RESTRICTED  WORLD TRADE  
ORGANIZATION  IP/C/M/62 
1 June 2010 
 
 (10-3009) 
Council for Trade-Related Aspects of 
Intellectual Property Rights  
 
 
 
MINUTES OF MEETING 
 
Held in the Centre William Rappard on 2 March 2010  
 
Chairperson:  Ambassador Karen Tan (Singapore) 
 
  The present document contains the record of the discussion which took place during the 
TRIPS Council meeting held on 2 March 2010. 
 
A.
 NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT ........................................................1  
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. .....................17  
H. REVIEW OF THE APPLICATION OF THE PROVISION OF THE SECTION ON 
GEOGRAPHICAL INDICATIONS UNDER ARTICLE 24.2 ...............................................................17  
I. FOLLOW -UP TO THE SEVENTH ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE 
DECISION ON THE IMPLEMENTATION OF ARTICLE 66.2  OF THE TRIPS  AGREEMENT ...............18  
J. TECHNICAL COOPERATION AND CAPACITY BUILDING .............................................................21  
K. LETTER FROM THE CHAIR OF THE GENERAL COUNCIL CONCERNING WAYS TO 
IMPROVE THE TIMELINESS AND COMPLETENESS OF NOTIFICATIONS AND OTHER 
INFORMATION FLOWS ...............................................................................................................30  
L. INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO ..............................31  
M. OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS ...............32  
N. OTHER BUSINESS ......................................................................................................................35  
O. ELECTION OF THE CHAIRPERSON ..............................................................................................45  
 
 
A. NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT  
1. The Chairperson  said that, since its meeting in October 2009, the Council had received a 
number of supplements and updates to earlier notif ications of laws and regulations notified under 
Article 63.2 of the Agreement.  Saint Vincent and the Grenadines had updated the notification of its IP/C/M/62 
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  intellectual property laws and regulations;  Tha iland had notified a Ministerial Regulation on the 
Application for Patent Protection to Implement the Patent Cooperation Treaty;  Hong Kong, China 
had notified an ordinance amendi ng certain intellectual property laws;  and Singapore had notified 
amendments to its copyright laws and regulations.  These notifications were being circulated in the 
IP/N/1/- series of documents.  In addition, Tunisi a had provided revised responses to its Checklist of 
Issues on Enforcement.  These responses were bei ng circulated in document IP/N/6/TUN/1/Rev.1. 
2. The Chairperson urged those Members whose in itial notifications remained incomplete to 
submit the outstanding material without delay.  Sh e also reminded other Members of their obligation 
to notify any subsequent amendments of their laws and regulations without delay after their entry into 
force.  In particular she reminded those Members who had made any changes to their laws and/or 
regulations to implement the Deci sion on TRIPS and Public Health a nd who had not yet notified such 
changes to the Council to do so. 
3. As regards notifications of contact points unde r Article 69 for the exchange of information 
and cooperation on trade in infringing goods, she said  that, since the Council's meeting in October, 
Burkina Faso had notified its contact point.  In ad dition, an update to a contact point notified earlier 
had been received from Switzerland.  These notifications had been circulated together with an updated 
list of all contact points in document IP/N/3/Rev.11.  Since the circulation of the revised list, further 
updates had been received from the European Union and Canada, and were be ing circulated in an 
addendum to that document. 
4. The Council took note
 of the information provided. 
B. REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION  
5. The Chairperson  said that, as regards the reviews of national implementing legislation that 
had been initiated at the Council's meetings since April 2001, there were five reviews that still 
remained on the Council's agenda.  These reviews con cerned Cuba;  Fiji;  Grenada;  Saint Kitts and 
Nevis;  and Suriname. 
6. The Council took note  of the information provided and agreed  to revert to the matter at its 
next meeting.  
C. REVIEW OF THE PROVISIONS OF ARTICLE 27.3( B) 
D. RELATIONSHIP BETWEEN THE TRIPS  AGREEMENT AND THE CONVENTION ON BIOLOGICAL 
DIVERSITY  
E. PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE  
7. The Chairperson  recalled that, at its meeting in March 2006, the Council had agreed to 
maintain its present method of work on these matte rs, and to keep this method under review to assess 
whether any change might prove appropriate in the light of developments.  Accordingly, she 
suggested that the Council continue its past prac tice of discussing these three agenda items together 
on the basis of contributions by Members.  She informed the Council that, since its meeting in 
October 2009, the Council had received a communication from Bolivia on the review of 
Article 27.3(b) of the TRIPS Agreement circulat ed in document IP/C/W/545 and Corrigendum 1. 
8. The representative of Bolivia  said that her government attached great importance to the 
review of Article 27.3(b).  She said that the review  of Article 27.3(b) was an important and topical 
issue that had been raised earlier by other Member countries and groups of countries.  She said that 
her delegation's presentation was mean t to contribute to the examinati on of this issue which required a  IP/C/M/62 
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  multilateral solution aimed at ruling out the possibility of the patenting of life forms, including 
biological resources, micro-organisms, ge nes, genetic sequences and non-biological or 
microbiological processes.  She requested that, in or der to ensure that this subject was given the 
attention it deserved, her statement be incorporated  in the report of the Council for the stocktaking 
exercise in March 2010.  
9.  She said that the review of Article 27.3(b) was an issue within the mandate of the Doha Work 
Programme according to paragraph 19 of the Doha  Ministerial Declaration and it was also an 
implementation-related issue and concern under para graph 12, oriented to address a number of 
implementation problems faced by Members.  The Government of Bolivia considered that the 
exclusion from patentability of life forms was one of the most important issues within the Doha 
Development Agenda.  She said that document IP/C /W/545 contained three parts:  the first dealing 
with the rationale for the exclusion of patentability  of life forms;  the second with the protection of 
plant varieties;  and the third with the protection of traditional knowledge and the rights of indigenous 
peoples and the urgency to review Article 27.3(b).  She said that Article 27.3(b) allowed Members to 
exclude from patentability plants and animals a nd essentially biological processes for the production 
of plants and animals, but not micro-organisms, non-biological or microbiological processes.  
Furthermore, Members were required to provide plan t variety protection either by patents or by an 
effective sui generis  system of protection or by any combination thereof.  Article 27.3(b) was subject 
to review four years after the entry into fo rce of the WTO agreements.  Section III.A of 
document IP/C/W/545 referring to "patenting of life forms" was based on the fact that there was no reason to make an artificial distinction between  plants, animals and micro-organisms and also 
between "essentially biological" processes for the pr oduction of plants and animals (which might be 
excluded) and non-biological and microbiological processes (which might not be excluded).  She said that, since the adoption of the TRIPS Agreement, ther e had been a proliferation of patents and patent 
applications involving micro-organi sms and other biological resources.  The result was concentration 
of ownership of patents in a few entities (largely  based in developed countries) with detrimental 
effects on competition and on social and economi c situation, including food sovereignty and 
livelihood of farmers, that most affected the vulnerable and poor, including indigenous peoples in 
developing countries.  Moreover, patenting of lif e forms promoted an imbalance in the current 
intellectual property system.  The TRIPS Agreement, while granting monopoly rights to private parties, did not explicitly recognize the collective rights of indigenous peoples and local communities 
over their biological resources and traditional knowle dge, farmers' rights or the sovereign rights of 
States, which had serious social, economic and ethical  implications that were adverse, especially for 
developing countries. 
10. Regarding Section III.B of document IP/C/W/545 on  the protection of plants varieties, she 
said that patenting of plants was already taking place in several developed countries, and that there 
was misappropriation of biological resources wher e plants and seeds originating in developing 
countries were being patented, usuall y without the knowledge or consent of the countries of origin.  In 
addition, there had been significant corporate cont rol over the agriculture in dustry due to various 
mergers and acquisitions.  She said that it was importa nt to ensure that innovations of indigenous and 
local farming communities and the continuation of tr aditional farming practices, including the right to 
use, exchange, save seeds and sell their harvest, were recognized and protected. 
11. With regard to the subject of traditional know ledge and the rights of indigenous communities 
as well as the urgency to review Article 27.3(b), sh e said that various developments had taken place at 
national, regional and international levels that highlighted the need to conduct concrete  and expedited 
discussions on the review of Article 27. 3(b).  In brief, two of the most  relevant devel opments were the 
adoption of the United Nations Declaration on th e Rights of Indigenous Peoples in 2007 and the new 
Bolivian Political Constitution approved in 2009 by referendum with more than 60 per cent of 
support.  She quoted several articles of the new Const itution that were relevant to deliberations in the 
framework of the DDA.  She said that Article 255.II 4 and 7 of the Constitution states that: "The IP/C/M/62 
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  negotiation, signature and ratification of treaties w ill be governed by the following principles: respect 
for the rights of indigenous peoples and peasants;  ha rmony with nature, protection of biodiversity and 
prohibition of private appropriation of plants, anim als, micro-organisms and any living matter for 
exclusive use and exploitation."  Additionally, Article 382 states that it "is the competence and duty of 
the State to defend, recover and protect biological material coming from natural resources, ancestral 
knowledge and anything else that originate in the territory".  She said that the new Constitution 
responded to the legitimate concerns  of indigenous peoples and all Boliv ians in general.  This was an 
important first step, but not sufficient.  She said that since Members were dealing with a problem which did not respect national borders, it needed an international solution under the WTO negotiations.  She said that Bolivia was not th e only country facing these challenges as several 
developing countries, small peasants or indige nous peoples shared these concerns, which among 
others, were:  to put an end to biopiracy, due to the extensive patenting of life forms, misappropriation 
of biological resources originating from developi ng countries by developed countries;  to stop the 
increasing concentration of corporate control over th e agriculture industry due to various acquisitions 
and the overuse of intellectual property rights, und ermining the rights of indigenous peoples, local 
community and farmers, including the right to exch ange, and save seeds and State's food security and 
sovereignty;  to stop the prosecution of farmers in de veloping countries for alle ged patent violations;  
to update the TRIPS Agreement in relation with  international developments, such as the UN 
Declaration on the Right of Indigenous Peoples;  and finally, to limit the proliferation of trade 
agreements and initiatives focused on enforcement of intellectual property that pressured developing 
countries to adopt a particular model of intellectua l property, which was not in their best interest. 
12. She said that all these reasons mentioned above  allowed the DDA and the TRIPS Council to 
have a strong case for an in-depth and accelerated review of Article 27.3(b).   
13. The second representative of Bolivia
 said that, for the past five centuries, indigenous peoples 
in Bolivia had carried the memory of the biggest genocide in the history of humanity and of the irrational violation and appropriation of thei r collective rights and traditional knowledge.  
Transnational corporations, with the support of their countries, had appropriated Bolivian natural 
forestry resources, minerals, water and biodivers ity, leaving Bolivians in extreme poverty and 
polluting Bolivian lands.  In the name of deve lopment, technology, and scientific research, 
pharmaceutical and agro-industrial companies from developed countries came to expropriate and 
appropriate life by modifying the genes and chromo somes that formed part of the life of plants, 
animals, and the indigenous peoples themselves without  consulting the indigen ous peoples, on top of 
which they prohibited Bolivians from using th ese products through the multilateral intellectual 
property system which should be safeguarding collectiv e interest, and not only private interests.  He 
said that none of the age-old knowledge and collect ive traditions of the indigenous populations were 
properly protected by the intellectual property system .  He appealed to the international community 
and to the international organizations to respect th e life and knowledge of the indigenous peoples.  He 
also urged the WTO, in particular the TRIPS Council, to develop mechanisms to ensure the 
participation of the indigenous peoples and of ci vil society in order to guarantee the life and the 
collective knowledge of the indige nous peoples in its entirety, and to provide the necessary protection 
for folklore and genetic resources, a principle of life that Bolivian had maintained for centuries.   
14. He informed that, at the universal periodic review of the Human Rights Council held in 
Geneva in February 2010, the Plurinational State of Bolivia had shown the progress it had made in 
recognizing the rights of indigenous peoples:  bot h the United Nations Declaration on the Rights of 
Indigenous People and the International Labour Organization's Indigenous and Tribal Peoples 
Convention (also referred to as ILO-Convention 169), had been substantively incorporated in the new 
Constitution approved by constitutional referendum on 25  January 2009.  They formed part of the 
country's national legislation:  the ILO-Conven tion 169 as Law 1257 of 11 June 1992, and the 
Declaration through Law 3760 of 7 November 2007.  He said that the UN Declaration on the Rights 
of Indigenous People stipulated that member Stat es - which were in fact represented in the TRIPS  IP/C/M/62 
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  Council - shall recognize the right of indigenous peoples" to practice and revitalize their cultural 
traditions and customs.  This includes the right to maintain, protect and develop the past, present and 
future manifestations of their cultures, such as arch aeological and historical sites, artefacts, designs, 
ceremonies, technologies and visual and performing arts  and literature."  The Declaration also stated, 
in operative paragraph 31.1, that: "Indigenous peoples have the right to maintain, control, protect and 
develop their cultural heritage, traditional knowledge  and traditional cultural expressions, as well as 
the manifestations of their sciences, technologi es and cultures, including human and genetic 
resources, seeds, medicines, knowle dge of the properties of fauna and flora, oral traditions, literatures, 
designs, sports and traditional games and visual and performing arts.  They also have the right to 
maintain, control, protect and develop their in tellectual property over such cultural heritage, 
traditional knowledge, and trad itional cultural expressions." 
15. He said that the people of Bolivia, through th e new Constitution, addressed elements that the 
indigenous peoples considered to have a value th at transcended everyday life, values that they 
considered sacred, such as the f act that life, regardless of the form it took, could not be privately 
appropriated or patented by any company.  Artic le 255.II.7 of the Bolivian Constitution states that: 
"negotiation, signing and ratification of inte rnational agreements shall be governed ( inter alia)  by the 
following principles: harmony with nature, the protec tion of biodiversity and the prohibition of forms 
of private appropriation for the use and exclusive e xploitation of plants, animals, micro-organisms and 
any living matter."  He said that many indigenous  peoples perceived Western culture as one in which 
everything was marketable:  plants, biological r esources, and even life - and that was where the 
trouble lay.  Natural and legal persons had been able, through various legal mechanisms such as 
Article 27.3(b), to acquire economic rights over different forms of life, so that biological resources, 
micro-organisms and hence genes ultimately became  the property of companies or private persons.  
By allowing this situation to exist, what was re ally happening was that biopiracy of biological 
resources, plants or genes was being promoted without any consideration for the rights of the 
indigenous peoples who owned biological resources and associated traditional knowledge.  The result 
was impoverishment, not only material but also moral.  Faced with this hard reality, he said that the 
indigenous peoples of Bolivia, with their world view, were proposing an alternative form of 
co-existence between human beings in which people w ould live in harmony with nature as reflected to 
a certain extent in document IP/C/W/545.  He said that it was a philosophy of "better living" ("allin 
kawsay" in Quechua) in harmony with nature - as opposed to living better at the cost of others or 
interfering with others;  it advocated abandoning th e capitalist consumer logic in which everything 
was marketable in favour of respect for life, resp ect for nature and a more harmonious life between 
human beings.  He said that the WTO could not cling to a policy of favouring exclusively transnationals, which in the name of science, were appropriating the genes of life, or of 
micro-organisms, plants and animals, and even th e music of indigenous peoples.  If Members were to 
assume their responsibility for the life of humankind and of the planet - mother earth - as a whole, 
they had a moral obligation towards humanity and towards nature, as State representatives, to amend 
these international instruments that were contrary to  the ethical principles of the indigenous peoples 
and of developing countries to make them more  inclusive, democratic and participatory. 
16. The representative of Cuba
 supported the statements made  by Bolivia, and said that 
document IP/C/W/545 was a positive contribution to the work of the Council in respect of the review 
of Article 27.3(b).  She recalled that Article 27.3( b) was a result of the pressure put by developed 
countries and the biotechnology industry to impose private and monopoly rights on biological 
resources and traditional knowledge.  During the TR IPS negotiations and later, the majority of 
developing countries had objected to the possibility of patenting of life forms, and proposals had been 
put forward to this end, such as documents IP/C/W/206 and WT/GC/ W/302.  Nevertheless, there was 
no in-depth discussion of these proposals because of some developed countries' objection.  Members 
could not even reach an agreement on the scope of th e review;  developing countries wanted to have a 
substantive and not procedural review.  The TRIP S Agreement promoted the grant of patents in 
respect of inventions where there were biological  resources or traditional knowledge involved, but IP/C/M/62 
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  there was no provision on the protection of these resources and knowledge against unlawful 
misappropriation and use.  This led to the submi ssion of a number of proposals to amend the TRIPS 
Agreement including document IP/C/W/474 co-sponsor ed by Cuba.  She said that the review of 
Article 27.3(b) was one of the outstanding implemen tation issues which were an integral part of the 
Doha work programme.  The current negotiations should deal with all of the issues arising in 
document JOB(01)/152/Rev.1 with the same level of attention as the other implementation issues.  
Finally she highlighted the importance of para graph 11 on page 3 of document IP/C/W/545 in 
English, which, she thought, gave substantive argum ents for the immediate review of Article 27.3(b). 
17. The representative of Nicaragua
 welcomed the submission and presentation made by Bolivia.  
She said that the TRIPS Council had not had substan tive discussion on the review of Article 27.3(b) 
and that document IP/C/W545 would undoubtedly help Members reactivate the work of the Council.  
She said that this issue was a matter of interest to  developing countries, in particular those who had 
major indigenous populations.  As proposed by Boli via, Members should consider the reason for the 
provisions on micro-organisms, non-biological an d microbiological processes, and should review 
Article 27.3(b) in order to agree to a provision that  would make the patenting of life forms impossible.  
She fully supported the proposal contained in doc ument IP/C/W/545 and hoped that the proposal 
would guide future discussion as part of the stocktaking proposal to be done in March 2010.  
18. The representative of Ecuador  informed the Council that the Government of Ecuador was 
considering a series of constitutional provisions th at would prohibit intellectual property rights on 
derived products or synthesized products based  on genetic resources and associated traditional 
knowledge.  He recognised the concerns raised  by Bolivia over the ongoing misappropriation of 
biodiversity and associated traditional knowledge.  He  said that the issue of patenting of life forms 
was a matter of interest and the Council should clarify the means and extent to which Members 
needed to carry out their mandates.  He said that the patentability of plant varieties was another issue 
which needed in-depth discussion.  As a multicul tural country, he said that Ecuador shared the 
concerns expressed by Bolivia and others and ther efore fully supported a careful consideration of 
document IP/C/W/545 and duly valued the conclusion therein.   
19. The representative of China  said that her delegation would re main cautious on how to define 
biological resources and would examine whether there was any overlap or distinction between 
biological resources and genetic resources.  Sh e would come back with a detailed study on 
document IP/C/W/545 after consulting with capital-based experts.  
20. The representative of Angola, speaking on behalf of the LDC Group , said that the review of 
Article 27.3(b)  had a link to the mandate given in the Doha Ministerial Declaration, which instructed 
the Council, in pursuing its work programme includi ng under the review of Article 27.3(b), the review 
of the implementation of the TRIPS Agreement unde r Article 71.1 and the work foreseen pursuant to 
paragraph 12 of the Declaration, to examine, inter alia , the relationship between the TRIPS 
Agreement and the CBD, the protection of trad itional knowledge and folklore.  The LDC Group 
maintained that the review of Article 27.3(b) shou ld clarify that plants and animals as well as micro-
organisms and other living organisms and their pa rts should not be patented and that natural 
processes, products, plants and living organisms should not be patented either.  He said that it was 
equally important to maintain the flexibility on the protection of plant varieties based on individual country systems and needs, which would contribut e to improving the food security of indigenous 
peoples, to ensuring the protection of  their inventions and to access.   
21. As regards the relationship between the TR IPS Agreement and the CBD , the LDC Group 
welcomed the informal consultations undertaken by the Director-General.  He said that biodiversity 
was an important source of livelihood for populations  living in rural areas in most LDCs.  Benefit 
arising from the use of such resources and trad itional knowledge by multinational companies could 
barely be shared with local communities, which was a matter of concern to the LDC Group.  A  IP/C/M/62 
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  corrective solution could only be achieved by in serting a mandatory disclosure requirement in the 
TRIPS Agreement.  He said that it was equally important to ensure that patent applicants 
demonstrated evidence of prior informed consent from the competent author ities in the country of 
origin of genetic resources and agreement on the sh aring of benefit arising from the appropriation of 
such resources and traditional knowledge.   
22. The representative of Bangladesh  supported the statement made by Angola on behalf of the 
LDC Group. 
23. The representative of Switzerland  made his preliminary remark s on document IP/C/W/545.   
He said that his delegation would make detailed co mments at the next TRIPS Council meeting.  He 
said that inventions in all fields of technology , including biotechnology, deserved adequate patent 
protection.  Accordingly, the review of Article 27.3( b) should not lead to any lowering of the level of 
patent protection for biotechnological inventions.  He  said that, in the field of biotechnology, certain 
exclusions of patentability were possible according to  the first sentence of Article 27.3(b), and that 
Article 27.3(b) was a balanced provision which t ook into account various interests and needs of 
Members.  He said that Switzerland promoted the protection and patentability of inventions rather 
than mere discoveries.  Switzerland had also made use of the flexibility in the TRIPS Agreement at 
the national level.  His delegation was convinced that biotechnology held many promises for mankind 
both in developing and devel oped countries and thus needed to be incentivised.  He noted that patent 
systems granted the exclusive right of commercial e xploitation of an invention for a limited period of 
time so that the inventor could recoup his invest ment in developing and marketing his invention.  
Consistent with its policy of promoting the protec tion of biotechnological inventions, his delegation 
had listened attentively to the concerns raised by  a considerable number of WTO Members over the 
patent protection of the invention based on genetic  resources and associated traditional knowledge and 
reports of biopiracy.  His delegation had also subm itted proposals to WIPO and to the Council on how 
to enhance transparency in patent applicati on procedures by providing, through a disclosure 
requirement, a relevant point of reference for later sh aring of benefits arising from the invention.  The 
call for such a disclosure requirement only made  sense if Members accepte d the patentability of 
biotechnogical inventions, as today biotechnological i nventions accounted for a large number of the 
inventions relating to genetic res ources and traditional knowledge.  He  said that for this reason his 
delegation had co-sponsored documen t TN/C/W/52, in which more than two-thirds of the WTO 
membership had proposed modalities language for th ree TRIPS-related issues.  He said that the 
Director General's consultations on the TRIP S issues had provided useful and constructive 
engagement among Members, and doc ument TN/C/W/52 provided a useful basis for the way forward. 
24. The representative of Guatemala  said that more than 40 percent of the population in 
Guatemala were indigenous peopl es and her delegation shared several points raised in document 
IP/C/W/545, which involved the economic and cultural aspects of patenting of life forms.  She hoped 
that it could engender future discussion. 
25. The representative of Nigeria, speaking on behalf of the African Group , recalled that the 
African Group had submitted some relevant proposal s in the past.  The Group would have a further 
look at the proposal contained in document IP/C/W/545 and make comments at the next TRIPS Council meeting. 
26. The representative of China
 said that, after many years of discussion in the TRIPS Council, 
there was an emerging consensus among Members a bout the importance of prior informed consent 
and equitable sharing of benefit arising from the use of genetic resources and associated traditional 
knowledge and the avoidance of erroneously grante d patents. No Member would ever agree that 
misappropriation was appropriate.  However divergence still loomed large on how to achieve the 
objectives of the CBD and how to prevent misa ppropriation.  Some Members insisted on the 
introduction of a mandatory requirement into the TR IPS Agreement to disclose the origin of generic IP/C/M/62 
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  resources and associated traditional knowledge as a necessary step to achieve  the CBD objectives 
while others considered WIPO to be the best forum for solving such an issue, especially with the new 
mandate of the Intergovernmental Committee on Intellectual Property and Genetic Resources, 
Traditional Knowledge and Folklore (IGC).  Some argued that national systems played an important 
role in achieving the CBD objectives, while others shared the concerns of biopiracy but remained 
open to the proposal on the amendment of TRIPS Agreement and hoped to preserve the balance in 
patent systems.  Therefore, the differences am ong Members dwelled on means rather than ends.  
27. She said that although her delegation welcomed  the WIPO IGC's new mandate, it thought the 
progress was far from expeditious to solve the urgent issue of biopiracy that deprived the legitimate 
rights and economic dividends of indigenous peoples.  The legal nature of outcomes of the IGC work 
- whether it would be legally binding or not - was still unclear.  Therefore the WIPO IGC was not an 
appropriate venue, especially for preventing misappr opriation through patent applications.  Instead, 
the TRIPS Council was the best and indispensable venue for solving this issue as the TRIPS Agreement was an international agreement on tr ade-related intellectual property issues.  The 
implementation of the TRIPS Agreement was suppor ted by the WTO dispute settlement mechanism, 
which other international treaties lacked.  Bi opiracy primarily took place in the process of  
international trade, as shown by Members at th e previous TRIPS Council meetings.  Moreover, 
Article 29 of the TRIPS Agreement contained a mandat ory requirement for patent applicants to fully 
disclose the invention in a manner sufficiently clear and complete as a condition of patent 
applications.  Therefore there were both necessity and feasibility to refer this issue to the TRIPS 
Council.  She proposed a clarification to Article 29 by either adding a footnote to Article 29 on the 
disclosure requirement, including disclosure of information on prior informed consent and access and 
benefit sharing, or attaching an annex to the TRIPS Agreement having the same content. 
28. She agreed that national-based systems were im portant to implement prior informed consent 
and access and benefit sharing regimes.  However, as  biopiracy was an international issue, disciplines 
at the international level were indispensable.  Th is was the same as the protection of patents, 
copyrights and trademarks, which were all subject to the enforcement at the national level, but 
international disciplines had been introduced into the WTO legal framework fifteen years ago.  She 
said that countries' legitimate rights over generic resources had been recognized and established by 
the CBD for eighteen years but the rights of indigenous peoples failed to be protected from misappropriation due to the lack of mandatory and transparent provisions in the TRIPS Agreement, 
such as the mandatory disclosure requirement in pate nt applications.  Meanwhile, she agreed that the 
disclosure requirement alone was not sufficient to address the issue of misappropriation because 
misappropriation could also take place in the area s of trademark, copyright and other intellectual 
property.  Therefore she said that her delegation was not against the on-going work in other forums, 
but believed that the TRIPS Council was an important forum and should not be ignored. 
29. Turning to the proposal of contractual arrangements, she said that contracts should be an 
agreement reached voluntarily between parties wi th equal status.  If indigenous peoples and 
multinational companies did not have equal status, sh e questioned how an equitable contract could be 
concluded.  She said that although the mandatory disclosure requirement was necessary, it might not 
be sufficient.  Nevertheless it was a first step to be taken by patent appli cants.  Patent examiners 
would then check ex officio  whether the applicant was in compliance with disclosure requirement.  
Regarding undue burden to the patent applicants, she said that it was the due cost that should be borne 
by the patent applicant and society to ensure that  the right of indigenous peoples had not been unfairly 
abused before the exclusive right was granted.   
30. Regarding the draft modalities contained in document TN/C/W/52, she said that Members 
were free to choose strategies in pushing forward their proposals and this did not deter them from 
discussing issues from a technical perspective.  Sh e noted that, as Members agreed at the Hong Kong 
Ministerial Conference, market access of services could wait until NAMA achieved a breakthrough.   IP/C/M/62 
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  She said that although there was no natural link between NAMA and market access of services, 
Members could reach consensus among themselves duri ng the negotiation.  The work on the issues of 
TRIPS/CBD and GI extension was similar in this re gard.  Though they were different in nature, they 
could be linked to each other b ecause they were both implementation-related issues that bore the same 
characteristics falling within the developmental di mension which was a core element of the Doha 
Round. 
31. The representative of El Salvador  said that the TRIPS Council had been instructed to examine 
the relationship between the TRIPS Agreement and the CBD and the protection of traditional 
knowledge and folklore.  The Hong Kong Minister ial Conference stated that Members should 
redouble efforts in order to look at the relationshi p between the TRIPS Agreement and the CBD.  She 
said that her delegation would make comments on document IP/C/W/545 at the next TRIPS Council 
meeting in order to have a broad-based discussion. 
32. The representative of India  supported the statements made by  China and the LDC Group.  He 
said that inadequacy in the TRIPS Agreement to combat biopiracy and misappropriation of genetic 
resources and traditional knowledge needed no elab oration after the exhaustive technical discussion 
over the  past ten years.  Intellectual property rights were granted as a quid pro quo  for disclosure in 
accordance with the objectives and principles of the TRIPS Agreement set out in Articles 7 and 8 and 
other provisions.  The incomplete  disclosure requirement as contained in Article 29 was leading to an 
imbalance in the TRIPS Agreement that needed to be  rectified.  This aspiration had been voiced by a 
vast majority of the WTO membership, including de veloped and developing countries.   He said that 
the TRIPS Agreement continued to ignore numerous  intellectual property related obligations provided 
for in the CBD, including obliging countries to coopera te to ensure that patents and other intellectual 
property rights did not run counter to the objectives of the CBD (Article 16.5 of the CBD).  This contradiction not only obstructed the proper implementation of the CBD but also caused an imbalance 
in the TRIPS Agreement.  His delegation was disappoi nted at the lack of serious engagement in the 
TRIPS Council despite of the shared objectives of prevention of misappropriatio n of genetic resources 
and traditional knowledge and steady progress in the CBD.  He said that a protocol including the 
issues of genetic resources, traditional knowledge and access and benefit sharing wa
s expected to be 
adopted at the 10th meeting of the CBD Conference of Parties at Nagoya in October 2010.  He said 
that it was time for the Council to come out of a paralysis on the important developmental issue of 
TRlPS/CBD.   He said that the steep rise in bio- prospecting for natural remedies and other purposes 
and patent applications based on genetic resources and associated  traditional knowledge  could have 
undesirable consequences in the absence of intern ationally acceptable legal regulations.  Justice 
delayed was justice denied.  He said that Members would be well-advised to read a recent report by 
the African Centre for Biosafety entitled "Pirating African Heritage - The Pillaging Continues", which 
revealed seven new cases, adding on to the 36 cases mentioned in the Centre's 2006 report.  All the 
details were available at the Centre's website:  www.biosafetyafrica.net.   
33. As regards the way forward, he said that document TN/C/W/52 provided a sound basis for the 
substantive and procedural treatment of the issu es of TRIPS/CBD, Gl extension and Gl register.  
Document TN/C/W/52 contained key parameters th at the 108 proponents would like to see reflected 
in a Ministerial decision on the three TRIPS-related issues.  It contained a balanced proposal since it 
was an outcome of constructive engagement, flexib ilities and accommodation of interests of the vast 
majority of the membership, including developed and developing countries, and most LDCs.  He 
appreciated the consultations on the  issues of TRIPS/CBD and GI extension as outstanding 
implementation issues held by the Director-General since March 2009.  He said that the consultations 
served the mandate contained in paragraph 39 of the Hong Kong Mini sterial Declaration which called 
for intensification of consultations by the Director -General.  He said that the chairmanship of the 
Director-General and the participation  of ambassadors had provided meaningful and constructive 
engagement among Members involved in the exercise.  The consultations had provided an 
opportunity for detailed technical discussions.  However, it was important that the momentum IP/C/M/62 
Page 10  
 
