging.  For other tobacco products, the Paper 
stated that the proposed design features for the pl ain packaging were still under development and that 
consultations would be held  on them in the second half of 2011.  According to the Consultation Paper, 
Australia would also require that all tobacco packet s be coloured a shade of dark olive brown with 
matt finish and that cigarette packets display graphi c health warnings that cover 75 per cent of the 
front of the packet in addition to the one alread y covering 90 per cent of the back, together with a 
further warning to cover one of the side pane ls.  The other side panel was to display the 
manufacturer's details and a bar code .  No details were given of ch anges in warning requirements for 
other tobacco products such as cigars.  The Consulta tion Paper further stated that all cigarette packs 
had to be rectangular in shape with a flip-top opening , and that no branding, colours or design features 
other than those specified would be permitted.  Sh e said that these requirements would be in addition 
to Australia's existing laws and other provisions which prohibit the use of tobacco brand names on 
non-tobacco products and ban advertising campaigns that target consumers.  Retail displays of 
tobacco products were also either banned al ready or to be banned throughout the country. 
169. She said that these proposed measures would re quire all producers and importers of tobacco 
products to adopt highly standardized packaging wh ich would in turn prevent sellers from asserting 
their intellectual property rights on packaging fo r cigarettes and other tobacco products, thereby 
depriving consumers of important information on th e products they buy.  The Dominican Republic 
was concerned as to the consistency of these m easures with Australia's obligations as a WTO 
Member.  IP/C/M/66 
 Page 27 
 
 
  170. She said that, because the proposed measures had serious consequences, it was important to 
ensure that the policy objectives they underpinne d were legitimate.  According to Australia's 
notification to the TBT Committee, the measures we re designed to "reduce the appeal of tobacco 
products to consumers;  increase the effectiveness of  health warnings on the packaging of tobacco 
products;  and reduce the ability of the packaging of tobacco products to mislead consumers about the 
harmful effects of smoking".  Apparently, each of the se objectives formed part of a broader plan that 
sought to reduce the number of smokers in Australia.   However, she said th at it was unclear to her 
delegation as to how the proposed measures would contribute to meeting that goal. 
171. She said that her delegation was also concerne d that plain packaging might have unwanted 
effects that undermined the proposed health objectives.   For example, if tobacco products were to be 
sold in standard packs thus making product differe ntiation difficult, sellers might feel compelled to 
compete solely on the basis of price, causing a drop  in retail prices which might in turn produce an 
increase in the demand and consumption of tobacco  products, including cigarettes and cigars.  
Furthermore, to sell tobacco products in plain p ackaging might make the production and sale of fake 
and counterfeit tobacco products easier, which wo uld increase the sale and consumption of non-
regulated products.  In other words, the plain packaging measures proposed could actually run counter 
to the objectives sought. 
172. She said that the Dominican Republic was al so concerned over the compatibility of the 
proposed measures with the TRIPS Agreement a nd the Paris Convention for the Protection of 
Industrial Property ("Paris Convention").  Artic le 20 of the TRIPS Agreement prohibited the 
imposition of unjustified barriers that affect trademarks .   She said that a ban on the use of trademarks 
and a requirement for brand names to be displa yed using a standard fo rmat and lettering would 
obviously "encumber" their use.  Article 20 gave  two instances of such encumbrance:  (a) a 
requirement to "use [a trademark] in a special form";  and (b) a requirement for use in a manner detrimental to its capability to distinguish the go ods or services of one undertaking from those of 
other undertakings.  
173. She said that the proposed measures would requi re use of trademarks in a special form.  
Manufacturers of tobacco products would have to meet the following requirements for displaying the brand name:  use a standard font style and size;  use a dark olive brown background colour with a 
matt finish;  use only the top and bottom of the packet and the bottom quarter of the front surface.  Because of their design these restrictions would be "detrimental" to the capability of trademarks to 
distinguish the goods or services of one undertaking from those of other undertakings.  With the 
packaging stripped of virtually all of the products' distinctive features and with a standardized brand 
name display, packets would look very mu ch alike to consumers and retailers.   
174. She said that it would be most helpful to her delegation if Australia could explain how these 
measures could be justified and sp ecify the evidence it used as a basis for showing that the plain 
packaging requirement would meet the objectives set out in the notification and, more generally, how 
tobacco consumption would be redu ced.  It would also be useful to know whether Australia had 
explored the kind of effects that the plain packag ing requirement would have on low budget generic 
type tobacco products and on unregulated trade in tobacco products, such as illegally imported 
counterfeit or fake products. 
175. With respect to the obligation of Members to comply with Article 10 bis of the Paris 
Convention, which prohibited "all acts of such a natu re as to create confusion by any means whatever 
with the establishment, the goods, or the industrial or commercial activities, of a competitor", she said 
that, in the view of the Dominican Republic, ther e was a serious risk that the proposed generic 
packaging requirements might lead sellers to use p ackets that create confusion.  Indeed, one of the 
plain packaging requirements seemed to have  been designed to prevent consumers from 
distinguishing between different tobacco products.  Pursuant to the plain packaging requirement, all IP/C/M/66 
Page 28  
 
  distinctive features that currently appeared on a ci garette packet would have to be removed.  As 
observed earlier, although the brand name would appear , this information woul d have to be conveyed 
in a standard font style and font size and displayed on a dark olive brown background with a matt finish, and could only be placed on the top and botto m of the packet and on the bottom quarter of the 
front surface.  This meant that the appearance of  competitors' tobacco products would be almost 
identical and there was a genuine risk that consum ers in a retail market context would be unable to 
adequately distinguish between them. 
176. In view of the above, the Dominican Republic re quested that Australia take account of these 
concerns and review the Bill accordingly. 
177. The representative of Australia said that her delegation welcomed the opportunity to discuss 
this extremely important public health issue in th e TRIPS Council and to explain the health policy 
underpinnings of the Australian Government's propo sal.  In order to provide some context for 
Members, she said it was worth noting that some 3 m illion Australians continued to smoke daily, that 
smoking killed over 15,000 Australians per year and that the cost to Australia's society and economy 
was over $31.5 billion per annum.  This was the polic y context in which the Australian Government 
approached this issue. 
178. She said that, on 7 April 2011, the Australian Mi nister for Health and Ageing had released for 
public comment the Consultation Paper and draft le gislation to mandate the plain packaging of 
tobacco products.  The consultation period had cl osed on 6 June 2011.  The comments lodged were 
currently being considered by the Australian Govern ment.  She said that Australia had been a global 
leader in tobacco control over the past 30 years and had implemented a comprehensive range of 
measures to reduce smoking rates.  These incl uded extensive and con tinuing public education 
campaigns on the dangers of smoking;  age restri ctions on tobacco purchase;  comprehensive bans on 
tobacco advertising, promotion and sponsorship;  bans on smoking in workplaces and enclosed public 
places;  bans on smoking in cars with children and increasingly in open air public places where children may be exposed to second hand  smoke;  bans and restrictions on the retail display of tobacco 
products;  pricing measures through excise and cust oms duties;  and mandatory graphic health 
warnings on tobacco product packaging. 
179. She said that tobacco packaging was one of the l ast remaining forms of tobacco advertising in 
Australia and the plain packaging legislation was the next logical step in Australia's tobacco control 
efforts.  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 legislation proposed by 
Australia was expected to commence on 1 January  2012, and would require all tobacco products 
offered for retail sale on or after 1 July 2012 to be compliant.  The proposed legislation was part of a 
comprehensive package of new reforms to combat  smoking announced by the Australian Government 
in April 2010.  Other elements of the packag e were a 25 per cent increase in tobacco excise - 
Australia's tobacco excise and excise-equivalent dut y was already high by international standards and 
now amounted to A$8.40 on a packet of 25 cigarettes, and A$10.09 on a packet of 30;  increased investment in anti-smoking social marketing campai gns;  and legislation to bring restrictions on 
tobacco advertising on the Internet in to line with restrictions in othe r media and at retail points of sale. 
180. She said that these measures had been recommend ed by Australia's leading public health 
experts on the National Preventative Health Taskfor ce, and accepted by the Australian Government.  
The Taskforce had considered that plain packag ing would improve public health by reducing the 
attractiveness and appeal of tobacco products to  consumers;  reducing the ability of tobacco 
packaging to mislead consumers about the harmfu l effects of smoking;  increasing the noticeability 
and effectiveness of mandated health warnings.  IP/C/M/66 
 Page 29 
 
