RESTRICTED  WORLD TRADE  
ORGANIZATION  IP/C/M/65 
10 May 2011 
 (11-2394) 
Council for Trade-Related Aspects of  
Intellectual Property Rights  
 
 
 
MINUTES OF MEETING 
 
Held in the Centre William Rappard on 1 March 2011  
 
Chairperson:  Mr. Martin Glass (Hong Kong, China) 
 
  The present document contains the record of the discussion which took place during the 
Council for TRIPS meeting held on 1 March 2011. 
 
Subjects discussed
 Page nos.  
A. N OTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT .........................................................2 
B. R EVIEWS OF NATIONAL IMPLEMENTING LEGISLATION ..............................................................3 
C. R EVIEW OF THE PROVISIONS OF ARTICLE 27.3( B)......................................................................4 
D. R ELATIONSHIP BETWEEN THE TRIPS  AGREEMENT AND THE CONVENTION ON 
BIOLOGICAL DIVERSITY .............................................................................................................4 
E. P ROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE ...................................................4 
F. F OLLOW -UP TO THE REVIEW UNDER PARAGRAPH 8 OF THE DECISION ON THE 
IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON THE TRIPS  
AGREEMENT AND PUBLIC HEALTH ...........................................................................................21 
G. N ON-VIOLATION AND SITUATION COMPLAINTS ......................................................................36 
H. R EVIEW OF THE IMPLEMENTATION OF THE AGREEMENT UNDER ARTICLE 71.1 ......................37 
I. R EVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON 
GEOGRAPHICAL INDICATIONS UNDER ARTICLE 24.2 ...............................................................38 
J. F OLLOW -UP TO THE EIGHTH ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE 
DECISION ON THE IMPLEMENTATION OF ARTICLE 66.2  OF THE TRIPS  AGREEMENT ...............38 
K. T ECHNICAL COOPERATION AND CAPACITY BUILDING .............................................................39 
L. L ETTER FROM THE CHAIR OF THE GENERAL COUNCIL CONCERNING WAYS TO 
IMPROVE THE TIMELINESS AND COMPLETENESS OF NOTIFICATIONS AND OTHER 
INFORMATION FLOWS ...............................................................................................................40 
M. I NFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO ..............................41 
N. O BSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS ...............41 
O. O THER BUSINESS .......................................................................................................................43 
P. E LECTION OF THE CHAIRPERSON ..............................................................................................43 
 
 
 
  IP/C/M/65 
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  A. N
OTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT  
1. The Chairman said that, since its meeting in October 2010, 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: 
• China had notified its revised Patent Law, which inter alia  implemented the WTO Decision 
on the "Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and 
Public Health", providing the legal basis for China to act as an exporting Member, as well as 
an importing Member, where a na tional emergency or any extraordinary state of affairs 
occurred, or public interests so required.  This  notification had been received just after the 
Council's previous meeting and, as had been agr eed by the Council at that meeting, reference 
to it had been added to the Council's report to  the General Council on its review of Paragraph 
6 System;1 
• Chinese Taipei had supplemented its list of "o ther laws and regulations" with information 
concerning its Patent Attorney Act; 
• Israel had notified laws on appellations of or igin and geographical indications, on copyright 
and on patents, as well as ordina nces on designs and trademarks; 
• Barbados haw notified amendments to its copyri ght act and related regul ations, an Intellectual 
Property (Miscellaneous Provisions) Act, and a Pa tents (Priority Protection) Order Act;  and 
• Finland had notified amendments to its laws and regulations on copyright, trademarks, 
collective marks, geographical indications, designs, patents, plant variety rights, utility 
models, layout-designs of integrated circuits, protection of undisclosed information, and on 
the openness of government activities.  In additi on, it had notified legislation relating to the 
prevention of the abuse of intellectual property rights, civil judicial procedures and remedies, provisional judicial measures, special requirements related to border measures, criminal procedures and penalties, administrative pr ocedures and remedies, and other laws. 
These notifications were being circulated in the IP/N/1- series of documents. 
2. The Chairman urged those Members whose initia l notifications remained incomplete to 
submit the outstanding material without delay.  He also reminded other Members of their obligation to 
notify any subsequent amendments of their laws a nd regulations without delay after their entry into 
force.  He in particular reminded those Members who had made any changes to their laws and/or 
regulations to implement the Decision on TRIPS and public health and 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, he said that, since the Council's meeting in October, 
Lesotho had notified its contact point.  In addition, updates to contact points notified earlier had been received from the European Union and Latvia. 
4. The Council took note
 of the information provided. 
                                                      
1 Document IP/C/57 and Corr.1.  IP/C/M/65 
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  B. REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION  
5. The Chairman  said that, as regards the reviews of na tional implementing legislation that had 
been initiated at the Council's meetings since April 2001, there were three reviews that still remained 
on the Council's agenda.  These reviews concerned Cuba ;  Fiji;  and Saint Kitts and Nevis.  He urged 
the delegations concerned to provide  the outstanding material as soon as possible, so as to allow the 
Council to complete the follow-up to these reviews. 
6. Turning to the arrangements for the review of  Maldives' implementing legislation, he said 
that, at the meeting of the General Council on 14 December 2010, Maldives had informed Members 
that it would graduate from the United Nati on's list of least developed countries as from 
1 January 2011, as decided by the United Nations General Assembly in 2005.   
7. The representative of Maldives  said that Maldives was no longer an LDC as of 
1 January 2011 and a beneficiary of special and differential treatment accorded to the LDCs.  
Therefore, she wished to inform the Council of th e status of its on-going work towards compliance 
with TRIPS obligations as a non-LDC. 
8. The IP regime of Maldives was still in the pr ocess of development, although IP protection had 
been an explicit policy goal of the Government in th e past few years.  Maldives had joined WIPO in 
2004 for the purpose of developing an effective IP regime.  Since then, various technical assistance programmes had been sought from WIPO, including technical advice on the establishment of a 
modern Intellectual Property Office in January 2004.  In advising the Government, WIPO had recommended to formulate a national IP strategy based on a careful identification and selection of intellectual property policy options that would best serve the social and economic development 
needs of Maldives.  However, like in many other developing countries, IP remained a novel field 
for policy makers, the business community and for the general public.  Maldives needed sufficient 
analytical capacity and perhaps ex amples of best practices to help its policy makers to discuss IP 
issues and link related opportunities to developmental policies. 
9. Notwithstanding these capacity constraints, Maldives had p assed a law governing copyright 
and related rights in October 2010.  The Law No 23/2010 had been enacted to establish the standards 
for copyright and related rights required by the TRIPS Agreement.  Furthermore, an Industrial 
Property Act had been drafted in English.  The I ndustrial Property Act was being translated into 
Maldives' official language Dhivehi for debate in  Parliament.  The Copyright Law (Law 23/2010) was 
presently only available in Dhivehi and was being translated back to English, primarily for the 
purpose of notification to the WTO.  The law was available at http://trade.gov.mv. 
10. WIPO's technical assistance, especially in drafti ng the laws, was of immense value.  Maldives 
and WIPO had agreed on a work programme, the sp ecific aim of which was to fully comply with 
TRIPS obligations.  She expressed her dele gation's gratitude for WIPO's support. 
11. As she had also mentioned at the Genera l Council's meeting in December 2010, the 
graduation from LDC status had brought new challeng es, which Maldives was dealing with in spite of 
its vulnerability and lack of capacity.  Moreove r, Maldives had been undergoing a democratic 
transition for the past few years that had include d the formulation of a new Constitution in 2008 and 
relevant laws.  The on-going work on the legislative agenda had put a heavy burden on Parliament to 
expedite the laws necessary for the compliance w ith Maldives' international legal obligations.  
Nonetheless, Maldives remained committed to its TRIPS obligations and willing to work with 
relevant organizations and its deve lopment partners, including with WIPO, to fulfil the notification 
and review requirements.  She appealed to the understanding of the membership in relation to 
Maldives' initial notification. IP/C/M/65 
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  12. The Chairman
 suggested that the Council request the S ecretariat to remain in contact with the 
delegation of Maldives concerning TRIPS notificati on and review procedures, and that the Council 
come back to the arrangements for the review of Maldives' implementing legislation later this year, 
once the Council had received the necessary not ifications of laws and regulations. 
13. The Council took note  of the statements made and so agreed . 
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  
14. The Chairman  suggested that the Council continue it s past practice of addressing the three 
agenda items together on the basis of the contributions by Members.   
15. He recalled that, at the Council's meeting in  October 2010, India had suggested that the 
Council invite the CBD Secretariat to brief the Council on the outcome of the tenth meeting of the Conference of the Parties to the Convention on Biol ogical Diversity (COP10) held in Nagoya, Japan 
in October 2010.  In the context of his consulta tions with a number of delegations on the pending 
requests for observer status by intergovernmental organizations, Members had not reached agreement 
on that suggestion.  However, in the course of those discussions, Japan had expressed its willingness 
to make a presentation, in its capacity as the host co untry of COP10, on the outcome of the meeting.  
He suggested that the Council offer the floor to Japan to make the presentation before opening the 
floor for discussion.  He also informed the Council th at Bolivia wished to introduce a room document 
on the review of Article 27.3(b) of the TRIPS Agreement.
2   
16. The representative of Japan  said that COP10 had been held from 18 to 29 October 2010 at the 
Nagoya Conference Centre and that more than 13,0 00 participants had atte nded, including delegates 
from member countries, representatives of indigenous peoples and civil societies.  The conference had 
been accompanied by about 350 side-events, among which the Interactive Fair for Biodiversity had 
attracted more 11,800 participants.  One of the major outcomes of COP10 was the Nagoya Protocol 
on Access to Genetic Resources and the Fair and E quitable Sharing of Benefits Arising from their 
Utilization (the Nagoya Protocol) and the Stra tegic Plan for Biodiversity 2011-2020.   
17. He said that the CBD had started its work  on access and benefit sharing in 2000 by 
establishing an Ad-Hoc  Open-Ended Working Group on Access and Benefit Sharing.  The Eighth 
Meeting of the Conference of the Parties to the Convention on Biological Diversity had instructed the Working Group to complete its work with regard  to the international access and benefit-sharing 
regime at the ear1iest possible time before COP10.  That target had successfully been achieved by the 
adoption of the Nagoya Protocol at COP10 after nine meetings of the Working Group.   
18. Under the Nagoya Protocol, each Party should  take concrete measures to implement 
effectively the third objective of the CBD, i.e. the fair and equitable sharing of the benefits arising 
from the utilization of genetic resources, and other relevant provisions.  The Nagoya Protocol had 
been open for signature by Parties since February 2011 and would enter into force on the 90
th day 
after the date of deposit of the 50th instrument of ratification, acceptance, approval or accession by 
Parties.  
                                                      
2 Subsequently circulated as document IP/C/W/554.  IP/C/M/65 
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  19. He said that the Nagoya Protocol would fac ilitate access to genetic resources and promote 
their utilization because of transparency, clarity a nd legal certainty of access and benefit-sharing 
legislation in providing countries.  The Protocol wo uld contribute to the conservation and sustainable 
use of biological diversity through facilitating fair and equitable benefit sharing.  The Protocol would 
enable and strengthen the compliance with domes tic access and benefit-sharing legislation or 
regulatory requirements through the collection of info rmation related to prior informed consent and 
mutually agreed terms at designated checkpoints.  The Protocol would enable fair and equitable 
sharing of benefits arising from the utilization of traditional knowledge associated with genetic 
resources according to mutually agreed terms w ith indigenous and local communities holding such 
knowledge, thereby contributing to respect, pr eservation and maintenance of their knowledge. 
20. Article 6 of the Nagoya Protocol obliged each Party to take measures to improve access to 
genetic resources, including to provide for transparency and clarity of domestic access and benefit-sharing legislation or regulatory requirements, information on how to apply for prior informed 
consent, a written prior informed consent decision, fo r the issuance of a permit or its equivalent as 
evidence of a decision to grant prio r informed consent.  Article 5 c onfirmed the principle of Article 15 
of the CBD that the monetary and non-monetary benefits arising from the utilization of genetic 
resources shall be shared in a fair and equitable ma nner and that such sharing shall be upon mutually 
agreed terms.   
21. Article 15 of the Protocol provided that each Party shall take appropriate, effective and 
proportionate measures to provide that genetic r esources utilized within its jurisdiction had been 
accessed in accordance with prior informed consent and that mutually agreed terms had been 
established.  Article 17 stipulated the designation of  one or more checkpoints to collect information 
related to prior informed consent and mutually agr eed terms as one of the measures to be taken by 
parties to support compliance.  Article 17 also provi ded that the information related to prior informed 
consent, the source of genetic resources, the esta blishment of mutually agreed terms, and the 
utilization of genetic resources would be provided to  the Party providing prior informed consent and 
to the Access and Benefit-sharing Clearing-Hou se, as appropriate, and that checkpoints should be 
relevant to the collection of  relevant information at, inter alia , any stage of research, development, 
innovation, pre-commercialization or commercializa tion.  Those provisions provided effective and 
flexible measures to ensure each  party's compliance with the CBD while taking into account their own 
national policies and other situations.   
22. He said that the Nagoya Protocol had several  provisions related to traditional knowledge 
associated with genetic resources.  For example, Ar ticles 5, 7 and 12 provided that each Party shall 
take measures, as appropriate, in order that the benefits arising from the utilization of traditional 
knowledge associated with genetic resources were  shared in a fair and equitable manner upon 
mutually agreed terms. There were provisi ons related to access for non-commercial research 
purposes, cases of emergencies and the relationship w ith international agreements and instruments.  
Article 10 provided for global mu ltilateral benefit-sharing mechanism to address the sharing of 
benefits derived from the utilization of genetic res ources that occurred in transboundary situations or 
for which it was not possible to obtain prior informed consent.  There were also provisions related to 
the evaluation of its effectiveness. 
23. In conclusion, he said that constructive solu tions had been reached on three contentious 
issues, i.e. derivatives, compliance and retroactive app lication due to efforts made by the participants.  
It was the responsibility of each Party to cooperate  with each other for the successful implementation 
of the Nagoya Protocol.  
24. The representative of the Plurinational State of Bolivia  said that, as stated in 
document IP/C/W/545, the review of Article 27.3(b)  was part of the mandate of the Doha Work 
Programme under paragraph 19 of the Ministerial Declar ation.  It was an implementation-related issue IP/C/M/65 
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  under paragraph 12 of the Ministerial Declaration,  which mentioned the adoption of a Decision to 
address implementation problems (WT/MIN(01)/17) and stated that "negotiations on outstanding 
implementation issues shall be an integral part of the Work Programme". 
25. In the 15 years since the adoption of Article 27.3(b), WTO Members had witnessed a race to 
patent life forms and parts thereof, a trend that was extremely worrying given its ethical and moral 
implications and its adverse eff ects in areas of major importance to developing countries, such as 
agriculture, food, climate change and health.   
26. Article 27.3(b) established Members' obligatio n to grant patents for micro-organisms and 
microbiological and non-biological processes.  That provision also allowed Members to award patents for plants, animals and biological processes, t hus promoting a new phase in which capitalism 
expanded into nature in a way that had never been seen before, and which amounted to the 
privatization of life itself.  Consequently, the last 15 years had seen a proliferation of patents and patent applications concerning a wide range of life forms, including human life itself or parts thereof, 
such as proteins, genes, gene sequences, cells, cell lines and tissue. 
27. Many reports had documented that phenomenon.  In 1999, 918 patents had been awarded for 
rice, maize, soya and sorghum seed; most of those had gone to just six multinational corporations.  In 
2000, an investigation had revealed that patents ha d been pending or had been granted on more than 
500,000 genes or partial gene seque nces of living organisms.  Of those, over 9,000 patents involved 
161,195 whole or partial human genes.  In 2005, a study had shown that nearly 20 per cent of all 
human genes had been patented in the United St ates, in other words 4,000 of almost 24,000 human 
genes. 
28. The patentability of life forms promoted by Artic le 27.3(b) raised serious ethical and moral 
concerns for many cultures and populations around the world.  Those concerns had been raised on a 
number of occasions by groups of developing coun tries and international bodies.  For example, 
according to the 1999 United Nations Human Development Report, the current patent system was leading to "a silent theft of centuries of knowledge from developing to  developed countries". 
29. The extension of patents to life forms was based  on the idea that life forms and parts thereof 
were human inventions and, as such, patentable.  That concept promoted the commercialization of life 
and nature, reducing their value to nothing more th an a mercantile and commercial vision.  Such a 
vision was far removed from the culture, values and be liefs of many peoples and societies, for whom 
life was something sacred and special that could not be considered a human invention or treated as 
just another commodity.  Above all, its u se should not be monopolized by a select few. 
30. A system that treated human beings and their vital characteristics as merchandise reduced the 
value of life to an economic valu e and consigned humanity to a lowe r level of moral development.  
Humanity and human progress should not be measu red only in economic and commercial terms, but 
rather in terms of human values and dignity. 
31. A serious consequence of Article 27.3(b) had b een the concentration of patents on life forms 
in the private sector, most notably in the hands of a few multinational corporat ions based in developed 
countries.  The situation was especially worrying in the seed sector, where 67 per cent of the market 
was controlled by the ten largest corporations, and around 40 per cent by only two of them.  That 
situation could also be seen in other areas of biotech nology and should be taken very seriously indeed. 
32. Patents on life forms also had a negative impa ct in terms of access.  Some developing 
countries were concerned that the rights afforded to  patent holders could restrict the use of their 
genetic resources, as well as the use of those resources by indigenous peoples.  Patents on life forms  IP/C/M/65 
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  and parts thereof could also adversely affect the exports and commercial activities of developing 
countries. 
33. The granting of patents on life forms and parts th ereof was often justified on the basis that it 
encouraged innovation and promoted research.  Howe ver, there was increasi ng evidence that that 
premise was not entirely true,  and that dominant and concentrative model also frustrated innovation, 
stifled research and had a negative impact on scien tific progress, something already highlighted by 
numerous academics, experts and even Nobel Prize winners in a broad range of scientific fields. 
34. The effects of allowing the patenting of life form s and parts thereof were particularly felt in 
the area of agriculture and food due to the unpreceden ted control of the food chain by a small number 
of corporations.  The combination of the concentrati on of market control with the ability to patent had 
paved the way for a comprehensive takeover of gene tic resources, seeds and by-products by certain 
corporations, which had led to a greater concentrat ion of power and, in turn, ever increasing food 
prices, the inhibition of agricultural innovation an d the undermining of farmers' rights.  That 
constituted an assault on the foundations of age-old traditional farming practic es and undermined one 
of the farmers' oldest rights, which was to save, harvest and replant seeds. 
35. The negative impact of biological material patent s in the area of food had been condemned on 
a number of occasions.  For instance, the UN Special Rapporteur on the right to food had informed the General Assembly that "the expansion of intell ectual property rights can constitute an obstacle to 
the adoption of policies that encourage the mainte nance of agrobiodiversity and reliance on farmers' 
varieties.  Intellectual property rights reward a nd encourage standardization and homogeneity, when 
what should be rewarded is agrobiodiversity, particul arly in the face of the emerging threat of climate 
change […].  In addition, intellectual property ri ghts […] can constitute a direct impediment to 
innovation by farmers".  Another noteworthy factor was that the companies concerned were starting 
to profit from one of the most dangerous threats to humanity, climate change.  Several corporations 
had joined the race to patent plants and parts thereof that could represent strategic resources for 
mankind in the future. 
36. In 2008, a report by the ETC Group had revealed that some 532 patents had been requested 
by or granted to corporations for plants and genes that were resistant to climate change (otherwise 
known as "climate ready" due to their resistance to drought, floods and frost).  Although the historical 
responsibility for climate change lay with developed countries, it could be anticipated that such action 
might lead to developing countri es being asked to pay for access to resources that, in many cases, they 
themselves had developed and that were critical for combating climate change. 
37. The public health consequences of allowing the pa tenting of life forms and parts thereof could 
also be very severe.  Such patents could have a negative effect on innovation in the sector, impede 
access to relevant technologies a nd hamper access to medicines, va ccines and essential treatment for 
those unable to pay for them. 
38. That new phase of capitalism focused on paten ting and privatizing life.  There was economic 
greed to patent life.  And yet the patenting of  biodiversity, seeds and related medicines posed a 
significant threat.  The process led to a prolif eration of laws and policies under which life was 
considered a patentable material, whereas in the past  it had been unthinkable to treat life and any part 
of it as an object or something that could be patented. 
39. In conclusion, he emphasized that the patenti ng of life forms was simply unacceptable.  The 
patenting of life forms posed a serious danger to  all mankind, but in particular to developing 
countries.  The control of life forms and parts thereo f lay in the hands of a few multinationals based in 
developed countries.  Such corporations might even tually be allowed to exercise a monopoly over the 
use of those life forms and parts thereof.  That s ituation was critical for developing countries, for IP/C/M/65 
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  which important decisions relating to food, health  and climate change would be resolved in the 
interests of maximizing profits rather than the we ll-being of mankind.  Patents on life forms and parts 
thereof threatened the traditional practices of indi genous farmers and peoples,  as well as the exports 
of developing countries.  The costs of such a system  exceeded the benefits.  That problem affected all 
of mankind and required an international solution.  Bolivia therefore proposed that Article 27.3(b) be 
amended to prohibit the patenting of all life forms a nd parts thereof.  In the view of his delegation, 
that was an essential part of the Doha Developmen t Round mandate and the best contribution that the 
WTO could make to achieve the development objectives. 
40. The representative of Ecuador
 said that the Bolivian room document reaffirmed the need for 
in-depth discussions on the prevention of biopiracy  and misappropriation and that the Council should 
consider and debate that document.   
41. The representative of China  said that, given the complexity of the issue of the patenting of life 
forms, the Council should further study its impact and come up with tangible solutions in the future.   
42. She thanked the delegation of Japan for its  presentation on the Nagoya Protocol, but 
expressed her disappointment that the CBD Secretaria t was not able to make such a presentation as 
they had done at WIPO and the WHO.   
43. She said that Articles 15 and 16 of the Nagoya Pr otocol provided that each Party shall take 
appropriate, effective and proportiona te legislative, administrative or policy measures to provide that 
genetic resources and associated traditional knowle dge utilized within its jurisdiction had been 
accessed in accordance with prior informed consent and that mutually agreed terms had been 
established as required by domestic access and benefit- sharing legislation or regulatory requirements 
of the other party.  Parties shall, as far as possibl e, and as appropriate, cooperate in cases of alleged 
violation of domestic access and benefit-sharing legislation or regulatory requirements.   
44. Given that patents were important in the u tilization of genetic resources and associated 
traditional knowledge, WTO Members should take a ppropriate and effective measures in patent 
applications to avoid misappropriation.  According to the Doha Declaration, the review of Article 
27.3(b) should include the examination of relati onship between the TRIPS Agreement and the CBD.  
The TRIPS Agreement, the CBD and the Nagoya Pr otocol should operate in a mutually supportive 
manner.  Mandatory disclosure requirements would improve the transparency of the utilization of 
genetic resources and associated traditional knowle dge, help to prevent misappropriation and avoid 
erroneous patents, and bring little  burden to patent applicants and patent authorities.   
45. The Director-General's consultations on the issues of TRIPS/CBD and GI extension had 
provided opportunities for detailed technical discussions  without getting trapped in theological issues.  
She said that the issues of TRIPS/CBD and GI extension were both implementation-related issues in the Doha Round, negotiations on those issues must be an integral part of the work programme and the 
outcome of those two issues must be part of the Single Undertaking.  Noting that the negotiations on the issue of GI register had developed a draft le gal text, she called upon the Director-General to 
continue his consultations and move to te xt-based consultations as early as possible. 
46. The representative of Canada
 requested that a two-page submission her delegation had 
provided in the context of the Director-General's  recent informal consultations on the relationship 
between the TRIPS Agreement and the CBD be taken on record.3  On 17 February 2011, Canada and 
16 other Members had discussed how misappropriation of genetic materials and associated traditional 
knowledge were addressed in various national system s.  That two-page submission, along with the 
subsequent discussions, served to reinforce Ca nada's understanding that there were already a 
                                                      