  generated should not slacken on this important issue where there was a clear a cceptance of the shared 
objectives to combat misappropriation and biopiracy, wh ile adhering to the concepts of prior informed 
consent end equitable benefit sharing.  He looked fo rward to the Director-General's next meeting and 
expected progress to be dovetailed 
into the stocktaking exercise by senior officials in March 2010.   
34. Turning to the work in the WIPO IGC, he we lcomed the renewed manda te of the IGC and the 
constructive engagement of members in WIPO.  Nevertheless he said that the TRIPS Council should 
not get distracted by the work of WIPO as th e mandate of the IGC was different from the WTO 
mandates contained in paragraph 12 of the Doha Ministerial Declaration and paragraph 39 of the 
Hong Kong Ministerial Declaration.  Serious and meaningful discussions on the TRIPS/CBD issue 
could take place only in the WTO.  The renewed mandat e of the IGC explicitly stated that the work of 
the IGC was without prejudice to the work pursued in other forums.   
35. The representative of Pakistan  fully supported the statements made by China and India.   
36. The representative of Cuba  reiterated the urgency to commence negotiations on the 
amendment of the TRIPS Agreement with a view to introducing a mandatory requirement of disclosure of origin of biological resources a nd/or associated traditional knowledge and prior 
informed consent and access and benefit sharing.  She said that the disclosure proposal had been 
supported by the majority of the WTO membership, and that, as one of the co-sponsors of documents 
IP/C/W/474 and WT/GC/W/590, her delegation attached great importance to this issue.  She said that 
Members needed political will to demonstrate their flexibilities in order to find solutions according to 
the Hong Kong Ministerial Declaration.  Turning to the work in the WIPO IGC, she said that there 
was lack of consensus on the work  of intersessional working groups in December 2009.  In addition to 
the fact that the TRIPS Council and the WIPO IGC had different mandates as pointed out by India, 
she noted that there was no political will to  make headway in the WIPO IGC.   
37. The representative of Australia
 said that, as a mega-diverse country with an indigenous 
population, Australia took these issues very seriously .  Australia was actively engaged in discussions 
on the issue of genetic resources in WIPO, which w as the most appropriate forum for discussion.  
With respect to the Bolivian submission (document IP/C/W/545), she said that her delegation was still 
considering that document and would respond with  comments at the next meeting of the TRIPS 
Council.  Responding to the statements made by  Switzerland, China and India, she reiterated 
Australia's view on the parallelism of three TR IPS-related issues.  Regarding the disclosure 
requirements, she said that these indeed merited further consideration but there was no agreed negotiating mandate to include this issue in the Doha Round.  She asked for China's proposal of 
footnotes to Article 29 or Annex to the TRIPS Ag reement in writing so that her delegation could 
consider the proposal in detail.   
38. The representative of Indonesia
 reiterated that, as one of the proponents of document 
TN/C/W52, his delegation attached great importa nce to the TRIPS/CBD issue and that Members 
should make substantive progress in the WTO.  A number of convincing economic studies clearly 
showed that the values set by intellectual prope rty rights on genetic resources and associated 
traditional knowledge could reach up to US$500 to  800 billion annually.  One of the convincing 
references was the book entitled "Commercial Use of Bi odiversity:  Access to Genetic Resources and 
Benefit-Sharing" written by Kerry Ten Kate and Sara h A. Laird.  He said that there was an urgent 
need to enhance disciplines on the disclosure require ment for the protection of genetic resources and 
associated traditional knowledge since this requi rement would prevent the continued losses of 
developing countries, particularly of mega-diverse countries such as Indonesia.  He said that 
Indonesia was of the view that negotiations for the protection of genetic resources and associated traditional knowledge in WTO should not be rega rded as overlapping with the negotiation in the 
WIPO IGC or the CBD Ad-Hoc  Open-Ended Working Group on Access and Benefit.  Indonesia was 
of the opinion that the process in the WTO coul d usefully complement or even strengthen the  IP/C/M/62 
 Page 11 
 
 
  processes in these two forums.  All of the pro cesses had a ultimate goal which was to create an 
effective protection regime of genetic resources and associated traditional knowledge.  In the context 
of the WTO, it could also be part of global efforts to encourage fair and balanced international trade.  
39. The representative of Egypt  associated his delegation with the statement made by Nigeria on 
behalf of the African Group on document IP/C/W/ 545.  He said that the protection of biological 
resources, traditional knowledge and folklore was an important developmental issue with implications 
for the preservation and development of Egyptian natura l cultural heritage.  In view of the importance 
of this issue, he continued to support engagement  in negotiations on the TRIPS/CBD issue, which was 
a critical part of the implementation-related issu es and concerns as contained in the Doha Work 
Programme.  He urged other Member s to engage in this issue of prime importance to developing 
countries that would hopefully be a part of th e developmental gains of the Doha Development 
Agenda.  He said that technical discussions on this issue had been ongoing for almost a decade.  During this period several submissions had been made with the aim of clarifying  the issues so that an 
effective and consistent framework could be estab lished to enable the WTO Members to meet their 
obligations under both the TRIPS Agreement and the CBD.  The essence of Members' efforts was that 
the TRIPS Agreement should be amended in order to  provide that Members require a patent for an 
invention relating to biological materials or a ssociated traditional knowledge to disclose the source 
and country of origin of the biological resource  and associated traditional knowledge used in the 
invention.  Furthermore, the applicant must also  provide evidence of prior informed consent and 
evidence of fair and equitable benefit sharing under relevant national regimes.  He reaffirmed that 
there was a solid case supported by a majority of  the WTO membership for commencing text-based 
negotiations as presented in document IP/C/W/474.  He encouraged the engagement of the Director-
General in his mandated consultative process on th e TRIPS/CBD issue and looked forward to the 
Director-General continuing this consultation towa rds a possible outcome.  He requested that all 
Members engage constructively therein and stressed the important development concerns.  He urged 
that the outcome of the negotiations on the TR IPS/CBD issue should lead to the mandatory 
requirement for patent applicants to disclose th e origin of biological materials and traditional 
knowledge used in their inventions, evidence of  prior informed consent and benefit sharing 
arrangements with the country of origin and the relevant communities.  Finally, he welcomed the 
Bolivian submission under agenda item of the review of Article 27.3(b) of the TRIPS Agreement, and 
considered that the three issues ra ised in that document, namely the patenting of life forms, the 
protection of plant varieties, and the issue of  traditional knowledge and the rights of indigenous 
communities, represented central issues with key imp lications for developing countries.  He agreed 
with the importance of the conclusions presented th erein and the need for immediate attention.   
40. The representative of Nigeria, speaking on behalf of the African Group
, supported the draft 
modalities for TRIPS issues as contained in document TN/C/W/52.  He said that three TRIPS issues 
must be dealt with in a parallel a nd expeditious manner.  He said that, after more than eleven years of 
negotiations, Members had come to the conclusion  that the only way to  combat biopiracy and 
misappropriation of genetic resources and traditi onal knowledge was through an amendment of the 
TRIPS Agreement.  He said that the amendment would ensure the disclosure of the origin of 
biological resources, evidence of prior informed c onsent and equitable benefit sharing, which would 
add value to resources in developing countries, and would also ensure the balance between indigenous 
peoples and intellectual property right owners.  He we lcomed the engagement of the Director-General 
as mandated by the Hong Kong Ministerial Declar ation where several rounds of questions and 
answers had helped clarify most, if not all, of the c oncerns being raised.   To that end, he urged to 
commence text-based negotiations on the three TRIPS issues as soon as possibl e.  He agreed with 
China that the TRIPS Council was an appropriate forum for that negotiation.    
41. The representative of Norway  reaffirmed that there was no conflict between the TRIPS 
Agreement and the CBD, and that the two treaties could and should be impl emented in a mutually 
supportive manner, while the relationship between the two instruments would be enhanced by IP/C/M/62 
Page 12  
 