 
  181. She said that her delegation had noted the comments from the Dominican Republic referring 
to an alleged lack of scientific evidence to indi cate that a plain packaging requirement would work.  
She observed, however, that there was a body of  peer-reviewed literature on the public record 
indicating that a plain packaging requirement would c ontribute to Australia's objectives.  All of that 
literature was available on the preventative health we bsite, the details of which she would be happy to 
furnish to Members.  Australia did not consider that the plain packaging proposal would have a 
significant impact on the illicit trade in tobacco pr oducts since already branded products were quickly 
and readily counterfeited.  Nevertheless, she said that anti-counterfeiting markings would be allowed 
to be used on the packaging provided those mark ings were not linked to tobacco marketing or 
promotions and did not interfere with graphic health warnings.  She said that the Australian 
Government considered that the smoking of an y tobacco products, whether licit or illicit, was 
fundamentally harmful to human health. 
182. She said that Australia was, and would continue  to be, fully committed to its international 
obligations to protect intellectual property rights,  including the rights of trademark owners.  She 
assured all Members that, in framing its policy on plai n packaging, Australia had paid full regard to 
the TRIPS Agreement and would ensure that the new policy was implemented in a manner that was 
consistent with that Agreement. 
183. The representative of Honduras said that her de legation endorsed the concerns expressed by 
the Dominican Republic regarding the Australian Bill,  the purpose of which was to attempt to protect 
human health.  Australia's measure caused systemic  concerns because, according to her delegation's 
view, its implementation would be detrimental to trad emark owners.  The obligation to apply or fit in 
with specific forms for display on  tobacco packaging would require certain adjustments to their 
trademarks in order to satisfy Australia's "health wa rning" requirements.  This special requirement to 
create novel "plain packaging" for this product would make it difficult for a trademark to distinguish a 
product from that of a competitor.  This was contra ry to Article 20 of the TRIPS Agreement and failed 
to take account of the legitimate interests of trad emark owners, as stipulated in Article 17 of the 
Agreement. 
184. She said that, as a Member of the WTO whose objective was to oversee trade law, Honduras 
was committed to fulfilling the undertakings made under the trade agreements.  This did not preclude 
Members from adopting certain sanitary measures for the protection of human health, as was the case 
here, which may also have trade implications.  Ho nduras was of the view that Australia's proposed 
measure could only be valid if it were revised to  achieve the pursued public health objectives in a 
manner consistent with the commitments and obliga tions under the WTO framework, in particular the 
provisions of the TRIPS Agreement.  Australia could rectify the measure by reducing the space 
designed for displaying the health warning on both si des of the packet, front and back, to use up only 
50 per cent or less of the surface for messages and pictograms of its choice.  This would allow the trademark owner more freedom to use the remain ing space to differentiate its own product, in 
recognition of its legitimate right to do so. 
185. She said that Honduras had had a similar experien ce in this regard when its Special Law on 
Tobacco Control was enacted through Decree No. 92-201 0.  While the original requirement had been 
that health warnings should take up 80 per cent of the package surface, this requirement was 
subsequently amended, and the spac e for health warnings reduced to  50 per cent on the front and back 
of the package, precisely because of the aforementioned considerations. 
186. The representative of Nicaragua said that her de legation shared the concerns regarding the 
Australian plain packaging bill 2011 presented by Au stralia.  If the plain packaging of tobacco 
products were to be implemented as outlined in th e Consultation Paper, this would go against the 
TRIPS Agreement and would also be in contravention of other intern ational trade agreements.  With 
respect to the TRIPS Agreement, she said that Arti cle 20 very clearly laid down that the use of a IP/C/M/66 
Page 30  
 
  trademark in the course of trade should not be unjus tifiably encumbered by special requirements, by 
use of a special form or use in a manner detrim ental to its capability to distinguish the goods or 
services of one undertaking from that of the competi tion.  The Australian bill on plain packaging did 
violate that provision because it would lay down a particular requirement for the trademark and would therefore hinder trade. 
187. She said that Article 15 of the TRIPS Agreemen t and Articles 6 and 7 of the Paris Convention 
provided that countries had to accept trademarks registered in other countries and that they may not discriminate against those trademarks.  These agreem ents implicitly required that parties to these 
agreements provide a positive right to the trademar k holders in question to use the trademark for the 
goods that they are selling.  The right to use a trademark must be put into practice, because having a 
theoretical right without having the practical us e of trademark would not be fair.  The TRIPS 
Agreement stipulated that any measure to deal with public health issues should be in keeping with the 
TRIPS principles and this would not be the case with respect to the Australian measure. 
188. With respect to the WHO Framework Convention on Tobacco Control, she said that this only 
contained recommendations on plain packaging and that there was no obligation on parties to the 
framework convention to use plain packaging.  As a tobacco producer, Nicaragua considered that the 
adoption of the law in question by Australia w ould undermine the rights of tobacco producers in 
Nicaragua and would therefore have a direct ef fect on their ability to generate revenue.  Her 
delegation would therefore like to request Australia to  consider amending the Bill, so that its right as a 
sovereign state to protect public health would not actually go against the rights that others enjoy under 
the TRIPS Agreement. 
189. She said that her delegation further believed that  the adoption of this measure in Australia 
would not be in keeping with Article 2.2 of th e TBT Agreement and that it might raise the TBT-
related issues in another forum.  Her delegati on believed that plain packaging would not affect 
consumer behaviour, and that the measure would ther efore not actually fulfil the goals laid down by 
Australia, rather it would simply mean economic difficulties for those having to comply with the 
legislation.  The Bill also violated Article 12.3 of the TBT Agreement as well as the Paris Convention 
on the Protection of Intellectual Property.  She inv ited Australia to take these concerns on board and 
refrain from adopting th e measures as outlined. 
190. The representative of Cuba thanked the Domini can Republic for having included this matter 
on the Council agenda.  He believed that the Bill co uld well have an effect on trademark use and it 
was therefore appropriate to have the TRIPS Council consider the proposed legislation.  This was a 
complex issue with two facets:  on one hand, there was the objective of protecting human health 
which motivated the measure, and on the other hand th ere were the potential implications for trade in 
tobacco products from the point of view of intellectual property rights.  The Bill's stated objectives were to improve public health by discouraging pe ople from taking up smoking, discouraging people 
who have given up smoking from relapsing, and re ducing people's exposure to smoke from tobacco 
products.  He said that Cuba considered these to  be legitimate objectives that were essential to 
high-level public health care, a human right that sh ould be defended and given priority by all States. 
191. He said that, nevertheless, for many of th e small and under-developed economies, tobacco 
products were an exportable staple on which thous ands of families in the rural areas depended.  
Moreover, as for any other legal products - that is  any products whose trade had not been forbidden - 
trade in tobacco products was governed by the rul es of the WTO and as a result, there were a number 
of legitimate questions and concerns regardi ng the impact of these regulations on trade. 
192. His delegation was concerned about how to prot ect the rights of owners under Article 16 of 
the TRIPS Agreement and to prevent counterfeiting or  unfair competition.  Plain packaging, he said, 
eliminated the distinctive elements of a brand an d the appearance of the packaging became uniform  IP/C/M/66 
 Page 31 
 