3 Canada's submission is included in an Annex to the present record.  IP/C/M/65 
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  multitude of different approaches in use to address the issue of misappropriation.  Those differences 
were particularly apparent am ongst those calling for a TRIPS amendment that would provide for 
mandatory disclosure requirements, prior inform ed consent and access and benefit sharing.   
47. In the view of her delegation, the TRIPS Agre ement and the CBD co-existed in a mutually 
supportive manner, and that view had only been reinforced in the Nagoya Protocol.  To that end, she 
was disappointed that some Members suggested, in the post-Nagoya context, that the revised 
overarching priority should be for the TRIPS Agre ement to become an enforcement mechanism for 
the CBD.  Nevertheless, her delegation was enc ouraged by a positive development emanating from 
the Director-General's informal consultations.  Sp ecifically, the two-page submissions submitted by 
Canada and 16 other Members could serve as a usef ul stepping stone for more productive discussions 
in the TRIPS Council, where the discussion had become  rather stale over the past number of years, 
and Members had been polarized and seemi ngly paralyzed as to what to do next.   
48. She said that tested and concrete solutions were  available to address the issue, including third 
party prior art submissions, databases, contract s and codes of conduct, which had a positive and 
effective track record.  Intellectual property system s provided for a number of useful tools to help 
prevent the misappropriation of gene tic materials and associated traditional knowledge.  One tool was 
the possibility of an unsolicited filing of prior art by a third party.  In addition, databases could play an 
important role in helping patent examiners establish the novelty of an invention, and could, in turn, 
protect holders by helping to preven t erroneously granted patents.   
49. While some Members had made worthwhile pro posals to that effect in the TRIPS Council, 
including Japan's proposed one-click database systems,  prior art databases merited consideration as a 
means to help ensure the harmonious co-existen ce of the TRIPS Agreement and the CBD because 
they were already being used by patent offices worldwide.  India's Traditional Knowledge Digital 
Library was one concrete example, and the Canadian  Intellectual Property Office was pleased to have 
it in its toolbox.   Other examples included the Korean Traditional Knowledge Portal, the Chinese 
Traditional Chinese Medicine Patents Database, the System-Wide Genetic Resources Programme of 
the Consultative Group on International Agricultu ral Research, and the World Bank's Indigenous 
Knowledge Databases.  Much could be achieved by  better connecting existing databases to patent 
systems, encouraging the creation of new database s, and ensuring easy and one-step access by patent 
examiners to those important resources.   
50. The multitude of genetic resources, users and holders made every case of access unique and 
largely a matter of private law between holders and us ers.  As such, contracts were worthwhile in that 
they recognized that uniqueness and provided a soluti on tailored to a specific user and holder of that 
genetic resource, directly linking all without interm ediaries.  In addition to being a means to help 
prevent the misappropriation of genetic resources and associated traditional knowledge, contracts 
could directly lead to both upfront and on-goin g financial benefits to the holder - unlike any 
mandatory disclosure requirement.   
51. All the Members should acknowledge that ac cess to genetic resources and associated 
traditional knowledge was, at least partly, a matter of corporate social responsibility and awareness.  
Indeed, in some cases, aw areness by a potential user of an in digenous or local community's strong 
bond with genetic resources or associated traditional knowledge might simply be lacking.  Members, 
individually and collectively, could be instrumental  in raising that awareness and in promoting the 
adoption by companies of codes of conduct or guidelines on access to genetic resources and 
associated traditional knowledge, including as new elemen ts of existing corporate social responsibility 
strategies.  That could also be expanded to a multi- stakeholder approach, with  industry-wide standard-
setting, independent certification and associated la belling. Such approaches had been successfully 
implemented in the areas of sustainable forestry, hum ane animal treatment, and fair trade.  Companies 
had become more responsible, communities had been empowered, and consumers were better IP/C/M/65 
Page 10  
 
  informed.  A similar approach fo r the access to genetic resources a nd associated traditional knowledge 
was certainly not out of reach.   
52. In closing, she invited other Members to  reflect on and discuss the above-mentioned 
alternative mechanisms, which prov ided concrete and realistic ways ahead.  The more widespread 
adoption of measures and instruments such as da tabases, contracts and codes of conduct would 
reinforce well-equipped patent systems.  The broad patent system based on the fundamental principles 
of novelty and inventiveness would not only prev ent the erroneous granti ng of patents but also 
prevent the misappropriation of genetic  resources and trad itional knowledge. 
53. The representative of Korea
 said that Article 27 of the TRIPS Agreement allowed Members 
to decide the patentability of life forms and provide d permissible exclusions from patentable subject 
matter based on public order and morality.  Bolivia's  proposal to prohibit the patenting of life forms 
might hamper the development of new technolog y, especially biotechnology.  Innovation in the 
pharmaceutical and biotechnology industries enhanced  the quality of life and living standards, and 
deserved adequate patent protection.   
54. He shared some Members' concern over biopira cy and misappropriation of genetic resources, 
but believed that the TRIPS Agreement was not a pr oper tool to address the objectives of the CBD.  
He doubted whether the disclosure requirement was an effective solution to prevent erroneously 
granted patents.  In his view, the disclosure requi rement could be burdensome for patent applicants 
and inevitably cause instability in patent systems.  He sought clarification as to whether and how the 
disclosure requirement could effectively he lp to address erroneous patents.   
55. He said that since the objectives of the TR IPS Agreement and the CBD were entirely 
different, his delegation could not agree to amend the TRIPS Agreement.  Nevertheless, his delegation 
was willing to engage constructively in finding solu tions to protect biodiversity and prevent biopiracy 
and misappropriation of genetic resources.  
56. The representative of Bolivarian Republic of Venezuela  thanked the delegation of Japan for 
its presentation on the Nagoya Protocol, while regr etting that the presentation had not been made by 
the CBD Secretariat.  He supported Bolivia's submis sion, and said that the review of Article 27.3(b) 
was an outstanding issue of the Doha Agenda.  Article 27.3(b) provided for the possibility of patenting micro-organisms or microbiological pro cesses.  The Constitution of the Bolivarian Republic 
of Venezuela expressly prohibited the patenting of lif e forms.  In Nagoya, his delegation disagreed to 
the text of the Nagoya Protocol on the ground that  it had diverted from its original objectives and had 
not covered the fundamental principles that had guide d its drafting and the spirit in which it had been 
conceived.  On the question of access to genetic resources, the sovereignty of States and their 
indigenous peoples over their biological resources was reaffirmed, and the authority to permit access 
to genetic resources therefore lay with national govern ments and was subject to national legislation.   
57. Article 1 of the Nagoya Protocol provided for the fair sharing of benefits  in order to guarantee 
biodiversity.  Accepting this principle would be as repugnant as to declare that the distribution of 
benefits in the field of arms production, between producers and buyers, would ensure peace.  Nothing 
was further from the truth:  all production of wea pons was a path leading inevitably to aggression and 
any possibility of patenting biodiversity could be the path leading to the end of the historical tradition 
of collective ownership of resources that stood in cont radiction to the law of patents.  Patents involved 
individual monopolies and the possibility of approp riating and eliminating resources that had been 
preserved virtually intact for thousands of years,  passing from generation to generation and were, in 
many cases, considered by indigenous peoples as sacr ed.  That ethical and moral principle would be 
impaired if patenting of life was to be authorized.    IP/C/M/65 
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  58. Article 4 of the United Nations Declaration on the Rights of Indigenous Peoples established 
the right of indigenous peoples to self-determination, given that it was precisely States in which those 
communities were present that had systematically viol ated their rights.  Article 5 established the right 
of such peoples to maintain their distinct economic , legal, political and social rights, which would 
undoubtedly be violated by the patenting of life fo rms.  Traditional resources should not come within 
the purview of intellectual property rights, and in the case of Venezuela, its sovereignty would be 
violated. 
59. The representative of Brazil  thanked the delegation of Japan for its presentation of the 
Nagoya Protocol, although she wish ed that the CBD Secretariat had made such a presentation.  She 
said that the approval of the Nagoya Protocol had increased the importance of the discussion in the 
TRIPS Council on how Members could establish a mutually supportive relationship between the 
TRIPS Agreement and the CBD.  There were clear in ternational parameters on prior informed consent 
and access and benefit sharing that would guide count ries in designing their national legislation.  The 
TRIPS Agreement had an essential role to play in en suring prior informed access to genetic resources, 
achieving equitable sharing of benefits arising from the use of traditional knowledge and genetic 
resources, and preventing erroneous patents.   
60. By linking patent processing with the observance of national laws on prior informed consent 
and access and benefit sharing, the patent system c ould be an important tool in helping compliance 
with such laws.  If patent applicants knew that they  would be asked to disclose the source or origin of 
genetic resources or associated traditional knowledge  anywhere in the world and the processing and 
validity of patents depended on the veracity of that  information, they would have a strong incentive to 
comply with national laws.  Such objectives could no t be achieved either by contractual arrangements 
or prior art procedures.  Contractual arrange ments on access to genetic resources and fair and 
equitable sharing of benefits were already in pl ace in many national laws including in Brazil.  
Contracts might work well if they were respected.  The problem would arise when there was a need to 
verify and ensure compliance, especially when ge netic resources or associated traditional knowledge 
in question were taken out of the country.  Anot her open question was how to prevent those who had 
not complied with prior informed consent and acce ss and benefit sharing requirements from profiting 
from their illegal acts.  Without a disclosure require ment in patent applications, there was no way to 
know that genetic resources were utilized in the patented invention and compliance would depend 
entirely on the good faith of collectors.   
61. Turning to prior art requirements, she said that  it was more a way of avoiding the grant of 
erroneous patents than of preventing misappropria tion.  Even as a means of preventing erroneous 
patents it was unrealistic for patent offices to have  information on all genetic resources and associated 
traditional knowledge.  Even if database systems we re established, they could never account for the 
entire universe of genetic resources and associat ed traditional knowledge in all possible forms, 
especially because a great part of such resources we re still unknown.  It would also be difficult to 
justify the high cost involved in that endeavour, esp ecially in comparison with the cost of a simple 
checkbox under the disclosure requirement.  In conc lusion, her delegation w as in favour of amending 
the TRIPS Agreement to include a mandatory requi rement.  Patent applicants should inform the 
providing country and the country of origin of ge netic resources and associated traditional knowledge 
utilized in inventions, and comply with prio r informed consent and access and benefit-sharing 
legislation.  The disclosure requirement was the most effective and least burdensome way for the 
TRIPS Agreement to support the compliance with the CBD and the Nagoya Protocol. 
62. The representative of Australia  said that his delegation had actively participated in the 
negotiation of the Nagoya Protocol and welcomed the outcome.  Referri ng to Bolivia's proposal of the 
patenting of life forms, he said that the curre nt flexibilities under Article 27.3(b) of the TRIPS 
Agreement were sufficient to allow Members to take  the decision on the patentability of life forms in 
accordance with their national policies.  He supporte d the intervention by Cana da.  As a mega-diverse IP/C/M/65 
Page 12  
 