  introducing a mandatory obligation in the TRIPS Agreement to disclose the origin of genetic 
resources and traditional knowledge in patent applic ations.  She said that Norway had introduced a 
proposal for such an amendment in June 2006, and be lieved that the proposal would support the aims 
of the CBD as well as be useful in ensuring that  patents were granted in accordance with the 
fundamental principles of patent laws.   
42. The representative of Brazil
 reiterated his delegation's pos ition on the relationship between 
the TRIPS Agreement and the CBD and on the pr otection of associated traditional knowledge and 
folklore.  He said that document TN/C/W/52 aimed at  enhancing the interests of various contracting 
parties in a balanced way.  He said that it was ea sy to argue that, in the perspective of developing 
countries, preventing misappropriation of genetic resources was the single most important issue out of 
the three TRIPS issues.  He said that proponents of document TN/C/W/52 considered that an 
amendment of the TRIPS Agreement to introduce a compulsory requirement of disclosure of the 
origin of genetic resources in patent applica tions was the most effective way to prevent 
misappropriation of biodiversity.  He said that the id entification of the origin of genetic resources was 
insufficient, and that it should be complemented by other mechanisms.  The discussions currently 
taking place at the CBD would provide a valuable input  for Members' deliberations at the WTO.  He 
shared the main thrust of the intervention made  by China and believed it provided Members with 
some useful and concrete ideas on how to make progress.  He said that it was time for Members to engage in text-based negotiations on the three TR IPS-related issues in the Doha Round.  In this 
connection, he expressed his delegation's satisfac tion with the Director-General's efforts and hoped 
that these efforts might lead to a successful outcome.  He said that several rounds of consultations had 
been extremely useful and should be continued.  The personal involvement of the Director-General 
provided evidence of the importance of reaching ag reement on the intellectual property issues within 
the wider context of the Doha Round.   
43. The representative of Peru
 reiterated his delega tion's position on the TRIPS/CBD issue.  He 
said that a multilateral mandatory disclosure requireme nt would be the best way to deal with this 
issue, as it would enable all countries to identify the source of genetic resource and the country of 
origin as well as prior informed con sent and fair benefit sharing.  There should be a platform to carry 
out the requirements of the CBD to avoid biopiracy.  There should be coordination and compatibility between the TRIPS Agreement and the CBD.  He said  that the intellectual property system was an 
important component in development and that this conviction together with the need to improve the 
intellectual property system to avoid its misuse was set out in document TN/C/W/52.  He urged 
Members to contribute to discussion on the proposal contained in that document, which intended to 
ensure access to genetic resources in line with national or international rules rath er than to prevent the 
access.  He said that the disclosure requirement would enable indigenous or local communities to 
control their own resources.  To avoid biopiracy should be the objective th roughout the intellectual 
property system which should benefit all peoples, in particular the local and indigenous community in 
the poorest areas of developing countries.  
44. The representative of Ecuador
 said that the discussions over the past nine years had shown the 
concerns of Members over the TRIPS/CBD issue, including unlawful use of biological resources as verified by Peru and others.  Biopi racy continued to exist as indicated in numerous articles and studies 
on cases of illegitimate use occurring in Africa.  He in formed that it had taken about thirteen years to 
invalidate a patent on the Enola bean which came  from Mexico under the pretext of administrative 
and judicial procedures in the United States.  He sai d that biopiracy was a matter of fundamental and 
primary concern to Ecuador, which was a small country but with important biodiversity.  For 
example, the number of bird species in Ecuador was twice as much as in the United States.  Ecuador was the second largest country in terms of endemic vertebrae diversity per unit of territory and the 
third largest in terms of diversity of amphibians.   Ecuador owned ten per cent of vertebrae-based 
animals of the world.  He said that documents IP/C/W/474 and TN/C/W/52 reflected the common 
objectives of preventing illegitimate use of biodi versity and associated traditional knowledge, and  IP/C/M/62 
 Page 13 
 
 
  contained proposals to amend the TRIPS Agreement in  order to have an appr opriate coordination with 
the principles and objectives of the CBD, including the sovereignty of countries over their own biodiversity, prior informed consent, equitable be nefit sharing and the disclosure of the source of 
biological resources and associated traditional know ledge.  He supported the statements made by 
China and India that the most appropriate forum for devising a multilateral and effective solution to 
the problems of unlawful use of genetic resources and biopiracy was the WTO because of the 
systemic and legal considerations mentioned in th e previous statements, especially the consideration 
of the WTO dispute settlement mechanism which c ould guarantee the adequate implementation of the 
WTO agreements.   
45. He welcomed the consultations of the Director-General on the TRIPS/CBD issue and 
supported their continuation with a view of initiating text-based negotia tions.  He said that all the 
intellectual property issues should be dealt with as  a package and that all of the concerns over 
adequate protection of biodiversity and traditional knowledge should be refl ected in the development 
dimension of negotiations as pa rt of the Single Undertaking.  
46. The representative of the United States
 said that the TRIPS Council should continue to be 
used to engage in a useful and constructive exch ange of views on these issues based on a sharing of 
national experiences by posing and responding to questions among Members.  This manner of 
working could and should continue to be the basis for the TRIPS Council's work on these issues.  She 
acknowledged that some Members had advocated  commencing negotiations on the basis of a 
proposed text to amend the TRIPS Agreement.  Ho wever, she reiterated that  her delegation did not 
support amending the TRIPS Agreement to address the concerns of the demandeurs  and did not think 
that doing so would be the most effective way of addressing these concerns.  She said that Members 
should focus on the shared objectives that had been re vealed through their work today.  She agreed 
that prior informed consent, e quitable benefit sharing for the use of genetic resources and related 
traditional knowledge and avoiding erroneously granted patents were important issues.  Where 
Members continued to diverge was on the premise that  a disclosure requirement would be an effective 
means of achieving these objectives.  Her delegatio n disagreed and therefore could not support the 
initiation of negotiations toward a pre-ordained outc ome that would not accomplish shared objectives.  
At a fundamental level, she said that the most cr itical element in ensuring appropriate prior informed 
consent and access and benefit sharing was the deve lopment and strengthening of national regimes in 
legal frameworks designed specifically to accomplish these objectives.  Bringing the patent system into the equation simply did not make sense, particularly in the absence of well-functioning prior 
informed consent and access and benefit-sharing regi mes.  She said that her delegation continued to 
puzzle over how new patent requirements, including th e possibility of denial of patents or revocation 
of patents in some circumstances, would help accomplish the legitimate and important objective that Members shared.  She said that the most effective wa y to ensure the effective sharing of benefits was 
to bring about the generation of benefits in the firs t place:  benefits would be generated when useful 
and good products were develope d and commercialized.  The existe nce of an incentive through the 
patent system was a critical element in encouragi ng such development and co mmercialization.  When 
this happened and when meaningful access and bene fit-sharing regimes were in place, then Members 
could have confidence that the common objectives they had identified in their work could be 
achieved.    
47. She said that the agenda of the Council limited Members' discussion to the consideration of 
the three items in tandem at this point.  She objected  strongly to any discussion in this context of other 
TRIPS-related issues.  The fact that some Member s deemed it expedient to address the TRIPS issues 
together as indicated in document TN/C/W52 did not overcome the US vigorous opposition to their being considered as a package.  These TRIPS issues s hould continue to be considered on their specific 
individual merits and within the specific bodies an d consultation mechanisms designed in previous 
Ministerial guidance.  She said that her delegati on was committed to remaining actively engaged in 
the Council's examination of these issues. IP/C/M/62 
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  48. The representative of Guatemala
 said that misappropriation of genetic resources and 
traditional knowledge had been fully discussed in the C ouncil.  In the view of her delegation, the best 
way to deal with this issue was the inclusion of  a mandatory disclosure requirement in the TRIPS 
Agreement.  As indicated in document IP/C/W/474, she said that this issue needed to be resolved 
quickly particularly because it was important to  developing countries, and the outcome of the 
negotiation should meet the needs and the interest s of developing countries.  She said that the 
TRIPS/CBD issue should not be linked to other issu es, and that it should be resolved on its own 
merits.  She fully supported the statement by Indone sia that discussions and negotiations taking place 
in WIPO and in the Council were not contradictor y.  Members should work constructively to ensure 
the progress made in both the organizations was complementary and mutually supportive.   In 
conclusion, she called for transparency in the process.   
49. The representative of Cameroon  supported the statements made by Nigeria on behalf of the 
African Group, India and China.  He said that the TRIPS/CBD issue was a great concern to his 
delegation, which was experiencing biopiracy, and that the TRIPS Council was an appropriate forum 
to deal with this issue.   
50. The representative of Argentina  said that the review of Article 27.3(b) should preserve the 
degree of flexibility in order to exclude from pa tentability plants, animals and essentially biological 
processes for the production of animals and plants .  Similarly, the flexibility should also be 
maintained regarding the effective sui generis  system for the protection of plant varieties.  
Accordingly, she said that there should be no change  of Article 27.3(b) as it, together with other 
provisions in the TRIPS Agreement, provided a suffic ient margin of freedom for Members to adjust 
their national systems based on their needs and inter ests.  She reiterated that her delegation did not 
support the artificial parallelism between the th ree TRIPS issues as indicated in document 
TN/C/W/52.  She said that misappropriation of genetic resources and tr aditional knowledge was a 
serious problem but her delegati on could not support the disclosure proposal.  She said that Members 
should continue to discuss the TRIPS/CBD issue while  looking at the substantive work taking place in 
WIPO.  She reminded Members of renewed mandate  of the WIPO IGC in September 2009 and the 
on-going work in the CBD.    
51. The representative of Japan  reiterated that the two issues of erroneously granted patents and 
CBD compliance should be discussed separately, a nd that the cases of biopiracy should be duly 
examined.  He said that a considerable number of Members, including Japan, had pointed out the 
importance of establishing comprehensive database  systems to address the issue of erroneously 
granted patents.  The TRIPS Council should have in-depth practical and technical discussion on the 
proposal of the database system.  He said that the case had not yet been made that the CBD compliance could be effectively monitored by a ma ndatory disclosure requirement in the patent 
system.  To the contrary, in the view of his dele gation, the mandatory disclosure requirement imposed 
undue burdens on patent applicants  and would cause legal uncertainty in the patent system.  
Moreover, such a mandatory requirement would inhibit benefit sharing because of the legal 
uncertainty which would discourage investment in th e biotechnology field.  Hence the best way to 
proceed was to analyse biopiracy on a case-by-case  basis, to clarify the issues and come up with 
optimal solutions.  He said that the discussion on the issue of the CBD compliance had been 
intensified at the CBD ABS Working Group which ai med to conclude at the tenth session of the CBD 
Conference of Parties in 2010.  He also informed  that the work of the WIPO IGC was underway and 
that the outcome of the IGC work should be duly taken note of.  He reserved the right to make 
comments on document IP/C/W/545 and asked for China' s statement in writing in order to have in-
depth examination.   
52. The representative of the European Union
 said that his delegation would make comments on 
the Bolivian submission later.  He recalled that th e two thirds of Members, including the EU, had co-
sponsored the proposal of specific modalities langua ge for the three TRIPS-related issues as contained  IP/C/M/62 
 Page 15 
 
 
  in document TN/C/W/52.  He said that the EU re mained firmly committed to this common platform 
on the TRIPS issues and supported a parallel treatment of  three issues with a view to a decision on the 
DDA modalities.  He welcomed the consultations  on the issues of GI extension and TRIPS/CBD 
conducted by the Director-General, which highlighted the importance of these i ssues.   He said that 
his delegation remained open to the proposal of am ending the TRIPS Agreement in order to introduce 
a disclosure requirement, as long as it was properly  calibrated.  He said that the disclosure 
requirement as set out in document TN/C/W/52 would allow Members to keep track of all patent applications globally with regard to genetic resources and help pate nt examiners to establish novelty, 
and thus contribute to preventing misappropriatio n of genetic resources and associated traditional 
knowledge.   He said that other proposals, such as the proposal of contractual arrangements between 
providers and users of genetic resources and the pr oposal of databases, were certainly useful but not 
sufficient to meet the objectives pursued in documen t TN/C/W/52.  In other words, they would not 
have the same effectiveness as the mandatory disclos ure requirement.  He said that a broad consensus 
for a decision on the DDA modalities could only be found if the three TRIPS-elated issues were part of it.  Nevertheless, his delegation remained open to discussion and prepared to engage constructively 
with other Members on these issues. 
53. The representative of New Zealand
 reiterated his delegation's stake in this issue, saying that 
while very few patents originated from New Zealand, it did have a systemic interest in the stability of 
the patent system and had a significant indigenous interest, in particular in preventing the misappropriation of New Zealand's genetic resour ces and traditional knowledge.  While the domestic 
policy in New Zealand was still evolving, it was clear that his delegation's interests were much wider 
than erroneous patents and misappr opriation of genetic resources.  His delegation had always been 
concerned that a narrow WTO response related to pa tent disclosure requirements would only detract 
from broader issues associated with the protection of traditional knowledge and biological resources 
and many of these issues were not intellectual propert y-related and so could no t be resolved through 
intellectual property systems.  Therefore, solutions  needed to be developed within the WIPO IGC, 
which was able to look at all of these issues in a ho listic and coordinated way.  This was not a way of 
deflecting or avoiding the issue.  He said that Ne w Zealand was active and constructive in the WIPO 
IGC.  He said that, as one of the proponents of a renewed mandate of the IGC which contained a 
promise of concrete outcomes on these issues, his de legation was putting its efforts into the fulfilment 
of the IGC mandate.  Finally, he said that the pa rallelism would seriously undermine prospects for 
progress on the TRIPS/CBD issue because Members would not be able to consider the TRIPS/CBD 
issue on its merits.   
54. The representative of Chinese Taipei
 recalled that his delegation had raised some important 
technical issues, such as the de finition of associated traditional knowledge and the trigger of the 
disclosure application.  While these questions had no t yet been answered satisfactorily, he hoped that 
the on-going Director-General's consultations would clarify these questions.  He reiterated that his 
delegation did not support paralle lism as each issue should be discussed on its own merits.  He 
confirmed that, due to the complexity of the issue,  his delegation had not yet come to a conclusion 
about the necessity of amending the TRIPS Agreement.  
55. The representative of Turkey  said that the issues of TRIPS/CBD and protection of traditional 
knowledge and folklore were of high importance for her delegation.   Her delegation had followed 
closely developments at the WIPO IGC and particip ated in the discussion in a constructive manner.   
She said that, as one of the co-sponsors of doc ument TN/C/W/52, her delegation advocated 
parallelism for the three TRIPS issues and beli eved that the work in the WTO could be 
complementary to that of WIPO.    
56. The representative of El Salvador  reiterated that Members needed to double their efforts on 
the work of the TRIPS/CBD issue and that all the technical aspects should be examined.  She also 
recalled Members' mandate on this issue.   IP/C/M/62 
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  57. The representative of Chile
 recognized the importance of the biopiracy issue, especially to 
developing countries.  Turning to the Bolivian subm ission, he said that his delegation would make 
further comments at the next meeting of the TR IPS Council.  He said that Members should not mix 
the TRIPS/CBD issue with other intellectual property issues as this would impede progress.  He said that while Members should follow the on-going work at  the WIPO IGC, they needed to step up their 
efforts in the WTO in order to achieve progress in both forums. 
58. The Council took note
 of the statements made under these three agenda items and agreed  to 
revert to them at its next meeting.   
F. NON-VIOLATION AND SITUATION COMPLAINTS  
59. The Chairperson  recalled that, at its last meeting, the TRIPS Council had agreed to 
recommend to the Seventh Session of the Ministerial Conference that a decision be taken to extend 
the moratorium on TRIPS non-violation and situation complaints.  Pursuant to this recommendation, 
Ministers had directed the TRIPS Council to contin ue its examination of the scope and modalities for 
complaints of the types provided for under subpara graphs 1(b) and 1(c) of Article XXIII of GATT 
1994 and make recommendations to their next Session,  which they had decided to hold in 2011.  It 
was agreed that, in the meanti me, Members would not initiate such complaints under the TRIPS 
Agreement.  This decision had been circulated in document WT/L/783. 
60. The representative of China  said that her delegation continue d to believe that non-violation 
and situation complaints should not be applicab le under TRIPS, as the TRIPS Agreement differed 
significantly from other WTO agreements.  While in the areas of trade in goods and services Members had agreed upon concessions that could be measu red in economic terms, the TRIPS Agreement 
provided for a minimum level of protection that co nsisted of requirements for national legal norms 
which were not based on economic terms and did not  take the shape of schedules.  She said that 
Members' obligations under the TRIPS Agreem ent were confined to compliance with these 
requirements and it was therefore difficult to iden tify any modalities and scope for complaints under 
Article 23.1(b) and (c) of GATT 1994 under the TRIPS Agreement.   
61. She said that, from a legal perspective, any meas ure that was fully consistent with the TRIPS 
Agreement could not be challenged by other Memb ers.  If such measures were allowed to be 
challenged with the argument that another Member's  interests were being nullified or impaired, legal 
uncertainty would increase in the business envir onment worldwide and this could give business 
circles another opportunity to discredit the WTO syst em.  Her delegation was glad that Members had 
agreed not to initiate non-violation complaints under the TRIPS Agreement until 2011.  She requested 
the minority of Members that held a different view  to reconsider their position on this matter and 
hoped that the TRIPS Council would be able to  agree on unanimous recommendations on this item 
before the end of the following year. 
62. The representative of Ecuador
 said his delegation agreed with China that such complaints did 
not belong under the TRIPS Agreement.  In contrast to the rules on trade in goods, the TRIPS 
Agreement dealt with intangibles such as knowledge and folklore.  He said that Ecuador's position 
had not changed and requested that the minority  of Members opposing these arguments reconsider 
their position. 
63. The representative of the United States  said that it had been a significant concession on the 
part of the United States to agree with Members to extend the moratorium on non-violation and situation complaints at the last Ministerial Confer ence.  Her delegation maintained that non-violation 
complaints were fully appropriate in the context of the TRIPS Agreement.  The extension of the 
moratorium until the next Ministerial Conference had been intended to allow Members to submit 
proposals on the scope and modalities for such co mplaints.  Her delegation remained ready to  IP/C/M/62 
 Page 17 
 
 
  continue to work constructively with other Member s on how this issue could be handled at the next 
Ministerial Conference.   
64. The Chairperson  suggested that the Council agree to k eep this item on the agenda as a regular 
item in order to allow Members who may have new thinking on the matter to share it, and also to 
enable it to revert to the question of the further organization of its work in light of any future 
suggestions.  
65. The Council so agreed .  
G. REVIEW OF THE IMPLEMENTATION OF THE AGREEMENT UNDER ARTICLE 71.1.   
66. No statements were made  under this agenda item. 
67. The Council agreed  to revert to the matter at its next meeting. 
H. REVIEW OF THE APPLICATION OF THE PROVISION OF THE SECTION ON GEOGRAPHICAL 
INDICATIONS UNDER ARTICLE 24.2   
68. The Chairperson  recalled that Article 24.2 provided that the Council should keep under 
review the application of the provisions of the GI Section of the Agreement.  She urged those delegations that had not yet provided responses  to the Checklist of Questions contained in 
document IP/C/13 and Add.1 to do so.  Furthe rmore those Members that had already provided 
responses could provide updates to the extent there had been any significant ch anges in the way they 
provided protection to geographical indications. 
69. The representative of China
 said that China did not have any changes to its earlier responses 
to the checklist.  Although the "W/52 group" preferred to raise this issue at the Special Session of the 
TRIPS Council, she wished to emphasize the importance China attached to the issue of GI extension.  
She also recalled her position on negotiation modalities that she had explained in her intervention on 
TRIPS and CBD. 
70. She said that several Members had entered into bilateral agreements on GIs amongst 
themselves.  In order to better review the app lication of the GI section under Article 24.2 and to 
deepen Members' understanding of these issues, she suggested that Members notify to the Council the 
bilateral GI agreements they had entered into and share information on them with the Council.  She 
believed that this would facilitate the review and enhance transparency.  In addition to studying the 
issue themselves, Members could request the Secretar iat to conduct a survey of these GI agreements 
and to report the outcome of its survey to the Counc il.  She believed that this could form a good basis 
for Members to further their studies on this matt er and facilitate the work on this outstanding 
implementation  issue under the Doha mandate.  
71. The representatives of India , Ecuador , Angola  and Brazil  supported the suggestion made by 
China.  
72. The representative of the United States  said that she agreed that it would be helpful for the 
Chair to invite Members to inform the Council of  agreements that were specific to geographical 
indications.  However, she believed that it would be useful for those notifications to come in first, 
before any proposal regarding a survey could be considered. 
73. The Chairperson  suggested that the Council agree to en courage Members to share information 
on and notify bilateral agreements related to the protection of geographical indications, which they 
had entered into, to the Counc il under this agenda item. IP/C/M/62 
Page 18  
 