 
  for all marks, making it difficult for consumers to  identify and differentiate tobacco products on the 
basis of brand preference.  At the same time, th e lack of distinctive elements would make the 
packaging easier to reproduce and could lead to an increase in illicit trade in counterfeit products 
which would threaten the rights of owners.  In view  of these foreseeable implications of the Australian 
bill, his delegation would be grateful if Australia could share with all Members the scientific evidence 
at its disposal concerning the direct link between the measure and the health protection objectives it 
was seeking to achieve, in the light of Article 8 of the TRIPS Agreement.  It would also be useful to 
know whether Australia had considered other measures,  less restrictive of inte llectual property rights, 
that would achieve the same health objectives and, if so, whether it could provide Members with the 
results of the analysis conducted.  His delegatio n would be grateful if Australia could provide 
information on these issues at the next regular session of the TRIPS Council. 
193. The representative of Ukraine said that her delegation would like to echo the concerns 
expressed by other countries regarding Australia's no tification G/TBT/N/AUS/67 on its Tobacco Plain 
Packaging Bill of 2011.  Ukraine considered that the adoption of this legislation and the introduction 
of the plain packaging requirements and the pro posed terms would violate the provisions of the 
TRIPS Agreement, in particular Articles 8.1, cer tain provisions of Articles 6 and 7 of the Paris 
Convention as incorporated into the TRIPS Agreement, Article 17, and Article 20 of the TRIPS Agreement.  On 2 June 2011, Ukraine had sent its comments and questions to the Australian 
government department of Foreign Affairs and Tr ade, and urged the Australian Government to 
consider the revision of the proposed draft in orde r to make it WTO consiste nt.  Her delegation was 
confident that the Australian Government would car efully consider the concerns of Members about 
the proposed legislation and ensure its compatibility  with the requirements of the TRIPS Agreement. 
194. The representative of Brazil said that his delega tion had listened to the Dominican Republic's 
reasons for having brought this issue to the attenti on of the Council as well as Australia's explanations 
of the rationale for introducing its plain packaging legi slation for cigarettes.  He said that this was yet 
another example of the extremely diversified a nd complex interplay between public health on one 
hand, and intellectual property rights on the othe r.  Brazil recognized the importance of the matter 
under discussion, and accordingly reserved its rights to revert to this issue in the future for more 
detailed comments. 
195. The representative of India said that the matte r raised important questions on the interplay 
between the TRIPS Agreement and the right of a Memb er to protect public health.  There had been a 
number of experimental studies on plain packaging.  A study by Wakefield, Germain and Durkin had 
shown that as brand design information was progressi vely removed from cigarettes, they were seen as 
less appealing and the cigarettes in the packs were considered to be less satisfying and of lower 
quality.  A major Canadian study had concluded that "plain and generic packaging of tobacco 
products, all other things being e qual, through its impact on image formation and retention, recall and 
recognition, knowledge and consum er attitudes and perceived utility, would likely depress the 
incidents of smoking uptake by non-smoking teens a nd increase the incidence of smoking cessation 
by teens and adult smokers".   
196. He said that the WHO Framework Convention on Tobacco Control stated that parties should 
consider adopting measures to restrict or prohibit the use of logos, colours, brand images, or promotional information on packaging other than brand names and product names displayed in a 
standard colour, and font type.  This could in crease the noticeability and effectiveness of health 
warnings and messages, prevent the package fro m detracting attention from them, and address 
industry package design techniques that may suggest that some products are less harmful than others. 
197. While refraining from comments on the specific elements of the Australian measure under 
discussion, he said his delegation wished to make observations on the larger systemic issue of protection of public health and the TRI PS Agreement.  The Appellate Body in EC - Asbestos  had held IP/C/M/66 
Page 32  
 
  that it is "undisputed that WTO Members have the ri ght to determine the level of protection of health 
that they consider appropriate in a given situation".  The panel in EC - Trademarks and Geographical 
Indications  had explained that the TRIPS Agreement gene rally provided negative rather than positive 
rights.  The panel had stated that "the TRIPS Ag reement does not generally provide for the grant of 
positive rights to exploit or use certain subject matte r, but rather provides for the grant of negative 
rights to prevent certain acts.  This fundamental f eature of intellectual property protection inherently 
grants Members freedom to pursue legitimate pub lic policy objectives since many measures do attain 
those public policy objectives lie outside the scope of  intellectual property rights and do not require an 
exception under the TRIPS Agreement".  Any interp retation of the TRIPS Agreement had to be done 
keeping in view the objectives and th e principles of this Agreement. 
198. He said that Article 8 of the TRIPS Agreem ent provided enough flexibility for Members to 
adopt measures necessary to protect public health  and nutrition and to promote public interest in 
sectors of vital importance to the socio-economic  and technological developments.  The Doha 
Declaration on the TRIPS Agreement and Public Hea lth also made it clear that the TRIPS Agreement 
did not, and should not prevent Members from taking measures to protect public health and that the 
TRIPS Agreement should be interp reted and implemented in a manner supportive of WTO Members' 
rights to protect public health.  His delegation be lieved it was implicit in the TRIPS Agreement, and 
especially in Article 20, that a high degree of dome stic regulatory autonomy had to be afforded to a 
Member to enact measures to protect and promote public health. 
199. The representative of New Zealand said that her delegation welcomed the Australian 
legislation for the plain packaging of tobacco pr oducts.  The disastrous effects of smoking could not 
be overstated.  Smoking was one of the leading pr eventable causes of early deaths and caused around 
85 per cent of lung cancers and was linked to many othe r types of cancers.  It was also a major cause 
of heart attacks, strokes, serious respiratory di seases such as emphysema, bronchitis and asthma, and a 
range of other conditions including blindness and infe rtility.  Numerous scientific studies showed that 
plain packaging of tobacco produc ts would lead to positive public health outcomes by reducing the 
attractiveness and desirability of smoking and incr easing the prominence of public health warnings. 
200. She said that, as a comprehensive suite of tob acco control measures, plain packaging would 
contribute to efforts to reduce smoking rates.  New Zealand applauded Australia's commitment to 
taking the next step to reduce smoking rates through the introduction of plain packaging of tobacco products.  She also noted that the guidelines agreed by the Conference of Parties to the World Health 
Organization Framework Conventio n (FCTC) on tobacco control in 2008 for the implementation of 
Articles 11 and 13 of the FCTC recommended that parties consider the introduction of plain 
packaging.  New Zealand also appreciated to hear that Australia had paid close attention to its WTO 
obligations in developing its plain packaging proposal.  Members should recall that the Doha 
Declaration on the TRIPS Agreement and Public Hea lth had confirmed that the TRIPS Agreement did 
not and should not prevent Members from taking measures to protect public health.  The TRIPS 
Agreement could and should be interpreted and implemented in a manner supportive of Members' 
rights to protect public health, and to use to the full the provisions in the TRIPS Agreement which 
provided flexibility for this purpose. 
201. The representative of Uruguay said that his de legation was concerned a bout the inclusion of 
this item in the agenda of the Council for TRIPS.  Uruguay considered it a general principle that the 
protection of public health fell within the soverei gn authority of states and that every country was 
therefore entitled to legislate in the public interest , as had recently been recognized in the Punta del 
Este Declaration on the implementation of the W HO Framework Convention on Tobacco Control.  In 
that Declaration, the 172 countries parties to th e Convention had reaffirmed their commitment to 
prioritize the implementation of health measures d esigned to control tobacco consumption, and had 
reasserted the right of states to define and implemen t national public health policies to protect their 
people.  In Uruguay's case, the implementation of tobacco control policies had led to notable  IP/C/M/66 
 Page 33 
 