  country with a unique indigenous culture, Australia ha d a strong interest in equitable access to genetic 
resources and associated traditional knowledge.  As a Party to the CBD, Australia shared the relevant 
CBD objectives.  Australia's national experience indica ted that effective benefit-sharing regimes could 
be implemented without making changes to patent systems.  Australia's access and benefit-sharing 
systems was consistent with its obligations unde r the CBD.  Under Australia's access and benefit-
sharing systems, a permit was required to obtain access  to biological resources for research into their 
genetic and bio-chemical properties.  Stream lined permanent arrangements applied for non-
commercial research.  A benefit-sharing agreement was required before a permit for commercial research could be issued, and prior informed cons ent of indigenous owners was required when the 
genetic resources were on indigenous  peoples' land.  The benefit-sharing arrangement must include 
protection for and valuing of indi genous peoples' knowledge to be u sed.  The Australian Government 
had developed a model benefit-sh aring agreement, including suggest ed monetary and non-monetary 
benefits and addressing intellectual property ownership.  All agreem ents to date had followed the 
model closely.   
63. Finally, he said that his delegation was prepar ed to engage constructively in discussions in 
international forums.  Nevertheless, it considered  that the disclosure requirement merited further 
consideration in conjunction with  other options.  The Director-General's consultations on the 
TRIPS/CBD issue had been productive, but there we re a range of central policy issues yet to be 
resolved.  Many of those depended on the details  lacking in the proposal contained in document 
TN/C/W52, including the nature and scope of the proposed disclosure requirement, which underlined 
the need for detailed technical consideration of all options taking into account the work in other 
forums.   
64. The representative of Angola, speak ing on behalf of the LDC Group
 said that the Group was 
particularly interested in ensuring  that the outcome of the review of Article 27.3(b) did not constrain 
LDCs from using the TRIPS Agreement to advan ce national development interests nor result in 
situations that would run counter to morality.  As indicated in paragraph 19 of the Doha Ministerial 
Declaration, the discussions on the review of Article  27.3(b) were closely linked to the discussions on 
the relationship between the TRIPS Agreement a nd the CBD as well as the protection of traditional 
knowledge and folklore.   
65. He reiterated that the LDC Group's position was that life forms should not be patented and 
that the review of Article 27.3(b) should clarify the patentability of plants and animals as well as 
microorganisms and all other living organisms and their parts.  Further, natural processes for the 
production of plants, animals and ot her living organisms should not be subject to patent protection.  
Meanwhile, it was important to maintain the flexibility of the sui generis  system for the protection of 
plant varieties.  The sui generis  system could be developed a nd implemented by the individual 
country based on its own needs, which would contri bute to improving food security by ensuring that 
indigenous peoples' inven tions were protected and access to seed guaranteed. 
66. He thanked the delegation of Japan for its exhaustive presentation on the Nagoya Protocol, 
which paved the way for negotiations on the TRIPS/ CBD issue in the WTO.  He appreciated the 
efforts undertaken by the Director-G eneral Pascal Lamy to conduct parallel informal consultations on 
the issues of TRIPS/CBD and GI extension.  Those consultations were useful  in allowing Members to 
acknowledge existing legal regimes to prevent misap propriation and protect ge ographical indications.  
He said that biodiversity was an important resour ce of the livelihood of populations living in rural 
areas in most LDCs, yet benefits arising from the appropriation of such resources and the use of 
traditional knowledge by multinational corporations  had barely been shared with the communities 
concerned.  That issue should be addressed thr ough introducing a mandatory disclosure requirement 
into the TRIPS Agreement.  Meanwhile, it was equally  important to ensure that patent applicants 
demonstrated that they had obtained prior informed  consent from competent au thorities in the country  IP/C/M/65 
 Page 13 
 
 
  of origin of genetic resources and that arrangement s to facilitate the sharing of the benefits arising 
from the appropriation of such resources a nd/or traditional knowle dge were in place. 
67. The representative of Nigeria  thanked the delegation of Japan  for its presentation, and said 
that he preferred that the CBD Secretariat make such a presentation.  He said that the African Group 
and other Members were demanding the protection of genetic resources and associated traditional 
knowledge through a mandatory disclosure requireme nt as proposed in document TN/C/W/52.  The 
disclosure requirement would, in addition to comba tting biopiracy, strengthen the credibility of patent 
systems through the facilitation and assessment of nov elty and inventiveness criteria, thereby assuring 
that the patent system did not issue bad patents.   
68. He appreciated the consultations being held by the Director-General in accordance with 
paragraph 39 of Hong Kong Declaration and said th at those consultations had provided opportunities 
for detailed technical discussions without getting in to the issue of mandate.  He hoped that those 
consultations would lead to the am endment of the TRIPS Agreement.  
69. The representative of India  said that the presentation made by the delegation of Japan 
provided an overview of the Nagoya Protocol, but did not always give the needed details of 
substantive provisions.  Many developing countries belie ved that there were limitations in the Nagoya 
Protocol to tackle the misappropriation of gene tic resources and traditional knowledge in patent 
applications and that the solution lay in the amendment of the TRIPS Agreement to include 
mandatory disclosure requirements.  He reiterated his dele gation's request for the CBD Secretariat to 
make a presentation in the WTO, as the CBD Secretar iat had already done so in WIPO.  He supported 
the statements made by the delegations of Brazil and China.   
70. He conveyed his sense of disappointment at the lack of progress on the TRIPS/CBD issue 
despite a clear mandate, nine years' extensive t echnical work, and the overw helming support of the 
majority of the WTO Membership.  He said that it was time to start text-based negotiations as an 
integral part of the Single Undertaking and that an outcome on the TRIPS/CBD issue was essential for India as a development tool deliverable in the Doha Round.   
71. The representative of Peru
 shared the concerns raised by the delegations of China, Brazil, 
India and others.  He regretted that the CBD S ecretariat was unable to make a presentation in the 
TRIPS Council.  Referring to the linkage between  the TRIPS Agreement and the CBD, he said that 
the CBD recognized States' sovereign right over th eir genetic resources, while the TRIPS Agreement 
allowed the patenting of genetic resources, whic h was not equivalent to biopiracy, but did not 
guarantee the compliance with prior informed con sent and fair and equitable benefit sharing as 
provided in the CBD and the Nagoya Protocol.  Ther efore, his delegation advocated an amendment to 
the TRIPS Agreement, which would bring the TRI PS Agreement in line with the CBD.  Since 2003, 
his delegation had tabled several working docume nts on the amendment to the TRIPS Agreement in 
the WTO and other forums.  To introduce the disclos ure requirement into international systems would 
be an effective way to deal with the misappropr iation of genetic resources and traditional knowledge, 
as it would request patent applicants to identify the country of origin of genetic resources as well as 
provide the evidence of prior informed consent and fair and equitable benefit sharing.  The 
amendment proposal would ensure the compatibility  between the TRIPS Agreement and the CBD.   
72. He acknowledged the importance of the intellect ual property system as a tool to promote 
economic, social and cultural development, while indicating the need to improve the system by 
preventing the misappropriation of genetic resour ces.  As one of the co-sponsors of document 
TN/C/W/52, he said that Peru was not trying to im pede the use of genetic resources, but wanted to 
protect genetic resources against biopiracy.  The di sclosure requirement would help to recognise the 
States' right over their genetic resources and therefore provide countries with development 
opportunities.  The disclosure requirement would also  help to make an appropriate balance between IP/C/M/65 
Page 14  
 
  intellectual property system, especially the patent system, and the needs of indigenous communities in 
developing countries. 
73. The representative of South Africa
 said that the relevance of the Nagoya Protocol to the work 
of the TRIPS Council was obvious.  A large group of developing countries had proposed an amendment to the TRIPS Agreement in order to introduce a mandatory disclosure requirement in 
patent applications in accordance with documen t WT/GC/W/590.  In that document, patent 
applications were required to include the origin of biological resources and/or associated traditional 
knowledge, prior informed consent and access and benef it sharing.  In that context, he welcomed 
Article 6 of the Nagoya Protocol that required Member s to take steps to ensure  prior informed consent 
to be obtained, and Article 5 that recognised that the benefits arising from the utilization of genetic 
resources be shared in a fair and equitable manner.   
74. He said that, while national approaches were a step in the right direction, such diverse 
approaches might fall short of ensuring the universal  accrual of benefits from the use of genetic 
resources.   The best guarantee for achieving such  benefits lay in the amendment of the TRIPS 
Agreement by requiring mandatory disclosure.  He re iterated his delegation's call for inclusion of the 
CBD Secretariat in the work of the TRIPS Counc il and said that the relationship between the CBD 
and the TRIPS Agreement should be further articul ated in light of developments and guidelines 
provided by the Nagoya Protocol. 
75. The representative of Indonesia
 supported the discussion on the patentability of life forms 
with a view to having a clear perspective. He  urged all Members to engage in constructive 
discussions, and make substantive progress on the issues of TRIPS/CBD and the protection of 
traditional knowledge and folklore.  Given the importa nce of those issues to developing countries, he 
reiterated the urgency of amending the TRIPS Agreement to include a disclosure requirement.  As an 
organization that valued development, the WTO must  come up with rules and parameters that would 
enhance and benefit development.  The potential of  genetic resources and trad itional knowledge could 
become one of key elements for economic welfare for people in developing countries.  Given the 
adoption of the Nagoya Protocol, he  also urged all Members to take necessary steps to incorporate the 
principles of the CBD and the Nagoya Protocol into the TRIPS Agreement.  It would be in the best interest of all Members to articulate how to afford  sufficient protection of genetic resources and how 
to establish fair practices of the use of genetic resources.   
76. The representative of the European Union
 reaffirmed his delegation's commitment to the 
Nagoya Protocol, and said that the European Union would ratify and implement it as soon as possible.   
77. He said that Bolivia's document addressed the impor tant issue of patenting of life forms and 
expressed ethical and moral concerns.  However, his delegation was not in favo ur of amending Article 
27.3(b), as that provision, in conjunction with Article 27.1 and 27.2, provided WTO Members with 
sufficient flexibilities to modulate their patent protection of biotechnology inventions according to their needs, interests and ethical standards.   
78. As one of the co-sponsors of document TN/C /W/52, his delegation had proposed modalities 
for the three TRIPS-related issues under the Doha Development Agenda, namely GI register, TRIPS/CBD and GI extension.  His delegation was committed to that common platform on TRIPS issues and supported their parallel treatment.  He we lcomed the resumption of the Director-General's 
consultations on the issues of GI extension a nd TRIPS/CBD, and indicated that his delegation 
remained open to amending the TRIPS Agreement to  introduce a mandatory disclosure requirement.  
Indeed, provided the requirement was properly calib rated, it would allow Members to keep track at 
the global level of all patent app lications with regard to genetic resources and associated traditional 
knowledge, and would help patent examiners establish novelty mo re accurately and contribute to 
prevent the misappropriation of genetic res ources and associated traditional knowledge.   IP/C/M/65 
 Page 15 
 
 
  79. The representative of Colombia  said that biodiversity was an opportunity for economic and 
social development.  An approach focusing on the sustainable use of biodiversity should generate 
tangible benefits for developing countries.  The obj ective was to help overcome poverty while at the 
same time creating opportunities for new produ ction ventures based on the development of 
biotechnological know-how.   
80. He said that, as a mega-diverse country, Colombia  was deeply concerned about the scourge of 
biopiracy.  It therefore closely followed every action at the international level aimed at combating or 
preventing illegal access to its genetic resour ces, products derived th erefrom and traditional 
knowledge associated with such resources.  This was why Colombia had signed the Nagoya Protocol 
on 2 February 2011.  The Protocol developed the th ird objective recognized in the CBD, i.e. the fair 
and equitable sharing of benefits arising out of the utilization of genetic resources and the traditional 
knowledge associated with such resources.  The Protoc ol sought to provide legal certainty for both the 
countries of origin and the users of genetic reso urces or traditional knowledge.  The Protocol's 
provisions that aimed at patent applicants disclos ing the origin of genetic resources or associated 
traditional knowledge and demonstrating that pr ior informed consent had been secured were 
necessary for the proper monitoring of genetic resources and traditional knowledge as well as for 
monitoring compliance with the provisi ons on access and fair benefit sharing. 
81. He said that his delegation had advocated the mutually supportive relationship between the 
principles enshrined in the CBD and the rules set fo rth in the TRIPS Agreement in the Council and in 
other forums where the issue was discussed.  In his view, the fact that othe r Members recognized this 
relationship in the WTO and in other internationa l organizations was a very positive sign.  He hoped 
that others would acknowledge the reality of the situation and contribute to successful progress in the 
discussions on this subject in the WTO. 
82. The representative of Japan  said that the issue of biopiracy should be addressed with a clear 
distinction between the issue of erroneously gran ted patents and that of CBD compliance.  The 
Nagoya Protocol provided solutions to the issue of CBD compliance with provisions for the review of their effectiveness.  WTO Members should respect those solutions.  Discussions on the issue of CBD 
compliance in other forums would re-negotiate what had been agreed to in the Nagoya Protocol.  The 
priority was the implementation of the Nagoya Protocol.  In addition, the Council should take into 
account the work being conducted in the WIPO Intergovernmental Committee on Intellectual 
Property and Genetic Resources, Traditional K nowledge and Folklore (IGC), especially its 
intersessional working groups.   
83. Turning to the Bolivian proposal, he reiterate d his delegation's position that the incentive 
given by patent systems was critical in the field of biotechnology.   
84. The representative of Turkey
 indicated the importance of having a balanced and 
comprehensive agreement on the three TRIPS-related i ssues.  He said that those three issues should be 
treated in parallel as part of the Single Undertaki ng.  He was open to the proposal to amend the TRIPS 
Agreement in order to introduce disclosure requireme nts.  He said that harmonization between the 
TRIPS Agreement and the CBD would contribute to the protection of global environment and would 
prevent the extinction of species and biopiracy.   
85. He said that, under the draft Turkish Patent La w, when an invention was based on genetic 
resources or traditional knowledge, the source of th e genetic resource or traditional knowledge had to 
be disclosed.  The details of the disclosure require ment were provided in the implementing regulation, 
which would enter into force after the adoption of the draft Patent Law.   IP/C/M/65 
Page 16  
 
  86. The representative of Ecuador
 said that, given the complexity and relevance of the Nagoya 
Protocol to the work in the TRIPS Council, his de legation supported India's suggestion to invite the 
CBD Secretariat to make a presentation on the Nagoya  Protocol in the TRIPS Council.  He recalled 
that more than 80 WTO Members had co-sponsor ed document IP/C/W/474, which covered their 
concerns over Article 27.3(b) of the TRIPS Agreemen t.  The incorporation of the principles of prior 
informed consent, fair and equitable benefit sh aring and the disclosure of the sources of genetic 
resources and associated traditional knowledge into the TRIPS Agreement would effectively prevent 
biopiracy.  Members should also be able to introdu ce specific provisions on the legal effects of non-
compliance with the disclosure requirement.   
87. He further said that database systems or contract arrangements were precarious as they did 
not solve the fundamental problem.  An amendmen t to the TRIPS Agreement to introduce the above-
mentioned principles and to introduce the provisions on the legal effect of non-compliance was needed to resolve the problem of misappropriation and biopiracy.  Therefore, he said that Members 
should begin negotiations on the basis of the Directo r-General's consultations in order to fulfil their 
mandate provided in the Doha Work Programme. 
88. The representative of Chile
 said that the three agenda items were of high priority to his 
delegation and that it had participated actively in  the Director-General's consultations.  Although 
Chile was not a megadiverse country, it had endemi c genetic varieties because of its geographical 
characteristics.  As a party to the CBD, Chile wa s considering the development of legislation to 
regulate the use of genetic resources.  The Fisheries Research Institute, which was part of a ministry 
in Chile, was trying to gather data on genetic resour ces in Chile.  The Ministry of Agriculture had the 
authority to reach contractual agreements and could ensure compliance with the CBD.  
89. He said that the divergences on the TRIPS/CBD i ssue had existed for a long time.  Chile was 
open to exploring the advantages and disadvantages of various options on the table, including 
contractual arrangements, database systems, a nd mandatory disclosure requirements, within the 
framework of the TRIPS Council.  However, the ar tificial linkage between the issues of TRIPS/CBD 
and GIs would have an effect on that discussion. 
90. The representative of Kenya  congratulated Maldives on its graduation from the United 
Nations list of least developed countries.  While he thanked Japan for its presentation on the Nagoya 
Protocol in its capacity as the host country of the Pr otocol, he said that the presentation should have 
been made by the CBD Secretariat.  He supported th e CBD Secretariat's observer status in the TRIPS 
Council, which would enable Members to seek clarif ications on various subject matters of the Nagoya 
Protocol.   
91. He said that the instrument established by the Na goya Protocol appeared to be voluntary in 
nature, as seen in its Articles 6 and 17.  Besides it was not clear what remedies were available for parties not meeting their obligations.  He said that  the delegation of Japan was keen to indicate that 
some countries had requested the establishment of checkpoints, such as intellectual property 
examination offices and authorities providing regul atory approval of prod ucts, and had demanded 
mandatory disclosure requirements at those chec kpoints, but those requests did not get support of 
other countries.  He appreciated the choice of la nguage of "some countries"  and "other countries" 
without clarity on the fractionation of those requesting it and those opposing it.  
92. In conclusion, he said that the instrument re quired to prevent biopiracy and misappropriation 
of traditional knowledge and folklore was not yet achieved from the perspective of intellectual 
property, and that mandatory disclosure require ments were a solution which would provide a 
mechanism to monitor the use of genetic resources, traditional knowledge and fo lklore for intellectual 
property rights and therefore to enhance the impl ementation of prior informed consent and access and  IP/C/M/65 
 Page 17 
 
 
  benefit sharing with the owners or custodians of genetic resources and traditional knowledge.  
Therefore, his delegation supported the propo sal of mandatory disclosure requirements. 
93. The representative of Switzerland  said that biotechnology held great promises for mankind, 
both the developing and the developed world investme nt in research and inventive activities in the 
field of technology should be stimulated through patent rights.  Patents protected only the commercial 
exploitation of inventions for a limited time, after which the invention fell into the public domain.  
The inventor could either disclose his invention to obtain patent protection or keep it a trade secret.  
Mere discoveries of something new in the nature were  not patentable.  In other words, life forms as 
such could not and must not be patented.  Patent s should only be granted for new, inventive and non-
trivial contribution to the advancement of tec hnology, which required an inventive effort and a 
considerable resources and inv estment by the inventor.   
94. Article 27.3(b) was a balanced  provision providing Members with the necessary degree of 
flexibility.  A non-burdensome disclosure requirement in  patent applications relating to the source of 
genetic resources or traditional knowledge on wh ich the invention was based could contribute 
meaningfully to enhancing transparency, legal certa inty and patent examination standards, including 
novelty.  The disclosure requirement in the TRI PS Agreement could help promote an understanding 
of the importance and benefits that biotechnology held  for mankind and of the role patents could play.  
Therefore, his delegation had co-sponsored the moda lities text contained in document TN/C/W/52.  
He thanked the Director-General for resuming his consultations on the issues of TRIPS/CBD and GI 
extension and said that those consultations should not lag behind the general pace of work under the 
Doha Work Programme. 
95. The representative of El Salvador  said that, given the importance attached by WIPO to 
finding a solution for the three agenda items, she welc omed the proposal to invite the representative of 
WIPO IGC to present a report on its recent activities at the next meeting of the TRIPS Council.  Referring to the consultations held by the Direct or-General, she requested the WTO Secretariat to 
prepare a written report on the status of those cons ultations in addition to a verbal report made by the 
Director-General to the General Council.    
96. The representative of Chinese Taipei
 said that the TRIPS/CBD issue was a critical issue 
concerning a number of different stakeholders.  While there was a need to ensure that the owners of 
genetic resources and traditional knowledge had a fa ir and equitable benefit-sharing mechanism, 
inventors needed an incentive to invent and i nnovate, which should not be  reduced, and the legal 
certainty of patent systems needed to be preser ved without placing undue burden on either patent 
examiners or patent applicants.  All those princi ples should be considered to evaluate different 
approaches or proposals.  She indicated her delega tion's willingness to participate in discussions and 
consultations in the TRIPS Council.  
97. Referring to the Bolivian proposal, she supported Australia's intervention, saying that the 
flexibilities provided for in Article 27.3(b) allowed Members to implement the patent protection of 
biotechnology appropriately at domestic level by ta king into account their own needs and interests.  
The review of Article 27.3(b) should not lead to any lowering of the level of patent protection for 
biotechnological inventions.  She did not support the artificial parallelism between the issues of 
TRIPS/CBD, GI extension and GI re gister, and said that the attempt to make such a linkage between 
the three TRIPS issues and to include  them jointly as part of the Single Undertaking was not helpful.  
Each issue should be discussed and considered on its own merits.  She urged the Director-General to 
intensify his open-ended c onsultations on the two implementation-related issues. 
98. The representative of the United States  said that parties to the Nagoya Protocol were required 
to designate a national focal point or authorit y to make information regarding access procedures 
available, and in cases where there were multiple co mpetent authorities in a country, to clarify what IP/C/M/65 
Page 18  
 