  74. The Council so agreed
. 
I. FOLLOW -UP TO THE SEVENTH ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE DECISION ON 
THE IMPLEMENTATION OF ARTICLE 66.2  OF THE TRIPS  AGREEMENT  
75. The Chairperson  recalled that, at its last meeting, the Council had taken up its seventh annual 
review of developed country Memb ers' reports on their implementation of Article 66.2 of the TRIPS 
Agreement.  In concluding that item, she had indi cated that she would provide delegations with an 
opportunity at the present meeting to make furthe r comments on the information submitted for that 
meeting that they might not yet have been able to study.  Since that meeting, the Council had received 
additional new detailed reports from the European  Union and individual member States, namely 
Austria, Belgium, the Czech Republic, Denmark, Fi nland, France, Germany, Spain, Sweden and the 
United Kingdom (available as an advance copy of document IP/C/W/536/Add.7). 
76. At that meeting, she had also informed the Council of a second workshop on transfer of 
technology under Article 66.2 that the Secretariat ha d organized, at the request of the delegation of 
Lesotho on behalf of the LDC Group, back to back with the Council's meeting.  The representative of 
Bangladesh had expressed his appreciation of the event and had requested that the Secretariat 
organize another workshop this year.  She said that she trusted that the Secretariat would follow up 
with the LDC Group concerning that request. 
77. The representative of the European Union  said that his delegation was committed to the 
annual review exercise and to the provision on in centives for technology transfer under Article 66, 
with a view to helping least developed countries to  create a sound and viable technological base.  The 
EU report was composed of two parts:  first a general introduction, including a description of the 
methodology used, and, second a series of deta iled sheets presenting the existing incentives to 
technology transfer.  These sheets were divided into  two parts:  first, the incentives used by the 
European Union as such and, second, incentives given by some of the individual member States.   
78. As to the methodology, he said that first, the notion of technology transfer was a rather broad 
concept encompassing not only intellectual property, but also many other aspects.  This was why the 
report referred to the ways and means through wh ich companies required technology from foreign 
sources.  Secondly, the type of technologies to be transferred included not only physical objects or equipments, but also the acquisition of know-how , including management or production skills.  
Thirdly, it was important to keep in mind that tec hnology transfer was often one component of a much 
more complex project or strategy by private compan ies rather than a stand-alone activity.  Fourthly, 
foreign direct investment was an obvious channel fo r technology transfer but general research projects 
between private and public partners were also im portant in helping least developed countries to 
benefit from technologies and to adapt them to thei r specific needs.  Finally, incentives could only 
take the form of encouragement, promotion and f acilitation of the potentially most fruitful projects in 
the framework of a global and compre hensive approach to development. 
79. In this context, the European Union consid ered that the relevant incentives could be 
regrouped in terms of objectives.  His delegation had identified six general objectives and this was 
duly reflected in the annual reports:  (i) to promot e projects such as direct investment, licensing or 
franchising or sub-contracting;  (ii) to improve access to available techniques and industrial processes;  (iii) to support joint research projects;  (iv) to  provide training in technology management and 
production methods;  (v) to provide capacity building;  (vi) to encourage trade in technological goods.  The detailed sheets of the report described only incen tives which had a strong link to at least one of 
these objectives, with a few exceptions which concer ned trade in European countries and institutions. 
80. In order to present the contributions from the European Commission and individual EU 
member States in the same way, the approach had been streamlined and a standard form, based on the  IP/C/M/62 
 Page 19 
 
 
  information listed in the TRIPS Council Decision of  19 February 2003, had been established.  That 
standard included the following information:  (i) th e name of the incentive;  (ii) its description;  
(iii) the beneficiary countries with an indication if the incentive was specifi c for a least developed 
country or not;  (iv) the objectives in terms of incentives given;  (v) the eligible countries or 
institutions;  (vi)  the type of technology transferre d, if such information was available, which was not 
always the case;  (vii) the functioning of the programme in practice;  (viii) examples of on-going or 
implemented projects;  (ix) statistics on the use of the incentive or on the number of supported 
projects, if available;  and (x) contact details of the persons responsible for the programme.   
81. The annual report had identified more than  50 projects and programmes from both the 
European Union and its member States.  Highlighting five of them, he first mentioned the European & 
Developing Countries Clinical Trials Partnershi p (EDCTP), which had been created in 2003 as a 
European response to the global health crisis caused by the three main poverty-related diseases, 
i.e. HIV/AIDS, malaria and tuberculosis.  The beneficiary countries were sub-Saharan African 
countries and the overall budget was €400 million over seven years.  The main  objectives were, first, 
to accelerate the development of new clinical and improved interventions, in particular drugs and 
vaccines to fight these three diseases;  second, to foster the integration of the national scientific health 
research programmes of the EU member States;  and, third,  to strengthen the R&D capacity in 
sub-Saharan Africa. 
82. The second project he wished to highlight was the EU Research in Neglected Infectious 
Diseases (NID), the objective of which was to support R&D to improve existing and develop new approaches for preventing, diagnosing, treating a nd controlling neglected infectious diseases which 
were applicable, acceptable and affordable in disease endemic countries.  The third project was called 
BIO CIRCLE, which aimed at increasing the participa tion of researchers outside Europe in European-
funded research projects under the seventh EU R esearch and Development Framework Programme in 
the following four areas:  food, agriculture, fisheries and biotechnology. 
83. The fourth project was the ACP Science and Technology Programme, the overall objective of 
which was to support ACP countries in formul ating and implementing science and technology 
policies which could lead to sustainable developm ent and to a reduction of poverty through economic 
growth and integration in the global economy.  The fifth project that he highlighted was SwitchAsia, 
which had a special focus on small and medium enterprises and aimed at promoting economic prosperity and poverty reduction in Asian countries through sustainable growth with reduced 
environmental impact by industries and consumer s in line with international environmental 
agreements and processes.  He added that further details about these projects were available in the 
annual report.   
84. The representative of Bangladesh
 said that transfer of technology would enhance LDCs' 
productive capacity, which was crucial for economic  development, including compliance with TRIPS 
obligations.  He reiterated some of the observations he had made in the sixth annual review of Article 
66.2.  Workshops on Article 66.2 had been very usef ul, and he wished to have a similar workshop in 
2010, back to back with the Council's end-of-year meeting.  Article 66.2 was exclusively for LDCs, 
and was of a mandatory type.  He requested deve loped country Members to submit their reports on a 
regular basis and LDC-wise, avoiding mixing their c ontents with usual technical assistance.  More 
specifically, he requested each and every developed country Member, when reporting on Article 66.2, 
not to address Article 67.  He reiterated hi s call to devise a common format for reporting on 
Article 66.2. This was necessary for the sake of tran sparency and user-friendliness.  He said that he 
remained as interested as before to hear of any technology that developed country Members had 
transferred to LDCs.   
85. The representative of Egypt  believed that the protection a nd enforcement of intellectual 
property rights should contribute to the promotion of  technological innovation and to the transfer and IP/C/M/62 
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  dissemination of technology as reflected in the objectiv es of the TRIPS Agreement.  In this regard, the 
transfer of technology represented a foundation stone th at justified the granting of exclusive rights.  
As such, the effective transfer of technology to developing countries was a reflection of the 
effectiveness of an IP system that functioned to pr omote innovation.  In this  regard, he fully supported 
an effective implementation of the obligation by developed WTO Members to provide incentives to 
enterprises and institutions within their territories that would achieve effective technology transfer to 
LDCs in accordance with Article 66.2 of the Agreement.  He also believed that the issue of technology transfer had received attention in many quarters including, but not limited to, the United 
Nations Conference on Trade and Developmen t (UNCTAD), the United Nations Industrial 
Development Organization (UNIDO) and the World Intellectual Property Organization (WIPO).  It 
had also received attention at the WTO, not only in  the TRIPS Council, but equally so in the Working 
Group on Trade and Transfer of Technology, wher e considerable work had been undertaken since 
2002 and where there was a need to achieve some concre te results at this stage.  In pursuit of that 
goal, Egypt believed that there were a number of means to ensure compliance with Article 66.2, as 
well as with the broader obligations enshrined in Article 7 of the TRIPS Agreement.  His delegation 
would remain engaged in ensuring this compliance, and looked forward to a constructive engagement 
with all Members on this important issue of the transfer of technology.   
86. The representative of Angola
 thanked the representative of th e European Union for his report, 
which was extensive and revealed the actions that ha d been or would be taken.  It was important to 
have the time to digest all the information and he said that he would come back with some specific 
comments on certain of the activities that were planned at the Council's next session. 
87. The representative of India  said that Article 66.2 was an important obligation in the TRIPS 
Agreement on developed country Me mbers, and flowed directly from the objectives contained in 
Article 7.  He supported the point made by Bangl adesh calling upon countries not to mix transfer of 
technology with technical assistance and not to mix supporting obligations under Article 66.2 and Article 67.  Technology transfer was vital for im proving the productive capacity of LDCs and would 
complement other efforts being undertaken in th e WTO under the Aid for Trade initiative.  Transfer 
of technology had cross-cutting importance. In th is regard, he recalled the explicit provisions on 
technology transfer in most multilateral enviro nmental agreements, e.g. the UN Framework 
Convention on Climate Change (UNFCCC) and the outcome document of 15th Conference of the 
Parties (COP 15) at Copenhagen in December 2009.  Special focus should also be given to clean 
technologies under WTO provisions.  He also supported the request made by Ministers at the LDC 
Trade Ministerial Meeting in October 2009 for th e establishment of a monitoring mechanism to 
review situations where enterprises and institu tions in developed c ountry Members provided 
technology transfer to LDCs as a result of the in centives and the effectiveness in creating a viable 
technological base in LDCs.  This would enable bett er impact analysis of efforts made by developed 
countries under that provision. 
88. The representative of Rwanda
 said that technical assistance and technology transfer were 
complementary and should be discussed separately.  In this regard, he supported the statement by 
Bangladesh.  With regard to the EU report, he supp orted the remark made by Angola, and said that it 
would be useful to meet with the European Un ion to discuss the six objectives and to see how LDCs 
could benefit.  
89. The representative of China  supported the statements by Bangladesh, India and Rwanda. 
90. The Chairperson  said that, since some delegations had indicated that they wished to make 
further comments on the reports, a further opport unity would be provided at the Council's next 
meeting to make comments on the information submitte d that they had not yet been able to study. 
91. The Council took note  of the statements made.  IP/C/M/62 
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  J. TECHNICAL COOPERATION AND CAPACITY BUILDING  
92. The Chairperson  recalled that, at its last meeting, th e Council had taken up its annual review 
of technical cooperation.  Given that some info rmation from Members and other intergovernmental 
organizations had only been made available a shor t time before the review, she offered Members a 
further opportunity to make comments on that material.  Since that meeting, the Council had received 
additional information from the European Union and individual member States and agencies, namely 
Austria, Bulgaria, the Czech Republic, Finland, Fr ance, Germany, Hungary, Italy, Portugal, Spain, 
Sweden and the United Kingdom, as well as the European Patent Office (document IP/C/W/539/Add.7).  As regards inte rgovernmental organizations, the Council had 
received additional information from the Internationa l Union for the Protection of New Varieties of 
Plants (UPOV) and the World Customs Organizat ion (WCO) (documents IP/C/W/541/Add.3 and 4, 
respectively). 
93. As regards notifications of contact points for technical cooperation on TRIPS, since the 
Council's meeting in October, updates to contact  points notified earlier had been received from 
Switzerland and the European Union.  These notifica tions had been circulated in a complete updated 
list of all contact points in document IP/N/7/Rev.3.  Subsequent to the circulation of that document, a 
further update had been receive d from Canada, which would be distributed in due course in an 
addendum to that document. 
94. She recalled that, at the Council's meeting in October, Brazil had introduced an addendum to 
its earlier communication on "Technical Cooperation an d Capacity Building:  'Cluster' A of the 
Development Agenda" (document IP/C/W/513).  Si nce this communication had been received just 
before the meeting, it had only been available as an  advance copy, but had since then been circulated 
in document IP/C/W/513/Add.1. 
95. As regards LDC needs assessments, she recalle d that paragraph 2 of the TRIPS Council's 
2005 decision on the "Extension of the Transiti on Period under Article 66. 1 for Least-Developed 
Country Members" provided that "with a view to  facilitating targeted technical and financial 
cooperation programmes, all the le ast-developed country Members will provide to the Council for 
TRIPS, preferably by the 1 January 2008, as much in formation 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 Bangladesh, 
available as an advance copy of document IP/C/W /546, and earlier from two other Members, namely 
Sierra Leone and Uganda. 
96. As she had foreshadowed at the Council's last meeting, in response to a request from the LDC 
Group, the Secretariat had organized a workshop on LDC priority needs for technical and financial 
cooperation just after the Council's meeting in Oct ober.  This technical level workshop had brought 
together delegates and other officials from LDC and developed country Members, and from the WTO 
and WIPO Secretariats.  It had been designed to promote practical dialogue and coordination on the 
needs assessment process.  As she had mentioned in October, depending on feedback and guidance 
received from the Members concerned, it was envisaged that the Secretariat would organize follow-up activities in the coming year. 
97. The representative of the Secretariat
 said that the length of his statement was in itself a 
measure of the importance he hoped to give to th e LDC needs assessment process, and an indication 
of the degree of support the Secretariat wished to contribute to it.  The process had been established 
by the TRIPS Council in 2005.  It was now movi ng into a mature phase and as the LDC Members 
were taking important steps and investing cons iderable effort and resources in defining and 
articulating their priority needs, it might be timel y to provide the Council with a general update on 
this process.  A key concern th roughout had been that the process was owned by the LDC Members IP/C/M/62 
Page 22  
 
  and designed to serve their priority needs and to facilitate ways for other Members to meet those 
needs in a coordinated manner.  His understanding w as that, in order to be most useful, the process 
needed to identify areas of key interest to developm ental and other objectives of  the LDCs concerned;  
and to assist those Members to identify how the IP system, including the implementation of the 
TRIPS Agreement, could serve as a tool to achieve their public policy goals and their individual 
priority needs.  The WTO Secretariat itself was renewing its efforts to support the process as a 
facilitator, but of course remained entirely res ponsive to the needs and directives of Members. 
98. One important development over the past year ha d been paying more attention to a possible 
increased role of the Aid for Trade and the Integr ated Framework initiatives as sources of resources 
and support for the process.  Accordingly, as some  Members had requested, the Secretariat had given 
an opportunity to the coordinator of Aid for Trad e and a representative of the Integrated Framework 
Executive Secretariat at the Council's meeting in October 2009 to inform Members of the 
opportunities under these initiatives and to advise LDC Me mbers on the steps they would need to take 
in order to make use of those ex isting mechanisms.  In addition, a Secretariat background note giving 
full details of those initiatives had been circulat ed in document IP/C/W/544.  These two initiatives 
together provided an important opportunity to pr ogress both the needs assess ment itself, but also, 
perhaps more importantly, ways of sustainably fu lfilling those needs.  However, it was up to the 
Members concerned to decide how they would like to  make use of those opportunities and the role of 
the Secretariat was limited to providing technical advice and informing of the opportunities available 
and what the possible avenues were.   
99. As already mentioned by the Chair, the Secretariat had held a very fruitful workshop 
back-to-back with the Coun cil's meeting in October, this complying with the request put by the LDC 
Group.  The workshop had intentionally been held at a technical level and had been intended to 
promote dialogue and coordination on the needs assessment process itself so as to enhance the 
alignment of available resources with the priority needs identified by individual LDC Members.  It 
had facilitated the exchange of views and expe riences between the LDC Members concerned and 
industrialized countries, as well as the Secretariat itself, and included other areas, such as the 
Integrated Framework and Aid for Trade, and a key partner in this area, WIPO.  Details of that 
workshop were available online on a special webpage  set up to facilitate di scussion and information 
on the needs assessment process.   
100. The workshop had been particularly useful in harvesting the experience of individual 
Members who had already undertaken the needs assessment.  This was an important part of the 
process in that it allowed for mutual learning between  the Members concerned, so that the process in 
one country could help informing the others.  So me of the most important presentations at that 
workshop had been from the Member s themselves, who had set out the approach they had taken and 
the practical lessons they had learnt from that a pproach.  The workshop was intended to be practical 
and focused on the grass roots experiences of the c ountries themselves.  In addition there had been 
strong emphasis on coordination, in particular be tween intergovernmental organizations and the 
providers of technical assistance, so that paralle l initiatives actually reinfor ced each other and were 
effectively coordinated, and did indeed suppor t LDC Members in achieving their goals with 
maximum leverage from the resources available.  Mo re details were available in the presentations and 
the summary available on the website.   
101. As to the follow-up to that exercise, he said that the workshop had not been considered a 
stand-alone effort, but rather a step in a coor dinated programme of activities that had been put 
together directly in response to the requests of the LDC Members.  Indeed, the biennial technical 
assistance and training plan that had commenced just two months before provided for three 
subregional workshops on the needs assessment process fo r LDCs to be held in the course of the year.  
The purpose of those forthcoming workshops was to support LDC Members in providing as much 
information as possible to the Council on their priority  needs in order to assist them to take the steps  IP/C/M/62 
 Page 23 
 
 
  necessary to implement the TRIPS Agreement, while  taking due account of each country's individual 
developmental and other domestic objectives.  As al ready noted, that initiative responded to a specific 
request made by the LDC Group at the Council's me eting in June 2009.  These workshops would also 
provide an opportunity to present a new guidebook intended to support LDC Members in undertaking 
and coordinating the needs assessment in a fast a nd effective manner.  The objective was to ensure 
maximum coordination of the providers of technical assistance, and the Secretariat would be doing its 
utmost to ensure that other intergovernmental organizations and other active agencies involved in 
technical assistance would take part in those worksh ops so that the focus would not merely be on the 
needs assessment of LDC Members, but also in establishing pathways, structures and coordination 
mechanisms to sustainably and effectively me et the needs that they had identified.   
102. Furthermore, the Secretariat intended to hold a symposium on the needs assessment process 
for Geneva-based delegates in the cour se of 2011.  That formed a part of the overall biennial technical 
assistance and training programme.  The Secretaria t was focusing in that coordinated effort on 
involving a wide spectrum of potential providers of technical assistance, both from among the WTO 
membership and from other international organiza tions and agencies.  This would ensure that 
coordination was as effective as possible and that the priority needs identified by LDC Members had 
the best chance of being met in a systematic fa shion.  The Secretariat was also exploring the 
possibility of organizing three subregional workshops  in 2010:  (i) for English-speaking African LDC 
Members in early June in Uganda;  (ii) for the As ia-Pacific region in Bangladesh in late July;  and 
(iii) for French-speaking African LDC Members in  early November.  The Secretariat had already 
stepped up coordination with interna tional organizations active in this field, so that project delivery 
could be more coordinated and guided by the n eeds assessment, and so that the needs assessment 
process was better harmonized with parallel prog rammes and existing activities that dealt with 
TRIPS-related areas.  Another key priority had been to harvest the experience and practical lessons of 
needs assessment activities undertaken so far, so that further countries could benefit in planning and 
undertaking their programmes, as well as exploring subregional and regional possibilities where these 
were appropriate and accorded with the needs assess ed, once again reflecting an interest expressed on 
the part of LDC Members.   
103. He said that a dedicated webpage had been pr epared to help inform Members on the needs 
assessment process and to increasingly provide pr actical resources available in that process 
(background, origin, etc).  It also highlighted the roles of the Aid for Trade initiative and the 
Integrated Framework.  The webpage also summa rized key developments and provided links to 
relevant official texts and documents, as well as the presentations from the workshop convened in 
2009.  The dedicated webpage was intended only as a practical tool for making existing information more readily available, to bring it together in one  place and to facilitate aw areness and coordination.  
It did not touch on the substantive aspects, which re mained in the hands of the Members concerned.  
The dedicated webpage was easily accessible under the WTO website through the "TRIPS 
Agreement" and "specific TRIPS issues" gateway pages.
1 
104. The representative of the European Union  reaffirmed the commitment of his delegation to its 
obligation under Article 67 of th e TRIPS Agreement to provide, on request and on mutually agreed 
terms and conditions, technical and financial cooperation in favour of  developing and least developed 
country Members.  The EU annual report included three types of activities:  (i) activities by the EU 
itself;  (ii) activities by its individual member States;  and (iii) activities by the European Patent 
Office.   
105. He highlighted three specific technical activiti es carried out by the European Union itself.  
The EU-China Project on the Protection of Intellectual Property Rights (IPR2) was a cooperation project between the European Union and China.  It  consisted of a genuine partnership between the 
                                                     