 
  improvements, including a 24 per cent drop in the pr evalence of daily smokers, air pollution in closed 
public spaces had fallen by over 90 per cent and, mo re significantly, hospitalization for myocardial 
infarction has declined by 17 per cent. 
202. He said that Article 20 of the TRIPS Agreement provided that the use of a trademark should 
not be unjustifiably  encumbered by special requirements.  Recently, states had shown the clear 
tendency to prioritize the implementation of measu res designed to control tobacco consumption in 
their territories because of its devastating health, social, economic and envir onmental consequences.  
Uruguay was therefore of the view that the measure proposed by Australia should raise no objections since it was consistent with the provisions of the WTO Agreements. 
203. The representative of the Philippines said that hi s delegation shared the concerns expressed by 
other delegations on how the Bill violated Article 20 of the TRIPS Agreement.  The Philippines were 
still in the process of evaluating the proposal and therefor e reserved the right to revert to this issue at 
later meetings of the Council. 
204. The representative of Chile said that this was a complex issue on which his delegation did not 
yet have all the elements needed to form a final opinion.  On a preliminary basis, he nevertheless 
wished to raise two systemic aspects.  The first concerned use of flexibiliti es afforded by the TRIPS 
Agreement on public health grounds.  Numerous discussions had taken place in the Council on the 
importance of the flexibilities contained in the TRI PS Agreement for public health reasons, as well as 
the flexibilities on grounds of public interest, and of those applied to prevent abuse of intellectual 
property rights under Article 8 of the TRIPS Agreem ent.  He said that the case before the Council 
further strengthened the legitimacy and importance of  flexibilities, particularly in the public health 
sphere.  This case highlighted that the flexibiliti es in question had been established not only for the 
benefit of developing countries, as people usually tended to  think, but also because their use might be 
necessary in developed countries such as Australia. 
205. The second issue concerned the proper balance be tween use of a flexibility afforded by the 
TRIPS Agreement - since this was a legitimate tool provided for by the system - and the provisions 
governing the protection of intellectual property rights , in this instance trademarks.  It was without 
question that the flexibilities needed to be applie d in a manner that was fully consistent with the 
protection provided for in the TRIPS Agreement, and that their use could not unjustifiably undermine 
intellectual property rights recognized in the Agreemen t, including the relevant provisions of the Paris 
Convention.  He emphasized that Chile entirely shar ed Australia's concern regarding public health 
protection.  Nonetheless, the present case raised questions which called for careful and in-depth 
analysis.  Chile would closely follow implementation of the legislation in Australia because of the 
potential repercussions of the issue in systemic terms. 
206. The representative of Zambia said noted Australia 's statement that it was committed to fulfil 
its international obligations, including those under TR IPS Agreement.  In light of this, her delegation 
would like to know how plain packaging conformed to  Australia's obligation under Article 20 of the 
TRIPS Agreement.  Her delegation would also be grateful to receive information on any impact 
assessments undertaken by Australia to arrive at the conclusion that plain packaging would reduce the 
appeal of tobacco products to consum ers, particularly the young people. 
207. Marking and labelling provided consumers an important basis for making informed choices 
on the products in question. As other delegations that  had spoken before her, she would be interested 
to hear how Australia would ensure that consumer s were not subject to more harmful, high-toxin 
tobacco products through plain packaging.  It was her delegation's view that the Bill - if implemented 
-  would not only be counter to obligations under Article 20 of the TRIPS Agreement but would also 
have lasting negative effects for small and medium  size enterprises, without any guarantee that the 
measure would lead to reduced appeal of tobacco products to consumers. IP/C/M/66 
Page 34  
 
  208. The representative of Switzerland said that his delegation was supportive of public health 
measures in the area of anti-smoking.  At the same  time, it was clear that such measures had to 
comply with TRIPS obligations and had to be im plemented in a TRIPS-c onsistent manner.  In 
particular, such measures had to be appropriate to  achieve the goal and the public interest for which 
they were being implemented, and they had to be  supported by relevant evidence that they could 
actually achieve the stipulated goal.  Furthermore, such measures could not be more restrictive than 
necessary to achieve the public health objective, as compared to other measures which could equally 
achieve that same objective through less restrictive measures. 
209. Therefore, he said, while fully sharing Austra lia's concerns with regard to the damaging 
effects of smoking for individual and public health, the right balance had to be struck between such 
public health measures and the safeguards of prope rty rights, including intellectual property rights, 
and in the case at hand, the rights of trademark ow ners.  His delegation appreciated the assurances 
given by the delegation of Australia and trusted that, in the further elaboration of its draft legislation 
and its later implementation, the Australian legislat or would take into account the legitimate interests 
of trademark owners in a manner compatible with its  international obligations, and in particular with 
Articles 17 and 20 of the TRIPS Agreement. 
210. The representative of Ecuador said that his de legation had listened with sympathy to the 
concerns raised by the Dominican Republic and ot hers that the Bill could affect these countries' 
exports and how it complied with the provisions of  the TRIPS Agreement, particularly as tobacco 
products were generally e xported by developing countries.  Given the complexity and all the concerns 
connected with the issue, however, his delegation beli eved that Members needed to go deeper into the 
debate on the relationship between TRIPS, intellect ual property rights, trademarks and protection of 
public health, and that further debate and study was required on this issue. 
211. The representative of Norway said that it was w ithin a Member's right to implement necessary 
measures in order to protect public health.  Her de legation trusted that the Australian measures would 
be implemented in a manner that was consistent w ith the TRIPS Agreement.  She said that Norway 
had also implemented a number of measures to co mbat smoking, and she would follow developments 
regarding the plain packaging issue with great interest. 
212. The representative of Mexico said that, while rec ognizing Australia's efforts to protect public 
health and ensure full protection of its citizens, he r delegation would nevertheless like to reiterate the 
high level of concern on the draft bill.  Even meas ures taken to protect public health had to comply 
with the TRIPS Agreement, in particular Articles 8 and 20 which had been repeated various times in 
interventions made by others.  It was clear that  this proposal could go beyond these protection 
requirements and could actually be counter-produ ctive and have undesired results, for example by 
increasing consumption through a reduction in price.   Her delegation believed that the Australian 
proposal went beyond the scope of international instruments in this area. 
213. The representative of China said that the Austra lian draft bill had the legitimate objective to 
protect human health by introducing legislation on plain packaging on tobacco products, with the aim 
to reduce their appeal to consumers and increase the effectiveness of health warnings.  Although 
Articles 15 and 16 of the Bill provided some assurances for the effect of a trademark or an industrial design, Article 14 stipulated that a trademark and industrial design could be prevented from use on 
tobacco products, or the conditions of their use c ould be specified, which had led to some debate on 
its compatibility with the TRIPS Agreement.  Noting that the measure was currently only a draft bill 
for comment, he said that China would keep a close watch on its development. 
214. The representative of the Dominican Republic th anked Australia for its explanations and said 
that the Dominican Republic had no intention to qu estion the right of countries to enact legitimate 
policies to protect public health, which was the s overeign right of each state which the Dominican  IP/C/M/66 
 Page 35 
 