  each authority's respective responsibility might be.  That could assist those who were interested in 
conducting research to obtain appropriate access without obstruction to their research.  Parties who required prior informed consent must provide for le gal certainty, clarity and transparency for their 
domestic requirements and for fair and non-arb itrary rules and procedures on accessing genetic 
resources.  Regulatory predictability was vital for attracting and sustaining research and investment, 
and for generating benefits to be shared.  Clarity and transparency in domestic procedures would also 
help research to be conducted in a legitimate manner.   
99. He noted that there was no patent disclosure requirement in the Nagoya Protocol, which 
underscored his delegation's view that the shared  objectives could be met by the access and benefit-
sharing provisions of the Protocol and that there was no need for a patent-related disclosure 
requirement.   Companies, universities and research in stitutes in the United Stat es were interested to 
learn whether parties to the CBD planned to ad opt the Nagoya Protocol and how they would 
implement the Protocol.  Similarly, since it was gove rnments that would enter into the Protocol, his 
delegation was interested to learn their views a nd did not see a need for the CBD Secretariat to 
present information about implementation by parties.   
100. Referring to Bolivia's paper, he associated his delegation with the statements made by the 
delegations of Korea and Switzerland, saying that a patent could only be granted if three patentability 
criteria were met.   
101. He said that the TRIPS Council had continued to engage in a useful and constructive 
exchange of views on those issues based on a sh aring of national experiences and by posing and 
responding to questions from Members.  The Co uncil could and should continue to work on those 
issues.  His delegation did not support amending the TRIPS Agreement to address the concerns of 
some Members, and did not think that doing so would be the most effective way to address these 
concerns.  During the Council's meetings in th e past, Members had discussed patents and the 
relationship of intellectual property to the CBD at length.  In his view, proposals to mandate the 
disclosure of the source of genetic resources, prior informed consent and mutually agreed terms would 
neither improve the patent system, nor promote the shared objective of providing a mechanism to 
address misappropriation.  Such proposals would inj ect significant uncertainty and unpredictability 
into a system that was essential to promote the i nnovation that could solve many of the problems that 
faced the world.   
102. The risks posed to the benefits that flew  from innovation were not worth the price, 
particularly when new patent disclosure requireme nts would offer so little to promote the shared 
objectives. The patent examination process was not  a suitable mechanism for ensuring compliance 
with unrelated regulatory requirements.  Patent ex aminers did not review inventors' tax filings, or 
verify inventors' vehicle permits, or enforce safety rules in the inventors' laboratories.  Nor should patent examiners be required to verify the origin of genetic resources.   
103. Because of the importance of patents and the need  for patent applications to be appropriately 
searched and examined, Members needed to be careful  about what the patent system would be asked 
to do besides issue quality patents.  Asking the pate nt system to enforce the requirements of another 
international agreement would result in costli er patents and in increased processing times.  
Furthermore, asking patent applicants to pay more to file a patent application, and to file more 
complicated patent applications, would discourag e inventors from seeking patent protection, and 
encourage them to protect the invention as a trade se cret, or to avoid commercializing the invention.   
104. The role of the patent system was to encour age innovation.  Innovation was important to 
societies to promote public health by finding new treatments and cures for life threatening diseases, 
new tools to increase energy effici ency as well as disease-resistan t plants.  The ability to obtain a 
patent in the United States and many other countri es provided an important incentive for universities,  IP/C/M/65 
 Page 19 
 
 
  research centres and companies to invest in research to  find solutions to the problems that threatened 
the food supply and the health of our peoples.  
105. He said that he recognized that some delegati ons might believe that the benefits of patent 
disclosure requirements would outweigh the cost to  patent applicants and to society.  These 
delegations suggested that the patent disclosure requirement was merely a transparency tool.  
Disagreeing with this, he said that his delegation believed that patent disclosure requirements would 
burden applicants, examiners and society, and would not provide a benefit to the holders of genetic 
resources.  
106. For example, the U.S. Patent No. 2,717,437 was the patent for the hook and loop fastener 
product known by the Trademark VELCRO.   That  invention was the work of a Swiss amateur-
mountaineer and dog owner, George de Mestral.  One day after a hike in the mountains, he and his 
dog both returned home covered with burrs (plant seed-sacs/genetic resources).  Observing the burr 
clinging to the tiny loops in the fabric of his pant s, de Mestral developed hook and loop fasteners. If 
that patent application had been filed today, would de Mestral have been required to disclose where he 
had found the burrs?   
107. Under the Swiss Patent Law, disclosure was required where the inventor had access to a 
genetic resource, where the contact was sufficient to identify specific properties relevant to the 
invention, and where the invention was directly  based on the genetic resources or traditional 
knowledge.  In that example, those burs, as seedpods , would likely be considered genetic resources. 
The inventor had pulled the burs off his pants, and observed hooks on the burrs and loops on his 
pants, so that would ostensibly qualify as sufficien t contact.  The inventor had used the properties of 
the burrs to create hook and loop fasteners.  It w ould seem that disclosure would likely be required 
under that example but Members should ask them selves why and how would knowing that the burr 
came from Switzerland help the patent examiner iden tify prior art or determine whether the invention 
was patentable.  How Switzerland w ould have actually benefited from the disclosure and what if the 
source was not clear, for example, where the invention was a mix of, or drew upon knowledge of, 
many different genetic resources from different countries.    
108. The complexity of such disclosures could be staggering.  For example, in 1966, a genetic 
resource had been discovered in one of the US national parks, which led to the invention of 
polymerase chain reaction (PRC), a common and often indispensible technique used in medical and biological research laboratories.  As of February  2011, there had been more than 19,000 U.S. patents 
relating to PCR.  That was only one genetic resour ce, and the 19,000 plus patents a demonstration of 
how dispersed knowledge from genetic resources coul d become.  There was no benefit proportional to 
the cost from such a requirement .  Instead, there was a burdensom e and unpredictable requirement 
with which each and every patent applicant and ex aminer would need to grapple with.  Moreover, 
those requirements were new and untested in many cases, so their full impact on innovative activities 
around the world had not been evaluated.   
109. At a time when people needed innovators to deve lop inventions to solve the world's problems, 
they should not make innovations harder to recognize .  There were alternatives that could help guard 
against erroneously granted patents.  He endorsed Canada's intervention, saying that databases of 
traditional knowledge could be impr oved so that users could search those databases easily, and obtain 
accurate results.  In addition, tools to enable thir d parties to provide documen ts to patent examiners 
and patent work-sharing activities could also help  examiners make the appropriate patentability 
decisions.  To address misappropriation, however, soluti ons needed to be found outside of the patent 
system.  Members were attempting to do that in thei r national systems and in other forums.  A patent 
system model would provide inad equate disciplines to address the problem of misappropriation.  IP/C/M/65 
Page 20  
 
  110. He said that, according to the US universities and companies, the patent disclosure 
requirements introduced a risk into the patent system  that made litigation of patents more expensive 
and reduced the value of a patent.  With reduced pa tent valuation, universities, research institutions 
and companies were less able to obtain a revenue stream to fund continued research and development. 
That meant that they could afford fewer graduate students or employees, and fewer research projects 
in general.  While there was no shortage of disease in the world, it was unfortunate that the research 
that could be done was only when countries create d an environment permitting the research – and not 
driven by other factors such as where the disease was most prevalent or most likely to become a 
global problem.   
111. The best mechanism for addressing misappropriation,  in the view of his delegation, would be 
to employ a contractual model within a national sy stem with control and benefits retained by the 
holders of the underlying genetic resources and traditional knowledge.  The contract approach 
encouraged research and development, and created a sustainable economic model.  On the other hand, 
requiring disclosure of the origin of genetic resour ces added uncertainty to the patent system and was 
destined to shift resources from researchers to pate nt attorneys, without improving the patent system, 
and by putting any benefit sharing agreements at risk.   
112. The representative of Norway
 believed that the relationshi p between the TRIPS Agreement 
and the CBD would be enhanced by introducing a mandatory disclosure requirement in the TRIPS 
Agreement.  She recalled that her delegation ha d introduced a proposal for an amendment of the 
TRIPS Agreement in June 2006.  She welcomed th e adoption of the Nagoya Protocol, which provided 
an important step forward in achieving the third ob jective of the CBD, namely the fair and equitable 
sharing of the benefits arising out of the utilizatio n of genetic resources.  That would contribute to 
achieving the other two CBD objectives, conservation of biological diversity and the sustainable use 
of its components.  Introducing the mandatory disclosure requirement in the TRIPS Agreement would represent a significant contribution in enhancing mutual supportiveness of the TRIPS Agreement and 
the CBD, including the provisions of prior inform ed consent, benefit sharing, compliance and 
monitoring in the Nagoya Protocol. 
113. The Chairman
 said that there continued to be a broad diversity of views on whether or not to 
amend Article 27.3(b).  He noted that India had renewed its proposal that the CBD Secretariat be 
invited to brief the Council on the Nagoya Protocol.  El Salvador had proposed to invite the WIPO 
Secretariat to brief on the work of the IGC, and also requested the Secretariat to prepare a written 
report on the Director-General's consultations on th e outstanding implementati on-related issues.  He 
said that he would pass on that request to the Di rector-General's Office together with various 
comments.  
114. The representative of Nigeria  said that his delegation needed time to reflect those proposals, 
particularly looking at their implications for on-going negotiations.  
115. The representative of the United States  said that his delegation needed time to reflect on the 
proposals to invite the CBD Secretariat and the WIPO  Secretariat to make presentations in the TRIPS 
Council and would welcome informal consultations. 
116. The Chairman  suggested that the Council request the Chair to continue consulting on the 
earlier suggestion that the CBD Secretariat be i nvited to brief the Council on the outcome of the 
Nagoya meeting, as well as on the suggestion that th e WIPO Secretariat be invited to brief on the 
work of the IGC.   
117. The Council took note  of the statements made under these three agenda items and so agreed .   IP/C/M/65 
 Page 21 
 
 
  F. FOLLOW -UP TO THE REVIEW UNDER PARAGRAPH 8 OF THE DECISION ON THE 
IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON THE TRIPS  
AGREEMENT AND PUBLIC HEALTH  
118. The Chairman  recalled that, at its meeting in Oc tober 2010, the Council had conducted its 
annual review of the "Decision on the Implementation of Paragraph 6 of the Doha Declaration on the 
TRIPS Agreement and Public Health" ("the Decisi on").  The record of that discussion had been 
annexed to the TRIPS Council's report to the General Council (IP/C/57 and Corr.1). 
119. As requested by the TRIPS Council, he had he ld consultations with a number of Members on 
follow-up to the review, including the question of  a workshop and various other proposals.  All 
delegations he had consulted had agreed that the annua l review had been very useful and constructive.  
However, at the same time, many delegations had felt that the discussion had not been fully 
exhausted.  The consultations had confirmed the broad support fo r following up open questions and 
outstanding issues at the present meeting.  Con sequently, the item had been placed on the agenda. 
120. In the course of the annual review, a number of de legations had said that they hoped to further 
share national experiences, and some delegations had referred to some general or specific issues that 
they wished to explore in greater detail.  During his consultations, some de legations had re-confirmed 
their intention to provide additional information on some of the specific  issues that had been identified 
during the annual review.   
121. In light of those consultations, he said that he had requested the Secretariat to prepare a list of 
issues that Members had identified at the Council's October meeting as requiring further discussion or 
information so as to help Members prepare for th e present follow-up discussion.  This list had been 
faxed to Members on 16 February 201 1.  It highlighted these issues on the basis of the record of the 
annual review.  However, he said th at if there were also some othe r issues that Members would wish 
to follow up, they should feel free to address them. 
122. The Chairman said that, during his consultati ons, some delegations had reiterated their 
proposal for an open-ended workshop involving all th e key stakeholders.  However, views continued 
to diverge on this proposal.  According to the proponents, now that the Council had had a productive 
discussion on these matters at its October meeting,  such a workshop would allow for information 
gathering directly from industry and other stakehol ders, and would usefully complement the work 
carried out by the Council.   
123. Some other delegations, however , had reiterated that this was a Member-driven process, and 
underlined that the outstanding issues should first be followed up amongst Members and that an 
open-ended workshop remained premature at this st age.  They had reiterated that the outstanding 
issues were part of a Member-driven process that had to be followed up amongst Members first.   
124. It had also been suggested that the Council c ould dedicate sufficient time to the next annual 
review at its October meeting later in the year. 
125. The Chairman recalled that, at the previous annual review, the Secretariat had briefed the 
Council on the procedural requirements of acceptance.  In order to further assist Members in drawing 
up their instruments of acceptance, the Secretariat had promised to make the information, together 
with a model instrument of acceptance, available in  writing.  This information was now available on a IP/C/M/65 
Page 22  
 
  new webpage on "How to Accept the Protocol Am ending the TRIPS Agreement" ("the Protocol").
4 
This could be accessed through the dedicated gateway page on "TRIPS and Public Health".5 
126. During the annual review, some delegations had expressed an interest in obtaining 
information on the implementing legislation that  a number of Members had already adopted and 
notified to the Council.  In response to this, th e Secretariat had created a new webpage compiling 
national implementing legislation that had been not ified to the Council.  The webpage listed those 
Members that had notified their domestic implementa tion of the Paragraph 6 System ("System"), and 
provided links to the relevant documentation.  This webpage could also be accessed through the 
dedicated gateway page on "TRIPS and Public Health".6 
127. Updating Members on the status of acceptances of  the Protocol that was done at Geneva on 
6 December 2005, he said that, since the Council's meeting in October 2010, Croatia had notified its 
acceptance of the Protocol on 6 December 2010, foll owed by Senegal on 18 Jan uary 2011 (documents 
WT/Let/747 and 753, respectively).  Thirty-three notifications of acceptance of the Protocol, including from the European Communities, had been r eceived up to that point.  The Protocol was to 
enter into force for the Members that had accepted it upon acceptance of the Protocol by two thirds of 
the Members.  It was open for ac ceptance by Members until 31 Decemb er 2011, or a later date that 
may be decided by the Ministerial Conference .   
128. The representative of Canada
 expressed her delegation's appr eciation for the joint technical 
symposium that the WTO, WIPO and WHO had orga nized in February 2011 on Access to Medicines, 
Patent Information and Freedom to Operate.  The symposium had been an informative gathering that 
had highlighted the fact that access to medicines was a crosscutting issue.   
129. She turned to follow-up information on a question that had been raised during the last annual 
review concerning the Private Member's Bill C-3 93.  It sought to amend Canada's Access to 
Medicines Regime (CAMR), which constituted the na tion's domestic implementation of the System.  
After having been examined by a parliamentary committee, Bill C-393 was moving to the third and 
final reading stage of Canada's legislative pro cess.  A vote could possibly occur as early as the 
following week.  Out of respect for the parliame ntary process, her delega tion would refrain from 
making any comments on the specific elements of th e Bill.  However, in her Government's view, 
CAMR worked well in its current form.  She recal led that also her delegation had asked a number of 
questions at the Council's meeting in October 2010 to which responses remained outstanding. 
130. The representative of Canada provided an update on Canada's comprehensive strategy to fight 
disease and improve healthcare worldwide.  During the annual review, her delegation had informed 
the Council of several funding initiatives, includi ng an additional Can$540 million contribution it had 
made to the Global Fund in September 2010.  Si nce then, it had continued to operationalize the 
Muskoka Initiative on Maternal, Newborn and Ch ild Health.  Canada's Can$1.1 billion in new 
funding over five years would focus on three key paths.  The first was on strengthening health systems to improve service delivery at the local level by training more health workers and expanding 
access for mothers and children to n eeded health care facilities and care at the local level.  The second 
focus was on addressing the diseases and illnesses that were the leading causes of mother and child 
mortality.  The third key path focused on im proving nutrition by increasing access to healthful, 
nutritious foods and nutritional supplements that he lped reduce mortality.  Given that sub-Saharan 
Africa faced the greatest challenges in addressing mate rnal and child mortality, 80 per cent of the new 
Canadian contribution would flow to that region, specifically to Mozambique, Mali, Malawi, Nigeria, 
                                                     