 
1  Available at http://www.wto.org/ english/tratop_e/trips_e/ldc_e.htm IP/C/M/62 
Page 24  
 
  European Union and China.  With about €11 m illion from the European Union and €5 million from 
China, IPR2 had been launched in November 2007 for a four-year period.  IPR2 targeted the reliability, efficiency and accessibility  of the IP protection system towards establishing a sustainable 
environment for effective IPR enforcement in Chin a.  This was done by supporting a comprehensive 
framework of technical assistance and coopera tion with the Chinese authorities and institutions 
promoting the environment of IP protection in China.  In practice, IPR2 organized seminars, 
symposia, workshops, studies, training programm es, study tours and information management 
activities across six core components:  (i) legal frame work;  (ii) capacity building;  (iii) access to 
information;  (iv) enforcement;  (v) support to ri ght holders;  and (vi) trademarks and designs.   
106. The EU-WIPO Intellectual Property Rights Pr oject for Bangladesh was an EU initiative 
implemented by WIPO.  The project budget was €1.22 million, of which €1.10 million was the EU 
contribution.  The implementation of the project had started in July 2008 and was expected to end in 
July 2011.  The purpose of that project was to st rengthen national capacity to develop, modernize, 
administer and use the IP system to meet national developmental objectives taking into account the relevant international standards, including tho se in the area of IP under the TRIPS Agreement. 
107. Finally, the EU TradeCom Facility Project was an ACP Group Programme financed by the 
European Development Fund. It was divided into three main complementary components, each with its specific beneficiaries and results, namely:  formul ation of trade policies;  trade negotiations;  and 
implementation of trade policies and international trade agreements.  For all programmes, the choice 
and precise contents of technical activities were subject to an exchange of views between representatives of the European Union and of the pa rtner country.  Due account was taken of the level 
of development and the needs of each partner co untry.  Further details on technical cooperation 
activities by the EU member States could be found in document IP/C/W/539/Add.7. 
108. The representative of Bangladesh
 said that, as a founding Member of the WTO, Bangladesh 
was a signatory to the TRIPS Agreement.  When  Bangladesh had signed the Agreement it had not 
realized the extent of its obligations.  Now as things  were unfolding gradually,  it had started to realize 
the difficulties.  It was easy to see trade in agricultural and non-agricultural goods and even in 
services, but it was not that easy to discern trade-re lated intellectual property rights.  However, he 
believed that even LDCs had an obligation to im plement the TRIPS Agreement, taking into account 
the flexibilities they were entitled to.   
109. He thanked the Secretariat for selecting Bangl adesh as a possible venue for the subregional 
workshop on TRIPS needs assessment.  As far as TRI PS obligations were concerned, the LDCs did 
not have any lack of willingness:  the problem was la ck of capacity.  To enable them to comply with 
the TRIPS obligations, appropriate technical assist ance, without conditions, was needed.  Moreover, 
technical cooperation to LDCs should not hinge on the degree  of compliance with the TRIPS 
Agreement.  LDCs needed policy space and flex ibilities to implement the TRIPS Agreement phase by 
phase.  LDCs deserved the utmost attention of Members to address their supply side constraints.   
110. Bangladesh had identified some areas where it needed technical cooperation to achieve its 
objectives.  It intended to develop its own in frastructure and strengthen its financial and 
administrative capacities to encourage research and i nnovation and enforce IP rights.  It needed to 
develop an IP policy, formulate or strengthen so me of the existing laws to make them TRIPS-
compliant, restructure its institutions, and undert ake training and awareness building programmes 
among the policy makers, IP enforcing agencies a nd consumers.  Apart from those, Bangladesh 
needed to preserve its genetic resources, traditiona l knowledge and folklore with a view to gaining 
from commercialization of these resources.  For that, Bangladesh needed the support of the 
international community.   IP/C/M/62 
 Page 25 
 
 
  111. In view of their special needs and requirement s, their economic, financial and administrative 
constraints, and their need for flexibility to creat e a viable technological base, LDCs had not been 
required to apply the provisions of the TRIPS Agreem ent, other than Articles 3, 4 and 5, for a period 
of 10 years, i.e. until 31 December 2005.  Unfortunately, the special situation of LDCs had not improved much by the 2005 deadline.  Therefore, by a decision of 29 November 2005, the TRIPS  
Council had granted a further extension of the transition period up to 1 July 2013 on the basis of duly 
motivated requests of LDCs (document IP/C/40).  
112. In accordance with paragraph 2 of this decisi on, LDCs were to provide as much information 
as possible, preferably by 1 January 2008, on their individual priority needs for facilitating targeted technical and financial cooperation.  In fulfilmen t of this obligation, Bangladesh was pleased to 
submit its TRIPS needs assessment to the WTO, following the good examples of  Uganda and Sierra 
Leone.   
113. In the WTO, technical cooperation was a core el ement of the development dimension.  Under 
the TRIPS Council decision of 29 November 2005, developed country Memb ers were to provide 
technical and financial cooperation in favour of LDC Members in accordance with Article 67 of the 
TRIPS Agreement in order to effectively address th e needs identified in accordance with paragraph 2 
of the decision.  Technical cooperation was more than helping needs assessment and should include, 
but should not be limited to, assistance in the prep aration of laws and regulations on the protection 
and enforcement of IP rights as well as on the pr evention of their abuse, and support regarding the 
establishment or reinforcement of domestic offices and agencies relevant to those matters, including 
training of personnel. 
114. Bangladesh did not have a stand-alone IP Policy.  It had inherited a set of IP laws and rules 
from the colonial regime.  After independence in 1971, it had adopted those laws and rules and had 
amended or updated some of them.  In its submission , it had given a brief description of the IP laws 
and rules that existed in Bangladesh and their leve l of consistence with the TRIPS Agreement, as 
mentioned in Annex 1 to the document.  It had al so proposed a comprehensive action matrix that it 
intended to follow to ensure a TRIPS-consistent IP regime, which was contained in Annex 2.  In the 
action matrix, it had delineated the present position,  action needed and expected outcome in the 
following areas:  IP policy, technology transfer, la ws and regulations, strengt hening of IP institutions, 
awareness raising, IP enforcement, IP negotiation,  and protection of folklore, traditional knowledge 
and cultural expressions etc.  In part (vii) of its  submission, Bangladesh had identified ten projects, 
amounting to only US$71.04 million, which should be good candidates for technical and financial 
assistance from development partners as a bare minimum to implement the TRIPS Agreement in 
Bangladesh.  Bangladesh looked forward to eagerly engagi ng with them in the not-too-distant future.   
115. Technology transfer would play a vital role  in enhancing the overall productive capacity 
including TRIPS compliance of Bangladesh.  TR IPS Article 66.2 mandated developed country 
Members to provide incentives to en terprises and institutions in thei r territories for the purpose of 
promoting and encouraging technology transfer to LD C Members in order to enable them to create a 
sound and viable technological base.  Unfortunately, Bangladesh was not yet enabled to create a sound and viable technological base as envisaged in that provision.  Bangladesh sincerely intended to 
use the transition period to create an enabling envi ronment to comply with TRIPS obligations and 
integrate into the multilateral trading system.  T echnical cooperation alone could not do the trick.  
Technical cooperation and technology transfer needed to be combined within the extended  transition 
period to create a viable technological base.  Otherwise, at the end of the current transition period, 
Bangladesh might find itself in a situation that woul d warrant it to seek further extensions which was 
not its intention.   
116. Bangladesh had tried to fulfil its obligation to submit a needs assessment report  with its own 
resources albeit a little late.  It had tried to give as much information as possible, and would try to IP/C/M/62 
Page 26  
 
  give further information if the situation so dema nded.  Now it was the turn of developed country 
Members to fulfil their obligation.  Bangladesh l ooked forward to an active engagement with WTO 
Members and other development partners which w ould contribute to its objective of fulfilling its 
TRIPS obligations incrementally as mentioned in the needs assessment. 
117. The representative of Angola
 believed that the seminars or workshops mentioned by previous 
speakers were important, because they served to enhance the capacity and the knowledge of officers 
in LDCs.  Once a needs assessme nt was established, it was im portant to adopt measures and 
mechanisms to make implementation effective.  Ug anda and Sierra Leone had already prepared their 
needs assessment and, following th e implementation of this assessmen t, there was a kind of vacuum.  
Therefore, it was important for LDCs' partners not  simply to focus on workshops and seminars.  
Although they were good, LDCs needed specific measur es.  One such measure was digitization of IP 
offices.  In this regard, it was important to identify the needs and to find mean s to meet them.  That 
would not only help national offices to protect IPRs, but  also to register patents.  Such a measure was 
not only beneficial at the national level, but also to other countries who wished to protect their IPRs 
abroad.  Therefore, it was important for the TRIPS Council to start thinking about measures that went 
above and beyond needs assessment.   
118. The representative of Zambia  said she appreciated the fact that the Secretariat had been able 
to swiftly respond to the request her delegation had made .  It was clear that gaps remained in terms of 
ensuring that LDCs carried out th eir needs assessments, bearing in  mind that the 2013 deadline was 
approaching fast.  Apart from workshops and semina rs, it would be useful to have country-specific 
missions so that, by 2013, individual countries would have had an opportunity to identify their needs 
and to request the necessary implementation capacity and technical assistance.  It was important to 
ensure that the needs assessment process not only le d to TRIPS compliance, but also fostered the 
development objectives of individual LDCs. 
119. The representative of Brazil  referred to the statement made by Zambia and said that that was 
exactly what Brazil had meant in the proposal presente d at the Council's last meeting, namely that the 
specific needs of countries in need of technical  cooperation be achieved by these activities.  She 
believed that technical cooperati on and capacity building under Article  67 should not only concentrate 
on implementation of the obligations.  To be effectiv e, it should be broader in nature and also teach 
how to make legitimate use of the flexibilities under the TRIPS Agreement, as well as of its 
provisions related to transfer of technology and mitig ation of abuse of intellectual property rights.   
120. To achieve that goal, Brazil had suggested that the 14 proposals in "Cluster A" of the WIPO 
Development Agenda could provide a useful guiding framework in making Article 67 more 
responsive to developing country specific needs.  At the Council's last meeting, Brazil had presented 
in document IP/C/W/153/Add.1 a form of stock taking of capacity building activities regarding a 
project development in Mozambique on sanitary cont rols related to pharmaceuticals in which all these 
14 recommendations had been observed.  By doing so , it had expected to overcome the resistance of a 
few countries that opposed its proposal on that matter .  She hoped that, since that meeting, delegations 
had had enough time to analyse this form, and th at the present meeting could agree that Members 
should take into consideration these 14 recommendati ons when providing technical cooperation under 
Article 67.   
121. She said that, at the last meeting, the repr esentative of Egypt, speaking on behalf of the 
African Group, had listed the following principles, which, in the view of that Group, should govern 
technical cooperation activities under Article 67:  t echnical and financial c ooperation needed to be 
(i) development-oriented, demand-driven and tran sparent, taking into account the priorities and 
special needs of developing countries, especially LDCs , as well as the different  levels of development 
of Members;  (ii) promote a development-oriented intellectual property culture;  (iii) place particular 
emphasis on the needs of small and medium-sized en terprises and institutions dealing with a specific  IP/C/M/62 
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  research and cultural industry;  (iv)  promote measur es that would help countries deal with intellectual 
property-related anti-competitive practice by prov iding technical cooperation to the developing 
countries, especially LDCs at their request in order to better understand the interface between IP 
rights and competition policy;  (v) further develop infrastructure and other technical facilities with a 
view to making international intellectual property in stitutions more efficient and more fairly-balanced 
between intellectual property protection and the public  interest;  (vi) strengthen national capacity for 
the protection of domestic creations, innovations and inventions and suppor t the development of 
national and specific and technological infrastru cture;  and (vii) mainstream development 
considerations.  Brazil endorsed such princi ples as a minimal base for consensus.   
122. The representative of Argentina  said that Argentina was one of the countries that had 
promoted the WIPO Development Agenda and par ticipated actively in the negotiations that had 
resulted in the adoption of the Agenda.  She we lcomed the Brazilian document IP/C/W/513/Add.1, 
which illustrated the fact that the project fo rmat was practical and easy to implement. 
123. The representative of India  said that he appreciated the efforts of Brazil to develop a model 
form for technical cooperation projects.  In that c ontext, he also recalled the proposal by Brazil as 
contained in document IP/C/W/513 about the linkages between the work in the WTO and the work in 
WIPO.  The model form prepared by Brazil woul d undoubtedly contribute to transparency of 
technical cooperation projects.  He recognized th e importance of technical cooperation and capacity 
building in the TRIPS Agreement from the viewpoint of  developing countries.  Like Brazil, he saw a 
clear link between the work in the TRIPS C ouncil and the 14 recommendations on technical 
assistance and capacity building issues contained in Cl uster A of the WIPO Development Agenda that 
had been adopted by the WIPO General Assembly in 2007.  Some  of the recommendations referred 
to the TRIPS Agreement and one recommendation sp ecifically referred to the agreement between 
WIPO and the WTO.  Cluster A of the Developmen t Agenda provided a rele vant guiding framework 
for discussions in the TRIPS Council.  Techni cal assistance activities should be demand-driven, 
transparent, neutral and accountable, and take into  consideration the special needs of developing 
countries, in particular LDCs.  This would fac ilitate effective compliance with the obligation to 
provide targeted technical cooperation programmes for LDCs. 
124. The representative of Cuba  supported the statements by Braz il, Argentina and India, as well 
as document IP/C/W/513.  She said that it would be a good idea to promote a link between the WIPO Development Agenda, particularly the Cluster A,  and the work of the Council with respect to 
technical cooperation and capacity building.  In reviewing the Cluster A recommendations, one found 
principles that could very well guide the Council in the area of technical cooperation and capacity 
building, for example, the principle that technical assistance be directed toward development and meet 
specific demands, be transparent and take into account  special priorities of developing countries and 
in particular LDCs, as well as various le vels of development of Members.   
125. The representative of Ecuador
 expressed interest in the Brazilian proposal in document 
IP/C/W/513/Add.1.  The principles developed in th e Development Agenda that WIPO had adopted as 
a work plan should be part of the framework of technical activities and capacity building under Article 67 of the TRIPS Agreement.  That docum ent would facilitate the Council's discussion and 
enable it to assess and in particular to clarify genuine needs of developing Members of the WTO in terms of the intellectual property system.  For that  reason, he urged Members that still had certain 
concerns regarding the adoption of the recommendations and principles of the Development Agenda, 
which had been clearly described by Egypt, speaking for the African Group at the Council's 
October 2009 and the present meeting, and by Brazil a nd India, to focus their efforts in order to make 
best use of the limited resources available and as a result to comply with the objectives and the 
principles established in Articles 7 and 8 of the Agreement. IP/C/M/62 
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  126. The representative of the United States
 recognized Brazil's continuing interest in technical 
cooperation.  The US report on the implementation of Article 67 of the TRIPS Agreement that had 
been submitted for the Council's October 2009 meeting provided a deta iled account of US efforts to 
work together with its trading partners to pr ovide such assistance.  Regarding Brazil's paper 
concerning the Development Agenda and the recommendations that the WIPO Committee on 
Development and IP had been tasked to implement,  she said that the United States had been actively 
and constructively involved in that WIPO Committe e since its establishment in October 2007, as well 
as in the earlier provisional committee on the develo pment agenda, and would c ontinue to be engaged 
with the work of that Committee in order to contribute to its continued success.  The WIPO 
Committee on Development and IP had had four mee tings thus far, with the fifth planned for 
April 2010.  Although much work had been accomp lished, the Committee was still in its formative 
stages.  The Committee was worki ng with the WIPO Secretariat to establish the proper and necessary 
steps to be taken to implement each of the adopted recommendations, including programme and 
budgetary issues related to implementation.  Tho se recommendations expressly concerned the work of 
WIPO and many did not make sense outside that  context, as they concerned the core mission, 
responsibilities, capabilities and resources of WIPO .  To presuppose outside of the working and 
functioning of the Committee how those recommend ations should apply to WIPO and its activities 
was highly inappropriate, particularly at this n ascent stages of addressing the Committee's task of 
implementation.   
127. The representative of Egypt  said that he believed that enga ging in technical cooperation and 
capacity building activities were a core function and mandate in the TRIPS system.  Through effective 
technical cooperation and capacity building activities,  developing and least developed countries could 
reap specific benefits and make full use of th e TRIPS Agreement and its flexibilities.  As was 
mentioned by the delegate of Brazil, at the C ouncil's meeting in October 2009, the African Group had 
referred to the key principles that were enshrined in  Cluster A of the WIPO Development Agenda that 
had been adopted by the WIPO member states as c ontaining the principles that should guide technical 
assistance and capacity building in the area of intellect ual property.  He believed that they represented 
a consensus among them that reflected an approach to the broad concepts of technical assistance and 
capacity building in areas of intellectual property and were not specifically pertaining to one 
institutional context to the exclusion of others.  The principles entailed the essence of ongoing efforts 
to bring about a balance in the intellectual prope rty protection debate, and should, at a minimum, 
ensure widespread endorsements.  He called on a ll Members to focus on those essential principles and 
provide qualitative assessments of their technical as sistance and capacity building efforts accordingly.  
In this regard, Egypt welcomed the proposal th at had been presented in document IP/C/W/513 by 
Brazil to integrate Cluster A of the WIPO Deve lopment Agenda into the discussion in the WTO on 
technical cooperation and capacity building.  In this regard he welcomed any additions and 
appendices to this document.   
128. The representative of Canada  said that her delegation was committed to implementing the 
Development Agenda at WIPO by mainstreamin g the development dimension in all of the 
organization's activities, including its recommenda tions under Cluster A on technical assistance and 
capacity building.  The recommendations under the WIPO Development Agenda expressly concerned 
WIPO's activities as well as its core mission responsibilities, abilities and resources.  Although 
linkages could be drawn between the Development Ag enda and the Article 67 process, she was of the 
view that the WIPO efforts in this sense were complementary and should not form the basis of the 
consideration of issues related to technical assistan ce and capacity building under Article 67.  In fact, 
in addition to Article 4 of the 1995 agreement betw een the WIPO and the WTO on legal and technical 
assistance and technical cooperation, recommendation 14 in Cluster A of the Development Agenda 
illustrated that the efforts of the two Organizations in that sense were compleme ntary.  Canada wished 
to reiterate its commitment under both the WTO and WI PO with regard to those issues and believed 
that the two Organizations should wo rk collaboratively on these matters.    IP/C/M/62 
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  129. The representative of China  associated herself with Brazil, India and other Members in 
attaching importance to technical cooperation under the TRIPS Agreement.  She believed that there 
was a general recognition in the TRIPS Council that there was a gap between developed and 
developing countries in terms of intellectual property and she belie ved that technical cooperation 
should and could be a necessary step in filling these gaps.  She also supported the idea by Bangladesh 
that there should be a link between technical coopera tion and transfer of technology so that the least 
developed country Members could be nefit from technical cooperation.  
130. The representative of Japan  said that the improvement of the IP system was crucial for 
(i) continuous development from the perspective of  innovation and the appropriate IP protection;  
(ii) the development of local industry through the creation of grants;  and (iii) the promotion of 
investment from foreign countries, for instance.  In  this connection, the ongoing discussion at WIPO 
in the context of the WIPO Development Agenda, es pecially in connection with Cluster A, was also 
important with regard to technical  cooperation activities in the field of IP.  Japan, as a WIPO member 
state, attached importance to that Agenda and w as committed to its effective implementation.  Given 
that the different capacities and responsibilities s howed the difference in constituencies between 
WIPO and the WTO, not all of the recommendations in the WIPO Development Agenda were directly 
relevant to the technical cooperation and capacity building under Article 67.  This aspect should be 
duly taken account of.   
131. The representative of Switzerland  thanked the delegation of Bangladesh for introducing its 
priority needs assessment report.  He said that, by bringing together the various stakeholders 
concerned with the implementation of technical cooperation and capacity bui lding under Article 67, 
the workshop on LDC priority needs had greatly e nhanced the understanding of participants regarding 
the question of if and how existing international coordination mechanisms and available expertise 
could be made use of also for the purposes of r esponding in an effective a nd expeditious manner to 
LDC priority needs assessments and national tec hnical cooperation programmes in the TRIPS area in 
addition to and beyond assistance by individual donors.  He also thanked Brazil for the two 
submissions presented in previous meetings.  As a member of WIPO and the WTO, as well as in its 
own national capacity, Switzerland had developed its technical assistance and capacity building 
activities in full cooperation with beneficiary countries according to their needs.  Technical 
cooperation and capacity building should certainly be demand-driven, transparent and accountable.  
Those were very horizontal principles for the deliv ery of technical cooperation and capacity building.  
However, subscription to these broad principles did not require a formal link between the 
recommendations contained in the Development Ag enda and Article 67.  Switzerland had been 
closely involved in the work and negotiations in WIPO that had led to the adoption of the 
45 recommendations of the Devel opment Agenda.  Those recommendations specifically addressed the 
mandate and the work of WIPO as agreed in the context of WIPO's Development Agenda.  Most of 
them, including many under Cluster A, did not make sense outside of that context as they concerned 
the core mission responsibilities, capabilities and re sources of WIPO, as had already been stated by 
other delegations.  In conclusion, he reiterated Switzerland's commitme nt with regard to the related 
issues in both the WTO and WIPO.  He believe d that the two Organizations should work 
collaboratively, but each of them within  its respective context and mandate.   
132. The representative of Rwanda  commended Bangladesh for having completed its exercise of 
priority needs assessment and hoped that Bangl adesh would be able to implement the TRIPS 
Agreement by 2013.  More importantly, he hoped that Bangladesh would build a sound and viable 
technological base in the near future.  When the TRIPS Council had requested LDCs to submit their 
needs assessment by January 2008, it did not establis h or indicate any funding or support mechanism 
to assist countries to implement and to build capacity with a view to implementing the TRIPS Agreement.  He wondered how to ensure that the needs assessments that ha d been submitted were 
being supported in an effective manne r.  Considering the time consumed and effort put into this, it 
would be frustrating if there were no tangible im plementation.  The countries which had already IP/C/M/62 
Page 30  
 