 
  Republic supported.  But her delegation wanted to ma ke sure that Members who take such steps also 
abide by their commitments in the WTO and other international fora, and take into the account the 
possible effects on trade flows of small and vul nerable economies in developing countries.  Her 
delegation hoped that Australia ha d taken this message on board, and was looking forward to further 
collaboration on this issue in the future. 
215. The representative of Australia thanked delega tions for the discussion and said that, while 
emphasising again the very clear public health policy underpinning of the proposed legislation and 
Australia's absolute determination to reduce smoking rates, her delegation would also like to reassure 
Members of its continued commitment to framing le gislation and policies in line with Australia's 
international obligations. 
216. The representative of the World Health Orga nization (WHO) said that the WHO viewed 
tobacco use as one of the greatest threats to public  health the world has ever faced.  Tobacco 
consumption currently killed nearly six million people a year through direct use and the deadly effects 
of second-hand smoke, and an average of one pe rson every six seconds and one in ten adults 
succumbed to tobacco use.  Tob acco was indeed the single most preventable cause of death in the 
world today.  It was the only legal consumer produc t that killed up to half of those who used it as 
intended and recommended by the manufacturer.  Moreover, tobacco was a prominent risk factor for six of the eight leading causes of death in the world.   The economic costs of tobacco use were equally 
as devastating as the public health costs, killing people  at the height of their productivity.  Yet these 
disastrous consequences continued in large part due to aggressive and widespread marketing and 
practices by multinational tobacco companies, incl uding through the use of targeted and precisely 
designed tobacco product packaging aiming to initia te and maintain addi ction among consumers. 
217. He said that a strong and irrefutable body of evidence had demonstrated that product 
packaging traditionally served as one of the tobacco industry's central vehicles in initiating and maintaining addiction to their le thal products among consumers.  For example, detailed analyses of 
tobacco industry documents had illustrated that tobacco companies viewed product packaging as a 
critical marketing strategy in promoting brand imag e in order to increase their market share, and 
target vulnerable segments of the population, includi ng women and children.  Peer-reviewed research 
indicated that plain packaging on tobacco products  would increase the impact of health warnings, 
reduce false and misleading messages that deceive  customers into believing that some tobacco 
products are safer than others, and reduce the attrac tiveness of products to segments of the population 
specifically targeted by tobacco companies.  Given that the majority of smokers began a lifetime of 
addiction before the age of 18, plain packaging would severely restrict the industry's capacity to 
appeal to young people.  In the context of the tact ics employed by the tobacco industry to use tobacco 
packaging to mislead consumers with respect to the level of risk to which consumers are exposed, he 
said plain packaging also circumvented and avoi ded communication of disparate levels of harm. 
218. He said that the tobacco industry would vehemen tly lobby in opposition to the introduction of 
plain packaging legislation, even in the face of overwhelming evidence.  Fundamentally, the 
introduction of plain packaging would represent the inability of tobacco companies to appeal to 
consumers in ways to which they are accustomed, and,  in this way, could affect the tobacco industry's 
economic interests.  It was important to note that th is nature of opposition to effective tobacco control 
policies was a traditional tactic employed by the tobacco industry as tobacco companies had operated 
for decades with the sole purpose of compromising pub lic health policies in order to expand market 
share.  WHO was of the view that a discussion in  this forum of these legitimate tobacco control 
measures would have a substantial impact on tob acco consumption and, in turn, on the national 
burden of disease attributed to non-communicable diseases, which represented 60 per cent of all 
deaths worldwide. IP/C/M/66 
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  219. Another representative of the WHO said that the WHO Framework Convention on Tobacco 
Control (FCTC) was the first international treaty negotiated under the auspices of the World Health 
Organization.  The Convention had been developed in response to the globalization of the tobacco 
epidemic and was an evidence-based treaty that re affirmed the right of all people to the highest 
standard of health.  It had been adopted by th e World Health Assembly on 21 May 2003 and had 
entered into force on 27 February 2005.  It had since become one of the most rapidly and widely 
embraced treaties in the United Nations history.  The Convention currently had 173 Parties and she 
noted that, of the 153 WTO Members, 138 were party to  the FCTC, and thus subject to the obligations 
it contained. 
220. She said that the WHO FCTC contained a number of provisions relevant to the issue of 
plain packaging of tobacco products.  Article 3 of  the WHO FCTC set out the collective objectives of 
the parties in negotiating the FCTC in the following  terms: "to protect present and future generations 
from the devastating health, social, environmental and economic consequences of tobacco consumption and exposure to tobacco smoke by prov iding a framework for tobacco control measures 
to be implemented by the Parties at the national, regional and international levels in order to reduce 
continually and substantially the prevalence of tobacco use and exposure to tobacco smoke." 
221. The general obligations of the parties to the WHO FCTC were set out in Article 5 of the 
FCTC, and included the developmen t and implementation of compre hensive multi-sectoral national 
tobacco control strategies, plans and programs in  keeping with the conv ention and any future 
protocols.  In addition, Article 5 made it clear in paragraph 2 (b) that each party to the WHO FCTC 
had committed itself to adopting, implementing and periodically updating an d reviewing effective 
legislative, executive, administrative and/or ot her measures aimed at inter alia preventing and 
reducing tobacco consumption. 
222. She said that in addition to these general ob ligations, the parties to the WHO FCTC had 
committed themselves to certain specific obligations, including in respect of measures relating to the 
reduction of demand for tobacco products.  Among these agreed measures were non-price measures to 
reduce demand for tobacco products, including the obligation on parties to adopt and implement 
effective legislative, executive, administrative or other measures necessary to fulfill their obligations 
under Articles 8 to 13 of the FCTC.  Importantly, Ar ticle 7 also included the obligation, through the 
Conference of the Parties, to propose appropriate guidelines for the implementation of Articles 8 to 
13.  In terms of specific obligations, Article 11 of the Convention required Parties to adopt and 
implement effective measures in respect of the pack aging and labelling of to bacco products, including 
health warnings and other appropriate messages. 
223. She said that Article 13 of the WHO FCTC had to be read in light of the broad definition 
of "tobacco advertising and promoti on" contained in Article 1(c) of  the FCTC as follows:  "'tobacco 
advertising and promotion' means any form of co mmercial communication, recommendation or action 
with the aim, effect or likely effect of promoting a tobacco product or tobacco use either directly or 
indirectly."  Article 13 of the FCTC required parti es to undertake a comprehensive ban of all tobacco 
advertising, promotion and sponsorship.  
224. As already noted, Article 7 of the WHO FCTC required the Conference of the Parties - 
the FCTC's governing body, which comprised all 173 pa rties to the FCTC - to adopt guidelines for the 
implementation of certain of the obligations undertak en by the parties, including those in Articles 11 
and 13.  With respect to the preparation of guidelines under the FCTC, she said that this was an 
intergovernmental process in which the parties to the Convention created working groups in which the 
text of the guidelines was elaborated by representativ es nominated by the parties before being sent to 
the Conference of the Parties for consideration for adoption.  Members should note that the IP/C/M/66 
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  Conference of the Parties had adopted all guidelines by consensus.  Resources and references used in 
the development of the guidelines for implementati on were made available to the public on the WHO 
FCTC website. 
225. She said that Members had already referred to the guidelines for the implementation of 
Articles 11 and 13 which specifically referred to taki ng measures in respect of plain packaging of 
tobacco products as a means of implementing party obligations to undertake a comprehensive ban of 
all tobacco advertising. 
226. She said that it might also be of interest to Members of the TRIPS Council to note two recent 
decisions of the Conference of the Parties of the FCTC, the governing body of the Convention which met every two years, most recently in November 2010 in Punta del Este, Uruguay.  The first decision 
of interest was the Punta del Este Declarati on (FCTC/COP4(5)) regarding public health policy, 
international trade and the activities of the tobacco industry, which specifically references Articles of 
the TRIPS Agreement as well as the Doha Declarati on on the TRIPS Agreemen t and Public Health.  
The second COP Decision of interest in this context (FCTC/COP4(18)) requested, inter alia, the FCTC Secretariat to cooperate w ith the WTO Secretariat with th e aim of sharing information on 
trade-related tobacco control issues.  She said th at all decisions were available on the WHO FCTC 
website - http://www.who.int/fctc/en/.  
227. She informed the Council that a draft protocol  to eliminate illicit trade in tobacco products 
was currently under negotiation.  The protocol woul d deal with certain matters, including counterfeit 
products, illicit trade and the like.  The final session of the Intergovernmental Negotiating Body, open 
to all parties to the FCTC, was exp ected to take place in March 2012. 
228. The Council took note of the statements made. 
L. INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO 
229. The Chairman updated the Council on the status of acceptances of the Protocol Amending the 
TRIPS Agreement.  He said that, since the Council' s previous meeting, Bangladesh had deposited its 
instrument of acceptance on 15 March (document WT /Let/758).  He encouraged Members that had 
not yet notified their acceptance of the Protocol to ensure that necessary measures were being taken in 
their capitals to allow the consideration of the acceptances in a timely fashion. 
230. Recalling some of the information on the pr ocedural requirements for acceptance that the 
Legal Affairs Division of the WTO Secretariat provide d to the Council at the previous annual review 
of the Paragraph 6 System, he said that, by accepting the Protocol, a Member signalled its consent that all Members were entitled to make use of the add itional flexibilities that the amendment provided.  
Since the acceptance of the Protocol and the adop tion of domestic implementi ng legislation were two 
distinct processes, there was no need to have in place any domestic implementing legislation at the time of acceptance of the Protocol. 
231. He also recalled that the Secretariat had made this information, together with a model 
instrument of acceptance, available in writing in or der to further assist Members in drawing up their 
own instruments of acceptance.  This information was available on a webpage on "How to Accept the 
Protocol Amending the TRIPS Agreement"
1, which could be accessed through the dedicated gateway 
page on "TRIPS and Public Health".2 
                                                      