 
4 http://www.wto .org/english/tratop_e /trips_e/accept_e.htm 
5 http://www.wto.org/english/trat op_e/trips_e/pharmpatent_e.htm 
6 http://www.wto.org/english/trat op_e/trips_e/amendment_e.htm  IP/C/M/65 
 Page 23 
 
 
  southern Sudan, Ethiopia, and Tanzania.  Add itionally, Canada would address gaps in maternal, 
newborn, and child health in Afghanistan, Haiti, and Bangladesh.   
131. In her delegation's view, though the System was a useful tool, it was not a panacea for the 
complex problem of access to medicines for the world's poor.  As pointed out previously, numerous non-trade policy issues were also at play, including  infrastructure, human capital, and a myriad of 
supply chain challenges.  These examples illustrated that some issues relati ng to access to medicines 
were simply outside the WTO's expertise.  Howeve r, she agreed with those who asserted that there 
were trade policy issues impacting on access to medicin es.  For instance, many Members continued to 
maintain tariffs on pharmaceutical products, including  patient-ready formats.  Some of the compounds 
on which these tariffs were being applied were fo r the same HIV/AIDS, malaria and tuberculosis 
medicines that the System sought to make more easily available. 
132. The website of an NGO-led initiative, called th e Malaria Taxes and Tariffs Advocacy Project 
(available at http://www.m-tap.org), contained recently-released data indicating that most malaria-endemic countries, where the disease was eith er the first- or second-leading cause of death, 
continued to maintain tariffs on anti-malarial commod ities, such as bed nets, medicines, insecticides 
and diagnostic tests.  The website also included an interactive tariff map by country, which illustrated 
that some WTO Members, whose citizens faced the threat of malaria, imposed tariffs, sometimes 
exceeding 20 per cent, on one or more of the five anti-malarial commodities lis ted in the report.  She 
said that the decisions taken by Guinea, Kenya, Uganda, Tanzania, Mauritius, and Papua New Guinea 
to eliminate tariffs on those commodities that help  fight malaria deserved recognition.  Ultimately, 
tariffs on medicines were a tax on the sick, and woul d not even bring any significant fiscal benefit to 
the countries that applied them.  Tariffs translated into higher prices, reduced  access, lower treatment 
coverage, and higher health expendi tures that were unlikely to off set what little fiscal revenue they 
realized.  Though she acknowledged that some countri es that imposed tariffs also provided waivers, 
the waivers themselves could create additional costs and lead to delivery delays. 
133. The representative of Canada expressed concern that the deadline for Members to accept the 
Protocol was fast approaching.  Members that  had not already done so should deposit their 
instruments of acceptance with the Secretariat as so on as possible before 31 December 2011.  She was 
interested to learn from those Memb ers who had yet to accept the Protocol why they had not done so.  
The Council could be used as a forum to share indi vidual experiences that could help those who had 
not yet been able to accept the Protocol  to overcome any potential obstacles. 
134. The representative of China
 noted that, although the annual review of the System had not 
been completed within the Council’s dedicated  whole-day session last October, substantial 
contributions by Members had helped to make it one of the most comprehensive and informative 
annual reviews ever conducted.  The remaining issu es and questions needed to be addressed at this 
meeting of the Council. 
135. Noting that Members had different views on how to interpret the fact that the System had 
only been used once, she asked about the potential imp lications of this limited use.  Projections had 
predicted that the System would be used more frequently in the future given the change in 
requirements for new medicines to treat diseases, and the implementation of the TRIPS Agreement by Members.  In particular, the implementation of full patent protection for pharmaceutical products in 
India and the approaching expiration of transition periods in LDCs could make it more difficult to 
procure generic versions of new medicines.  St atistics showed that the number of patients being 
treated for HIV/AIDS in developing countries ha d increased to 5.2 million in 2010 from 400,000 in 
2003.  Generic products were available for most of  the first line antiretroviral medicines to treat 
HIV/AIDS, while most of the se cond line treatments were subject to patent protection in many 
countries around the world.  The switch to second-line antiretroviral medicines would be at least three times more expensive, costing about US$465 per pers on per year.  Citing the report of the UN Special IP/C/M/65 
Page 24  
 
  Rapporteur, which indicated that one third of the world's population did not have access to affordable 
medicines, she said that the need for new medicin es in the developing world would be urgent and 
even more costly in the future if no measures were taken to remedy this situation.  This gave the 
System an enhanced significance even thoug h it had been rarely used so far.   
136. She noted that many Members saw the System as an administratively complex regulatory 
framework with restrictive requirements and burdenso me costs.  They felt that further analysis and 
evidence would be needed to determine whether th e System had fulfilled the mandate of the Doha 
Declaration, i.e.  whether it offere d an expeditious and effective solu tion to the public health problems 
encountered by developing and least developed countries with no or limited domestic pharmaceutical 
manufacturing capacities.  According to other Member s, the System could work.  The frequency of its 
use would not be the appropriate metric to measure its effectiveness.  The results had to be evaluated.  
Some Members believed that the issue of access to  medicines had been addressed by alternative 
approaches to compulsory licensing such as voluntary licensing, donation of health products and bulk purchase pricing mechanisms.  However, though Me mbers concerned appreciated donations from the 
developed world, they believed that voluntary li cencing was not enough to address the challenging 
public health issues they faced.   
137. The representative of China said that there was widespread agreement that the causes 
underlying public health and access to medicine  issues were broader.  Since the System only 
addressed one specific aspect of it, a holistic and comprehensive approach was therefore required.  
This could include the financing of research ta rgeting neglected diseases and the development of 
appropriate pricing and reimburseme nt policies.  Some of these measures could exceed the Council's 
mandate.  She quoted from the WTO Director-Gener al's opening speech at the trilateral symposium 
on "Access to Medicines:  Pricing and Procuremen t Policies", which had been jointly organized by 
the WTO, WHO and WIPO in July 2010.  On this o ccasion, he had said that "global public health is a 
complex puzzle.  Getting it right is a teasing challe nge, involving effective use of the full set of 
applicable policy tools.  But it is also a practical craft, rather than a theo retical excursion – meaning 
that we can and should learn from the actual experi ences of others in their efforts to create and 
disseminate needed treatments.  The full perspectiv e needs to cover the international trade dimension, 
but also consider domestic policies and practices, a nd above all, the evolving state of the actual global 
disease burden, priority setting for front line treat ments, and patterns of production and dissemination 
of medicines." 
138. She said that nobody could deny that patents a nd international trade were essential elements 
regarding the interface between public health and access to medicines in developing countries.  Some 
Members had pointed out that patents would often no t be the determining factor in the broader issue 
of access to medicines, stressing that many comp lex factors hampered access to medicines in 
developing countries, including suboptimal proc urement systems, poor distribution networks for 
medicines, and the lack of basic infrastructures, hospitals and health care professionals.  Systemic 
problems, such as taxes and tariffs on imported medici nes, or the lack of cold chain storage would 
often be overlooked in discussions at multilateral level.  However, while acknowledging that poor 
national healthcare systems were characteristic of many developing countries, she noted that intellectual property, especially patents, was also an important element in this regard.  Given that the 
TRIPS Council was the competent WTO body overlooking disciplines governing IP-related issues in international trade, and taking into account that in tellectual property rights were among the elements 
that played an important role for access to life- saving medicines, such as second line antiretroviral 
medicines, the issues related to access to medici nes should be addressed by the Council.  It was 
mandated to do so by Ministers at the Doha Ministerial Conference.  Whether the System had provided the adequate economic and political incentiv es to secure investment in production of generic 
medicines at affordable prices for markets with little  or no manufacturing capacity remained an issue, 
which deserved further examination.    IP/C/M/65 
 Page 25 
 
 
  139. In her delegation's view, Article 30 of th e TRIPS Agreement constituted an option for 
developing countries to address public health crises.  This was backed by the TRIPS Agreement and 
paragraph 4 of the Doha Declaration in which Mini sters had clearly reaffirmed "… the right of WTO 
Members to use, to the full, the provisions of th e TRIPS Agreement which provide flexibility for this 
purpose".  As discussed many times since the adoption of the Doha Declaration, Article 30 was a 
flexibility provided for by the Agreement itself, without the need to amend any of its provisions. 
140. Noting the broad discussion at the annual review, she called upon Members to agree on the 
organization of an open-ended workshop on the im plementation of the System.  This would allow 
gathering first-hand information, a nd suggestions could be made directly by the industry.  She also 
encouraged other Members to share information an d experiences in addressing public health issues so 
that the Council could formulate more tangible solutions for common challenges. 
141. The representative of India  recalled that the System had b een agreed after long and intense 
negotiations.  Its objective was to provide an expedi tious solution to the problem of countries with 
insufficient or no manufacturing capacities in the pharm aceutical sector.  It was therefore surprising 
that, after seven years, only limited use had been ma de of the System.  To his delegation's knowledge, 
in addition to the Rwanda-Canada case, there had only been three instances where efforts had been 
made to utilize the System.  The first had been by Médecins Sans Frontières (MSF), the second by 
Ghana and the third by Nepal.  All three efforts had been abandoned midway, while it had taken about 
three years to provide medicines to Rwanda.  His delegation had shared some  details on this during 
the previous Council meeting.  He suggested that other Members concerned or MSF could be asked to 
provide further details.   
142. He considered that the limit ed use of the System raised serious questions about its 
effectiveness and efficacy.  There was an urgent need  to analyze the reasons for this situation.  For 
this purpose, a range of important questions needed  to be examined, including cumbersome or time-
consuming procedures for granting compulsory licen ces, the impact of "TRIPS plus" provisions in 
regional trade agreements on the use of the Syst em, and the role of weaknesses in the domestic 
regimes of importing Members.  While the discussions  at the Council's last meeting had been fruitful, 
most of the questions had been left unanswered.  Additional questions on the systemic impact of 
"TRIPS plus" initiatives had also been  raised since these impinged on public health concerns.  His 
delegation was also awaiting responses to questions that Members had presented to the representatives 
of WIPO and the WHO.  There were still some im portant pieces that were missing from the puzzle.  
The resultant gaps could only be filled if all stake holders were involved in the process.   He therefore 
reiterated India's demand for a de dicated workshop open to all rele vant stakeholders, including 
government representatives, pharmaceutical companies,  civil society organizations and others, to 
better understand the reasons behind the limited use of the System. 
143. Referring to reports according to which 350 m illion persons were living with HIV/AIDS in 
the world of which only 5 million, representing ba rely 1.5 per cent, were being treated with 
medicines, the representative of th e Bolivarian Republic of Venezuela  noted that there was a clear 
relationship between counterfeit medicines and the excessively high prices of branded medicines.  
The poor opted for counterfeit medicines since br anded medicines were virtually inaccessible for 
them.  This also had a direct causal link with the advent of the TRIPS Agreement, which had made it 
possible to monopolize medicines.  This had led to  massive price increases that continued to grow 
exponentially. 
144. The System had been the General Council's attemp t to find an alternative that would alleviate 
the situation.  He noted, however, that many c ountries had not signed the Protocol, and that his 
delegation would not do so until it felt that the reform  would benefit its population.  The clearest sign 
that the System had been ineffective was the para doxical fact that its most ardent defenders were 
developed countries, particularly those that produced  both branded and generic medicines.  The main IP/C/M/65 
Page 26  
 
  reason why the mechanism had not worked was systemic .  It had taken Rwanda years to complete its 
first attempt, while others had been stranded halfway.  These e xperiences had dissuaded others, 
including Venezuela, from a ttempting to use the System.  He supported the call for an open-ended 
workshop with the participation of civil society, private companies and other institutions.  Such an 
event would provide a comprehensive overview of th e situation.  Hearing the viewpoints of other 
stakeholders would be beneficial for all. 
145. The representative of Angola, speaking on behalf of the LDC Group
, said that the LDC Group 
regarded the adoption of the Protocol as an important milestone in efforts to respond to the difficulties 
experienced by countries with no or insuffici ent manufacturing capacities.  However, only few 
Members had deposited their instruments of acceptance six years after the adoption of the Protocol.  It 
was therefore important to establish why countri es were not coming forward so that corrective 
measures could be taken.  For this purpose, th e LDC Group supported the proposal that an open-
ended workshop be held on the implementation of th e TRIPS amendment.  Such a forum could reveal 
where the impediments to the acceptance process lay,  and how they could be removed.  Information 
on how to accept the Protocol should be incorporat ed into the national and regional technical 
assistance and capacity building activities undertaken by the Secretariat.  He noted that a number of 
topics for further discussion and information had been  prepared through the Chairman's consultative 
process to facilitate the System's annual review.  Sharing experiences would certainly provide clarity 
on a meaningful use of the System and any obstacles to such use.  Information on alternatives would 
also be valuable to the LDCs.   
146. The representative of Japan  said that the System should not be considered in isolation, but as 
part of a broader effort to improve access to me dicines.  The Symposium on "Access to Medicines: 
Pricing and Procurement Practices", co-organized  by the WHO, WIPO and WTO in July 2010, had 
noted that other elements apart from intellectua l property rights were important for access to 
medicines.  These included procurement practices and hi gh tariffs.  It had also  been noted that only 
five per cent of medicines included on the WHO's lis t of essential medicines were patent-protected.   
147. He said that the follow-up to the annual review s hould focus on specific aspects, in particular 
concerns of potential importing Members and issu es which had been identified as requiring more 
information but which had not been answered yet.  Canada's efforts to share its experience at the 
previous meeting had provided a good example.  The list of issues that had been prepared by the 
WTO Secretariat would provide importa nt and useful guidance to that extent.  As regards the proposal 
that an open-ended workshop be organized, his delega tion regarded this initiative as premature.  The 
Council should first focus on how to make the System  work in a practical manner.  When discussing 
access to medicines, it was important to consider other elements apart from the System. 
148. The representative of Ecuador  recalled that the objective of the System was to provide an 
expedient and effective solution to the problem of  full access to medicines for Members with no or 
limited production capacity.  Council debates from th e previous year had enabled Members to go into 
greater detail about the System, how it worked, and its effectiveness with r espect to achieving the set 
objectives.  However, the use of the System had been  limited, after being in existence for almost eight 
years.  Therefore, in order to deal with the issues that could affect the effective implementation of the 
System, it would be necessary to hold a workshop in which all participants, including industry, 
government and other stakeholders could present their analyses.  With respect to the acceptance of the 
Protocol, his delegation supported the concerns expressed by the delegation of Venezuela.  It 
continued to have serious doubts about proceeding with  it, given the System's lack of efficiency and 
operability. 
149. The representative of Brazil  said that the Council's objectives were to assess whether the 
System was an expeditious solution for countries lacking manufacturing capacity, and to address any 
shortcomings that were impeding the System's effe ctive operation.  She reit erated her delegation's  IP/C/M/65 
 Page 27 
 
 
  proposal that the adequateness of the economic a nd political incentives provided by the System to 
secure investment in the production of generic medi cines at affordable prices be analyzed by the 
Council and other forums.  The fact that the Syst em had only been used once was strong evidence for 
inadequate incentives.  The System, as well as other TRIPS flexibilities, was a tool for helping ensure 
access to medicines at affordable  prices.  Her delegation was committed to make the necessary 
changes so that the System could perform the function for which it had been designed.  It was time to 
include other stakeholders in the discussion to be tter understand why the System was not being used, 
and to agree on ways to improve it.   
150. Access to medicines at affordable prices was pa rticularly important in Brazil given that its 
constitution guaranteed free and universal access to  healthcare for all citizens.  Under Brazil's 
HIV/AIDS programme, all persons living with HIV/ AIDS were entitled to receive free treatment.  
This included individual health exams, as well as the supply of medicines to treat HIV/AIDS and other opportunistic diseases.  210, 000 patients were under treatment for HIV/AIDS in her country, 
with the number increasing by 30,000 annually.  The estimated cost for the HIV/AIDS programme for 
2011 was US$500 million, which meant an annual cost  per patient of US$2,500.  Advances in drug 
development had provided more ef fective treatment resulting in significant gains in patients' 
longevity.  This was an important achievement, but it also entailed increased costs.  As patients developed resistance, more research and investment  would be needed to develop the next generation 
of drugs, which would come at a higher cost. 
151. Her Government had found a balance between the rights granted to IP holders and the 
interests of society as a whole.  Fifty-seven per cent of Brazil's HIV/AIDS patients used second and 
third generation antiretroviral drugs.  The use of these newer generations of drugs increased annually 
as the life expectancy of HIV/ AIDS patients in Brazil had grown from 58 months in 1995 to 
108 months in 2007.  In order to maintain th e sustainability of the programme, Brazil had 
continuously negotiated with drug makers to reduce the price of antiretrovirals and had made full use 
of the flexibilities under the TRIPS Agreement.  On e example had been the issuance of a compulsory 
licence for the antiretroviral drug Efavirenz in 20 07.  This was one of the most commonly used 
medicines in antiretroviral therapy.  In 2007, 38 per cent of Brazilian patients had been using it.  
Because of the growing number of patients and th e use of newer generation drugs, the costs of 
Efavirenz had been jeopardizing the HIV/AIDS pr ogramme.  At US$ 1.59 a dose, the costs for the 
Government had amounted to approximately US$ 42.9  million, or US$ 580 per patient, per year.  As a 
result of the compulsory licence, the cost per dose had been reduced to US$ 0.43 a dose.   
152. The representative of Peru
 noted that a workshop open to all stakeholders would enable 
Members, international organizations, the civil society and the pharmaceutical industry to express 
their views and to share experiences on both the ch allenges and opportunities that could be realized 
through the implementation of the System.  His de legation therefore supported the proposal made by 
the delegations of India, Brazil, China and others  to hold such a workshop in the course of 2011.  
Although the System had been established to ensure  that developing countries had access to generic 
medicines they could not produce domestically, it ha d only been used once since its establishment.  
During the last annual review, Members had exchanged views with respect to its use.  This enriching 
dialogue had enabled Members to look at problems and existing difficulties.  Some experiences had 
been positive while others had been less so.   
153. The representative of the European Union  recalled the importance of input from Members 
that had experience in implementing the System  and called upon them, in particular potential 
importing countries, to share more information and experiences. 
154. In response to the list of issues for furthe r discussion or information, which had been 
circulated by the Chairman in order to prepare for the follow-up to the annual review, he first 
addressed the issue regarding developed countries' ef forts to transfer technology to least developed IP/C/M/65 
Page 28  
 
  countries, in particular how they had implemented paragraph 7 of the Decision.  His delegation had 
put in place several programmes to provide incentives for technology transfer.  The details could be 
found in the annual reports on technology transf er, which summarized th e incentive programmes put 
in place by the European Union as a whole, as well as by individual member States.  Measures taken 
included the promotion of specific projects, such  as direct investment, licensing, franchising, 
subcontracting, joint research projects, training a nd technology, management  and production methods 
and capacity building.   
155. With respect to the measures taken to en sure the safety and efficacy of medicines 
manufactured under compulsory licences for export,  Regulation (EC) No.  816/2006 had established a 
system whereby approval would be granted on eith er the basis of a scientific opinion from the 
European Medicines Agency in consultation with the WHO, or by a national sanitary authority.  This 
assessment would be based on the same standards a nd criteria as for medicines intended for domestic 
use.  The standards and criteria offered the high est level of protection adopted by the relevant 
international organizations.   
156. Turning to the question of whether the ec onomic and political incentives provided by the 
System were adequate to secure investment in the production of generic medicines at affordable 
prices, he said that the political impetus to provi de such incentives lay with  the WTO membership.  
The European Union had put in place implementi ng legislation, according to which compulsory 
licences could be granted by the competent nationa l authorities, provided that the applications 
fulfilled the conditions with respect to the eligible  importing countries and that  no agreement could be 
reached with the right holder.  Verifying the fulfil ment of those conditions and monitoring the use of 
the System was necessary to ensure that it was not abused for purpo ses other than public health.  No 
further conditions or restrictions had been introdu ced in the EU implementing legislation.  On the 
contrary, the latter had even been made accessible to poor countries which were no WTO Members.  
Packaging and labelling requirements were not excessive ly costly, cumbersome or difficult to put into 
practice.  Those measures were justified for transparency and compliance purposes. 
157. In his delegation's view, the requirements of th e System were not responsible for the limited 
number of applications made to date.  They prov ided the necessary framework  for ensuring the proper 
use of the System.  He recalled the existence of  many other channels for access to medicines, 
including seeking voluntary licences or taking advant age of patents on several medicines that had 
either expired or would expire in the coming years.   The additional details provided by the delegation 
of Canada with respect to the supply of generi c medicines to Rwanda by Apotex showed that 
procedures could be swift.  Approva l had been given in less than six months through a special review 
stream, instead of the standard one year period.  The problems encountered may be specific to the 
case at hand.  It was premature to conclude from there that the System had failed to serve the objective of enhancing access to medicines without full y analyzing the difficulties.  On the contrary, 
prices had been lowered in the end due to harsh co mpetition by other generic suppliers on the market 
in Rwanda.  Economic incentives may have been low,  but to date, it had not been proven that there 
was any need for such incentives.  The System could not be criticized for its limited use if other 
alternatives were operating well enou gh to restrain the need to recu r to it.  Nevertheless, further 
information and reflection on concrete cases would be  valuable to better understand the issue in its 
broader context.   
158. Referring to the Chairman's list of issues, i.e.  the question whether TRIPS-plus provision 
such as data exclusivity had adverse effects on the right to access to medicines, the representative of 
the European Union noted that, in  most cases, the term of data exclusivity did not extend beyond the 
lifetime of patents.  In any event, under EU Regul ation (EC) No. 816/2006, data exclusivity did not 
apply to cases where a compulsory licence had been granted.  Therefore, it did not constitute an 
obstacle to the export of medicines under the System.    IP/C/M/65 
 Page 29 
 