  submitted their needs assessment had not been able  to go further.  He therefore wondered how to 
ensure that there was a clear a nd effective mechanism to support im plementation of the priorities as 
highlighted by beneficiary countries.  When the Council had decided on the 2013 deadline, the LDCs had been reluctant to endorse it.  It had not been easy  to agree that, within seven and half years, LDCs 
would be TRIPS-compliant.  The Council had eventu ally agreed, but having in mind that when the 
time came, countries would consider positively requ ests from LDCs for further extension.  He 
endorsed what Bangladesh had said:  the intention was not to request additional time, but rather to ask 
countries to faithfully support implementation so that by the deadline, countries having submitted 
their needs assessment could implement the TRIPS Ag reement.  Rwanda was finalizing its priority 
needs process and would submit a document to th e Council in due course.  He hoped that due 
consideration would be given to provide effective support. 
133. The representative of Australia
 thanked the Secretariat for the workshop, in particular for 
making it a practical and frank exercise and for c oordinating a diverse and relevant range of 
presenters.  Australia had found the exchanges enli ghtening and useful, particularly the sharing of 
national experiences by LDCs.  She thanked th e Members who had commented on their needs 
assessment process.  Australia was committed to m eeting its technical cooperation capacity building 
and assistance obligations under the TRIPS Agreemen t.  With regard to the Brazilian proposal to 
incorporate the WIPO Development Agenda into th e WTO, she supported the statement made by the 
United States. 
134. The Council took note  of the statements made. 
K. LETTER FROM THE CHAIR OF THE GENERAL COUNCIL CONCERNING WAYS TO IMPROVE THE 
TIMELINESS AND COMPLETENESS OF NOTIFICATIONS AND OTHER INFORMATION FLOWS  
135. The Chairperson  recalled that, at its meetings in J une and October 2009, 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 othe r information flows in the TRIPS Council's area 
of responsibility.  In order to facilitate the Council' s consideration of this issue, the Secretariat had 
presented at the October meeting a factual backgr ound note (IP/C/W/543), prepared at the Council's 
request, that summarized the relevant procedur es and provided information on the use of those 
procedures, as well as containing suggestions on  how to improve the transparency and user-
friendliness of the notification system.  Those dele gations which spoke on this  issue had supported the 
suggestions contained in that note to improve the transparency of the system, for example by making 
notifications more easily accessible on the WTO webp age.  The Secretariat had been encouraged to 
pursue this task and had been requested to repor t on any developments to the present meeting. 
136. The representative of the Secretariat  said that, as he had alread y mentioned at the Council's 
last meeting in introducing the background note IP /C/W/543, the Secretariat was exploring how to 
improve the transparency and user-friendliness of the notification system, for example by making 
notifications more easily accessible on the WTO webpage and in particular by establishing practical 
ways to make it easier for Members to prepare and s ubmit their notifications.  He stressed that these 
steps were purely practical and technical in character, operating entirely within the existing 
framework agreed by the Council and in line with the requirements of the TRIPS Agreement itself.  
The objective was to find practical ways to make th e existing framework that had been used by over 
120 Members in the course of nearly 15 years work increasingly user-friendly.   
137. Accordingly, the Secretariat had been working on making notifications and related 
information resources more easily available to Me mbers by reorganizing the relevant pages on the 
WTO website.  As already foreshadowed in the background note, the Secretariat had continued its 
preparation on a transparency toolkit page that  would provide a single access point for various  IP/C/M/62 
 Page 31 
 
 
  notifications and other various reports from Memb ers, as well as to related formats, guidelines and 
background materials. 
138. Article 63.2 of the TRIPS Agreement itself already recognized that steps should be taken to 
reduce the burden of notification procedures on Me mbers, including in cooperation with WIPO.  
Within its existing cooperation arrangement with WI PO, the Secretariat was looking at how to make 
better use of advances in technology to reduce delays, to facilitate the flow of information, to provide 
this information in a timely and practically useab le fashion and to reduce the administrative burden on 
Members when preparing and lodging notifications.  He stressed that any practi cal steps that might be 
taken to improve the management of the vast quan tity of information would be undertaken within the 
existing framework of the TRIPS Agreement and th e decisions already taken, as well as with the 
Secretariat's long-standing coopera tion arrangements with WIPO.  The fact that WIPO was currently 
overhauling its own legislative database made it esp ecially timely to explore ways of improving this 
linkage and thus reducing the burden on users of  the system and on WTO Members in particular. 
139. He stressed that the aforementioned improvements,  particularly in the way notifications could 
be accessed electronically, were purely intended to improve the accessibility of information provided 
under the existing notification requirements, and would not entail any change to the legal status to 
notified materials, nor to the obligations or entitlements of Members. 
140. Since this was still work in progress, he said that he would be happy to brief the Council 
again at its forthcoming meetings of any further developments and improvements that the Secretariat 
had been able to introduce into the system.  In th e meantime, the Secretariat was building this element 
into its technical assistance activities, including in  cooperation with WIPO, to ensure that Members 
could make best use of the system while si gnificantly reducing its administrative demands. 
141. The representative of Australia  welcomed the Secretariat efforts to improve the efficiency of 
information flows and the updates on its work, and expressed her support for the work to improve the 
timeliness and completeness of notificati ons and other information flows.   
142. The Chairperson  thanked Australia for its feedback and expressed her appreciation of the 
Secretariat's continued work on this issue.  She sugg ested that the Council revert  to the matter at its 
next meeting, in order to allow delegations to make any further comments they might have on this 
matter and also to allow the Secretariat to info rm the Council of any further developments and 
enhancements in improving the transparency and user-friendliness of the notification system.   
143. The Council took note  of the statements made and so agreed .  
L. INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO   
144. The Chairperson  recalled that, at its meeting in October 2009, the Council had agreed to 
forward to the General Council a proposal for a decision on a second extension of the period of 
acceptance by Members of the Protocol Amending the TRIPS Agreement.2  Pursuant to this proposal, 
the General Council had decided, at  its meeting of 17 December 2009, to further extend the period for 
acceptances of the Protocol until 31 December 2011 or such later date as might be decided by the 
Ministerial Conference.  This decision had been circulated in document WT/L/785.  
145. Regarding the status of acceptances of the Protocol Amending the TRIPS Agreement, she 
said that, since the Council's meeting in October 2009, the following Members had deposited their 
instruments of acceptance: Nicaragua on 25 January, and Pakistan on 8 February (documents WT/Let/663 and 664, respectively).  Sh e encouraged those Members that had not yet 
                                                     
 
2 Document IP/C/54. IP/C/M/62 
Page 32  
 
  notified their acceptance of the Protocol to ensure that necessary measures were being taken in their 
capitals to allow the consideration of the acceptance in a timely fashion.  To date, 28 instruments of 
acceptance had been deposited, including the one by the European Communities and its member 
States. 
146. The Council took note
 of the information provided. 
M. OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS  
147. The Chairperson  said that the list of the 17 pending re quests for observer status in the TRIPS 
Council by other intergovernmental organizations we re contained in document IP/C/W/52/Rev.11.  
She recalled that the Council had discussed these pendi ng requests at its prev ious meetings, but had 
not been able to reach consensus on any of them.  She said that, as requested by the Council at its last 
meeting, she had continued her c onsultations with interested dele gations on the request for observer 
status from the CBD secretariat but that, unfortunately, she was not in a position to report any new developments in their thinking concerning this request. 
148. The representative of Brazil
 reaffirmed its position that the CBD secretariat should be 
accepted as an observer in the TRIPS Council.  She said that, if for any reason the Council could not 
reach an agreement to grant observer status at this meeting, then the CBD secretariat should be 
extended ad hoc  invitations to each session of the Council until its proper acceptance as an observer.  
The rules of procedure regulated the observer status  for international intergovernmental organizations 
in the WTO and established objective criteria for the consideration of requests for observer status.  
According to these rules, requests for observer st atus should be considered on a case-by-case basis 
taking into account five criteria.  As to the first cr iterion, the nature of the work by the organization 
concerned, she said that it was redundant to emphasi ze how relevant the work of the CBD was to the 
discussions of the TRIPS Council since one only need ed to point out that the relationship between 
TRIPS and CBD was a permanent item on its agenda.  As to the second criterion, the nature of the 
organization's membership, she said that the CBD wa s a multilateral treaty with 193 parties, compared 
to the UN with 192, WIPO with 184, the WTO with 153, the WCO with 176, UPOV with 68 and the 
OECD with 30, which organizations were observers  in the TRIPS Council.  Third, all WTO Members 
were parties to the CBD, except for the United States;  Chinese Taipei;  Hong Kong, China and 
Macao, China.  As to the fourth criterion, recipr ocity respecting access to proceedings, documents and 
other aspects of observership, she believed that, while the TRIPS Council was ready to accept the 
CBD as an observer, it should consult the CBD secret ariat on this item and inform the membership.  
Concerning the fifth criterion, whether the organiza tion had been associated with the work of the 
contracting parties of the GATT 1947, she said that this was not the case for the CBD.  She believed 
that, in accordance with these obj ective criteria, there was no reason to oppose granting observer 
status to the CBD. 
149. The representative of India , supporting the statement made by Brazil, said that his delegation 
had raised the issue of observer status for the CBD secretariat over the Council's last several meetings.  
He noted with disappointment the lack of e ngagement by Members and their unwillingness to 
elaborate on any concerns they had on this issue.  He requested the Chair to continue consultations 
with interested delegations.  While he was awar e that there were 17 pending requests for observer 
status, he felt that the CBD presented a special case  due to its direct relevance to the issues being 
discussed in the Council, which had three regular ag enda items relevant to the CBD.  The CBD was 
doing useful work on ABS regimes, technology tr ansfer and cooperation and traditional knowledge, 
innovation and practices.   Secondly, 108 Members had co-sponsored the pr oposal in TN/C/W/52, 
which included the TRIPS-CBD issue.  Thirdly, di scussions under the Directo r-General's consultative 
process on outstanding implementation issues also included discussions on the TRIPS-CBD disclosure proposal, which sought to enhance mutual supportiveness between the TRIPS Agreement and the CBD.  Fourthly, the presence of the CBD secre tariat in Council meetings would help with the  IP/C/M/62 
 Page 33 
 
 
  coherence mandate of the WTO.  The TRIPS Agreem ent itself had provisions on coherence, with the 
last paragraph of the preamble establishing a mutu ally supportive relationship between the WTO and 
WIPO as well as other relevant  international organizations. 
150. He said that there were important developments taking place in the CBD, which Members 
needed to know due to their direct relevance to the agenda, for instance the run-up to the 
10th Conference of Parties in Nagoya in October 2010 and the expectation of a Nagoya protocol on 
ABS.   The Working Group on ABS had met in Montreal in November 2009 and was due to meet in Cartagena in March 2010.  Noting that the CBD secre tariat had been invited by WIPO in December 
2009 to provide information on the CBD negotiations since they had a bearing on discussions in the 
WIPO IGC, he wondered why the CB D secretariat could not also be invited to the Council.  He 
recalled the practice of the Special Session of the Committee on Trade and Environment and the 
Negotiating Group on Trade Facilitation of inviting th e CBD secretariat as an ad hoc invitee on a 
meeting-by-meeting basis.  He felt that the re quest from the CBD Secretariat should be decided 
positively and expeditiously.  Until then ad hoc invitation should be extended on a meeting-by-
meeting basis. 
151. The representative of Ecuador
 endorsed the statements made by Brazil and India and 
reaffirmed its support for the CBD to take part in  the Council's regular sessions.  He said that there 
was a very close relationship between the WTO and the CBD and there was a specific mandate as part of the Doha Declaration of 2001 on implementation which had to do with the relationship between 
TRIPS and CBD.  While there were criteria for accepting requests for observer status, he said that, until a decision on its permanent participation could be  taken, the CBD secretariat should be invited to 
take part in the Council's meetings as an ad hoc attendee. 
152. The representative of Egypt
 said that there were 17 pending requests from international 
intergovernmental organizations for observer status in  the Council for TRIPS, all of which he deemed 
to be equally relevant and important to its wo rk.  However, the request submitted by the CBD 
secretariat was particularly relevant due to the centrality of the TRIPS-CBD issue to the Council's 
work.  In an effort to accommodate certain concer ns while ensuring the important contribution that 
the CBD secretariat would bring to the Council's deliberations, his delegation strove to reach a 
constructive solution with regard to the admission of the CBD secretariat, as was the practice in other 
WTO committees, as an observer in a capacity as an ad  hoc attendee or ad hoc invitee, and that this 
invitation be extended on a meeting-by-meeting basi s pending the resolution of the broader principle 
on the consistent application of the criteria for observer status in the WTO.  He called upon other 
Members to accept such an invitation and to engage  in a constructive spirit in order not to create 
further obstacles for the Council's substan tive debate on this important issue. 
153. The representative of the United States  said that, as it had indicated at previous meetings, her 
delegation could not join consensus on this matter.   It was her understanding that the Chair would 
continue to consult on it. 
154. The representative of Angola , endorsing the statements made by Brazil, India and Egypt, said 
that he believed that it was very important th at the CBD secretariat and two African regional 
intellectual property offices, the African Intell ectual Property Organization (OAPI) and the African 
Regional Industrial Property Organization (ARIPO), be granted observer status.  This would enable 
OAPI and ARIPO to move things forward and provide advice. 
155. The representative of China  supported the statements by Brazil, India, Egypt and Angola 
regarding the observer status of the CBD secretaria t, noting that the relationship between the TRIPS 
Agreement and the CBD was a well recognized ou tstanding implementation issue under the Doha 
mandate and that such status could help facilitate  the discussion on this issue.  Pending the resolution IP/C/M/62 
Page 34  
 
  of this matter, she supported the suggestion to invi te the CBD secretariat to the Council's meetings on 
an ad hoc basis. 
156. The representative of Nigeria, speak ing on behalf of the African Group
, supported the 
statements made by India, Brazil and others rega rding the admission of the CBD Secretariat as an 
ad hoc observer into the Council on a meeting-by-m eeting basis.  The requests presented by the two 
African regional IP organizations OAPI and ARIPO were especially important  for African countries, 
in particular as the Council was focused on LDCs ' needs assessments.  The admission of these two 
bodies would go a long way in assisting LDCs in implementing the TRIPS Agreement.  
157. The representative of Angola  said that, since no Member had expressed any objections 
concerning the requests by OAPI and ARIPO, the Counc il could decide to grant observer status to 
them. 
158. The representative of Egypt  thanked the delegate of Angola for its excellent proposal.  He 
said that the issue of observer status in WTO co mmittees had been held hostage by the lack of 
transparent objective implementation of the criteria set out by Brazil regarding the nature of the 
organizations that were to be allowed.  He reca lled that the League of Arab States had applied for 
observer status in the WTO but had been denied that  right based on criteria that were neither objective 
nor transparent.  His delegation had taken the position that any new proposals for observer status be discussed taking into account the need for transparent and objective implementing criteria.  In order to 
show flexibility on this issue, his delegati on had accepted the admission of observers as ad hoc  
invitees or attendees, and that this designation be re newed from one meeting to another.  It would be 
pleased to accept the requests from ARIPO and OAPI as ad hoc  invitees or attendees, to be renewed 
from one meeting to another.  
159. The representative of Nigeria
 clarified that it was his proposal that ARIPO and OAPI be 
granted observer status and, given the systemic issu e raised by Egypt, he did not have any problem in 
inviting them on a meeting-by-meeting basis.  He en couraged the Chair to continue consultations to 
resolve this issue.  
160. The representative of Angola  said that, having heard the co mments by Egypt, the situation 
remained that there was no opposition to granting observer status to the two organizations.  Any 
further consultations on legal issues c ould take place at a later stage.  
161. The representative of Egypt  clarified that his delegation was fully supportive of the admission 
of OAPI and ARIPO as ad hoc invitees or ad hoc attendees, pending the resolution of the matter of the application of the objective criteria for observer stat us.  His delegation would be pleased to invite 
them to the Council's next meeting, and agreed th at, at each meeting, the Council should renew their 
admission to the Council's next session. 
162. The Chairperson
 clarified that the Council had before it a proposal to invite ARIPO and OAPI 
on an ad hoc meeting-by-meeting basis, pending the resolution on the application of the criteria for 
observer status. 
163. The representative of the United States  said that, as this was the first time she had heard this 
proposal, she would appreciate time to consider it.  Her delegation would be pleased to revert to it at 
the Council's next meeting.  
164. The Chairperson  suggested that the incoming Chair cons ult on the issue of observer status for 
international intergovernmental or ganizations.  She also suggested that the Council revert to this 
matter at its next meeting.  IP/C/M/62 
 Page 35 
 