1 http://www.wto.o rg/english/tratop_e /trips_e/accept_e.htm  
2 http://www.wto.org/english/trat op_e/trips_e/pharmpatent_e.htm  IP/C/M/66 
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  M. O
BSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS  
232. The Chairman said that the list of 15 pending  requests for observer status in the TRIPS 
Council by other intergovernmental organizations was contained in document IP/C/W/52/Rev.12.  
Although the Council had recently made some progress on two requests, it had not been able to reach consensus on the others. 
233. At its last meeting, the Council had requested hi m to continue his consultations on the matter.  
These consultations had focussed on the two issues that  Members had specifically discussed at the last 
meeting, namely the suggestion that the CBD Secretar iat be invited to the Council's meetings on an ad 
hoc, meeting-by-meeting basis, and the suggestion th at the ad hoc, meeting-by-meeting invitations to 
the Secretariats of the African Regional Intellect ual Property Organization (ARIPO) and the African 
Intellectual Property Organization (OAPI) be convert ed into a permanent observer status.  He said 
that, unfortunately,  he was not in a position to repo rt any new thinking with respect to these issues.   
234. He added that some dele gations had also referred to the othe r 14 pending requests.  Given that 
most of them had been pending for some time , some delegations had felt that the Council's 
consideration of these requests would be facilitate d if these organizations could provide up-to-date 
information, including on the nature of their work a nd the reasons for their interest in being accorded 
observer status.  The Chairman suggested that th e Council request the Secretariat to contact the 
organizations whose requests were pending to request such updated information. 
235. The representative of Kenya, speaking on behalf of the African Group, thanked the Council 
for its decision, at its meeting in June 2009, to grant ARIPO and OAPI ad-hoc observer status on a 
meeting-by-meeting basis.  The two organizations  undertook substantial exam inations of patents, 
trademarks and the industrial design applicati ons, and were also res ponsible for the grants, 
administration and harmonization of laws relating to  these fields of intellectual property in African 
countries.  Given the functions performed by these tw o bodies, it was apparent that they had a direct 
bearing on the work of the TRIPS Council.  Pr edictability of the relationship between the two 
Organizations and the WTO could be helpful in assisting African countries to implement the TRIPS 
Agreement.  He therefore requested the TR IPS Council to grant ARIPO and OAPI permanent 
observers status. 
236. The representative of Nigeria endorsed the statem ent made by representative of Kenya.  He 
also supported the CBD Secretariat's admission as an observer on a meeting-by-meeting basis, since 
the Council's work had a significant nexus with that of the CBD Secretariat.   
237. The representative of Egypt recalled his delegati on's position that there remained a systematic 
issue that had not been resolved.  Accordingly, havi ng heard the statements by Kenya and Nigeria, he 
felt that the best way forward was to welcome the continued participation of OAPI and ARIPO as ad-
hoc observers on a meeting-by-meeting basis.  Furthe rmore, he said that all pending requests should 
be dealt with equally. 
238. The representative of South Africa and Zamb ia supported the proposal by Kenya. 
239. The representative of India said that, while he w as open to the made at the previous informal 
meeting to consider all pending requests for obser ver status, the request from the CBD Secretariat 
presented a special case due to its direct relevance to three regular agenda items discussed in the 
Council.  The CBD was doing useful work on ABS re gimes, technology transfer and cooperation, and 
traditional knowledge.  The presence of the CBD Se cretariat in the Council's meetings would help 
with the coherence of WTO's mandate.  The CBD Se cretariat fulfilled all the required parameters for 
observership at the WTO.  It was an intergovernme ntal body, with more members than the WTO.  
Further, the overwhelming majority of WTO Member s were also parties to the CBD.  He did not  IP/C/M/66 
 Page 39 
 
 
  understand the opposition to granting ob server status to it.  The Members opposing the proposal had 
not provided any reason to deny such status to  the CBD.  He urged the Council to positively and 
expeditiously consider the request of CBD Secret ariat.  He proposed that until permanent observer 
status was granted, ad hoc invitations should be extended to it on a meeting-by-meeting basis. 
240. The representative of Ecuador supported the granti ng observer status to th e CBD Secretariat.  
He said that the CBD was an intergovernmental or ganization that had 192 members.  It dealt with 
specific substantive issues that were relevant to the Council's de bates. Further, given that the 14 
pending requests for observer status were not really  opposed, he suggested that the Council recognize 
the CBD Secretariat as a permanent observer, or at l east to invite it to participate in Council sessions 
on an ad hoc basis.   
241. The representative of China said that the TR IPS/CBD issue was an important one for the 
TRIPS Council meetings. It was regrettable that th e CBD Secretariat was still not an observer. China 
continued to support the proposal for granting observer st atus to the CBD Secretariat, at least on an ad 
hoc basis. 
242. The representatives of Brazil and Colombia s upported granting observer status to the CBD 
Secretariat. 
243. The representative of Peru said that all the requests for observer status were equally 
important.  It would be useful to have observe rs in the TRIPS Council because of the contribution 
they could make due to their experience with inte llectual property.  The CBD Secretariat's request was 
particularly relevant.  This issue had come up wh en the Council had discussed agenda items C,  D and 
E.  The relationship between TRIPS and the CBD  was clear, and he saw no reason why the CBD 
Secretariat should not be able to participate on an  ad hoc basis in the Council's work.  He would 
welcome any first-hand information that the CBD Secretariat could provide to the Council on the 
systems it had.  Therefore, Peru supported granting permanent observer status to the CBD Secretariat, 
or at least inviting it on an ad hoc basis. 
244. The representative of the United States joined Kenya, Nigeria, South Africa and Zambia in 
support of granting ARIPO and OAPI permanent observe r status.  However, he was not in a position 
to join those Members seeking to  include the CBD as an observer, either on a permanent or ad hoc 
basis. 
245. The Chairman suggested that th e Council request the Secretariat to contact the international 
intergovernmental organizations whose requests fo r observer status were pending to request updated 
information, including on the nature of their work an d their reasons for their interest in being accorded 
observer status.  This would enable the Council to re view these applications on a case-by-case basis at 
a later date. 
246. The Council took note of the statements made and so agreed. 
N. OTHER BUSINESS  
(i) Invitation to ARIPO and OAPI 
247. The Chairman recalled that, at its meeting in June  2010, the Council had agreed to grant an ad 
hoc observer status on a meeting-to-meeting basi s to the African Regional Intellectual Property 
Organization and the African Intellectual Property Orga nization.  He suggested that the Council again 
invite ARIPO and OAPI to attend the Council's next formal meeting on an ad hoc basis. 
248. The Council so agreed. IP/C/M/66 
Page 40  
 