 
  159. Addressing the question of what incentives Members had for accepting the Protocol and 
implementing the System, he said that each WTO Memb er was responsible for u ndertaking those acts.  
Numerous exporting countries had accepted and impl emented the Protocol, while others may have 
been observing how it worked in practice before doing so.  Any particular difficulties that importing countries were facing should be resolved through in ternational cooperation and technical assistance.  
It was therefore important that both sides communicated their needs and expectations. 
160. Taking up the issue on the Chairman’s list rega rding the budget available to actors from the 
private and public sectors with respect to the dist ribution of essential medicines, he said that some 
figures on projects and programmes initiated by the European Union in developing countries had 
already been provided at the Council's last meeting.   Recipient countries would be in a better position 
to provide further information on how the budget had been used. 
161. He finally addressed the issue of how international organizations, such as the WTO and 
WIPO, could better use their resources for technical  co-operation to implement TRIPS flexibilities in 
collaboration with other organizations includi ng UNCTAD, WHO and UNAIDS.  A strong network 
of cooperation already existed and appeared to func tion properly.  Several events had been jointly 
organized by the aforementioned organizations.  This  included the symposia that had been hosted by 
the WTO, WIPO and WHO in Geneva in June 2010 and February 2011.  His delegation would 
nevertheless welcome any additional initiatives or suggestions since there was always room for 
improvement in technical cooperation.  Furthe r information on experiences acquired to date, 
particularly by importing countries, on their needs and on the technical obstacles they had encountered, would be helpful in this regard.   
162. The representative of the United States
 referred to the productive exchange among Members 
during the last annual review.  However, more i nput was still needed from the potential users of the 
System about their experiences and considerations. As  reflected in the Chairman's list of issues of 
16 February 2011, there were a number  of questions that had been ask ed but had been left unanswered 
by delegations, particularly those from potential importing countries.  In response to the question 
about technology transfer to least developed count ries, his delegation had provided several examples 
at the Council's last meeting, whic h were reflected in the minutes (IP/ C/M/64, paras. 260, 262 to 264).  
Efforts to transfer technology, as well as reflections to further promote such transfer, were on-going.  Technology transfer was, however, not merely ab out licensing of patents.  Many pharmaceutical 
companies had decided not to seek patents in LDCs  anymore.  As a result, though no patent rights 
existed to be licensed in these cases, technology was still being transferred. 
163. With regard to the safety and efficacy of me dicines procured under the System, the US had 
already provided details on a 2004 policy initia tive wherein a US Food and Drug Administration 
review could be used to streamline the process th rough which a generic antiretroviral could be added 
to the WHO pre-qualification list.  This would help  to ensure that medicines procured under the 
System were safe and effective, without requiring a separate review by the importing Member. 
164. As the delegation of Canada had explained with respect to tariffs, the Abuja Declaration of 
the Africa Summit on Roll Back Malaria had alrea dy recognized in 2000 that domestic taxes and 
import tariffs were an obstacle to access to bed ne ts, anti-malarial medicines, insecticides used in 
indoor residual spraying, and rapid diagnostic tests necessary to fight malaria.  They made the tools to fight and treat malaria less available to the poor.  There were also a significant number of open 
questions regarding potential importing Members' experiences, as well as of those Members that had 
reported their attempts to use the System.  For th e Council’s review to be effective, his delegation 
supported calls for developing co untries to report on their considerations and experiences in 
evaluating whether and how to use the System.  Given that the System had been developed by Members, for Members, it was not clear how it co uld be assessed without such experiences.  His IP/C/M/65 
Page 30  
 
  delegation therefore looked forwar d to continuing working within the Council and did not see a need 
to depart from its procedures. 
165. The representative of Canada
 said that the delegation of Indi a and other delegations had made 
a factual error in referencing a multi-year process fo r the export of generic medicines to Rwanda.  As 
his delegation had noted at the last annual review a nd at previous meetings, reference to a three-year 
period was simply not correct.  The process of  utilizing CAMR had been operationalized and 
successfully completed in a matter of months.  If th ere had been extended delays beyond that, those 
had not been due to the functioning of CAMR , but to other factors beyond the scope of his 
Government.  He referred Members to the facts as set out at previous meetings and reflected in the respective minutes.   
166. He reiterated the call on other Members for answ ers to the questions his delegation had asked 
at the previous annual review.  The current meeti ng had been characterized as a follow-up meeting.  
Canada had provided follow-up responses to matt ers that had arisen in October 2010, but the 
questions that it had asked, recorded in paragraphs  121, 143, 273 and 274 of the minutes, were left 
unanswered.  Perspectives of Members were the biggest missing piece.  Echoing the delegations of 
the European Union and the United States, he noted  that the Council had received little information on 
experiences with the System from potential importers, or those who had at least explored this possibility. 
167. His delegation had, for example, referred to the role of states, in particular as regards tariffs.   
Governments, not the private sector, were responsible for such tariffs which were directly relevant for 
access to affordable medicines.  He asked the Indi an delegation why India imposed tariffs on all five 
commodities implicated in the fight against malaria, a nd how this helped its efforts to combat malaria.  
This question was of direct releva nce to the work of the Council and the WTO.  While his delegation 
had not foreclosed on the possibility of a workshop, it was evident that the real gaps lay in the sharing 
of experiences of states and of information on the policies they exercised.  Those had a direct impact 
on access to affordable medicines. 
168. The representative of Kenya
 informed the Council that his delegation was in the process of 
accepting the Protocol.  The instrument of acceptance would soon be deposited.  This was in line with 
the new constitution of 4 August 2010, which had affirmed the right to healthcare for all citizens.  The 
use of the System could boost the Government’s effo rts of meeting its obligations on health and IPRs 
under the new constitution.  He supported the prop osal for an open-ended workshop, which would 
provide an opportunity for sharing and excha nging ideas, information and experiences amongst 
stakeholders.  It would facilitate an enhanced use of the System as envisaged during the highly 
volatile negotiations that ha d led to its adoption.   
169. The representative of Switzerland  said that, during the previous annual review as well as in 
the current discussion on the System, the delegations th at had made interventions were either potential 
exporting countries, or countries with considerable  domestic pharmaceutical manufacturing capacity.  
Those were not the Members for which the System  had been established.  Potential beneficiary 
Members with no or limited manufacturing capacity in the pharmaceutical sector therefore needed to voice their concerns and to set out the problems they  may have faced in their attempts to use the 
System.  Only on the basis of their experience coul d the Council evaluate the System with respect to 
its workability, expeditiousness, and whether other stakeholders should participate in the Council's 
future review discussions. 
170. He noted that the delegate of India ha d referred to a number of cases where potential 
beneficiary countries, such as Ghana and Nepal,  had started but had later abandoned the drug 
procurement process under the System.  The delegate of India had stated that more information on these cases could be received from those countries in an open-ended workshop on the System.   IP/C/M/65 
 Page 31 
 
 
  However, this information should be shared in the Council's discussion as part the annual review.  
This would allow the Council to consider follow-up st eps for the next annual review.  The Chairman's 
list of issues for further discussion or information fo llowing the last annual review constituted a useful 
basis for a well-structured discussion.  Many of the issues pertained to potential beneficiary countries 
under the System.  In order to have a meaningful review, it would be important to have input from 
those countries.   
171. He continued by sharing information on a number of  issues on the Chairman's list.  First, with 
respect to the transfer of technology, his delega tion had submitted its report on the implementation of 
Article 66.2 TRIPS (IP/C/W/551/Add.2).  In partic ular, paragraphs 28 and 29 pertained to capacity 
building in the public health and pharmaceutical sectors.   
172. Regarding measures taken by potential exporting Members to ensure the safety and efficacy 
of medicines procured under the System, he reporte d that the Swiss implementing legislation provided 
that, when a compulsory licence was granted under the System, a manufacturing authorization had to be obtained according to Article 5, paragraph 1 of the federal drug law (HMG).  Recognized standards 
for good manufacturing also had to be respected (Article 7 HMG).  For finished pharmaceutical 
products, an additional authorization under Article 18, paragraph 1(b) HMG w ould have to be sought 
from the Swiss Agency for Therapeutic Products (Swissmedic).  The licensee was, however, not 
required to obtain marketing approval for a pro duct manufactured under the licence, as would be the 
case under Article 9 of the HMG if marketing was in tended in Switzerland.  The motivation for this 
dispense was to make the procedure as expeditious as possible, and to give the beneficiary country the 
choice of applying its own safety standards and marketing approval procedures.  However, the 
beneficiary country had the option of mandating a sp ecialized external organization to carry out its 
required safety tests.  In Switzerland, this coul d be done by the Swiss Agency for Therapeutic 
Products upon receiving a request from the beneficiary co untry.  With regard to test data protection, 
his delegation concurred with the European Union th at this should not pose any problems in cases of 
licences granted under the System.   
173. With respect to incentives for Members to implement the System, the representative of 
Switzerland said that greater efforts would be required from potential exporting countries than from potential beneficiary countries.  Exporting countries  needed to amend their national legislation to 
provide for grants of Paragraph 6-type licences.  Th ey also had to establish the associated procedures 
and safeguards as required by the System.  On the other hand, potential beneficiary countries were 
primarily required to provide reasonable measures proportionate to their administrative capacities in 
order to prevent diversion of the imported pharmaceutical products from their domestic to third 
country markets.  This would, in any event, be in  the interest of a beneficiary country which faced a 
public health problem and therefore sought recourse to the System. 
174. Regarding incentives for the acceptance of the Prot ocol, it was only coherent for Members to 
expeditiously proceed with their domestic procedures.   The System had been adopted after four years 
of long and difficult negotiations.  It was a unanimously adopted solution to an issue that had been 
deemed to be of pressing importance at the time.  Each Member now had to take the necessary steps 
to accept and effectively implement the multilateral d ecision at the national level.  It was therefore 
surprising to learn that the delegations of Vene zuela and Ecuador were planning to deposit their 
respective instrument of acceptance only after havi ng been convinced that the mechanism would have 
positive benefits for them.  
175. He recalled the Chairman's opening remarks in which he had reported that 33 Members, 
including the European Communities, had deposited th eir instruments of acceptance of the Protocol.  
This meant that another 42 Members were needed to accept the amendment before it could enter into 
force by the deadline of end of 2011.  He urged Members that had not yet accepted the Protocol to 
undertake the necessary steps to do so without further delay. IP/C/M/65 
Page 32  
 
  176. In reaction to Canada's allegation that ta riffs were impeding access to medicines, the 
representative of India
 referenced WHO figures, according to which the average wholesale price of 
medicines had fallen to 60 per cent of the branded me dicines price after expiry of the patent in the 
United States.  This finding concerned a market se gment with just one generic competitor, whereas 
prices had fallen to 29 per cent of the branded pri ce in case of ten competitors.  Another study of the 
US market had also found that the prices of gene ric medicines had decreased with the number of 
competitors in the market.  A study of the French Agence nationale de la recherche had drawn similar 
conclusions for some developing country markets.  Upon exploring determinants of anti-retroviral 
medicine prices in Brazil and 13 African countri es, it had found that the introduction of generic 
competition remained an essential factor for loweri ng prices even after controlling of other relevant 
factors. 
177. The representative of the Bolivarian Republic of Venezuela  reiterated the need for an open 
workshop to provide constructive feedback to de veloping countries and potential importers.  This 
would not be easy given that nothing of that nature had been tried before.  As the example of Rwanda 
had shown, it had taken years to successfully comp lete the process.  Others had abandoned their 
efforts halfway.  But efforts had to persist.  Th is explained his delegati on's concern about committing 
to a process that would likely be difficult and complicated.  Therefore, doubts about the System needed to be addressed before committing to it.   
178. The representative of Ecuador
 said that it was the sovereign decision of each Member to ratify 
an agreement.  The experience to date indicated th at the System did not work.  This was evident from 
the fact that despite being established in August 2003, there were no other experiences beyond those 
that had already been discussed.  He asked the Swiss delegation what its real interests in the System 
were given that it had one of the largest pharmaceu tical industries in the world, what programmes it 
had created to deal with public health in devel oping countries, and what its interests were in 
preventing the convening of a workshop. 
179. In support of the delegation of India, the representative of Brazil  provided an example to 
illustrate the impact of patent rights on prices.  In  Brazil, Abacavir was an important medicine to treat 
HIV/AIDS patients.  In 2007, the drug had cost US$2.1 per dose.  When the patent had expired in 
2008, the cost of the drug had fallen to US$0.88, i.e.  a reduction of almost 60 per cent. 
180. The representative of the Secretariat  noted that on the occasion of the enhanced annual review 
of the System at the Council's last meeting, the Secretariat had provided a detailed overview of the 
technical co-operation efforts it had undertaken in re lation to public health and access to medicines.  
In a brief update to supplement that report, he said that public health as well as the TRIPS provisions 
that were most relevant to innovation and access to medi cines continued to form an integral part of the 
Secretariat's technical assistance efforts.  This em phasis on public health had strengthened since the 
adoption of the Doha Declaration.  Since the TR IPS waiver in 2003 and the Protocol Amending the 
TRIPS Agreement in 2005, virtually all techni cal cooperation activities concerning TRIPS had 
addressed the System.  These had included regi onal workshops, Geneva-based events, national 
seminars, or other more tailored activities.  This amounted to a large number of activities that were 
very diverse in character. 
181. He said that three general trends in technical cooperation had been identified in October.  The 
first was the increasing trend towards partnerships  with other organizati ons, both within and beyond 
the established trilateral partnership between the Secretariats of the WHO, WIPO and the WTO.  This 
trend was occurring at the planning, coordination and programme delivery levels, so as to ensure that 
the necessary breadth of expertise was available, and to more effectively leverage the investment of 
resources.  The second trend was towards providing a stronger practical understanding of the relevant 
elements of the TRIPS Agreement and how they could be practically embedded into operational 
procurement programmes with greater interconnec tion between the technical cooperation activities  IP/C/M/65 
 Page 33 
 
 
  and those responsible for the procurement of medici nes.  The third trend was towards exploring the 
possibilities arising from the enhanced and more in tegrated information basis that was emerging, 
including on patent coverage, prices and access to me dicines by vulnerable populations.  This strong 
base of information was enabling technical coope ration to become more focused, tailored and 
practically oriented towards specific drug procurement objectives.   
182. Those trends had been consolidated since the previous Council meeting.  On the first point, 
cooperation with other internationa l organizations in the conduct of such technical assistance had been 
further enhanced.  Efforts to coordinate and prov ide mutual support for the programme partners had 
increased.  Following the Doha Declaration and th e establishment of the System, the WHO had 
become a regular participant in all regional and Geneva-based activities to the extent that resource 
constraints had permitted.  It had thus joined WI PO as the WTO Secretariat's traditional partner, and 
had brought a vital public health pe rspective to each of the programmes .  In addition, others 
concerned with access to medicines, including civi l society, public sector procurement initiatives, 
industry representatives, public private partnerships , and policy analysts, had also been closely 
involved.  Events such as the Colloquium fo r Teachers and the Advanced Course had included 
presentations from participating scholars and policy anal ysts from a wide range of countries.  Many of 
these participants had chosen to address access to me dicines and related issues in their presentations. 
183. He said that the increased focus on technical cooperation in relation to public health and 
intellectual property had been assisted through activ e dialogue, coordination and partnership with the 
WHO and WIPO.  Such highly productive collabora tion had facilitated the further involvement of 
WHO and WIPO experts in WTO technical cooperati on activities.  This had enabled more effective 
and tailored technical cooperation efforts that we re subsequently being conducted from a better 
informed factual background.  Earlier in the year , a regional seminar had taken up this issue.  The 
"WTO Regional Workshop on Intellectual Property and Public Policy for Central and Eastern European and Central Asian Countries" had benef ited from the valued contributions of colleagues 
from WIPO, and experts from both the WHO headquar ters in Geneva and from its regional office 
responsible for Europe. 
184. He said that the trilateral cooperation had also  led to joint technical cooperation activities, 
including technical symposia co-organized by th e three Secretariats.  A report on the "Access to 
Medicines:  Pricing and Procurement Practices" sy mposium, held in Geneva on 16 July 2010, had 
already been provided at the Council's last meeting.   The symposium had laid out several themes for 
continuing cooperation with respect to the exchange of  empirical data and practical experience.  As a 
follow up to that activity, the three Secretariats  had jointly organized a second symposium on 
18 February 2011.  Hosted by the WHO, the event ha d taken up one of the speci fic themes covered in 
the inaugural symposium, namely "Access to Me dicines, Patent Information and Freedom to 
Operate".  To strengthen the technical basis of discussions, the symposium had been preceded by a 
WIPO-hosted workshop on 17 Fe bruary 2011 on "Patent Searches and Freedom to Operate". 
185. The objectives of the most recent symposium had been (i) to highlight the importance of easy 
access to patent information for providing access to medicines, (ii) to show how patent information could be used in determining the freedom to operate for improving access to medicines, (iii) to explore what kind of patent information would be required for this purpose, (iv) to explore to what 
extent this information was available and accessible, and (v) to identify information gaps that needed 
to be addressed.  The symposium had focused on ne w research outcomes and data that could provide 
an empirical and practical basis for discussion.  Speakers had described several projects aimed at 
deriving a better understanding of access to medicines issues through the enhanced use of patent 
information tools.  Various providers and users of  intellectual property information had shared their 
perspectives.  These had included representatives  from research-based industries, procurement 
initiatives, the generic pharmaceutical industry, an d information providers such as national patent 
offices.  At a strictly technical level, this had b een a capacity building event and not a policy forum.  IP/C/M/65 
Page 34  
 