 
  165. The Council took note  of the statements made and agreed  to proceed as suggested by the 
Chair.  
N. OTHER BUSINESS  
(i) Dates of the Council's meetings in 2010 
166. The Chairperson  recalled that, at its meeting in Oct ober 2009, the Council had agreed to the 
dates for its meetings in 2010.  Given some sche duling conflicts, the Chair-designate had requested 
her to ask whether it would be acceptable to the Coun cil to hold its next meeting a week earlier than 
originally scheduled, i.e. on Tu esday and Wednesday 8 and 9 June, instead of 15 and 16 June.   
167. The Council so agreed .  
(ii) Operation of the Paragraph 6 System 
168. The Chairperson  recalled that paragraph 8 of th e Decision on the Implementation of 
Paragraph 6 of the Doha Declaration on the TRIPS Ag reement and the Public Health provided that the 
Council for TRIPS should review annually the functioning of the System set out in the Decision with a view to ensuring its effective operation and should annually report on its operation to the General 
Council.  The TRIPS Council held its sixth review of the Paragraph 6 System at its meeting in 
October 2009.  The seventh review was sch eduled to take place in October 2010.  
169. At the Council's review in October 2009, the Council had requested her to hold a round of 
informal consultations on the operation of the System  before this formal meeting for the purpose of 
providing a platform to share experiences and look at concerns in an informal setting, without 
prejudicing the outcome.  In response to that request, she had held an informal meeting on 
12 February 2010.   
170. She said that she had found the informal meeti ng to be very constructive.  Her impression had 
been that Members were interested in sharing expe riences on the use of the System and were ready to 
engage in practical fact-based discussions in orde r to have a full understanding of the operation of the 
System. 
171. As regards the specific points made by delegati ons, she said that some delegations had been 
concerned that the System had been used only on ce by Rwanda and Canada which, in their view, 
raised the question of whether the System had me t its objective of providing an expeditious solution 
to problems faced by countries with insufficient or  no manufacturing capacities in the pharmaceutical 
sector.  It had also been said that the fact that the System had only been used once did not imply that it 
was inadequate, since there were also other ways to  get medicines to patients.   Some delegations had 
argued that the number of licences issued under the Sy stem was not the proper measure of its success, 
and that the use of the System by Rwanda and Canada had demonstrated that the System could work 
effectively.  They considered that the System coul d only play a supportive role in the wider effort to 
improve access to essential medicines, and that its mere existence could have had a positive impact on 
drug prices.    
172. Concerns had also been expressed about the peri od of some three years that it had taken to 
deliver the medicines to Rwanda in this particular case.  In this respect, Canada had shared experience 
on its use of the System, giving a detailed account of the timeline of the shipments under the System, attributing the bulk of the time consumed not to th e specific requirements of the Paragraph 6 System, 
but to factors such as identifying a recipient count ry for the available medicine, and the government 
procurement process in the recipient country wh ich required a competitive tendering process.    IP/C/M/62 
Page 36  
 
  173. As regards the topics that might warrant more di scussion, it had been suggested that the focus 
could be on the experience from the use of the Sy stem by Rwanda and Canada  to consider whether 
the System was working effectively.  Some delega tions had said that the performance of the System 
could be appraised more generally to assess whether there were any procedural problems regarding its 
operation.  Some Members had said that, bearing in mind that the System was demand-driven, it 
would be helpful to know whether there were some  concrete obstacles preventing potential importers 
from procuring under it.  Among other issues men tioned that might merit further discussion were 
safety and efficacy of medicines procured under the System, government procurement, and the dissemination of information with a view to building capacity in developing countries to use the System.  
174. She said that Members had also discussed the a ppropriate ways to address the aforementioned 
issues, agreeing that annual reviews were a good plat form for sharing experiences and evaluating the 
operation of the System.  However, some delegations  had suggested that this work be complemented 
by organizing a dedicated workshop open to all st ake-holders.  Some other delegations had said that 
the review process was a Member-driven exercise, but  believed that its usefulness could be enhanced, 
inter alia , by more factual input.   
175. Finally, there had been calls for the Chair to consult with interested  delegations on how to 
best address the issues raised in this discussion.   A number of delegations had expressed their 
willingness to participate in any consultations that  the Chair might decide to hold on the matter. 
176. The representative of Angola, speaking on behalf of the LDC Group
, said that the LDC Group 
considered the adoption of the Protocol Amending the TRIPS Agreement in 2005 in order to respond 
to difficulties experienced by countries with no or  insufficient manufacturing capacity to be an 
important milestone.  He noted with disappointment that, since the adoption of the decision, only few Members had deposited their instruments of acceptance of the Protocol.  It was important to establish 
why countries were not forthcoming so that corre ctive measures could be taken.  The LDC Group 
welcomed the 12 February 2010 informal consulta tion undertaken by the Chair regarding potential 
impediments to the ratification process and how this  could be facilitated.  During that meeting, 
proposals had been made to hold workshops to a ddress any difficulties encountered and to map out 
the way forward which could be expected to help  expediting the ratification process by individual 
Members.  The LDC Group supported this proposal .  He said that the issue of ratifying the 
amendment of the TRIPS Agreement should also be a regular feature in national and regional 
technical assistance and capacity building ac tivities undertaken by the Secretariat.  
177. The representative of India
 supported Angola's request to hold a workshop to discuss 
potential obstacles to the use of the Paragraph 6 Syst em, if any, and to have detailed deliberations on 
the way forward.  His delegation was of the view  that it was time to move beyond the legalistic 
consideration of this item in the annual review.  An  in-depth study could only be effectively carried 
out through a dedicated workshop.  He request ed holding Chair's consultations regarding the 
workshop modalities, its organization, participation and related dates.  
178. The representative of Korea  welcomed the constructive proposal put forward by India, 
Angola and other developing countr y delegations regarding the impl ementation of the Paragraph 6 
System.  The System was supported by all Members.  If it was not working properly, it needed to be 
looked at.  The organization of a workshop would be  the proper way forward, as the devil was in the 
details.  Such a workshop should serve to exchange pr actical information, and the list of participants 
and topics for discussion should be prepared in adva nce.  Participants should involve experts from 
IGOs and NGOs, including government officials from Rwanda, as well as representatives from the Canadian generic company which had gathered prac tical experience in the use of the Paragraph 6 
System.  IP/C/M/62 
 Page 37 
 
 
  179. The representative of the United States  regretted that she was put in a position again to 
consider a request for a decision by Members under the agenda item "Other Business".  She reiterated 
that the rules of procedure for the TRIPS Council clearly stated that no decisions or other actions could be sought under this agenda item.  Undul y long debates were to be  avoided.  The TRIPS 
Council should limit itself to taking note of the stat ements of delegations as well as the reactions from 
other Members.  If there was an interest in making another effort to have a discussion as already 
agreed to, her delegation would be open to th e Chair providing an opportunity to do so. 
180. She said that the Chair's consultation regarding the Paragraph 6 System had been agreed as an 
opportunity to share both experiences and concerns.  It had been disappointing that, except for an interesting presentation by Canada, Members had not u sed this valuable opportunity to share such 
experiences.  Her delegation had taken note of co ncerns expressed by some Members about the 
annual review, noting that the output from the re view depended on what Members provided as input 
to the process.  She was open to discussing with  Members any ideas for improving the operation of 
the annual review, but the existing mechanisms shoul d be looked at before entering into a debate on 
new approaches.   
181. The representative of Colombia
 supported the proposal made by  Angola on behalf of the LDC 
Group to hold a workshop.  This would usefully enab le Members to learn more about the subject and 
to clarify matters.   
182. The representative of Argentina  supported the suggestion to hold a workshop in Geneva on 
the use of the Paragraph 6 System.  
183. The representative of Nigeria , speaking on behalf of the African Group, recalled the Group's 
support for the organization of a workshop.  The Ch air should hold consultations on the participation 
and topics to be covered.  Those should include issu es related to the safety and quality of medicines. 
184. The representative of Brazil  said that the informal consu ltations held on 12 February had 
provided Members with an opportunity to engage in useful discussions, including on any obstacles 
preventing developing countries from making full use of  the System.  In her view, it was apparent 
from the consultations that the Paragraph 6 System  had not met the expectations of most of the 
developing countries when it was first designed in 2005 .  It had been used only once, and both the 
supplier and the beneficiary had experienced difficulti es in that particular case.  She agreed with the 
United States that Members needed to look at the existing mechanisms before new approaches were to 
be considered, but relevant stak eholders should also be involved in order to fully understand the 
difficulties encountered by countries and internationa l organizations regarding the implementation of 
the Paragraph 6 System.  This would allow for a proper assessment as to whether the System was 
working effectively and provided an expeditious solution to the problem of ensuring access to 
medicines in countries with insufficient or no ma nufacturing capacity.  Her delegation supported the 
proposal that a workshop be held under the auspices of the TRIPS Council.  
185. The representative of Canada  said that the WTO 2003 Decision on TRIPS and Public Health 
had been intensively negotiated and was unanimously s upported by all WTO Members.  The Decision 
represented a delicate balance that took into consider ation the interests of many stakeholders with 
divergent views.  The Paragraph 6 System was never intended to solve the issue on its own, but was 
designed to be used as one piece in a broader intern ational strategy to combat diseases that affected 
the developing world.  Since its adoption, the inte rnational environment for procurement of drugs had 
significantly changed with the introduction of a vari ety of other global mechanisms and alliances that 
offered additional choices to countries to obtain medi cines.  Canada's experience demonstrated that 
the System could work to combat diseases in th e developing world.  Her delegation had shared 
experiences regarding the System's use and functi oning with the TRIPS Council, at WTO workshops, IP/C/M/62 
Page 38  
 
  in bilateral consultations, as well as during the Council's informal consultation held on 
12 February 2010. 
186. The representative of Canada said
3 that his delegation was pleased with the historic and 
multilateral solution which the WTO had adopted through the 30 August 2003 Decision.  It provided 
another avenue for developing countries to access medicines needed to respond to public health 
problems, while ensuring that intellectual property protection was maintained for the development of 
new and better drugs.  Since it had been one of the first countries to implement the Decision, it did not 
have the benefit of modelling its legislation on that of another WTO Member.  When drafting 
"Canada’s Access to Medicines Regime" (CAMR), legi slators had to adhere to the WTO Decision's 
humanitarian objectives while balancing often comp eting policy objectives.  Those had included:  
facilitating access to lower-cost pharmaceutical pr oducts in countries facing public health problems, 
while respecting Canada's obligations under TRIPS and other international treaties;  respecting 
Canada's patent regime;  encouraging generic comp anies to participate in CAMR;  and ensuring that 
products exported under CAMR would meet the same  safety, efficacy and quality standards as those 
retained for the Canadian market.  He recalled that, in negotiating the waiver, WTO Members had 
adopted certain safeguard provisions to prevent th e diversion of generic medicines to unintended 
recipients. The administrative procedures under CA MR were based on these required safeguards.  The 
main features of CAMR were available at www.camr.gc.ca.   
187. He provided a detailed timeline of events as th ey related to the WTO Decision adopted on 
30 August 2003.  In September 2003, his delegation had announced its intention to implement the 
Waiver.  In May 2004, the Act to Amend the Pate nt Act and the Food and Drugs Act had been passed, 
establishing the legal framework for CAMR wh ich came into force in May 2005.   
188. In December 2005, Health Canada had receive d a submission for Apo-TriAvir (a triple 
combination HIV/AIDS drug) by the Canadian co mpany Apotex, the review of which had been 
completed in June 2006, that was in less than six months rather than the allowable 12 months.  On 
13 July 2007, Apotex had sent letters seeking vo luntary licences to three pharmaceutical companies, 
GlaxoSmithKline, Boehringer Ingelheim and Shire BioChem Inc., to use their relevant patents to 
produce and export 15,600,000 tablet s of Apo-TriAvir to Rwanda. 
189. On 19 July 2007,  Rwanda had become the first country to notify the WTO of its intention to 
use the Paragraph 6 System, announcing that it intend ed to import 15,600,000 tablets of TriAvir under 
the System.  Apotex had filed an application with the Commissioner of Patents for an authorization 
under CAMR to produce and export Apo-TriAvir to Rwanda on 4 September 2007 and the licence 
had been granted on 19 September 2007.  On 4 Oct ober 2007, Canada had notified the WTO of the 
first authorization issued under the System.   
190. In May 2008, Apotex had announced that it had won the Rwanda public tender to supply 
Apo-TriAvir.  This was followed by the first shipment of 6,785,000 tablets to Rwanda in 
September 2008, amounting to approximately half of the authorized amount.  In September 2009, 
Apotex had sent its second shipment of 7,628,000 ta blets to Rwanda, thus completing the country’s 
order.   
191. The year which had elapsed between Health Ca nada's approval of Apo- Triavir in June 2006 
and the voluntary licensing negotiati ons and Rwanda's notification could be attributed to the fact that 
no country had come forward requesting drugs under the Paragraph 6 System. 
                                                      
3 As requested by the delegation of Canada, this an d the following paragraphs reflect the statement it 
made at the Council's informal consultations on 12 February 2010.  IP/C/M/62 
 Page 39 
 
 
  192. He said that CAMR was intended to be a demand- driven measure that would come into play 
when a recipient country had identified a requirement and a foreign supplier had been selected.  In the 
Rwandan case, Apotex had undertaken to develop A po-TriAvir before any recipient country had been 
identified.  The approach had therefore not been based on actual demand, but on proposed supply.  While it had taken three-and-a-half years for Apotex  to identify a recipient country and to secure a 
supply contract, only a small amount of that time had been taken up by CAMR procedures.   
193. He said that it was also worth noting that one should not live under the impression that 
Apotex had spent months in discussions with br and-name companies seeking voluntary licences or 
agreement for a compulsory licence.  Apotex ha d initiated these discussions at a time when it could 
not indicate a destination for its product or the volum es that eventually would be shipped.  It had 
therefore not been in a position to apply for a com pulsory licence at that time.  When Rwanda had 
come forward as a potential recipient in July 200 7, all the brand-name companies concerned had 
provided either a voluntary licence or had agreed to  the issuance of a compulsory licence within two 
to three weeks.  Apotex had then applied for a compulsory licence in September 2007, which had 
been granted only two weeks later.  Apotex had not been awarded the supply contract for another 
eight months.  
194. In his view, a range of points deserved further consideration.  Some countries could simply 
not afford essential medicines, no matter how lo w the costs were.  This was recognized by his 
delegation which promoted alternative options, such  as tax incentives for donations, to help address 
this reality.  The health delivery systems in some  developing countries were inadequate in terms of 
well-trained medical staff and infrastructure to deliv er and administer medicines.  Since the Waiver 
had come into existence, a number of international procurement systems had been developed, such as 
the Clinton Foundation, that were key to delivering medicines to people in need.  Furthermore, many 
brand-name companies had charitable programmes by which they donated medicines.  It was also 
possible that the mere existence of the Paragr aph 6 System had a potential positive impact on drug 
prices.  He considered that it was a reality th at the growing capacity of generic pharmaceutical 
industries in developing countries to produce drugs at increasingly lower costs presented a challenge 
for Canadian generic companies to compete.  Fina lly, more awareness raising and capacity building to 
enable health authorities in developing countries to use the Paragraph 6 System could be needed. 
195. In his delegation's view, neither the Paragraph 6 System nor CAMR were a panacea.  They 
could only play a supportive role in the effort to improve access to essential medicines.  Their purpose 
was to ensure that TRIPS rules would not stand in the way of exports of generic medicines to those 
countries in greatest need.  But they could not generate supply.  Areas which would merit further 
discussion included government procurement, safety a nd efficacy of medicines, and dissemination of 
information and capacity building with respect to the Paragraph 6 System. 
196. The representative of Egypt
 said that finding a solution to the difficulties encountered by 
countries with limited or no manufacturing capacity to ensure access to medi cines was critical for 
developing countries, in particular in Africa.  He expressed concerns that the System had not been as 
helpful as expected in addressing this critical public health problem.  Given that the System had only 
been used once and that only a limited number of WTO Members had accepted the Protocol 
Amending the TRIPS Agreement, he wondered whethe r it was providing an effective and expeditious 
solution.  The following questions needed to be addressed:  the administrative and regulatory 
complexity of the system, the lack of apprecia tion for appropriate business methods in supplying 
markets and addressing associated overhead costs, and constraining requireme nts.  He supported the 
proposal that a workshop be organized to address these and other relevant questi ons.  It should include 
all the various stockholders.  He urged those Memb ers which seemed reluctant to join consensus on 
the convening of such a workshop to reconsider thei r position in light of the direct effect on access to 
medicines and ultimately on human rights.  IP/C/M/62 
Page 40  
 