  (ii) Annual review of the functioning of the Paragraph 6 System 
249. The Chairman recalled that, at its last me eting, the Council had requested him to hold 
consultations on any further follow up to the annual review of the functioning of the Paragraph 6 
System held in October 2010, and the preparations for the forthcoming annual review to be held in 
October 2011.  During his consultati ons with a number of delegations, a ll of them had shared the view 
that the last annual review conducted on the de dicated day in October 2010 and the follow-up 
discussion in March had been very useful and cons tructive.  All delegations had also shared the 
importance they attach to this matter. 
250. Some delegations had said that they still had not heard the views of the civil society and 
industry, and had reiterated their suggestion concerning a workshop op en to all stakeholders that 
should be organized so that it could feed into  the 2011 review.  Some other delegations had 
emphasized that this was first of all a process betw een Members and regretted that they had still heard 
very little from potential importers and beneficiar ies of the System concerning any problems they 
might have faced.  Therefore, these delegations had fe lt that such a workshop would be premature.  It 
had also been said that there could be, at some poi nt, a stakeholder meeting in the broader context of 
access to medicines, which should not be focused ex clusively on the Paragraph 6 System, but should 
also include other issues such as pricing, procuremen t and customs tariffs.  It had also been said that, 
if such a workshop were to be organized, it shoul d not be in lieu of a workshop dedicated to the 
Paragraph 6 System. 
251. Regarding the preparations for the next annual re view, all delegations had shared the desire to 
make it as productive and constructive as possible.  Some delegations had said that the focus should 
be on receiving more information from beneficiaries.  It had been said that the October 2010 questions 
and the March 2011 follow-up questions were a good starting point for the preparations.  In addition, 
there had been a suggestion that the Council wo rk towards timely acceptances of the Protocol. 
252. The Chairman said that it was his intention to  pursue further consultations after the June 
meeting on the preparations of the Council's next an nual review and the issue of a possible workshop.  
He suggested that the Council should work on the assumption that the annual review would at least 
follow a similar approach to that  which had been widely welcomed  by delegations in October 2010, 
noting that consultations would continue on further ways of improving and preparing for the review. 
253. The representative of India reiterated his delega tion's request for an open-ended workshop on 
the implementation of the Paragraph 6 System.  There was a need to move beyond the mere annual 
ritualistic review of the working of the System. To date, its use had been sub-optimal.  Since the issue 
was of fundamental importance and interest to most WTO Members, it was important to hold a 
dedicated workshop, which would provide an opportunity for substantive and serious discussion on 
the relevant issues and involve all relevant stake holders.  There was no a priori assumption that the 
Paragraph 6 System was unworkable or that it ne eded to be amended.  However, a fact-based 
discussion eight years after its adoption was essen tial for understanding its functioning and improving 
its operationalization. 
254. Although the previous discussion on this subject had been useful, it had not depicted the full 
picture.  The scope of discussion ha d to be expanded in order to invo lve other stakeholders. There was 
a need to understand why Doctors Without Borders (MSF) had argued that the System was neither expeditious nor a solution to the problem, why A potex, a Canadian pharmaceutical company, had said 
that the System was unworkable, and why the System had only been used once. He asserted that the answer to many of these questions could be found if  the Council agreed to a dedicated workshop.  He 
was puzzled by some Members' opposition towards this proposal because many of them were 
supportive of enlarging the debate in the DSU negotia tions.  In that forum, they had suggested that  IP/C/M/66 
 Page 41 
 
 
  allowing unsolicited and amicus curiae briefs in pa nel and Appellate Body proceedings would enrich 
the debate and would lead to better quality panel reports that would add to the credibility of the WTO.  
However, with respect to the Paragraph 6 Syst em, which so many Members wanted to better 
understand, some delegations insisted on limiting th e discussion to Members only.  He hoped that 
constructive engagement would clear the road bloc ks to an early organization of an open-ended 
workshop on the Paragraph 6 System. 
255. The representative of the Bolivarian Republic of Venezuela said that considerable efforts had 
been taken to reach consensus on holding an open-ended workshop to help Members better 
understand why the System had not worked in all th ese years.  When he had asked the Chair at the 
beginning of the meeting why this issue had not been  put on the agenda, the Chair had replied that he 
would provide Members with information on hi s consultations under "Other Business".  The 
representative of Venezuela said that he had t hought that agreement had been reached in those 
consultations to place the matter on the Council's agenda .  As established by the rules of procedure, 
substantive discussions could not be held under "Other Business" and the issue should therefore not have been placed under that item without the agreem ent by India and other sponsors of its proposal, 
including Venezuela.  Sponsors alone could withdraw  a proposal before agreement is reached.  He 
said that if no opportunity were provided to learn the full reasons that had prevented the System from 
being used, his delegation would request that th ere be no further extensions of the period of 
acceptance of the Protocol Amending the TRIPS Agreement. 
256. The Chairman said that delegations could ask  for items to be included on the Council's 
proposed agenda up to ten working days prior to the da te set for its meeting.  In the absence of such a 
request, he had taken up this matter under "Other Bu siness" so that he could inform the Council about 
his consultations.  As he had already indicated at the beginning of the discussion, it was his intention to pursue further consultations after the meeting on the preparations of the Council's next annual 
review and the issue of a possible workshop with  a view to reaching consensus on the matter. 
257. The representative of Ecuador said that there ha d been no consensus on the workshop.  The 
request had been made in the interest of deep ening the debate among Members on the Paragraph 6 
System that his delegation was hoping to exped ite. The Council had held useful discussions on the 
matter, but needed to take them further.  In support of the statements made by India and Venezuela, he 
highlighted the need to fully understand how the Syst em worked, what its most effective aspects were 
and how its effectiveness could be guaranteed.  To do so, he urged Members to reach consensus on an 
open-ended workshop that would include industry, acad emia, and civil society, so that everyone could 
work together to clarify the situation. 
258. The representative of Canada said that his delegati on's particular interest in issues related to 
the Paragraph 6 System and welcomed the Chair's consultations on this matter, as well as Bangladesh' 
acceptance of the Protocol Amending the TRIPS Agreemen t.  He appreciated the Secretariat's work in 
providing further information and guidance with a view to facilitating the task of Members which still 
had to accept the Protocol and encouraged those Me mbers to proceed.  This would concretize one of 
the more significant developments in the Doha Development Round.  It would constitute welcome 
news for the Ministerial Conference in December, if additional Members accepted the Protocol in time so that the derogations could then become  a permanent part of the TRIPS Agreement. 
259. He thanked the Secretariat for distributing the report on the trilateral symposium held by the 
WTO, WIPO and WHO in February 2011, con cerning various issues affecting access to essential 
medicines.  Both this and the previous sym posium had been good opportunities to delve into a 
complex subject matter.  Information provided coul d serve Members' respective constituencies.  The 
trilateral symposia also confirmed the positive collaboration between the three international 
organizations. He encouraged similar acti vities to be organized in the future. IP/C/M/66 
Page 42  
 