  For this reason, there had been no specific conclu sions or outcomes.  However, it was worth noting 
that the symposium had included a vigorous and insightful discussion covering the challenges of 
access and making use of patent information to build a clearer overview of freedom to operate issues 
pertaining to product development and access to medi cines.  The symposium had concluded with a 
note of cautious optimism about the potential for an  improved and more geographically representative 
coverage of patent informati on.  Full details would be post ed on the websites of the three 
organizations so that the material could be used to support continuing dialogue and technical cooperation in this field.   
186. The resources that were being developed to support technical cooperation included the table 
of legislation implementing the System.  The tabl e had been created and posted on the WTO website 
in response to specific requests made at the previo us Council meeting.  There had also been other 
material developed subsequent to  the previous October's discussion.  The material would help 
Members understand the necessary steps and practical implications of accepting the Protocol.  It had been presented on the basis of the discussions and ba ckground explanations provided at the previous 
Council meeting.  The material addressed the freque ntly asked questions in this subject area, and 
provided a model form for acceptance of the TRIPS Amendment.  It also made some important 
practical points.  In particular, it distinguished between the act of acceptance of the TRIPS Amendment and the implementation of the System.  On the one hand, acceptance could be described as a means of confirming on the international plan e that other Members were entitled to use this 
flexibility.  On the other hand, a choice whether or not to use the system was a separate matter, in the 
domain of domestic implementation, including through necessary legislation.  Members were already 
entitled to make use of the System even in advance of the amendment coming into force. 
187. The representative of the WHO
 provided further information on two questions featuring on 
the Chairman's list of issues.  The first concerned an analysis of how international organizations such 
as the WTO and WIPO could better utilize their te chnical cooperation resources to implement TRIPS 
flexibilities through their collaboration with ot her organizations, including UNCTAD, WHO and 
UNAIDS.  Since the adoption of the WHO Global Strategy and Plan of Action on Public Health, 
Innovation and Intellectual Property, the WHO, WT O and WIPO had intensified their collaboration 
on all issues regarding public health and intellectua l property.  The three Secretariats were meeting 
monthly to coordinate their current activities and to di scuss future joint efforts in the fields of training 
and capacity building, technical assistance and e ducational activities, which included collaboration 
with the WIPO Academy.  This collaboration av oided duplication through parallel programmes.  
Instead, it allowed each organization to bring its sp ecific strengths and expert ise in jointly designed 
programmes.  This had led to better designed programmes and greater efficiency in programme 
development and delivery.   
188. The second comment related to the request that the WHO prepare a detailed report on the 
coverage of TRIPS flexibilities in its technical assist ance activities.  He said that further information 
on this issue would be included in his Organizati on's next report on technical cooperation activities, 
due to be circulated ahead of the Council's meeting in  October.  In advance of the forthcoming report, 
two recent joint activities would merit a brief prese ntation.  Following the first WHO, WIPO and 
WTO symposium on "Access to Medicines: Pricing and Procurement Practices", the three organizations had organized anothe r trilateral technical symposium on "Access to Medicines, Patent 
Information and Freedom to Operate" at the WH O on 18 February 2011.  It had focused on the 
growing importance of patent information for public health, especially in the areas of procurement of 
medicines, technology transfer and freedom to operate  strategies.  The challenge of locating relevant 
and up-to-date information on the patent status of ke y essential health products had been highlighted.  
This was often a highly complicated undertaking, partic ularly for people that were not trained in this 
area.  The meeting had thus confirmed that there w as a need to facilitate acc ess to this information, 
and to help procurement officers and other health officials in finding and interpreting it according to 
their needs.  In collaboration with WIPO and the WTO, the WHO would continue to work to make  IP/C/M/65 
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  patent information more accessible and understa ndable to people from the health sector.  The 
programme of the symposium, a background paper,  and all presentations could be found on the 
websites of the three organizations.  Webcasts of  all presentations and discussions would also be 
made available online.   
189. Furthermore, with regard to the issue of the implementation of TRIPS flexibilities, an 
upcoming joint UNAIDS, WHO and UNDP Policy Br ief on "Using TRIPS Flexibilities to Improve 
Access to HIV Treatment" would review how countri es could use and had used those flexibilities to 
increase access to HIV treatment.  The policy brief would be published later in March. 
190. Referring to the Chairman's list of issues, the representative of WIPO  addressed the request to 
it to provide "information on projects under its Development Agenda, c overing the development 
dimension with respect to the effective use and implementation of TRIPS flexibilities".  The 
Development Agenda (DA), which had been agr eed by the member States of WIPO in 2007, 
contained 45 recommendations to enhance the development dimension of the Organization's 
activities.  Key were recommendations 13, 14, 17, 22 and 25, which focused on enhancing the 
understanding and use of flexibilities in the intell ectual property system.  In November 2009, the 
Fourth Session of the Committee on Development a nd Intellectual Property (CDIP) had discussed 
recommendation 14, and it had requested WIPO to prepare a document on flexibilities in the area of 
patents.  At the Fifth Session of the CDIP in April 2010, the Committee had discussed a preliminary 
document on "Patent-Related Flexibilities in th e Multilateral Framework and their Legislative 
Implementation at National and Regi onal Levels" (CDIP/5/4).  It ha d requested the Secretariat to 
review the document to reflect Members' comment s and to include new flexibilities, and to propose a 
work programme on flexibilities for consideration by the Committee.  Such a future work programme 
on flexibilities in the IP system had been agreed at the Sixth Session of the CDIP in November 2010 
(based on document CDIP/6/10).  It covered work in  the area of patents, stocktaking of WIPO's 
activities relating to flexibilities in the IP system , and technical assistance in the use of such 
flexibilities. 
191. She reported that the CDIP had agreed on a range  of activities with respect to flexibilities.  
The first activity included work on five new pate nt-related flexibilities.  Those included WIPO's 
continuation of work on transitiona l periods, patentability of  substances existing in nature, disclosure-
related flexibilities, ex-officio IP office cont rol of contractual anticompetitive clauses, and 
examination systems.  This work was being undertaken by WIPO's Innovation and Technology 
Sector: Patents and Innovation Division.  The CDIP  had also agreed that WIPO should organize 
national and regional seminars for the exchange of  practical experiences in the implementation of 
flexibilities.  In this context, a regional seminar on the effective implementation and use of several 
patent-related flexibilities would be organized by  the Innovation and Technology Sector in Bangkok 
in March 2011.   The Deputy Director General of  WIPO's Development Sector had drawn the CDIP’s 
request to the attention of other non-patent-related areas at WIPO, with  the view of organizing further 
seminars and workshops to address other fields of IP. 
192. She said that it had also been agreed that in formation on flexibilities be integrated into 
WIPO's technical assistance activities, legislative advice and capacity-building activities.  This was 
bearing in mind that Recommendation 1 of the DA provided that such assistance would be "inter alia, development oriented" and demand-driven.  The Depu ty Director General of the Development Sector 
had informed all WIPO divisions involved in techni cal assistance initiatives th at the CDIP decisions 
were a confirmation of WIPO's engagement in the area.  Furthermore, the CDIP had also agreed on 
the creation of a webpage that would be dedicated to the use of flexibilities.  Located on WIPO's 
website, the webpage would contain a roadmap indi cating the areas of WIPO's work relating to the 
flexibilities, as well as links to relevant sectors.  The page would also provide materials and output from WIPO seminars, workshops and technical assist ance activities dealing with the flexibilities.  A 
"resources" section would provide links to studies on flexibilities produced by WIPO, and by IP/C/M/65 
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  WIPO-commissioned experts, as well as to relevant  materials produced by other intergovernmental 
organizations. 
193. Finally, the CDIP had agreed upon the cr eation of a database accessible from the 
aforementioned webpage.  This would allow users to access relevant provisions on flexibilities in 
national IP laws, as well as information on national experiences and case studies in implementing the 
flexibilities.  The DA Coordination Division and WIPO's  IT Sector were undertaking preparations for 
the database.   
194. The representative of WIPO recalled that, taking into account the DA as well as the broader 
context of the United Nations' Millennium Developm ent Goals, her Organization had established its 
programme on Intellectual Property and Global Chal lenges.  Through this programme, WIPO, as the 
specialized United Nations agency responsible for intellectual property, endeavoured to lead the 
international policy dialogue on the intersection be tween intellectual property and global public policy 
issues, in particular as regards global health, cl imate change, and food security.  The focus on these 
three subject areas had been guided largely by member states' requests, inter a lia, in the DA, since the 
most immediate impact of many of these global problems was borne by developing and least 
developed countries.  WIPO was actively cooperating with diverse internationa l partners, particularly 
within the United Nations system, in order to contri bute to shared solutions for those challenges.   
195. She concluded by noting that public health was a central issue.  WIPO had engaged in the 
clarification of pertinent issues underlying health innovation and access to medicines.  The trilateral 
cooperation between the WHO, WIPO and the WTO had been established and was working well.  
Hopefully, it would contribute to the enhancement of the empirical and factual information bases for 
policy makers, and would support them in addressing in tellectual property issues in relation to global 
policy themes such as public health. 
196. The representative of the United States
 welcomed the webpage detailing how to accept the 
TRIPS amendment.  He hoped that it would assist Members in accepting the Protocol so that the Council's objective of getting the amendment passed could be achieved.   
197. The Chairman
 said that there was no consensus on any further follow-up to the annual review 
or on the preparations for the Council's next annual review in October, including whether, and if so 
how and when, to hold an open-ended workshop, or how to approach the requests for further 
information as listed in the annex to the fa x he had sent to Members and Observers on 
16 February 2011.  He suggested that his successor be requested to consult with Members on any 
further follow-up and on preparations for the next annual review. 
198. The Council took note  of the statements made and so agreed.  
G. NON-VIOLATION AND SITUATION COMPLAINTS  
199. The Chairman  recalled that, at the Seventh Session of the Ministerial Conference, Ministers 
had directed the TRIPS Council to continue its  examination of the scope and modalities for 
complaints of the types provided for under subp aragraphs 1(b) and 1(c) of Article XXIII of 
GATT 1994 and make recommendations to their next S ession.  It was agreed that, in the meantime, 
Members would not initiate such complaints under the TRIPS Agreement.  The eighth Ministerial 
Conference would be held in Geneva on 15-17 D ecember 2011.  At its mee ting in March 2010, the 
TRIPS Council had agreed to keep the item on non-vi olation and situation complaints on the agenda 
as a regular item so as to allow Members who would ha ve new thinking to share it, and also enable 
the Council to revert to the question of the further or ganization of its work in the light of any future 
suggestions.  IP/C/M/65 
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  200. The representative of the United States  said that, in the past, WTO Members had agreed to 
extend the moratorium on non-violation and situa tion complaints.  That had been a significant 
concession on the part of the United States, as the mo ratorium had been set to expire at the Sixth 
Ministerial Conference.  His delegation nonetheless maintained that non-violation complaints were fully appropriate in the context of the TRIPS Agre ement.  The views of the United States were well 
known in that regard, as reflected in document IP/C/W/194.  The possibility of non-violation disputes 
had been a part of the GATT dispute settlement sy stem since the beginning.   The TRIPS Agreement 
had been carefully negotiated to accommodate diffe rent legal regimes and to  accommodate Members' 
need to achieve policy objectives.  The availability  of non-violation complaints would merely assist 
Members in their efforts to preserve the balance of concessions and to protect against measures that 
frustrate legitimate expectations. Accordingly, the United States was of the view that the moratorium 
should expire at end of the upcoming Ministerial Conference. 
201. The representative of the Bolivarian Republic of Venezuela
 believed that non-violation and 
situation complaints could not be dealt with under the TRIPS Agreement and requested that the 
moratorium continue until the i ssue had been fully resolved. 
202. The representative of China  said that, since the TRIPS Agreement was quite different from 
GATT in nature and structure, she believed that appl ication of non-violation and situation complaints 
to the TRIPS Agreement was unnecessary and would raise fundamental concerns and limit the use of 
flexibilities.  She suggested that the next Minister ial Conference either suspended the application of 
non-violation and situation complaints under th e TRIPS Agreement or decide on an unlimited 
moratorium until Members decided otherwise. 
203. The representative of Nigeria, speaking on behalf of the African Group , endorsed the views of 
Venezuela and China.  He said that the next Mi nisterial Conference should agree that non-violation 
and situation complaints are inapplicable or, alternat ively, grant an indefinite moratorium to provide 
more certainty for Members planning their health policies. 
204. The representative of Switzerland  said that his delegation continued to take the view that 
non-violation complaints were applicable in the co ntext of the TRIPS Agreement, the same way that 
they were applicable to GATT and GATS.  The TR IPS Agreement had been concluded to achieve and 
obtain – across the markets of all WTO Members – minimum standards for the protection of IPRs. Those minimum standards, agreed and implemented in to national law, improved market access.  From 
that perspective, the TRIPS Agreement did not differ from GATT or from GATS.  All three 
agreements were aimed at improving market acce ss;  they were market access agreements.  The 
wording in Article 64.2 and 64.3 of the TRIPS Agre ement was clear in that non-violation complaints 
would not apply under the TRIPS Agreement after th e moratorium would have expired at the next 
Ministerial Conference. 
205. The Chairman
 said that the Council was to provide its recommendations to the Ministerial 
Conference at its end-of-year meeting in October.  In case any delegations had any ideas to share, he 
encouraged them to do so as soon as possible so as to allow the Council sufficient time to consider 
them. 
206. The Council took note  of statements made and agreed  to revert to the matter at its next 
meeting.  
H. REVIEW OF THE IMPLEMENTATION OF THE AGREEMENT UNDER ARTICLE 71.1 
207. No statements were made  under this agenda item. 
208. The Council agreed  to revert to the matter at its next meeting. IP/C/M/65 
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  I. R
EVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON GEOGRAPHICAL 
INDICATIONS UNDER ARTICLE 24.2 
209. The Chairman  recalled that Article 24.2 provided that the Council shall keep under review the 
application of the provisions of the GI Section of the Agreement.  He recalled that, at its meeting in 
March 2010, the Council had agreed to encourag e Members to share information on and notify 
bilateral agreements related to the protection of ge ographical indications, which they had entered into, 
to the Council.  He therefore encouraged any Member  that was party to any such bilateral agreement 
and had not yet shared such information with the Coun cil to do so.  He also invited those delegations 
that had not yet provided responses to the Checklis t of Questions contained in document IP/C/13 and 
Add.1 to do so.  Also those Members that had al ready provided responses co uld provide updates to 
the extent there had been any significant changes to  the way they provided protection to geographical 
indications. 
210. The Council took note  of the information and agreed  to revert to the matter at its next 
meeting. 
J. FOLLOW -UP TO THE EIGHTH ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE DECISION ON 
THE IMPLEMENTATION OF ARTICLE 66.2  OF THE TRIPS  AGREEMENT  
211. The Chairman  recalled that, at its last meeting, the Council had taken up its eighth annual 
review of developed country Memb ers' reports on their implementation of Article 66.2 of the TRIPS 
Agreement.  In concluding that item, he had in dicated that he would provide delegations an 
opportunity at the present meeting to make furthe r comments on the information submitted for that 
meeting that they had not yet been able to study. 
212. The representative of Bangladesh, speaking on behalf of the LDC Group , said that there had 
been notable progress in the format and contents of reports submitted under the Article 66.2 review.  
However, there was still room for further improvement  to ensure that the process was not just about 
fulfilling notification obligations, but about having tangible results in terms of promoting and 
encouraging technology transfer to LDC Members in order to enable them to create a sound and 
viable technological base.  He thanked the WTO Secretariat for convening the eighth annual review, 
in line with the decision by the Ministers in Doha, Qatar in 2001, calling upon Members to put in place a mechanism for ensuring the monitoring and the full implementation of the Article 66.2 obligations.  He recalled that paragraph 1 of th e decision of the TRIPS Council of 19 February 2003 
called upon developed country Members to submit a nnually reports on action taken and planned in 
pursuant of their commitments under Article 66.2.  To this end, they shall provide new detailed 
reports every third year and, in the intervening ye ars provide updates to their most recent reports.  
Those reports shall be submitted prior to the last Coun cil meeting scheduled for the year in question.   
213. The purpose of the review was threefold:  first, to provide Members an opportunity to pose 
questions in relation to the information submitted and request additional info rmation;  second, to 
discuss the effectiveness of the incentives provided in  promoting and encouraging technology transfer 
to LDC Members in order to enable  them to create a sound and viable technological base;  and third, 
to consider any points relating to the operation of the reporting procedure established by the Decision.  
He thanked those developed count ries that had provided the pulse to the TRIPS Council on incentives 
they had provided to their enterp rises and institutions in their territories with a view to promoting and 
encouraging transfer of technology to LDCs in or der to enable them to create a sound and viable 
technological base.   
214. Article 66.2 contained an obligation for devel oped country Members.  This obligation was 
specific to LDCs and was about providing incenti ves to enterprises and institutions in developed 
country Members territories.  The purpose was to prom ote and encourage the tran sfer of technology;   IP/C/M/65 
 Page 39 
 