  197. The representative of Cuba
 supported holding a workshop with respect to the operation of and 
the problems associated with the Paragraph 6 System.  This matter had been extensively debated by 
Members at the informal meeting of 12 February 2010.   She suggested that informal consultations be 
held in order to address the way in wh ich the workshop would be conducted.  
198. The representative of Ecuador  agreed with the concerns expressed by India and other 
delegations with respect to the achievement of the objectives under the Paragraph 6 System.  As 
pointed out earlier by Egypt, there was a need for a solution that was both functional and speedy, in 
light of the emerging public health situations in countries with no manufacturing capacity in the 
pharmaceutical sector.  The experience gained so far seemed to indicate that the System was not producing the expected results.  He supported the propo sal that a workshop be held to allow for an 
open-ended and frank discussion with all stakeholde rs, without prejudging a specific outcome.  This 
would help to clarify the reasons why the System was not working.  Consultations should be held by the Chair to prepare such an ev ent.  The results of the worksh op and the situation regarding the 
functioning of the System could be taken up by the TRIPS Council at its next annual review in 
October.  
199. The representative of Indonesia
 shared the concerns expressed by Angola on behalf of the 
LDC Group, Brazil, Egypt and other delegations with  regard to the significant challenges that the 
implementation of the Paragraph 6 System was facing.  The procedures were not easy to follow, in particular as regards the criteria applying to tho se who qualified as an eligible importing Member and 
the conditions to be observed by exporting countri es.  The case of medicines exported from Canada to 
Rwanda under the System had demonstrated its complexity.  Although a compulsory licence had 
finally been issued by Canada, it had taken at le ast three years to complete the process.  The 
Paragraph 6 System was meant to address public hea lth challenges, including emergencies and other 
urgent situations.  Time was therefore a key factor  to be taken into account.  Timely implementation 
and delivery should be a priority since human lives  were at stake.  His delegation supported the 
proposal that a workshop be held as requested by a majority of the Members.  Such a workshop could 
contribute to providing answers to some of the questi ons raised and to exploring possible alternatives.  
It should include representatives from all relevant st akeholders, particularly government agencies, 
international organizations and the civil society.  
200. The representative of Australia
 said that her delegation suppor ted the Paragraph 6 System and 
had been one of the first Members to sign the Protocol Amending the TRIPS Agreement.  The 
explanation presented by Canada of its experiences in  using the System had been particularly useful.  
She called upon other Members to discuss their e xperiences or concerns with the System under the 
agenda item dedicated to this issue, or in an y informal consultations held by the Chair.  
201. The representative of Japan  said that the Paragraph 6 System and the Protocol Amending the 
TRIPS Agreement provided a useful mechanism.  He recognized that some Members had expressed 
concerns about the effectiveness of the System beca use of its limited use and the limited number of 
Members having accepted the Protocol Amending the TR IPS Agreement.  But this should not lead to 
hasty conclusions regarding the System's effec tiveness.  Discussions on the Paragraph 6 System, 
including the complementary role of other mechan isms, should be carried out annually, taking into 
account practical examples.  In this regard, the in formation provided by Canada at the informal 
consultation on 12 February 2010 ha d been productive and constructiv e.  His delegation was open to 
any suggestions regarding the way forward.  Avenue s should be explored in order to strengthen the 
System's annual review by the TRIPS Council so that Members could accura tely assess the situation 
and more effectively utilize the System. 
202. The representative of Switzerland  supported the intervention made  by Canada with regard to 
the negotiating history and the purpose of the Para graph 6 System.  The annual review embedded in 
the Decision of 30 August 2003 offered an appropriate  platform for Members to exchange views in  IP/C/M/62 
 Page 41 
 
 
  the TRIPS Council regarding the System's operation.  A more effective use of the annual review to 
present views and concerns and to share fact-based practical experiences could be encouraged.  Representatives from stakeholders who had been direc tly involved in the export of medicines from 
Canada to Rwanda under the System, particularly from the company Apotex which had supplied the 
medicines to Rwanda, could be invited.  This would provide Members with insight and experience 
and enhance their understanding of the wo rking of this particular case.   
203. While he suggested that some time be set aside  in the TRIPS Council or in dedicated earlier 
informal consultations to prepare the System's next  annual review in October,  he could not support the 
proposed format of an open-ended workshop with the participation of any self-declared stakeholders.  This would not necessarily provide a good forum for a focused and fact-based review, as it risked 
leading to a heated and politicized debate.  His dele gation wished to participate in any consultations 
held by the Chair with interested Members regard ing the preparation of the next annual review, how 
the System could be effectively used, and whet her the Council should meet beforehand to dedicate 
some time to this issue.   
204. The representative of the European Union
 said that his delegation was open to further 
discussions on this issue, either in the TRIPS Counc il or through an informal consultation process.  
Such an exercise was best conducted on the basis of facts and experiences presented by Members.  In 
particular, it would be useful to understand why on ly one developing country had used the System.   
205. The representative of China  supported the proposal that a workshop be held under the 
auspices of the TRIPS Council.  She said that a ll TRIPS Council Members attached great importance 
to this issue which was closely related to human rights and human lives, both of which would take 
precedence over any product or rights associated th ereto.  The issue concerned was technically 
complicated, as had been demonstrated by Canada  in its presentation on the export of generic 
medicines to Rwanda under the Paragraph 6 System at the informal consultations on 
12 February 2010.  The use of the System in th is case had brought up many technical issues which 
needed to be addressed in the process of implemen tation.  A detailed study of the Canada-Rwanda 
case would therefore be extremely helpful for all Members to reach a better understanding of what 
happened and to further discussions on the Paragraph 6 System.  She thanked the United States for its 
open attitude towards consultations to  be held by the Chair and towards improving the review process 
under paragraph 8 of the System.  Without prej udging the outcome, a fact-based workshop could 
greatly facilitate the next annual review.  It s hould be organized before the Council's meeting in 
October so that it could assist Members in preparing for the annual review.  
206. The representative of Angola  supported the proposal made by China regarding the dates of 
the workshop.  In reaction to the statement made by Switzerland, he said that the proposed workshop 
should not be limited to experiences related to the Canada-Rwanda case.  It would be equally 
important to include experiences in other cases.  He called upon other Members to approach the suggested workshop with an open mind, as it would o ffer a platform to express views and to defend 
positions.   
207. The representative of New Zealand
 recalled that in the past a request for consultations had 
been made by delegations to share their experiences,  but that this had not yet taken place.  At the 
informal consultations on 12 February 2010, Cana da was the only Member who came prepared to 
share its experience.  Instead of focusing on where and in what format to hold further consultations, 
he strongly encouraged that emphasis be put on th e exchange of practical experiences of other 
Members.  They should come to the meeting prep ared to do so, which would set the ground for a 
substantive discussion of the issues during the System 's next annual review at the Council's meeting in 
October.  IP/C/M/62 
Page 42  
 
  208. The representative of India
 sought clarification on whether rules of procedure prohibited 
Members from taking a decision under the agenda item "Other Business" and questioned whether this 
was the real reason which prevented Members from moving on.  He said that Korea had raised a valid point, i.e. the need to discuss details, and had proposed a reasonable way forward.  A fact-based 
discussion had to involve all relevant stakeholders.  Without prejudging the outcome, the output of the 
workshop could feed into a more substantive di scussion in the Council's meeting in October.  
Acknowledging that the Council had to take decisions by consensus, he pointed out that there was a clear recommendation from the African Group, th e LDC Group, as well as a number of other 
developing countries to hold a dedicated workshop.  
209. The representative of Brazil
 clarified that her delegation's experience in Mozambique did not 
fall under the Paragraph 6 System.  It was a different process, aiming at establishing local 
manufacturing capacity.  Her delegation was neverthe less ready to share any experience in any form 
decided upon by the Council. 
210. The representative of Chinese Taipei  asked whether the consultations, if continued by the 
incoming Chair, would be open-ended.  If they were restricted to interested Members, his delegation 
would like to participate in any such consultations.  
211. The Chairperson  recalled that, when the decision was taken at the Council's meeting in 
October 2009 to hold informal consultations, it w as based on the clear understanding that this was a 
one-off event which would not prejudge the outcome.  She noted that some delegations had said that 
they felt that more issues, including practical expe riences, could have been discussed.  She said that 
no decision regarding the appropriate way forward c ould be taken at this stage, as some Members 
wished to proceed on the basis of a workshop, whereas others preferred to look at possible ways to 
improve the current system.  She undertook to ask the incoming Chair to get in touch with interested delegations in order to explore how best to proceed on this matter. 
212. The Council took note
 of the statements made. 
(iii) Public health dimension of the TRIPS Agreement 
213. The representative of India  recalled that, at the Council's three previous meetings, his 
delegation had shared details of th e serious impediments to access to medicines caused by seizures of 
medicines at EU ports.  Those deta ils referred to 17 seizures by the Dutch authorities in the year 2008, 
a seizure in Frankfurt in May 2009 and another seizu re in Paris in October 2009.  In all cases, the 
consignments had originated from developing coun tries and had mostly been destined for other 
developing countries, including Brazil, Peru, Co lombia, Ecuador, Mexico, Nigeria, Venezuela and 
Vanuatu.  EU customs authorities had acted on the basis of Council Regulation (EC) No. 1383/2003.  
In the absence of concrete steps taken by the EU to address this problem, his delegation wished to 
update Members on developments since the Council's last meeting.  
214. His Government had continued its bilateral effo rts with the European Union at the level of 
Ministers, senior officials in capitals and Indi a's Mission to the EU in Brussels.  The Indian 
Commerce Secretary and the Ambassador to the EU  had formally sought details of the seizures 
including (i) the duration of the seizures;  (ii) th e names of the drugs, expor ters and importers;  and 
(iii) details of the right holders whose rights ha d allegedly been infringed.  Quoting its Customs 
authorities, the EU had claimed that 34.6 per cent of counterfeit medicines had originated in India 
during a certain calendar year.  His delegation took such allegations seriously but had not received 
any further details from the EU despite formal requests made in this regard.  Calls for a review of the 
EU Council Regulation in question had been echoe d by other developing countries, as well as 
European and Dutch parliamentarians, and civil soci ety organizations engaged in public health-related 
work in the least developed parts of the world.   IP/C/M/62 
 Page 43 
 
 
  215. His delegation recognized some of the steps ta ken by he EU, which included an "Explanatory 
Note" of July 2009 addressed to its member States on the application of the Council Regulation (EC) 
No 1383/2003.  Disregarding the permissiveness of th e Regulation itself, this note had merely shifted 
the blame to member States for the way in which th ey were applying their national laws and in which 
national courts were interpreting them.  The review  of the Council Regulation was a routine exercise 
and had started in September 2008 before the issue of  drug seizures had been raised in the WTO.  In 
his view, the process was not aimed at addressing issues emerging from such seizures.  The scope of the review excluded the Regulation's compatib ility with WTO provisions, including GATT and 
TRIPS provisions, as well as the spirit of the Doha Declaration.  His delegation was also closely following the work of the newly established Work ing Group on Pharmaceuticals in the European 
Parliament, chaired by MEP David Martin.  
216. The representative of India considered that  the action taken on the ground by the EU 
contradicted its repeatedly stated commitment to  the Doha Declaration and access to affordable 
medicines and various efforts undertaken to that ex tent.  The drug seizures provided a test for this 
commitment.  He did not see any concrete measure s, including any signs that the Council Regulation 
be reviewed, in spite of its inc onsistency with the provisions of GATT, the TRIPS Agreement and the 
spirit of the Doha Declaration on the TRIPS Agreement and Public Health.  
217. Due to its systemic implications, the issue of drug seizures was not a pure trade issue and had 
repercussions in other sectors too, as had been evid enced by a recent seizure of mobile phones in an 
EU member State.  Those seizures represented "TRIPS-plus" enforcement measures which ignored 
Article 1.1 of the TRIPS Agreement, according to  which more extensive protection could only be 
granted "provided that such protection does not cont ravene the provisions of this Agreement".  Such 
higher levels of protection would disturb the bala nce enshrined in the Agreement, including in the 
Preamble, the Objectives and Principles in Artic les 7 and 8, as well as Article 41.1 of the TRIPS 
Agreement, which provided that all TRIPS enforc ement procedures "shall be applied in such a 
manner as to avoid the creation of barriers to leg itimate trade and to provide for safeguards against 
their abuse".  An obvious strategy of establishing "TRIPS-plus" enforcement norms was evidenced by 
the deliberate confusion of quality issues with  intellectual property rights in international 
organizations such as WHO, as well as by certain "TRIPS-plus" initiatives in WIPO, WCO and UPU.  Such "TRIPS-plus" elements were also a regul ar feature in FTA negotiations and those on the 
so-called Anti-Counterfeiting Trade Agreement (ACT A) which was being negotiated in secrecy and 
with the exclusion of a vast majority of c ountries, including developing countries and LDCs. 
218. He explained that generic drugs formed th e backbone of public health programmes in 
developing countries.  Targeting of legitimate gene ric medicines would have deleterious effects on 
access to affordable and efficacious medicines and public health budgets.  Donations from some 
developed countries to the poor popula tions of the world could not fill the gaps in a sustainable way. 
219. He noted that questions had been raised in the Council on the sub-optimal use of the 
Paragraph 6 System.  The drug seizures in question cr eated a further impediment to the working of the 
System, as those drugs transiting through the EU would most likely violate the IPRs in the country of transit and could consequently be seized under Council Regulation (EC) No. 1383/2003. 
220. His delegation attached the highest level of im portance to the protection and enforcement of 
IPRs in accordance with the TRIPS Agreement and the Doha Declaration on the TRIPS Agreement and Public Health.  But IPR pr otection and enforcement could not  breach TRIPS or GATT provisions, 
nor could it override the fundamental tenets of inte rnational humanitarian law, the right of access to 
medicines and the balance of rights and obligations  in the TRIPS Agreement.  The widespread and 
repeated seizures under Council Regulation (EC) No. 1383/2003 had an adverse systemic impact on 
the principle of universal access to medicines, na tional public health budgets, legitimate trade in 
generic medicines, South–South trade and the use of TRIPS flexibilities.  It seriously impaired the IP/C/M/62 
Page 44  
 
  efforts of civil society organizations engaged in providing medicines and improving public health in 
the least developed parts of the world.  As long as the Damocles' sword of the Council Regulation was 
hanging over their heads, no comfort could be taken from the fact that the frequency of seizures had 
been reduced or that the matter was being looked  into.  He called upon the European Union to 
urgently review the Regulation and to bring it in to conformity with WTO provisions, as well as to 
respond to his delegation's formal requests a nd to share information on the seizures.  
221. The representative of Brazil
 associated himself with the statement made by India.  His 
delegation had repeatedly voiced its concerns over the seizure of generic drugs in transit by EU 
member States based on allegations of patent infri ngement, particularly the seizure of a shipment 
bound for Brazil of Losartan Potassium, a medicine used in the treatment of high blood pressure,  by 
Dutch customs in December 2008.   
222. Since the Council's last meeting, a few developm ents had taken place.  On a positive note, the 
European Parliament had set up a Working Group on Innovation, Access to Medicines and Poverty-
Related Diseases.  The working group had been la unched on 27 January 2010 an d was co-chaired by a 
small coalition of European deputies who were sensitive to the issue of  access to affordable 
medicines.  It relied on technical support by so me NGOs, including Médicins Sans Frontières, and 
global health advocates.  The MEPs had made refere nce to a few priority matters, one of which was 
the need to review the operation of Council Regulation (EC) No. 1383/2003, already under review by the Commission itself.  They had announced that th eir efforts would concentrate on making the use of 
the European legislation less conducive to  potential abuse by patent holders.   
223. He recalled that, at the Council's last mee ting, his delegation ha d reported on contacts 
between representatives of the European Commission and his own country, both in Brussels and 
Geneva, which had not led to any progress in modify ing the most controversial elements of the said 
EU Regulation, especially regarding the fiction of manufacturing.  As the situation remained 
unchanged, the possibility of new seizures was s till a matter of concern for his delegation.  
224. He referred the Council to Professor Frederick Abbott's paper on the "Seizure of generic 
pharmaceuticals in transit based on allegation of patent  infringement – a threat to international trade 
and development and public welfar e", published in WIPO's journal.  He quoted the following passage 
from the paper:  "Imagine for example, a German  computer software firm SAP sought to shop 
programme discs from Hyderabad to Bogotá via Mi ami, and US customs seize and detain the 
programme discs because of an allegation of patent infringement by IBM based on a US software patent.  Since the European Patent Office does not grant software patents, IBM presumably does not 
have protection in Europe.  Would the European Un ion consider this illegitimate patent infringement 
action?"  
225. The representative of Argentina
 shared Brazil's and India's concerns regarding the seizure of 
generic drugs in transit.  When decisions were take n in such cases, they should take into account the 
need to provide access to me dicines in developing and least developed countries. 
226. The representative of Egypt  said that his delegation was concerned about the increasing 
number of instances relating to the enforcement of IPRs that negatively affected public health in 
developing countries.  Those had occurred in a manne r that distorted and ran counter to the TRIPS 
Agreement.  They were symptomatic of the broa der push to instil enforcement provisions globally 
which went beyond those commensurate with the re quirements in the TRIPS Agreement and stood 
against developing countries' interest.  He viewed re cent incidents as part of a wider drive, also at the 
IGO level, to introduce IPR enforcement measures th at ran counter to the 2001 Doha Declaration on 
the TRIPS Agreement and Public Health.  He was concerned that provisions on IPR enforcement in 
certain plurilateral and bilateral initiatives, in cluding in some economic partnership agreements, 
would hinder access to medicines.  IP/C/M/62 
 Page 45 
 
 
  227. The representative of Ecuador , supporting the statements made by Brazil, India, Egypt and 
Argentina, voiced concern that there had been no  genuine exchange of information in respect of 
solutions regarding the issue of generic medicines in  transit.  As India had indicated, his delegation 
was one of the countries affected by the seizures of ge neric medicines in transit by EU customs.  This 
type of measure was contrary to the established rights in the TRIPS Agreement and the GATT.  He 
asked the EU for additional clarification and cautione d against negotiations in other fora that could 
have a negative impact on trade in  legitimate generic medicines. 
228. The representative of China  shared the concerns expressed by India and Brazil and supported 
their statements. 
229. The representative of the European Union  said that, although this item was being raised for 
already the fourth time in the Council, there was nothing new to discuss.  Since India had brought up 
the well-known cases of detention of generic medici nes in Frankfurt and Paris, his delegation had 
investigated the French case.  Th e investigation confirmed that the French customs had detained more 
than a million tablets of the medicine.  Those consi gnments had been put back on the market after the 
right holder had confirmed that it had no intention of pursuing the case, not least because the 
European Commission had drawn the attention of  the pharmaceutical industry and the customs 
authorities to the issue of generic medicines in tran sit.  He wondered whether India or Brazil wanted 
the customs to treat every shipment of medicines as  if it were a diplomatic bag.  The quantity of 
infringing drugs in circulation would justify c ontinuous surveillance by customs authorities.   
230. Since the French incident, referred to by India at the Council's meeting in October 2009, there 
had been no further cases.  The reference to the "S word of Damocles" was therefore unfounded.  He 
was surprised that, even after meetings at the am bassadorial level in Brussels at which the measures 
taken by the European Commission together with the EU member States' customs authorities had 
been explained, India and Brazil continued to claim that nothing had been done and that they had not 
been informed.   
231. He said that this matter had been considered a nd resolved in cooperation with right holders 
and customs authorities.  A review of the Council Regulation (EC) No. 1383/2003 was under way.  
His delegation was doing considerable work to comb at infringing medicines, originating in part in 
China.  He also referred to recent st atistics elaborated from data provided, inter alia , by Médecins 
sans Frontières, which showed that more than 40 per cent of the drugs circulating in India were 
substandard. 
232. The Council took note  of the statements made.  
O. ELECTION OF THE CHAIRPERSON  
233. The Chairperson  recalled that, at its meeting of 22 February 2010, the General Council had 
taken note of the consensus on a slate of names of chairpersons for WTO bodies.  On the basis of the 
understanding reached, she proposed that the Counc il for TRIPS elect Mr. Martin Glass from Hong 
Kong, China as its Chairperson for the coming year by acclamation. 
234. The Council so agreed .  
 
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