  260. His delegation was pleased with the high level of activity regarding the review of the System.  
The last review had provided an opportunity for de legations to provide additional information with 
respect to their experience.  Un fortunately, the kind of feedback his delegation was hoping for from 
some of the potential beneficiaries of the System  had not been received, including any potential 
concerns that they may have had with it.  This was directly related to the suggestion that an open-
ended workshop be held.  As noted in the past, his delegation was, in principle, not opposed to the 
idea.  However, it would seem premature to go ahead with it before a full scale exchange of 
experiences among Members was completed. 
261. While interested stakeholders could sometimes provide additional persp ectives that could be 
helpful for Members, the key in this case was to focus on decision makers, i.e. the Members 
themselves.  He noted that it was them who decide d whether to use the System, and not MSF, Apotex, 
or other stakeholders that had been mentioned.  Therefore, if the Council were to have a valuable 
engagement with other parties, first and foremost, it had to do its homework within the membership.  
It was important to have answer s to a number of outstanding questions that had been asked by his 
delegation and by others with respect to some Members' experiences.  He therefore encouraged 
Members who had been unable to share their experien ces in the previous annual review, to do so at 
the forthcoming review. 
262. The representative of Zambia said that her dele gation had an interest in ensuring that the 
Paragraph 6 System was effectively implemented.   Since the Council was mandated to review the 
System annually, the preparations for these reviews we re important.  She was surprised that the issue 
was being discussed under the agenda item "Other Busi ness", given that there were so many issues 
that related to the System, including the informati on on the status of acceptances of the Protocol.  She 
believed that it should have come under a substant ive agenda item.  She said that her delegation 
wanted to ensure that, whatever mechanism were  to be used, the work would highlight how the 
System could be used in order to maximize its benefits. 
263. The representative of Nigeria said that he was concerned about Venezuela's statement on 
further extensions of the period of acceptance of the Protocol.  Members of the African Group were 
making efforts in order to proceed with its acc eptance.  In any case, the 2003 waiver decision 
continued to apply.  Any calls for not exte nding the period for acceptance had far-reaching 
implications for the African Group, which was the ma jor beneficiary of the System.  It had been the 
demandeur for discussions on matters related to TR IPS and public health and the debate itself had 
helped bringing down prices of medicines, irrespec tive of whether the System had been used or not. 
264. The representatives of Cuba and China supporte d the proposal on a dedicated open-ended 
workshop on the implementation of the Paragraph 6 System.  The representative of China added that 
such a workshop would help Members to gather fi rst-hand information and suggestions from industry 
and would usefully assist them in their discussions in the Council. 
265. The Council took note of the statements made. 
(iii) Ninth annual review under paragraph 2 of the decision on the "Implementation of 
Article 66.2 of the TRIPS Agreement" 
266. The Chairman said that, since its meeting in  March 2011, the Council had received additional 
reports relating to its eighth re view from the European Union and individual member States, namely 
Austria, Belgium, Finland, France, Germany, the Slovak Republic, Spain, Sweden, and the United Kingdom (document IP/C/W/551/Add.7). 
267. Turning to the arrangements for the Counc il's ninth review under the decision on the 
"Implementation of Article 66.2 of the TRIPS Ag reement", he recalled that paragraph 1 of the  IP/C/M/66 
 Page 43 
 
 
  Decision provided that developed country Members shall submit annually reports on actions taken or 
planned in pursuance of their commitments under Article 66.2.  To this end, they were to provide new 
detailed reports every third year and, in the interv ening years, provide updates to their most recent 
reports.  These reports were to be submitted prior to the last Council meeting scheduled for the year in 
question.  Paragraph 3 of the decision determined th e information that had to be provided in these 
reports. 
268. The first, second and third sets of detailed annual reports under the Decision were presented 
to the Council's end-of-year meetings in 2003, 20 06 and 2009, and updates to the Council's meetings 
in the intervening years.  Therefore, this year  developed country Members should submit the second 
set of updates to the new detailed reports they pr ovided in 2009 on actions taken or planned in 
pursuance of their commitments under Article 66.2 prior to the Council's end of year meeting 
scheduled for 25-26 October.  As provided in para graph 2 of the Decision, the Council shall review 
these updates at that meeting. 
269. Accordingly, he suggested that developed count ry Members be requested to provide updates 
to their reports on actions they had taken or planned in pursuance of their commitments under 
Article 66.2 by 30 September, i.e. about three weeks before the meeting, in order to allow their timely 
circulation and review at the Council's meeting in October. 
270. The Council so agreed. 
271. The representative of the Secretariat said that the 2003 Decision followed through on the 
decision of Ministers at Doha to establish a mechanism for ensuring the monitoring and full 
implementation of Article 66.2 obligations.  On t op of earlier reports on Article 66.2 implementation, 
this monitoring system had yielded a significant body of material on reported incentives and 
programmes related to technology transfer, approach ing 100 reports in all, some extending to over 
100 pages.  This sheer volume of information clearly  created a challenge for delegations to obtain a 
general overview of the reported material. 
272. In recent years, workshops had been held to help delegations prepar e for the annual review 
that was required to take place at the final Council meeting for the year.  This enabled those 
delegations that had made reports to explain the deta ils of their submissions, and then for an informal 
dialogue to take place between LDC representati ves and the reporting countries, to deepen 
understanding of the information needs of LDC represen tatives and of the content of the submissions.  
This discussion had also turned to questions of how the reporting format and content could be enhanced and focussed so as to improve the utility and consistency of the reports on implementation 
of Article 66.2. 
273. Since the feedback had been positive from these recent events, the Secretariat had scheduled a 
similar event for the afternoon of October 24, immedi ately preceding the Council's next meeting.  The 
Secretariat intended to coordinate with LDC Memb ers to ensure that the workshop continued to 
provide a useful service for those Members in partic ular, in providing an informal supplement to the 
Council's formal review of the submissions and in helping to promote understanding and accessibility 
of the information reported.  As noted at the C ouncil meeting in October 2012, this would again be 
guided by the interests and the priorities of the delegations concerned and the LDC Group in 
particular. 
274. The representative of Zambia thanked the Secretariat for its report on the work it had 
undertaken in relation to Article 66.2.  She also th anked those delegations th at had made submissions, 
which her delegation was still studyi ng in light of the discussions delegations had had in the past, 
especially the constructive discussions in October 2010. IP/C/M/66 
Page 44  
 
  275. The Council took note of the statements made. 
(iv) Other reviews 
276. The Chairman said that, as had already been discussed under a previous agenda item, the 
Council would take up at its October 2011 meeting its annual review of t echnical cooperation under 
Article 67.  Furthermore, the Council would have on its agenda the final transitional review under 
Section 18 of the Protocol of the Accessi on of the People's Republic of China. 
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