 
  the ultimate objective was to enable LDCs to crea te a sound and viable technological base.  That 
effort should be the basis for measuring the effectiv eness of incentives provided to LDCs.  In order to 
ensure quality reporting, there was a need for the Council to begin deliberating on critical elements 
with a view to developing a common understanding of the contents of the reports.  He said that the 
LDC Group had identified two critical areas in relation to the Article 66.2 obligations:  the definition 
of technology transfer and illustrations of the type of incentives. 
215. As regards the definition of technology transfer , it was clear from the reports that had so far 
been submitted that there was a lack of comm on understanding of what constituted technological 
transfer.  Hence the inclusion in some reports of t echnical cooperation activities.  It would be useful to 
provide a non-exhaustive list of what could possibl y be regarded as technology transfer for the 
purposes of Article 66.2.   
216. Regarding the type of incentives, it would equa lly be important to ha ve a non-exhaustive list 
to guide the reports.  It would also be useful to have showcases, and to hold brainstorming sessions on 
specific examples of incentives that had led to transfer of technolog y and subsequent contribution to 
the building of a sound and viable technology base in LDCs.   
217. In order to draw best practices, there was a need  to ensure that the reports were LDC-specific 
and that incentives resulting in transfer of tec hnology were distinct from technical cooperation 
activities provided under Article 67.  The reports should also provide an indication of funding or 
budget allocated for staff incentive programmes and fo llow a harmonized format.  To this end, he 
reiterated the proposal that the Council identify clear parameters on the nature of technology transfer 
and on the types of incentives provided by deve loped countries to their enterprises and the 
institutions.  To this end the LDC Group had circulated  a possible template that could be considered.  
He looked forward to receiving remarks on that.  It  would also be useful to work towards having a 
toolkit for assessing the impact of technology transfer. 
218. The Council took note  of statements made. 
K. TECHNICAL COOPERATION AND CAPACITY BUILDING  
219. The Chairman  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 were made available only a short time before the review, he had indicated that he would 
offer a further opportunity to make comments on that  material.  Since that meeting, the Council had 
received additional information from the Africa n Regional Intellectual Property Organization 
(ARIPO) (IP/C/W/549/Add.6).   
220. As regards notifications of contact points for technical cooperation on TRIPS, since the 
Council meeting in October, updates to contact poi nts notified earlier had been received from the 
European Union and Korea.   
221. As regards LDC needs assessments, he recalle d that paragraph 2 of the TRIPS Council's 2005 
decision on the "Extension of the Transition Peri od under Article 66.1 for Le ast-Developed Country 
Members" provided that "with a view to facilitatin g targeted technical and financial cooperation 
programmes, all the least-developed country Me mbers will provide to the Council for TRIPS, 
preferably by the 1 January 2008, as much inform ation as possible on their individual priority needs 
for technical and financial cooperation in order to assist them taking steps necessary to implement the 
TRIPS Agreement".  To date, such information had been received from five Members, namely Sierra 
Leone, Uganda, Bangladesh, Rwanda and Tanzania.  At the Council's last meeting, Rwanda had 
complemented its earlier needs assessment with th e proposed Rwanda Development and IP Capacity 
Building Project which intended to translate the needs assessment iden tified into a concrete technical IP/C/M/65 
Page 40  
 
  assistance project (IP/C/W/548/Add.1).   The needs assessment of Tanzania had also been presented 
to the Council's last meeting (IP/C/W/552).  
222. He urged those least-develope d country Members that had not yet provided information on 
their individual priority needs for tec hnical and financial cooperation to do so. 
223. The Council took note
 of the information provided and agreed  to revert to the matter at its 
next meeting.  
L. LETTER FROM THE CHAIR OF THE GENERAL COUNCIL CONCERNING WAYS TO IMPROVE THE 
TIMELINESS AND COMPLETENESS OF NOTIFICATIONS AND OTHER INFORMATION FLOWS  
224. The Chairman  recalled that, at its past five meeti ngs, the Council had had on its agenda the 
letter from the Chair of the General Council concerning ways to improve the timeliness and 
completeness of notifications and ot her information flows in the area of its responsibility.  In order to 
facilitate the Council's consideration of this issue,  the Secretariat had presented to the October 2009 
meeting a factual background note IP/C/W/543 it ha d prepared at the Council's request that 
summarized the relevant procedures and provided in formation on the use of these procedures, as well 
as contained suggestions on how to improve the tr ansparency and user-friendliness of the notification 
system.  Furthermore, the Secretariat had orally re ported on further developments  in this area.  Those 
delegations that had spoken on this issue had s upported the suggestions contained in that note to 
improve the transparency of the system, and had encour aged the Secretariat to pursue this task.  At its 
last meeting, the Council had agreed to revert to  this agenda item at the present meeting so as to 
provide Members a further opportunity to share an y comments they might have on the matter, and 
also to allow the Secretariat to  inform the Council on any further enhancements to its services 
improving the transparency and user-fri endliness of the notification system. 
225. The representative of the Secretariat  said that the basis of the wo rk in this area remained the 
framework for notifications established by the decisions  of the Council.  The specific steps to improve 
the timeliness and completeness of notifications and other information flows, in response to the letter 
from the Chair of the General Council, had proceed ed in the light of the document commissioned by 
this Council (IP/C/W/543), and the Council's review of  that document.  Significant progress had been 
made in improving the transparency and user-frie ndliness of the notification system, but much work 
still needed to be done.  So far, some key step s included the establishment of a joint portal for 
notification, created with the indispensable coope ration and support of WIPO ; the implementation of 
a Members' transparency toolkit;  and the inco rporation of notified materials and notification 
procedures into technical cooperation activities.   
226. Document IP/C/W/543 had reported a very high ra te of coverage of laws provided in initial 
notifications to the Council, but a more mixed reco rd for subsequent notifications of new laws and 
amendments introduced since the original notification had been made.  The improved system for providing notifications, including the implementation of the portal and incorporation of that element 
into regular technical cooperation activities, see med to have helped Members in updating their 
notifications, and had simplified and streamlined the flow of documentation, especially since the 
WIPO-WTO common portal became fully operational. 
227. The most recent development had been the pr esentation of the two contact point lists 
established under Articles 67 and 69 in the form of a drop down list, to make that valuable practical 
information more accessible than the paper based fo rmat which had been difficult to access and to use 
in a routine manner.  That was a small, but signifi cant, step towards the stat ed objective of making the 
remarkable body of valuable practical informati on that was embedded in 15 years of notifications 
more readily accessible and therefore put more system atically to use to serve the beneficial purpose  IP/C/M/65 
 Page 41 
 
 
  for which it was designed.  He said that he was hopefu l that when he would report back to the Council 
under the Chairman's successor, he would have further practical steps to outline.   
228. The Chairman  suggested that the Council agree to re vert to this agenda item at its next 
meeting so as to provide Members a further opport unity to share any comments they might have on 
the matter, and also to allow the Secretariat to in form the Council of any further enhancements to its 
services improving the transparency and user-friendliness of the notification system.   
229. The Council took note  of statements made and so agreed . 
M. INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO 
230. The Chairman  recalled that, under this agenda item, in formation had usually been provided in 
relation to new accessions to the WTO and developmen ts in the area of dispute settlement, as well as 
about acceptances of the recent TRIPS amendment.  He  said that he had already provided information 
on acceptances of the TRIPS amendment under item F, and on this occasion he had no other new 
developments to report in these areas. 
N. OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS  
231. The Chairman  said that the list of 15 pending requests for observer status in the TRIPS 
Council by other intergovernmental organizations was contained in document IP/C/W/52/Rev.12.  
Although the Council had recently made some progress on two requests, it had not been able to reach consensus on the other requests.  At its last mee ting, the Council had requested him to continue his 
consultations on the matter.  These had focused on th e two issues that the Council had discussed at its 
last meeting, namely the suggestion that the CBD Secretariat be invited to the Council's meetings on 
an ad hoc meeting-by-meeting basis;  and the suggestion that the ad hoc meeting-by-meeting 
invitations to the secretariats of ARIPO and OAPI be converted into a permanent observer status.  
Unfortunately, he was not in a position to report any new thinking in respect to those issues. 
232. The representative of Brazil
 said that her delegation was in favour of all pending requests for 
observer status, but there was one particular case, the CBD request, which had been presented a long time before.  She could not understand why the obser ver status of the CBD had been denied by one 
delegation. 
233. The representative of Bangladesh, speaking on behalf of the LDC Group
, endorsed the views 
of Brazil.  He considered that the same treatment offered to AR IPO and OAPI should be applied to 
other organizations and suggested to grant them observer status on an ad hoc meeting-by-meeting 
basis until the Council agreed on criteria to apply. 
234. The representative of Ecuador  endorsed the views of Brazil a nd Bangladesh and reiterated his 
view that the CBD Secretariat should be recognized as an observer, at least on an on-going basis until 
permanent status could be granted. 
235. The representative of India  said that his delegation supported the statements made by Brazil, 
Bangladesh and Ecuador.  There was a strong linka ge between TRIPS and CBD and therefore the 
presence of the CBD Secretariat in the TRIPS Council would be a great benefit to WTO Members.  
He therefore strongly supported the CBD request. 
236. The representative of Angola  endorsed the position of the LDC Group and other countries.  
The treatment granted on a meeting-by-meeting basi s to ARIPO and OAPI should be extended to the 
CBD.  He recalled that there was a pending issue in  the Council relating to the relationship between IP/C/M/65 
Page 42  
 
  the TRIPS Agreement and the CBD.  The Council shoul d remain a technical body and he considered 
particularly useful to give an opportunity to the CBD Secretariat to make comments. 
237. The representative of China
 supported the views expressed regarding the pending requests.  
The relevance of the CBD Secretariat to the C ouncil was obvious and she did not see any substantial 
reason to oppose the observer status of the CBD Secret ariat.  It should be granted observer status at 
least on an ad hoc basis.  
238. The representative of Peru  endorsed the views of Brazil, Bangladesh, India and China.  The 
15 applications made by various organizations we re of equal importance.   They could make a 
significant contribution to the work of the Council.  However,  the application made by the CBD 
Secretariat was particularly relevant.  His dele gation did not see any reason why the CBD could not 
participate on an ad hoc basis.  Its participa tion would be quite valuable.  The CBD was very 
important in terms of intellectual pr operty.  It would be very useful for all Members to have first-hand 
information which could be provided by the CBD Secret ariat with respect to the system used in that 
forum.  He therefore supported the request made by the CBD Secretariat to ach ieve an observer status 
on an ad hoc basis.  He appealed to Members for flexibility and understanding. 
239. The representative of Indonesia  said that the adoption of the CBD Nagoya Protocol had made 
it more relevant for the Council to discuss the re lationship between the TRIPS Agreement and the 
CBD.  He believed that it was high time to grant observer status to the CBD Secretariat as this 
organization was quite relevant to discussions in th e Council.  Allowing the CBD Secretariat to take 
part in the Council's meetings would not impair but rather enrich the discussions and widen the 
Council's perspective. 
240. The representative of Nigeria, speak ing on behalf of the African Group , supported the 
admission of the CBD Secretariat as an observer  on a meeting-by-meeting basis.  He also reiterated 
his position that the two TRIPS implementing bodies in Africa, i.e. ARIP O and OAPI, should be 
granted a permanent observer status.  He did not see any reason why such a decision would not be adopted right away. 
241. The representative of Kenya
 endorsed the statement made by Nigeria on behalf of the African 
Group.  The CBD Secretariat should be granted ob server status and the two African regional IP 
organizations should be gr aduated from ad hoc observers to perman ent status since all of them had a 
useful role to play in the Council. That notwith standing, he did not have any problem with the 
admission, as observers, of all the organiza tions listed in document IP/C/W/52/Rev.12. 
242. The representative of Zimbabwe  joined those who had advocated for the admission of the 
CBD Secretariat on an ad hoc basis.  He also supported the position of the African Group regarding 
ARIPO and OAPI.  
243. The representative of the United States  said that he had no objection to granting permanent 
observer status to ARIPO and OAPI.  He said that  he would refer the views expressed concerning the 
CBD Secretariat to capital.  However, he could not  join the Members seeki ng to include the CBD as 
an observer either on a permanent or on an ad hoc basis at that time. 
244. The representative of Egypt  said that his delegation's positi on was well known.  He welcomed 
OAPI and ARIPO as ad hoc observers on a meeting-by -meeting basis.  All pending requests should be 
dealt with equally. 
245. The Chairman  said that the Council seemed unable to achieve consensus on either of the two 
specific proposals that had been made.  He theref ore suggested that that his successor continue 
informal consultation on these points.    IP/C/M/65 
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  246. The representative of Brazil  said that, for clarification, he wished to know if there were any 
objections, apart from the United States to the CBD  case, to the granting of observer status on a case-
by-case, meeting-by-meeting basis to other organiza tions.  He understood that the delegation of Egypt 
would like to see other delegations also being granted a permanent observer status.   
247. The representative of Egypt  said that he welcomed giving OAPI and ARIPO ad hoc observer 
status on a meeting-by-meeting basis.  All the othe r organizations should be dealt with on the same 
basis as OAPI and ARIPO.  After that, the Council c ould discuss giving permanent observer status to 
all the organizations. 
248. The representative of Nigeria, speaking on behalf of the African Group , thanked the United 
States for its favourable response to the request by  ARIPO and OAPI.  He also urged Members to 
look at document IP/C/W/549/Add.6, which gave a clear indication of the activities being undertaken 
by ARIPO.  He suggested that the Chair continue consultations to see if c onsensus could be reached. 
249. The Chairman  suggested that the Chair consult on the issue of observer status for 
international intergovernmental orga nizations.  He said that the cons ultations could cover an ad hoc 
observer status for the CBD, a permanent observer status for ARIPO and OAPI, and the consideration 
of ad hoc meeting-by-meeting observer status for other organizations on the list.   
250. The Council took note  of statements made and so agreed . 
O. OTHER BUSINESS  
251. The Chairman  recalled that, at its meeting in June 2010, the Council had agreed to grant an 
ad hoc observer status on a meeting-to-meeting b asis to the African Regional Intellectual Property 
Organization and the African Intellectual Property Orga nization.  He suggested that the Council again 
invite ARIPO and OAPI to attend the Council's next formal meeting on an ad hoc basis. 
252. The Council so agreed . 
P. ELECTION OF THE CHAIRPERSON  
253. The Chairman  recalled that, at its meeting of 22 February 2011, the General Council had 
noted the consensus on a slate of names of chai rpersons for WTO bodies.  On the basis of the 
understanding reached, he proposed that the Council for TRIPS elect H.E. Mr Federico A. González 
from Paraguay as its Chairperson for the coming year by acclamation. 
254. The Council so agreed . 
_______________ IP/C/M/65 
Page 44  
 
   
ANNEX 
 
 
 At the request by the delegation of Canada, the text it submitted at the Director-General's 
informal consultations on 17 Fe bruary 2011 is reproduced below. 
  
_______________ 
  
MISAPPROPRIATION OF GENETIC RESOURCES 
  There is no universally accepted definition fo r the concept of misappropriation of genetic 
resources (GR); this is also true in Canada.  A pa tent application contains claims outlining the subject 
matter for which protection is being sought, a descr iption which teaches the invention and optionally 
drawings and/or sequence listings, depending if they are required for the disclosure of the invention. 
Patent applications concerning an invention which includes biological material has additional requirements for the description.  A deposit, as of th e filing date, of a sample of biological material 
associated with the invention may, in some, but not all cases, be required for the description to 
sufficiently disclose the invention. 
 
 Patent applications can be submitted electroni cally or in hard copy.  An applicant must 
request an examination within five years of f iling a patent application.  Once a request for 
examination is filed (and the associated fee is paid), the application is transferred to the examiner who 
is the expert in the field of the subject matter.  Examiners review the claims, description and drawings 
to verify they conform to the Patent Act and Rules.   A search is carried out to identify any relevant 
prior art (generally, written documentation that sh ows that what is being claimed is not novel or 
obvious).  The application is examined in view of  the criteria of novelty, obviousness, support, utility, 
patentable subject matter, and general complianc e with the Canadian Patent Act and Rules and 
jurisprudence.  
 Canada has no specific government-level rules for patents for inventions based on genetic 
resources and associated traditional knowledge (TK).  There are, also, no specific patent practices for 
the processing of applications involving genetic  resources and traditional knowledge.  However, 
under section 34 of the Patent Act and as further provided for in chapter 18 of the Canadian 
Intellectual Property Office's (CIPO) Manual of Pate nt Office Practice, any person may file prior art 
with the Commissioner of Patents, and protest against the granting of a patent.  Any prior art material 
so submitted becomes part of the file of the application.   Patent applications involving genetic resources are treated by the same process and assessed 
using the same criteria as any other patent application.   In Canada, there are no distinct or specialized 
approaches for search and examination of invent ions based on genetic resources and associated 
traditional knowledge. Furthermore, Canadian pate nt examiners do not necessarily concentrate or 
restrict their searches to particular areas of t echnology, but rather tailor their searches to suit the 
subject matter covered by the patent application.  The success of these searches has more to do with 
the availability of prior art sources and database s than with disclosure of the source country.  
 
 Of note, the focus on greater access for IP offi ces to digital libraries of genetic resources such 
as India's Traditional Knowledge Digital Library (TKDL) has proved to be a practical way of 
protecting GR and TK within the patent system.  Having greater database access helps examiners in determining what is traditional knowledge, howev er, any references obtained from these sources must 
be able to be made available to the applicant in order for them to be citable under Canadian Patent  IP/C/M/65 
 Page 45 
 
 
  Law (i.e., secret information can not be used as a ba r to patentability).  The selection of the database 
for a given search is the decision of the examiner.  CIPO notifies the Council of Scientific & Industrial Research (CSIR), the TKDL provider, of  the number of times documents from the database 
are cited by examiners as prior art.  The Canadi an Patent Act allows for third-party protests and 
submissions of prior art.  Prior art submissions from TKDL, as with any other public database, are 
acceptable under these provisions.  
  The current system by which different types of patents are categorized and classified does not allow for patents to be identified according to whethe r they contain a claim to genetic or biological 
material.  Furthermore, there are no means for an ex aminer to verify whether the source or origin of 
material, as identified by the applicant, is accurate.    
  Since genetic resources do not stop at nationa l borders, limiting prior art searches to any 
given source country would be counterproductive and may overlook relevant prior sources located in 
other countries.  Rather, Canadian patent examiner s perform broader searches according to the subject 
matter;  chapter 17 of the Manual of Patent O ffice Practice provides comprehensive guidelines on 
biotechnology, including as regards novelty.   
__________